chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, Urticaria
Clinical narrative: Hives; Localized arm pain/Left arm pain; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiration date unknown) via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. Medical history included nasal allergy from an unknown date. Concomitant medications included montelukast sodium (SINGULAIR) taken for nasal allergy and travoprost (TRAVATAN). The patient previously took Benadryl and experienced drowsy. The patient experienced localized arm pain (also reported as left arm pain) and fatigue both on 17Dec2020. The patient also experienced hives on 22Dec2020. The patient reported that she did not take any treatment in response to the events as Benadryl makes her very drowsy; patient might take one when she gets home from work. There were no relevant laboratory tests. The patient recovered from localized arm pain and fatigue both on 19Dec2020 while patient has not recovered from hives. The patient considered the events localized arm pain and fatigue as related to the vaccine while hives was not considered related to the vaccine (reported as "They didn't start right away, so don't make that connection."). The patient's due date for next dose is on 05Jan2021.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event urticaria cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Flushing, Hypoaesthesia
Clinical narrative: Facial numbness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EH9899) at single dose on 14Dec2020 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced some side effects that were on the list of side effects for the product; but she also did get some facial numbness that went away. She called to ask if she should be concerned about that because other people have said that facial numbness is not on the list of side effects for the product. The outcome of the event was recovered on an unspecified date.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: Facial numbness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EH9899) at single dose on 14Dec2020 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced some side effects that were on the list of side effects for the product; but she also did get some facial numbness that went away. She called to ask if she should be concerned about that because other people have said that facial numbness is not on the list of side effects for the product. The outcome of the event was recovered on an unspecified date.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EH9899) at single dose on 14Dec2020 for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient experienced some side effects that were on the list of side effects for the product; but she also did get some facial numbness that went away. She called to ask if she should be concerned about that because other people have said that facial numbness is not on the list of side effects for the product. The outcome of the event was recovered on an unspecified date.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary mass, Bone pain, Bone swelling, Chills, Lymphadenopathy
Clinical narrative: lymph nodes may be swollen in the armpit/Bump in her armpit; there was like a ball in the armpit and its sore; lymph nodes swollen was reported as worsened/ it is now worse this morning; Shakes; temperature was up to 102F, she had the fever; Chills; Collar bone being swollen; collar bone area is swollen and sore as well; This is a spontaneous report from a contactable nurse (patient herself).  A 41-year-old female patient (non-pregnant) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# EK5730), via an unspecified route of administration on 21Dec2020 in right arm at single dose for not get Covid again. There were no medical history and concomitant medications. Prior to vaccine, she did have a positive test for Covid, it was confirmed on 18Nov2020. Caller stated that she had had no reactions to any vaccines previously. Caller stated that she was calling about the COVID vaccine. She did not know if this was a possible side effect, she got the vaccine on Monday, and then 18 hours later her temperature was up to 102F, she had the fever, chills, and shakes. Now this morning, she was noticing her lymph nodes may be swollen in the armpit, there was like a ball in the armpit and its sore. Lymph nodes swollen was reported as worsened. She was noticing the collar bone area was swollen and sore as well. Caller stated that she was noticing all these symptoms on the side of where she got the vaccine. Caller further confirmed that on 21Dec2020 was the first dose of the covid vaccine. The temperature fever, and shakes started on 22Dec2020 at 1 am. The bump in her armpit was noticed this morning on 23Dec2020 however the collar bone being swollen she actually noticed that last night (22Dec2020) it was sore but it was now worse this morning. Her temperature of fever was 99.7 F on 23Dec2020 and today this morning and was gone now. Caller stated that the expiry date and the NDC was not listed on her card. Her 2nd dose was not scheduled yet, they just told her it would be in 3 weeks. Invesgation assessment was no. Outcome of fever was recovered in Dec2020, outcome of chills, shakes and "there was like a ball in the armpit and its sore" was unknown, and outcome of other events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: lymph nodes may be swollen in the armpit/Bump in her armpit; there was like a ball in the armpit and its sore; lymph nodes swollen was reported as worsened/ it is now worse this morning; Shakes; temperature was up to 102F, she had the fever; Chills; Collar bone being swollen; collar bone area is swollen and sore as well; This is a spontaneous report from a contactable nurse (patient herself).  