chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Central pain syndrome, Lymphadenopathy, Myalgia, SARS-CoV-2 test
Clinical narrative: I got the vaccine a week ago and I'm still having muscle pain, joint pain, swollen and painful lymph nodes, shooting pains in centralized locations on arms, legs and feet. Ibuprofen does not help. Onl; I got the vaccine a week ago and I'm still having muscle pain, joint pain, swollen and painful lymph nodes, shooting pains in centralized locations on arms, legs and feet. Ibuprofen does not help. Onl; Swollen and painful lymphnodes; shooting pains in centralized locations on arm, legs and feet; This is a spontaneous report from a contactable other healthcare professional. A 27-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 18:15 (Batch/Lot number and Expiry date was not reported) (at the age of 27-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient had allergy to wellburtin. Concomitant medications included allergy medicines. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 22Jan2021 18:15 (Batch/Lot number and Expiry date was not reported) for covid-19 immunization. The patient did not receive any other vaccine within 4 weeks of covid-19 vaccine. The patient did not have covid prior vaccination. On 13Feb2021, the patient experienced joint pain, muscle pain, swollen and painful lymphnodes and shooting pains in centralized locations on arm, legs and feet. It was reported that the patient got the vaccine a week ago and she was still having muscle pain, joint pain, swollen and painful lymph nodes, shooting pains in centralized locations on arms, legs and feet. Ibuprofen did not help and only heat. The patient did not receive any treatment for the reported events. Laboratory tests on 20Feb2021 included: sars-cov-2 test (covid test type post vaccination (rapid test) and results were pending. The clinical outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Headache, Injection site pain
Clinical narrative: severe pain at injection site; severe joint pain; pain at the base of skull; severe headache and chills; chills; The pain woke me from sleep and I was unable to rest thereafter; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 46 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 13:30 (Batch/Lot Number: EN6201) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included menopause from an unknown date and unknown if ongoing , food allergy from an unknown date and unknown if ongoing known allergies crab meat , food allergy from an unknown date and unknown if ongoing known allergies to some fish. Concomitant medication(s) included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported; progesterone (PROGESTERONE) taken for an unspecified indication, start and stop date were not reported. The patient previously took opioids and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity. The patient experienced 11 hours after the vaccination, the symptoms include severe pain at injection site, severe joint pain, pain at the base of skull, severe headache and chills. The pain woke her from sleep and she was unable to rest thereafter on 20Feb2021 with outcome of recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: severe pain at injection site; severe joint pain; pain at the base of skull; severe headache and chills; chills; The pain woke me from sleep and I was unable to rest thereafter; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 46 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 13:30 (Batch/Lot Number: EN6201) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included menopause from an unknown date and unknown if ongoing , food allergy from an unknown date and unknown if ongoing known allergies crab meat , food allergy from an unknown date and unknown if ongoing known allergies to some fish. Concomitant medication(s) included estradiol (ESTRADIOL) taken for an unspecified indication, start and stop date were not reported; progesterone (PROGESTERONE) taken for an unspecified indication, start and stop date were not reported. The patient previously took opioids and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity. The patient experienced 11 hours after the vaccination, the symptoms include severe pain at injection site, severe joint pain, pain at the base of skull, severe headache and chills. The pain woke her from sleep and she was unable to rest thereafter on 20Feb2021 with outcome of recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Circumstance or information capable of leading to medication error, Fatigue, Flushing, Headache
