chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Pain in extremity
Clinical narrative: arm is really numb; arm is painful; it is now cramping up; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number and Expiry Date are Not Provided), via an unspecified route of administration on 29Mar2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Investigation assessment was not provided. It was reported that she got the Pfizer shot on the 29th, and on an unspecified date in Mar2021, her arm was numb, it was really painful, she has taken Ibuprofen and done everything, she was ready to do something that call handler was not able to clarify, and fight, and on an unspecified date in Mar2021, it was now cramping up, so she was seeking recommendations. Speakerphone recording notification given and caller says she was at the clinic there are people there, then says hold on and abruptly disconnects the call. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Condition aggravated, Heart rate, Hypoaesthesia
Clinical narrative: the numbness it is definitely seems to be getting worse; Balance is off; have the phantom sensations; feeling somewhat disconnected mentally; my left arm has pain; Symptoms related to facial numbness in my face and left side arm and leg; have a tension style headache - no migraine symptoms; Vision is so hard to focus; This is a spontaneous report received from a contactable consumer (patient).   A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: F128734), via an unspecified route of administration in arm right on 29Mar2021 at 09:45 (at the age of 54-year-old), as a dose 1, single for COVID-19 immunisation. Medical history included multiple sclerosis. Past drug event included Neurontin, Accutane, rapiflo and experienced known allergies. Concomitant medications in two weeks included siponimod (MAYZENT), diphenhydramine hydrochloride (BENADRYL), vit d, 83 aspirin taken for an unspecified indication. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 29Mar2021 at 15:00, the patient with multiple sclerosis day of equal to the symptoms related to facial numbness in his face and left sidearm and leg. Balance was off the patient have not fallen but weirdly any touching on his face leaves residual sensation for minutes and was somewhat painful. Arm and leg do not necessarily have the pain but do have the phantom sensations and general numbness. Stated that, the patient was feeling some-what disconnected mentally and not sure what to do about that. Although the shot was in his right arm, his left arm has pain where the shot would have been - weird. Next day on 30Mar2021, for the numbness it was definitely seemed to be getting worse. Also, now he had a tension style head-ache, no migraine symptoms on 29Mar2021. Blood oxygen level was 98 percent. Numbness really only set on this morning with the facial residual sensations, Temp was 97.8f, HR was 83bpm. Stated that, the patient really had to think about doing things with his body and he hope that makes sense. No chest pain or breathing issues. Balance way off vision was so hard to focus. The events resulted in physician office visit. Treatment was not received for the events. On 30Mar2021, the patient underwent lab tests and procedures which included Temp was 97.8f (body temperature), resulted as 97.8 Fahrenheit, HR was 83BPM (Heart rate), resulted as 83, Blood Oxygen level is 98 percent (oxygen consumption), resulted as 98 percent. The outcome of the events was reported as resolving.   No follow-up attempts were possible information about lot/batch number could not be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Mental disorder, Oxygen consumption, Pain in extremity, Phantom limb syndrome, Tension headache
Clinical narrative: the numbness it is definitely seems to be getting worse; Balance is off; have the phantom sensations; feeling somewhat disconnected mentally; my left arm has pain; Symptoms related to facial numbness in my face and left side arm and leg; have a tension style headache - no migraine symptoms; Vision is so hard to focus; This is a spontaneous report received from a contactable consumer (patient).   A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: F128734), via an unspecified route of administration in arm right on 29Mar2021 at 09:45 (at the age of 54-year-old), as a dose 1, single for COVID-19 immunisation. Medical history included multiple sclerosis. Past drug event included Neurontin, Accutane, rapiflo and experienced known allergies. Concomitant medications in two weeks included siponimod (MAYZENT), diphenhydramine hydrochloride (BENADRYL), vit d, 83 aspirin taken for an unspecified indication. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 29Mar2021 at 15:00, the patient with multiple sclerosis day of equal to the symptoms related to facial numbness in his face and left sidearm and leg. Balance was off the patient have not fallen but weirdly any touching on his face leaves residual sensation for minutes and was somewhat painful. Arm and leg do not necessarily have the pain but do have the phantom sensations and general numbness. Stated that, the patient was feeling some-what disconnected mentally and not sure what to do about that. Although the shot was in his right arm, his left arm has pain where the shot would have been - weird. Next day on 30Mar2021, for the numbness it was definitely seemed to be getting worse. Also, now he had a tension style head-ache, no migraine symptoms on 29Mar2021. Blood oxygen level was 98 percent. Numbness really only set on this morning with the facial residual sensations, Temp was 97.8f, HR was 83bpm. Stated that, the patient really had to think about doing things with his body and he hope that makes sense. No chest pain or breathing issues. Balance way off vision was so hard to focus. The events resulted in physician office visit. Treatment was not received for the events. On 30Mar2021, the patient underwent lab tests and procedures which included Temp was 97.8f (body temperature), resulted as 97.8 Fahrenheit, HR was 83BPM (Heart rate), resulted as 83, Blood Oxygen level is 98 percent (oxygen consumption), resulted as 98 percent. The outcome of the events was reported as resolving.   No follow-up attempts were possible information about lot/batch number could not be obtained.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: the numbness it is definitely seems to be getting worse; Balance is off; have the phantom sensations; feeling somewhat disconnected mentally; my left arm has pain; Symptoms related to facial numbness in my face and left side arm and leg; have a tension style headache - no migraine symptoms; Vision is so hard to focus; This is a spontaneous report received from a contactable consumer (patient).   A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: F128734), via an unspecified route of administration in arm right on 29Mar2021 at 09:45 (at the age of 54-year-old), as a dose 1, single for COVID-19 immunisation. Medical history included multiple sclerosis. Past drug event included Neurontin, Accutane, rapiflo and experienced known allergies. Concomitant medications in two weeks included siponimod (MAYZENT), diphenhydramine hydrochloride (BENADRYL), vit d, 83 aspirin taken for an unspecified indication. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 29Mar2021 at 15:00, the patient with multiple sclerosis day of equal to the symptoms related to facial numbness in his face and left sidearm and leg. Balance was off the patient have not fallen but weirdly any touching on his face leaves residual sensation for minutes and was somewhat painful. Arm and leg do not necessarily have the pain but do have the phantom sensations and general numbness. Stated that, the patient was feeling some-what disconnected mentally and not sure what to do about that. Although the shot was in his right arm, his left arm has pain where the shot would have been - weird. Next day on 30Mar2021, for the numbness it was definitely seemed to be getting worse. Also, now he had a tension style head-ache, no migraine symptoms on 29Mar2021. Blood oxygen level was 98 percent. Numbness really only set on this morning with the facial residual sensations, Temp was 97.8f, HR was 83bpm. Stated that, the patient really had to think about doing things with his body and he hope that makes sense. No chest pain or breathing issues. Balance way off vision was so hard to focus. The events resulted in physician office visit. Treatment was not received for the events. On 30Mar2021, the patient underwent lab tests and procedures which included Temp was 97.8f (body temperature), resulted as 97.8 Fahrenheit, HR was 83BPM (Heart rate), resulted as 83, Blood Oxygen level is 98 percent (oxygen consumption), resulted as 98 percent. The outcome of the events was reported as resolving.   No follow-up attempts were possible information about lot/batch number could not be obtained.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Hypoaesthesia
Clinical narrative: numbness of his right ear and right side of the face; little bit blood in his nose; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number: EP6955) via an unspecified route of administration in right arm on 16Mar2021 (at the age of 28-years) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 16Mar2021 (after one hour of vaccination) patient's right ear got numb, then experienced right face numbness after a few hours he thinks, and then a little bit blood in his nose (nose bleeding). Duration of reaction/event was reported as 1 day for events. Patient wants to know that what should he do for second vaccine. On 17Mar2021, the outcome of all events was resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Hyperhidrosis, Hypoaesthesia, Pain
Clinical narrative: had numbness in hands; stomach was terrible; Felt like labor pains; lots of sweating; 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 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date the patient medical history and concomitant medications was not reported. The patient experienced had numbness in hands, stomach was terrible, felt like labor pains, lots of sweating. The outcome of all events was unknown.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Maternal exposure timing unspecified, Uterine pain
