chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the local health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 1.0
Sex: F
Vaccine: UNK, UNK, UNK
Symptoms: Discomfort, Hypersensitivity, Pyrexia, Urticaria
Clinical narrative: Hives on both legs in entirety - thighs, knees, calves, and feet.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. THE HCF is working with the local health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This report is related to a deviation from recommended CDC COVID vaccine dosing guidelines; the patient has not suffered any adverse events as of the time of this report.  The patient received her first dose of Pfizer on 12/12/2021. She did not receive the second dose in her primary Pfizer series. The mother of the child requested that the patient receive Moderna today and restart her primary series with Moderna rather than Pfizer, as Moderna has higher efficacy and was not available for her child's age group at the time of her first vaccination. She is making this request due to a desire for the increased efficacy of Moderna compared to Pfizer.  Discussed with medical director, decision made to allow mother of child to restart patient's primary series with Moderna. Discussed with mother of child that this is a deviation from the CDC recommendations and, as a result, there is limited data on effectiveness or risks when changing from the standard schedule. Mother of child acknowledges the above, and decides to proceed with Moderna vaccination today.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question.  Healthcare is working  on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 35.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Induration, Injection site streaking, Pruritus
Clinical narrative: Monkeypox vaccine #2,  awoke in AM with radiating induration, itch and 1 streak from forearm to upper arm
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Agency consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the DPHE on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, No adverse event
Clinical narrative: I did not have an adverse reaction to the vaccination. I contracted Covid-19 a little over 2 months from my 4th dose of the vaccine.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. HCF consulted with the local Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. The HCF is working with the local health dept. on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare facility consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: On the 7/10/2022 had a harsh sore throat. Took a home COVID-19 test and it was negative. Then on 07/11/2022 had brain fog along with sore throat. Home tested again on 07/12/2022 and it was positive. Had a telehealth appointment with physicians at the local medical center and was prescribed PAXLOVID. COVID-19 home test negative. Tested neg on 07/20.
Age: 36.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received vaccination 7 days prior to the scheduled dosing date.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine stored beyond 30 days recommended in the refrigerated state. Event reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. It was recommended repeating this dose. Patient sent a letter to inform them of the need to repeat the dose. We are working on a compliance improvement plan. Reinstated vaccination privileges.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated and boosted once.   COVID breakthrough infection
Age: 66.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Chills, Discomfort, Pyrexia
Clinical narrative: Patient started experiencing shivering around 4 pm, a fever of 105 degrees farenheit at around 6 pm, and feeling of pressure going from his legs to the feet.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Enlarged lymph nodes in groin
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient confirms she was fine prior to the injection. Injection done in the left arm but having pain in the right-side, which prevents her from lifting her right arm properly.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient developed a rash around and near injection site a few days after vaccine administration. Patient went to the urgent care where she was prescribed cephalexin.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine stored beyond 30 days recommended in the refrigerated state. Event reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. It was recommended repeating this dose. Patient sent a letter to inform them of the need to repeat the dose. We are working on a compliance improvement plan. Reinstated vaccination privileges.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles to right upper chest, shoulder, ear and neck Treated with Valtrex, Lyrica, calamine and silvadene cream.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working  on a compliance improvement plan and has been reinstated vaccination privileges.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received a vaccine stored beyond 30 days recommended in the refrigerated state. Event reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. It was recommended repeating this dose. Patient sent a letter to inform them of the need to repeat the dose. We are working on a compliance improvement plan. Reinstated vaccination privileges.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: A SHOT WAS ADMINISTERED A DAY PAST BUD. No adverse drug reactions were noted.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered one day past BUD.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Headache, Nausea