Clinical narrative: nausea; fatigue; chills; headache; feeling flushed; thinking about not having her 2nd dose; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Unk,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced nausea, fatigue, chills, headache,feeling flushed and thinking about not having her 2nd dose on an unspecified date.The patient wanted to know whether she should still get her 2nd dose or not because she has read information that getting the vaccine after recovering from previous Covid infection would act as a booster since she already have developed some antibodies after being infected with the virus.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; fatigue; chills; headache; feeling flushed; thinking about not having her 2nd dose; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Unk,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced nausea, fatigue, chills, headache,feeling flushed and thinking about not having her 2nd dose on an unspecified date.The patient wanted to know whether she should still get her 2nd dose or not because she has read information that getting the vaccine after recovering from previous Covid infection would act as a booster since she already have developed some antibodies after being infected with the virus.  Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Headache; 99 deg. Fahrenheit fever; Achey; Tiredness; Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in arm left on 18Feb2021 (at the age of 23-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included Factor V Leiden. The patient had no known allergies. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in arm left on 28Jan2021 (at the age of 23-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 19Feb2021, the patient experienced headache, achey, tiredness, 99 deg. Fahrenheit fever, sore arm at injection site. Treatment was not received for the events. On 19Feb2021, the patient underwent lab tests and procedures which included fever (body temperature), resulted as 99 Fahrenheit. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; 99 deg. Fahrenheit fever; Achey; Tiredness; Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in arm left on 18Feb2021 (at the age of 23-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included Factor V Leiden. The patient had no known allergies. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in arm left on 28Jan2021 (at the age of 23-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 19Feb2021, the patient experienced headache, achey, tiredness, 99 deg. Fahrenheit fever, sore arm at injection site. Treatment was not received for the events. On 19Feb2021, the patient underwent lab tests and procedures which included fever (body temperature), resulted as 99 Fahrenheit. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Flushing, Nausea
Clinical narrative: Within first seven minutes of receiving shot, felt a flush and weak (sat down at chair provided).  Felt quezy and weak.Symptoms disappeared by 15 minutes post injection and I felt comfortable in leav; Felt quezy and weak; weak (sat down at chair provided); This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6198) via an unspecified route of administration (Age at vaccination 65-year) in Left Arm on 17Feb2021 at 02:00 PM as dose 2, single for COVID-19 immunization. Medical history included Known allergies: allergic to dust, printing ink, swiss chard, halibut fish, all from an unknown date and unknown if ongoing. Concomitant medication included rosuvastatin taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL9262) administered in left arm on 27Jan2021 at 02:00 PM for COVID-19 immunization. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. The patient received no other vaccine in four weeks. On an unspecified date the patient experienced within first seven minutes of receiving shot, felt a flush and weak (sat down at chair provided), felt quezy and weak. Symptoms disappeared by 15 minutes post injection and she felt comfortable in leaving pharmacy and driving home within 25 minutes. The patient received no treatment for the adverse events. The clinical outcome of the events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6201) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. Consumer stated, patient had first shot 3 weeks ago, and patient had a sore arm which was fine. patient had second shot yesterday and patient, arm isn't even as sore as it was it was from first one and I have no other symptoms. Does that means patient have a dud? The outcome for event was unknown.  Information of Batch/ Lot number have been requested. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Pain in extremity
Clinical narrative: I checked my blood sugar levels and they seems to be extremely high; I do have a little soreness but it only seems to affect me when I raise my arm; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 10Feb2021 15:30 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced in morning I checked blood sugar levels and they seems to be extremely high, I do have a little soreness but it only seems to affect me when i raise my arm. It is not painful probably the right word, but it is sore. Patient stated, wondered if that was a reaction to the shot to increase in blood sugar level patient arms seems fine. Blood sugar level checked it twice and just trying to figure out if that is normal reaction or not. Patient wanted to know only question really is, is this a normal reaction to have the blood sugar number higher. The patient underwent lab tests and procedures which included blood glucose was extremely high. The outcome of event was unknown.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Muscular weakness