Clinical narrative: pregnant; abdominal cramps; its uterine pain; This is a spontaneous report from a contactable pharmacist. A 39-years-old pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the pregnant patient had been having abdominal cramps after having the Pfizer BioNTech COVID19 vaccine. Patient was unsure if it due to the vaccine or if its uterine pain on unspecified date. The pain went away and she will be going to see her OBGYN. She was wondering if this was a reported side effect especially in pregnant woman. The outcome of abdominal cramps and uterine pain was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Throat tightness
Clinical narrative: Throat tightening; dizziness; headache; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 24Mar2021 12:30 (Lot Number: EN6207) , (at the age of 44-year-old),as a single dose for covid-19 immunisation. Medical history included endometriosis from an unknown date and unknown if ongoing, seasonal allergy from an unknown date and unknown if ongoing and Known allergies: thimerosal, 4-Phenylenediamine base, methyldibromoglutaronitrile, disperse Orange 3, goldsodiumthiosulfate, textile dye mix from an unknown date and unknown if ongoing. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, ferrous fumarate, norethisterone (KAITLIB FE) taken for an unspecified indication, start and stop date were not reported. The patient previously took thimerosal and experienced drug hypersensitivity, gold sodium thiosulfate and experienced drug hypersensitivity. If covid prior vaccination and If covid tested post vaccination: No and If other vaccine in four weeks: No. On 24Mar2021 at 12:45, (15 minutes after the shot), the patient experienced throat tightening, dizziness, headache and, shortness of breath. The patient did not receive treatment for the events. The outcome of the events was reported as unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness of the face; This is a spontaneous report from a contactable consumer. A patient of an unspecified gender and age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was not reported) via an unspecified route on unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced numbness of his right ear and right side of the face. Patient also had nose bleeding and it has been resolved now. Reporter stated that his cousin also had numbness of the face after the 1st dose and was advised by his doctor not to get mRNA vaccines. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body aches; This is a spontaneous report received from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Reporter informed that she knew of someone who had the Pfizer vaccine and developed a fever and body aches after the second dose on 02Apr2021. The fever and body aches last for a day. Seriousness of the events were reported as non-serious. The outcome of the events was recovered on 03Apr2021.  Follow-up (07Apr2021): New information was received from a contactable consumer includes: reporter informed that she was aware of the event on Friday, 02Apr2021 and reported the event within the 24 hours reporting requirement.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Urinary tract infection
Clinical narrative: UTI; splitting headache; sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, administered in arm right on 29Mar2021 (Monday) at 14:15 as dose 1, single for COVID-19 immunisation. Medical history included multiple sclerosis from 1998 to an unknown date, UTIfrom an unknown date and unknown if ongoing. Concomitant medications included ciprofloxacin (CIPRO [CIPROFLOXACIN]) taken for UTI from 26Mar2021 to an unspecified stop date; fingolimod hydrochloride (GILENYA) taken for multiple sclerosis from an unspecified start date and ongoing. The patient stated that She just wanted to talk to someone about having felt like a sore arm for two days (unspecified date in Mar2021), which she expected that from a shot in the arm and she was not concerned about that, but today (unspecified date) she woke up with a splitting headache (31Mar2021), she does not know, because she did not get sick right away, since this is the third day after the shot if she should do something about the headache or wait it out, she has multiple issues she battles anyway outside of this, she has done no treatment yet, she heard not to do anything on TV and do not take Tylenol to build up immune, but she wants to take something, which is why she guesses she called to see what she could take. The patient further stated that she started a new medication, Cipro, which was an antibiotic she was given for a UTI she got diagnosed four days ago (on an unspecified date), which she was now taking it, thought UTI started ten days ago, she did not get diagnosed until last Thursday (unspecified date) when she went to the doctor who confirmed her thoughts that she had a UTI. The outcome of all the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Maternal exposure during pregnancy, Pyrexia, Vomiting