Clinical narrative: Patient, 34-year-old female, arrived to the vaccine clinic nervous and was received by registration. Patient then proceeded to the vaccinations area and the team noticed nervous and she mentioned she was scared and nervous when siting down to receive her first Moderna vaccine at 5:24pm. She stood up and walked to the exit table and mentioned she needed to sit down as she felt lightheaded. After 10 seconds she walked out to the observation area, then came back in complaining about dizziness. As we were approaching to sit her down, she had a nursincuple episode, so we assisted her to the ground. It took her a couple of minutes to be able to fully open her eyes, but she was responsive, no acute shortness of breath and she had pulpable pulses in the low 70s, at the time it was a bit clammy to bilateral upper extremities. As symptoms recovered, she continued to have slight headache, complaining of bilateral paresthesia to the hands and we tried to slow down her breathing, but respiratory rate was in the 20s. After a few minutes we attempted to sit her up while she was still on the ground and gave her some water, she became lightheaded again, a little bit nauseated again and felt like she needed to lay down, so she did. We waited another several minutes and she stared to feel improved, still having a little bit of paresthesia bilateral hands and we sat her up a second time and got her into a chair. Her husband arrived, as she had arrived by herself and developed lightheadedness, recurring nausea again and generalized weakness, so we placed her back to the ground and felt like her symptoms were not improving but not necessary getting worse. At that time, we called 911, EMS arrived at 6:10pm and did an evaluation and blood pressure was normal, 140s/x, heart rates were in the 80 but continued to have lightheaded and generalized weakness. EMS did orthostatics on her and assessment on her and did not feel like she was not having a severe allergic reaction to the vaccine. Patient opted to go home versus transported to the hospital. Continued to have some generalized weakness and lightheadedness. Departed at 6:30pm. No medical history and not on medications at all, ate today and drinks lot of fluids.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Syncope
Clinical narrative: Patient, 34-year-old female, arrived to the vaccine clinic nervous and was received by registration. Patient then proceeded to the vaccinations area and the team noticed nervous and she mentioned she was scared and nervous when siting down to receive her first Moderna vaccine at 5:24pm. She stood up and walked to the exit table and mentioned she needed to sit down as she felt lightheaded. After 10 seconds she walked out to the observation area, then came back in complaining about dizziness. As we were approaching to sit her down, she had a nursincuple episode, so we assisted her to the ground. It took her a couple of minutes to be able to fully open her eyes, but she was responsive, no acute shortness of breath and she had pulpable pulses in the low 70s, at the time it was a bit clammy to bilateral upper extremities. As symptoms recovered, she continued to have slight headache, complaining of bilateral paresthesia to the hands and we tried to slow down her breathing, but respiratory rate was in the 20s. After a few minutes we attempted to sit her up while she was still on the ground and gave her some water, she became lightheaded again, a little bit nauseated again and felt like she needed to lay down, so she did. We waited another several minutes and she stared to feel improved, still having a little bit of paresthesia bilateral hands and we sat her up a second time and got her into a chair. Her husband arrived, as she had arrived by herself and developed lightheadedness, recurring nausea again and generalized weakness, so we placed her back to the ground and felt like her symptoms were not improving but not necessary getting worse. At that time, we called 911, EMS arrived at 6:10pm and did an evaluation and blood pressure was normal, 140s/x, heart rates were in the 80 but continued to have lightheaded and generalized weakness. EMS did orthostatics on her and assessment on her and did not feel like she was not having a severe allergic reaction to the vaccine. Patient opted to go home versus transported to the hospital. Continued to have some generalized weakness and lightheadedness. Departed at 6:30pm. No medical history and not on medications at all, ate today and drinks lot of fluids.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Chest discomfort, Chest pain, Electrocardiogram ST segment depression, Electrocardiogram T wave abnormal, Electrocardiogram abnormal
Clinical narrative: Woke up the next morning with chest pain and palpitations and chest tightness Came to office, normal exam and vitals. EKG ordered and abnormal. recommend going to ER
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Left ventricular hypertrophy, Palpitations, Right atrial enlargement
Clinical narrative: Woke up the next morning with chest pain and palpitations and chest tightness Came to office, normal exam and vitals. EKG ordered and abnormal. recommend going to ER
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain, Wrong product administered
Clinical narrative: the 4 year old patient accidentally received 2 doses of varicella vaccine -he was supposed to get proquad and kinrix - instead he initially got varicella separately (accidentally) and kinrix. the medical assistant noticed this after patient left, called family back to administer the MMR, but accidentally gave Proquad (so MMR and Varicella) instead of MMR alone -patient has are soreness but no other symptoms - this VAERS report is being submitted 2 hours after vaccine administeration
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: ITCHING,RASH AND HIVES ON THE BACK,UNDER ARM, LEGS...SYMPTOMS COME AND GO
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test abnormal, Chest pain, Epstein-Barr virus infection, Epstein-Barr virus test positive
Clinical narrative: Shingles and Epstein Barr virus activation (w normal white blood cell for some reason). Pain (stabbing right chest through to back) started and shingles rash appeared a few days later, as confirmed by Emergency Room doctor. Positive EBV blood test after a few weeks of extreme fatigue.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Herpes zoster, Rash, White blood cell count normal
Clinical narrative: Shingles and Epstein Barr virus activation (w normal white blood cell for some reason). Pain (stabbing right chest through to back) started and shingles rash appeared a few days later, as confirmed by Emergency Room doctor. Positive EBV blood test after a few weeks of extreme fatigue.