Clinical narrative: feeling washed out; complaining of excessive tiredness; complaining of weakness to her leg muscles; uses a walker; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 93-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm right on 22Jan2021 16:30 (at the age of 93 years) as single for covid-19 immunization. Medical history included High blood pressure, acid reflux from an unknown date and unknown if ongoing. Concomitant medication(s) included calcium, omeprazole, valsartan, vitamin d taken for an unspecified indication, start and stop date were not reported. The patient previously took cleocin [clindamycin hydrochloride] and experienced drug hypersensitivity. Patient got no other vaccine in four weeks. On an unspecified date of 2021 the patient experienced complaining of excessive tiredness, complaining of weakness to her leg muscles, uses a walker while on 25Jan2021 13:00 patient started feeling washed out. Patient did not receive any treatment for Adverse Event. The outcome of the event feeling washed out was not recovered. While outcome of the rest of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Therapeutic response unexpected
Clinical narrative: excess energy; seemed to make him stronger; This is a spontaneous report from a contactable consumer reported for himself. A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9262; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 08Feb2021 (at the age of 71-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing controlled high blood pressure (has had this forever), ongoing high cholesterol (takes medication for this). The patient previously received shingles vaccine and flu vaccines in past, but no events reported for those vaccines. The patient previously took first dose of BNT162B2 (Lot Number: EK4176) on 19Jan2021 10:45 (at the age of 71-year-old) for covid-19 immunisation and experienced the same as dose 2, an increase in energy. There were no concomitant medications. Additional vaccines administered on same date of the Pfizer suspect; prior Vaccinations (within 4 weeks); AE(s) following prior vaccinations included none. The patient experienced excess energy and seemed to make him stronger on unspecified date in Feb2021. Patient had both injections and was wondering did anyone report excess energy after the shots. It was noted that he had this experience after the shot. He was walking 2-3 miles and works out every day. After the first vaccine he had the same experience, an increase in energy. There were no other side effects, just excessive energy where he always wanted to be up and going. Caller explained he never had anything like this happen after a vaccine. He had no sore arm and no side effects at all, no headache, nausea, feeling bad. The product seemed to make him stronger and given him so much energy. The product had him up at 8am, making him want to work in his yard, lift weight where he had been able to increase his repetitions, it made him stronger he feels like. He told all his friends so they can get it; he remarked they should put it in a shake. Events did not result in emergency room or Physician office visit. Clinical outcome of event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Muscle spasms
Clinical narrative: Legs cramps and muscle spasms/horrible legs cramps in the right leg/very, very intense/real intense/weren't constant, was like a contraction; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN9581; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Right on 10Feb2021 11:00 (at the age of 73-year-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetes, factor v leiden carrier from an unknown date and unknown if ongoing All family has factor 5 blood from her mother's side of the family. Her grandchildren's parents both have factor 5 blood, lower limb fracture from an unknown date and unknown if ongoing, broke her right leg and was down for 9 weeks. Developed a huge blood clot and was hospitalized last year. Had a pulmonary embolism. Confirmed this was prior to the COVID-19 Vaccine, suspected covid-19 from an unknown date and unknown if ongoing Was COVID positive in Sep2020. Was on antibiotics, oxygen, and quarantined. Ran a temperature for one day and had a headache for one day, pregnancy from an unknown date and unknown if ongoing  Had leg cramps when she was pregnant and maybe once a year, muscle spasms from an unknown date and unknown if ongoing, Had leg cramps when she was pregnant and maybe once a year, thrombosis from an unknown date and unknown if ongoing. Concomitant medications included insulin taken for diabetes mellitus, start and stop date were not reported; metformin taken for diabetes mellitus, start and stop date were not reported; rivaroxaban (XARELTO) taken for factor v leiden carrier, thrombosis, start and stop date were not reported; vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. No adverse events following prior vaccinations. On 11Feb2021 05:00, patient experienced leg cramps and muscle spasms which weren't constant, was like a contraction. Would stop and go. At 5AM was real intense. Was real intense at 8AM. She pushed her heel out to calm it down. Ever since she got up and moving around she hasn't had it. Patient stated that she was wondering if it could be a side effect of the COVID-19 Vaccine. The patient underwent lab tests and procedures which included body temperature: ran a temperature for one day on Sep2020. The events did not require a visit. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Motion sickness, Nausea, Vomiting
Clinical narrative: throwing up; slight headache; nausea or what feels like motion sickness; nausea or what feels like motion sickness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 06Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced throwing up, slight headache, nausea or what feels like motion sickness on 06Feb2021. It was reported that, patient had side effects and different reaction since Saturday after she had the vaccine. The patient wanted to know what she could do with her feeling after having the vaccine. Patient was feeling better yesterday. She took the vaccine on Saturday morning and since Saturday night she had been throwing up, had a slight headache, and nausea or what feels like motion sickness. When she got up this morning she still felt a little nauseous and wanted to know what to do about this. Also enquired what should she do about the second dose, she was due to go back on the 22Feb2021. Patient was unable to reach the doctor and was going to try and get her doctor again. The outcome of the events throwing up, slight headache was recovering and nausea or what feels like motion sickness was not recovered.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain
Clinical narrative: Back ache; Neck ache; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269 and expiry date: unknown), dose 2 via an unspecified route of administration on 08Feb2021 as DOSE 2 (age at vaccination: 75-years-old), SINGLE for covid-19 immunisation. Medical history included spinal operation (back surgery) and nerve injury (nerve damage). The patient received dose 1 of BNT162B2 for covid-19 immunisation (Lot: EL1284) on 16JAN2021. The patient experienced back ache and neck ache on 10Feb2021. Therapeutic measures were taken as a result of back ache and neck ache (Treatment: Consumer stated. "I already take pain pills. From the back surgery that I had left some nerve damage. So I have been taking 'Norge' (further not clarified). I don't know I am way take Aspirin or anything. Right now I am taking Aleve along with it, 3 Aleve a day. The medication that I am taking prescribed my doctor too. First one is Xtampza 36mg twice a day. Other medication is OxyContin 20mg twice a day."). Outcome of the event was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; sore arm; This is a spontaneous report from a contactable Consumer. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 12:00 (at the age of 37 years) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 12:00 PM as dose 1, single for covid-19 immunisation. The patient previously took phenothiazine and experienced drug hypersensitivity. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No Other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The patient experienced headache and sore arm on 11Feb2021 08:00. Patient did not receive any treatment for the events. The outcome of events was recovered on unknown date in 2021.  Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Woke with severe sciatic pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 14:00 (at the age of 71 years), as DOSE 1, SINGLE for covid-19 immunisation at Military Facility. Medical history included pacemaker insertion on an unspecified date of 2010 (pacemaker), ongoing back disorder (including any illness at time of vaccination: has always had back problems) from an unspecified date. There were no concomitant medications. Patient received the first dose of the Covid-19 vaccine yesterday afternoon. The patient experienced Sciatica on 11Feb2021. He woke today (on 11Feb2021) with severe sciatic pain on the lower right side of his back and hip. He had always had problems with his back. Is this something that had been reported before. The clinical outcome of the event was unknown at the time of report.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Overdose, Pain, Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician. This Physician reported similar events for fifteen patients. This is second of fifteen reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as dose 1, 1.3 mL, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, 15 persons received vaccine from vials that has been reconstituted with 1.3 ml instead of 1.8 ml on an unspecified date, they reported significant body aches, nausea, vomiting, diarrhea on an unspecified date. The outcome of the events was unknown at the time of report. Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021189080 Same reporter/drug/event, different patient;US-PFIZER INC-2021189081 Same reporter/drug/event, different patient;US-PFIZER INC-2021189079 Same reporter/drug/event, different patient;US-PFIZER INC-2021189076 Same reporter/drug/event, different patient;US-PFIZER INC-2021189073 Same reporter/drug/event, different patient.;US-PFIZER INC-2021189078 Same reporter/drug/event, different patient;US-PFIZER INC-2021189074 Same reporter/drug/event, different patient.;US-PFIZER INC-2021189071 Same reporter/drug/event, different patient.;US-PFIZER INC-2021189072 Same reporter/drug/event, different patient.;US-PFIZER INC-2021189075 Same reporter/drug/event, different patient;US-PFIZER INC-2021189077 Same reporter/drug/event, different patient;US-PFIZER INC-2021189069 Same reporter/drug/event, different patient.;US-PFIZER INC-2021189070 Same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Therapeutic response unexpected
Clinical narrative: Second shot-arthritis type symptoms really got better; tired first thing in morning; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN9581, Expiry Date: Unknown), dose 2 via an unspecified route of administration on Arm Left (left shoulder area) on 10Feb2021 as a DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included thyroid problems from an unknown date. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3246) dose 1 via an unspecified route of administration on left arm (bicep/tricep area) 20Jan2021 (at the age of 59-years-old) as a DOSE 1, SINGLE for covid-19 immunisation and experienced first shot-arthritis felt kind of better, which was odd, first shot-arthritis symptoms came back and tired first thing in morning. The patient had second shot-arthritis type symptoms really got better on 11Feb2021and tired first thing in morning on an unspecified date in 2021. once started moving around noticed shoulder did not hurt and her hands felt relaxed. This would pretty much be an undocumented trial with the effects from it. She had a first shot a couple weeks ago and right afterwards was like "wow", arthritis feels kind of better, which was odd. It lasted 3-4 days and then arthritis symptoms came back. Got second shot and arthritis symptoms were better, shoulder did not hurt and hands relaxed. Pfizer maybe onto something for people with arthritis. The outcome of the events was unknown.  Follow-up attempts completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Muscle twitching, Myokymia
Clinical narrative: Left sided facial myokymia/Started in orbicularis oculi muscle for a few days then spread to all facial muscles on the left side/idiopathic facial myokymia; mouth deviation to the left due to continuous muscle twitching; This is a spontaneous report from a contactable HCP reported for herself that. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 20Jan2021 12:00 (Batch/Lot Number: Unknown) as DOSE 2 SINGLE for covid-19 immunization(Age at vaccination 35 years). The patient past Medical history included hypothyroidism from an unknown date and unknown if ongoing and optic neuritis from Jun2013 to an unknown date. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, probiotics (PROBIOTICS) taken for an unspecified indication and vitamin d no's (VITAMIN D NOS) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no allergies reported. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 02Feb2021, the patient experienced Left sided facial myokymia/Started in orbicularis oculi muscle for a few days then spread to all facial muscles on the left side/idiopathic facial myokymia and mouth deviation to the left due to continuous muscle twitching. No sensory issues. No weakness. Had evaluation by neurologist who ordered brain MRI to rule out MS and brainstem lesions, MRI report normal. The patient is treated with oral gabapentin and currently titrating dose up without benefit. Only precipitating event he can think of was getting the vaccine. The event outcome was not recovered.  Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: vomiting; Chills; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN5318, Expiration Date: not reported), via an unspecified route of administration, administered in right arm on 06Feb2021 (at the age of 77 years old) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure (as reported) from an unknown date. Concomitant medications included amlodipine taken for blood pressure; colecalciferol (VITAMIN D 3) taken for vitamin supplementation; zinc for an unspecified indication; minerals nos, quercetin, thioctic acid, vitamins nos (EMERGEN-C) taken for an unspecified indication and cyanocobalamin (VIT B12) taken for an unspecified indication - all taken from 2019 and ongoing. On 13Feb2021 at 02:00, the patient experienced chills and was vomiting a half an hour later at 02:30. The patient did not knowhow long the chills lasted but probably lasted maybe an hour and a half. She went back to sleep and her husband gave her another blanket. The patient was vomiting for maybe 5 minutes. The patient recovered from chills on 13Feb2021 at 03:30 and from vomiting on 13Feb2021 at 02:35.