chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Gait disturbance, Headache, Hepatic enzyme, Hepatic enzyme increased
Clinical narrative: can not walk, or eat by himself needs help; his sputum is thick and brown; low platelets; Elevated liver enzymes; low sodium and unstable phenotypes; rashes all over his body; fever of 100.8 next day friday the 9th woke up with a 104 temp; headache; coughing and his sputum is thick and brown; felt like flue symptoms; extreme body ache; his eyes are unable to open for most times; can not walk, or eat by himself needs help; This is a spontaneous report from a contactable consumer (parent). A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiry date were not reported), via an unspecified route of administration on 08Apr2021, as single dose for COVID-19 immunization. Patient medical and concomitant medications were not re-ported. On 08Apr2021, patient same day developed a fever of 100.8 next day friday the 9th woke up with a 104 temp and ever since (5 days) has had a fever, rashes all over his body, today he started coughing and his sputum is thick and brown, felt like flu symptoms within an hour, extreme body ache, his eyes are unable to open for most times, cannot walk, or eat by himself needs help and headache. Also reported his condition was low platelets, elevated liver enzymes, low sodium and un-stable phenotypes. Treatment received at hospital includes cortisone, paracetamol (TYLENOL), ceftriaxone sodium (ROCEPHIN) and azithromycin. On 08Apr20212 underwent body temperature measurement and result was fever of 100.8 next day friday the 9th woke up with a 104 temp, on unknown date low sodium and unstable phenotypes was done and result was low sodium, underwent liver enzymes test and result was elevated liver enzymes, had platelet count test and result was low platelets and had sputum test and result was sputum is thick and brown. The outcome of the events was un-known.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Pain, Platelet count, Platelet count decreased, Pyrexia
Clinical narrative: can not walk, or eat by himself needs help; his sputum is thick and brown; low platelets; Elevated liver enzymes; low sodium and unstable phenotypes; rashes all over his body; fever of 100.8 next day friday the 9th woke up with a 104 temp; headache; coughing and his sputum is thick and brown; felt like flue symptoms; extreme body ache; his eyes are unable to open for most times; can not walk, or eat by himself needs help; This is a spontaneous report from a contactable consumer (parent). A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiry date were not reported), via an unspecified route of administration on 08Apr2021, as single dose for COVID-19 immunization. Patient medical and concomitant medications were not re-ported. On 08Apr2021, patient same day developed a fever of 100.8 next day friday the 9th woke up with a 104 temp and ever since (5 days) has had a fever, rashes all over his body, today he started coughing and his sputum is thick and brown, felt like flu symptoms within an hour, extreme body ache, his eyes are unable to open for most times, cannot walk, or eat by himself needs help and headache. Also reported his condition was low platelets, elevated liver enzymes, low sodium and un-stable phenotypes. Treatment received at hospital includes cortisone, paracetamol (TYLENOL), ceftriaxone sodium (ROCEPHIN) and azithromycin. On 08Apr20212 underwent body temperature measurement and result was fever of 100.8 next day friday the 9th woke up with a 104 temp, on unknown date low sodium and unstable phenotypes was done and result was low sodium, underwent liver enzymes test and result was elevated liver enzymes, had platelet count test and result was low platelets and had sputum test and result was sputum is thick and brown. The outcome of the events was un-known.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Sputum abnormal, Sputum test
Clinical narrative: can not walk, or eat by himself needs help; his sputum is thick and brown; low platelets; Elevated liver enzymes; low sodium and unstable phenotypes; rashes all over his body; fever of 100.8 next day friday the 9th woke up with a 104 temp; headache; coughing and his sputum is thick and brown; felt like flue symptoms; extreme body ache; his eyes are unable to open for most times; can not walk, or eat by himself needs help; This is a spontaneous report from a contactable consumer (parent). A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiry date were not reported), via an unspecified route of administration on 08Apr2021, as single dose for COVID-19 immunization. Patient medical and concomitant medications were not re-ported. On 08Apr2021, patient same day developed a fever of 100.8 next day friday the 9th woke up with a 104 temp and ever since (5 days) has had a fever, rashes all over his body, today he started coughing and his sputum is thick and brown, felt like flu symptoms within an hour, extreme body ache, his eyes are unable to open for most times, cannot walk, or eat by himself needs help and headache. Also reported his condition was low platelets, elevated liver enzymes, low sodium and un-stable phenotypes. Treatment received at hospital includes cortisone, paracetamol (TYLENOL), ceftriaxone sodium (ROCEPHIN) and azithromycin. On 08Apr20212 underwent body temperature measurement and result was fever of 100.8 next day friday the 9th woke up with a 104 temp, on unknown date low sodium and unstable phenotypes was done and result was low sodium, underwent liver enzymes test and result was elevated liver enzymes, had platelet count test and result was low platelets and had sputum test and result was sputum is thick and brown. The outcome of the events was un-known.