chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Palpitations, Paraesthesia, Pyrexia
Clinical narrative: Facial tingling/numbness to face contralateral to injection site starting 30 minutes  (time 1600) after injection and spreading to entire face.  Symptoms resolved 4 hours later.  Intermittent palpitations starting during this time  which have not resolved to this day.  Twelve hours (time 0330) after injection experienced common reported adverse effects (arthralgia, myalgia, headache, chills, severe neck pain, headache) in addition to unexpected  supraclavicular lymph node swelling on injection side.  Consistent fever of 102 degree  fahrenheit starting 12 hours (time 0330) post injection and lasting  for 20 hours, after which remained 99-100 for an additional 8 hours. Started to take Tylenol 15 hours after vaccine dose  (0630). Also have continued to have dull headaches since vaccine dose.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Pain, Pyrexia
Clinical narrative: Symptoms started at 3:00 AM on 01/05/2021, complains of headache, body aches, temp 100.4, congeston, fatigue. Took Tylenol for fever.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Recipient presented to PCP office 12 days post injection with swelling and mild erythema with warm to touch area of injection.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA received on 1/17/2021.  Woke up at 8;00 am on 1/18/2021 with fever of 100.4 degrees.
Age: 87.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: No known symptoms
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Malaise, Paraesthesia, Pruritus
Clinical narrative: I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a large room that was busy with my mask, jacket and glasses on, I calmed down but did not feel well. I walked to my car, my fingers were a little tingly, then when I took my mask off the left side of my face was swelling, tingly, red (I have rosacea- but this was different) I did not panic, but I knew something was wrong. I decided to drive to the hospital instead of driving home, the valet said my face was swelling. I went to the ER - was given Pepic and Benadryl via an IV - I was there for observation - as I was waiting for my medication, I began to feel itchy at the base of my neck and on my chest
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: I had a full body sensation of being hot, a little dizzy, not well, I figured it was waiting in a large room that was busy with my mask, jacket and glasses on, I calmed down but did not feel well. I walked to my car, my fingers were a little tingly, then when I took my mask off the left side of my face was swelling, tingly, red (I have rosacea- but this was different) I did not panic, but I knew something was wrong. I decided to drive to the hospital instead of driving home, the valet said my face was swelling. I went to the ER - was given Pepic and Benadryl via an IV - I was there for observation - as I was waiting for my medication, I began to feel itchy at the base of my neck and on my chest
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Erythema, Haemorrhage, Insomnia, Joint range of motion decreased
Clinical narrative: began feeling soreness like a punch in the arm progressing to barely able to lift arm. Disturbed my sleep for two nites. Soreness remained and daily gained the ability to raise my arm.  Rash on forearms worse on right than left. They were itchy/burning slightly reb bumps that tore easily and lite bleeding from rubbing. The pain/stiffness went deeper into the elbow feeling thick and dead like with pain at certain twists of movement. I still had muscular strength for a pushup or two but noticed tenderness/weakness in right elbow. Rash remains today applying Neosporin and or lotions.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Rash, Rash pruritic
Clinical narrative: began feeling soreness like a punch in the arm progressing to barely able to lift arm. Disturbed my sleep for two nites. Soreness remained and daily gained the ability to raise my arm.  Rash on forearms worse on right than left. They were itchy/burning slightly reb bumps that tore easily and lite bleeding from rubbing. The pain/stiffness went deeper into the elbow feeling thick and dead like with pain at certain twists of movement. I still had muscular strength for a pushup or two but noticed tenderness/weakness in right elbow. Rash remains today applying Neosporin and or lotions.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Skin burning sensation, Swelling, Tenderness
Clinical narrative: began feeling soreness like a punch in the arm progressing to barely able to lift arm. Disturbed my sleep for two nites. Soreness remained and daily gained the ability to raise my arm.  Rash on forearms worse on right than left. They were itchy/burning slightly reb bumps that tore easily and lite bleeding from rubbing. The pain/stiffness went deeper into the elbow feeling thick and dead like with pain at certain twists of movement. I still had muscular strength for a pushup or two but noticed tenderness/weakness in right elbow. Rash remains today applying Neosporin and or lotions.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: AFTER  2 WEEKS, redness, swelling, itching, warm to touch appeared.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Fatigue, Myalgia, Pain in extremity