A 41-year-old female patient (non-pregnant) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# EK5730), via an unspecified route of administration on 21Dec2020 in right arm at single dose for not get Covid again. There were no medical history and concomitant medications. Prior to vaccine, she did have a positive test for Covid, it was confirmed on 18Nov2020. Caller stated that she had had no reactions to any vaccines previously. Caller stated that she was calling about the COVID vaccine. She did not know if this was a possible side effect, she got the vaccine on Monday, and then 18 hours later her temperature was up to 102F, she had the fever, chills, and shakes. Now this morning, she was noticing her lymph nodes may be swollen in the armpit, there was like a ball in the armpit and its sore. Lymph nodes swollen was reported as worsened. She was noticing the collar bone area was swollen and sore as well. Caller stated that she was noticing all these symptoms on the side of where she got the vaccine. Caller further confirmed that on 21Dec2020 was the first dose of the covid vaccine. The temperature fever, and shakes started on 22Dec2020 at 1 am. The bump in her armpit was noticed this morning on 23Dec2020 however the collar bone being swollen she actually noticed that last night (22Dec2020) it was sore but it was now worse this morning. Her temperature of fever was 99.7 F on 23Dec2020 and today this morning and was gone now. Caller stated that the expiry date and the NDC was not listed on her card. Her 2nd dose was not scheduled yet, they just told her it would be in 3 weeks. Invesgation assessment was no. Outcome of fever was recovered in Dec2020, outcome of chills, shakes and "there was like a ball in the armpit and its sore" was unknown, and outcome of other events was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Bone pain, Bone swelling, Chills, Oedema peripheral
Clinical narrative: lymph nodes may be swollen in the armpit/Bump in her armpit; there was like a ball in the armpit and its sore; lymph nodes swollen was reported as worsened/ it is now worse this morning; Shakes; temperature was up to 102F, she had the fever; Chills; Collar bone being swollen; collar bone area is swollen and sore as well; This is a spontaneous report from a contactable nurse (patient herself).  A 41-year-old female patient (non-pregnant) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# EK5730), via an unspecified route of administration on 21Dec2020 in right arm at single dose for not get Covid again. There were no medical history and concomitant medications. Prior to vaccine, she did have a positive test for Covid, it was confirmed on 18Nov2020. Caller stated that she had had no reactions to any vaccines previously. Caller stated that she was calling about the COVID vaccine. She did not know if this was a possible side effect, she got the vaccine on Monday, and then 18 hours later her temperature was up to 102F, she had the fever, chills, and shakes. Now this morning, she was noticing her lymph nodes may be swollen in the armpit, there was like a ball in the armpit and its sore. Lymph nodes swollen was reported as worsened. She was noticing the collar bone area was swollen and sore as well. Caller stated that she was noticing all these symptoms on the side of where she got the vaccine. Caller further confirmed that on 21Dec2020 was the first dose of the covid vaccine. The temperature fever, and shakes started on 22Dec2020 at 1 am. The bump in her armpit was noticed this morning on 23Dec2020 however the collar bone being swollen she actually noticed that last night (22Dec2020) it was sore but it was now worse this morning. Her temperature of fever was 99.7 F on 23Dec2020 and today this morning and was gone now. Caller stated that the expiry date and the NDC was not listed on her card. Her 2nd dose was not scheduled yet, they just told her it would be in 3 weeks. Invesgation assessment was no. Outcome of fever was recovered in Dec2020, outcome of chills, shakes and "there was like a ball in the armpit and its sore" was unknown, and outcome of other events was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Hypertension
Clinical narrative: The patient is a nurse who was well until COVID vaccination.   She was observed for 15 after vaccination and did well.  She then returned to her medical unit.  About 30 minutes after vaccination, she became extremely cold, dizzy, had a transient headache, and was found to be hypertensive.  Her nurse colleagues placed her in a Bair hugger and she was still cold.  On arrival to the ED, she was hypertensive (max 170/107), subdued and initially reporting dizziness, headache now resolved, otherwise well-appearing on exam, with no signs or symptoms to suggest classic allergic reaction or anaphylaxis.  A tryptase level sent to further assess for the possibility of atypical allergic reaction, and she was initially just observed.  When she didn't improve and continued to report dizziness especially with standing, and reported that she hadn't had much to eat or drink all day, she was given a fluid bolus and a snack.     After 2.5 hours of observation, during which time the blood pressure fluctuated, the patient felt much improved.  She was less hypertensive (150/89 at discharge) with no intervening symptoms.  She was discharged and did not return to the ED.  I am not aware of follow-up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure fluctuation, Dizziness, Dizziness postural, Feeling cold, Headache
