chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: She tested positive for Covid 19 two weeks later; She tested positive for Covid 19 two weeks later; This is a spontaneous report from a contactable healthcare professional (patient). A 57-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient said that she was tested COVID-19 positive two weeks after (30Jan2021) the first dose on 16Jan2021. The patient said that she was fully recovered today and advised by their health department that she was fit to work. The patient was scheduled to have her second dose tomorrow 06Feb2021, concerning if there was a problem or if it was okay to take the second dose tomorrow. The outcome of the events was recovered.  Information on Lot/Batch has been requested.; Sender's Comments: The reported tested positive for SARS-Cov-2 two weeks after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: night vision improved the night after he took the vaccine and seemed to be a stable improvement; This is a spontaneous report from a contactable consumer (patient himself). A 70-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9526, expiration date was unknown), via an unspecified route of administration on the left arm on 02Feb2021 at 09:30 at a single dose for COVID-19 immunization. The vaccine facility type was reported as the public health clinic/veterans administration facility. Relevant medical history included that the patient had beginnings of cataracts and his night vision was beginning to diminish from an unknown date. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. He was not tested for COVID post vaccination. The patient reported that it was not an adverse event, but his night vision improved the night after he took the vaccine on 03Feb2021 at 02:00, and seemed to be a stable improvement. The patient did not receive any treatment for the event. The outcome of the event was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion
Clinical narrative: severe overall headache; nasal congestion; This is a spontaneous report from a contactable consumer (self-reported). A 77-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration, at Left Arm on 03Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM 11), hypertension and hypothyroidism. Concomitant medication included metformin, levothyroxine sodium (SYNTHROID), hydrochlorothiazide, triamterene (DIU) and blood pressure medication (unspecified). The patient previously took ibuprofen and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination, included; blood pressure Med, metformin, synthroid, DIU. The patient was the not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 04Feb2021, the patient woke up at 3 AM with severe overall headache and nasal congestion. At 6: 30 am took Tylenol tabs 2. Had head and nasal congestion as well and no treatment was taken for nasal congestion. Symptoms did not clear up for nearly 10 hours. Outcome of the events was recovered on an unknown date in Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gout
Clinical narrative: Felt like an old man; Gout flare/gout attack; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got Pfizer vaccine and a huge gout flare/ gout attack the next day. Felt like an old man, but better now. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Hypoaesthesia, Movement disorder, Sensory disturbance
Clinical narrative: Bell's Palsy; Left sided droop of her mouth; Slight change in sensation all over her mouth; Unable to tightly close left eye, or able to raise left eyebrow; Slight numbness left side of face; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EM9810) in the left arm, at single dose, on 04Feb2021 at 14:15, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included high cholesterol and lichen planopilaris of the scalp, both from an unspecified date. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included ergocalciferol (VIT D); ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); doxycycline; rosuvastatin and minoxidil. On 04Feb2021, at 17:00, the patient experienced a slight change in sensation all over her mouth with left sided droop of her mouth, unable to tightly close left eye, or able to raise left eyebrow. Also slight numbness left side of face. Emergency room/department or urgent care required. The patient went to Urgency Care diagnosed with Bel's Palsy. Treatment was received: prednisone and valacyclovir. The patient did not recover from the events a time of this report. Post the vaccination, the patient has not been tested for COVID-19.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Eye disorder, Hypoaesthesia oral
Clinical narrative: Bell's Palsy; Left sided droop of her mouth; Slight change in sensation all over her mouth; Unable to tightly close left eye, or able to raise left eyebrow; Slight numbness left side of face; This is a spontaneous report from a contactable consumer (patient).   A 68-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EM9810) in the left arm, at single dose, on 04Feb2021 at 14:15, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included high cholesterol and lichen planopilaris of the scalp, both from an unspecified date. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included ergocalciferol (VIT D); ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS); doxycycline; rosuvastatin and minoxidil. On 04Feb2021, at 17:00, the patient experienced a slight change in sensation all over her mouth with left sided droop of her mouth, unable to tightly close left eye, or able to raise left eyebrow. Also slight numbness left side of face. Emergency room/department or urgent care required. The patient went to Urgency Care diagnosed with Bel's Palsy. Treatment was received: prednisone and valacyclovir. The patient did not recover from the events a time of this report. Post the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis
Clinical narrative: Diverticulitis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: diverticulitis (medically significant). The clinical course was reported as follows: The patient reported that she received the first dose of the vaccine on 25Jan2021. The patient was scheduled to take the second shot on 15Feb2021. The patient contracted diverticulitis and mentioned that it was "nothing serious" and was prescribed with "common" antibiotics such as metronidazole and "cipro" (ciprofloxacin).  Therapeutic measures were taken as a result of diverticulitis. The clinical outcome of the event, diverticulitis, was unknown.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Malaise, Palpitations, Presyncope, Sluggishness
Clinical narrative: woke up feeling unwell a few hours ago; wife felt sluggish during the walk; her heart was racing; hands were shaking; she felt as if she was going to faint; This is a spontaneous report from a contactable consumer (patient's husband).   A 36-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 05Feb2021 12:30 for Covid-19 immunisation, being a caregiver.  The patient medical history and concomitant medications were not reported. The patient previously received flu vaccine for immunization and had side effects. On 06Feb2021 she woke up feeling unwell a few hours before reporting. Reporter and patient went for a 4 mile walk and she felt sluggish during the walk and her heart was racing, hands were shaking and she felt as if she was going to faint. When they arrived back home the reporter checked her heart rate and it was not that high and her symptoms were subsiding. The reporter would like to know if his wife should go to the ER. A few years before the patient had side effects from the flu vaccine so he was expecting her to have a reaction to the Pfizer COVID vaccine. The patient underwent lab tests and procedures which included heart rate: it was not that high on 06Feb2021.  The outcome of events was recovering. The reporter assessed the events as not serious.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: woke up feeling unwell a few hours ago; wife felt sluggish during the walk; her heart was racing; hands were shaking; she felt as if she was going to faint; This is a spontaneous report from a contactable consumer (patient's husband).   A 36-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 05Feb2021 12:30 for Covid-19 immunisation, being a caregiver.  The patient medical history and concomitant medications were not reported. The patient previously received flu vaccine for immunization and had side effects. On 06Feb2021 she woke up feeling unwell a few hours before reporting. Reporter and patient went for a 4 mile walk and she felt sluggish during the walk and her heart was racing, hands were shaking and she felt as if she was going to faint. When they arrived back home the reporter checked her heart rate and it was not that high and her symptoms were subsiding. The reporter would like to know if his wife should go to the ER. A few years before the patient had side effects from the flu vaccine so he was expecting her to have a reaction to the Pfizer COVID vaccine. The patient underwent lab tests and procedures which included heart rate: it was not that high on 06Feb2021.  The outcome of events was recovering. The reporter assessed the events as not serious.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: felt like she had COVID all over again which last 48 hours; felt like she had COVID all over again which last 48 hours; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization.  Medical history included COVID-19 from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient received first dose of COVID-19 vaccine on 30Jan2021 and stated that after her first COVID-19 vaccine she felt like she had COVID all over again which last 48 hours. She is asking if she has to get the second COVID-19 vaccine after having the virus. The patient recovered from the event on unspecified date.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Loss of personal independence in daily activities, Myalgia, Pyrexia
Clinical narrative: felt like she had COVID all over again which last 48 hours; felt like she had COVID all over again which last 48 hours; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization.  Medical history included COVID-19 from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient received first dose of COVID-19 vaccine on 30Jan2021 and stated that after her first COVID-19 vaccine she felt like she had COVID all over again which last 48 hours. She is asking if she has to get the second COVID-19 vaccine after having the virus. The patient recovered from the event on unspecified date.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient developed a fever after getting her second COVID vaccine yesterday. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tiredness; This is a spontaneous report from a contactable consumer (patient's son). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on 24Jan2021 13:30 at a single dose for COVID-19 immunization. The patient had no medical history and family medical history. There were no concomitant medications. On 24Jan2021, the patient experienced sore arm and tiredness. Right after the vaccine she noticed her arm was sore. Later she also felt a tiredness. She was scheduled to receive the second dose 14Feb2021, but she was unsure if she will get it. The events did not require a visit to physician or ER. There were no additional vaccines administered on same date of Pfizer suspect. Prior to vaccination, the patient was not diagnosed with COVID-19. The facility where the vaccine was administered was in a hospital. No relevant tests done. The event sore arm recovered on 28Jan2021, while the event tiredness on 26Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for herself and her husband.  This is the first of two reports. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient tested positive for COVID-19 and had minor symptoms on an unspecified date. Outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111850 same reporter/drug, similar events, different patient.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: severe headache 8hours after second shot; chills at 12hours; This is a spontaneous report from a non-contactable consumer (patient).  