chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: chills; pushing pain in both arms; This is a spontaneous report from a Pfizer sponsored program from contactable consumer (patient). A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. Patient after her last dose of covax on 27Jan2021 experienced chills a week ago and is wondering if this is from the covax and a pushing pain in both arms. No treatment received for the events . The outcome of event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Pyrexia
Clinical narrative: She mentioned that she has had a fever on and off, joint pain, and headaches; She mentioned that she has had a fever on and off, joint pain, and headaches; She mentioned that she has had a fever on and off, joint pain, and headaches; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 2021(3 weeks ago from reported date), as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was due for her second dose, but mentioned that she has not been well for 8 days and told to rescheduled her second dose for Saturday. On 2021, the patient had a fever on and off, joint pain, and headaches. The patient had a fever of 102 degree Fahrenheit. Patient enquired if these side effects could possibly appear 3 weeks out after receiving the 1st dose. She asked if she could receive the vaccine while sick, and if not will she still be fine receiving the 2nd dose even later than Saturday as she does not feel safe doing so. She has yet to get in touch with her health care provider as of calling. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Blood glucose abnormal, Blood glucose increased, Chills, Fatigue
Clinical narrative: anemia; elevated liver enzymes; low protien; Elevated Blood Sugars; Fatigue; Headache; Chills; Fever; Feels awful/ I feel really bad; Feel terrible; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205 and expiration date not reported) via an unspecified route of administration, administered in right arm on 08Mar2021 05:00 as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin; tamsulosin and insulin aspart (NOVOLOG). The patient reported that he regulates his blood sugar by insulin pump giving him insulin when he needed it. The patient stated that he felt awful. He felt terrible. He could not function. Without drugs, he feels really bad. He got the vaccine on 08Mar2021 and for a couple of days, he felt okay but after that, he just feels really terrible. He does not know what to do. He stated that the events probably started on 10Mar2021. He does not remember but it has been a couple of days since he got the vaccine, quite "hard feeling for him". He stated that he drove up to the stadium in his car, answered a bunch of questions, sat down at his reservation number, got his shot on his arm and drove away. As treatment for these events, he stated, Tylenol, he had taken about 1000 units at least once a day or sometimes twice a day but it varies. If he does not take it, he feels really bad. He does not like to take drugs so, he was trying not to take it. He asked what he was supposed to do. It was also reported that on 11Mar2021 16:00, the patient experienced Fatigue, Headache, Chills, Fever. He had elevated blood sugars on 19Mar2021. On an unspecified date, he had a CBC done which showed anemia, elevated liver enzymes and low protein. He had not been able to function at a normal level. No treatment was given in response to these events. The outcome of the events was not recovered. The patient underwent COVID test post vaccination via nasal swab (PCR) on 02Mar2021 and was negative and on 19Mar2021 and was negative. The reporter assessed the events Feels awful and Feel terrible was related.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Full blood count, Headache, Hepatic enzyme, Hepatic enzyme increased
Clinical narrative: anemia; elevated liver enzymes; low protien; Elevated Blood Sugars; Fatigue; Headache; Chills; Fever; Feels awful/ I feel really bad; Feel terrible; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205 and expiration date not reported) via an unspecified route of administration, administered in right arm on 08Mar2021 05:00 as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin; tamsulosin and insulin aspart (NOVOLOG). The patient reported that he regulates his blood sugar by insulin pump giving him insulin when he needed it. The patient stated that he felt awful. He felt terrible. He could not function. Without drugs, he feels really bad. He got the vaccine on 08Mar2021 and for a couple of days, he felt okay but after that, he just feels really terrible. He does not know what to do. He stated that the events probably started on 10Mar2021. He does not remember but it has been a couple of days since he got the vaccine, quite "hard feeling for him". He stated that he drove up to the stadium in his car, answered a bunch of questions, sat down at his reservation number, got his shot on his arm and drove away. As treatment for these events, he stated, Tylenol, he had taken about 1000 units at least once a day or sometimes twice a day but it varies. If he does not take it, he feels really bad. He does not like to take drugs so, he was trying not to take it. He asked what he was supposed to do. It was also reported that on 11Mar2021 16:00, the patient experienced Fatigue, Headache, Chills, Fever. He had elevated blood sugars on 19Mar2021. On an unspecified date, he had a CBC done which showed anemia, elevated liver enzymes and low protein. He had not been able to function at a normal level. No treatment was given in response to these events. The outcome of the events was not recovered. The patient underwent COVID test post vaccination via nasal swab (PCR) on 02Mar2021 and was negative and on 19Mar2021 and was negative. The reporter assessed the events Feels awful and Feel terrible was related.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Protein total, Protein total decreased, Pyrexia, SARS-CoV-2 test