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on 24Mar2021 as single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. On 31Mar2021, after a week the patient got tested positive for covid virus. She was scheduled for 15Apr for the second dose appointment, but it is more than 21 days and she wondering if she should continue the second dose. She is under quarantine right now. On 31Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test was positive. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: she experienced pain in her arm that she cant hardly move; she experienced pain in her arm that she cant hardly move; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route administered in right arm on 23Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's second dose of the vaccine was due that day (at the reporting time) asking whether it was safe for her to get the second dose as she experienced pain in her arm that she can't move hardly on an unspecified date in 2021. She also wanted to know if she could get her second dose of the vaccine at a different arm. The outcome of events was unknown at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Balance disorder, Headache, Hypersomnia
Clinical narrative: Discombobulated; I was hanging up against wall; My equilibrium was completely off; the headache got on my left side, It's sharp as somebody hit you with a nail; I have been taking 2-3 hours nap and that's not me; He was afraid. He cannot explain it, he can take pain,  but with vaccine he couldn't even open the eyes; This is a spontaneous report from a contactable consumer.  A 74-year-old male consumer reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left upper arm on 22Mar2021 (at the age of 74years-old) at single dose for COVID-19 immunization. Medical history included high cholesterol and 'prostate'.  Concomitant drugs included  Flomax 0.4 mg for prostate, one a day, Simvastatin 40 mg once daily for High Cholesterol and Clonazepam 2 mg for sleep for years. The patient reported that he received first dos of vaccine and the next day was discombobulated. He was hanging up against wall. His equilibrium was completely off that got better little bit but he was still wobbly but the headache got on his left side, he felt like he was having a stroke and he still has a headache that comes and goes, it was sharp as somebody hit you with a nail and he just does not know if he should take second shot or not since he was afraid. ''He cannot explain it, he can take pain,  he had done operations (Clarification unknown) and everything but with vaccine he couldn't even open the eyes, his equilibrium was so off and sleeps, he has been taking 2-3 hours nap and that's not him."   As per treatment, the only thing they gave him was Aspirin or Advil. He tried Tylenol and it did not work and he tried everything and then he tried Sinutab and he tried Motrin, he tried everything. At the time of reporting the patient had not recovered.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she experienced arm soreness; 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), via an unspecified route of administration on 19Mar2021 (Lot number: not reported) as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced arm soreness and wanted to know if she could take Tylenol before the second dose. The patient was scheduled for the second dose on 30Apr2021. The outcome was unknown for the reported event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: left cheek was swollen and red; left cheek was swollen and red/red dots on the skin near his left eye; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A 80-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date was not provided), via an unspecified route of administration, in last week Tuesday, on 06Apr2021, as a single dose for COVID-19 immunisation. Patient medical history included hernia and relapsing polychondritis. Concomitant medications were not reported. Upon call E-transferring to unit the patient mentioned that his symptoms started last week and he was able to notice a couple a days ago that his left cheek was swollen and red and he thought that it was sunburn but it started to itch a couple of days ago and his cheek was swollen to about the size of a softball in circumference and about 1/8th to 1/16th of an inch thick which takes up the whole check. He further stated that he also had red dots on the skin near his left eye. He mentioned that he will be seeing his Cardiologist shortly for a hernia that appeared. The patient has an extremely rare condition called Relapsing Polychondritis in which his ears bleed from and takes steroids for it. He is asking for what to do with his swollen cheek and should he proceed with his Hernia operation. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19, MENB
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: Daughter tested positive for covid on 2 separate tests.; fever 5 hrs later; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for his daughter. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown, via an unspecified route of administration on 09Apr2021 as a single dose for COVID-19 immunization. On an unknown date, the patient started therapy with Trumenba (MENINGOCOCCAL GROUP B RLP2086; Suspension for injection, Lot# and expiration date not reported) via unknown route of administration as single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Apr2021 (reported as 5 hr. later vaccination), the patient experienced fever. It was reported that the patient (daughter) tested positive for covid on 2 separate tests. Patient wanted to clarify whether she gets covid on Trumenba. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She got positive to COVID; She got positive to COVID; 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: unknown), via an unspecified route of administration on 23Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient got positive to covid, after receiving first dose of vaccine. Patient was scheduled to receive her second dose on the 13April2021 and wanted to know if she will still be able to get the second dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he tested positive for covid-19. The first dose was given last March 21and his2nd schedule is on April 11.; he tested positive for covid-19. The first dose was given last March 21and his2nd schedule is on April 11.; This is a spontaneous report from a contactable consumer (reporting on himself). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not provided), first dose via an unspecified route of administration, on 21Mar2021, at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that, the patient received his first dose on 21Mar2021 and tested positive for Covid-19 on an unspecified date. And, the patient was enquiring if he can take the second dose, since he tested positive for covid-19. The patient underwent lab test and procedure Covid-19 positive. The outcome for the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number were not reported), dose 2 via an unspecified route of administration on 31Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that he got his 2nd shot last 31Mar2021 and after 10 days he experienced really bad diarrhea on Apr2021. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, Rhinorrhoea
Clinical narrative: soreness in his right arm; nasal congestion; running nose and sniffing; This is a spontaneous report from a contactable consumer (patient himself).  A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot/Batch number: unknown) via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, (after having breakfast today), the patient experienced soreness in his right arm, nasal congestion and running nose, sniffing and was annoyed by it. Patient was asking whether he can talk a medication with acetaminophen in it because he read on the fact sheet that Acetaminophen should be avoided after getting the shot. The patient further stated that he had 2 types of medicine now (Goodsense Nasal Decongestant and Cold & Flu day relief). The cold and flu day relief has Acetaminophen in it. Patient wants to know which medicine was safe to take now. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: She tested positive for Covid-19 since the first dose; She tested positive for Covid-19 since the first dose; This is spontaneous report received from Pfizer Sponsored Programt. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for Covid-19 since the first dose and tested negative today (09Apr2021). The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report from a contactable consumer (patient) also received via Pfizer sponsored program.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient experienced sinus infection on an unspecified date. The patient called and mentioned that he had called earlier and spoke to someone who had a lot of questions, and was transferred to the "medical department". The patient had received the 1st and 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE on 12Mar2021 and 02Apr2021 respectively. He mentioned that he was currently under antibiotics (Augmentin) due to sinus infection during the 1st and 2nd dose and so he wanted to ask if it would interfere with the efficacy of the vaccine and development of antibodies. He wanted to talk with a medical representative. The patient was informed based on PFIZER-BIONTECH COVID-19 VACCINE revised documents dated 06Apr2021, no information was found on interaction with antibiotics, and was referred to HCP for guidance/The call was cold transferred and was provided number. Case considered as serious (medically significant). The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot# and expiration date were not reported), via an unspecified route of administration on unspecified date at as a SINGLE DOSE for COVID-19 vaccination. Medical history and concomitant medication were not reported. Patients want to change the time to go appointment for second dose. She got a headache after first dose and still has a headache and it's getting better. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Hypoxia
Clinical narrative: Hypoxic; Heart arrhythmia; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After use of product on an unspecified date, the patient become hypoxic and developed heart arrhythmia. The patient was admitted and treated in the hospital on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Illness, Nasopharyngitis, Nausea
Clinical narrative: sick; nausea; chills; body aches; cold chills; with nausea persisting for "2 weeks" and being the most "prevalent"; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (BNT162B2)Solution for injection, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.The patient medical history and concomitant was not reported. On unknown date, The patient experienced sick, nausea, body aches cold chills, with nausea persisting for "2 weeks" and being the most "prevalent" (condition aggravated) .The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: sick; nausea; chills; body aches; cold chills; with nausea persisting for "2 weeks" and being the most "prevalent"; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (BNT162B2)Solution for injection, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.The patient medical history and concomitant was not reported. On unknown date, The patient experienced sick, nausea, body aches cold chills, with nausea persisting for "2 weeks" and being the most "prevalent" (condition aggravated) .The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Rash, Urine abnormality
