chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Hypertension, Rash
Clinical narrative: Rash is noticeably better /  skin color has lightened  / blood pressure seems lower; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for an unknown indication.   The patient's past medical history included neck pain and shoulder pain. Concurrent medical conditions included rash, blood pressure and spinal cord injury (right side of his spinal cord over the years).   On 29th November 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 29th November 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the unexpected therapeutic effect to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient had high blood pressure and a rash on his right arm and right side of his face for 8 to 9 years. The patient had experienced pain on the right side of neck and right shoulder blade and right side of his spinal cord over the years. The rash on the right side of his face was described as presenting on the jaw looks like a vine.  The patient received Shingrix on the right arm and Flu vaccine on the left arm. The patient reported that the rash was noticeably better.  The skin color where the rash was dark and it had lightened since yesterday. He also said his blood pressure seems lower since getting the vaccine yesterday.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Vaccine positive rechallenge
Clinical narrative: flu-like symptom; body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms and general body pain. On an unknown date, the outcome of the influenza-like symptoms and general body pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination not reported. The patient received the first dose of the Shingrix vaccine about 2.5 months ago (she does not remember the dates) and she experienced body aches and flu-like symptom. The reporter consented to follow up. For further tolerance of 2nd dose refer case US2020AMR237568.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR237568:2nd dose
Age: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Extra dose administered
Clinical narrative: Patient received one extra dose; Diarrhea; This case was reported by a other health professional via call center representative and described the occurrence of diarrhea in a 1-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 494S5, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) and Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season).   On 1st December 2020, the patient received the 3rd dose of FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device. On 1st December 2020, unknown after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device and an unknown time after receiving FluLaval Tetra 2020-2021 season and FluLaval Tetra 2020-2021 season, the patient experienced extra dose administered. In December 2020, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea and extra dose administered were unknown.   It was unknown if the reporter considered the diarrhea to be related to FluLaval Tetra 2020-2021 season and Flulaval 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 reported as follows: The reporter was medical assistant. All the vaccines had the same lot number and expiration date. It was reported that the patient received one extra dose of Flulaval, which led to extra dose administered and after that the patient experienced diarrhea. The reporter consented to follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Malaise, Nausea, Night sweats
Clinical narrative: Hot; Cold sweats/having night sweats, like she was hot and cold; Cold sweats/having night sweats, like she was hot and cold; Chills; Shakes; intense nausea/ nauseous; just feels nauseous and depleted; it feels like she has the flu; she didn't know if maybe her body was low on oxygen, she didn't feel out of breath, but she just didn't feel well overall; This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899, expiry: Mar2021), via intramuscular route of administration (left deltoid) on 17Dec2020 17:40 at a single dose for COVID-19 immunisation. The patient's medical history included sulfa drug allergies. There were no concomitant medications used. The patient was having some intense nausea, and throughout the night, she had night sweats. It was further stated that she woke up a 12AM, today (18Dec2020), and she just felt like she had the flu. She was nauseous, and she was having night sweats, like she was hot and cold, and she tried to go back to sleep, but then she had an episode of chills and the shakes, and every time she was about to fall asleep, it was like her body would wake her up. Patient stated that in her mind, she didn't know if maybe her body was low on oxygen, she didn't feel out of breath, but she just didn't feel well overall. All these persisted until about 3AM, and then she went back to sleep. She woke up for the day around 530AM, and she feels a little better now, like she doesn't have the hot and cold fever feeling anymore, she just feels nauseous and depleted. She stated that she sees on her information sheet that these are possible side effects to getting the vaccine, but it feels like she has the flu. Outcome of the events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Hot; Cold sweats/having night