Clinical narrative: arm soreness, red and swollen then on 01/18/21 got severely SOB, had muscle aches and very fatigue
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: arm soreness, red and swollen then on 01/18/21 got severely SOB, had muscle aches and very fatigue
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Hyperhidrosis
Clinical narrative: Covid vaccine #1 3 days ago. Last night she started having chills diaphoresis broke out in sweats and having abdominal pain
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: I developed an UTI, treated with macrobin.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diabetic ketoacidosis, Electrocardiogram, Laboratory test, Nausea
Clinical narrative: nausea and vomiting  possible cause of diabetic ketoacidosis and svt
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular tachycardia, Vomiting
Clinical narrative: nausea and vomiting  possible cause of diabetic ketoacidosis and svt
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Hypotonia, Muscle tightness, Restless legs syndrome
Clinical narrative: A few minutes after having the 1st vaccine, both of my legs started moving up and down by themselves. I couldn't stop this. This lasted about 10 minutes. Then I felt all my leg muscles tightening and loosening. I couldn't stop this. This lasted for  about 24 hours -into the next day. I have this reaction when given Compazine. I did notice there is a drug in your vaccine that is in Compazine called  polyethylene  glycol. I'm wondering if my reaction to polyethylene  glycol could have caused this reaction. I also had this reaction when I had surgery and this reaction started. The nurse pulled something they had on my legs off and my heart stopped. I had my heart checked out thoroughly and it is fine. I'm very concerned about the 2nd dose. I want to be vaccinated , but not if I could hurt me because of my allergies. Could you please let me know your opinion. My husbands had the vaccination with no problem.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: A 2'' area of redness, swelling, and irritation around injection site. The area was painful and itchy. Within  24 hours it more than doubled in sixe. . It began resolving 48 hours later with a decrease in redness.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: temperature excursion; This spontaneous report was received from a registered nurse and refers to a 5-month-old patient of an unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 09-FEB-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter (lot # T017688, expiration date: 21-MAY-2022) (strength and route of administration were not reported) for prophylaxis. According to the reporter, the temperature excursion was -13.3 degrees Celsius for a time frame of 4 hours and 15 minutes on an unspecified date, without any previous temperature excursion; which was detected by a digital data logger.
Age: 32.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; patient accidently received a dose of either MMRlI or VARIVAX mixed with a non Merck diluent/ the diluent used was for SHINGREX; This spontaneous report was received from a registered nurse and refers to a 32-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided.  On 23-DEC-2020, the patient was accidently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter (route of administration, anatomical localization, lot # and expiration date were unknown) for prophylaxis or with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 ml (route of administration, anatomical localization, lot # and expiration date were unknown) for prophylaxis, that was reconstituted with a sterile diluent for zoster rgE vaccine (mammalian) (SHINGRIX) (reported as SHINGREX, non-Merck diluent), also reported as so 1b mono phospholipid lipid a qs-21 natural compound extracted from the soap bark tree combined in liposomal formulation (dose, route of administration, lot # and expiration date were unspecified). The patient did not complain of any adverse reactions. The reporter was unsure of the exact patient that received the incorrectly prepared measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) or varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of two case reports from the same reporter.; Sender's Comments:  US-009507513-2101USA001854:
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Facial paralysis, Herpes zoster, Post herpetic neuralgia
Clinical narrative: stroke; Bells palsy; postherpetic neuralgia; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. The pt's concurrent conditions, medical history an concomitant medications were not reported.  On 24-AUG-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) in a pharmacy (exact dose, site and route of administration, lot# and expiration date were not reported) for the long term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated for the following injuries, resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, post herpetic neuralgia, Bell's palsy and stroke.  The outcome of the events was unknown. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.  Upon internal review, the events of Bell's palsy and stroke were determined to be medically significant.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site rash