Clinical narrative: Fever of 102 F; severe vomiting; Joint pain; patient was pregnant, second trimester (24 weeks); This is a spontaneous report from a contactable consumer, the patient. A 28-year-old pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration on the left arm on 30Mar2021 at 10:15 as a single dose (at the age of 28-years-old) for COVID-19 immunisation. Medical history included Blood pressure high and migraine. The patient had no known allergies. The patient's last menstrual period was on 08Oct2020. Concomitant medications included nitrofurantoin (MACROBID), escitalopram oxalate (LEXAPRO), propranolol (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204), via an unspecified route of administration in the right arm on 09Mar2021 at 09:00 as a single dose (at the age of 28-years-old) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was pregnant, second trimester (24 weeks). The patient reported the delivery date on 19Jul2021. On 30Mar2021 at 09:00, the patient experienced fever of 102 F, severe vomiting 24 hours and joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the adverse events. The clinical outcomes of the events fever, severe vomiting and joint pain was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling, Myalgia
Clinical narrative: having pain with walking and when he reach to get something; he might have swelling the butt; muscle pain in back of legs; This is a spontaneous report from a contactable consumer or other non hcp (Patient) reporting himself.  A 65-year-old male patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1681), via an unspecified route of administration on 02Mar2021 (Age at vaccination: 65-years-old) as single dose for covid-19 immunization. Medical history included knee and hip replaced done 9 years ago. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Batch/lot number: EL3302) on 09Feb2021 (Age at vaccination: 65-years-old) as single dose for covid-19 immunization and experienced muscle pain in back of legs. It was reported that he got the first dose on 09Feb2021 and the next following week or week after started experiencing muscle pain in back of legs. stated then on 02Mar2021 he received the second dose and is still experiencing leg pains but it is not always it is only like if he goes for a walk outside for a couple of minutes and then all of a sudden he starts having pain in the back of his leg in the muscle area. Caller wanted to know if the muscle pain in the back of his legs is because of the vaccine. stated just so you know his wife had her vaccine at the same place but a different time and she is experiencing pain in her left leg. Upon Follow-up, dated 03Jun2021, it was reported that both legs muscle pain after a week of receiving the first dose of the Pfizer covid vaccine. patient wanted to know if knee and hip replaced done 9 years ago have anything to do with the pain he is having. His doctor stated they are finding it the pain gets intensify with/when replacement is done. patient received the second dose on 02Mar2021 and has been having pain with walking and when he reaches to get something, he was ok when sitting. He also stated that he might have swelling the butt. he got the pain shot, was taking diclofenac 75 mg and was also prescribed Flexeril but he does not take it as he does not like the make it makes him feel. Therapeutic measures were taken as a result of muscle pain in back of legs. The outcome for the events was reported as unknown at the time of this report.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient received both doses of COVID vaccine. Unfortunately, he was among the few people who experienced swollen lymph nodes as a side effect on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021360008 same reporter/drug/event, different patients
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low fever; This is a spontaneous report received from a contactable consumer, Pfizer employee. A male patient of an unknown age received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was not reported that the patient received any medication within two weeks prior to the COVID-19 vaccine. It was not reported that the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, it was not reported that the patient was diagnosed with COVID-19. Since the vaccination, it was not reported that the patient had been tested for COVID-19. On an unknown date, the patient experienced low fever. The clinical outcome of the event low fever was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Supplier updated as Pfizer; Narrative was updated for Concomitant drugs, vaccine in four weeks and COVID-19 Prior to the vaccination and after the vaccine.  Follow-up(27Jul2021):This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of a query. The response included: It would be 04Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: her armwhere the vaccine was injectedbecame completely numb; This is a spontaneous report from a contactable consumer (patient), from a Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration in arm on 30Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient took her first dose today, 30Mar2021. An hour after that, while driving, her arm where the vaccine was injected became completely numb specifically her pinky and ring finger. Her next dose will be on 20APR2021. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected. Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: closing up of throat; shortness of breath; Trouble breathing; This is a spontaneous report from a contactable consumer (patient herself).  A 24-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 29Mar2021 15:00 as Dose 1, single for COVID-19 immunization and administered at hospital. Medical history included bipolar disorder, fast heart rate, urinary problems, insomnia; all from an unknown date and unknown if ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and since the vaccination, the patient not diagnosed with COVID-19. The patient received other medications (concomitant medications) within 2 weeks of vaccination. The patient previously took bactrim and cephalexine; experienced Drug allergy. On 29Mar2021 19:00, the patient experienced closing up of throat, shortness of breath and trouble breathing. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fibromyalgia, Gait disturbance, Myalgia, Pain