Clinical narrative: his urine got extremely dark; urinating white streamy lines; rash on his arm; This is a spontaneous report from a contactable consumer reported for himself, report received from a Pfizer sponsored program. A male patient of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported) via an unknown route of administration on an unknown date as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced his urine got extremely dark, urinating white streamy lines and rash on his arm. The outcome of the events was unknown.  No follow-up attempts were needed. Information on the lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: Left underarm lymphoma 2 days after vaccine; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown and expiration date was not reported), via an unspecified route of administration, in left arm on 08Apr2021 at 10:15 (at the age of 43-year-old) at single dose for COVID-19 immunization. Medical history included fibrous breast, known penicillin allergy and bee allergy; patient was not pregnant. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient received the vaccine at a Public Health Clinic/Veterans Administration facility. The patient experienced left underarm lymphoma, two days after vaccination, on 10Apr2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of the event was not resolved.  Information about the Lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal association, a causal relationship between the suspect drug bnt162b2 and event 'lymphoma' cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731 ), dose 2 via an unspecified route of administration, administered in Arm Right on 10Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included First dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Left arm on 20Mar2021 as single dose for covid-19 immunisation, time the Vaccination Was Given (24 hour clock): 1626 (first dose). Patient her first dose, she had a swollen arm. She knew this was normal. She had no rash, but the swelling lasted quite a few days. That evening, she had night chills. She was feeling cold day and night. No matter how much or what she was wearing she was constantly cold. Eventually her arm swelling went down after 5 days. She iced, massaged and used the arm as advised, but it was the chills that were unbelievable. She had her 2nd dose on 10Apr2021. That one wiped her out. She never gets headaches, and she got a headache. She never has had a headache to compare. The headache started on Sunday in the middle of the night, it woke her up and has lasted until today. It is dissipating and she is taking Tylenol for it. She has joint pain everywhere, all over, her hands, feet, and everything. Caller added if this is a side effect, she hopes it goes away, she feels crippling. She has nausea all the time. She's forcing fluids. She ate toast to keep her stomach acids down so she wouldn't vomit. She knows it will go away. Caller asking how soon her symptoms will go away and how may persons have reported the same symptoms she is having. She has low blood pressure and knows what that feels like. With her chills she couldn't sleep or stop feeling cold or function. Her chills stopped on the 8th or 9th, caller confirmed 9Apr2021. Second dose, 10Apr2021, LOT number ER8731, right arm injection. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Patient did not have any Medical History (including any illness at time of vaccination). The outcome of the event Headache was recovering, for joint pain and Nausea was not recovered and for low blood pressure it was unknown.     No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy in her feet and lower legs; This is a spontaneous report from a contactable consumer (patient) received via a sales representative.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 and dose 1, both via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  When the patient received the first dose of vaccine and within approximately 24 to 48 hours, started experiencing neuropathy in her feet and lower legs. Her neuropathy was almost gone and then she got her second vaccine and within 4 hours the neuropathy returned with the same intensity she felt after the first vaccine. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: experiencing headache after the first dose on 9th of April; This is a spontaneous report from a Pfizer sponsored program support from a contactable consumer. This consumer (patient's husband) reported for a female patient (wife) that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number and expiration date was not reported) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient, experienced headache after the first dose on 09Apr2021. Caller stated that they already went to the hospital and was given medical advice already. Her wife was better now, he said. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Pyrexia
Clinical narrative: tested positive for covid-19; tested positive for covid-19 with symptom; developed a low grade fever; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the 1st dose of the Covid-19 vaccine on 20Mar2021. On 23Mar2021 patient developed a low grade fever. On 03Apr2021 patient had high fever and went to hospital, a swab test was done and patient was positive for covid-19. The reporting consumer questioned if the patient should receive the second dose tomorrow. The outcome of the events was unknown.  Information related to batch/Lot number was requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Palpitations
