chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I started out being very fatigue with a headache, head cold with congestion. I dealt with this for two days then went to Urgent care.  I tested for COVID-19 and the results were positive. The day I tested my throat was extremely sore. I was prescribed Paxlovid and albuterol inhaler, and Benzonatate. In about five days later I tested negative but to this day I still have congestion.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I started out being very fatigue with a headache, head cold with congestion. I dealt with this for two days then went to Urgent care.  I tested for COVID-19 and the results were positive. The day I tested my throat was extremely sore. I was prescribed Paxlovid and albuterol inhaler, and Benzonatate. In about five days later I tested negative but to this day I still have congestion.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy, Myalgia, Pyrexia, Swelling
Clinical narrative: Arm swelling centered at deltoid, and radiating up to Left lateral neck,  Fever and myalgias.  1 cm supraclavicular node noted on Left (same side as injection).   No angioedema of face, no wheezing, cough, chest pain or SOB.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Headache, Pain, Pyrexia
Clinical narrative: I had a slight fever and achiness with headache and cough. I tested positive for COVID-19 on March 25, 2023. I called and received PAXLOVID for 5 days. On day six I tested negative. As of today, I feel fine but still have a little bit of a cough.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a slight fever and achiness with headache and cough. I tested positive for COVID-19 on March 25, 2023. I called and received PAXLOVID for 5 days. On day six I tested negative. As of today, I feel fine but still have a little bit of a cough.
Age: 71.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Headache, SARS-CoV-2 test positive
Clinical narrative: I had vaccination on 09/20/2022. On 01/16/2023 I tested COVID-19 Negative. On 01/17/2023 I tested COVID-19 Positive. I contacted my physician on 01/18/2023 and prescribed me the Paxlovid. I finished the medication. I tested COVID-19 Positive 3 days after being COVID-19 Negative. I have continuation of my headaches since COVID-19.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 1440 ml instead of 720 ml.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Diarrhoea, Faeces soft, Pyrexia
Clinical narrative: I had a cough, diarrhea  / soft stool.  Wanted to note a low grade fever on the date of vaccination that lasted for a day. My doctor prescribed some Paxlovid and I began taking that evening
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a cough, diarrhea  / soft stool.  Wanted to note a low grade fever on the date of vaccination that lasted for a day. My doctor prescribed some Paxlovid and I began taking that evening
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Started having red dotted rashes appear on my legs. They started itching really bad, so I went to an Urgent Care. The Urgent Care doctor told me that it actually wasn't a rash and to go to the hospital. Went to the Emergency Room and had bloodwork drawn. Didn't find out the results and told to go to my regular doctor on the following monday. My doctor referred me to a Dermatologist, the appointment is 2 months away. Doctor also wants me to see an Infectious Disease doctor, but I'm waiting for Authorization. The rash on my legs started moving up to my thighs.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Temperature excursion
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Myalgia, Oropharyngeal pain
Clinical narrative: I had a sore throat, fever 101.2, chills, muscle aches, and nonproductive cough. I tested positive for COVID-19 at home. I went to the clinic, and they offered me Paxlovid. I was feeling better by then so I decided not to take the Paxlovid.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had a sore throat, fever 101.2, chills, muscle aches, and nonproductive cough. I tested positive for COVID-19 at home. I went to the clinic, and they offered me Paxlovid. I was feeling better by then so I decided not to take the Paxlovid.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: pfizer bivalent booster for 12yrs+ was given to 9yr old patient, no adverse symptoms
Age: 66.0
Sex: F
Vaccine: HEPAB, PNC20, TDAP, VARZOS
Symptoms: Influenza like illness, Neck pain, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm swollen with pain radiating to her neck,  Flu- like symptoms
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Malaise