Clinical narrative: anemia; elevated liver enzymes; low protien; Elevated Blood Sugars; Fatigue; Headache; Chills; Fever; Feels awful/ I feel really bad; Feel terrible; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205 and expiration date not reported) via an unspecified route of administration, administered in right arm on 08Mar2021 05:00 as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pravastatin; tamsulosin and insulin aspart (NOVOLOG). The patient reported that he regulates his blood sugar by insulin pump giving him insulin when he needed it. The patient stated that he felt awful. He felt terrible. He could not function. Without drugs, he feels really bad. He got the vaccine on 08Mar2021 and for a couple of days, he felt okay but after that, he just feels really terrible. He does not know what to do. He stated that the events probably started on 10Mar2021. He does not remember but it has been a couple of days since he got the vaccine, quite "hard feeling for him". He stated that he drove up to the stadium in his car, answered a bunch of questions, sat down at his reservation number, got his shot on his arm and drove away. As treatment for these events, he stated, Tylenol, he had taken about 1000 units at least once a day or sometimes twice a day but it varies. If he does not take it, he feels really bad. He does not like to take drugs so, he was trying not to take it. He asked what he was supposed to do. It was also reported that on 11Mar2021 16:00, the patient experienced Fatigue, Headache, Chills, Fever. He had elevated blood sugars on 19Mar2021. On an unspecified date, he had a CBC done which showed anemia, elevated liver enzymes and low protein. He had not been able to function at a normal level. No treatment was given in response to these events. The outcome of the events was not recovered. The patient underwent COVID test post vaccination via nasal swab (PCR) on 02Mar2021 and was negative and on 19Mar2021 and was negative. The reporter assessed the events Feels awful and Feel terrible was related.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: grandparents are due to receive their second dose of the Pfizer Covid vaccine 21Mar2021 but someone in their house is being tested for Covid-19; This case has been considered invalid as there is no indication that the patient experienced an event under BNT162B2.   This is a spontaneous report received from a contactable consumer. This consumer reported for a male patient (grandparent) that:  Serious: No  Drug information: Characterization of drug role: Suspect Proprietary medicinal product name: PFIZER-BIONTECH COVID-19 VACCINE Active Drug substance name: PFIZER-BIONTECH COVID-19 VACCINE  Reporter Subtype: Caregiver Product: PFIZER-BIONTECH COVID-19 VACCINE Dose number: 1  Question: Caller's grandparents are due to receive their second dose of the Pfizer Covid vaccine 21Mar2021 but someone in their house is being tested for Covid-19 and she is seeking further guidance for this. Will e-transmit as potential AE. Response: Referred caller to HCP for further discussion. Provided off-label disclaimer. Informed caller that Pfizer is unable to make treatment recommendations. Spoke from attached document CONS-Can I Receive the Vaccine with a Prior or Current COVID-19 Diagnosis (US) (v2.0) and CONS-who should not get the vaccine (v3.0).   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Added exposure to COVID-19 as medical history and made case invalid as other info not qualifying for AE reporting-medical information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypersensitivity, Hypertension, Hypoaesthesia
Clinical narrative: had allergic reaction within 2 mins of receiving Pfizer vaccine dose 2; needle pricks on face; numbness in face; increased blood pressure/high BP (170/100); tested positive for COVID; tested positive for COVID; seeing spots on face/chin/neck; vertigo; nausea; diarrhea; exhaustion; Elevated thyroid, blood sugar, cholesterol; Elevated thyroid, blood sugar, cholesterol; Elevated thyroid, blood sugar, cholesterol; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included diabetic, known allergies: sulfa, statins and environment. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization. On 20Jan2021, the patient had allergic reaction within 2 mins of receiving Pfizer vaccine dose 2 (needle pricks on face, numbness in face, increased blood pressure). The patient was taken to the hospital by an ambulance, given fluids and then sent home with instructions to take benadryl. One month later (15Mar2021), patient started experiencing COVID symptoms. On 17Mar2021, after seeing spots on face/chin/neck, vertigo, nausea, diarrhea, high BP (170/100), exhaustion, the patient went to the ER and tested positive for COVID. Elevated thyroid, blood sugar, cholesterol were normal 2 weeks prior (Mar2021). The patient received treatment for the events allergic reaction, needle pricks on face, numbness in face and increased blood pressure. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: had allergic reaction within 2 mins of receiving Pfizer vaccine dose 2; needle pricks on face; numbness in face; increased blood pressure/high BP (170/100); tested positive for COVID; tested positive for COVID; seeing spots on face/chin/neck; vertigo; nausea; diarrhea; exhaustion; Elevated thyroid, blood sugar, cholesterol; Elevated thyroid, blood sugar, cholesterol; Elevated thyroid, blood sugar, cholesterol; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included diabetic, known allergies: sulfa, statins and environment. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization. On 20Jan2021, the patient had allergic reaction within 2 mins of receiving Pfizer vaccine dose 2 (needle pricks on face, numbness in face, increased blood pressure). The patient was taken to the hospital by an ambulance, given fluids and then sent home with instructions to take benadryl. One month later (15Mar2021), patient started experiencing COVID symptoms. On 17Mar2021, after seeing spots on face/chin/neck, vertigo, nausea, diarrhea, high BP (170/100), exhaustion, the patient went to the ER and tested positive for COVID. Elevated thyroid, blood sugar, cholesterol were normal 2 weeks prior (Mar2021). The patient received treatment for the events allergic reaction, needle pricks on face, numbness in face and increased blood pressure. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Vomiting
Clinical narrative: vomiting; chills; wasn't feeling well; This is a spontaneous report from a contactable consumer. A 37-year-old male patient (reporter's son) received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, on Mar2021, at 3pm as a single dose, for COVID-19 immunisation. Medical history included COVID-19 infection, in June or July 2020. It was reported that the patient had a very severe case of the COVID-19, which lasted for 2 weeks and the patient was very ill. The patient's concomitant medications were not reported. In Mar2021, the patient experienced vomiting, chills and wasn't feeling well. The patient had told the reporter that he was going to go to sleep and see if he feels better. The reported stated that the patient moved away a few weeks ago so he didn't have a doctor there. The clinical outcome of the events vomiting, chills, wasn't feeling well was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experiencing pain on his left side arm; This is a spontaneous report from a Pfizer-sponsored. A contactable male consumer, the patient of unspecified age received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 04Mar2021 via unspecified route as a single dose for COVID-19 immunisation. The patient medical history included hypertension from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced pain on his left side arm and other side effects. The outcome of the event was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer reported in response to Non-HCP follow-up letter sent in cross reference case. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation causes pain, right knee-could barely walk and all of her joints that had been previously hurt in the past started killing her. The patient experienced rash on 16Feb2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was recovered.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Chills, Fatigue, Headache
Clinical narrative: clusters of small blisters; splotchy red rash; felt very unwell; headache; Fever; chills; exhausted; had little sleep; pain in my neck and left shoulder; pain in my neck and left shoulder; sore muscles; This is a spontaneous report received from a contactable consumer (patient). This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 03Mar2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient the patient had not been diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fish oil, Men's Multivitamin and "avmacol," all from unknown dates for unknown indications. The patent reported he started having pain in his neck and left shoulder; further described as like sore muscles, for which he was annoyed enough to take ibuprofen and use ice packs. On Sunday 07Mar (2021) the patient noticed there were clusters of small blisters all over his left shoulder and neck, overlaying a splotchy red rash; reporting they were mostly on the left shoulder, but started in the center of his chest and went all through to his back and stopped at his spine. The patient also reported the past very days he felt very unwell, enough to miss work. Aside from the rash/blisters, he had a headache, chills, and a fever that had come and gone, which measured 103.4 at it's worst. He reported taking dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) every six hours which he thought helped, and he reported using cold compresses for the rash, blisters. He stated he felt exhausted the whole time but had little sleep, which was helped by the dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol for a few hours. He reported today (as of 22Mar2021) was the first day in a few that he'd felt alive enough to report. The blisters/rash were about the same, "but the blisters." The events required a doctor or other healthcare professional office/clinic visit. The clinical outcomes of pain in my neck and left shoulder, sore muscles, cluster of small blisters, splotchy red rash, felt very unwell, headache, fever, chills, exhausted, and had little sleep were reported as recovering. It was also reported the patient was tested for COVID-19 post vaccination, and on 14Mar2021 had a negative nasal swab.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Malaise, Myalgia, Neck pain, Pyrexia