A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot_number El3248), via an unspecified route of administration at single dose in the left arm on 04Feb2021 07:00 AM for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on 14Jan2021 08:00 AM in the left arm for covid-19 immunisation. On 04Feb2021, the patient experienced severe headache 8hours after second shot, chills at 12hours. No treatment required. The outcome of the events was recovered on an unspecified date in Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: large quarter sized hives all over; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via unspecified route of administration on left arm on 05Feb2021 at 08:30 AM at single dose for COVID-19 immunization. The relevant medical history included known allergies: lyrica, possibly cilantro, pollens; insulin resistance; vitamin D def (Vitamin D deficiency); GERD (Gastrooesophageal reflux disease). Concomitant medications included metformin, famotidine (PEPCID), clarithromycin (CLARTIN), topirmate, diphenhydramine hydrochloride (BENEDRYL). The patient previously received first dose of BNT162B2 (lot number: EH9899) at the age of 35 years old, via unspecified route of administration on left arm on 11Jan2021 at 03:30 PM for COVID-19 immunization (first vaccine administered and was fine then had hives and swollen eye on the day the second was to be administered. Delayed shot- received solumedrol shot and prednisone oral with benedryl/pepcid/atarax). The patient took second shot 1 week later on Friday with prednisone on board - woke up on Sunday AM with large quarter sized hives all over. The event resulted in emergency room/department or urgent care. The event was reported serious due to hospitalization. Treatment received included urgent care- Solumedrol shot- RXs. No other vaccine in four weeks. The outcome of the event was recovering.; Sender's Comments: Based on available information and plausible temporal association,  a possible contributory role of the subject drug BNT162B2 cannot be excluded for the reported event large quarter sized hives all over. 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache
Clinical narrative: chills; slight headache; joints aching; muscles aching; fatigue; weakness; This is a spontaneous report from a contactable healthcare professional. A 77-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 06Feb2021 14:00 at a single dose for covid-19 immunization. The patient medical history was reported as none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included bupropion, levothyroxine, sumatriptan succinate (IMITREX) and vitamin nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3246) at the age of 77-year-old via an unspecified route of administration right arm on 16Jan2021 14:00 at a single dose for covid-19 immunization. On 07Feb2021 11:00 PM (reported as 33 hours post [23:00] second vaccination), the patient had chills, slight headache, joints aching, muscles aching, fatigue and weakness. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious, and the patient did not received treatment for the adverse events. The outcome of the events was recovered on Feb2021.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: chills; slight headache; joints aching; muscles aching; fatigue; weakness; This is a spontaneous report from a contactable healthcare professional. A 77-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 06Feb2021 14:00 at a single dose for covid-19 immunization. The patient medical history was reported as none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included bupropion, levothyroxine, sumatriptan succinate (IMITREX) and vitamin nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3246) at the age of 77-year-old via an unspecified route of administration right arm on 16Jan2021 14:00 at a single dose for covid-19 immunization. On 07Feb2021 11:00 PM (reported as 33 hours post [23:00] second vaccination), the patient had chills, slight headache, joints aching, muscles aching, fatigue and weakness. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious, and the patient did not received treatment for the adverse events. The outcome of the events was recovered on Feb2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). A 72-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as COVID-19 vaccine; lot number: EN5318; expiration date: unknown), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunisation . The patient 's medical history was none. Concomitant medication included NP [pending clarification]. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that she did not have side effects from the shot. The patient added that 2 days after the shot (01Feb2021 08:00 AM), she got shingles. The patient reported that the event as non-serious. She received treatment for the event (medicine) and the adverse event result in doctor or other healthcare professional office/clinic visit. The patient has not been for COVID-19 since the vaccination. The outcome of the event was recovering.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Muscular weakness, Paraesthesia
Clinical narrative: Left hand, specifically thumb, has numbness and tingling; Left hand, specifically thumb, has numbness and tingling; Unable to perform daily activities with this hand after vaccination.; muscle weakness in right thigh.; This is a spontaneous report from a contactable Other HCP (patient). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in right arm on 06Feb2021 07:45 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included isotretinoin (ACCUTANE). The patient previously received first dose of BNT162B2 on unknown date 11:15 on right arm. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no Known allergies. On 06Feb2021 14:00, the patient had Left hand, specifically thumb, has numbness and tingling. Unable to perform daily activities with this hand after vaccination. Also muscle weakness in right thigh. It was unknown if treatment was received for the events. The events resulted in Disability or permanent damage. The outcome of all events was not resolved.  Information about lot/batch number has been requested.; Sender's Comments: A contribution from BNT162B2 to reported events cannot be fully excluded based on the temporal relationship and lack of alternate explanation at this time. Case will be  reassessed if additional information is received 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