Clinical narrative: rash on her ribcage; shivers / chills; headache; feeling tired; redness/ (at the injection site); little rash on the right arm (at the injection site); This case was reported by a consumer and described the occurrence of shivers in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior outbreak of shingles near her eye (last September)). Previously administered products included zostavax and shingrix with an associated reaction of injection site pain (refer the case US2020229492).   On 17th November 2020, the patient received the 2nd dose of Shingrix. On 17th November 2020, less than a day after receiving Shingrix, the patient experienced shivers, headache, tiredness, injection site erythema and injection site rash. On 18th November 2020, the patient experienced rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shivers, headache and tiredness were recovered/resolved and the outcome of the injection site erythema, injection site rash and rash were not recovered/not resolved.   The reporter considered the shivers, headache, tiredness, injection site erythema and injection site rash to be related to Shingrix. It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported After receiving the 2nd dose of Shingrix the patient experienced shivers, chills, headache, feeling tired. These events were "horrible" but they have since resolved. The patient experienced redness or little rash on the right arm (at the injection site) which has not yet resolved. On 18th November 2020 she noticed that she had a rash on her ribcage. The ribcage rash is better at the time of report (it is not painful nor does it itch) but it has not resolved. This case has been linked with case US2020229492, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229492:same patient (1st dose
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: rash on her ribcage; shivers / chills; headache; feeling tired; redness/ (at the injection site); little rash on the right arm (at the injection site); This case was reported by a consumer and described the occurrence of shivers in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior outbreak of shingles near her eye (last September)). Previously administered products included zostavax and shingrix with an associated reaction of injection site pain (refer the case US2020229492).   On 17th November 2020, the patient received the 2nd dose of Shingrix. On 17th November 2020, less than a day after receiving Shingrix, the patient experienced shivers, headache, tiredness, injection site erythema and injection site rash. On 18th November 2020, the patient experienced rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the shivers, headache and tiredness were recovered/resolved and the outcome of the injection site erythema, injection site rash and rash were not recovered/not resolved.   The reporter considered the shivers, headache, tiredness, injection site erythema and injection site rash to be related to Shingrix. It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported After receiving the 2nd dose of Shingrix the patient experienced shivers, chills, headache, feeling tired. These events were "horrible" but they have since resolved. The patient experienced redness or little rash on the right arm (at the injection site) which has not yet resolved. On 18th November 2020 she noticed that she had a rash on her ribcage. The ribcage rash is better at the time of report (it is not painful nor does it itch) but it has not resolved. This case has been linked with case US2020229492, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229492:same patient (1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Fatigue, Musculoskeletal discomfort, Osteoarthritis
Clinical narrative: Side pain; Soreness / of the arm/ leg pain; degenerative hip woresning; Redness of the arm; Increase in temperature; Tiredness; This case was reported by a consumer and described the occurrence of pain localized in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer and degenerative joint disease. Concomitant products included Flu unspecified (Influenza vaccine) and pneumococcal vaccine (Pneumonia Vaccine).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix and an unknown time after receiving Influenza vaccine, the patient experienced pain localized, pain in arm, erythema of extremities, high temperature, tiredness and degenerative joint disease. On an unknown date, the outcome of the pain localized, pain in arm and degenerative joint disease were unknown and the outcome of the erythema of extremities, high temperature and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain localized, pain in arm, erythema of extremities, high temperature, tiredness and degenerative joint disease to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine at the end of October at around 2pm. The patient experienced side and leg pain on opposite sides two weeks after receiving the 1st dose of the Shingrix vaccine.  