chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient diagnosed with COVID-19, confirmed by PCR; Patient diagnosed with COVID-19, confirmed by PCR/ Vaccine Failure; This is a spontaneous report from a contactable physician. A 74-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on an unspecified date as single dose, then second dose on 19Feb2021 (lot number and expiration date not provided) intramuscular, administered in right arm on as single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. On 14Apr2021, the patient was diagnosed with COVID-19, confirmed by PCR. The patient was hospitalized for four days and received steroids and Remdesivir as treatment medication. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Muscle twitching, Skin tightness
Clinical narrative: both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE)), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:30 (Batch/Lot Number: EP7533) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation .  Medical history included high blood pressure (HBP) from an unknown date and unknown if ongoing , supraventricular tachycardia (PAT) from an unknown date and unknown if ongoing, had Bell's palsy from 2001 to an unknown date. No known allergies. Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; enalapril taken for an unspecified indication, start and stop date were not reported.  The patient did not have any vaccines in four weeks and did not have covid prior to vaccination. In 2001, the patient had Bell s palsy (Medical history). Her left side paralysis never fully went away. Now, both of her doses of vaccine led to facial tightening, twitching, and slightly more paralysis on 23Mar2021 11:30 with outcome of unknown. She did not regret taking the vaccine and would do it again. Her mainly reason for reporting this was that she wanted to know if the vaccine was still effective. No treatment was received. No covid test post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lacrimation increased, Nasal congestion, Nasopharyngitis, Rhinorrhoea
Clinical narrative: neck to her fingertips are numb and she can't move it; cold; Runny nose; Congestion; Watering eyes; This is a spontaneous report received from a contactable consumer. A 87-years-old female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The consumer talked to nurse about mom, she had the Pfizer shot yesterday. Her neck to her fingertips were numb and she can't move it. She had cold, congestion, runny eyes, and a running nose. They haven't gone there yet because they were waiting to talk to see what to do. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Pain
Clinical narrative: Chills; Headache; Body sore; hot; This is a spontaneous report from a contactable consumer (Patient reported). A 61-years-old male patient 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 immunisation. Patient medical history and concomitant medications were not reported. It was reported that patient received Pfizer Covid first dose yesterday and experienced chills, headache, body sore, hot, and he still has headache and body sore today. The patient further wanted to know if its ok to drink Theraflu. Patient had already spoke to the safety department but did not have any reference number to provide. The outcome of the events chills, hot was unknown and outcome for headache and body sore was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Pain to the injection; can't lift or use my arm; headache; This is a spontaneous report from contactable consumer. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection) (Lot Number: EL3247, Expiry date: May2021), via unspecified route of administration on unspecified date as single dose for COVID-19 Immunization. Patient medical history and concomitant medication were not reported. Patient experienced pain to the injection site, can not lift or use my arm and headache. She stated that no fever at this time. Was fine after getting the shot yesterday and by the evening my arm started to really hurt and now in the morning it was worse with a headache on unspecified date. Treatment received to event she took Tylenol. Outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Pyrexia, SARS-CoV-1 test
Clinical narrative: Drug ineffective; and on Monday she tested positive for Covid; and is experiencing fever; and is experiencing fever and fatigue; This is a spontaneous report from a contactable consumer(Patient herself). A female patient of unspecified age had received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 02-APR-2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, Caller reports that she got her first dose 2 weeks ago today and she tested positive for Covid and was experiencing fever and fatigue. She is supposed to go back for her second dose on April 26th but reported that her Quarantine ends by April 25th and she wasn't sure if she was supposed to go or delay her second dose. Caller also reports that her husband also had the same situation. She reports that he received his first dose, tested positive but had more severe symptoms with congestion, fever and fatigue and he is also supposed to go for his second dose on April 26th. Caller reports that she already spoke with safety, no reference number for that encounter. E-transmitting. Survey offered. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: she is now having "pretty severe" diarrhea; This is a spontaneous report from a contactable Other Health Professional (Nurse, self-reported). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 13Apr2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced she is now having "pretty severe" diarrhea. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: period became heavy 8 hours after the shot/passed several golf ball size blood clots; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EWO153), via an unspecified route of administration, administered in arm left on 15Apr2021 10:45 (at the age of 40-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. The patient had no covid-19 prior vaccination. The patient previously received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), administered in arm left on 24Mar2021 11:00 AM (at the age of 40-years-old) for covid-19 immunization. There were no concomitant medications. It was reported that the patient's period became heavy 8 hours after the shot (15Apr2021 08:00 PM) and she passed several golf ball size blood clots. The clots and heavy bleeding subsided by 6am. This has never happened to her before in her life so it was most likely vaccine related. She contacted her PCP who told her to see her OBGYN ASAP. She was waiting for her OBGYN to call her back. The patient did not received any treatment for the event. The outcome of the event was recovered. The patient did not covid-19 tested post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller received the Pfizer Covid vaccine on 21Mar2021 and subsequently tested positive for Covid 19.; Caller received the Pfizer Covid vaccine on 21Mar2021 and subsequently tested positive for Covid 19.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on 21Mar2021 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 Pfizer covid vaccine on 21Mar2021 and subsequently tested positive for COVID-19. She was scheduled for the 2nd dose, more than 21 days apart, she also asked if she is still recommended to get the 2nd dose of covid-19 vaccine after. The patient underwent lab tests and procedures which included sars-cov-2 test: tested positive for COVID 19 on an unknown date. The outcome of the events was unknown.     Information on lot number/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicitis
Clinical narrative: Appendicitis symptoms; Acute stomach pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Apr2021 13:15 (at the age of 30years) as single dose for Covid-19 immunization. There were no medical history and concomitant medications. The patient is not pregnant at the time 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. On 16Apr2021 12:00PM, the patient experienced appendicitis symptoms and acute stomach pain. There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.    Information about lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Biliary tract disorder, Constipation, Dehydration, Diverticulitis, Hyperhidrosis
Clinical narrative: diverticulitis aggravated by added bile in digestive tract.; diverticulitis aggravated by added bile in digestive tract.; agonizing pain; dehydration; constipation; sweating profusely; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:15 (Batch/Lot Number: ew0169) as SINGLE DOSE for covid-19 immunisation, at 60 years old. Medical history included diverticulitis and recurring atypical pneumonia from an unknown date. No other vaccine in four weeks and no other medications in two weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has no known allergies. There were no concomitant medications. On 16Apr2021 23:45, the patient experienced diverticulitis aggravated by added bile in digestive tract. Spent entire night in agonizing pain and sweating profusely. Perhaps aggravated by dehydration/constipation. Reporter stated he suggests that people with this condition completely avoid nuts or other lipid/fatty acid foods as much as possible. Treatment was not given for the events. The events recovered on an unspecified date in Apr2021.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: diverticulitis aggravated by added bile in digestive tract.; diverticulitis aggravated by added bile in digestive tract.; agonizing pain; dehydration; constipation; sweating profusely; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:15 (Batch/Lot Number: ew0169) as SINGLE DOSE for covid-19 immunisation, at 60 years old. Medical history included diverticulitis and recurring atypical pneumonia from an unknown date. No other vaccine in four weeks and no other medications in two weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has no known allergies. There were no concomitant medications. On 16Apr2021 23:45, the patient experienced diverticulitis aggravated by added bile in digestive tract. Spent entire night in agonizing pain and sweating profusely. Perhaps aggravated by dehydration/constipation. Reporter stated he suggests that people with this condition completely avoid nuts or other lipid/fatty acid foods as much as possible. Treatment was not given for the events. The events recovered on an unspecified date in Apr2021.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: angioedema of left lower lip; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729, expiration date not reported), via an unspecified route of administration, administered in the left arm on 09Apr2021 17:00 at single dose for covid-19 immunisation. Medical history included asthma, degenerative disc disease, migraines, allergies: shellfish intolerance, nickel allergy, skin allergy to some kind of plastic/foam. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); sertraline; ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE); fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); minocycline. The patient experienced angioedema of left lower lip on 16Apr2021 01:00. The patient was given methylprednisolone 4 mg dose pack as treatment for the event. The patient has no prior vaccination and no covid test post vaccination. The patient had not recovered from the event at the time of the report.