Age: 31.0
Sex: F
Vaccine: UNK
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Longer, heavier, more painful periods
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Cardiovascular symptom, Chest pain, Magnetic resonance imaging abnormal
Clinical narrative: Received both doses (1st Jan 2021 and 2nd Feb 2021) of Covid vaccine. Developed chest pain and other cardiac symptoms resulting in a diagnosis of pericarditis and pleurisy in July of 2021 which lead treatment. Developed severe/debilitating hip pain July 2021 resulting in diagnosis 3 months later of diagnostic testing of Avascular Necrosis. Prognosis concluded total joint replacement required on bilateral hips (R 12/20/21 & L 5/20/22) Developed severe knee pain on Dec. 2021 resulting in more diagnostic testing with concluding AVN in bilateral knees requiring joint placement. Left shoulder pain developed in 05/2022 resulting in diagnostic testing concluding avascular necrosis which will also need total joint replacement. Attempted core decompression to left knee on 08/05/22 to relieve severe pain with no success noted at this time.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Osteonecrosis, Pericarditis, Pleurisy, Surgical failure
Clinical narrative: Received both doses (1st Jan 2021 and 2nd Feb 2021) of Covid vaccine. Developed chest pain and other cardiac symptoms resulting in a diagnosis of pericarditis and pleurisy in July of 2021 which lead treatment. Developed severe/debilitating hip pain July 2021 resulting in diagnosis 3 months later of diagnostic testing of Avascular Necrosis. Prognosis concluded total joint replacement required on bilateral hips (R 12/20/21 & L 5/20/22) Developed severe knee pain on Dec. 2021 resulting in more diagnostic testing with concluding AVN in bilateral knees requiring joint placement. Left shoulder pain developed in 05/2022 resulting in diagnostic testing concluding avascular necrosis which will also need total joint replacement. Attempted core decompression to left knee on 08/05/22 to relieve severe pain with no success noted at this time.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Pulmonary embolism, Renal disorder, Thrombectomy
Clinical narrative: Saddle pulmonary embolism which lead to loss of a kidney
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vena cava filter insertion, Vena cava filter removal
Clinical narrative: Saddle pulmonary embolism which lead to loss of a kidney
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Paraesthesia, Syncope
Clinical narrative: Approximately 10 min after receiving a Moderna vaccination, patient experienced syncope and passed out for a few seconds. When he regained consciousness he said he felt lightheaded, sweaty, and arms felt tingly. Asked patient how his breathing was, he said it was fine. We gave him a bottle of water, which he drank. Started feeling better. He remained sitting on floor. Blood pressure 10 minutes after syncope: 96/60. Patient said he remembers passing out in the 4th grade after receiving a vaccination. He said his blood pressure always runs low. We had him remain sitting for another 15 minutes. He said he felt much better, so we had him stand up and sit in a chair. No dizziness. We offered to call his family but patient did not feel it was necessary.  One hour after receiving vaccination patient said he felt perfectly fine and left pharmacy.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: When I left Pharmacy and got in my car after the first vaccine, the left side of my face went numb for 3 hrs. The second shot it went numb for one hr. The first booster it went numb and has stayed numb.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Tremor
Clinical narrative: Patient with no previous immunization allergy or contraindications had a serious adverse reaction the following day at their home. She called the pharmacy and spoke to me about having a reaction that sounded almost like hypoglycemia--shaking, irritability, inability to sleep, etc. I instructed her to go to the ER immediately. She was treated for an allergic reaction to the vaccine and sent home. Will follow up with patient on next shift.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt felt lightheaded and passed out for a few seconds 3-4 minutes after vaccination
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Disorientation, Fall, Haematoma, Skin laceration
Clinical narrative: Patient went back to work after receiving his second Moderna shot. He works remotely from his desk from home.  He stood up at his desk and fell on the floor.  When he awoke, he had a hemotoma and cut on his right face and top of head.  He was disoriented and I offered to take him to the ER.  His tongue had been bitten down on by his jaw teeth and left a huge open gash wound the length of his tongue. I wanted to have his tongue sewn back together it was that deeply cut through on his tongue. Date of Death: 09-22-2021
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue biting, Tongue injury
Clinical narrative: Patient went back to work after receiving his second Moderna shot. He works remotely from his desk from home.  He stood up at his desk and fell on the floor.  When he awoke, he had a hemotoma and cut on his right face and top of head.  He was disoriented and I offered to take him to the ER.  His tongue had been bitten down on by his jaw teeth and left a huge open gash wound the length of his tongue. I wanted to have his tongue sewn back together it was that deeply cut through on his tongue. Date of Death: 09-22-2021