Clinical narrative: My symptoms started about 12/02/2022. On 12/09/2022 I felt unwell and on 12/12/2022 I tested positive for COVID-19.  I called my PCP but she was not in and so I spoke to another doctor who sent me for a prescription for Paxlovid. I took Paxlovid for five days. I had a sore throat and off and off headaches, fatigue. On 12/09/2022 there was a persistent cough and I felt worsened and unwell generally. I have recovered from my COVID-19 symptoms.  I do not consider this illness an adverse effect of the vaccine. I was not hospitalized.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: My symptoms started about 12/02/2022. On 12/09/2022 I felt unwell and on 12/12/2022 I tested positive for COVID-19.  I called my PCP but she was not in and so I spoke to another doctor who sent me for a prescription for Paxlovid. I took Paxlovid for five days. I had a sore throat and off and off headaches, fatigue. On 12/09/2022 there was a persistent cough and I felt worsened and unwell generally. I have recovered from my COVID-19 symptoms.  I do not consider this illness an adverse effect of the vaccine. I was not hospitalized.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Vertigo, Vomiting
Clinical narrative: I had my vaccination on 03/18/2022. On 12/21/2022 I got very bad vertigo. I am still working through it on 04/12/2023. I am still unsure what is causing it. My eyes were jiggling and I have vomiting dizziness. I saw physical therapist who gave me tips on the Epley Maneuver. I am working on getting referrals to ENT to see if it is something more serious.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Condition aggravated, Depression, Hypertension, Hypoaesthesia
Clinical narrative: Normal muscle pain in the beginning, but now my arms from my shoulder to my elbows is painful, I have had limpedema in my arms but never pain like this. I cant lay on my side. I am going to 2 different places for the arm pain. I cant lift them, reach with them, latch my bra, etc. It is just getting worse and I am seeing 2 different therapists for this pain and I was told that I am not the only one with this issue. Cant Sleep on my side, I am more depressed and don't go out much. Also have neck pain that feels like severe muscle pain. It wakes me up from hollering in my sleep.  Heart Palpitations, I take metropolol and lisinopril High Blood Pressure, Weight gain-14lbs in 32 days.  Also I have numbness in my hands.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Myalgia, Neck pain, Pain in extremity, Palpitations
Clinical narrative: Normal muscle pain in the beginning, but now my arms from my shoulder to my elbows is painful, I have had limpedema in my arms but never pain like this. I cant lay on my side. I am going to 2 different places for the arm pain. I cant lift them, reach with them, latch my bra, etc. It is just getting worse and I am seeing 2 different therapists for this pain and I was told that I am not the only one with this issue. Cant Sleep on my side, I am more depressed and don't go out much. Also have neck pain that feels like severe muscle pain. It wakes me up from hollering in my sleep.  Heart Palpitations, I take metropolol and lisinopril High Blood Pressure, Weight gain-14lbs in 32 days.  Also I have numbness in my hands.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Sleep disorder, Spondylitis, Weight increased, X-ray abnormal
Clinical narrative: Normal muscle pain in the beginning, but now my arms from my shoulder to my elbows is painful, I have had limpedema in my arms but never pain like this. I cant lay on my side. I am going to 2 different places for the arm pain. I cant lift them, reach with them, latch my bra, etc. It is just getting worse and I am seeing 2 different therapists for this pain and I was told that I am not the only one with this issue. Cant Sleep on my side, I am more depressed and don't go out much. Also have neck pain that feels like severe muscle pain. It wakes me up from hollering in my sleep.  Heart Palpitations, I take metropolol and lisinopril High Blood Pressure, Weight gain-14lbs in 32 days.  Also I have numbness in my hands.
Age: 24.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: PAITENT WAS GIVEN 2 BIVALENT INJECTIONS . ONE ON 11/2022 AND 04/12/2023
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Blood test, Echocardiogram, Laboratory test, Magnetic resonance imaging head
Clinical narrative: On December 24 experienced a TIA
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: On December 24 experienced a TIA
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt received vaccine that was prepared with expired diluent.  No side effect reported for event.