Sex: U
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site joint pain
Clinical narrative: deep pain in left shoulder; not be able to go back to sleep; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246), via intramuscular route of administration on 26Jan2021 at 19:30 as single dose in left deltoid, and second dose of BNT162B2 (Lot Number: EN6201), via unspecified route of administration, on 16Feb2021 18:30, as single dose in left deltoid for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jan2021, the patient experienced deep pain in left shoulder. Pain was not muscular as much as seemingly in the shoulder socket. Not as noticeable when active in the day but makes it difficult to sleep well or will wake him up hurting and not be able to go back to sleep. Patient don't know if it was a nerve issue of the joint but does not feel like the muscle itself. Pain seems to be constant, but more pronounced on times. There was no treatment received for the events. Outcome of the event was not recovered for deep pain in left shoulder and unknown for sleep disorder.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Nausea, Pain
Clinical narrative: She has chronic urticaria; she had extreme nausea and pain and broke out into full hives; she had extreme nausea and pain and broke out into full hives; she had extreme nausea and pain and broke out into full hives; She threw up for the first time; She is is extremely tired; stomach cramping/stomach was hurting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration for COVID-19 immunization as a single dose on 08Apr2021. The patient's medical history and concomitant medications were not reported. She stated she had a reaction to her second dose of the vaccine that she received on Thursday, 08Apr2021. She has chronic urticaria so her allergist expected she would have some kind of reaction. Friday her stomach was hurting, she had extreme nausea and pain and broke out into full hives. She took a Benadryl and then took another and the hives subsided in an hour and a half. She has had stomach cramping, diarrhea and nausea since last Friday. She threw up for the first time about an hour and a half ago. She is extremely tired. She stated she called the doctor and the doctor told her to call Pfizer and we would tell her what to do. The caller asked if these symptoms are normal and asked for treatment recommendations. The outcome of event hives was recovered and outcome of event for vomiting was unknown. The outcome of other events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Urticaria chronic, Vomiting
Clinical narrative: She has chronic urticaria; she had extreme nausea and pain and broke out into full hives; she had extreme nausea and pain and broke out into full hives; she had extreme nausea and pain and broke out into full hives; She threw up for the first time; She is is extremely tired; stomach cramping/stomach was hurting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration for COVID-19 immunization as a single dose on 08Apr2021. The patient's medical history and concomitant medications were not reported. She stated she had a reaction to her second dose of the vaccine that she received on Thursday, 08Apr2021. She has chronic urticaria so her allergist expected she would have some kind of reaction. Friday her stomach was hurting, she had extreme nausea and pain and broke out into full hives. She took a Benadryl and then took another and the hives subsided in an hour and a half. She has had stomach cramping, diarrhea and nausea since last Friday. She threw up for the first time about an hour and a half ago. She is extremely tired. She stated she called the doctor and the doctor told her to call Pfizer and we would tell her what to do. The caller asked if these symptoms are normal and asked for treatment recommendations. The outcome of event hives was recovered and outcome of event for vomiting was unknown. The outcome of other events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Muscle spasms
Clinical narrative: they are both experiencing sharp pain in the lower abdomen.; it kind of feel like cramps on my arms; This is a spontaneous report received via Medical Information Team and from a contactable consumer (patient). This 28-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiry date- UNKNOWN) via an unspecified route of administration (at the age of 28-years-old) on an unspecified date as single dose for covid-19 immunization. Relevant medical history and concomitant medications were not reported. On an unknown date, the patient had sharp abdominal pain on my right side and then now it started to basically spread and feel like cramps on my arms and abdominal side. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Cerebral disorder, Dizziness
