chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Loss of consciousness, Malaise, Pain in extremity, Palpitations, Peripheral swelling
Clinical narrative: she passed out; she couldn't see; sick; stomach started to hurt; had chills; her arms hurt; she was freezing; her arm had swollen like a balloon; her arm had swollen like a balloon and became hard as a rock; hit her head; dizzy; she couldn't walk around her house; Her heart was "loudly" palpating; extremely low blood pressure/Her heart was "loudly" palpating; This spontaneous report as received from a consumer concerning herself a 67  year old patient. Pertinent medical history, drug reactions and allergies, and concomitant medications were reported as none.  Early in June 2017, the patient was vaccinated with a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the left arm for prophylaxis (route of administration, lot number and expiration date were not reported).   In June 2017, reported as later that same date after received the vaccine, she started to feel sick. She reported that her stomach started to hurt, had chills, and her arms hurt. As the day progressed, her sickness continually "got worse and worse". She reported that she was freezing despite tons of clothing and layers on. The next day her arm had swollen like a balloon and became hard as a rock. At one point she passed out and hit her head on her dresser. When she woke up, she couldn't see, and eventually her sight came back in blobs/spots (blindness transient). Over the next week, approximately in June 2017, it progressively became worse and she reported being so dizzy that she couldn't walk (blindness transient) around her house without grabbing onto a wall (Gait inability). Her heart was "loudly" palpating (Heart rate decreased) and she had an extremely low blood pressure. One doctor told her that her "heart is just not operating as it should", however a different doctor said her heart was fine. After completing a detox, changing her diet, and taking vitamin supplements she slowly started feeling better (also reported as not recovered by the same reporter). She reported that she "hasn't been the same" since she received that re-vaccination. She still currently experienced dizziness from time to time and was afraid to take the COVlD-19 vaccine due to her adverse experience with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine. None laboratory test was performed  The outcome of illness, hypotension, heart rate decreased, gait inability, dizziness, head injury, induration, peripheral swelling, feeling cold, pain in extremity, chills and abdominal pain upper was reported as not recovered. The outcome of loss of consciousness and blindness transient was reported as recovered, on an unspecified date in 2017 (conflicting information also reported as not recovered).        The causal relationship between the events and therapy with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was  assessed as related  by reporter.  Upon internal review the events of passed out and she couldn't see (Blindness transient )was considered to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: an expired dose of ROTATEQ was administered to a patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-DEC-2020 (also reported as 2020), the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S017634 exp date 08-DEC-2020) orally. There were no prior temperature excursions for the administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Death, Herpes zoster
Clinical narrative: shingles; death; Information has been received from a lawyer refers to an erderly male patient. The patient's medical history and concurrent conditions were not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions, in medical office. Subsequently, the patient was treated by various healthcare providers at medical offices for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of shingles was not reported. On 28-JUL-2018, the patient died (the cause of death and autopsy information were not reported). The reporter considered death and shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Brain scan normal, Headache, Horner's syndrome, Lagophthalmos, Ultrasound Doppler
Clinical narrative: I have Horner's Syndrome / onset coincides with receiving dose 1 of Shingrix; my right eye is effected with partial closings; experiencing headaches, pretty much constantly; This case was reported by a consumer and described the occurrence of horner's syndrome in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced horner's syndrome (serious criteria GSK medically significant), lagophthalmos and headache. On an unknown date, the outcome of the horner's syndrome and lagophthalmos were unknown and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the horner's syndrome, lagophthalmos and headache to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of Shingrix and pretty much in the days after, the problems started. The patient stated that he/she had located very minimal information on a link with Shingrix and Horner's Syndrome and he/she had Horner's and the onset coincides with receiving dose 1 of Shingrix. The patient had a brain scan, lung scan and carotid artery scan to rule out tumors as a cause of the Horner's Syndrome and the scans had all been good, but his/her right eye was affected with partial closing and he/she was experiencing headaches, pretty much constantly. The patient wanted to know if we had any reported information on a link with Shingrix and, if so, was that information we would share with patient. The patient was concerned about the financial aspect of all the testing, concerned about the constant headaches and also about the eye and certainly, concerned about the 2nd dose. The patient mentioned that he/she did like information to get an idea of how long this might last and if it would resolve and wanted to let him/her know if we had any information.