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest discomfort, Oedema peripheral, Tenderness
Clinical narrative: Left breast pain x 2 days, left axillary swelling/tenderness x 1 day, chest heaviness x 1 day
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: She developed redness, swelling, induration, heat, and itching. The swelling measured about 4x3 inches. She was given Tylenol and Benadryl. The swelling increased from 8/10 to 8/11. It lingered for 4-5 days.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Tremor
Clinical narrative: She felt light headed and then passed out, she had some shaking at that time. She had some shaking at that time. She is feeling better now.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Headache and vomiting after Covid vaccine
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: DTAP vaccine was expired at time of administration. Patient will return to receive up to date vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Anxiety, Depression, Fatigue, Social avoidant behaviour
Clinical narrative: patient is an obese male otherwise previously healthy, and received COVID vaccines on 8/10/2021 and 8/31/2021. Parents started noticing patient's worsening behavior--disorganized, depression (more withdrawn), more tired, more anxiety (admitted to mental health inpatient unit from 2/18-2/22)--and followed up with clinic since December 2021.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received Moderna Covid vaccine 6m-5y in our office today in error: Given 0.25 mL 6/18/2022 IM LEFT LATERAL Moderna AS1412B. The patient previously received the following: COVID-19 6M-4Y Pfizer-BioNtech 6/23/2022 Given 0.2 mL 6/16/2022 IM LEFT LATERAL Pizer FT9142
Age: 74.0
Sex: M
Vaccine: RAB
Symptoms: Wrong product administered
Clinical narrative: Rabies immune globulin 300 units/1 mL given intramuscularly when the order was for Rabies Vaccine 1 mL given intramuscularly
Sex: F
Vaccine: PNC20
Symptoms: Fatigue, Gastrointestinal disorder, Impaired work ability, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: I received the Prevnar pneumonia vaccine on 8/10/22. By that evening, I had arm pain, which I expected. By 8/11/22, I could not lift my left arm, my entire arm including my fingers were tingling, along with facial tingling. , I had a fever and extreme fatigue to the point I could not get out of bed. Gastrointestinal issues for 3 days, and I missed a day of work. And I was unable to function normally because the fatigue lasted until 8/14/22. I am immune compromised, as I have Lupus, Sjorgens and Ankliosing Spondylitis. My Doctor highly recommended that I get this vaccine based on my diagnosis. I felt this was odd because I don't suffer from neuropathy at all. The Prevnar by Pfizer was from Lot # FJ2605
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Paraesthesia, Paraesthesia, Pyrexia
Clinical narrative: I received the Prevnar pneumonia vaccine on 8/10/22. By that evening, I had arm pain, which I expected. By 8/11/22, I could not lift my left arm, my entire arm including my fingers were tingling, along with facial tingling. , I had a fever and extreme fatigue to the point I could not get out of bed. Gastrointestinal issues for 3 days, and I missed a day of work. And I was unable to function normally because the fatigue lasted until 8/14/22. I am immune compromised, as I have Lupus, Sjorgens and Ankliosing Spondylitis. My Doctor highly recommended that I get this vaccine based on my diagnosis. I felt this was odd because I don't suffer from neuropathy at all. The Prevnar by Pfizer was from Lot # FJ2605
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Eye irritation, Injection site pain, Injection site pruritus, Pruritus
Clinical narrative: She got her vaccine, she started with a red swelling on her left arm, and then a rash that broke out that moved to both arms, and it was whelps, itching and bumps on her arms and legs.   She called and reported it to the pharmacy where she got her vaccine, told her if it did not get any better, which she did.  She saw them, recommended for her to see a dermatologist and has been going to them ever since.  She was given a steroid shot and some steroid cream.  Then it did not get any better, went back and had biopsy done of one of the areas, was put on steroid pills which she took for a month and it cleared up.  Once the steroids were out of her system she broke out again.  Went back and was put on Hydroxychloroquine and then tested positive for COVID on 7/13/22 and after a week the rash came back.  She has to go back to the dermatologist today for the reaction again.    Dermatologist.    It's almost a year and she is still having this issue, and has scars from the rashes, and cannot figure out what is causing this rash and what to do and it is almost unbearable.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Blood test, COVID-19, Erythema, Peripheral swelling