Clinical narrative: brain felt like it wasn't working; Dizziness; mental fog; exhaustion; weak; shaky; upper back neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; Non-stop pressure behind her neck, forehead, eyes; Injection site arm throbbing really bad; This is a spontaneous report from a contactable patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:15 (Batch/Lot number was not reported), at the age of 35-years-old as a single dose for COVID-19 immunization. The patient is not pregnant. Medical history included poly cystic ovary syndrome. The patient had no known allergies. Concomitant medication included ethinylestradiol, etynodiol diacetate (KELNOR) for birth control; metformin; ascorbic acid, betacarotene, biotin, capsicum annuum fruit, colecalciferol, collagen marine, curcuma longa, cysteine hydrochloride, equisetum arvense, fallopia japonica, hyaluronic acid, iodine, keratin, lysine, methionine, piper nigrum, selenium, serenoa repens, tocotrienols nos, withania somnifera, zinc (NUTRAFOL); all start and stop date were not reported. The patient had side effects which started within 45 minutes (also reported as within 30 minutes) of injection. Dizziness, mental fog, she felt like she was looking in through someone else's body. She doesn't know how she drove home from appointment. Her brain felt like it wasn't working, chronic exhaustion, weak, shaky, upper back neck shoulders and head all hurt severely. Non-stop pressure behind her neck, forehead, eyes with headache. Injection site arm was throbbing really bad at night. Symptoms lasted 8 days. The events occurred on 26Mar2021 11:00. No treatment was received. The patient had no other vaccine in four weeks. The patient had no prior vaccination and was not tested for COVID post vaccination. The outcome of the events was recovered with sequel.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Mental disorder, Neck pain, Ocular discomfort
Clinical narrative: brain felt like it wasn't working; Dizziness; mental fog; exhaustion; weak; shaky; upper back neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; Non-stop pressure behind her neck, forehead, eyes; Injection site arm throbbing really bad; This is a spontaneous report from a contactable patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:15 (Batch/Lot number was not reported), at the age of 35-years-old as a single dose for COVID-19 immunization. The patient is not pregnant. Medical history included poly cystic ovary syndrome. The patient had no known allergies. Concomitant medication included ethinylestradiol, etynodiol diacetate (KELNOR) for birth control; metformin; ascorbic acid, betacarotene, biotin, capsicum annuum fruit, colecalciferol, collagen marine, curcuma longa, cysteine hydrochloride, equisetum arvense, fallopia japonica, hyaluronic acid, iodine, keratin, lysine, methionine, piper nigrum, selenium, serenoa repens, tocotrienols nos, withania somnifera, zinc (NUTRAFOL); all start and stop date were not reported. The patient had side effects which started within 45 minutes (also reported as within 30 minutes) of injection. Dizziness, mental fog, she felt like she was looking in through someone else's body. She doesn't know how she drove home from appointment. Her brain felt like it wasn't working, chronic exhaustion, weak, shaky, upper back neck shoulders and head all hurt severely. Non-stop pressure behind her neck, forehead, eyes with headache. Injection site arm was throbbing really bad at night. Symptoms lasted 8 days. The events occurred on 26Mar2021 11:00. No treatment was received. The patient had no other vaccine in four weeks. The patient had no prior vaccination and was not tested for COVID post vaccination. The outcome of the events was recovered with sequel.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: brain felt like it wasn't working; Dizziness; mental fog; exhaustion; weak; shaky; upper back neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; Non-stop pressure behind her neck, forehead, eyes; Injection site arm throbbing really bad; This is a spontaneous report from a contactable patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:15 (Batch/Lot number was not reported), at the age of 35-years-old as a single dose for COVID-19 immunization. The patient is not pregnant. Medical history included poly cystic ovary syndrome. The patient had no known allergies. Concomitant medication included ethinylestradiol, etynodiol diacetate (KELNOR) for birth control; metformin; ascorbic acid, betacarotene, biotin, capsicum annuum fruit, colecalciferol, collagen marine, curcuma longa, cysteine hydrochloride, equisetum arvense, fallopia japonica, hyaluronic acid, iodine, keratin, lysine, methionine, piper nigrum, selenium, serenoa repens, tocotrienols nos, withania somnifera, zinc (NUTRAFOL); all start and stop date were not reported. The patient had side effects which started within 45 minutes (also reported as within 30 minutes) of injection. Dizziness, mental fog, she felt like she was looking in through someone else's body. She doesn't know how she drove home from appointment. Her brain felt like it wasn't working, chronic exhaustion, weak, shaky, upper back neck shoulders and head all hurt severely. Non-stop pressure behind her neck, forehead, eyes with headache. Injection site arm was throbbing really bad at night. Symptoms lasted 8 days. The events occurred on 26Mar2021 11:00. No treatment was received. The patient had no other vaccine in four weeks. The patient had no prior vaccination and was not tested for COVID post vaccination. The outcome of the events was recovered with sequel.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Constipation, Cough, Decreased appetite