Sex: U
Vaccine: VARZOS
Symptoms: Ventilation/perfusion scan normal
Clinical narrative: I have Horner's Syndrome / onset coincides with receiving dose 1 of Shingrix; my right eye is effected with partial closings; experiencing headaches, pretty much constantly; This case was reported by a consumer and described the occurrence of horner's syndrome in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced horner's syndrome (serious criteria GSK medically significant), lagophthalmos and headache. On an unknown date, the outcome of the horner's syndrome and lagophthalmos were unknown and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the horner's syndrome, lagophthalmos and headache to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected adult as per vaccine indication. The age at vaccination was not reported. The patient received 1st dose of Shingrix and pretty much in the days after, the problems started. The patient stated that he/she had located very minimal information on a link with Shingrix and Horner's Syndrome and he/she had Horner's and the onset coincides with receiving dose 1 of Shingrix. The patient had a brain scan, lung scan and carotid artery scan to rule out tumors as a cause of the Horner's Syndrome and the scans had all been good, but his/her right eye was affected with partial closing and he/she was experiencing headaches, pretty much constantly. The patient wanted to know if we had any reported information on a link with Shingrix and, if so, was that information we would share with patient. The patient was concerned about the financial aspect of all the testing, concerned about the constant headaches and also about the eye and certainly, concerned about the 2nd dose. The patient mentioned that he/she did like information to get an idea of how long this might last and if it would resolve and wanted to let him/her know if we had any information.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pyrexia, SARS-CoV-2 test positive, Throat irritation
Clinical narrative: tested positive for COVID19 via antigen test; tested positive for COVID19 via antigen test; having no sense of taste and smell; having no sense of taste and smell; fever; scratchy throat; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ168J), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After getting vaccinated, patient developed a fever on 22Dec2020. On 23Dec2020, the patient has no taste and smell and tested (used the Sofia test) positive for COVID. The patient was told to quarantine and take off work for 10 days. The patient has felt like she has had a scratchy throat. Patient has not taken her allegra. The outcome of events was unknown.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination and the event onset.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient received the PFIZER-BIONTECH COVID-19 MRNA VACCINE and then tested positive for COVID; patient received the PFIZER-BIONTECH COVID-19 MRNA VACCINE and then tested positive for COVID; This is a spontaneous report from a contactable pharmacist.  A 40-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Unknown), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history included high body mass index (BMI) from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 22Dec2020, the patient received the PFIZER-BIONTECH COVID-19 MRNA VACCINE and then tested positive for COVID; and showed symptoms. The events were assessed as medically significant. The clinical course was reported as follows: The 40-year-old female patient, with comorbidities "like high BMI", received the Pfizer BioNTech COVID vaccine on 18Dec2020 and she had tested positive for COVID on 22Dec2020 and she was showing symptoms; however, they were not severe. The pharmacist did not describe the symptoms. In response to further probing, the pharmacist stated, "can I do this tomorrow because I need to call patient and ask her about if they have an opinion regarding the monoclonal antibodies treatment." The pharmacist wanted to know if there was information on consumers receiving antibodies after receiving the vaccine. The pharmacist stated the patient was eligible for antibody treatment. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 22Dec2020.  The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: The reported  tested positive for COVID after immunization with BNT162B2 is considered related to the administration of the suspect, BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sleep disorder
