chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Mobility decreased, Pain, Photophobia
Clinical narrative: was not able to get out of bed or have lights on; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Unbearable Headache; Continues eye twitching; Extremely tired; had a hard time walk due to the body aches; had a hard time walk due to the body aches; This is a spontaneous report from a non-contactable nurse (patient).  A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced Knot, Swollen and heat at the injection site, unbearable Headache that pain relievers would not help, Continues eye twitching, Extremely tired, and was not able to get out of bed or have lights on. She had a hard time walk due to the body aches. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Mobility decreased cannot be excluded.  The case will be reassessed if additional information becomes available.  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: Blepharospasm, Fatigue, Headache, Injection site induration, Injection site swelling
Clinical narrative: not able to get out of bed or have lights on; Unbareable Headache; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Continues eye twitching; Exteremly tired; 102.5 fever; Body Aches; had a hard time walk due to the body aches; This is a spontaneous report from a non-contactable nurse (patient).  A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient previously received first dose BNT162B for COVID-19 immunization and experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers would not help, continues eye twitching, extremely tired, and was not able to get out of bed or have lights on. she had a hard time walk due to the body aches.  After second shot, she also experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers would not help, continues eye twitching, extremely tired, and was not able to get out of bed or have lights on, she had a hard time walk due to the body aches, and 102.5 fever that didn't want to come down. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Considering a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The case will be reevaluated should additional information become available. 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: Injection site warmth, Mobility decreased, Pain, Photophobia, Pyrexia
Clinical narrative: not able to get out of bed or have lights on; Unbareable Headache; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Knot, Swollen and heat at the injection site; Continues eye twitching; Exteremly tired; 102.5 fever; Body Aches; had a hard time walk due to the body aches; This is a spontaneous report from a non-contactable nurse (patient).  A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient previously received first dose BNT162B for COVID-19 immunization and experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers would not help, continues eye twitching, extremely tired, and was not able to get out of bed or have lights on. she had a hard time walk due to the body aches.  After second shot, she also experienced knot, swollen and heat at the injection site, unbearable headache that pain relievers would not help, continues eye twitching, extremely tired, and was not able to get out of bed or have lights on, she had a hard time walk due to the body aches, and 102.5 fever that didn't want to come down. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Considering a vaccine-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events cannot be completely excluded. The case will be reevaluated should additional information become available. 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: significant arm pain at site; This is a spontaneous report from a contactable Other HCP.  An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose in arm for COVID-19 immunisation at the age of 82-year-old. Medical history and concomitant medications were unknown. The patient complained of significant arm pain at site the at evening on 20Jan2021. Thus far, no other notable symptoms. The outcome of the event was unknown. Information on Lot/bath number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Encephalitis, Gait disturbance, General physical health deterioration, Illness
Clinical narrative: encephalitis; has stopped walking; diarrhea; getting sick/He is not doing well; This is a spontaneous report from a Pfizer Sponsored program. A non-contactable consumer reported for her brother that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EE8492), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Her brother was hospitalized after the COVID vaccine and has stopped walking. He was not doing well. He also had diarrhea. Her brother did get the vaccine and now he has encephalitis. He was in the hospital but he is out now. He got the vaccine and then started getting sick. And he is not the only one. She could send in evidence of all of this. The consumer was on the Internet and (social media name) reading about the COVID Vaccine. She has complaints about it not being FDA approved, and not being approved to prevent COVID-19. She just saw in another location that 30 people in a nursing home died. 30 people have died in nursing homes. There are 32 side effects and she has all 32 of them. She wanted to speak with the scientists or manufacturers of the COVID vaccine. Someone in development. She is really concerned about the vaccine. It has many side effects. It is not FDA approved. It is also not approved to prevent COVID-19. Even if you get the vaccine you could still get COVID. It is not studied long term. Even doctors have said that. There have been many deaths. You don't know what will come of it. She does not know why Pfizer does not pull this back. She has seen videos that have been taken down because Pfizer does not want people to see the real news. They need to show these on the real news. Consumer clarified that she did not have any side effects. She did not take the vaccine. She does not take any vaccines. People need to learn about their nutrition. They need to tell people to take Zinc, Vitamin C, stop eating animal products and meat. She is vegan and she has never gotten sick. No flu or anything. Meat lowers your immune system. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Mobility decreased