The patient also reported experiencing soreness and redness of the arm, an increase in temperature, and tiredness. The soreness and redness of the arm, increased temperature, and tiredness started at 9pm on the day of receiving the vaccine.  The patient stated that these lasted for two days. The patient was told by her doctor that the side pain could be from her degenerative hip, but they were unsure about the leg pain. She has already gotten the pneumonia and flu vaccines along with the 1st dose of the Shingrix vaccine, but at different times. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Side pain; Soreness / of the arm/ leg pain; degenerative hip woresning; Redness of the arm; Increase in temperature; Tiredness; This case was reported by a consumer and described the occurrence of pain localized in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included breast cancer and degenerative joint disease. Concomitant products included Flu unspecified (Influenza vaccine) and pneumococcal vaccine (Pneumonia Vaccine).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix and an unknown time after receiving Influenza vaccine, the patient experienced pain localized, pain in arm, erythema of extremities, high temperature, tiredness and degenerative joint disease. On an unknown date, the outcome of the pain localized, pain in arm and degenerative joint disease were unknown and the outcome of the erythema of extremities, high temperature and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain localized, pain in arm, erythema of extremities, high temperature, tiredness and degenerative joint disease to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine at the end of October at around 2pm. The patient experienced side and leg pain on opposite sides two weeks after receiving the 1st dose of the Shingrix vaccine.  The patient also reported experiencing soreness and redness of the arm, an increase in temperature, and tiredness. The soreness and redness of the arm, increased temperature, and tiredness started at 9pm on the day of receiving the vaccine.  The patient stated that these lasted for two days. The patient was told by her doctor that the side pain could be from her degenerative hip, but they were unsure about the leg pain. She has already gotten the pneumonia and flu vaccines along with the 1st dose of the Shingrix vaccine, but at different times. The reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Pain
Clinical narrative: inflammation at the injection site; achiness all over; This case was reported by a consumer via call center representative and described the occurrence of injection site inflammation in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number UNK, expiry date unknown) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site inflammation and general body pain. On an unknown date, the outcome of the injection site inflammation and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site inflammation and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced achiness all over and inflammation at the injection site. The reporter consented to follow up. This case has been linked with case US2020AMR239268, reported by same reporter for same patient.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema
Clinical narrative: redness half-way down her arm about the size of her palm; looks like bruising; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th November 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th November 2020, 1 days after receiving Shingrix, the patient experienced erythema of extremities and bruising of arm. On an unknown date, the outcome of the erythema of extremities and bruising of arm were recovering/resolving.   The reporter considered the erythema of extremities to be related to Shingrix. It was unknown if the reporter considered the bruising of arm to be related to Shingrix.  Additional details were reported as follows: The patient received the 1st dose of Shingrix and the next day, she experienced redness half-way down her arm about the size of her palm. The patient stated that presently it was starting to resolve and looks like bruising. The reporter did not consent to follow-up and declined to provide her healthcare professional's information.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Rash erythematous, Rash macular