Clinical narrative: clusters of small blisters; splotchy red rash; felt very unwell; headache; Fever; chills; exhausted; had little sleep; pain in my neck and left shoulder; pain in my neck and left shoulder; sore muscles; This is a spontaneous report received from a contactable consumer (patient). This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 03Mar2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient the patient had not been diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fish oil, Men's Multivitamin and "avmacol," all from unknown dates for unknown indications. The patent reported he started having pain in his neck and left shoulder; further described as like sore muscles, for which he was annoyed enough to take ibuprofen and use ice packs. On Sunday 07Mar (2021) the patient noticed there were clusters of small blisters all over his left shoulder and neck, overlaying a splotchy red rash; reporting they were mostly on the left shoulder, but started in the center of his chest and went all through to his back and stopped at his spine. The patient also reported the past very days he felt very unwell, enough to miss work. Aside from the rash/blisters, he had a headache, chills, and a fever that had come and gone, which measured 103.4 at it's worst. He reported taking dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) every six hours which he thought helped, and he reported using cold compresses for the rash, blisters. He stated he felt exhausted the whole time but had little sleep, which was helped by the dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol for a few hours. He reported today (as of 22Mar2021) was the first day in a few that he'd felt alive enough to report. The blisters/rash were about the same, "but the blisters." The events required a doctor or other healthcare professional office/clinic visit. The clinical outcomes of pain in my neck and left shoulder, sore muscles, cluster of small blisters, splotchy red rash, felt very unwell, headache, fever, chills, exhausted, and had little sleep were reported as recovering. It was also reported the patient was tested for COVID-19 post vaccination, and on 14Mar2021 had a negative nasal swab.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Sleep deficit
Clinical narrative: clusters of small blisters; splotchy red rash; felt very unwell; headache; Fever; chills; exhausted; had little sleep; pain in my neck and left shoulder; pain in my neck and left shoulder; sore muscles; This is a spontaneous report received from a contactable consumer (patient). This 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6202) via an unspecified route of administration in the left arm on 03Mar2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination the patient the patient had not been diagnosed with COVID-19 and had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fish oil, Men's Multivitamin and "avmacol," all from unknown dates for unknown indications. The patent reported he started having pain in his neck and left shoulder; further described as like sore muscles, for which he was annoyed enough to take ibuprofen and use ice packs. On Sunday 07Mar (2021) the patient noticed there were clusters of small blisters all over his left shoulder and neck, overlaying a splotchy red rash; reporting they were mostly on the left shoulder, but started in the center of his chest and went all through to his back and stopped at his spine. The patient also reported the past very days he felt very unwell, enough to miss work. Aside from the rash/blisters, he had a headache, chills, and a fever that had come and gone, which measured 103.4 at it's worst. He reported taking dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) and dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) every six hours which he thought helped, and he reported using cold compresses for the rash, blisters. He stated he felt exhausted the whole time but had little sleep, which was helped by the dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol for a few hours. He reported today (as of 22Mar2021) was the first day in a few that he'd felt alive enough to report. The blisters/rash were about the same, "but the blisters." The events required a doctor or other healthcare professional office/clinic visit. The clinical outcomes of pain in my neck and left shoulder, sore muscles, cluster of small blisters, splotchy red rash, felt very unwell, headache, fever, chills, exhausted, and had little sleep were reported as recovering. It was also reported the patient was tested for COVID-19 post vaccination, and on 14Mar2021 had a negative nasal swab.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Burning sensation, Chills, Pain