Clinical narrative: encephalitis; has stopped walking; diarrhea; getting sick/He is not doing well; This is a spontaneous report from a Pfizer Sponsored program. A non-contactable consumer reported for her brother that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EE8492), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Her brother was hospitalized after the COVID vaccine and has stopped walking. He was not doing well. He also had diarrhea. Her brother did get the vaccine and now he has encephalitis. He was in the hospital but he is out now. He got the vaccine and then started getting sick. And he is not the only one. She could send in evidence of all of this. The consumer was on the Internet and (social media name) reading about the COVID Vaccine. She has complaints about it not being FDA approved, and not being approved to prevent COVID-19. She just saw in another location that 30 people in a nursing home died. 30 people have died in nursing homes. There are 32 side effects and she has all 32 of them. She wanted to speak with the scientists or manufacturers of the COVID vaccine. Someone in development. She is really concerned about the vaccine. It has many side effects. It is not FDA approved. It is also not approved to prevent COVID-19. Even if you get the vaccine you could still get COVID. It is not studied long term. Even doctors have said that. There have been many deaths. You don't know what will come of it. She does not know why Pfizer does not pull this back. She has seen videos that have been taken down because Pfizer does not want people to see the real news. They need to show these on the real news. Consumer clarified that she did not have any side effects. She did not take the vaccine. She does not take any vaccines. People need to learn about their nutrition. They need to tell people to take Zinc, Vitamin C, stop eating animal products and meat. She is vegan and she has never gotten sick. No flu or anything. Meat lowers your immune system. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: it hurt more than her first vaccination and much sooner; arm was sore; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2, via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced it hurt more than her first vaccination and much sooner; arm was sore on 21Jan2021 with outcome of unknown. Yesterday afternoon at approximately 1 p.m. EST, she saw a post on (Social media name) from a friend who received her 2nd Pfizer COVID-19 vaccine. She stated she received it the day before (20Jan2021) and it hurt more than her first vaccination and much sooner. She stated that her arm was sore that day (21Jan2021) but no other side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 11 days after he tested positive for Covid; 11 days after he tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient (consumer's husband) of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient got his 1st dose of vaccine and 11 days after he tested positive for Covid on 08Jan2021. He wanted to know if he could take the second dose of the Covid vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: Have a soreness on her arm where injection occurred; Being achy, tired; Being achy, tired; This is a spontaneous report from a contactable consumer, the patient.  A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient reported that after receiving the 2nd dose of the Covid 19 vaccine she report being achy, tired and have a soreness on her arm where injection occurred. The symptoms subsided after 24 hours. The clinical outcome of the events achy, tired and have a soreness on her arm where injection occurred was recovering.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: dry cough; This is a spontaneous report via a Pfizer-sponsored program from a contactable consumer (patient) reported for self. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced dry cough on 16Jan2021. He was supposed to get his second on 06Feb2021, but they didn't give him a time. He was given the COVID vaccine by his local health department. Relayed to reach out to them, and they should be able to give him a time. While he was talking, he was coughing and stated he had a dry cough this morning. The outcome of event was unknown.   Information on the lot/ batch number has been requested.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Paraesthesia
Clinical narrative: severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; This is a spontaneous report from a contactable other hcp. A 81-years-old female patient (not pregnant) received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: sulfa. No covid prior vaccination. No covid tested post vaccination. The patient's concomitant medications were not reported. The patient experienced severe back and leg pain and paresthesias bilaterally on 05Jan2021. The events resulted in hospitalization. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a drug-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events severe back and leg pain and paresthesias cannot be completely excluded. The case will be reevaluated should additional information become available. 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: U