Clinical narrative: She got her vaccine, she started with a red swelling on her left arm, and then a rash that broke out that moved to both arms, and it was whelps, itching and bumps on her arms and legs.   She called and reported it to the pharmacy where she got her vaccine, told her if it did not get any better, which she did.  She saw them, recommended for her to see a dermatologist and has been going to them ever since.  She was given a steroid shot and some steroid cream.  Then it did not get any better, went back and had biopsy done of one of the areas, was put on steroid pills which she took for a month and it cleared up.  Once the steroids were out of her system she broke out again.  Went back and was put on Hydroxychloroquine and then tested positive for COVID on 7/13/22 and after a week the rash came back.  She has to go back to the dermatologist today for the reaction again.    Dermatologist.    It's almost a year and she is still having this issue, and has scars from the rashes, and cannot figure out what is causing this rash and what to do and it is almost unbearable.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test positive, Scar, Urticaria
Clinical narrative: She got her vaccine, she started with a red swelling on her left arm, and then a rash that broke out that moved to both arms, and it was whelps, itching and bumps on her arms and legs.   She called and reported it to the pharmacy where she got her vaccine, told her if it did not get any better, which she did.  She saw them, recommended for her to see a dermatologist and has been going to them ever since.  She was given a steroid shot and some steroid cream.  Then it did not get any better, went back and had biopsy done of one of the areas, was put on steroid pills which she took for a month and it cleared up.  Once the steroids were out of her system she broke out again.  Went back and was put on Hydroxychloroquine and then tested positive for COVID on 7/13/22 and after a week the rash came back.  She has to go back to the dermatologist today for the reaction again.    Dermatologist.    It's almost a year and she is still having this issue, and has scars from the rashes, and cannot figure out what is causing this rash and what to do and it is almost unbearable.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basal cell carcinoma, Deafness, Malignant melanoma, Tinnitus
Clinical narrative: had a basal cell on her face; got melanoma on her arm; hearing loss in the left hear and tinnitus sounds; hearing loss in the left hear and tinnitus sounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT number: EL3247, Expiry date: 21May2021), for COVID-19 immunization, reaction(s): "she was hauled off, they thought she had a TIA, which she did not and that may not have been related". The following information was reported: BASAL CELL CARCINOMA (medically significant), outcome "unknown", described as "had a basal cell on her face"; MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "got melanoma on her arm"; DEAFNESS (medically significant), TINNITUS (non-serious), outcome "unknown" and all described as "hearing loss in the left hear and tinnitus sounds". The events "had a basal cell on her face", "got melanoma on her arm" and "hearing loss in the left hear and tinnitus sounds" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Clinical course: With the second COVID-19 Vaccine she got melanoma on her arm. This was a three weeks difference. Then she had a basal cell on her face. She also experienced immediate hearing loss in the left hear and tinnitus sounds. Think COVID-19 Vaccine did something to her system or else wouldn't have gotten the melanoma. When she was a little kid, her mother took her out in the sun, she's very fair, and she burnt terribly. Thinks there's something about the COVID-19 Vaccine that pushed out those two forms of cancer: melanoma on her arm, and the basal cell on her face.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201057776 Same reporter/patient/ product and different dose/event;
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basal cell carcinoma, Deafness, Malignant melanoma, SARS-CoV-2 test, Tinnitus
Clinical narrative: had a basal cell on her face; got melanoma on her arm; hearing loss in the left hear and tinnitus sounds; hearing loss in the left hear and tinnitus sounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT number: EL3247, Expiry date: 21May2021), for COVID-19 immunization, reaction(s): "she was hauled off, they thought she had a TIA, which she did not and that may not have been related". The following information was reported: BASAL CELL CARCINOMA (medically significant), outcome "unknown", described as "had a basal cell on her face"; MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "got melanoma on her arm"; DEAFNESS (medically significant), TINNITUS (non-serious), outcome "unknown" and all described as "hearing loss in the left hear and tinnitus sounds". The events "had a basal cell on her face", "got melanoma on her arm" and "hearing loss in the left hear and tinnitus sounds" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Clinical course: With the second COVID-19 Vaccine she got melanoma on her arm. This was a three weeks difference. Then she had a basal cell on her face. She also experienced immediate hearing loss in the left hear and tinnitus sounds. Think COVID-19 Vaccine did something to her system or else wouldn't have gotten the melanoma. When she was a little kid, her mother took her out in the sun, she's very fair, and she burnt terribly. Thinks there's something about the COVID-19 Vaccine that pushed out those two forms of cancer: melanoma on her arm, and the basal cell on her face.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201057776 Same reporter/patient/ product and different dose/event;
