chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Fever of 103.9; Body pain; This is spontaneous case report received from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 10Mar2021 at 11:45AM (at the age of 68-years-old) as a single dose for COVID-19 Immunisation. Medical history included hashimoto's disease, psoriatic arthritis, peripheral neuropathy, atrial fibrillation from previous strokes and allergy to erythromycin. It was further specified that he had not received any other vaccines within 4 weeks prior to the COVID vaccine neither he had received any other medications within 2 weeks of vaccination. Furthermore, he was not been diagnosed with COVID-19 prior to vaccination neither had tested for COVID-19 since the vaccination. On 16Mar2021 at 03:00AM, patient experienced fever of 103.9, severe body aches and fatigue. Patient not taken any treatment for the reported events. The clinical outcome of the events (fever of 103.9, severe body aches and fatigue) was not recovered at the time of the report.   Information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated reporter information, added patient's first name and age, added Health Care Professional Information for vaccine administration, removed vaccination facility phone number; added test date for body temperature; added stop date and dose number of the vaccine dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The patient was cross-vaccinated due to an error of the vaccinator. The patient had already received Moderna and was mistakenly given Pfizer
arm was hurting; experienced a strong taste and smell of disinfect; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting) and TASTE DISORDER (experienced a strong taste and smell of disinfect) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, DONEPEZIL, CLONAZEPAM, GABAPENTIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTIVITAMIN & MINERAL for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting) and TASTE DISORDER (experienced a strong taste and smell of disinfect). At the time of the report, PAIN IN EXTREMITY (arm was hurting) and TASTE DISORDER (experienced a strong taste and smell of disinfect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On July 13, 2017 we noted that the temps were out of range on July 9 (refrigerator-60.6) (freezer-unknown) for 12.10 Hours.
Following an endometrial ablation and absolutely no menstrual bleeding for 14 months, I started my period the night of the second Pfizer vaccine and am now dealing with period cylces about 25 days apart lasting 17-18 days.  Blood/hormone tests and biopsy have revealed no reason for this.  While I am a woman of perimenopausal age, I suspect the vaccine has played a part in this.  Almost as concerning is the fact that I have developed Rosacea that started a few days after the second vaccine.  Never had skin problems in my life.  Face is bright red.  Was most pronounced mid- to late-May 2021.  No topical treatments from dermatologist have worked.  Dermatologist noted they have seen an uptick in skin inflammation and Rosacea since vaccine became available.
Patient received vaccine on 4.9.21.  Patient responded to symptoms survey on 4.12.21.  Stated that he had severe side effects including dizziness / weakness; also stated that he was unable to move for 48 hours; had intense diarrhea and had hallucinations.  (reported not within first 4 hours - unsure on timeframe) - did not seek any medical care per electronic chart review.
This spontaneous report was received from a physician via a company representative concerning a 53 year old female patient of an unknown race. The patient's concurrent conditions, medical history, concomitant medication and drug reactions/allergies were not reported. It was reported that, on an unspecified date, the patient received a dose of ZOSTAVAX vial 19400 PFU subcutaneously (frequency, lot number and expiration date not reported) for prophylaxis. The physician reported that on an unspecified date, after the administration of ZOSTAVAX, the patient experienced a four to five inch area of significant redness and swelling on her arm. It was unknown if the subject sought for medical attention, if lab tests were performed or if she received treatment for the events. At the reporting time, the outcome of the events erythema and swelling arm was unknown. The causal relationship between the events and ZOSTAVAX was unknown.
"Patient received second Pfizer dose of covid19 vaccination in right arm, lot EL1283 at approximately 1140.  Remained in auditorium for 15 minutes.  As patient was walking back to work location stated she had bilateral tingling in arms. Patient returned to Vaccine Clinic and made contact with writer. Patient escorted to alcove for additional monitoring.  Upon further investigation patient stated she experienced itching in throat that was self limiting in initial 15 minutes.   VS 1200 L arm BP 167/92, HR 90, SpO2 97% 1202 Patient states improvement in bilateral arm tingling. 1205 L arm BP 139/90, HR 96, SpO2 98% 1207 Patient states complete resolution of bilateral arm tingling. 1210 L arm BP 144/91, HR 96, 99% SpO2 1215 ambulated with patient.  No return of symptoms. Patient returned to work.