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Severe tooth pain; This is a spontaneous report from the Pfizer-sponsored programs. A contactable consumer reported that 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 05Jan2021 at single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter was calling for a patient that was in severe tooth pain since there was no doctor available to ask. Reporter said that the patient had the first dose on 05Jan2020. Reporter was asking if there is interference of drugs like, ibuprofen, antibiotic, and anti-inflammatory. Reporter was asking if there is a website to check regarding these interactions. Reporter also said that it was an emergency since the patient would take a strong antibiotic for root canal. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Haematochezia
Clinical narrative: passing blood in stool; stomach cramping; This is a spontaneous report from a contactable consumer.  A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248), via an unspecified route of administration at single dose on 18Jan2021 for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced passing blood in stool on 21Jan2021, stomach cramping on 20Jan2021, he had a couple of bowel movements this morning much more dark, not bright red blood like they were before on 22Jan2021. The patient was hospitalized for passing blood in stool from 21Jan2021 to 22Jan2021. The outcome of passing blood in stool was recovered on 22Jan2021, of stomach cramping was recovered on 21Jan2021, of had a couple of bowel movements this morning, much more dark, not bright red blood like they were before was unknown
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced a little sore in the arm after the first dose; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), 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 experienced a little sore in the arm after the first dose on an unspecified date with outcome of unknown.  Information on lot number/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: fatigue; headache; This is a spontaneous report from a non-contactable consumer (patient) received via a sales representative.  A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included COVID-19 from Oct2020 to an unspecified date.  The patient's concomitant medications were not reported. On an unspecified date, the patient experienced fatigue and headache. The patient outcome of the events was recovered (symptoms only lasted for about 24 hours).  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: she had a sore arm and a little nausea for a few hours; she had a sore arm and a little nausea for a few hours; This is a spontaneous report from a contactable healthcare professional (the patient).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient had no underlying conditions. The patient's concomitant medications were not reported. After the injection, the patient had a sore arm and a little nausea for a few hours but felt great now and looked forward to completing the series. She was happy with the vaccine. She will soon receive the second dose. The clinical outcome of sore arm and a little nausea was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Pain in extremity
Clinical narrative: had a sore arm; her head felt heavy; This is a spontaneous report from a contactable consumer (parent). A contactable consumer (parent) reported for a female of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on 23Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medication were not provided. The patient stated that she received her first dose of the Covid-19 vaccine on 23Dec and had a sore arm and her head felt heavy. She was normal by the next day. The events outcome was recovered on 24Dec2020.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: she was vomiting and felt nauseous; she was vomiting and felt nauseous; This is a spontaneous report from a contactable consumer (patient).   This female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 13Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on 23Dec2020 for covid-19 immunisation and had a sore arm and her head felt heavy. On 13Jan2021 about an hour after the second dose, the patient was vomiting and felt nauseous with outcome of recovered on 14Jan2021.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling too great; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sales representative. This patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient experienced not feeling too great on an unspecified date with outcome of unknown.    No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on neck/ shoulders/ upper back; This is a spontaneous report from a contactable consumer (patient) A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization on 16Jan2021 at single dose.  Medical history included spasmodic dystonia and migraines.  