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: had a basal cell on her face; got melanoma on her arm; hearing loss in the left hear and tinnitus sounds; hearing loss in the left hear and tinnitus sounds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, LOT number: EL3247, Expiry date: 21May2021), for COVID-19 immunization, reaction(s): "she was hauled off, they thought she had a TIA, which she did not and that may not have been related". The following information was reported: BASAL CELL CARCINOMA (medically significant), outcome "unknown", described as "had a basal cell on her face"; MALIGNANT MELANOMA (medically significant), outcome "unknown", described as "got melanoma on her arm"; DEAFNESS (medically significant), TINNITUS (non-serious), outcome "unknown" and all described as "hearing loss in the left hear and tinnitus sounds". The events "had a basal cell on her face", "got melanoma on her arm" and "hearing loss in the left hear and tinnitus sounds" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Clinical course: With the second COVID-19 Vaccine she got melanoma on her arm. This was a three weeks difference. Then she had a basal cell on her face. She also experienced immediate hearing loss in the left hear and tinnitus sounds. Think COVID-19 Vaccine did something to her system or else wouldn't have gotten the melanoma. When she was a little kid, her mother took her out in the sun, she's very fair, and she burnt terribly. Thinks there's something about the COVID-19 Vaccine that pushed out those two forms of cancer: melanoma on her arm, and the basal cell on her face.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201057776 Same reporter/patient/ product and different dose/event;
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 041A421A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-MAR-2021 13:00 in left arm for covid-19 prophylaxis. Age at time of vaccination 46 years old. It was unknown if patient experienced any adverse event after covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect vaccine included: Pfizer covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin, were not reported and batch number: EWO185-H and expiry: UNKNOWN) dose was not reported, administered on 15-NOV-2021 13:00 in left arm for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date in JUL-2022 the patient experienced covid-19 infection (dose number in series 2). The patient received non-company suspect Paxlovid (form of admin, route of admin, were not reported and batch number: unknown and expiry: UNKNOWN) dose was not reported, administered from 19-JUL-2022 to 23-JUL-2022 for covid-19 treatment. While taking Paxlovid patient immediately experienced bitter taste in mouth. Patient stopped taking it and the taste in mouth went away. Patient had an extreme overreaction to any food or drink that was bitter, making it wholly inedible. Patient thought it was from the Paxlovid which was still in system (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and Paxlovid was discontinued. The patient recovered from bitter taste in mouth on 23-JUL-2022, had not recovered from extreme over reaction to any food or drink that is bitter, and the outcome of covid-19 was not reported. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adverse food reaction, COVID-19, Dysgeusia
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 041A421A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-MAR-2021 13:00 in left arm for covid-19 prophylaxis. Age at time of vaccination 46 years old. It was unknown if patient experienced any adverse event after covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received non-company suspect vaccine included: Pfizer covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin, were not reported and batch number: EWO185-H and expiry: UNKNOWN) dose was not reported, administered on 15-NOV-2021 13:00 in left arm for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date in JUL-2022 the patient experienced covid-19 infection (dose number in series 2). The patient received non-company suspect Paxlovid (form of admin, route of admin, were not reported and batch number: unknown and expiry: UNKNOWN) dose was not reported, administered from 19-JUL-2022 to 23-JUL-2022 for covid-19 treatment. While taking Paxlovid patient immediately experienced bitter taste in mouth. Patient stopped taking it and the taste in mouth went away. Patient had an extreme overreaction to any food or drink that was bitter, making it wholly inedible. Patient thought it was from the Paxlovid which was still in system (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable and Paxlovid was discontinued. The patient recovered from bitter taste in mouth on 23-JUL-2022, had not recovered from extreme over reaction to any food or drink that is bitter, and the outcome of covid-19 was not reported. This report was non-serious.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Flank pain, Injection site erythema, Injection site swelling, Mass, Pain