sweats, like she was hot and cold; Cold sweats/having night sweats, like she was hot and cold; Chills; Shakes; intense nausea/ nauseous; just feels nauseous and depleted; it feels like she has the flu; she didn't know if maybe her body was low on oxygen, she didn't feel out of breath, but she just didn't feel well overall; This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899, expiry: Mar2021), via intramuscular route of administration (left deltoid) on 17Dec2020 17:40 at a single dose for COVID-19 immunisation. The patient's medical history included sulfa drug allergies. There were no concomitant medications used. The patient was having some intense nausea, and throughout the night, she had night sweats. It was further stated that she woke up a 12AM, today (18Dec2020), and she just felt like she had the flu. She was nauseous, and she was having night sweats, like she was hot and cold, and she tried to go back to sleep, but then she had an episode of chills and the shakes, and every time she was about to fall asleep, it was like her body would wake her up. Patient stated that in her mind, she didn't know if maybe her body was low on oxygen, she didn't feel out of breath, but she just didn't feel well overall. All these persisted until about 3AM, and then she went back to sleep. She woke up for the day around 530AM, and she feels a little better now, like she doesn't have the hot and cold fever feeling anymore, she just feels nauseous and depleted. She stated that she sees on her information sheet that these are possible side effects to getting the vaccine, but it feels like she has the flu. Outcome of the events was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Intensive care
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable pharmacist.  A 55-year-old female patient received the bnt162b2 (BNT162B2; also reported as: PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history included eosinophil process allergic reaction, fish, iodine and shellfish allergy; all from an unknown date and unknown if ongoing. Concomitant medications were not reported.  The patient previously took rabies vaccine for immunization and experienced anaphylactic reaction on an unspecified date. On 17Dec2020, the patient experienced anaphylaxis; which required hospitalization, and was assessed as medically significant. The patient was hospitalized for anaphylaxis from 18Dec2020 to an unknown date. The clinical course was reported as follows: The pharmacist called about a patient who received the COVID-19 vaccine on 17Dec2020 and started having a reaction approximately 30 minutes later. The patient used epinephrine (EPIPEN) and 50 mg of diphenhydramine hydrochloride (BENADRYL) and returned to the hospital on 18Dec2020. The patient was currently in the intensive care unit (ICU) receiving an epinephrine drip. The patient had a previous history of an anaphylactic reaction to the rabies vaccine, eosinophil process allergic reaction, fish, iodine and shellfish allergy. The patient was stabilized but continued to have reactions (not specified). The pharmacist had not seen the patient and was reaching out to Pfizer on behalf of the physicians. The pharmacist believed this had been reported by the hospital. The pharmacist had no patient information. Therapeutic measures were taken as a result of anaphylaxis. The clinical outcome of the event, anaphylaxis, was unknown.   The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event anaphylaxis due to temporal association. However patient previous history of allergic reaction cannot be excluded to have played a contributory role
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Pain, Pyrexia
Clinical narrative: dry cough; low grade fever/he had a low grade temperature of 99.0 Fahrenheit last night and 101.0 Fahrenheit this morning; body pain; body weakness; This is a spontaneous report from a contactable Nurse  A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 16Dec2020 10:30 at single dose for covid-19 immunisation. Medical history was none (no relevant patient or family medical history). The patient's concomitant medications were not reported. On 17Dec2020 the patient experienced low grade fever, temperature of 99.0 F on 17Dec2020 and 101.0 F on 18Dec2020, body pain and weakness with outcome of not recovered. On unknown date the patient experienced also cough with unknown outcome. The event fever was considered serious as medically significant and was reported as worsened. The reporter wanted to know what to do. The caller read somewhere not to take Tylenol, though he did take one this morning. He was to increase fluid intake but what other treatment was recommended.   Information on Lot/Batch has been requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, fever, body pain, cough and weakness there is a reasonable possibility that the events are related to BNT162 vaccine. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Nausea, Vomiting