Clinical narrative: tested positive for covid; tested positive for covid; coughing; congestion; could not sleep that night; her temperature is still low/temperature was lower around 96 or 97; fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EH9899), via an unspecified route of administration on 15Dec2020 at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the Covid-19 shot 8 days ago on 15Dec2020. She tested positive for COVID on 23Dec2020. She worked in the emergency room, clarified she was a certified Nurse Assistant (CNA). She was hesitant about taking the COVID-19 vaccine. She was curious since she has been around the virus 24/7 since the pandemic started since she works in the emergency room. When she took the COVID-19 shot, stated she felt great the next day and could not sleep at night in Dec2020 which is not normal for her. It's nothing like the flu shot. It was strange since she has been around the virus all this time, she felt like she had COVID in Feb2020, but she was not tested then. She does not ever get sick and she was down for two days with a fever in Dec2020. After those two days, she always had a low-grade fever of 98 or 99 which was constant. After she took the COVID vaccine her temperature was normal, her temperature was lower around 96 or 97 in Dec2020. She woke up on 23Dec2020 and she had congestion and her temperature was still low. She went to work, and she was told she looked like she had no sleep. She was coughing 23Dec2020 morning, but she did not have any symptoms as far as temperature. She realized that the COVID 19 shot is only 50% effective. She is asking if she should get the second dose. The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 30 mins after vaccination caller was notified patient tested positive for covid; 30 mins after vaccination caller was notified patient tested positive for covid; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. 30 mins after vaccination caller was notified patient tested positive for covid on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available (30 mins after vaccination Covid test found positive), no effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID represents the pre-existing infection prior to vaccine use.  Further information like confirmative COVID 19 Nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: tested positive COVID; tested positive COVID; nasal congestion; loss of smell; This is a spontaneous report from a contactable physician (patient).  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730, Expiration Date Mar2021), via an unspecified route of administration in her right deltoid on 19Dec2020 at single dose for COVID-19 immunization.  Medical history included ongoing Crohn's disease from 2007/ diagnosed at 33 years old. There were no other concomitant drugs. The doctor who received the COVID vaccine stated that she must had been exposed to the virus prior to receiving the vaccine because she became symptomatic 48 hours after getting the vaccine. She noted that on Pfizer website recommended that a person not get the vaccine until 6 weeks after active infection but she of course did not know she had been exposed and when her second dose was due, she would not be 6 weeks after active infections. The vaccine was received on 19Dec2020 and she tested positive on 22Dec2020. The only symptoms she had experienced after testing positive are nasal congestion and loss of smell and they started on 21Dec2020 in the morning. She had had no worsening of her Crohn's disease. The only testing she had had done was the PCR testing for COVID. No treatments for the symptoms at this point. The outcome of the events tested positive COVID was not recovered, while for other events was unknown.; Sender's Comments: A causal role of BNT162B2 would seem unlikely based on the temporal gap between the vaccination therapy and the event onset.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Headache, Nasal discomfort
Clinical narrative: Tested positive for covid; Tested positive for covid; This is a spontaneous report from a contactable nurse (patient). A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscularly at right arm on 18Dec2020 14:30 at single dose for COVID-19 immunization. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed severe nasal burning sensation the first two days of injection along with severe headache that lasted for 4 days. He lost his sense of taste and smell (23Dec2020) 5 days after vaccine was administered, tested positive for Covid (23Dec2020 16:30) with use of ABBOTT rapid test which was performed at his employment. Pending Covid nasal swab fulgent which was obtained on 23Dec2020 and sent out to reference lab. Patient was just wondering if any of these symptoms and/or testing positive after administration was a rare side effect. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was not recovered.; Sender's Comments: Vaccine BNT162B2 provides protection to COVID-19 after at least 7 days have elapsed from the second dose (21 days post first injection). These conditions are not met in the present report. The reported symptoms are compatible with COVID-19 illness.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Viral test