Clinical narrative: Heaviness on chest; woke up and had heart palpitations or heart was racing; This is a spontaneous report received from a contactable consumer (Patient). This 59-year-old female patient reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8733; Expiration Date: 31Jul2021) via an unspecified route of administration into the upper left arm on 01Apr2021 16:30 (at the age of 59-year-old) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she woke up and had heart palpitations or heart was racing on 02Apr2021 (late night) to early morning 03Apr2021. On 03Apr2021, she felt heaviness on chest and was fine and went on about her business. Patient woke up and had heart palpitations or heart was racing, on 04Apr2021, she reported that it happened again for a shorter period of time around 05:00 in the morning and again on Sunday night and Monday morning. She called the General Practitioner on Monday and went in and had an EKG done and it didn't show anything and made an appointment with the Cardiologist. On 07Apr2021, it happened again and she went to the Emergency room 08Apr2021 at 02:00 and had an EKG done and there was nothing. On 09Apr2021, the Cardiologist ran a battery of tests including complete work up, heart monitor, a stress test and echocardiogram, but nothing had happened since the 07Apr2021.  The patient believes it is directly related to the Pfizer Covid Vaccination and stated she never had any heart problems and prior to this for the last two months, caller has exercised daily on the elliptical for an hour.  It wasn't as if she exerted herself and something happened but she did exercise the Thursday before the Vaccination. She was scheduled to receive the second dose Pfizer Covid 19 Vaccine on 22Apr2021 and she was not keen on doing this given the situation. No prior vaccinations within four weeks. The patient took German Measles Vaccine and had high, high fever and a seizure at the age of 6. Caller does not have NDC/lot/expiration to provide and states this was a long time ago. Outcome for the events was unknown.  No Follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID 19; loss of taste; loss of smell; This is a spontaneous report from a non-contactable consumer (parent). A 37-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 09Apr2021 as a single dose for COVID-19 vaccination. Medical history included 3 adult children had a wrestling meet a couple weeks ago and one of the wrestlers tested positive (exposure to COVID-19). The patient's concomitant medications were not reported.  On unspecified date in Apr2021, the patient experienced loss of taste, loss of smell and tested positive for COVID 19. The seriousness of the events was reported as non-serious by the reporter. The reporter enquired about a false positive test after vaccination. The reporter stated " I have COPD. Should I be concerned about him testing positive?" (as reported). It was also reported that reporter second dose was on 10Apr2021. The clinical outcome of the loss of taste, loss of smell and tested positive for COVID 19 was unknown  No follow up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Chills, Fatigue
Clinical narrative: anxiety; fever; chills; nausea; fatigue; arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site; arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site; arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site; blood pressure for one hour- reaching 193/112; This is a spontaneous report received from a contactable consumer (reporting on herself). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration in on 30Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient ask was the vaccine kept at -90 degrees. When its injected was it still really cold. Why do you think Covid rates are going up if more and more people are getting vaccinated. Patient received first dose of the BNT162B2 vaccine on 30Mar2021. After receiving the vaccine, the paramedics monitored her blood pressure for one hour- reaching 193/112 on 30Mar2021. She states this could have been from anxiety though. The next morning on 31Mar2021, her arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site. For six days she had fever, chills, nausea, and fatigue. After two and a half weeks the injection site was still raised and brownish, it looks more like a birthmark than a rash on her arm. Patient asking these side effects normal. She recently had an uncle die of Covid. Does the vaccine work against new strains patient was asking. Patient ask second dose side effects worse than the first dose and what are the 6 months top line analysis results of the BNT162B2. She ask should I get the second shot and say if I don't get the second dose will I be protected. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: anxiety; fever; chills; nausea; fatigue; arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site; arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site; arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site; blood pressure for one hour- reaching 193/112; This is a spontaneous report received from a contactable consumer (reporting on herself). A 50-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration in on 30Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient ask was the vaccine kept at -90 degrees. When its injected was it still really cold. Why do you think Covid rates are going up if more and more people are getting vaccinated. Patient received first dose of the BNT162B2 vaccine on 30Mar2021. After receiving the vaccine, the paramedics monitored her blood pressure for one hour- reaching 193/112 on 30Mar2021. She states this could have been from anxiety though. The next morning on 31Mar2021, her arm that was injected was huge and red, approximately the size of a baseball, and it was painful around the injection site. For six days she had fever, chills, nausea, and fatigue. After two and a half weeks the injection site was still raised and brownish, it looks more like a birthmark than a rash on her arm. Patient asking these side effects normal. She recently had an uncle die of Covid. Does the vaccine work against new strains patient was asking. Patient ask second dose side effects worse than the first dose and what are the 6 months top line analysis results of the BNT162B2. She ask should I get the second shot and say if I don't get the second dose will I be protected. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: Something getting his eyes red; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for himself. An male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported that patient took both doses of Covid vaccine and first dose did not do any good for him, something getting his eyes red. Patient administered a lot of eye drops and further Inquiring if he could get a booster shot. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Hyperhidrosis, Prothrombin time