Clinical narrative: Nausea; Vomiting; Chills; Migraine like headache; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), via an unspecified route of administration (left arm) from 18Dec2020 (01:15 PM) to 18Dec2020 13:15 at single dose for COVID-19 immunization. The patient's medical history included PDA (Patent ductus arteriosus) ligation, fatty liver disease, and anxiety. Concomitant medications included melatonin, escitalopram oxalate (LEXAPRO), balsalazide sodium (BALZIDE), multivitamin, and prebiotic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient experienced nausea, vomiting, chills, and migraine like headache the night after she received the vaccine (18Dec2020 07:00 PM). There was no treatment received for the reported adverse events. The outcome of events was recovering. This case is reported as non-serious.   Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: body ache; muscle and joint pain; muscle and joint pain; fever; injection site pain; chills; headache; This is a spontaneous report from a contactable consumer.  A non-pregnant 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685), via an unspecified route of administration in the right arm on 18Dec2020 10:15 at single dose for COVID-19 immunization.  Medical history included COVID-19 (prior to vaccination).  Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC). No other vaccinations were given within four weeks and the patient had no known allergies.  On 18Dec2020 23:30, the patient experienced body ache, muscle and joint pain, fever, injection site pain, chills and headache.  No treatment was received for the events.  The clinical outcome of body ache, muscle and joint pain, fever, injection site pain, chills and headache was recovering.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: body ache; muscle and joint pain; muscle and joint pain; fever; injection site pain; chills; headache; This is a spontaneous report from a contactable consumer.  A non-pregnant 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EJ1685), via an unspecified route of administration in the right arm on 18Dec2020 10:15 at single dose for COVID-19 immunization.  Medical history included COVID-19 (prior to vaccination).  Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC). No other vaccinations were given within four weeks and the patient had no known allergies.  On 18Dec2020 23:30, the patient experienced body ache, muscle and joint pain, fever, injection site pain, chills and headache.  No treatment was received for the events.  The clinical outcome of body ache, muscle and joint pain, fever, injection site pain, chills and headache was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Laboratory test, Myalgia, Pyrexia
Clinical narrative: Fever; Shortness of breath; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient).  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, expiration date unknown, 1st dose via an unspecified route of administration on 18Dec2020 14:00 at a single dose at right arm for COVID-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient experienced fever, shortness of breath, headache and muscle ache on 19Dec2020 01:00 am. There was no treatment received for the events. The patient underwent lab tests and procedures on 19Dec2020 which included COVID test post vaccination (Nasal Swab): unknown result (pending). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. The action taken in response to the events was not applicable. The outcome of the events was recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever; Shortness of breath; Headache; Muscle ache; This is a spontaneous report from a contactable consumer (patient).  A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, expiration date unknown, 1st dose via an unspecified route of administration on 18Dec2020 14:00 at a single dose at right arm for COVID-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient experienced fever, shortness of breath, headache and muscle ache on 19Dec2020 01:00 am. There was no treatment received for the events. The patient underwent lab tests and procedures on 19Dec2020 which included COVID test post vaccination (Nasal Swab): unknown result (pending). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. The action taken in response to the events was not applicable. The outcome of the events was recovering.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Neck pain, Pain
Clinical narrative: it felt as if pulsing was radiating was coming from the upper middle of my spine; feeling really achy in shoulders both arms and neck; left arm hurt with any motion; feeling really achy in shoulders both arms and neck; feeling really achy in shoulders both arms and neck; This is a spontaneous report from a contactable healthcare professional.  A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), intramuscularly in the left arm on 16Dec2020 12:00 at a single dose for COVID-19 immunization.  Medical history was none.  The patient's concomitant medications were not reported. There was no known allergies.  On 16Dec2020 at 16:00, the patient experienced feeling really achy in shoulders both arms and neck and left arm hurt with any motion.  On 17Dec2020, it felt as if pulsing was radiating, coming from the upper middle of spine.  No treatment was received for the events.  The outcome of the events was recovered with sequel on an unspecified date.