Clinical narrative: Chills; fluctuating temperature 0.5 -1 degree  changes; Localized pain; Slightly burning sensation in the right thigh; This is a spontaneous report from a contactable consumer (patient). This 69-year-old male patient 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, reported as about 19 days ago (as of 22Mar2021), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported he received the second dose about 19 days ago and still had on and off side effects like minor chills, fluctuating temperature 0.5 -1-degree changes, localized pain that went away and slightly burning sensation in the right thigh. The clinical outcomes of minor chills, fluctuating temperature 0.5 - 1-degree changes, and slightly burning sensation in the right thigh were unknown. The clinical outcome of localized pain was recovered on an unspecified date.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: The swollen lymph nodes is on both sides, but is subsiding; On the side where she got her shot the swelling has come down to her collar bone.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot number and expiry was not reported) via an unspecified route of administration on 03Mar2021 as single dose for covid-19 immunization. Medical history included 2 Autoimmune diseases. The patient's concomitant medications were not reported. On an unspecified date, after receiving the vaccine she noticed her lymph nodes were swollen. The patient reported the swollen lymph nodes is on both sides but is subsiding. The patient questioned if second dose should be taken as it is scheduled for 24Mar2021 and enquired if it will get worse.  Follow up letter has been generated for lot/batch number and for further information  Follow-up (22Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported for herself that:   Follow-up (22Mar2021): Follow up information included. The patient reportedly noticed 5 days later that she had swollen glands around her neck. She has autoimmune problems, Sjogren's, which affects the lymphatic system. When she asked her doctor he said it was a side effect from the vaccine. She is supposed to go on 24Mar2021 for her second dose. The swollen glands have calmed down now. On the side where she got her shot the swelling has come down to her collar bone.  No follow-up attempts are possible; information about lot/batch number cannot been obtained  This follow-up report is being submitted to amend previously reported information: The classification of at risk was removed as true event PT Lymphadenopathy is reported.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Intervertebral disc protrusion, Malaise
Clinical narrative: Sick process; Slip disc; Back ache; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in Mar2021, reported as between 01Mar2021 and 10Mar2021, as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were unknown. The patient reported he had a slipped disc and was taking pain relievers for backache which helped him sleep better at night. He reported he received the first dose of BNT162B2 somewhere in between 01Mar2021 and 10Mar2021; his second dose was due on 31Mar2021. The patient inquired if he could take ibuprofen after vaccination with BNT162B2 and if he could drink alcohol after vaccination. The patient reported he had been going through a sick process ever since vaccination, inquiring if that was normal. The clinical outcome of sick process was not recovered, the outcome of slipped disc and backache were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza, Multiple allergies, Pyrexia
Clinical narrative: Allergies; Flu; fever; headache; my nose keeps running; This is a spontaneous report received from a non-contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 02Mar2021 as a single dose for COVID-19 immunisation. Medical history included pollen allergy, which the patient reported gets worse during spring, from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient reported that during Spring season, her allergies to pollen got much worse. She stated it had nothing to do with COVID-19. She stated she received the first dose of BNT162B2 on 02Mar2021 and the second dose was due 23Mar2021. She reported she had a little bit of allergies, possibly a little bit of the flu last week, further reporting it had nothing to do with COVID. She reported that last week (as of 22Mar2021) she had a little bit of the flu, reported as nothing major, fever of 99 degrees Fahrenheit that went away, headache that went away, and allergies were terrible. She stated she usually took loratadine, pseudoephedrine sulfate (CLARITIN-D) for a couple days, although this time she would not take any antihistamines before her vaccination tomorrow. She further reported sometimes she took cetirizine (ZYRTEC) on a regular basis, although she was not going to take it tomorrow. She didn't know if she could take guaifenesin (MUCINEX) because her nose kept running. The clinical outcomes of allergies and flu were unknown; the outcome of fever and headache were recovered in Mar2021; the outcome of her nose kept running was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Allergies; Flu; fever; headache; my nose keeps running; This is a spontaneous report received from a