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: mild headache; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via an unspecified route of administration in the left arm on 22Jan2021 07:15 AM (at the age of 34-years-old) as dose 1, single for COVID-19 immunisation. The medical history included Factor XI bleeding disorder from an unknown date and unknown if ongoing, left and right hip replacements on the Summer of 2003 and the summer of 2007, non-hodgkin's lymphoma from 08Jan2001 and finished the treatment in the fall of 2003 (since then, the patient have not had cancer). Concomitant medication included amphetamine (DESXTROAMP-AMPHETAMINE) taken for an unspecified indication, start and stop dates were not reported. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. The patient experienced a mild headache on 24Jan2021, two days after the first dose. It was reported that the event could have been due to any number of other things. The outcome of the event was unknown. The patient was vaccinated with the second dose of BNT162B2 on 12Feb2021 07:15.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Not sure whether to describe as "adverse", his urinary urgency subsided (enlarged prostate) from partially filled bladder and was replaced by a typical bladder "awareness"; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9262, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 12Feb2021 at 10:15 (at the age of 77-years-old) as dose 2, single for COVID-19 immunisation. Medical history included urinary urgency and enlarged prostate both from an unknown date. The patient has no known allergies in vaccine based on list of chemicals posted by Pfizer and CDC. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient has unspecified concomitant medications received within two weeks for blood pressure and prostate. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient experienced not sure whether to describe as "adverse", his urinary urgency subsided (enlarged prostate) from partially filled bladder and was replaced by a typical bladder "awareness" on 12Feb2021. The event started a few hours after the vaccine and remained for 3 days. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was unknown.   No follow-up attempts are possible. No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site pain
Clinical narrative: After the second dose, mild flu like symptoms that appeared approximately 12 hrs after the injection and lasted for approximately 24hrs; Pain at the site of injection for 48hrs; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247, Expiration date not reported), via an unspecified route of administration, administered in the right arm on 11Feb2021 10:00 (at the age of 37-years-old), as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247, Expiration date not reported), via an unspecified route of administration, administered in the right arm on 20Jan2021 14:00 (at the age of 37-years-old), as dose 1, single for COVID-19 immunization and experienced Moderate pain at the site of injection that appeared 8hrs after the injection and lasted for 48hrs. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced after the second dose, mild flu like symptoms that appeared approximately 12 hrs after the injection and lasted for approximately 24hrs and pain at the site of injection for 48hrs on 11Feb2021 21:00. Patient did not receive treatment as a result of the events and events did not result to emergency room or physician office visit. The outcome of recovered of mild flu like symptoms was recovered on an unspecified date on Feb2021 and pain at the site of injection on 13Feb2021 21:00.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Discomfort, Pain in extremity, Pyrexia
Clinical narrative: pain in the arm; fever; pain in bones; general discomfort; This is a spontaneous report from a 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 and expiration date was not reported), via an unspecified route of administration on 22Feb2021 as dose number unknown, single for COVID-19 immunisation. Medical history was not reported. Concomitant medication was not reported. On 23Feb2021, the patient experienced pain in the arm, fever, pain in bones and general discomfort. Caller was asking in regards of her mother who received the vaccine yesterday, she wants to know if it was safe for the patient to take Ibuprofen to treat her symptoms and today morning she presented the following side effects: pain in the arm, fever, pain in bones and general discomfort. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Myalgia, Pain