Clinical narrative: Swelling at the injection site; red blotches / rash; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On 4th December 2020, unknown after receiving Shingrix, the patient experienced red blotches. On an unknown date, the patient experienced injection site swelling. The patient was treated with hydrocortisone (Hydrocortisone Cream) and benadryl (nos) (Benadryl Cream). On an unknown date, the outcome of the injection site swelling and red blotches were unknown.   It was unknown if the reporter considered the injection site swelling and red blotches to be related to Shingrix.  Additional details were provided as follows: The patient was a healthcare professional. The age at vaccination was not reported. The patient received Shingrix and had rash on mid-section and back and she described it as red blotches. The patient also had swelling at the injection site. The patient had treated with hydrocortisone cream and benadryl cream. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Swelling at the injection site; red blotches / rash; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On 4th December 2020, unknown after receiving Shingrix, the patient experienced red blotches. On an unknown date, the patient experienced injection site swelling. The patient was treated with hydrocortisone (Hydrocortisone Cream) and benadryl (nos) (Benadryl Cream). On an unknown date, the outcome of the injection site swelling and red blotches were unknown.   It was unknown if the reporter considered the injection site swelling and red blotches to be related to Shingrix.  Additional details were provided as follows: The patient was a healthcare professional. The age at vaccination was not reported. The patient received Shingrix and had rash on mid-section and back and she described it as red blotches. The patient also had swelling at the injection site. The patient had treated with hydrocortisone cream and benadryl cream. The reporter consented to follow-up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: ACHY; tired; headache; UPSET STOMACH; tenderness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ulcerative colitis.   On 3rd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, less than a day after receiving Shingrix, the patient experienced pain, tiredness, headache, upset stomach and injection site tenderness. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the tiredness, headache, upset stomach and injection site tenderness were recovering/resolving.   It was unknown if the reporter considered the pain, tiredness, headache, upset stomach and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that on 3rd December 2020 patient received 2nd dose of Shingrix in left arm and on same day patient felt achy, tired with a headache and an upset stomach and tenderness at the injection site. The achy feeling has resolved and the other symptoms were resolving. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Dermatitis atopic, Dry skin, Prurigo, Pruritus
Clinical narrative: has a history of skin cancer / did a biopsy showed squamous cancer / left leg in two areas had cancer; was diagnosed with Prurigo or PRN / his left leg in two areas and right leg have Prurigo; experienced atopic dermatitis / did a biopsy showed atopic dermatitis; 5 bumps on both his legs and arms / bump on his belly; itchy welts; itches; he has really rough skin; bumps are crusty; This case was reported by a consumer via call center representative and described the occurrence of skin cancer in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, the patient experienced skin cancer (serious criteria GSK medically significant), prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust. The patient was treated with topical steroid nos (Steroid Cream) and antibiotics nos (Oral Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the skin cancer, prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust were unknown.   It was unknown if the reporter considered the skin cancer, prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported but could be 79 or 80 years. Between July to November 2020, the patient received 1st dose of Shingles vaccine and a week after the vaccination, the patient experienced atopic dermatitis and was diagnosed with Prurigo or PRN. The patient could not 100 percent confirm that he received the Shingrix because he did not have the lot number, but he believed that it was not Zostavax because his vaccine required 2 doses. The patient claimed that he had 5 bumps on both his legs and arms that were itchy welts and bump on his belly. From last year patient had skin cancer, they did a biopsy on his legs and it showed squamous cancer and atopic dermatitis and it keeps getting worse. The patient stated that when they did the biopsy, his left leg in two areas had cancer and Prurigo but his right leg did not show cancer, but it did have Prurigo. The patient claimed that the condition spreads as he itches it and he had really rough skin. The patient was given steroid cream but that did not help him, so he took an oral antibiotic from a previous diagnosis. The patient reported that his bumps are crusty. The patient reported that he was scheduled to get the 2nd dose on 15th January 2021. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Scab, Skin cancer, Squamous cell carcinoma, Swelling, Urticaria