non-contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 02Mar2021 as a single dose for COVID-19 immunisation. Medical history included pollen allergy, which the patient reported gets worse during spring, from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient reported that during Spring season, her allergies to pollen got much worse. She stated it had nothing to do with COVID-19. She stated she received the first dose of BNT162B2 on 02Mar2021 and the second dose was due 23Mar2021. She reported she had a little bit of allergies, possibly a little bit of the flu last week, further reporting it had nothing to do with COVID. She reported that last week (as of 22Mar2021) she had a little bit of the flu, reported as nothing major, fever of 99 degrees Fahrenheit that went away, headache that went away, and allergies were terrible. She stated she usually took loratadine, pseudoephedrine sulfate (CLARITIN-D) for a couple days, although this time she would not take any antihistamines before her vaccination tomorrow. She further reported sometimes she took cetirizine (ZYRTEC) on a regular basis, although she was not going to take it tomorrow. She didn't know if she could take guaifenesin (MUCINEX) because her nose kept running. The clinical outcomes of allergies and flu were unknown; the outcome of fever and headache were recovered in Mar2021; the outcome of her nose kept running was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Insomnia, Irritability, Middle insomnia
Clinical narrative: Arm soreness; She couldn't sleep; Woken up every 20 minutes; Was on fire all last night; Sweaty; Very irritable; This is a spontaneous report from a contactable consumer (patient). This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunisation. Medical history included an ankle sprain which the patient stated occurred prior to vaccination, from  an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received a tetanus shot on an unknown date for immunisation. The patient reported she received the first dose of BNT162B2 yesterday and last night she couldn't sleep and was woken up every 20 minutes, further reporting she was on fire all last night, was sweating and was very irritable. She also reported today (as of 22Mar2021) she developed arm soreness. She inquired if this was normal. The clinical outcomes of she couldn't sleep, woken up every 20 minutes, on fire all last night, sweaty and arm soreness were unknown. The clinical outcome of very irritable was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; She couldn't sleep; Woken up every 20 minutes; Was on fire all last night; Sweaty; Very irritable; This is a spontaneous report from a contactable consumer (patient). This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunisation. Medical history included an ankle sprain which the patient stated occurred prior to vaccination, from  an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received a tetanus shot on an unknown date for immunisation. The patient reported she received the first dose of BNT162B2 yesterday and last night she couldn't sleep and was woken up every 20 minutes, further reporting she was on fire all last night, was sweating and was very irritable. She also reported today (as of 22Mar2021) she developed arm soreness. She inquired if this was normal. The clinical outcomes of she couldn't sleep, woken up every 20 minutes, on fire all last night, sweaty and arm soreness were unknown. The clinical outcome of very irritable was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension, Illness
Clinical narrative: Hypertension 226/136; Felt dizzy; Sick; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 07Jan2021 (at the age of 74-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Two days after dose 1 of BNT162B2 (09Jan2021) the patient experienced hypertension, felt dizzy, and sick. The patient had not experienced dizziness and hypertension before. She decided not to receive dose 2 of BNT162B2 and wanted to know if it was too late to receive dose 2. The patient underwent lab tests and procedures which included blood pressure measurement of 226/136. The outcomes of hypertension, felt dizzy, and sick were unknown.  No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: sometimes loses her memory; This is a spontaneous report received from a non-contactable consumer (patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 27Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient sometimes lost her memory. The patient wanted information on how to receive the second dose of BNT162B2. She received dose 1 on the 27th day a month ago (27Feb2021). During the call she stated she sometimes lost her memory. The outcome of sometimes lost her memory was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pruritus, Vaccination site pain