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Disease recurrence, Headache, Lymphoedema, Pain in extremity
Clinical narrative: a recurrence of cellulitis in her right arm; a recurrence of cellulitis in her right arm; headache; sore arm; Lymphoedema; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program, Pfizer First Connect. A 78-year-old female patient received the first (1st) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Jan2021 at a single dose as COVID vaccine. Medical history included cancer survivor and cellulitis in her right arm from being a cancer patient. Concomitant medication included quinine sulfate (LEXIQUIN). It was reported that after the 1st dose of the vaccine, the patient experienced a very bad headache and a sore arm on 2021 and didn't want to miss her 2nd dose. She wanted to know if it's still alright to get her 2nd dose and had some other questions. Her 1st dose of the Pfizer COVID vaccine was 2 weeks ago, afterwards on 2021, a recurrence of cellulitis in her right arm from being a cancer patient; she was put on Levaquin and her doctor told her she may absolutely not get her 2nd dose until at least 15 days after her Levaquin treatment. She's supposed to go for second shot this Saturday (also reported as Friday) but ended up coming down with lymphoedema on 2021. She also came down with cellulitis in her arm after receiving the first injection, which happens a lot to her. She's still on Levaquin and would be done in 3 days. She would like to know how many days she needed to wait to get the vaccine after stopping that. She would like to know how long she could wait in between doses and whether the effects of the 2nd dose of the COVID vaccine would be worse than the 1st. She would also like to know if she has to wait too long, what would happen. Would she need to start all over again? She also wanted to know about getting a new appointment. She spoke to the CDC yesterday and they told her 45 days, and she wanted to know if that was alright or not. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Electrocardiogram, Fall, Heart rate
Clinical narrative: passed-out/he fell; light-headed; passed-out/he fell; This is a spontaneous report from a contactable other healthcare professional reported that an 82-year-old male patient received the first dose of bnt162b2 (BNT162B2 also reported PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure and stents. He was on a blood thinner medication. On unspecified date, he felt light-headed. He passed-out a week and a day after the first injection, when he bent over to get something out of the dishwasher. He was found on the ground with broken dishes and he didn't recall how he fell. He was sent to his cardiologist who did an EKG, a blood pressure reading then took his heartrate, and everything was fine. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed-out/he fell; light-headed; passed-out/he fell; This is a spontaneous report from a contactable other healthcare professional reported that an 82-year-old male patient received the first dose of bnt162b2 (BNT162B2 also reported PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at SINGLE DOSE for Covid-19 immunisation. Medical history included high blood pressure and stents. He was on a blood thinner medication. On unspecified date, he felt light-headed. He passed-out a week and a day after the first injection, when he bent over to get something out of the dishwasher. He was found on the ground with broken dishes and he didn't recall how he fell. He was sent to his cardiologist who did an EKG, a blood pressure reading then took his heartrate, and everything was fine. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Feeling abnormal, Headache, Nausea, Oral discomfort
Clinical narrative: she was so miserable; terrible headache; lips and tongue were burning; lips and tongue were burning; anaphylactic event; little nauseas/severe nausea/she was so nauseas/nausea was overwhelming; This is a spontaneous report from a contactable consumer (patient). A elderly (reported as almost 80 years old) female patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 02Feb2021 13:30 at single dose for covid-19 immunization. Medical history included allergy to latex and shellfish (iodine), cancer, anaphylactic reaction she had 15-20 years ago where it was much worse and she could not swallow or breathe. The patient's concomitant medications were not reported. Patient received her 1st dose of the Pfizer covid vaccine. She is reported to have experienced severe nausea and terrible headache, lips and tongue were burning which she says reminds her of an anaphylactic reaction she had 15-20 years ago where it was much worse and she could not swallow or breathe. Patient would like to know whether her side effects are normal and her side effects post- vaccine whether they have been reported before. Patient would like to know if the 2nd shot of the covid vaccine is going to be worse and if the side effects after the 1st dose are going to be worse. She received the first COVID-19 vaccine on 02Feb2021. She felt fine until late that evening. She got a little nauseas. It just so happens the next day she was scheduled for her 3 month check-up with her internist. She told the doctor she was a little nauseas that last night, but was fine that day. She clarified further she received the COVID-19 vaccine on 1:30pm on 02Feb2021. Around 3:00pm on 03Feb2021, she was so nauseas, she was so miserable. She called the pharmacist and asked what could she possibly take. The pharmacist told her to drinks lots of water, drink Gatorade, and have her doctor order something to treat the nausea. Caller states she couldn't get a hold of her doctor. However, she did what the pharmacist told her to do by drinking water and Gatorade. The nausea was overwhelming. She got this terrible headache. Later in the day, her lips and tongue were burning. She thought to herself "oh my gosh, I'm having an anaphylactic event". She does keep an EpiPen on her. She took 2 Benadryl. She didn't know if she could take Advil and Benadryl at the same time, so she didn't do that.  