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: it felt as if pulsing was radiating was coming from the upper middle of my spine; feeling really achy in shoulders both arms and neck; left arm hurt with any motion; feeling really achy in shoulders both arms and neck; feeling really achy in shoulders both arms and neck; This is a spontaneous report from a contactable healthcare professional.  A 28-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), intramuscularly in the left arm on 16Dec2020 12:00 at a single dose for COVID-19 immunization.  Medical history was none.  The patient's concomitant medications were not reported. There was no known allergies.  On 16Dec2020 at 16:00, the patient experienced feeling really achy in shoulders both arms and neck and left arm hurt with any motion.  On 17Dec2020, it felt as if pulsing was radiating, coming from the upper middle of spine.  No treatment was received for the events.  The outcome of the events was recovered with sequel on an unspecified date.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Rash
Clinical narrative: fine rash noted Saturday evening on arms and chest w /slight itchiness; occasional itchiness on Friday w/ no rash noted/fine rash noted Saturday evening on arms and chest w /slight itchiness; face felt prickly and itchy; face felt prickly and itchy; This is a spontaneous report from a contactable nurse (the patient).  A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EH9899, via Intramuscular route of administration in right arm, on 17Dec2020 at 16:30, at single dose for COVID-19 immunization. The vaccine was administered at Hospital Facility. The patient did not receive other vaccine in four weeks. The patient medical history included sinus infections and past history of mono. The patient had allergy to kindest care hand sanitizer, alcare and eucerine hand cleanser. The patient's concomitant medications included ascorbic acid, zinc oxide (IMMUNE BOOST OTC). The patient on 17Dec2020 at 17:15, felt face prickly and itchy. No airway distress. Benadryl was administered at 22:30 that night. Physician was made aware. Occasional itchiness was observed on 18Dec2020. No rash noted. Fine rash was noted on 19Dec2020 evening on arms and chest with slight itchiness. No Covid-19 was diagnosed prior vaccination. Covid-19 was not tested. The outcome of the events was resolving.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Body aches; Muscle pain; Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 28-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BionTech), via an unspecified route of administration, on 18Dec2020 at 12:00 PM, at single dose, for Covid-19 immunisation. Medical history was none. Concomitant included an unspecified birth control medication within 2 weeks of vaccination. The patient experienced body aches, muscle pain, chills, headache and fatigue all on 19Dec2020 at 07:00 AM with outcome of recovering. No therapeutic measures were taken as a result of the events. The events were considered non serious.  The information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Pain
Clinical narrative: arm pain at injection site; redness from injection site up over shoulder; Tired; chills; body aches; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on 17Dec2020 at 12:45 on arm at single dose for COVID-19 immunization. The patient medical history included SVT (Supraventricular tachycardia) with ablation, silicone sensitivity. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no any other medications patient received within 2 weeks of vaccination. The patient experienced tired, chills, body aches, arm pain at injection site, redness from injection site up over shoulder, all on 17Dec2020. All gone within 48 hours of injection. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovered in Dec2020 within 48 hours of injection. The report was reported as non-serious.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: After 2 hours of receiving the Vaccine I got joint pain, tiredness, and severe headache. It's been more than 24 hours and I'm still having the same symptoms.; After 2 hours of receiving the Vaccine I got joint pain, tiredness, and severe headache. It's been more than 24 hours and I'm still having the same symptoms.; After 2 hours of receiving the Vaccine I got joint pain, tiredness, and severe headache. It's been more than 24 hours and I'm still having the same symptoms.; This is a spontaneous report from a contactable consumer and contactable other-Health Care Professional (HCP).  A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm on 18Dec2020 07:45 PM (at the age of 33 years-old) as a single dose for COVID-19 vaccination. Medical history was unknown. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were no other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Dec2020 at 09:30 PM, the patient experienced joint pain, tiredness, and severe headache. The report was reported as non-serious. Treatment was not received for joint pain, tiredness, and severe headache. The clinical outcome of joint pain, tiredness, and severe headache was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Heart rate increased, Malaise, Nausea