The patient's concomitant medications were not reported. On 18Jan2021, approximately 36 hrs after injection, patient experienced rash on neck/ shoulders/ upper back with outcome of unknown.Information on the batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever/low grade fever; Headache; This is a spontaneous report from a Pfizer Sponsored Program  via a contactable nurse (patient). A 44-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EV1685) via an unspecified route of administration in right deltoid on 13Jan2021 14:30 at single dose for COVID-19 immunisation. She received her first dose of BNT162B2 on 23Dec2020 13:30 (at age of 44 years old) for COVID-19 immunisation. There was no medical history. The patient's concomitant medications were not reported. The patient received the second dose of her Pfizer vaccine on 13Jan2021. She has a headache and fever (on Jan2021), which lasted a whole week. She still had a headache and a low grade fever and today is day 8th. Inquiring if that is a normal side effect, with the vaccine is it common or how long should she expect this. She received Advil and Tylenol as treatment. She had COVID test yesterday (20Jan2021) it was negative. Relatedness of drug to events headache and fever was reported as related by reporter because she had them since the second dose. Events outcome was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain, Pain in extremity
Clinical narrative: body aches; sore arm; runny stools; fatigue; This is a spontaneous report from non-contactable consumer, the patient via Sales Representative. A 77-year-old male consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on an unspecified date  as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced body aches, sore arm, runny stools, and fatigue. The clinical outcome of body aches, sore arm, runny stools, and fatigue was unknown.    No follow-up attempts are possible. Information about lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain
Clinical narrative: feeling fatigued; achy with lymphadenopathy; achy with lymphadenopathy; This is a spontaneous report from a contactable nurse reported for herself. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. After receiving the second dose of the vaccine, she reported feeling fatigued, achy with lymphadenopathy. Event took place after use of product. The outcome of events was unknown.   Information on batch/lot number was requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Caller Got covid vaccine 12Jan- tested positive on 19Jan; Caller Got covid vaccine 12Jan- tested positive on 19Jan; This is a spontaneous report from a Pfizer sponsored program. A non-contactable male consumer (Patient) reported a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced tested positive on 19Jan2021 and wondering if it's okay to get the second dose.  The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Pyrexia, Spinal pain
Clinical narrative: spine pain; headache; light headed; Temp of 105; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021, reported as between 16:00-17:00, (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Jan2021, the patient experienced spine pain, headache, lightheadedness and a temperature of 105 (units not provided). The patient was treated for the events, reportedly he took an ibuprofen (ADVIL) the morning of 21Jan2021 and coffee throughout the day. The clinical outcome of spine pain, headache, lightheadedness and a temperature of 105 was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain
Clinical narrative: achy; little diarrhea; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unknown age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 19Jan2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient got the first dose on 19Jan2021  (last Tuesday) and now (22Jan2021) experienced little diarrhea and achy.  Outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: passed out; This is a spontaneous report from a Pfizer sponsored program from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient woke up next morning on 21Jan2021 to go to bathroom and passed out. The outcome of event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity, Sleep disorder due to general medical condition, insomnia type
Clinical narrative: sharp, shooting pain in the tips of her fingers; shooting pain in the tips of her fingers, joints and back; shooting pain in the tips of her fingers, joints and back; pains woke her from her sleep; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), 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 previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at single dose for COVID-19 immunization. Patient experienced sharp, shooting pain in the tips of her fingers, joints and back. The symptoms started 10 hours after administration of the 2nd dose of the bnt162b2 on an unspecified date, and lasted for 12 hours. The pains woke her from her sleep. Event took place after use of product. The outcome of the events was recovered on unspecified dates.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: immunocompromised patient; immunocompromised patient; tested positive for COVID/nasal congestion; tested positive for COVID/nasal congestion; This is a spontaneous report from a contactable physician. A 65-year-old female patient (nurse) received bnt162b2 (Pfizer BioNTech COVID 19 vaccine), via an unspecified route of administration, the first dose on an unspecified date and the second dose on 14Jan2021, at single dose for covid-19 immunisation. The patient's medical history included immunocompromised. Concomitant medications were not reported. The immunocompromised patient received her second dose of Pfizer vaccine on 14Jan2021. On 20Jan2021, she developed nasal congestion and her son became sick the same day. Both tested positive for COVID. The physician asked would you consider giving the monoclonal ab to her? Physician knew the expectation was mild disease not severe but would you consider giving her the monoclonal? Outcome of the events was unknown.  Information about lot and batch number had been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "tested positive for COVID".