Age: 10.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Patient had a vasovagel syncope
Age: 64.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Anticoagulant therapy, Arthralgia, Computerised tomogram abnormal, Erythema, Groin pain
Clinical narrative: I had vaccination on 10/07/2022. On 03/17/2023 I ended up in the hospital. I had a small pinch in my calf a few days prior. I thought it was a sports injury. The pain radiated from calf to behind my knee cap with a red line. It was sore in that area. On 03/17/2023 the pain was from top of foot up the calf all the way up to my groin. The red line was visible. I went to the urgent care and they did a MRI and CAT Scan. I had a massive blood clot and I was rushed into surgery. The blood clot was pulled out but they couldn't get all of it. I am presently on blood thinners and I am being monitored with a specialist.
Age: 64.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Magnetic resonance imaging abnormal, Pain, Pain in extremity, Surgery, Thrombectomy
Clinical narrative: I had vaccination on 10/07/2022. On 03/17/2023 I ended up in the hospital. I had a small pinch in my calf a few days prior. I thought it was a sports injury. The pain radiated from calf to behind my knee cap with a red line. It was sore in that area. On 03/17/2023 the pain was from top of foot up the calf all the way up to my groin. The red line was visible. I went to the urgent care and they did a MRI and CAT Scan. I had a massive blood clot and I was rushed into surgery. The blood clot was pulled out but they couldn't get all of it. I am presently on blood thinners and I am being monitored with a specialist.
Age: 64.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Thrombosis
Clinical narrative: I had vaccination on 10/07/2022. On 03/17/2023 I ended up in the hospital. I had a small pinch in my calf a few days prior. I thought it was a sports injury. The pain radiated from calf to behind my knee cap with a red line. It was sore in that area. On 03/17/2023 the pain was from top of foot up the calf all the way up to my groin. The red line was visible. I went to the urgent care and they did a MRI and CAT Scan. I had a massive blood clot and I was rushed into surgery. The blood clot was pulled out but they couldn't get all of it. I am presently on blood thinners and I am being monitored with a specialist.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Product storage error
Clinical narrative: temperature excursion
Age: 54.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient here for first dose of Covid vaccine series.  Pfizer Bivalent dose was given, Pfizer monovalent should have been given. No side effects reported.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Pt reported fever following day after vaccine admin. Today reported swelling, warm to touch, pain/stiffness, redness along entire back of upper arm.
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Skin warm
Clinical narrative: Pt reported fever following day after vaccine admin. Today reported swelling, warm to touch, pain/stiffness, redness along entire back of upper arm.
Age: 63.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Tested positive for Covid on 03/29/2023.  High fever of 101, body aches, congestion, coughing days 2 though 7
Age: 63.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid on 03/29/2023.  High fever of 101, body aches, congestion, coughing days 2 though 7
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Passenger received the vaccine after the 30 day window for storage in a refrigerator(not in freezer) had ended.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Diarrhoea, Dyspnoea, Headache
