chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling, Throat irritation, Vaccination site pain
Clinical narrative: sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; Swollen soft palate, nose, eyes; scratchy throat on eating red meat, milk, or cheese; muscle and joint pain; earache; pain was all over; muscle and joint pain; headache; exhaustion; pain at injection site; slight fever; mild nausea; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264), on right arm via an unknown route of administration on 03Feb2021 13:45 for COVID-19 immunization. Medical history included VonWillebrand's and history of lyme disease. The patient had allergy to peanut and allergy to latex. Concomitant medications included unspecified vitamin supplements. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL3302) on Left arm, on 13Jan2021 13:30 for COVID-19 immunization. Patient stated, "After first shot in left arm, only on her left side she had: Muscle and joint pain, earache, goopy eye, headache, exhaustion, and pain at injection site from 12 hours to 36 hours after shot administered. Second shot in right arm: Same as above (muscle and joint pain, earache, headache, exhaustion, and pain at injection site), although no eye drainage and pain was all over with slight fever, mild nausea in Feb2021. Lasted from 12 hours to 36 hours after the test. Arm remained sore longer, but not problematic. Bizarre possible response: 6 days after second shot on 09Feb2021 17:30, the patient experienced sudden allergic type reaction to mammal products; Swollen soft palate, nose, eyes, scratchy throat on eating red meat, milk, or cheese. Patient did not need epi-pen but needed double dose of benadryl. Events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Benadryl and epi-pen on hand was received as treatment for events. The events were assessed as non-serious by the reporter. Outcome of events muscle and joint pain, earache, headache, exhaustion, pain at injection site, pain was all over, slight fever, mild nausea was recovered in Feb2021, whereas outcome for other events was reported as unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: pneumonia; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Three weeks after the first vaccination, the patient experienced pneumonia on an unspecified date. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Tiredness; Fever; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 09Feb2021 at 17:00 at a single dose on the right arm for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 09Feb2021 at 19:00, the patient experienced headache, tiredness and fever. Patient received Acetaminophen as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered on an unspecified date. The events were considered non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased
Clinical narrative: Slight increased heartbeat for about one hour; Headache for the rest of the day; This is a spontaneous report from a contactable consumer (patient) reported that a 64-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: En-6201, expiry date unknown) in the hopsital via an unspecified route of administration on 11Feb2021 at 12:00 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced slight increased heartbeat for about one hour at 12:30 then a headache for the rest of the day both on 11Feb2021. The outcome of the event slight increased heartbeat for about one hour was recovered on 11Feb2021 at 13:30 and the outcome of the event headache for the rest of the day was recovered on Feb2021. The patient did not receive treatment for the events. The events was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm and headache overnight; sore arm and headache overnight; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration (right arm), on 11Feb2021 10:00, at single dose, for covid-19 immunization. Medical history included celiac disease. Concomitant medication included bupropion. The patient experienced sore arm and headache overnight on 11Feb2021 18:00. The patient recovered from the events on 12Feb2021. The patient took ibuprofen (ADVIL) as treatment for the events (self-prescribed). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.   No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Dysphonia, Dyspnoea
Clinical narrative: Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Loss of Appetite; Throat swelling; Headache; Malaise; Shortness of Breath; Thick Mucus in Nose & Throat; Thick Mucus in Nose and Throat; Horseness and Sore Throat; Horseness and Sore Throat; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on right arm on31Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included autoimmune, tachycardia, acid reflux, penicillin allergy, walnuts allergy. Concomitant medication included estradiol and levothyroxine. The patient previously took lanolin and erythromycin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 patient experienced fatigue, body aches/ soreness, chills, swollen and sore tongue, diarrhea, loss of appetite, throat swelling requiring 2 visits to the ER (emergency room). Culminating in Steroid injection and oral Prednisone. Headache, malaise, shortness of breath, thick mucus in nose and throat, hoarseness and sore throat. The adverse events result in Doctor or other healthcare professional office/ clinic visit and Emergency room/department or urgent care. The seriousness of the events was assessed as non-serious by the reporter. Therapeutic measurements were received for the events with steroid injection at the ER and oral Prednisone. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glossodynia, Headache, Increased upper airway secretion, Increased viscosity of upper respiratory secretion