Clinical narrative: Tested positive for covid; Tested positive for covid; This is a spontaneous report from a contactable nurse (patient). A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) intramuscularly at right arm on 18Dec2020 14:30 at single dose for COVID-19 immunization. Medical history included asthma. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed severe nasal burning sensation the first two days of injection along with severe headache that lasted for 4 days. He lost his sense of taste and smell (23Dec2020) 5 days after vaccine was administered, tested positive for Covid (23Dec2020 16:30) with use of ABBOTT rapid test which was performed at his employment. Pending Covid nasal swab fulgent which was obtained on 23Dec2020 and sent out to reference lab. Patient was just wondering if any of these symptoms and/or testing positive after administration was a rare side effect. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of the events was not recovered.; Sender's Comments: Vaccine BNT162B2 provides protection to COVID-19 after at least 7 days have elapsed from the second dose (21 days post first injection). These conditions are not met in the present report. The reported symptoms are compatible with COVID-19 illness.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Influenza virus test positive
Clinical narrative: positive for Covid with symptoms; positive for Covid with symptoms; positive for streph; positive for influenza; This is a spontaneous report from a contactable physician and nurse. A 68-year-old female patient received bnt162b2, via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced positive for COVID with symptoms, positive for streph and positive for influenza in Dec2020. Additional Context: caller stated that she had a patient that got Covid vaccine on 17Dec2020 who was complaining of muscle aches, no fever, sudden loss of taste and smell in the last 24 hours, sore throat and a cough. Stated that she cannot attribute the cough to the vaccine. Stated that she was screened for COVID, streph and influenza. Stated that she was positive for covid and streph. Stated that she does not think that and wanted to know if the vaccine would cause a positive from a rapid test. Outcome of the events was unknown.  The Lot/Batch and expiry date has been requested.; Sender's Comments: The reported positive for COVID with symptoms after immunization with BNT162B2 is considered related to the suspect, BNT162B2.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, SARS-CoV-2 test positive, Streptococcus test positive
Clinical narrative: positive for Covid with symptoms; positive for Covid with symptoms; positive for streph; positive for influenza; This is a spontaneous report from a contactable physician and nurse. A 68-year-old female patient received bnt162b2, via an unspecified route of administration on 17Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced positive for COVID with symptoms, positive for streph and positive for influenza in Dec2020. Additional Context: caller stated that she had a patient that got Covid vaccine on 17Dec2020 who was complaining of muscle aches, no fever, sudden loss of taste and smell in the last 24 hours, sore throat and a cough. Stated that she cannot attribute the cough to the vaccine. Stated that she was screened for COVID, streph and influenza. Stated that she was positive for covid and streph. Stated that she does not think that and wanted to know if the vaccine would cause a positive from a rapid test. Outcome of the events was unknown.  The Lot/Batch and expiry date has been requested.; Sender's Comments: The reported positive for COVID with symptoms after immunization with BNT162B2 is considered related to the suspect, BNT162B2.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Heart rate increased, Hypersensitivity, Illness
Clinical narrative: allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Rash, SARS-CoV-2 antibody test
Clinical narrative: allergic reaction; had been a little sick since she had it; she really felt bad; weak; rash on her legs/ rash all over her; Fever/ feverish; a fast heart rate that comes and goes; Hasn't felt good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration in left arm on 21Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were reported as none. She indicated she received vaccine on 21Dec2020 and noticed a rash on her legs in the shower on 24Dec2020. She hadn't felt good since done on 21Dec2020. She had a rash all over her, didn't realize when went back and read a paper, said a bad rash all over body, what should she do, take a Benadryl. She stated the health department gave the vaccine. She had been a little sick since she had it. Tuesday was really bad, all day on Tuesday, she really felt bad. She woke up with a rash at the time of the report on 24Dec2020, she thought she had a fever, but didn't check, that was last night and this morning, but at the time of the report she didn't think she had a fever. The rash, she was covered in a fine rash all over her body, she had thought it had happened with an allergic reaction immediately. When asked for outcome of not feeling good, stated she felt ok, it was just the rash, that was what she was most concerned about, stated she did have a fast heart rate that comes and goes on 21Dec2020. When she awoke this morning, she was just weak, and feverish, she didn't take her temperature, she should have, but she took a shower a few minutes and saw the rash, thought it was probably all combined. Stated her card said on 11Jan2021, she should take the second dose, and wanted to known should she take it if this is all connected. The patient had tested positive for COVID antibodies on an unspecified date. The outcome of the events "rash on her legs/ rash all over her" and "Fast heart rate" was not recovered, while other events were unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lip erythema, Lip swelling