Clinical narrative: flush; fast heartbeat (120bpm); rash; nausea; dizzy, lightheaded; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient (pregnant: no) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration at arm left on 19Dec2020 11:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included celecoxib (CELEXA), ethinylestradiol and etonogestrel (NUVARING) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefalexin(KEFLEX) and cefdinir(OMNICEF) and experienced allergies. The patient experienced flush, fast heartbeat (120bpm), rash, nausea, dizzy, lightheaded, feeling unwell on 19Dec2020 12:00 PM, the events resulted in emergency room/department or urgent care. Treatment of Benadryl received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Dec2020.  Information on the lot/Batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: flush; fast heartbeat (120bpm); rash; nausea; dizzy, lightheaded; feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient (pregnant: no) received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration at arm left on 19Dec2020 11:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included celecoxib (CELEXA), ethinylestradiol and etonogestrel (NUVARING) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefalexin(KEFLEX) and cefdinir(OMNICEF) and experienced allergies. The patient experienced flush, fast heartbeat (120bpm), rash, nausea, dizzy, lightheaded, feeling unwell on 19Dec2020 12:00 PM, the events resulted in emergency room/department or urgent care. Treatment of Benadryl received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Dec2020.  Information on the lot/Batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, SARS-CoV-2 test negative
Clinical narrative: I got increasing pain at my injection site, it was very sore. The soreness spread through my muscles; I got increasing pain at my injection site, it was very sore. The soreness spread through my muscles; headache; general fatigue; This is a spontaneous report from a contactable consumer (patient herself).  A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via intramuscular in the left arm, as first single dose on 04Dec2020 (at 17:30) for COVID-19 immunisation. Relevant medical history included allergy to Latex. Relevant concomitant medications included loratadine (CLARITIN), birth control and multivitamin. The patient stated 'I got the vaccine on Friday and today (Saturday) half way through my shift at around 3:00 pm I got increasing pain at my injection site, it was very sore. The soreness spread through my muscles and I got a headache and general fatigue''. The patient did not perform a Covid test prior vaccination but after vaccination Nasal Swab, COVID test, Rapid PCR was Negative. The patient was not treated for the events. She was recovering from the events.   Information on lot/batch number has been requested
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Injection site pain 14 hours after with body aches; 28 hours after fevers 102 sever body aches rigors; Injection site pain 14 hours after with body aches; 28 hours after fevers 102 sever body aches rigors; This is a spontaneous report from a contactable physician (patient himself).  A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on the left arm, as first single dose on 18Dec2020 (at 12:45) for COVID-19 immunisation. Relevant medical history included acid reflux and allergy to cats. Relevant concomitant medications included omeprazole (PROTONIX). 14 hours after vaccination, the patient had injection site pain with body aches. 28 hours after vaccination, he had fevers 102, sever body aches and rigors. However, it was reported that onset of the events was on 19Dec2020 at 17:00. The patient did not have loss of smell, SOB, dyspnea, loss of taste or diarrhea. The patient did not perform COVID test prior or after vaccination. No treatments were given for the events. The patient was recovering from the events.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Fatigue, Pallor
Clinical narrative: Felt lightheaded and dizzy.; Felt lightheaded and dizzy.; skin pale; very fatigued; she was currently breastfeeding; she was currently breastfeeding; This is a spontaneous report from a contactable health care professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 18Dec2020 (at the age of 34-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the vaccination. It was unknown if the patient was pregnant at the time of vaccination. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. On 18Dec2020, the patient felt lightheaded and dizzy and was brought to the observation area, ambulatory. She denied shortness of breath, itching or difficulty swallowing. No rash was noted, but the skin was pale. Water was provided to the patient. It was reported that the patient was currently breastfeeding, was very fatigued, probably dehydrated and had not eaten breakfast. She stayed in the observation area until 10:37, drank a total of 3 bottles of water and was up to the restroom ambulating on her own. Her blood pressure was 131/83, heart rate was 83 and "100% on RA" as reported. She left ambulatory to drive home and was informed to notify the appropriate person of this episode prior to a second dose of vaccine. It was unknown if treatment was received for the events "felt lightheaded and dizzy", "skin pale", and "very fatigued". Since the vaccination, it was unknown if the patient had been tested for COVID-19. The patient recovered from the events "felt lightheaded and dizzy", "skin pale", and "very fatigued" on an unspecified date in 2020, while the clinical outcome of "she was currently breastfeeding" was unknown.   No follow-up attempts are possible; information on lot/batch cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020504266 mother/baby case, same reporter /drug , different patient