Clinical narrative: has a history of skin cancer / did a biopsy showed squamous cancer / left leg in two areas had cancer; was diagnosed with Prurigo or PRN / his left leg in two areas and right leg have Prurigo; experienced atopic dermatitis / did a biopsy showed atopic dermatitis; 5 bumps on both his legs and arms / bump on his belly; itchy welts; itches; he has really rough skin; bumps are crusty; This case was reported by a consumer via call center representative and described the occurrence of skin cancer in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 6 months after receiving Shingles vaccine, the patient experienced skin cancer (serious criteria GSK medically significant), prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust. The patient was treated with topical steroid nos (Steroid Cream) and antibiotics nos (Oral Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the skin cancer, prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust were unknown.   It was unknown if the reporter considered the skin cancer, prurigo, atopic dermatitis, local swelling, urticaria, pruritus, skin rough and crust to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported but could be 79 or 80 years. Between July to November 2020, the patient received 1st dose of Shingles vaccine and a week after the vaccination, the patient experienced atopic dermatitis and was diagnosed with Prurigo or PRN. The patient could not 100 percent confirm that he received the Shingrix because he did not have the lot number, but he believed that it was not Zostavax because his vaccine required 2 doses. The patient claimed that he had 5 bumps on both his legs and arms that were itchy welts and bump on his belly. From last year patient had skin cancer, they did a biopsy on his legs and it showed squamous cancer and atopic dermatitis and it keeps getting worse. The patient stated that when they did the biopsy, his left leg in two areas had cancer and Prurigo but his right leg did not show cancer, but it did have Prurigo. The patient claimed that the condition spreads as he itches it and he had really rough skin. The patient was given steroid cream but that did not help him, so he took an oral antibiotic from a previous diagnosis. The patient reported that his bumps are crusty. The patient reported that he was scheduled to get the 2nd dose on 15th January 2021. The reporter consented to follow-up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Influenza, Nausea
Clinical narrative: Severe arm pain, joint pain, mild nausea, severe flu symptoms, chills fever and weakness and sinus drainage
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sinus operation
Clinical narrative: Severe arm pain, joint pain, mild nausea, severe flu symptoms, chills fever and weakness and sinus drainage
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: sore arm, 2 inch red circle, itchy and warm to touch but not as bad as yesterday (day of shot).  Onset within an hour of vaccine
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I experienced soreness in my right arm at the injection site and a few days later it went away.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Head discomfort, Lymphadenopathy, Mononucleosis heterophile test negative
Clinical narrative: Tonsillar and occipital Lymph node moderate swelling. Difficulty Swallowing. Stiffness in head and neck. Profound fatigue. methylprednisoLONE (Medrol, Pak,) 4 mg tablet and azithromycin (Zithromax Z-Pak) 250 MG tablet mono test negative After 5 days on medications nodes size reduced, tenderness, stiffness, fatigue remain, but overall improved.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Tenderness, Tonsillar hypertrophy
Clinical narrative: Tonsillar and occipital Lymph node moderate swelling. Difficulty Swallowing. Stiffness in head and neck. Profound fatigue. methylprednisoLONE (Medrol, Pak,) 4 mg tablet and azithromycin (Zithromax Z-Pak) 250 MG tablet mono test negative After 5 days on medications nodes size reduced, tenderness, stiffness, fatigue remain, but overall improved.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm, Vaccination site mass, Vaccination site warmth
Clinical narrative: Lump post vaccine, dissipated.  Lump returned on 1/16/2021 with redness and very warm to the touch. Lasted 48 hours. Redness dissipated. Lump present skin is warm to the touch at vaccine site
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Flatulence, Headache, Injection site pain
Clinical narrative: Sluggish feeling on 1/16/2021; extreme thirst chills, gassy, loose bowel movement - caramel color . Injection site soreness; today 1/18/21 slight headache - Tylenol dose, headache now subsiding; all other symptoms have resolved.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Thirst
Clinical narrative: Sluggish feeling on 1/16/2021; extreme thirst chills, gassy, loose bowel movement - caramel color . Injection site soreness; today 1/18/21 slight headache - Tylenol dose, headache now subsiding; all other symptoms have resolved.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Influenza like illness, Sensation of foreign body
Clinical narrative: has ?flu like sx?, chills, red face, when sitting ?feels like a pill is stuck in her throat?. Had Covid one month ago.  Sx resolved today (1/14/21)
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: DOLOR MUSCULAR Y DE CABEZA FIEBRE  ESCALOFRIOS SUDORACION  CANSANCIO
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: DOLOR MUSCULAR Y DE CABEZA FIEBRE  ESCALOFRIOS SUDORACION  CANSANCIO
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pruritus, Rash, Urticaria