Clinical narrative: muscle pain; joint pain; feeling sick; body aching; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 06Feb2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 16Jan2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient had muscle pain and joint pain, felt sick, body aching and she was feeling terrible. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Incorrect route of product administration, Pain, Pain in extremity
Clinical narrative: pink oval rash approx 3.5 in long X 2 in wide w/white ring around it; the shot was administered about halfway up on the back side of my arm, only subcutaneously, not intramuscular.; immediate pain; fatigue; arm really still hurt; she wasn't getting oxygen; This is a spontaneous report from a contactable consumer.A 62-years-old female patient received first dose of bnt162b2 (BNT162B2), subcutaneous, administered in Arm Left on 04Feb2021 14:45 (Batch/Lot Number: EN9581) (at the age of 62-years-old) as dose 1, single for covid-19 immunization. Medical history included mitral valve prolapse, intermittent jaw pain, drug hypersensitivity (sulfa). Concomitant medications included calcium (CALCIUM) and multivitamin.  There was no other vaccine in four weeks. The patient did not had Covid prior vaccination and did not test for Covid post vaccination. On 04Feb2021 at 15:00, the patient experienced immediate pain, fatigue and Inappropriate route of vaccination and on 05Feb2021, the patient experienced pink oval rash approx. 3.5 in long X 2 in wide w/white ring around it, arm really still hurt and wasn't getting oxygen. It was reported that first, the shot was administered about halfway up on the back side of her arm, only subcutaneously, not intramuscular. (Wore a very short sleeve shirt, so wrongly placed shot was not due to clothing issue). Had immediate pain that felt unusual as it didn't stop after shot was given. Drove to designated parking area to wait required 15-30 min. After a few minutes she removed mask as it seemed like she wasn't getting oxygen, but she thought maybe feeling that a shot given improperly was causing her stress. Wasn't wheezing, do not have asthma, etc. Did some deep breathing and after a minute or so, felt breathing returned to normal. Stuck around for a half hour or so just to make sure, but her arm really still hurt. Very tired that evening. Also first evening the painful area expanded. Following day had pink oval rash approx. 3.5 in long X 2 in wide w/white ring around it. More pain & very tired that day. Next day rash turned red, pain to touch. Tired to day 3. Rash for 18+ days but receded. The events were not treated. On 04Feb2021, the patient recovered from difficulty breathing and was recovering from other all events.  Follow-up attempts completed. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: pink oval rash approx 3.5 in long X 2 in wide w/white ring around it; the shot was administered about halfway up on the back side of my arm, only subcutaneously, not intramuscular.; immediate pain; fatigue; arm really still hurt; she wasn't getting oxygen; This is a spontaneous report from a contactable consumer.A 62-years-old female patient received first dose of bnt162b2 (BNT162B2), subcutaneous, administered in Arm Left on 04Feb2021 14:45 (Batch/Lot Number: EN9581) (at the age of 62-years-old) as dose 1, single for covid-19 immunization. Medical history included mitral valve prolapse, intermittent jaw pain, drug hypersensitivity (sulfa). Concomitant medications included calcium (CALCIUM) and multivitamin.  There was no other vaccine in four weeks. The patient did not had Covid prior vaccination and did not test for Covid post vaccination. On 04Feb2021 at 15:00, the patient experienced immediate pain, fatigue and Inappropriate route of vaccination and on 05Feb2021, the patient experienced pink oval rash approx. 3.5 in long X 2 in wide w/white ring around it, arm really still hurt and wasn't getting oxygen. It was reported that first, the shot was administered about halfway up on the back side of her arm, only subcutaneously, not intramuscular. (Wore a very short sleeve shirt, so wrongly placed shot was not due to clothing issue). Had immediate pain that felt unusual as it didn't stop after shot was given. Drove to designated parking area to wait required 15-30 min. After a few minutes she removed mask as it seemed like she wasn't getting oxygen, but she thought maybe feeling that a shot given improperly was causing her stress. Wasn't wheezing, do not have asthma, etc. Did some deep breathing and after a minute or so, felt breathing returned to normal. Stuck around for a half hour or so just to make sure, but her arm really still hurt. Very tired that evening. Also first evening the painful area expanded. Following day had pink oval rash approx. 3.5 in long X 2 in wide w/white ring around it. More pain & very tired that day. Next day rash turned red, pain to touch. Tired to day 3. Rash for 18+ days but receded. The events were not treated. On 04Feb2021, the patient recovered from difficulty breathing and was recovering from other all events.  Follow-up attempts completed. No further information expected.