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immediate post-injection reaction, Joint swelling, Rash, Rash pruritic
Clinical narrative: Right wrist swollen and painful; Right wrist swollen and painful; Immediate itchy rash on lower left arm between wrist and elbow; This is a spontaneous report from a contactable consumer (the patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number BH9899), via an unspecified route of administration in the left arm on 17Dec2020 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included rheumatoid arthritis (RA), penicillin allergy, and contact dermatitis to multiple agents. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included: prednisone, leflunomide (ARAVA), hydroxychloroquine sulfate (PLAQUENIL), meloxicam, "and more" (as reported, unspecified), all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 17Dec2020 at 10:30, the patient experienced immediate itchy rash on lower left arm between wrist and elbow. On day 2 post vaccine (19Dec2020), her right wrist was swollen and painful. The patient did not receive any treatment for the events. The clinical outcome of immediate itchy rash on lower left arm between wrist and elbow and right wrist swollen and painful was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Developed pain and swelling in right index finger late evening after injection of vaccine, same side as vaccine injection; Developed pain and swelling in right index finger late evening after injection of vaccine, same side as vaccine injection; This is a spontaneous report from a contactable physician (the patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), intramuscularly in the left arm on 18Dec2020 at 17:15 (at the age of 68-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension and history of prostate cancer. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Dec2020 at 23:00, the patient developed pain and swelling in his right index finger late evening after injection of the vaccine, on the same side as vaccine injection (as reported). The patient was treated for pain and swelling in his right index finger with ibuprofen 600 mg (MANUFACTURER UNKNOWN). The clinical outcome of pain and swelling in his right index finger was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer (patient) and healthcare professional (HCP). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection via an unspecified route of administration on 18Dec2020 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included HTN (hypertension) and known allergies sulfa. Concomitant medications included pneumococcal vaccine polysaccharide 23valent (PNEUMOVAX 23) on 14Dec2020 in right deltoid and varicella zoster vaccine RGE (CHO) (SHINGRIX) on 14Dec2020 in left deltoid. The patient did receive other vaccines (PNEUMOVAX 23 and SHINGRIX) within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 18Dec2020, the patient experienced soreness at injection site. No treatment was provided for the event soreness at injection site. The outcome of the event soreness at injection site was recovered in Dec2020. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Arm felt tingly after; This is a spontaneous report from a non-contactable nurse. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection intramuscular in the left arm on 20Dec2020 at 12:30 (at the age of 30-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no medical history. There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 20Dec2020 at 12:30, the patient experienced arm felt tingly after. No treatment was provided for the event arm felt tingly after. The outcome of the event arm felt tingly after was recovered in Dec2020. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: had 1 episode of shortness of breath; tachycardia; dizziness / light headedness; This is a spontaneous report from a contactable consumer reporting for herself. This 29-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at 15:30, at single dose, for COVID-19 immunization. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history was not reported. The patient was not diagnosed with COVID before vaccination. Concomitant medications included vitamin C and sambucus nigra fruit (ELDERBERRY) and unspecified multivitamin and immune support. On 19Dec2020 at 23:30 the patient experienced one episode of shortness of breath, tachycardia, dizziness. Lasted for about 20 minutes and totally resolved within 1.5 hours. Continuing to have light headedness 24 hours after. Emergency room/department or urgent care required. No treatment was given. COVID was tested post vaccination on 20Dec2020 via nasal swab (rapid test), with negative result. The events were resolving.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Erythema, Injection site bruising, Injection site pain, Peripheral swelling