Clinical narrative: I WAS SICK; chills; shortness of breath; loss of apetite; Muscular aches and pains; diarrhea; constipation; dry cough; nausea; hoarse voice; extream fatigue; Generalized prickle sensation; Walking difficulty; This is a spontaneous report from a contactable physician (patient). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613) intramuscularly route of administration in left shoulder on 18Mar2021 at noontime as single dose for and  patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6198) via an unspecified route of administration in right shoulder on 25Feb2021 at noontime as single dose for covid-19 immunization. Patient medical history was not reported. The concomitant medication(s) included lisinopril, amlodipine, evolocumab (REPATHA), rosuvastatin calcium (CRESTON) taken for an unspecified indication, start and stop date were not reported. The patient experienced with both vaccination, i was sick with typical COVID-19 Symptoms chills, shortness of breath, loss of apetite, muscular aches and pains, diarrhea, constipation, dry, nausea, hoarse voice, extream fatigue, generalized prickle sensation, walking difficulty. Patient had expected some slight discomfort at the injection sites, however that did not occur. The patient did not require medical intervention, the patient was not seen in the emergency department, the patient was not hospitalized and was not admitted to an Intensive care. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient receive recent (2 Vaccination) vaccines for SARS-Cov2 other than PFIZER-BIONTECH COVID-19 mRNA VACCINE prior to the event being reported. The patient has not receive any other vaccines around the time of PFIZER-BIONTECH COVID-19 mRNA VACCINE vaccination. The patient underwent lab tests and procedures and diagnosed positive for COVID-19 on 27May 2020. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphonia, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: I WAS SICK; chills; shortness of breath; loss of apetite; Muscular aches and pains; diarrhea; constipation; dry cough; nausea; hoarse voice; extream fatigue; Generalized prickle sensation; Walking difficulty; This is a spontaneous report from a contactable physician (patient). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613) intramuscularly route of administration in left shoulder on 18Mar2021 at noontime as single dose for and  patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6198) via an unspecified route of administration in right shoulder on 25Feb2021 at noontime as single dose for covid-19 immunization. Patient medical history was not reported. The concomitant medication(s) included lisinopril, amlodipine, evolocumab (REPATHA), rosuvastatin calcium (CRESTON) taken for an unspecified indication, start and stop date were not reported. The patient experienced with both vaccination, i was sick with typical COVID-19 Symptoms chills, shortness of breath, loss of apetite, muscular aches and pains, diarrhea, constipation, dry, nausea, hoarse voice, extream fatigue, generalized prickle sensation, walking difficulty. Patient had expected some slight discomfort at the injection sites, however that did not occur. The patient did not require medical intervention, the patient was not seen in the emergency department, the patient was not hospitalized and was not admitted to an Intensive care. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient receive recent (2 Vaccination) vaccines for SARS-Cov2 other than PFIZER-BIONTECH COVID-19 mRNA VACCINE prior to the event being reported. The patient has not receive any other vaccines around the time of PFIZER-BIONTECH COVID-19 mRNA VACCINE vaccination. The patient underwent lab tests and procedures and diagnosed positive for COVID-19 on 27May 2020. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Nausea, Pain, Paraesthesia
Clinical narrative: I WAS SICK; chills; shortness of breath; loss of apetite; Muscular aches and pains; diarrhea; constipation; dry cough; nausea; hoarse voice; extream fatigue; Generalized prickle sensation; Walking difficulty; This is a spontaneous report from a contactable physician (patient). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613) intramuscularly route of administration in left shoulder on 18Mar2021 at noontime as single dose for and  patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6198) via an unspecified route of administration in right shoulder on 25Feb2021 at noontime as single dose for covid-19 immunization. Patient medical history was not reported. The concomitant medication(s) included lisinopril, amlodipine, evolocumab (REPATHA), rosuvastatin calcium (CRESTON) taken for an unspecified indication, start and stop date were not reported. The patient experienced with both vaccination, i was sick with typical COVID-19 Symptoms chills, shortness of breath, loss of apetite, muscular aches and pains, diarrhea, constipation, dry, nausea, hoarse voice, extream fatigue, generalized prickle sensation, walking difficulty. Patient had expected some slight discomfort at the injection sites, however that did not occur. The patient did not require medical intervention, the patient was not seen in the emergency department, the patient was not hospitalized and was not admitted to an Intensive care. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient receive recent (2 Vaccination) vaccines for SARS-Cov2 other than PFIZER-BIONTECH COVID-19 mRNA VACCINE prior to the event being reported. The patient has not receive any other vaccines around the time of PFIZER-BIONTECH COVID-19 mRNA VACCINE vaccination. The patient underwent lab tests and procedures and diagnosed positive for COVID-19 on 27May 2020. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: severe gout attack in right foot - I'm on day 11 with no end in sight; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 16Apr2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received second dose of  bnt162b2 (Lot Number: ew0150), via an unspecified route of administration, administered in arm left on 05Apr2021 12:15 as single dose for covid-19 immunisation. The patient medical history included penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: en6208) on 15mar2021 12:30 PM in left arm for covid-19 immunisation. The patient experienced severe gout attack in right foot - I'm on day 11 with no end in sight on 06Apr2021 20:00. The patient reported she had pretty severe, she just got 2nd shot Monday last week ago, and 2 days later (as reported) she got a very severe gout reaction and she never had that in her life, she wanted to know that was the known side effect of the Covid vaccine. No fever. Repeated as she got a very severe gout reaction in her foot, was in the red skin cause, its more than a rash, it's incredibly painful and her entire foot get swollen. And she had been to the doctor, they diagnosed her for the gout. She never had a gout previously in her life, she did not have any other food trigger or anything else that they think and cause, so she just wondering was that, It was known reaction that continually determined. She was just trying to figure out, why this was happening? She couldn't walk. The adverse event result in Doctor or other healthcare professional office/clinic visit Emergency room/department or urgent care. Treatment received for the adverse event included Indomethacine- Prednisone. The outcome of event goat was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood pressure measurement, Dizziness, Dysstasia
Clinical narrative: syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; body pain; headache; felt uneasy; nausea/Felt like throwing up; dizzy/lightheaded; Profuse sweating; EKG showed low heart rate, blood pressure; EKG showed low heart rate, blood pressure; feeling weak; could not stand; Feeling worse; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Cholesterol (blood cholesterol abnormal) from an unknown date. There were no concomitant medications. The patient previously received first dose of BNT162B2 for covid-19 immunisation on 24Mar2021. The patient also previously received naproxen and experienced allergies. The patient experienced syncope, soreness overnight in left arm, expanding pain to left shoulder, strong fever/low fever, body pain, headache, felt uneasy, nausea/felt like throwing up, dizzy/lightheaded, profuse sweating, ekg showed low heart rate, blood pressure, feeling weak, could not stand and feeling worse all on 15Apr2021 at 13:00. All the reported events caused hospitalization for 1 day. It was reported that After receiving Pfizer vaccine at 4pm developed Soreness overnight in left arm, expanding pain to left shoulder. Strong Fever and body pain in morning. Feeling worse throughout morning after breakfast of tea and fruits. While having lunch at 1.30 pm felt uneasy and nausea and could not complete lunch. Felt like throwing up and got up feeling dizzy and lightheaded. Experienced syncope and had to lie down on kitchen floor. Tried to get up with help from family members but could not stand and had to lie down again on floor. Profuse sweating. Wife called 911 and ambulance who arrived and checked pulse, EKG showed low heart rate, blood pressure. Taken by ambulance and paramedics to hospital Emergency where IV fluids were given to stabilize and discharged after 4 hours of observation. Still feeling weak, headache, low fever. Taking Tylenol and fluids while recovering. Adverse event start date: 15Apr2021. Adverse event start time: 01:00 PM. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): low on 15Apr2021, EKG (electrocardiogram): showed low heart rate, blood pressure on 15Apr2021 and pulse/heart rate (heart rate): low on 15Apr2021. Therapeutic measures were taken as a result of all the events which includes IV fluids and Tylenol. Outcome of all the events was recovering  Information on batch/lot number was requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Feeling abnormal, Headache, Heart rate, Heart rate decreased