Clinical narrative: In late February 2023 I began feeling symptoms that began as a high fever of 103.7.  I was nauseous and had diarrhea with a headache and body aches.  My cough was so bad I would vomit.  It tested positive for COVID-19 on February 24, 2023.  I took Paxlovid.  Within a day or so I began to feel better.  As of today, I still have a cough and my lungs are heavy with "muck".  I have trouble breathing for a little while in the morning.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nausea, Pain, Productive cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: In late February 2023 I began feeling symptoms that began as a high fever of 103.7.  I was nauseous and had diarrhea with a headache and body aches.  My cough was so bad I would vomit.  It tested positive for COVID-19 on February 24, 2023.  I took Paxlovid.  Within a day or so I began to feel better.  As of today, I still have a cough and my lungs are heavy with "muck".  I have trouble breathing for a little while in the morning.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Brain fog, Fatigue, Hemiparesis, Muscular weakness
Clinical narrative: 45 minutes after shot patient developed vertigo, tingling and weakness in right hand, fatigue and brain fog.  Normal accu-check and blood pressure.   Tingling and weakness and vertigo resolved within hours.  fatigue and brain fog continued past then
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Paraesthesia, Vertigo
Clinical narrative: 45 minutes after shot patient developed vertigo, tingling and weakness in right hand, fatigue and brain fog.  Normal accu-check and blood pressure.   Tingling and weakness and vertigo resolved within hours.  fatigue and brain fog continued past then
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody positive, Autopsy, Chills, Cough, Death
Clinical narrative: After the 2nd dosage on 3/26/2021, patient felt what he thought was normal flu like symptoms after the vaccine which we were told could be expected. Fever, shivers, and cough. On 3/29 started coughing w some streaks of blood in it. On 3/30 coughing more blood and went to ER. Spent two weeks in the hospital until he finally passed on 4/13/2021. An Autopsy was performed and was signed by Dr., listed above.Autopsy Report showed ANCA associated glomerular nephritis and Organizing pneumonia. Autopsy report noted potential triggers for ANCA production include immune dysregulation & drugs such as propothiouracil, hydralazine, penicillamine,  minocycline etc.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Glomerulonephritis, Haemoptysis, Influenza like illness, Organising pneumonia, Pyrexia
Clinical narrative: After the 2nd dosage on 3/26/2021, patient felt what he thought was normal flu like symptoms after the vaccine which we were told could be expected. Fever, shivers, and cough. On 3/29 started coughing w some streaks of blood in it. On 3/30 coughing more blood and went to ER. Spent two weeks in the hospital until he finally passed on 4/13/2021. An Autopsy was performed and was signed by Dr., listed above.Autopsy Report showed ANCA associated glomerular nephritis and Organizing pneumonia. Autopsy report noted potential triggers for ANCA production include immune dysregulation & drugs such as propothiouracil, hydralazine, penicillamine,  minocycline etc.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenopathy, Positron emission tomogram
Clinical narrative: Enlarged marker lymphnodes, awaiting plan for biopsies and treatment
Age: 52.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: There was no adverse effect per the patient but the wrong vaccine was given to the patient. He was to receive a hepatitis B vaccine
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient inadvertently received a duplicate dose of Prevnar 20 on 4/7/23.  She had already received a dose of Prevnar 20 from her doctor's office on 1/24/23.
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: PATIENT STATED THAT APPROXIMATELY 4 TO 6 HOURS AFTER GETTING VACCINE HE EXPERIENCED SEVERE PAIN IN HIS LEFT ARM. THE PAIN PERSISTED FOR SEVERAL HOURS TO THE POINT THAT HE HAD TO GO TO BED. PT STATES THAT IT WAS NOT UNTIL 12 HOURS LATER THAT HE STARTED FEELING BETTER. PATIENT STATES HE DOES NOT WANT TO GET 2ND SHOT.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Administration site swelling
Clinical narrative: right arm got a little swollen where the Kinrix was administer.