Clinical narrative: blister on her index finger; injection site is "typical bruise looking and is tender; injection site is "typical bruise looking and is tender; This is a spontaneous report from a contactable physician (who is also the patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient noticed a blister on her index finger and said it was a round, red, raised, red spot on the index finger of the same side of her vaccination. She also stated that the injection site was typical bruise looking and was tender but did not look red or raised. The outcome of the events was unknown.  The information on Lot /Batch Number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Erythema, Pain in extremity
Clinical narrative: blister on her index finger; injection site is "typical bruise looking and is tender; injection site is "typical bruise looking and is tender; This is a spontaneous report from a contactable physician (who is also the patient). This female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)  via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient noticed a blister on her index finger and said it was a round, red, raised, red spot on the index finger of the same side of her vaccination. She also stated that the injection site was typical bruise looking and was tender but did not look red or raised. The outcome of the events was unknown.  The information on Lot /Batch Number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, SARS-CoV-2 test
Clinical narrative: Disequilibrium; This is a spontaneous report from a contactable nurse (patient).  This 38-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 18Dec2020 at 04:00 PM at single dose for COVID-19 immunisation. Vaccine location was right arm.  The patient was vaccinated at hospital, age at vaccination was 38-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications were unknown. On 20Dec2020, the patient experienced disequilibrium. The event was reported as non-serious. The patient was tested for Covid post vaccination through a nasal swab on 20Dec2020, results are unknown. Outcome was recovering. No treatment was received for the event. Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Left arm start swelling at the injection site and down to the elbow  around 5:30pm; This is a spontaneous report from a contactable consumer reporting for herself.     A 47-years-old female patient  received  bnt162b2 (BNT162B2; Lot #Eh9899) vaccine, via an unspecified route of administration in the left arm  on 20Dec2020 10:00 at single dose for covid-19 immunisation .  Medical history included hypertension from an unknown date , migraine from an unknown date , partial seizures from an unknown date , intracranial aneurysm from an unknown date. Concomitant medication included spironolactone (SPIRONOLACTONE), hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ), estradiol (ESTRADIOL).  The patient was allergic to lisinopril , amlodipine , gentamicin sulfate; methylmethacrylate;polymethylmethacrylate;zirconium dioxide , zonisamide .  The patient  left arm start swelling at the injection site and down to the elbow  around 5:30pm with outcome of recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Rash
Clinical narrative: Generalised rash; Injection 15 mins later developed generalized rash, palpitations and rash to face. I had to go home and take medication.; Injection 15 mins later developed generalized rash, palpitations and rash to face. I had to go home and take medication.; This is a spontaneous report from a contactable Nurse for herself.   A 29-years-old female patient  received  bnt162b2 (BNT162B2; Lot # FJ1685) vaccine , intramuscular in the right arm on 19Dec2020 08:00 at single dose for covid-19 immunisation .  Medical history included drug hypersensitivity from an unknown date , food allergy from an unknown date , allergy to metals from an unknown date.  The patient 15 mins after the injection  developed generalized rash, palpitations and rash to face. and  had to go home and take medication. The outcome of the event was recovered.
Sex: U
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: I feel a little Tachycardia; This is a spontaneous report from a contactable nurse reporting for him/herself.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced felt a little tachycardia on an unspecified date with outcome of unknown. The heart beat was 101 and body temperature was 97.7 F. The patient asked if she should go see her doctor or the emergency room or should she wait.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, SARS-CoV-2 test
Clinical narrative: His blood pressure keeps going up right now it is like 191/111, which is really high; Has been experiencing like severe headache for the past two days; This is a spontaneous report from a contactable consumer.  A 54-years-old male patient (reporter boyfriend, anesthesiologist) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe headache for the past two days and his blood pressure keeps going up on Dec2020 with outcome of not recovered.  On unspecified date the blood pressure was like 191/111, which was really high. As treatment the patient took some type of analgesic, ibuprofen (MOTRIN) or something, and he also took Propranolol to try to get his blood pressure down but it kept going up. The patient underwent COVID test on unspecified date with unknown results.   Information on lot/batch number are requested.