Clinical narrative: I have fibromyalgia and after I got the shot it is getting worse and worse; The pain in my body is horrible; Pain in legs; I cannot walk; I got severe joint and muscle pain; I got severe joint and muscle pain; This is a spontaneous report from a contactable consumer (the patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19 Vaccine, formulation: solution for injection, Batch/Lot Number: ER2613, NDC, UPC number and expiry date: unknown), via an unspecified route of administration in Left Arm on 08Mar2021 (at the age of 60-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing fibromyalgia. Patient had lot of medical conditions. The patient's concomitant medications were not reported. Probably on 18Mar2021 (about 10 days after the shot), the patient experienced horrible pain in the body, pain in legs, could not walk, got severe joint and muscle pain and fibromyalgia which got worse and worse after getting the shot. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I have fibromyalgia and after I got the shot it is getting worse and worse; The pain in my body is horrible; Pain in legs; I cannot walk; I got severe joint and muscle pain; I got severe joint and muscle pain; This is a spontaneous report from a contactable consumer (the patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19 Vaccine, formulation: solution for injection, Batch/Lot Number: ER2613, NDC, UPC number and expiry date: unknown), via an unspecified route of administration in Left Arm on 08Mar2021 (at the age of 60-years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing fibromyalgia. Patient had lot of medical conditions. The patient's concomitant medications were not reported. Probably on 18Mar2021 (about 10 days after the shot), the patient experienced horrible pain in the body, pain in legs, could not walk, got severe joint and muscle pain and fibromyalgia which got worse and worse after getting the shot. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Carpal tunnel syndrome, Hypoaesthesia, Joint swelling, Pruritus
Clinical narrative: carpal tunnel; Skin around collar bone was irritated/itchy; Skin around collar bone was irritated/itchy; swelling my elbows; wrists were feeling enflamed; my left thumb went partially numb, spread to index finger/right thumb and half of index finger also partially numb; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: En6205), via an unspecified route of administration, administered in Left arm on 13Mar2021 09:15 at the age of 38-years-old as dose 1, single for covid-19 immunisation. Medical history included did heavy lifting for years injuring his elbow tendons at times on unspecified date. The patient had no known allergies. Other medical history was none. Concomitant medication included Multivitamin gummies [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) taken for an unspecified indication from an unspecified date received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. Facility type vaccine was Hospital. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that within 10 minutes after dose 1, on 13Mar2021, his left thumb went partially numb, spread to index finger. In 20 min right thumb and half of index finger also partially numb. By days end (12 hrs later) on 13Mar2021 at 21:15, any place he had any amount of swelling his elbows and wrists were feeling enflamed. On an unspecified date, he was probably developing carpal tunnel, and did heavy lifting for years injuring his elbow tendons at times. 14 hours after injection, on 13Mar2021 at 23:15, Skin around collar bone was irritated/itchy. Went to bed and woke up without this concern. Next day thumbs still a partially numb. Took a week for them to be normal. The outcome of events, Skin around collar bone was irritated/itchy and Numbness in fingers was recovered on an unspecified date in Mar2021 and other events was unknown.   Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: carpal tunnel; Skin around collar bone was irritated/itchy; Skin around collar bone was irritated/itchy; swelling my elbows; wrists were feeling enflamed; my left thumb went partially numb, spread to index finger/right thumb and half of index finger also partially numb; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: En6205), via an unspecified route of administration, administered in Left arm on 13Mar2021 09:15 at the age of 38-years-old as dose 1, single for covid-19 immunisation. Medical history included did heavy lifting for years injuring his elbow tendons at times on unspecified date. The patient had no known allergies. Other medical history was none. Concomitant medication included Multivitamin gummies [vitamins nos] (MULTIVITAMINS [VITAMINS NOS]) taken for an unspecified indication from an unspecified date received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. Facility type vaccine was Hospital. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. It was reported that within 10 minutes after dose 1, on 13Mar2021, his left thumb went partially numb, spread to index finger. In 20 min right thumb and half of index finger also partially numb. By days end (12 hrs later) on 13Mar2021 at 21:15, any place he had any amount of swelling his elbows and wrists were feeling enflamed. On an unspecified date, he was probably developing carpal tunnel, and did heavy lifting for years injuring his elbow tendons at times. 14 hours after injection, on 13Mar2021 at 23:15, Skin around collar bone was irritated/itchy. Went to bed and woke up without this concern. Next day thumbs still a partially numb. Took a week for them to be normal. The outcome of events, Skin around collar bone was irritated/itchy and Numbness in fingers was recovered on an unspecified date in Mar2021 and other events was unknown.   Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Nausea, Pyrexia
Clinical narrative: Temperature of 105.6 for four or five hours; Patient threw up; Started to feel uncomfortable/Patient was feeling under the weather; Patient had shivers; nausea; visual effects; This is a spontaneous report from a contactable consumer (Parent) and from a Pfizer sponsored program regulatory authority from a contactable consumer. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 27Mar2021 at 10:30 (at the age of 36 years old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 for COVID-19 immunization on an unknown date. The patient experienced temperature of 105.6 for four or five hours on 27Mar2021; threw up and started to feel uncomfortable on 27Mar2021 the same evening of the vaccine; patient had shivers, felt under the weather, nausea and visual effects on an unspecified date (nausea, shivering and visual effects lasted 6 days). The patient underwent lab tests and procedures which included body temperature: 105.6 on 29Mar2021. The clinical outcome of the events pyrexia was recovered on 29Mar2021, vomiting was recovered on 27Mar2021; and malaise, chills, nausea and visual impairment was recovered on an unknown date.   The lot numbers for the vaccine, BNT162B2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: Temperature of 105.6 for four or five hours; Patient threw up; Started to feel uncomfortable/Patient was feeling under the weather; Patient had shivers; nausea; visual effects; This is a spontaneous report from a contactable consumer (Parent) and from a Pfizer sponsored program regulatory authority from a contactable consumer. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 27Mar2021 at 10:30 (at the age of 36 years old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 for COVID-19 immunization on an unknown date. The patient experienced temperature of 105.6 for four or five hours on 27Mar2021; threw up and started to feel uncomfortable on 27Mar2021 the same evening of the vaccine; patient had shivers, felt under the weather, nausea and visual effects on an unspecified date (nausea, shivering and visual effects lasted 6 days). The patient underwent lab tests and procedures which included body temperature: 105.6 on 29Mar2021. The clinical outcome of the events pyrexia was recovered on 29Mar2021, vomiting was recovered on 27Mar2021; and malaise, chills, nausea and visual impairment was recovered on an unknown date.   The lot numbers for the vaccine, BNT162B2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: I got my period 10 days early; This is a spontaneous report from a contactable consumer (patient, self-reported). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 16Mar2021 at 09:00 AM (age at vaccination: 43 years), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history was not reported. The patient did not have known allergies. Concomitant medication included sertraline. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and had heart flips four days after the first shot, continued through the whole vaccinated month. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On an unspecified date in Mar2021, the patient got her period 10 days early after the second dose. This never happened before in her life. The patient did not receive any treatment for the event. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site mass, Vaccination site pain
Clinical narrative: worse pain in the vaccination site and pain had abated; A hard itchy lump at the vaccinationsite.; A hard itchy lump at the vaccinationsite.; This is a spontaneous report from a contactable consumer (Patient). This is the first of two reports. A 41-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: en6206), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 at 12:00 (age at vaccination: 41 years) as dose 2, single for covid-19 immunization. Medical history included shellfish allergy and sulfonamide allergy (reported as sulfa). Concomitant medications included AMOXICILLIN. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8733) via an unspecified route of administration in the left arm on 06Mar2021 at 11:00 (at the age of 41-years-old) as a single dose for COVID-19 immunization and experienced vaccination site pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient experienced worse pain in the vaccination site and pain had abated, the patient somewhat felt a hard itchy lump at the vaccination site on 03Apr2021. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The outcome of the events were not recovered.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021382052 similar report from same reporter