Age: 12.0
Sex: M
Vaccine: COVID19, HPV9
Symptoms: Incorrect product formulation administered
Clinical narrative: Monovalent was given as 3rd dose booster instead of Bivalent
Age: 53.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: Took 4th shot in morning, by early evening had numbing of fingers on left hand (shot on left arm). Contacted doctor's office, saw different doctor. Still having same problem along with hand being ice cold, saw regular doctor 2 weeks later. (Doctor told me to wait for 2 weeks). Kept going back to Dr. about hand every 2 weeks and hand kept getting worse. In November, had an Electric shock thing done to arm. Visited with Hand specialist and Neurologist in the months following. Hand become worse, no longer able to make fist or thumbs up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diagnostic procedure, Imaging procedure, Laboratory test, Muscle contractions involuntary, Neuropathy peripheral
Clinical narrative: Palpitations Fasciculations Paresthesia/Neuropathy. Pt referred to cardiologist and two neurologists Later In April 2023, I will ask pt to sign release of information and forward specialist notes.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Palpitations Fasciculations Paresthesia/Neuropathy. Pt referred to cardiologist and two neurologists Later In April 2023, I will ask pt to sign release of information and forward specialist notes.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Client presented for 2nd dose in Moderna monovalent primary series and received expired vaccine. After administration of vaccine client sat 15 mins. in waiting area for observation of side effects. None noted. Expiration of the vaccine was not noted until 2:00 pm after clinic closed. Vaccine expired 04/01/2023. Client was contacted and informed of the incident, denied any side effects and potential for revaccination. Moderna was contacted to check viability of expired vaccine.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Client presented for 2nd dose in Moderna monovalent primary series and received expired vaccine. After administration of vaccine client sat 15 mins. in waiting area for observation of side effects. Non noted. Expiration of the vaccine was not noted until 2:00 pm after clinic closed. Vaccine expired 04/01/2023. Client was contacted and informed of the incident,denied any side effects and potential for revaccination. Moderna was contacted to check viability of expired vaccine. See below #19. Based on response from Moderna's analysts revaccination is not needed. client made aware.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Client presented for 1st dose of Moderna monovalent primary series and received expired vaccine. After administration of vaccine client sat 15 mins. in waiting area for observation of side effects. Non noted. Expiration of the vaccine was not noted until 2:00 pm after clinic closed. Vaccine expired 04/01/2023. Client was contacted and informed of the incident,denied any side effects and potential for revaccination. Moderna was contacted to check viability of expired vaccine. See below #19. Based on response from Moderna's analysis revaccination is not needed. client made aware.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Client presented for 2nd dose in Moderna monovalent primary series and received expired vaccine. After administration of vaccine client sat 15 mins. in waiting area for observation of side effects. None noted. Expiration of the vaccine was not noted until 2:00 pm after clinic closed. Vaccine expired 04/01/2023. Client was contacted and informed of this incident, denied any side effects and potential for revaccination. Moderna was contacted to check viability of expired vaccine. See below #19. Based on response from Moderna's analysis  revaccination is not needed. Clients made aware.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Pfizer 4/14/21 Lot# EP6955;  Pfizer 5/5/21 Lot# EW0176;
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Medical assistant transferred from Specialist reports 2 doses of expired PNUEMOVAX 23 was administered to 2 patients. Product expired 3/25/2023 and was administered today 3/29/2023. Product had not experienced any temperature excursions through the d; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 29-MAR-2023 (also reported as today), the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U027357 exp date: 25-MAR-2023) (dose and route not reported) as prophylaxis (expired product administered). Moreover, the product had not experienced any temperature excursions through the date of administration. No additional adverse events were reported (no adverse event)  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2303USA010647:
Age: 1.0
Sex: M
Vaccine: PNC13, PNC15
Symptoms: Rash
Clinical narrative: he developed a possible allergic reaction; he had a rash following the injection; This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with the first dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered for prophylaxis (strength, dose, dose number, lot number, expiration date, and route of administration were not provided), after three doses of  pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (strength, formulation, dose description, lot number, expiration date, route of administration, and indication were not provided) to complete the scheme of four doses.  On an unknown date, the patient developed a possible allergic reaction (hypersensitivity), he had a rash following the injection, not at the injection site, but on other parts of his body. At the time of reporting, the outcome of the events was not provided.  The causal relationship between the events with the suspect therapies was not reported.