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever; Chills; Body aches; Vomiting; Diarrhea; This is a spontaneous report from a contactable Nurse, received via a Pfizer Sales Representative. This Nurse reported similar events for 3 patients. This is the second of 3 reports. This patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), 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. On an unspecified date, the patient experienced fever, chills, body aches, vomiting and diarrhea. The symptoms began almost immediately after receiving the vaccination and lasted for about 12 hours. The clinical outcomes of the fever, chills, body aches, vomiting and diarrhea were unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021072645 ;US-PFIZER INC-2021072647
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in her arm /sore around the injection site, pain; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for an 84-year-old female patient that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3248), via an unspecified route of administration at arm on 21Jan2021 13:00 at single dose for COVID-19 immunization. The patient medical history was not reported.  There were no concomitant medications.  The patient experienced soreness in her arm /sore around the injection site, pain on 21Jan2021 with outcome of unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Disease recurrence, Fatigue, Pain in extremity
Clinical narrative: fatigue; arm soreness; flare up of right hip pain; flare up of right hip pain; This is a spontaneous report from a contactable Nurse (patient). A 65-years-old female patient received second dose of bnt162b2 (BNT162B2, LOT: EL 3248), via an unspecified route of administration from on 10Jan2021 10:30 at SINGLE DOSE on Left arm for covid-19 immunisation. Medical history included Prediabetes, spinal stenosis of right back, right hip pain, known allergies: Penicillin, sulfa, yellow jacket venom. No pregnant. The patient had no covid-prior-vaccination. The patient Historical Vaccine included COVID 19 for covid-19 immunisation at 65 years old, product=COVID 19, brand=PfizerBioN Tech, lot number=EJ 1685, administration date=20Dec2020, administration time=08:00 AM, vaccine location=Left arm; and After 12 hours (08:00 PM) experienced Blurred vision, fatigue , dizziness, tachycardia, arm soreness, after first vaccine 20Dec2020. Concomitant medication included gabapentin (GABAPENTIN), metformin (METFORMIN), paracetamol (TYLENOL), diclofenac (DICLOFENAC), zinc (ZINC). The patient experienced fatigue and arm soreness, and flair up of right hip pain after had received a epidural right hip block 5 days before 2nd injection since Jan2021. No treatment received. The event recovered in Jan2021. No covid-tested-post-vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She is currently experiencing arm ache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reported for self. This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient was asking if it's okay to take ibuprofen (ADVIL) after the 1st dose. She was currently experiencing arm ache. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling hot, Headache, Malaise
Clinical narrative: not feeling well/feeling unwell; aches all over his body/Aches all over with muscles pains; muscle pains; headache; joint pain; chills; Injection site pain on left arm; body slightly warm/felt slightly warm; This is a spontaneous report from a contactable consumer (Patient's wife). A 81 years old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247 or EL3427), via an unspecified route of administration at Arm Left on 21Jan2021 09:33 at the 81 years old at single dose for COVID-19 immunization.   The medical history was none. The family medical history was none. The concomitant medications included warfarin from Mar2012 for Atrial fibrillation( AFib) and standard medications . The patient was not feeling well. All occurred on 21Jan2021 18:00, the patient developed symptoms, such as aches all over his body, aches all over with muscles pains with muscle pains, headache, joint pain, chills, injection site pain on left arm, body slightly warm, felt slightly warm, feeling unwell. He had chills all night and could not get warm. The reporter had not taken the patient's temperature yet. The patient takes regular medications. The patient was on warfarin and standard medications. The reporter stated the vaccine cards were mixed up because they did not write their names on them and the vaccine lot numbers looks like they were mixed up. Someone probably made a mistake because one says EL3247 and the other says EL3427, so she is not sure which it is. The handwriting is different on the cards. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was not Emergency Room Visit or physician's office required Prior Vaccinations (within 4 weeks). The outcome of the event was not recovered.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vaccination site pain