Expected mild pain and soreness at injection site for 48 hours after vaccination.  However, on day 7 after vaccination, I developed what seems to be referred to as "Covid Vaccine Arm."  Symptoms onset today.  I now have a red, swollen, round area approximately 3" in diameter at the site of the vaccine.  It does not itch, burn, or have any pain associated.
PROBLEMS WITH HANDS AND FEET; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced problems with hands and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of problems with hands and feet was not reported. This report was non-serious.
The next day after I had your medication down by my wrist was the veins in your hand one of my veins was deep red purple;  it make me little nervous to get the second shot; well I did have the arm problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 11Jun2021 11:45 (Lot number: EW0187) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Verbatim: Fibromyalgia; "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. Concomitant medication(s) included: ATENOLOL; LOSARTAN; GABAPENTIN. The following information was reported: VEIN DISCOLOURATION (non-serious) with onset 12Jun2021, outcome "not recovered", described as "The next day after I had your medication down by my wrist was the veins in your hand one of my veins was deep red purple;  it make me little nervous to get the second shot"; LIMB DISCOMFORT (non-serious) with onset 12Jun2021, outcome "unknown", described as "well I did have the arm problem".  Additional Information: Patient stated that next day after medication, well did have the arm problem but the next day after had medication down by wrist was the veins in hand one of veins was deep red purple and it took it some time to go away. It was about 3 inches long.  Medication: Patient stated, Pfizer, no it was vaccination for COVID vaccine. When paraphrased the concern, patient said that no that wasn't for 15 minutes it was for 4 hours and called his brother and had never seen vein do that and it was about 3 inches long and it was right when woke up, it was like someone has taken you know a mark, so it stood right out it wasn't faint. Yeah, was saying, and was wondering if anybody else has reported that, but because it makes me little nervous to get the second shot. Patient was informed about the Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 20:00 from Monday to Friday and for Saturday and Sunday timings are 9 AM to 15:00 as per EST. Other Vaccine (Prior to 4 weeks patient stated it was no. Vaccination site details: Available. Time of vaccination patient stated that she doesn't know the specific time it was in the morning, it was at 11 O' Clock, but they were late so about 11:45 because she had to wait. Patient stated that no, she think she will give them a call and she is scared to get the second shot, and get to know what that mean it could be normal don't know but  didn't see it reported on any list that's why she called.  Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Currently the patient is not experiencing any side effects. No additional AE; HCP states a 13-monlh-old male patient was given PROQUAD and VARIVAX instead of VARIVAX and MMR II.; HCP states a 13-monlh-old male patient was given PROQUAD and VARIVAX instead of VARIVAX and MMR II.; This spontaneous report was received from a medical assistant, referring to a 13-months-old male patient. The patients' pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 14-SEP-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), also; it was prescribed measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (formulation, strength, dose, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not reported), however; instead of this, it was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml) (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T010092, which has been verified to be valid, expiration date reported and validated as 19-SEP-2021) (inappropriate schedule of product administration and wrong product administered). At the time of this report the patient was not experienced any side effects, no additional adverse events were reported.
c/o "up most of the night. Fever, chills, nausea. Much pain at injection site - for several days. Exhausted but went to work and felt weak" after vaccination.