Age: 71.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; HCP called to report a TE with PNEUMOVAX 23 PFS. The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F).  The excursion was discovered upon looking at the data logs.  Data logger recorded a 46.7F temp on Marc; This spontaneous report was received from a consumer and refers to a 71-year-old patient of unspecified gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-MAR-2023, the patient was vaccinated with an improper stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 ml, lot #W027449, (expiration date: 25-SEP-2024), administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of 46.7F (47F) for 72 hours 0 minutes 0 seconds discovered upon looking at the data logs (product storage error). Data logger did not record again until logging a 43F temperature on 06-MAR-2023, worst case scenario of 46.7F was used for the full 72 hours of the weekend per health care professional direction. No additional adverse event was reported (no adverse event).  This is one from several cases from the same reporter. ; Sender's Comments:  US-009507513-2304USA002650: US-009507513-2304USA002667: US-009507513-2304USA002696: US-009507513-2304USA002675: US-009507513-2304USA002696: US-009507513-2304USA002759: US-009507513-2304USA002776: US-009507513-2304USA002932: US-009507513-2304USA002750: US-009507513-2304USA002696:
Age: 72.0
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; HCP called to report a TE with PNEUMOVAX 23 PFS. The outcome was "not supported" for the excursion of 72 hours 0 minutes 0 seconds at 46.7F (47F).  The excursion was discovered upon looking at the data logs.  Data logger recorded a 46.7F temp on Marc; This spontaneous report has been received from a health care professional (also reported as consumer, conflicting information), concerning a 72-year-old patient of unknown gender.   No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAR-2023, the data logger identified that pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot #W027449, experienced a temperature excursion of 46.7 Fahrenheit degrees (F), and since that date did not record again until logging a 43F temperature on 06-MAR-2023 (product storage error).   Consequently, on the date of the excursion, the patient, per HCP direction, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection syringe, at a dose of 0.5 milliliters (mL) administered for prophylaxis (lot# confirmed W027449 to be valid, expiration date reported and established as 25-SEP-2024; strength, frequency and route of administration were not provided). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002667:MSD US-009507513-2304USA002675:MSD US-009507513-2304USA002694:MSD US-009507513-2304USA002759:MSD US-009507513-2304USA002776:MSD US-009507513-2304USA002650:MSD US-009507513-2304USA002932:MSD US-009507513-2304USA002750:MSD US-009507513-2304USA002696:MSD US-009507513-2304USA002840:MSD US-009507513-2304USA002746:MSD
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shot and got shingles/shot doesn't always work/Suspected vaccination failure; Shingles seve enough for me, awful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot and got shingles/shot doesn't always work/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles seve enough for me, awful). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 1 month).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 The case was received from the patient interactive digital media. The reporter was sorry to inform that shot did not always worked. The patient had shot and got shingles and he/she could also have them again and it may made them less severe but his/her were severe enough and lasted about a month and it was awful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had jab and had it again/suspected vaccination failure; had it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had multiple times before age fifty).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had jab and had it again/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 29-MAR-2023 The case was received from the patient  interactive digital media. The patient had the jab and had it again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Bexsero administered by mistake; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 13-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB57AA, expiry date 31-AUG-2022) for prophylaxis.   In MAY-2022, the patient received the 1st dose of Bexsero. In MAY-2022, an unknown time after receiving Bexsero, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Bexsero administered by mistake). The outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-MAR-2023 On the day of reporting, the patient attended the clinic and a medical assistant realized this patient should not had received the first dose of Bexsero last year, but by mistake they administered it.  Then, the same day (day of reporting), the patient received an MCV4 vaccine (MenQuadfi). The reporter asked if the patient needed a second dose of Bexsero. The reporter consented to follow up. The patient received the first dose of Bexsero last year mistakenly, which led to inappropriate schedule of vaccine administered.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 30Sep2019, 2nd on 01Feb2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 5L3HB, expiry date 20-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th September 2019).   On 01-FEB-2023, the patient received the 2nd dose of Shingrix. On 01-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 30Sep2019, 2nd on 01Feb2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 06-APR-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 4-5 years ago, 2nd not received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 4 to 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 4-5 years ago, 2nd not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 06-APR-2023 The pharmacist reported that a patient never received the second dose of Shingrix.   The dose was given at a different pharmacy, and the exact date of administration, as well as lot number or expiration date information was unknown.   