Clinical narrative: The patient is a nurse who was well until COVID vaccination.   She was observed for 15 after vaccination and did well.  She then returned to her medical unit.  About 30 minutes after vaccination, she became extremely cold, dizzy, had a transient headache, and was found to be hypertensive.  Her nurse colleagues placed her in a Bair hugger and she was still cold.  On arrival to the ED, she was hypertensive (max 170/107), subdued and initially reporting dizziness, headache now resolved, otherwise well-appearing on exam, with no signs or symptoms to suggest classic allergic reaction or anaphylaxis.  A tryptase level sent to further assess for the possibility of atypical allergic reaction, and she was initially just observed.  When she didn't improve and continued to report dizziness especially with standing, and reported that she hadn't had much to eat or drink all day, she was given a fluid bolus and a snack.     After 2.5 hours of observation, during which time the blood pressure fluctuated, the patient felt much improved.  She was less hypertensive (150/89 at discharge) with no intervening symptoms.  She was discharged and did not return to the ED.  I am not aware of follow-up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Tryptase
Clinical narrative: The patient is a nurse who was well until COVID vaccination.   She was observed for 15 after vaccination and did well.  She then returned to her medical unit.  About 30 minutes after vaccination, she became extremely cold, dizzy, had a transient headache, and was found to be hypertensive.  Her nurse colleagues placed her in a Bair hugger and she was still cold.  On arrival to the ED, she was hypertensive (max 170/107), subdued and initially reporting dizziness, headache now resolved, otherwise well-appearing on exam, with no signs or symptoms to suggest classic allergic reaction or anaphylaxis.  A tryptase level sent to further assess for the possibility of atypical allergic reaction, and she was initially just observed.  When she didn't improve and continued to report dizziness especially with standing, and reported that she hadn't had much to eat or drink all day, she was given a fluid bolus and a snack.     After 2.5 hours of observation, during which time the blood pressure fluctuated, the patient felt much improved.  She was less hypertensive (150/89 at discharge) with no intervening symptoms.  She was discharged and did not return to the ED.  I am not aware of follow-up.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Neck pain, Tachycardia
Clinical narrative: Adverse reaction lightheaded, shaky, tremor, buzzing feeling in both legs, tachicardia up to 125, weak, feeling burning on neck and shoulder . Mild prurìtus tua and moddle skin.  Treated with 50 mg IM of Benadryl after 15 minutes
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Limb discomfort, Livedo reticularis, Pruritus
Clinical narrative: Adverse reaction lightheaded, shaky, tremor, buzzing feeling in both legs, tachicardia up to 125, weak, feeling burning on neck and shoulder . Mild prurìtus tua and moddle skin.  Treated with 50 mg IM of Benadryl after 15 minutes
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Tremor
Clinical narrative: Adverse reaction lightheaded, shaky, tremor, buzzing feeling in both legs, tachicardia up to 125, weak, feeling burning on neck and shoulder . Mild prurìtus tua and moddle skin.  Treated with 50 mg IM of Benadryl after 15 minutes
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: I received my first Covid vaccine 12/29/2020 around 1 PM. 14 minutes after injection I had a major dizzy spell and I almost passed out. My blood pressure was 184/101. No hx of HTN. They watched me for a while. My blood pressure/HR stayed up all evening and I felt just horrible. Did not have a good night. Bodyaches, low-grade fever, headache, nausea. A lot of pain at the injection site.  I have to keep taking Tylenol every four hours in order to control symptoms. Blood pressure improving but still elevated based on my norm. I feel like my immune system is in overdrive. No airway and breathing difficulties, chest pain or shortness of breath or rash. Nausea but no vomiting or diarrhea.  Drinking a lot of fluids. It was verified prior to vaccine administration that there was no counterindication receiving the vaccine with a history of having Covid. No timeline was given in between the dose and  Covid recovery.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Feeling abnormal, Headache, Injection site pain
Clinical narrative: I received my first Covid vaccine 12/29/2020 around 1 PM. 14 minutes after injection I had a major dizzy spell and I almost passed out. My blood pressure was 184/101. No hx of HTN. They watched me for a while. My blood pressure/HR stayed up all evening and I felt just horrible. Did not have a good night. Bodyaches, low-grade fever, headache, nausea. A lot of pain at the injection site.  I have to keep taking Tylenol every four hours in order to control symptoms. Blood pressure improving but still elevated based on my norm. I feel like my immune system is in overdrive. No airway and breathing difficulties, chest pain or shortness of breath or rash. Nausea but no vomiting or diarrhea.  Drinking a lot of fluids. It was verified prior to vaccine administration that there was no counterindication receiving the vaccine with a history of having Covid. No timeline was given in between the dose and  Covid recovery.