Clinical narrative: not feeling well/feeling unwell; aches all over his body/Aches all over with muscles pains; muscle pains; headache; joint pain; chills; Injection site pain on left arm; body slightly warm/felt slightly warm; This is a spontaneous report from a contactable consumer (Patient's wife). A 81 years old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247 or EL3427), via an unspecified route of administration at Arm Left on 21Jan2021 09:33 at the 81 years old at single dose for COVID-19 immunization.   The medical history was none. The family medical history was none. The concomitant medications included warfarin from Mar2012 for Atrial fibrillation( AFib) and standard medications . The patient was not feeling well. All occurred on 21Jan2021 18:00, the patient developed symptoms, such as aches all over his body, aches all over with muscles pains with muscle pains, headache, joint pain, chills, injection site pain on left arm, body slightly warm, felt slightly warm, feeling unwell. He had chills all night and could not get warm. The reporter had not taken the patient's temperature yet. The patient takes regular medications. The patient was on warfarin and standard medications. The reporter stated the vaccine cards were mixed up because they did not write their names on them and the vaccine lot numbers looks like they were mixed up. Someone probably made a mistake because one says EL3247 and the other says EL3427, so she is not sure which it is. The handwriting is different on the cards. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was not Emergency Room Visit or physician's office required Prior Vaccinations (within 4 weeks). The outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Pain
Clinical narrative: trouble sleeping; Was very achy all day yesterday with headache; Was very achy all day yesterday with headache; Minor chills; This is a spontaneous report from a contactable consumer reporting for themself. A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL8982/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included patient got sick and had suspected COVID on "03Aug" and became a long hauler and still have lingering symptoms. The patient previously received the first dose of BNT162B2 on an unknown date. Concomitant medication was not reported. On 21Jan2021, the patient had trouble sleeping that night, was very achy all day with headache and had minor chills. The woke up feeling well. The outcome of the events had trouble sleeping that night, was very achy all day with headache and had minor chills was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID 19 PCR test positive; COVID 19 PCR test positive; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249, Expiry Date: 31May2021), intramuscularly into left arm on 15Jan2021 at a single dose for COVID Prevention. The patient medical history was not reported. There were no concomitant medications. The patient experienced tested positive for COVID on 21Jan2021 after taking 1st dose of COVID vaccine. The patient tested positive for COVID after taking 1st dose of COVID vaccine and was calling to see what she should do about her 2nd dose. The reporter saw in the news that patients can wait up to 6 weeks after receiving the first dose of the vaccine to receive the second, she wants to confirm this information. The reporter was calling on behalf of herself as the patient. The patient got the Pfizer COVID-19 Vaccine last Friday (15Jan2021), and she took a COVID 19 PCR test on 21Jan2021, and the results came back as positive for COVID 19 today 22Jan2021. The patient was wondering what the recommendations are for getting the second dose if a patient tested positive for COVID 19, following having received the first dose. The patient was not complaining about the product, because the product has not had time to work yet. The patient believed the seriousness, it was medically significant because she was losing work over it. Causality: The reporter (patient) did not believe that she got COVID 19 because of the vaccine not working, she just did not think the vaccine had enough time to work before she was exposed. She had no other vaccines on the same day. After she got her first dose, there were a few side effects that she had but nothing was bad, so she was mad when she realized she had gotten COVID, therefore it was not the vaccines fault she got COVID. The reporter had some questions about how this vaccine works in the body. Her doctor thought that her now having tested positive for COVID, that might increase the immune response. The outcome of events was unknown.    Relatedness between reaction COVID-19 PCR test positive and bnt162b2, was unrelated by source of assessment: primary source reporter per method of assessment: Global Introspection.; Sender's Comments: Based on the information currently available, COVID-19 and lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass
Clinical narrative: very bad arm and leg lump getting bigger and bigger; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). This female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 on an unspecified date for COVID-19 immunization. Patient experienced very bad arm and leg lump getting bigger and bigger after taking the 2nd dose of the vaccine last Tuesday (Jan2021). Outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: experienced an improvement in her arthritis pain in her shoulder; This is a spontaneous report from a contactable consumer via a Pfizer Sales Representative. A female patient (reporter's mother-in-law) of unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at a single dose for COVID-19 immunization. Medical history included arthritis pain in her shoulder. Concomitant medications were not reported. The reporter's mother-in-law received the first dose of the Pfizer Covid vaccine and experienced an improvement in her arthritis pain in her shoulder. The outcome of the event was unknown.  No follow-up attempts are needed, no further information is expected. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This is a spontaneous report from a non-contactable healthcare professional reporting similar events for 6 patients. This is the 5th of 6 patients. A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 20Jan2021 as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. On an unknown date, the patient was sick. The outcome of the event sick was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076652 same drug and event, different patient