Clinical narrative: Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Loss of Appetite; Throat swelling; Headache; Malaise; Shortness of Breath; Thick Mucus in Nose & Throat; Thick Mucus in Nose and Throat; Horseness and Sore Throat; Horseness and Sore Throat; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on right arm on31Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included autoimmune, tachycardia, acid reflux, penicillin allergy, walnuts allergy. Concomitant medication included estradiol and levothyroxine. The patient previously took lanolin and erythromycin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 patient experienced fatigue, body aches/ soreness, chills, swollen and sore tongue, diarrhea, loss of appetite, throat swelling requiring 2 visits to the ER (emergency room). Culminating in Steroid injection and oral Prednisone. Headache, malaise, shortness of breath, thick mucus in nose and throat, hoarseness and sore throat. The adverse events result in Doctor or other healthcare professional office/ clinic visit and Emergency room/department or urgent care. The seriousness of the events was assessed as non-serious by the reporter. Therapeutic measurements were received for the events with steroid injection at the ER and oral Prednisone. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Pain, Pharyngeal swelling, Swollen tongue
Clinical narrative: Fatigue; Body Aches/Soreness; Chills; Swollen and Sore Tongue; Swollen and Sore Tongue; Diarrhea; Loss of Appetite; Throat swelling; Headache; Malaise; Shortness of Breath; Thick Mucus in Nose & Throat; Thick Mucus in Nose and Throat; Horseness and Sore Throat; Horseness and Sore Throat; This is a spontaneous report from a contactable consumer (patient herself). A 70-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on right arm on31Jan2021 08:30 at single dose for COVID-19 immunisation. Medical history included autoimmune, tachycardia, acid reflux, penicillin allergy, walnuts allergy. Concomitant medication included estradiol and levothyroxine. The patient previously took lanolin and erythromycin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 patient experienced fatigue, body aches/ soreness, chills, swollen and sore tongue, diarrhea, loss of appetite, throat swelling requiring 2 visits to the ER (emergency room). Culminating in Steroid injection and oral Prednisone. Headache, malaise, shortness of breath, thick mucus in nose and throat, hoarseness and sore throat. The adverse events result in Doctor or other healthcare professional office/ clinic visit and Emergency room/department or urgent care. The seriousness of the events was assessed as non-serious by the reporter. Therapeutic measurements were received for the events with steroid injection at the ER and oral Prednisone. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: lips swelling; This is a spontaneous report from a contactable consumer reported for herself.    A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot number #EL9267on 14Feb2021 09:00 AM (at 58 year old) at single dose via unspecified route at the left arm, for COVID-19 immunization. Medical history included Anaphylactic reaction to the Capsaicin Family, thyroid and High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID), lisinopril, verapamil and loratadine (CLARITIN). The patient was not pregnant. No COVID prior vaccination. The patient had not been tested for COVID since the vaccination. On 14Feb2021 09:15 AM the patient experienced lips swelling. The outcome of the event was unknown. The patient visited Emergency room for the event and treatment was received, steroid shot and prednisone for 5 days.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Joint swelling, Malaise, Pain, Pyrexia
Clinical narrative: swelling around left wrist and hand-same arm as vaccine injection site; "a little fever", "felt a little warm.  A little unwell, not that bad"; swelling around left wrist and hand-same arm as vaccine injection site; pain/throbbing pain at the swelling location; A little unwell, not that bad; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling around left wrist and hand-same arm as vaccine injection site. He also said there was pain/throbbing pain at the swelling location. He also had "a little fever", "felt a little warm. A little unwell, not that bad". He did not take his temperature but stated "I took Tylenol and iced swelling location, it helped some. It is not quit as bad today, no more throbbing pain, still swelling and sore". The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: swelling around left wrist and hand-same arm as vaccine injection site; "a little fever", "felt a little warm.  A little unwell, not that bad"; swelling around left wrist and hand-same arm as vaccine injection site; pain/throbbing pain at the swelling location; A little unwell, not that bad; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling around left wrist and hand-same arm as vaccine injection site. He also said there was pain/throbbing pain at the swelling location. He also had "a little fever", "felt a little warm. A little unwell, not that bad". He did not take his temperature but stated "I took Tylenol and iced swelling location, it helped some. It is not quit as bad today, no more throbbing pain, still swelling and sore". The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Shot was very painful; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for invasive pneumococcal disease (immunization). The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) and the shot was very painful on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Shot was very painful; This is a spontaneous report from a Pfizer-sponsored program, 2020_2021 Strategy Research. A contactable healthcare professional (patient) reported that a male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for invasive pneumococcal disease (immunization). The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) and the shot was very painful on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Shot was very painful; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional reported that a male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 13; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for invasive pneumococcal disease (immunization). The patient's medical history and concomitant medications were not reported. The patient received pneumococcal 13-valent conjugate vaccine (Diphtheria CRM 197 Protein) and the shot was very painful on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in his arm after his vaccination; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for 2 patients. This is the second of two reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife received the shot and she noticed her arm was getting sore. The wife stated that the patient (her husband) also mentioned that he had soreness in his arm after his vaccination, but she does not think she wants to complete a report for her husband who had a sore arm from the COVID vaccination. She says he was not here right now, and he doesn't have anything wrong with him. She doesn't really think that he has anything else and she doesn't think it was that sore, he just commented that night that it was a little sore. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021156186 Same reporter/drug, similar event, different patient
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site bruising, Vaccination site pain
Clinical narrative: Injection site bruising and pain; Injection site bruising and pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), via an unspecified route of administration on 15Jan2021 08:00 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin.  The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced nausea, injection site bruising and pain at 15Jan2021 09:00AM. No prior covid vaccination. No Covid tested post vaccination. Facility type vaccine was Workplace Clinic. No other vaccine in four weeks. Events resulted in none of the above. Patient was recovered in 2021. No treatment received for adverse events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021182443 same reporter, same patient, same product (different dose), different events
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: angioedema - swelling of upper lip; This is a spontaneous report from a contactable physician. A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via intramuscular on 03Feb2021 12:00 at single dose in left arm for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM II), hypertension (HTN). No covid prior vaccination and no covid tested post vaccination. No known allergies. Concomitant medication included lisinopril. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via intramuscular on 14Jan2021 12:00 at single dose in left arm for COVID-19 immunization. No other vaccine in four weeks. The patient experienced angioedema - swelling of upper lip on 05Feb2021 08:00.  The event was resulted in doctor or other healthcare professional office/clinic visit. Treatment included prednisone/diphenhydramine/Pepcid. The outcome of the event was recovered in Feb2021.; Sender's Comments: A causal relationship between BNT162B2 and the event angioedema cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Staphylococcal infection
Clinical narrative: has a spot coming on that looks the same and feels the same as the MRSA he had before/red spot/little swollen on the outside/like a pimple; This is a spontaneous report from contactable consumers (patient and patient's wife) reported that a 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on the left arm on 26Jan2021 16:15 at a single dose for Covid-19 immunization. Medical history included ongoing blood pressure high, rheumatoid arthritis and diabetes; all from an unknown date and were diagnosed many years ago. The patient had MRSA before 12 years ago (2009). Concomitant medications included prednisone. It was reported that 12 years ago, he had MRSA. He thought he has it again. The patient clarified that he had MRSA about 12 years ago and he doesn't know if there was a chance the COVID-19 triggered the MRSA. He was not positive it was even MRSA. He has a spot coming on that he noticed last night (08Feb2021). The spot he has now looks the same and feels the same as the MRSA he had before. However, it's not the in the same area. It's in the same arm he got the shot in, which he doubted it has anything to do with the COVID-19 vaccine. It just looks and feels the same as it did 12 years ago when he had MRSA. The caller explains the spot was about the size of a dime, maybe a little bit smaller. There was a red spot of course. It shows on the outside, it's a little swollen on the outside, but there was a bigger area on the inside. He explained further there was more of it on the inside. The patient's wife told him it looks like a pimple. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died 15 min later; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reported that a female patient (mother) of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. The reporter stated her mother took the vaccine and died 15 min later.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died 15 min later
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia, Vaccination site pain