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: I received my first Covid vaccine 12/29/2020 around 1 PM. 14 minutes after injection I had a major dizzy spell and I almost passed out. My blood pressure was 184/101. No hx of HTN. They watched me for a while. My blood pressure/HR stayed up all evening and I felt just horrible. Did not have a good night. Bodyaches, low-grade fever, headache, nausea. A lot of pain at the injection site.  I have to keep taking Tylenol every four hours in order to control symptoms. Blood pressure improving but still elevated based on my norm. I feel like my immune system is in overdrive. No airway and breathing difficulties, chest pain or shortness of breath or rash. Nausea but no vomiting or diarrhea.  Drinking a lot of fluids. It was verified prior to vaccine administration that there was no counterindication receiving the vaccine with a history of having Covid. No timeline was given in between the dose and  Covid recovery.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Malaise, Palpitations, Rash
Clinical narrative: general feeling of malaise, redness over neck, chest and ears, tachycardia. Patient transported to ED via wheelchair for observation. Discharged from ED at 12:00 P.M
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Malaise, Tachycardia
Clinical narrative: general feeling of malaise, redness over neck, chest and ears, tachycardia. Patient transported to ED via wheelchair for observation. Discharged from ED at 12:00 P.M
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion involving PROQUAD; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 10-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T011302 (conflicting information as it was also reported as T021302), expiration date 19-FEB-2021 (route of administration not provided) for prophylaxis.  The vaccine had a temperature excursion of -5 degrees Celsius for 20 hours. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2012USA010555: US-009507513-2012USA010556: US-009507513-2012USA010579: US-009507513-2012USA010585: US-009507513-2012USA010590: US-009507513-2012USA010629: US-009507513-2012USA010652: US-009507513-2012USA010667: US-009507513-2012USA010678: US-009507513-2012USA010683: US-009507513-2012USA010686: US-009507513-2012USA010698: US-009507513-2012USA010722: US-009507513-2012USA010725: US-009507513-2012USA011227:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion involving PROQUAD; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 04-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T011302 (conflicting information as it was also reported as T021302), expiration date 19-FEB-2021 (route of administration not provided) for prophylaxis.  The vaccine had a temperature excursion of -5 degrees Celsius for 20 hours. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2012USA010555: US-009507513-2012USA010556: US-009507513-2012USA010579: US-009507513-2012USA010585: US-009507513-2012USA010590: US-009507513-2012USA010592: US-009507513-2012USA010652: US-009507513-2012USA010667: US-009507513-2012USA010678: US-009507513-2012USA010683: US-009507513-2012USA010686: US-009507513-2012USA010698: US-009507513-2012USA010722: US-009507513-2012USA010725: US-009507513-2012USA011227:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: no adverse event; patient received expired PNEUMOVAX; This spontaneous report as received from a registered nurse (also reported as medical assistant) referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.      On 21-DEC-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, lot # S005856 for prophylaxis (dose, route and site of administration were not reported) which had expired on 03-DEC-2020 (expired product administered).  There were no adverse events or product quality issues reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S005856; expirationdate: 03-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Tachycardia
Clinical narrative: not sure if last nights episode was an A Fib event; Woke up with a bout of tachycardia; This case was reported by a consumer and described the occurrence of atrial fibrillation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included paroxysmal atrial fibrillation (the patient not had any A Fib symptoms since an ablation was performed last summer).   On 15th December 2020, the patient received the 1st dose of Shingrix. In December 2020, 8 hrs after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria GSK medically significant) and tachycardia. On an unknown date, the outcome of the atrial fibrillation and tachycardia were recovered/resolved.   The reporter considered the atrial fibrillation and tachycardia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The patient had paroxysmal A-Fib for which he/she was being treated. The patient received 1st dose of Shingrix and 8 hours after vaccination, the patient woke up at around midnight with a bout of tachycardia and it subsided after about 10 to 15 minutes. The patient was not sure if last night's episode was an A Fib event or just Tachycardia and was trying to confirm that with his/her cardiologist. The patient wanted to know should he/she still get the 2nd shot as required in 2 months. The patient does believe that the event was related to the vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: suffering from recurrent zoster reactivation / SUSPECTED VACCINATION FAILURE / breakthrough shingles episodes; suffering from recurrent zoster reactivation since; It has been a living torment.; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix and an unknown time after starting famciclovir, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and feeling bad. The patient was treated with famciclovir. On an unknown date, the outcome of the vaccination failure, herpes zoster and feeling bad were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and feeling bad to be related to Shingrix.  