Clinical narrative: Had second  injection 10 am on 1/16/21 . Woke up at 1:30 am during night on  1/17 with rigors, took tylenol, temp in am 99.6. Had headache next day, Ok with tylenol.   Woke up in am of 1/18/21, itchy all over. Looked in mirror and had hives over right side of torso in back, and on chest and abdominal area in front. Very itchy. No shortness of breath. O2 sat 96%. Took 10 mg of Atarax I had at home for allergy itching. Called our Occupational Health office, instructed to call back if worsens or unresolves in next 24 hours.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Fatigue, dizzy with positional change (referred that to PCP as there was previous hx); H/A worse than normal (has daily but pending vision screen in one month)
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: soreness in left arm at shot injection site started around 8:00pm (shot was at 215pm). Upon awakening 1/19 at 6:00am, arm continued to be sore and I had fever registering at 102.5. I took two Tylenol then and again at 3:00pm. Headache appeared around 9:00am and was gone by 7:00pm. Temp began to decrease at 10am, to 101.1 and was 99.3 at 2:30pm. Sunday morning woke up with  no soreness in arm or fever/headache.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient initiated rescheduling of 2nd dose appt from 4 weeks to 3 weeks and there was failure to recognize the 28 days between appts was appropriate for Moderna series and there was an inadvertent change in Pfizer COVID-19 vaccine dose for dose 2 in series.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mobility decreased
Clinical narrative: swollen right lymph node, unable to move arm
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Headache, Intermenstrual bleeding, Vaginal haemorrhage
Clinical narrative: Vaginal bleeding/spotting/menstruation: on hormonal IUD and don't normally have any sort of period, but started spotting ~24 hours after 2nd dose of COVID vaccine. Associated with headache and cramping
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Lymph node pain
Clinical narrative: Pain in left arm for 5 days. Pain in lymph nodes under left arm going into the breast tissue starting on the second day. Tiredness, severe headache unrelieved by Tylenol for 2 days, chills, fever, joint pain, nausea.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pain in left arm for 5 days. Pain in lymph nodes under left arm going into the breast tissue starting on the second day. Tiredness, severe headache unrelieved by Tylenol for 2 days, chills, fever, joint pain, nausea.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Musculoskeletal discomfort
Clinical narrative: redness (gone as of yesterday), 1 lymph node swollen at right clavicle, discomfort in right lower back;  symptoms resolved 1/14/21 as of report.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Psychomotor hyperactivity
Clinical narrative: Mild but noticeable feeling of hyperactivity which continued about 8 hours.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nausea, Pyrexia
Clinical narrative: Fatigue, fever, severe joint pain, nausea. Nurse at doctor's office strongly encouraged me to report this.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Tenderness
Clinical narrative: swollen and tender gland on right side of jaw.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Fall, Fatigue
Clinical narrative: Though patient was experiencing pain due to her arthritis, soon after the vaccination (1-2 hours) she experienced increased knee pain in both legs. Since the vaccination, she has also had bad diarrhea. Lastly, the worst symptom she experienced was light headedness and fatigue. At around 8:30pm on the day of the vaccination, she got up from dinner to go to bed a bit early. She was feeling tired and started to fade. She fell backwards against the wall, hit her head and landed on her bottom. Thankfully, I was there to help her up and was able to stay up with her to ensure she didn't have a concussion. Admittedly, she did not drink much water that day so it's possible this exacerbated the side effects of the vaccine. Maybe the clinics can offer people water bottles or other hydrating beverages to ensure things like this don't happen?
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury
Clinical narrative: Though patient was experiencing pain due to her arthritis, soon after the vaccination (1-2 hours) she experienced increased knee pain in both legs. Since the vaccination, she has also had bad diarrhea. Lastly, the worst symptom she experienced was light headedness and fatigue. At around 8:30pm on the day of the vaccination, she got up from dinner to go to bed a bit early. She was feeling tired and started to fade. She fell backwards against the wall, hit her head and landed on her bottom. Thankfully, I was there to help her up and was able to stay up with her to ensure she didn't have a concussion. Admittedly, she did not drink much water that day so it's possible this exacerbated the side effects of the vaccine. Maybe the clinics can offer people water bottles or other hydrating beverages to ensure things like this don't happen?