Clinical narrative: Nausea/Mild nausea; Severe headache; Dry mouth; General Malaise; fatigue; Nighttime sweats.; Likely a low-grade fever; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Left arm), via an unspecified route of administration on 04Feb2021 08:15 AM at single dose for covid-19 immunisation. Patient was known allergies to penicillin. The patient's concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL3248, vaccine location= Left arm), on 15Jan2021 08:00 AM for covid-19 immunisation and experienced nausea, injection site bruising and pain. Patient was not pregnant. The patient experienced injection site pain, severe headache, dry mouth, mild nausea, general malaise, fatigue, nighttime sweats and likely a low-grade fever all at 05Feb2021 04:00AM. No other vaccine in four weeks. No covid tested post vaccination. Events resulted in none of the above. No treatment received for adverse events. The patient was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162107 same reporter, same patient, same product (different dose), different events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Scab, Scratch
Clinical narrative: They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They are scabbed like almost like scars; that scars on my arm; They were burning kind of and they scabbed over; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; This is a spontaneous report from a contactable consumer reported for herself.  A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), lot number# EL0142 via unspecified route at the arm on 26Jan2021 (at 56 year old) at single dose for COVID-19 immunization. Medical history was not reported, and concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient reported as follows: "I was scratching and it was starts to bleed ,I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection , they were kind of itched; they are scabbed like almost like scars; that scars on my arm , they were burning kind of and they scabbed over .Then the consumer added: I would say probably came on about I have to guess may be 3 to 5 days after I had the shot and they were kind of the itched and I was scratching and it was starts to bleed that want to I don't know about a week and a few days after I noticed on my arm, also noticed on my back of right trapezius muscle. So on top like on my in my back and behind my neck and it started all of my right side and I was awaken one night because they were burning kind of and they scabbed over so it was just look like scabbed kind of and when I scratch it scab kind of come off and it would bleeding kind of burn. "they are still there but they are having healed like on my arm have like you can see them, but they are scabbed like almost like scars. That scars on my arm, I can see they are still there, but they are not bleeding anymore." Regarding treatment she stated, "I only took Benadryl on one night because night before they woke me up because it was burning. They were hurting when I scratched them." The patient was recovered from wound bleeding while the outcome of the other events was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Vaccination site macule, Wound haemorrhage
Clinical narrative: They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They were kind of itched; I was scratching and it was starts to bleed; They are scabbed like almost like scars; that scars on my arm; They were burning kind of and they scabbed over; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection; This is a spontaneous report from a contactable consumer reported for herself.  A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), lot number# EL0142 via unspecified route at the arm on 26Jan2021 (at 56 year old) at single dose for COVID-19 immunization. Medical history was not reported, and concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient reported as follows: "I was scratching and it was starts to bleed ,I had a type of rash; little red dots on my arm, on my forearm and also my trapezius of on the same site of the injection , they were kind of itched; they are scabbed like almost like scars; that scars on my arm , they were burning kind of and they scabbed over .Then the consumer added: I would say probably came on about I have to guess may be 3 to 5 days after I had the shot and they were kind of the itched and I was scratching and it was starts to bleed that want to I don't know about a week and a few days after I noticed on my arm, also noticed on my back of right trapezius muscle. So on top like on my in my back and behind my neck and it started all of my right side and I was awaken one night because they were burning kind of and they scabbed over so it was just look like scabbed kind of and when I scratch it scab kind of come off and it would bleeding kind of burn. "they are still there but they are having healed like on my arm have like you can see them, but they are scabbed like almost like scars. That scars on my arm, I can see they are still there, but they are not bleeding anymore." Regarding treatment she stated, "I only took Benadryl on one night because night before they woke me up because it was burning. They were hurting when I scratched them." The patient was recovered from wound bleeding while the outcome of the other events was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: She had little reaction like fever; This is a spontaneous report from a contactable consumer (patient's son/daughter) via Pfizer sponsored Program.   An 84-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose in Feb2021 (9 days before this report) for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient had little reaction like fever in Feb2021 and also went to the hospital. The event was considered life threatening. The outcome of event was unknown.  Reporter wanted to know if her reaction was related to the vaccine even though she received it 9 days before, if it was possible that she was exposed to the virus and since she already received the vaccine if it will test false positive, and if she tested positive will she still be able to receive the 2nd dose.  Information on the lot/batch number has been requested.