Clinical narrative: syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; body pain; headache; felt uneasy; nausea/Felt like throwing up; dizzy/lightheaded; Profuse sweating; EKG showed low heart rate, blood pressure; EKG showed low heart rate, blood pressure; feeling weak; could not stand; Feeling worse; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Cholesterol (blood cholesterol abnormal) from an unknown date. There were no concomitant medications. The patient previously received first dose of BNT162B2 for covid-19 immunisation on 24Mar2021. The patient also previously received naproxen and experienced allergies. The patient experienced syncope, soreness overnight in left arm, expanding pain to left shoulder, strong fever/low fever, body pain, headache, felt uneasy, nausea/felt like throwing up, dizzy/lightheaded, profuse sweating, ekg showed low heart rate, blood pressure, feeling weak, could not stand and feeling worse all on 15Apr2021 at 13:00. All the reported events caused hospitalization for 1 day. It was reported that After receiving Pfizer vaccine at 4pm developed Soreness overnight in left arm, expanding pain to left shoulder. Strong Fever and body pain in morning. Feeling worse throughout morning after breakfast of tea and fruits. While having lunch at 1.30 pm felt uneasy and nausea and could not complete lunch. Felt like throwing up and got up feeling dizzy and lightheaded. Experienced syncope and had to lie down on kitchen floor. Tried to get up with help from family members but could not stand and had to lie down again on floor. Profuse sweating. Wife called 911 and ambulance who arrived and checked pulse, EKG showed low heart rate, blood pressure. Taken by ambulance and paramedics to hospital Emergency where IV fluids were given to stabilize and discharged after 4 hours of observation. Still feeling weak, headache, low fever. Taking Tylenol and fluids while recovering. Adverse event start date: 15Apr2021. Adverse event start time: 01:00 PM. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): low on 15Apr2021, EKG (electrocardiogram): showed low heart rate, blood pressure on 15Apr2021 and pulse/heart rate (heart rate): low on 15Apr2021. Therapeutic measures were taken as a result of all the events which includes IV fluids and Tylenol. Outcome of all the events was recovering  Information on batch/lot number was requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Nausea, Pain, Pain in extremity
Clinical narrative: syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; body pain; headache; felt uneasy; nausea/Felt like throwing up; dizzy/lightheaded; Profuse sweating; EKG showed low heart rate, blood pressure; EKG showed low heart rate, blood pressure; feeling weak; could not stand; Feeling worse; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Cholesterol (blood cholesterol abnormal) from an unknown date. There were no concomitant medications. The patient previously received first dose of BNT162B2 for covid-19 immunisation on 24Mar2021. The patient also previously received naproxen and experienced allergies. The patient experienced syncope, soreness overnight in left arm, expanding pain to left shoulder, strong fever/low fever, body pain, headache, felt uneasy, nausea/felt like throwing up, dizzy/lightheaded, profuse sweating, ekg showed low heart rate, blood pressure, feeling weak, could not stand and feeling worse all on 15Apr2021 at 13:00. All the reported events caused hospitalization for 1 day. It was reported that After receiving Pfizer vaccine at 4pm developed Soreness overnight in left arm, expanding pain to left shoulder. Strong Fever and body pain in morning. Feeling worse throughout morning after breakfast of tea and fruits. While having lunch at 1.30 pm felt uneasy and nausea and could not complete lunch. Felt like throwing up and got up feeling dizzy and lightheaded. Experienced syncope and had to lie down on kitchen floor. Tried to get up with help from family members but could not stand and had to lie down again on floor. Profuse sweating. Wife called 911 and ambulance who arrived and checked pulse, EKG showed low heart rate, blood pressure. Taken by ambulance and paramedics to hospital Emergency where IV fluids were given to stabilize and discharged after 4 hours of observation. Still feeling weak, headache, low fever. Taking Tylenol and fluids while recovering. Adverse event start date: 15Apr2021. Adverse event start time: 01:00 PM. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): low on 15Apr2021, EKG (electrocardiogram): showed low heart rate, blood pressure on 15Apr2021 and pulse/heart rate (heart rate): low on 15Apr2021. Therapeutic measures were taken as a result of all the events which includes IV fluids and Tylenol. Outcome of all the events was recovering  Information on batch/lot number was requested.