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Within minutes of injection Mom started getting nauseous.  When she stood to leave she was very light headed.  The nausea lasted about 3 hours, the lightheadness lasted all day, diminishing as the day went on, but still a problem at bed time.  She did sleep a lot that day. When she awoke the following day, symptoms had abated.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever >100, chills, body aches, H/A that is not resolved with Tylenol and unable to take ibuprofen
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Nausea, vomiting, chills, joint pain, muscle pain, fatigue
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, chills, joint pain, muscle pain, fatigue
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Throat irritation
Clinical narrative: PATIENT PRESENT THROAT ITCH AND SKIN RASH
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Injection site pain, Malaise, Myalgia
Clinical narrative: Chills, muscle pain, tiredness, injection site pain, feeling malaise
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Swelling
Clinical narrative: 01/05/2021 AT 6PM: BODY ACHES, SEVERE HEADACHES. LOCAL SORENESS, SWELLING
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Nausea
Clinical narrative: Mpderna COVID-19 Vaccine EUA   At 0630 pm fatigue  At 0930 severe chills / nausea /joint pain arm pain whole time resolved by 5pm next day
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Deafness, Deafness unilateral, Hypoacusis, Sudden hearing loss
Clinical narrative: Jan 11-vaccination day.  On Jan 14, in afternoon had tinnitus and muffled hearing that went away.    The next morning Jan15, complete sudden hearing loss on left ear.   Tinnitus and muffled hearing that has not went away.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Jan 11-vaccination day.  On Jan 14, in afternoon had tinnitus and muffled hearing that went away.    The next morning Jan15, complete sudden hearing loss on left ear.   Tinnitus and muffled hearing that has not went away.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4 Nausea loss of appetite headache
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever day after vaccine pain redness soreness at injection site body aches fatigue fever up to 102.4 Nausea loss of appetite headache
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Photophobia
Clinical narrative: 1/6/21 dizzy, nausea, photophobia- 45 minutes after vaccine
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Received vaccine on 1.6. 2021.  Arm muscle was sore and "thicker". the rest of that day.  DId not take any NSAID or acetaminophen. Awoke on 1.7. 2021 and arm muscle was still "thick" but not quite as sore.  However, muscle was red, warm to touch and intensely pruritic. about the size of a golf ball. Tried not to scratch. Took no NSAID, tylenol or antihistamine.  Awoke on 1.8. 2021 and arm thickness almost gone and about 50% of itching gone.  Took no otcs. awoke on 1.9. 2021, thickness and itching gone until awoke on 1.14. 2021. on 1.14. 2021 arm was slightly thick. Definitely warm to touch, red and intensely pruritic. Size of a baseball. On 1.15. 2021 still itching but not as warm or red or thick.  on 1.16. 2021 most of these had dissipated. On 1.17. 2021 all were gone.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Received vaccine on 1.6. 2021.  Arm muscle was sore and "thicker". the rest of that day.  DId not take any NSAID or acetaminophen. Awoke on 1.7. 2021 and arm muscle was still "thick" but not quite as sore.  However, muscle was red, warm to touch and intensely pruritic. about the size of a golf ball. Tried not to scratch. Took no NSAID, tylenol or antihistamine.  Awoke on 1.8. 2021 and arm thickness almost gone and about 50% of itching gone.  Took no otcs. awoke on 1.9. 2021, thickness and itching gone until awoke on 1.14. 2021. on 1.14. 2021 arm was slightly thick. Definitely warm to touch, red and intensely pruritic. Size of a baseball. On 1.15. 2021 still itching but not as warm or red or thick.  on 1.16. 2021 most of these had dissipated. On 1.17. 2021 all were gone.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: swelling, redness, warmth to touch, tenderness-this began later 1/15/2021 and continued throughout the weekend
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Severe generalized  pain Slept 30+ hours after injection  Nausea
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Fatigue, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: CHEST PAIN WITH COUGH, FATIGUE, CONGESTION, MINOR SORE THROAT,
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Musculoskeletal stiffness, Pruritus
Clinical narrative: 3 in red, swollen, hot at injection site. Noticed day one, currently bigger on day 5. Also starting to itch. Stiff neck.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain
Clinical narrative: Symptoms started 1/6/21 at 10 PM. Chills, body aches, no fever. Symptoms mild on 1/7/21 10am. Took Tylenol Xtra Strength.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Dose number two given on day 16.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Soreness in left arm persisting for 3 days, fever
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Swelling face, Swelling of eyelid
Clinical narrative: On 12/25, had swollen face and eyelids, short of breath all day.  Took Claritan and swelling subsided.  Felt fatigued for the next two weeks after.  Next dose scheduled for 1/22 and do not want to take it until I get official direction on what needs to be done proactively and after the next vaccine to ensure my safety.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: "Moderna COVID19 Vaccine EUA" patient had nonintractable episodic headache from time of vaccine 01/04/2021 through the time of visit 01/15/2021.