Age: 15.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Expired product administered
Clinical narrative: a patient received an expired RECOMBIVAX; This spontaneous report as received from a nurse referring to a 15 years old male patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.     On 21-DEC-2020, the patient was vaccinated with expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose # 2; 1 dosage form; lot # R001529, expiration date 07-NOV-2020, route was not provided) for prophylaxis. No further information was available. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: R001529; expirationdate: 07-NOV-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: UNK, VARZOS
Symptoms: Injection site inflammation, Nodular rash, Oral mucosal eruption
Clinical narrative: reaction around the mouth / white nodule like bumps; reaction around the mouth / inflammation in area of filler injection; This case was reported by a other health professional via other manufacturer and described the occurrence of nodular rash in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included hyaluronic acid (Restylane) for product used for unknown indication.   In December 2020, the patient received Shingles vaccine. On 18th June 2020, the patient started Restylane 1 ml at an unknown frequency. In December 2020, less than a month after receiving Shingles vaccine, the patient experienced nodular rash and injection site inflammation. The action taken with Restylane was unknown. On an unknown date, the outcome of the nodular rash and injection site inflammation were unknown.   It was unknown if the reporter considered the nodular rash and injection site inflammation to be related to Shingles vaccine.  Additional details were provided as follow: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The patient used 1ml Restylane 1.0 on patient in lips and NLF (nasolabial folds). The patient noticed white nodule like bumps and inflammation in area of filler injection site of Restylane. The patient experienced a reaction around the mouth in December 2020 also after receiving the Shingles vaccine, which described as white nodule like bumps and inflammation in area of filler injection.  The patient was injected with the COVID vaccine in January, 2021 but did not have a reaction associated with this. The patient received Moderna vaccine in January 2021. It was unknown if the reporter considered the nodular rash and injection site inflammation to be related to Restylane.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: Pain at injection site; Body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included eczema and arthritis.   On 20th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain and general body pain to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient herself. The patient received Shingrix in the left arm. The patient reported body aches and pain at injection site which lasted a day and then resolved.  The reporter consented to follow up. For tolerance in 2nd dose refer case US2021014428.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021014428:Same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: arm was tender at site that night /  soreness; This case was reported by a consumer via and described the occurrence of injection site tenderness in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number J454X, expiry date 4th October 2022) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovered/resolved.   It was unknown if the reporter considered the injection site tenderness to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient himself/herself. The patient did not have a history of reaction to any previous vaccines. The patient experienced that her arm was tender at site that night, and next day the soreness was lessened, and by 3rd day it was fine. The patient had not yet discussed symptoms with her physician and was referred to her physician for further evaluation and discussion. The reporter consented to follow up with her as well as with her pharmacist who administered the vaccine. For tolerance of 2nd dose, refer case US2021025175. This case had been linked with US2021025187 and US2021025175, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025187:same reporter US-GLAXOSMITHKLINE-US2021025175:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: got some rash in my legs just like the chicken pox; This case was reported by a consumer via interactive digital media and described the occurrence of varicella-like rash in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown.   It was unknown if the reporter considered the varicella-like rash to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  Patient received the 2nd dose of shingles vaccine and got some rash on legs just like the chicken pox. Patient mentioned that it was still better than having shingles. It was stated that patient had a cousin who had it twice and cousin said it was the most painful thing in the world. Patient paid insurance for himself and for his wife.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia
Clinical narrative: knocked me on my ass; This case was reported by a consumer and described the occurrence of debility in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced debility. On an unknown date, the outcome of the debility was unknown.   It was unknown if the reporter considered the debility 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 captured as adult as per vaccine indication. Patient mentioned that shingles shot were two shot series and basically 95 percent effective,however Patient received the Shingrix and patient knocked on ass for about 1 1/2 days.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sore arm at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient' friend. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient experienced sore arms at the injection site. The reporter stated that the patient was glad to receive the dose.  The follow-up would not possible as no contact details were available. For tolerance of 1st dose refer case US2021AMR025887. This is 1 of 4 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025865:same reporter US-GLAXOSMITHKLINE-US2021AMR025883:same reporter US-GLAXOSMITHKLINE-US2021AMR025865:same reporter US-GLAXOSMITHKLINE-US2021AMR025883:same reporter US-GLAXOSMITHKLINE-US2021AMR025887:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at site of injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2021, the patient received the 2nd dose of Shingrix (unknown). On 14th January 2021, less than a day after receiving Shingrix, the patient experienced injection site pain. On 15th January 2021, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the 2nd dose of Shingrix and less than a day after the vaccination patient had injection site pain. Patient used warm compress to manage pain and stated it felt fantastic after the heat and patient could go to sleep with no issue unlike the first dose. The reporter consented to follow up.
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This case was reported by a pharmacist and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th November 2020, the patient received Shingrix, Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 26th November 2020, less than a day after receiving Shingrix, Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix, Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist reported patient was administrated with Fluarix QIV-Shingirx and had allergic reaction. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: can't move it very well / can not lift arm above shoulders / can't put arm behind back to touch back; Left arm has been sore; This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number B4527, expiry date 2nd May 2022) and (batch number 954K5, expiry date 2nd May 2022) for prophylaxis.   On 5th October 2020, the patient received the 1st dose of Shingrix. On 5th October 2020, the dose was an unknown dose. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were unknown.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient's left arm had been sore and she could not move it very well. She could not lift arm above shoulders and could put arm behind back to touch back.  The reporter stated that the patient was due for second dose of Shingrix. The reporter did not consent to follow-up.