At the time of reporting, the second dose was planned to be administered on 6th April 2023, but had not yet been given. Reporting stated she was a floating pharmacist and might not be at that location for safety follow-up, but she would let the other staff know of possible follow-up by safety. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Details pertains to 1st dose of Shingrix in product tab.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 06-Apr-2023; no adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 06-Apr-2023) and NO ADVERSE EVENT (no adverse event) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 06-Apr-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 06-Apr-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 06-Apr-2023).    No concomitant medications were reported. Vial size was reported as 2.5 mL.Vial was initially stored in the refrigerator on 10-Feb-2023. Vial did not undergo any temperature excursions. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient accidentally received a booster dose of Moderna COVID-19 Vaccine instead of the 1st dose of the primary series on 10-APR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient accidentally received a booster dose of Moderna COVID-19 Vaccine instead of the 1st dose of the primary series on 10-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 Vaccine.     On 10-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 10-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient accidentally received a booster dose of Moderna COVID-19 Vaccine instead of the 1st dose of the primary series on 10-APR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient accidentally received a booster dose of Moderna COVID-19 Vaccine instead of the 1st dose of the primary series on 10-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient accidentally received a booster dose of Moderna COVID-19 Vaccine instead of the 1st dose of the primary series on 10-APR-2023).    No concomitant information was reported. It was reported that patient had no other adverse events. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe reaction with severe headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "thyroid goiters/goiters on neck" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "severe reaction with severe headaches". The event "severe reaction with severe headaches" required physician office visit. Therapeutic measures were taken as a result of headache.  Additional Information: Reporter's sister had a severe reaction with severe headaches. She also mentioned she read some crazy stuff on the internet. The timeline of the headaches matched after she got the vaccine. Reporter confirmed severe reaction was in regard to severe headaches. It started after getting the vaccine. Patient got the vaccine either late 2021 or early 2022. She did not get the vaccine when it came out. The headaches lasted 2-3 weeks; later clarified it was 3 weeks. In the beginning she could not lift her head, she was just laying out. Prior to the vaccine she did not have headaches. she stated patient still gets occasional headaches. There was no prior Vaccinations (within 4 weeks). There was no family medical history relevant to adverse events. Called primary care doctor initially. She was told not to take anything because it would interfere with vaccine. When the patient was not able to go to work or do anything she was prescribed ibuprofen or Aleve.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Muscular weakness, Pain in extremity
Clinical narrative: Weakness; pain in legs; pain in legs - legs give out at any given moment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, SINGLE , lot number and expiration date not provided), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE , lot number and expiration date not provided), for Covid-19 immunization. The following information was reported: ASTHENIA (non-serious), outcome "not recovered", described as "Weakness"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "pain in legs"; MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "pain in legs - legs give out at any given moment". The events "weakness", "pain in legs" and "pain in legs - legs give out at any given moment" required physician office visit. Therapeutic measures were taken as a result of asthenia, pain in extremity, muscular weakness.  Additional Information: Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. It was unknown if the patient had taken the vaccine within 4 weeks. It was reported that the patient was undergoing physical therapy to try and fix it and so far not helping. It was unknown if the patient had covid before vaccination and it was unknown if the patient had tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: I lost my sense of smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 13Sep2021 as dose 2, single (Lot number: FD3184) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, lot# FD8448), administration date: 23Aug2021, for COVID-19 immunization. The following information was reported: ANOSMIA (non-serious), outcome "not recovered", described as "I lost my sense of smell". The event "i lost my sense of smell" required physician office visit.  Additional information: the patient reported that: "I am writing in regards to the Pfizer Covid injections I received on 23Aug2021 (lot# FD8448) and 13Sep2021 (Lot# FD3184). I lost my sense of smell. I have been going to the doctors office every 6 months for check ups on when will I regain my sense of smell. My doctor advised me it was time to contact manufacturer in regards this matter. Its been almost 2 year and I still have not gotten my sense of smell back. I would like to fill an insurance claim with Insurance Company. I was not advised that I would permanently loose my sense of smell upon taking the injection. " it was also added that "I lost my sense of smell once I was vaccinated, my internal medicine doctor keep saying give it 6 months . Give it another 6 months. My body was compromised and I have to keep going to these specialist to get sense of smell back. I need to file an insurance claim. "