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Illness, Nausea, Pain, Pyrexia
Clinical narrative: fever; body aches so that she could barely walk; nausea; chills; sick; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EP6955; Expiration Date: 30Jun2021) via an unspecified route of administration (age at vaccination 77-year) in Left Arm on 31Mar2021 09:30 at AM as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from Dec2020 to an unknown date. The patient's concomitant medications were not reported. No prior vaccinations (within 4 weeks) were reported. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Administered Vaccines If applicable, list of all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. On 31Mar2021 the patient experienced fever, body aches so that she could barely walk, nausea, chills, sick. It was reported that "she had her first dose of the COVID-19 vaccine last Wednesday on 31Mar2021. She knows she had COVID-19 antibodies because she had the COVID-19 virus in Dec2020. They are saying on TV that people who have had the COVID-19 virus and gotten one COVID-19 vaccine should be ok. She thinks she has antibodies from the COVID-19 virus then she went and got the COVID-19 vaccine, and she got more COVID-19 antibodies. She doesn't want to get the second COVID-19 dose because she was so sick with the first COVID-19 vaccine. Clarified caller had fever and body aches so that she could barely walk. She also had a little nausea; the nausea wasn't really bad. Then when she saw on the TV that people who had antibodies maybe shouldn't get the second COVID-19 vaccine. She is scheduled for her second COVID-19 vaccine on 21Apr2021. She got her COVID-19 vaccine at Hospital. When probing for specific event details the caller reports she received her COVID-19 vaccine at 9:30AM on 31Mar2021 and that evening she had chills and a fever. She also had body aches and a little nausea. She had been sick, and she was afraid that she wouldn't be able to go to church on Easter Sunday because she felt bad, but she woke up feeling better on Sunday, 04Apr2021. She was able to go to church. Today, 05Apr2021 she has no symptoms at all. She's concerned over getting her second COVID-19 vaccine." Adverse Events does not require a visit to Emergency Room/Physician Office. No relevant tests were reported. The clinical outcome of the events was recovered on 05Apr2021.  No follow-up information needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy rash on both arms chest shoulders and back; Red rash on both arms chest shoulders and back; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, lot number: unknown) via an unspecified route of administration in the right arm on 20Mar2021 at 11:15 (at the age of 44-years-old) as dose1, single for COVID-19 immunization. Medical history was not reported. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, the patient experienced red itchy rash on both of her arms, chest, shoulders and back; the rash had not gone away. The events resulted in emergency room or department or urgent care. Therapeutic measures were taken as a result of events and included treatment with unspecified medication. The clinical outcome of the events red itchy rash on both arms chest shoulders and back was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country was added as United States and concomitant therapy selected as none.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Somnolence
Clinical narrative: serious headache; nausea; chills; was in bed, mostly sleeping, for 21 hours; This is a spontaneous report from a non-contactable consumer (Patient). A 66-years-old (Age group: Elderly 65+ Years) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7533, Expiration date was not reported), via an unspecified route of administration, in Left Arm on 27Mar2021 10:30 (at the age of 66-years-old) as dose 2, single for covid-19 immunisation. Patient received vaccine at Clinic The patient medical history included sinusitis from an unknown date and unknown if ongoing. The patient concomitant medications included oxybutynin (OXYBUTYNIN); fluticasone (FLUTICASONE); estrogens conjugated (PREMARIN). The patient had no known allergies. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number EN6199, Expiration date was not reported) via an unspecified route of administration, in Left Arm on 06Mar2021 11:30 for covid-19 immunization suffered from headache. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 10:30, the patient experienced serious headache, nausea, chills, was in bed, mostly sleeping, for 21 hours. Patient received treatment of one Vicadin and then 2 tylenol every 5 hours. The patient had recovered from the events on an unspecified date in 2021,