Clinical narrative: Lip swelling and redness; Lip swelling and redness; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (nor pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (right arm) on 21Dec2020 (10:45) at single dose for COVID-19 immunization. The patient's medical history included asthma. Concomitant medication included montelukast sodium (SINGULAIR) cetirizine hydrochloride (ZYRTEC) and acetazolamide sodium (DIAMOX), received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced lip swelling and redness on 24Dec2020 (04:00 AM). The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was advised to continue Singulair and given Benadryl and ointment as treatment for the adverse events. The outcome of events was unknown. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Chills, fever and a headache; Chills, fever and a headache; Chills, fever and a headache; tested positive; tested positive; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is 1st of two reports.  An adult female patient of unspecified age (30-40 yrs of age) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The nurse stated that they gave the vaccines to the patient the past week and the patient was COVID-19 positive at the time of the report. The nurse needed some guidance and needed to know if the patient could receive the second dose or what they were supposed to do. The patient tested positive for COVID-19 on 24Dec2020 after having chills, fever and a headache. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient might not be completely excluded.  The case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-2020513401 different patient, same drug and event
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Pain in extremity
Clinical narrative: Fever; Fatigue; Shortness of breath; Chest pain; Dizziness; Arm soreness; This is a spontaneous report from a non-contactable healthcare professional.  This 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unspecified date (at the age of 24 years-old, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were also no other medications taken in the last two weeks. On 24Dec2020, the patient experienced  fever, fatigue, chest pain, shortness of breath, arm soreness, and dizziness. The patient was not hospitalized for the events but received treatment with acetaminophen (TYLENOL). The clinical outcome of the events of fever, fatigue, chest pain, shortness of breath, arm soreness, dizziness was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Fatigue; Shortness of breath; Chest pain; Dizziness; Arm soreness; This is a spontaneous report from a non-contactable healthcare professional.  This 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on an unspecified date (at the age of 24 years-old, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were also no other medications taken in the last two weeks. On 24Dec2020, the patient experienced  fever, fatigue, chest pain, shortness of breath, arm soreness, and dizziness. The patient was not hospitalized for the events but received treatment with acetaminophen (TYLENOL). The clinical outcome of the events of fever, fatigue, chest pain, shortness of breath, arm soreness, dizziness was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: chills; body aches; tender left deltoid injection site pain.; fatigue; elevated temp/ tympanic temp of 100.8; This is a spontaneous report from a contactable nurse reporting for herself. A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 21Dec2020 12:30 as a single dose (dose 1) in the left arm (age at vaccination: 32 years old) for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered wasa hospital. There were no other vaccines given in the 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. Medical history included diagnosed with COVID-19 on 06Jul2020, irritable bowel syndrome (IBS), depression, attention deficit hyperactivity disorder (ADD), cervical spondylosis, and herpes simplex virus (HSV); no allergies to medications, food, or other products. Concomitant medication included methylphenidate hydrochloride (CONCERTA), sertraline hydrochloride (ZOLOFT), valacyclovir, levonorgestrel (LILETTA), and colecalciferol (VITAMIN D). The patient woke up at 0400 on 22Dec2020 with tympanic temp of 100.8, chills, body aches, and very tender left deltoid injection site pain. The events were reported as non-serious. Treatment with ibuprofen resolved the elevated temperature, however she spent all of 22Dec2020 with fatigue and body aches despite ibuprofen. The tender left deltoid persisted for a total of 3 days and then became more tolerable, less tender. The clinical outcome of elevated temp/ tympanic temp of 100.8 was resolved on 22Dec2020, of fatigue and body aches was recovered on 23Dec2020, and of chills and tender left deltoid was recovered on an unknown date. Since the vaccination, has the patient has not been tested for COVID-19.