Clinical narrative: Injection site was hurting bad; Not able to move her shoulder; Itching all over her body and now her face; This is a spontaneous report received from a contactable consumer. A 62-year-old female patient (reporter's wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date in Mar2021, reported as 10 days ago (as of 22Mar2021), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated his wife got the COVID vaccine 10 days ago (as of 22Mar2021) and the injection site was hurting bad for two days and she was not able to move her shoulder for two days. She also had itching all over her body and now her face (as of 22Mar2021) and it comes and goes. The reporter inquired how long it would last and was concerned if she got the second dose it might be worse; further inquiring what he should do. He reported he spoke with his doctor about his wife's side effects and his concern about her getting the second shot and whether or not he should get the vaccine, but his doctor didn't know anything. He stated Pfizer should give guidance on what to do about side effects. The clinical outcomes of injection site was hurting bad, not able to move her shoulder and itching all over her body and now her face were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia, Fluid intake reduced, Hypophagia, Pain
Clinical narrative: No taste in my mouth; Bitter taste in my mouth; I cannot drink water or eat food; I cannot drink water or eat food; Aches; This is a spontaneous report received from a non-contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose, via an unspecified route of administration on 16Mar2021 (Batch/Lot number Unknown) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient received the vaccination last Tuesday (16Mar2021). Ever since the vaccination she has no taste in her mouth and she has a bitter taste in her mouth. She cannot drink water or eat food and she has aches. She spoke with the doctor's office. The patient inquired if she needed to get a COVID-19 test. The outcome of the events no taste and bitter taste in mouth, cannot drink water or eat food and aches was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Brain fog; This is a spontaneous report from a contactable consumer (patient). This 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 unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported she received both doses of BNT162B2 and she had brain fog immediately after the second dose. The clinical outcome of brain fog was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: nausea; vomiting; stomach pains; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history included 'gallbladder our' and migraines. The patient's concomitant medication included galcanezumab gnlm (EMGALITY) for migraines. On an unspecified date on the day of the shot, the patient had fish and chips which she hadn't had since getting her 'gallbladder our' and she started her period the same day. On an unspecified date that night, she had a lot of nausea, vomiting and stomach pains. The outcome of events, nausea, vomiting and stomach pains was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye movement disorder, Feeling abnormal, Feeling cold, Nervousness
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.)   lump in my throat; turned red on my face and neck and chest and arms; when I get nervous; between my eyes on my forehead felt like a round circle (no bump) (past the bridge above eyebrows). It didn't hurt, but I felt something; felt odd; felt like my eyes were moving back and forth; very very cold; hands were ice cold; This is a spontaneous report received a contactable consumer, the patient. A 60-year-old adult female received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 14Mar2021 (at 60-years-old), for COVID-19 immunisation. Relevant medical history included high blood pressure, and diabetes. There were no concomitant medications or past drug history reported. The patient reported that she had a couple of reactions the first day, so she was afraid to take the second one. The patient stated that within eight minutes she had a lump in her throat, which she gets when she is nervous and was unsure if from shot or nervousness. The patient reported that then she turned red on her face, neck, chest, and arms. The patient reported that the redness lasted about six or seven hours and did not bother her at all. The patient explained that then between her eyes on her forehead felt like a round circle (no bump) past the bridge above eyebrows. The patient stated that it did not hurt but felt like something. The patient also stated that she felt like she was going to get headache, though did not. The patient reported that it just felt odd. The patient also stated that she felt like her eyes were moving back and forth. Though when she looked in the mirror, they were fine. The patient stated that the eyes happened three times but by the time she looked in the mirror they looked fine. The patient added that she never felt sick or anything though about six or eight hours later she got very very cold which only lasted about a minute. The patient stated that her hands were ice cold and then it all went back to normal. The outcome of the events turned red on my face and neck and chest and arms was recovered on an unspecified date in Mar2021 after 6-7 hours. The outcome of the event she got very very cold was recovered on an unspecified date in Mar2021 after one minute. The outcome of the events hands were ice cold, and felt like my eyes were moving back and forth was recovered on an unspecified date in Mar2021. The outcome of the events, lump in my throat, get nervous, between my eyes on my forehead felt like a round circle (no bump), felt something, and felt odd, was unknown.  Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.