Clinical narrative: Red irritated patch at injection site; Red irritated red patch at the injection site; Red irritated red patch at the injection site; pain down her left side; Shoulder to elbow painful; Shoulder to elbow swollen; Pain down her left side all the way to her LEFT thigh; Marshmallow size lump formed on her LEFT thigh; This case was reported by a consumer via call center representative and described the occurrence of swollen joints in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 6th August 2022, 1 hr after receiving Shingrix, the patient experienced swollen joints, pain in extremity, mass, pain and shoulder pain. On 7th August 2022, the patient experienced injection site erythema, injection site rash and injection site irritation. On an unknown date, the outcome of the swollen joints, pain in extremity, mass, injection site erythema, injection site rash, injection site irritation, pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the swollen joints, pain in extremity, mass, injection site erythema, injection site rash, injection site irritation, pain and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comment: The reporter was a patient. The patient received Shingrix vaccine and an hour after experienced her left shoulder to elbow was extremely painful and swollen. The patient had pain down her left side to the left thigh and almost immediately after receiving vaccine marshmallow size lump formed on left thigh and had not resolved. On the next day of received vaccine the patient had red irritated red patch at the injection site and the rash had not resolved. The patient does not had a doctor and had not seen in 20 years. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Refusal of treatment by patient, Tenderness
Clinical narrative: Red irritated patch at injection site; Red irritated red patch at the injection site; Red irritated red patch at the injection site; pain down her left side; Shoulder to elbow painful; Shoulder to elbow swollen; Pain down her left side all the way to her LEFT thigh; Marshmallow size lump formed on her LEFT thigh; This case was reported by a consumer via call center representative and described the occurrence of swollen joints in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 6th August 2022, 1 hr after receiving Shingrix, the patient experienced swollen joints, pain in extremity, mass, pain and shoulder pain. On 7th August 2022, the patient experienced injection site erythema, injection site rash and injection site irritation. On an unknown date, the outcome of the swollen joints, pain in extremity, mass, injection site erythema, injection site rash, injection site irritation, pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the swollen joints, pain in extremity, mass, injection site erythema, injection site rash, injection site irritation, pain and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comment: The reporter was a patient. The patient received Shingrix vaccine and an hour after experienced her left shoulder to elbow was extremely painful and swollen. The patient had pain down her left side to the left thigh and almost immediately after receiving vaccine marshmallow size lump formed on left thigh and had not resolved. On the next day of received vaccine the patient had red irritated red patch at the injection site and the rash had not resolved. The patient does not had a doctor and had not seen in 20 years. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site irritation, Injection site pain, Injection site rash
Clinical narrative: Red irritated patch at injection site; Red irritated red patch at the injection site; Red irritated red patch at the injection site; pain down her left side; Shoulder to elbow painful; Shoulder to elbow swollen; Pain down her left side all the way to her LEFT thigh; Marshmallow size lump formed on her LEFT thigh; This case was reported by a consumer via call center representative and described the occurrence of swollen joints in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 6th August 2022, 1 hr after receiving Shingrix, the patient experienced swollen joints, pain in extremity, mass, pain and shoulder pain. On 7th August 2022, the patient experienced injection site erythema, injection site rash and injection site irritation. On an unknown date, the outcome of the swollen joints, pain in extremity, mass, injection site erythema, injection site rash, injection site irritation, pain and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the swollen joints, pain in extremity, mass, injection site erythema, injection site rash, injection site irritation, pain and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comment: The reporter was a patient. The patient received Shingrix vaccine and an hour after experienced her left shoulder to elbow was extremely painful and swollen. The patient had pain down her left side to the left thigh and almost immediately after receiving vaccine marshmallow size lump formed on left thigh and had not resolved. On the next day of received vaccine the patient had red irritated red patch at the injection site and the rash had not resolved. The patient does not had a doctor and had not seen in 20 years. The reporter did not consent to follow up.