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: chills; body aches; tender left deltoid injection site pain.; fatigue; elevated temp/ tympanic temp of 100.8; This is a spontaneous report from a contactable nurse reporting for herself. A 32-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 21Dec2020 12:30 as a single dose (dose 1) in the left arm (age at vaccination: 32 years old) for COVID-19 vaccination. The facility where the most recent COVID-19 vaccine was administered wasa hospital. There were no other vaccines given in the 4 weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. Medical history included diagnosed with COVID-19 on 06Jul2020, irritable bowel syndrome (IBS), depression, attention deficit hyperactivity disorder (ADD), cervical spondylosis, and herpes simplex virus (HSV); no allergies to medications, food, or other products. Concomitant medication included methylphenidate hydrochloride (CONCERTA), sertraline hydrochloride (ZOLOFT), valacyclovir, levonorgestrel (LILETTA), and colecalciferol (VITAMIN D). The patient woke up at 0400 on 22Dec2020 with tympanic temp of 100.8, chills, body aches, and very tender left deltoid injection site pain. The events were reported as non-serious. Treatment with ibuprofen resolved the elevated temperature, however she spent all of 22Dec2020 with fatigue and body aches despite ibuprofen. The tender left deltoid persisted for a total of 3 days and then became more tolerable, less tender. The clinical outcome of elevated temp/ tympanic temp of 100.8 was resolved on 22Dec2020, of fatigue and body aches was recovered on 23Dec2020, and of chills and tender left deltoid was recovered on an unknown date. Since the vaccination, has the patient has not been tested for COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Rash
Clinical narrative: The next day a rash appeared on my forearms and now is on my ankles, calves and scalp.; Severe headache; chills; flu like symptoms; This is a spontaneous report from a contactable other healthcare professional (patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly at left arm on 18Dec2020 at 14:00 at single dose for covid-19 immunization at workplace clinic.  Medical history included hypolipidaemia, allergic to sulfa drugs (hives), allergy to adhesive (severe skin blistering).  There was non other vaccine in four weeks and no other medications in two weeks.  The patient previously took naproxen (NAPROSYN) and amoxicillin clavulanic acid (AUGMENTIN ) and was allergic to both drugs, and experienced anaphylaxis for naproxen.  The patient experienced severe headache, chills and flu like symptoms the night after the shot on 18Dec2020. The next day on 19Dec2020 at 10: 00 AM a rash appeared on her forearms and was on her ankles, calves and scalp at time of the report. No treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,  the patient had not been tested for COVID-19. The outcome of the events was not resolved.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: had another COVID test with positive results on 23Dec; had another COVID test with positive results on 23Dec; This is a spontaneous report from a contactable consumer. A 43-year-old female patient received bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 18Dec2020 at a single dose for covid-19 vaccination. The vaccination was done in the hospital. The patient's medical history and concomitant medications were not reported. The patient was initially tested negative for covid-19 on 13Dec2020. The patient was not pregnant. The patient believed she may have been infected with COVID as early as 13Dec2020 based on symptoms but test results at that time came back negative. She had vaccine on 18Dec2020 and when symptoms hadn't resolved had another COVID test with positive results on 23Dec2020. The event resulted to a doctor or other healthcare professional office/clinic visit. There was not treatment for the event. The reporter considered the events as non-serious. The outcome of the event was recovering.   Information about batch/lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dry mouth, Flushing, Hypoaesthesia oral