Additional details were provided as follows: The reporter (patient) was a family physician, reported via a webform. The age at vaccination was not reported. The patient received Shingrix vaccine over 2 years ago and since suffering from recurrent zoster reactivation. The patient stated that he was not interested in a lawsuit. The patient stated that he was just hoping there was a scientist there that could potentially stop what was happening. The patient wanted to know that had the adjuvant caused an inflammatory response that had led to this and was there some sort of treatment to reverse this.   The patient stated that it had been a living torment and he hope someone could help. The patient seen specialists and was on high doses of famciclovir on an ongoing basis just to keep it at bay, with breakthrough shingles episodes despite medication. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. This case had been linked with US2020249597 (wife case), reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020249597:same reporter (wife case)
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Rheumatoid arthritis, Vaccination failure
Clinical narrative: suffering from recurrent zoster reactivation / suspected vaccination failure / breakthrough shingles episodes; developed Rheumatoid arthritis since vaccination; suffering from recurrent zoster reactivation / breakthrough shingles episodes; It has been a living torment; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix and an unknown time after starting famciclovir, the patient experienced vaccination failure (serious criteria GSK medically significant), rheumatoid arthritis (serious criteria GSK medically significant), herpes zoster and feeling bad. The patient was treated with famciclovir. On an unknown date, the outcome of the vaccination failure, rheumatoid arthritis, herpes zoster and feeling bad were unknown.   It was unknown if the reporter considered the vaccination failure, rheumatoid arthritis, herpes zoster and feeling bad to be related to Shingrix.  Additional details were provided as follows: The reporter was a family physician, reported via a webform. The patient (reporter's wife) was a retired nurse. The age at vaccination was not reported. The patient received Shingrix vaccine over 2 years ago and since suffering from recurrent zoster reactivation. The reporter stated that he was not interested in a lawsuit. The reporter was just hoping there was a scientist there that could potentially stop what was happening. The reporter wanted to know that had the adjuvant caused an inflammatory response that had led to this and was there some sort of treatment to reverse this. The patient had also developed rheumatoid arthritis since vaccination. The reporter stated that it had been a living torment. The patient seen specialists and was on high doses of famciclovir on an ongoing basis just to keep it at bay, with breakthrough shingles episodes despite medication. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. This case had been linked with US2020249598, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020249598:same reporter (husband case)
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite
Clinical narrative: His wife ended up contracting Alpha-Gal by Ticks; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via contactable consumers (patient's husband, and patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient ended up contracting alpha-gal by ticks on an unspecified date. The reporter asked about the ingredients of the COVID-19 vaccine, if it contains mammalian cells, dairy, guinea pig 1 cell, or cholesterol origin. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure orthostatic, Electrocardiogram, Feeling abnormal, Laboratory test
Clinical narrative: near syncope episode, orthostatic; feels a little foggy; This is a spontaneous report from a contactable Physician. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on unspecified date in 2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The emergency medicine physician was monitoring a patient that came in from a vaccination event, stated that it was Pfizer BioNTech Covid 19 vaccine. The patient had a near syncopal episode. They did orthostatics (unspecified) and found that she was orthostatic (near syncope episode, orthostatic). There was no anaphylaxis reaction or allergic reaction. She still felt a little foggy. The physician did a blood glucose, labwork and EKG that look good. The physician wanted to know if there was any data for things that they should looking for with the vaccination and  will direct the patient to contact Pfizer to report it. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: near syncope episode, orthostatic; feels a little foggy; This is a spontaneous report from a contactable Physician. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on unspecified date in 2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The emergency medicine physician was monitoring a patient that came in from a vaccination event, stated that it was Pfizer BioNTech Covid 19 vaccine. The patient had a near syncopal episode. They did orthostatics (unspecified) and found that she was orthostatic (near syncope episode, orthostatic). There was no anaphylaxis reaction or allergic reaction. She still felt a little foggy. The physician did a blood glucose, labwork and EKG that look good. The physician wanted to know if there was any data for things that they should looking for with the vaccination and  will direct the patient to contact Pfizer to report it. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Sore arm; Dizziness; Tiredness; nausea; fever of 102°F; severe headache; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date unknown) intramuscular at the left arm on 18Dec2020 at a single dose for COVID-19 immunization in the hospital. Medical history included allergy to Sulfa from an unknown date. Concomitant medications included escitalopram and clonazepam. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient experienced sore arm after first 8 hours; dizziness, tiredness, nausea, fever of 102 F and severe headache all on an unspecified date in Dec2020 (reported as 12Dec2020 at 01:15 AM). The patient was tested for COVID post vaccination and had a nasal swab with negative results. The patient recovered from sore arm, dizziness, tiredness, nausea, fever of 102 F and severe headache all on an unspecified date in Dec2020.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Sore arm; Dizziness; Tiredness; nausea; fever of 102°F; severe headache; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date unknown) intramuscular at the left arm on 18Dec2020 at a single dose for COVID-19 immunization in the hospital. Medical history included allergy to Sulfa from an unknown date. Concomitant medications included escitalopram and clonazepam. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient experienced sore arm after first 8 hours; dizziness, tiredness, nausea, fever of 102 F and severe headache all on an unspecified date in Dec2020 (reported as 12Dec2020 at 01:15 AM). The patient was tested for COVID post vaccination and had a nasal swab with negative results. The patient recovered from sore arm, dizziness, tiredness, nausea, fever of 102 F and severe headache all on an unspecified date in Dec2020.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Nasal congestion, Oropharyngeal pain
Clinical narrative: Fever of 101.0; sore throat; light headedness; aches; chills; excessive sweating; nasal congestion; This is a spontaneous report from a contactable healthcare professional. A 32-year-old female patient received BNT162B2 (lot number and expiry date unknown) at a hospital, at age 32-year-old, intramuscular, on the left arm on 21Dec2020 19:45, at single dose (dose 1), for COVID-19 immunization. Medical history included anemia, anxiety, and urticaria. Patient was also diagnosed with COVID-19 prior to vaccination. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), lorazepam (ATIVAN), clonazepam (KLONOPIN), and diphenhydramine hydrochloride (BENADRYL) from unspecified dates. The patient previously took hydrocodone/acetaminophen (VICODIN), oxycodone / paracetamol (PERCOCET), pseudoephedrine hydrochloride (SUDAFED) on unspecified dates and had known allergies. On 21Dec2020 at 23:00 , the patient experienced fever of 101.0, sore throat, light headedness, aches, chills, excessive sweating and nasal congestion. No treatment was received for the events. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the events was recovering. Case is reported as non-serious.   Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever of 101.0; sore throat; light headedness; aches; chills; excessive sweating; nasal congestion; This is a spontaneous report from a contactable healthcare professional. A 32-year-old female patient received BNT162B2 (lot number and expiry date unknown) at a hospital, at age 32-year-old, intramuscular, on the left arm on 21Dec2020 19:45, at single dose (dose 1), for COVID-19 immunization. Medical history included anemia, anxiety, and urticaria. Patient was also diagnosed with COVID-19 prior to vaccination. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication included ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), lorazepam (ATIVAN), clonazepam (KLONOPIN), and diphenhydramine hydrochloride (BENADRYL) from unspecified dates. The patient previously took hydrocodone/acetaminophen (VICODIN), oxycodone / paracetamol (PERCOCET), pseudoephedrine hydrochloride (SUDAFED) on unspecified dates and had known allergies. On 21Dec2020 at 23:00 , the patient experienced fever of 101.0, sore throat, light headedness, aches, chills, excessive sweating and nasal congestion. No treatment was received for the events. Since the vaccination, has the patient has not been tested for COVID-19. The outcome of the events was recovering. Case is reported as non-serious.   Information on the lot/batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Urticaria
Clinical narrative: hives and sore throat the day after receiving COVID19 Vaccine; hives and sore throat the day after receiving COVID19 Vaccine; This is a spontaneous report from a contactable Nurse. A 46-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140, Expiry Date: 31Mar2021), intramuscular (injection left deltoid) on 18Dec2020 (around 1621) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has no prior vaccinations. The patient experienced hives/ She had body hives all over and sore throat the day after receiving COVID19 vaccine on 19Dec2020, within 24 hours. The patient took BENADRYL and was fine. Reporter was not sure if the patient would receive the second dose. The adverse event did not require a visit to the emergency room nor physician office. Outcome of the event was recovered on 19Dec2020.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Viral test negative