She is in sort of panic to get the second shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: she was so miserable; terrible headache; lips and tongue were burning; lips and tongue were burning; anaphylactic event; little nauseas/severe nausea/she was so nauseas/nausea was overwhelming; This is a spontaneous report from a contactable consumer (patient). A elderly (reported as almost 80 years old) female patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 02Feb2021 13:30 at single dose for covid-19 immunization. Medical history included allergy to latex and shellfish (iodine), cancer, anaphylactic reaction she had 15-20 years ago where it was much worse and she could not swallow or breathe. The patient's concomitant medications were not reported. Patient received her 1st dose of the Pfizer covid vaccine. She is reported to have experienced severe nausea and terrible headache, lips and tongue were burning which she says reminds her of an anaphylactic reaction she had 15-20 years ago where it was much worse and she could not swallow or breathe. Patient would like to know whether her side effects are normal and her side effects post- vaccine whether they have been reported before. Patient would like to know if the 2nd shot of the covid vaccine is going to be worse and if the side effects after the 1st dose are going to be worse. She received the first COVID-19 vaccine on 02Feb2021. She felt fine until late that evening. She got a little nauseas. It just so happens the next day she was scheduled for her 3 month check-up with her internist. She told the doctor she was a little nauseas that last night, but was fine that day. She clarified further she received the COVID-19 vaccine on 1:30pm on 02Feb2021. Around 3:00pm on 03Feb2021, she was so nauseas, she was so miserable. She called the pharmacist and asked what could she possibly take. The pharmacist told her to drinks lots of water, drink Gatorade, and have her doctor order something to treat the nausea. Caller states she couldn't get a hold of her doctor. However, she did what the pharmacist told her to do by drinking water and Gatorade. The nausea was overwhelming. She got this terrible headache. Later in the day, her lips and tongue were burning. She thought to herself "oh my gosh, I'm having an anaphylactic event". She does keep an EpiPen on her. She took 2 Benadryl. She didn't know if she could take Advil and Benadryl at the same time, so she didn't do that.  She is in sort of panic to get the second shot. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Anaphylactic reaction, Arthralgia, Dyspnoea, Ear pain
Clinical narrative: The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Myalgia, Neck pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Throat tightness, Toothache
Clinical narrative: The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Sudden hearing loss
Clinical narrative: She experienced a sudden deafness in her right ear in between receiving both her shots.; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date not reported), via an unspecified route of administration on 16Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a sudden deafness in her right ear in between receiving both her shots. Her second dose was on 06Feb2021. The outcome of event was unknown.  Information about batch/lot number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, SARS-CoV-2 test
Clinical narrative: vision loss; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: 183599) solution for injection, via an unspecified route of administration in left arm on 20Jan2021 at a single dose for Covid-19 immunization. Medical history included pacemaker, vitiligo, psoriasis, blood pressure, and autoimmune disorder. Concomitant medications included blood thinners and blood pressure medications. The patient experienced vision loss on an unspecified date. It was reported that patient went for an office/clinic visit to a doctor or other healthcare professional. Also went emergency room/department or urgent care. Patient did not receive any treatment. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 since vaccination. Covid-19 virus test: negative. The event was reported as non-serious however it caused disability. Outcome of the event was not recovered.  No follow-up activities are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Diaphragmatic paralysis, Phrenic nerve injury
Clinical narrative: phrenic nerve damage resulting in unilateral diaphragm paralysis; phrenic nerve damage resulting in unilateral diaphragm paralysis; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 03Feb2021 11:45 (lot number EN9581 and expiry date unknown) at single dose for Covid-19 immunization in the physician office (doctor's office/urgent care). Medical history included anxiety, scoliosis, milk thistle allergies, laundry detergent fragrance allergies. The patient has no covid prior vaccination. Concomitant medication included clonazepam (KLONOPIN), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP) and "multi-vita"; all from unspecified date for unspecified indication. The patient previously took diflucan and experienced allergies. The patient had no other vaccine in four weeks. On 05Feb2021 (two days after receiving vaccination), the patient experienced phrenic nerve damage resulting in unilateral diaphragm paralysis. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment due to the events. The patient was not covid tested post vaccination. The outcome of the events was recovering.  Follow-up activities are possible, information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Head injury
Clinical narrative: Patient passed hit her head; Stroke; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. A 68-year-old female patient received single dose of BNT162B2(Solution for injection, lot number and exp 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 was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient did not have COVID prior vaccination. On an unspecified date, the patient passed hit her head and had emergency surgery; and stroke. The adverse events resulted in: Hospitalization (date/s unspecified). The patient was not covid tested post vaccination. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.