Clinical narrative: flushing; lightheadedness; chills; tongue numbness; dry mouth; cold hands and feet; This is a spontaneous report from a contactable physician (patient herself). A 67-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 24Dec2020 13:15 in left arm at single dose for covid-19 immunization. Medical history included none. The patient was not allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included methylphenidate hydrochloride (RITALIN) and one-a-day ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS), both from Dec2020 for an unspecified indication. Immediately after vaccine, patient experienced flushing, then lightheadedness, and waves of flushing and chills every minute for several hours; tongue numbness, dry mouth, cold hands and feet; no rash, no breathing difficulty - normal vital signs on 24Dec2020 13:30. Patient received iv diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) and iv hydration after symptoms were not improving 3 hours later - several hours after this treatment, the flushing and chills continued, as did numbness of tongue and dry mouth. Symptoms were still present 22 hours after injection-waves of flushing and chills. The events were reported as non-serious and the events resulted in Emergency room/department or urgent care. Outcome of events were not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Vital signs measurement
Clinical narrative: flushing; lightheadedness; chills; tongue numbness; dry mouth; cold hands and feet; This is a spontaneous report from a contactable physician (patient herself). A 67-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK9231), via an unspecified route of administration on 24Dec2020 13:15 in left arm at single dose for covid-19 immunization. Medical history included none. The patient was not allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included methylphenidate hydrochloride (RITALIN) and one-a-day ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS), both from Dec2020 for an unspecified indication. Immediately after vaccine, patient experienced flushing, then lightheadedness, and waves of flushing and chills every minute for several hours; tongue numbness, dry mouth, cold hands and feet; no rash, no breathing difficulty - normal vital signs on 24Dec2020 13:30. Patient received iv diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID) and iv hydration after symptoms were not improving 3 hours later - several hours after this treatment, the flushing and chills continued, as did numbness of tongue and dry mouth. Symptoms were still present 22 hours after injection-waves of flushing and chills. The events were reported as non-serious and the events resulted in Emergency room/department or urgent care. Outcome of events were not recovered.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; This is a spontaneous report from a non-contactable Other healthcare professional (HCP) (patient). A 31-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E4284), via an unspecified route of administration on 22Dec2020 11:30 at a single dose in left arm for COVID-19 immunization. Medical history included asthma, known allergies: dust mites. The patient experienced soreness on day 2 (24Dec2020) and day 3 (25Dec2020), site of injection was swollen, painful, and itched on 24Dec2020. No other vaccine in four weeks received. No treatment received for these events. The patient had no COVID prior vaccination or no COVID tested post vaccination. This is a non-serious report. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: Headache; fatigue; general malaise; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number EJ1685, via an unspecified route of administration on Left arm from 22Dec2020 09:00 to 22Dec2020 09:00 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ademetionine (SAME). On 24Dec2020 09:00, the patient experienced headache, fatigue, general malaise at about 48 hours after receiving vaccine. Lasted about 1 day. The outcome of the events was recovered on 25Dec2020.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Malaise
Clinical narrative: Shoulder soreness, malaise; Shoulder soreness, malaise; This is a spontaneous report from a non-contactable physician reported for himself. A 46-year-old male patient received bnt162b2, lot:  EH9899, via an unspecified route of administration at 11:00am on 24Dec2020 at a single dose for covid-19 immunization. The patient's medical history included gout from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 24Dec2020, the patient experienced shoulder soreness and malaise. The outcome of the event was recovered on an unknown date. It was reported that the vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was given to the patient for the events. Patient was not diagnosed with COVID-19 prior to vaccination and patient have not been tested for COVID-19. Patient has no allergies to medications, food and other products.   No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: urticaria on the chest and leg; This is a spontaneous report from a contactable physician (patient). A 53-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 16Dec2020 21:00 at a single dose for COVID-19 immunization at the workplace clinic. Medical history included sulfa allergies. Concomitant medication included ibuprofen. The patient had not received other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced urticaria on the chest and leg on 24Dec2020 20:00. Outcome of the event was not recovered; no treatment was given for the event. The patient was not diagnosed with COVID prior vaccination and has not been tested for COVID post vaccination.  Information on the lot/batch number has been requested.