Clinical narrative: headache; fever/as high as 102.9 degrees Fahrenheit, now (22Dec2020) it's just over 100.0 degrees Fahrenheit; This is a spontaneous report from a contactable nurse.  A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK5730, via an unspecified route of administration, at the right arm, from 17Dec2020 18:30 at a single dose for covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), osteoarthritis (OA); patient already suffer joint pain and her current joint pain is no worse than usual, Raynaud's, palpitations and joint pain. Concomitant medications included amfetamine aspartate monohydrate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (MYDAYIS); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); and ibuprofen (IBUPRO).  It was reported that the patient has had fever daily. Initially on 18Dec2020 at 9:00, it was as high as 102.9 degrees Fahrenheit, now (22Dec2020) it's just over 100.0 degrees Fahrenheit. She also has had a headache daily(reported as started on 18Dec2020 at 9:00), but today's headache is much worse than previous days. The patient underwent lab tests and procedures on 18Dec2020 which included sars-cov-2 test/COVID-19 test/nasal swab with negative result. Outcome of events was reported as not recovered.  Therapeutic measures were taken as a result of events headache and fever included OTC medications (unspecified).  Follow-up attempts are completed. The information on the batch/lot number was obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia
Clinical narrative: Chills; joint pain; muscle pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 21-year-old female patient (not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular (Left arm) on 22Dec2020 09:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  There were no other medications received within 2 weeks of vaccination. The patient experienced chills, joint pain, and muscle pain on 22Dec2020 (19:00). There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was recovering. This case is non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Chest pain, Chills, Cough, Decreased appetite
Clinical narrative: Fever; chills; body aches; headaches; malaise; chest pain in side-lying; cough; diminished appetite; This is a spontaneous report from a contactable healthcare professional. A 30-year-old male (also reported as female) patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), intramuscular in the left arm on 17Dec2020 at 15:45 at a single dose for immunization. The patient had no relevant medical history. The patient din not have Covid prior to the vaccination and had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. It was reported that the patient had no other medications in two weeks and did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced fever, chills, body aches, headaches, malaise, chest pain in side-lying, cough, and diminished appetite starting at 11pm (23:00) on 17Dec2020 and gradually decreasing mild symptoms still present on 22Dec2020. The patient received no treatment for the adverse events and was not tested for COVID-19 after the vaccination. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause or require prolonged hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; headaches; malaise; chest pain in side-lying; cough; diminished appetite; This is a spontaneous report from a contactable healthcare professional. A 30-year-old male (also reported as female) patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), intramuscular in the left arm on 17Dec2020 at 15:45 at a single dose for immunization. The patient had no relevant medical history. The patient din not have Covid prior to the vaccination and had no known allergies to medications, food, or other products. The patient's concomitant medications were not reported. It was reported that the patient had no other medications in two weeks and did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced fever, chills, body aches, headaches, malaise, chest pain in side-lying, cough, and diminished appetite starting at 11pm (23:00) on 17Dec2020 and gradually decreasing mild symptoms still present on 22Dec2020. The patient received no treatment for the adverse events and was not tested for COVID-19 after the vaccination. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause or require prolonged hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, HIV test positive, Malaise, Pain in extremity
Clinical narrative: Left arm pain; generalized malaise; i was wiped out and wanted to sleep all day; This is a spontaneous report from a contactable Nurse. A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), via an unspecified route of administration on 22Dec2020 07:15 at a single dose (dose number 1, left arm) for COVID-19 immunization. Medical history included HIV+ and COVID-19 from an unspecified date. Concomitant medication included bupropion hydrochloride (WELLBUTRIN), trazodone, oxazepam (SERAX), valaciclovir hydrochloride (VALTREX), and ibuprofen from an unspecified date for an unspecified indication. The patient has allergies to Tegretol and AZT. The patient was diagnosed with COVID-19 prior to vaccination. The patient had no other vaccine in four weeks. The patient experienced left arm pain, generalized malaise (he was wiped out and wanted to sleep all day) on 22Dec2020 09:00. Treatment was not given. Event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19. The events were assessed as non-serious.