Clinical narrative: prothrombin time - INR  was  1.7 and  1.8; Had redness at the injection site; Felt awful; Hot and cold sweats; Loose stools; Exessive fatique; This is a spontaneous report from a contactable consumer.  A 36-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), dose 2nd intramuscular, administered in Arm Left on 11Mar2021 as single dose for covid-19 immunisation.  Medical history included Antiphospolipid disorder from 2018 and ongoing. Concomitant medication(s) included warfarin taken for antiphospolipid from 2018 and ongoing, lamotrigine taken for mood disorder from 2020 and ongoing, topiramate taken for migraine from 2020 and ongoing, hydroxyzine taken for sleep from 2020 and ongoing. Family medical history not relevant to Adverse event. The patient had redness at the injection site, felt awful, hot and cold sweats, loose stools and excessive fatigue on 12mar2021, prothrombin time - inr was 1.7 and 1.8 on 17Mar2021. The patient underwent lab tests and procedures which included prothrombin time: 1.7 on 17Mar2021, prothrombin time: 1.8 on 25Mar2021, Norm :Low :2.0, Norm High:3.0. Patient did not receive any treatment for the event redness at the injection site, felt awful, hot and cold sweats, loose stools and excessive fatigue. Event reported as non-serious. The outcome of the event redness at the injection site, felt awful, hot and cold sweats, loose stools and excessive fatigue was recovered on 13Mar2021, and unknown for prothrombin time - inr was 1.7 and 1.8.  No follow-up attempts are needed. No further information is expected
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Prothrombin time prolonged, Vaccination site erythema
Clinical narrative: prothrombin time - INR  was  1.7 and  1.8; Had redness at the injection site; Felt awful; Hot and cold sweats; Loose stools; Exessive fatique; This is a spontaneous report from a contactable consumer.  A 36-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), dose 2nd intramuscular, administered in Arm Left on 11Mar2021 as single dose for covid-19 immunisation.  Medical history included Antiphospolipid disorder from 2018 and ongoing. Concomitant medication(s) included warfarin taken for antiphospolipid from 2018 and ongoing, lamotrigine taken for mood disorder from 2020 and ongoing, topiramate taken for migraine from 2020 and ongoing, hydroxyzine taken for sleep from 2020 and ongoing. Family medical history not relevant to Adverse event. The patient had redness at the injection site, felt awful, hot and cold sweats, loose stools and excessive fatigue on 12mar2021, prothrombin time - inr was 1.7 and 1.8 on 17Mar2021. The patient underwent lab tests and procedures which included prothrombin time: 1.7 on 17Mar2021, prothrombin time: 1.8 on 25Mar2021, Norm :Low :2.0, Norm High:3.0. Patient did not receive any treatment for the event redness at the injection site, felt awful, hot and cold sweats, loose stools and excessive fatigue. Event reported as non-serious. The outcome of the event redness at the injection site, felt awful, hot and cold sweats, loose stools and excessive fatigue was recovered on 13Mar2021, and unknown for prothrombin time - inr was 1.7 and 1.8.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with COVID; This is a spontaneous report from a contactable consumer (patient) reported for herself via medical information team. A female consumer with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 23Mar2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. The patient stated that she got the first dose of the Pfizer Covid 19 vaccine on 23Mar2021 and was diagnosed with COVID on 02Apr2021. Her second dose is scheduled for tomorrow, 14Apr2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: pain in throat; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had pain in throat on an unspecified date and would like to reschedule the second dose of the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: headache; fever; chills; This is a spontaneous report from a contactable consumer (patient's daughter) from a Pfizer sponsored program. A female patient of an unspecified age received the second dose of (BNT162B2) (Pfizer Covid-19 Vaccine) via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of (BNT162B2) (Pfizer Covid-19 Vaccine), via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. On an unspecified date of Apr2021, the patient was having headache, fever and chills, after getting the second dose of the vaccine yesterday and because of that they were calling to ask if the patient could take Tylenol. The outcome of the reported events was unknown at the time of reporting.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; fatigue; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (called on behalf of her father) reported for a male patient that, he received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for Injection) via an unspecified route of administration on 27Mar2021 as a SINGLE DOSE of COVID-19 immunization. Approximately on an unknown date in 2021, the patient experienced chills and fatigue. The caller asked if how long the side effects will last. The outcome for the events was not recovered.  No follow up attempts are needed. No further information is expected.