Only the diluent of was administered; Only the diluent of was administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2022, the patient received Shingrix. On 2nd March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-Mar-2020 Reporter's Comments:  Only the diluent of of the Shingrix was administered to patient. The reporter did not have the lot number of the diluent. The reporter consented to follow up. Additional supportive information: The patient only received diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
This is a spontaneous report from a contactable healthcare professional on behalf of a doctor reporting similar events for 4 patients. This is the 4th of 4 reports. A 70-year-old female patient received PREVNAR 13 (Lot# J80525, Exp date Apr2016, NDC number: 0005-1971-02), intramuscular in left deltoid, on 06Feb2015 at 8:55 am, at single dose. Relevant medical history included ongoing diabetes, ongoing hyperthyroidism, ongoing hyperlipidemia, ongoing hypertension and ongoing gastroesophageal reflux. Concomitant medications included RECOMBIVAX HB (manufacturer Merck) (Lot# K014190, Exp date 24Oct2016), intramuscular in right arm, on 06Feb2015, at unspecified dose and frequency; metformin tablet, via oral route, from/to an unspecified date, at 1DF daily, for unspecified indication; losartan potassium, oral, from/to an unspecified date, at 100 mg 1x/day, for unspecified indication; omeprazole capsule, oral, from/to an unspecified date, at 40 mg 2x/day (1 cap 2x/day), for unspecified indication; hydrochlorothiazide tablet, oral, from/to an unspecified date, at 25mg daily (1 tab daily), for unspecified indication; atorvastatin tablet, oral, from/to an unspecified date, at 20 mg daily (1 tab daily), for unspecified indication; multivitamins tablet, oral, from/to an unspecified date, at 1DF daily, for unspecified indication; AMBIEN, oral, from/to an unspecified date, at 5mg as needed, for unspecified indication. The patient experienced acute swelling in arm, local superficial swelling; arm pain; redness; 6 mm induration and mild erythema on 06Feb2015. The events required an emergency room or doctor visit, but the patient was not hospitalized. She had a follow-up visit on 10Feb2015 and reported to doctor that she had these symptoms for 4 days. Patient was seen again on 23Feb2015. The events acute swelling in arm, local superficial swelling and arm pain were recovering at the time of this report; event redness was not recovered; outcome of events 6 mm induration and mild erythema was unknown. Follow-up (03Mar2015): This follow-up report is being submitted to amend previously reported information: call was from a contactable healthcare professional reporter who was calling on behalf of a doctor.
Dural venous sinus thrombosis  complicated by intracranial hemorrhage and seizure
3:28 pm - shot, 7:00 pm unable to move arm, 10:00 pm - severe chills w/shivering temp of 101, 11:30 pm - chills and fever 102.8, 12:00 am chills, weakness, diarrhea for 8 hours, felt ill for about 48 hours?
Runny nose/blew and blew my nose/ it kept pouring; Sneezing for 3 hours; Redness; Couldn't eat, just drank; Sore arm; Fever/fever all night; Nauseated; Chills; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose/blew and blew my nose/ it kept pouring), SNEEZING (Sneezing for 3 hours), INJECTION SITE ERYTHEMA (Redness), EATING DISORDER (Couldn't eat, just drank) and VACCINATION SITE PAIN (Sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (No medical history reported.). Concomitant products included LANSOPRAZOLE for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose/blew and blew my nose/ it kept pouring), SNEEZING (Sneezing for 3 hours), INJECTION SITE ERYTHEMA (Redness), EATING DISORDER (Couldn't eat, just drank), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever/fever all night), NAUSEA (Nauseated) and CHILLS (Chills). At the time of the report, RHINORRHOEA (Runny nose/blew and blew my nose/ it kept pouring), SNEEZING (Sneezing for 3 hours), INJECTION SITE ERYTHEMA (Redness), EATING DISORDER (Couldn't eat, just drank), VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever/fever all night), NAUSEA (Nauseated) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Upon internal review on 27-Sep-2022, non-significant correction was performed to update case level seriousness.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Slept poorly after vaccine. Started with fever in AM. Complained of headache and nausea. Temperature at home was 38.9 (C), at the clinic it was 102 degrees and the patient was weak. On 06/29/2006, sister states the patient is doing fine.
This case was reported by a physician and described the occurrence of red raised skin on arms in a 12-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 29 July 2009 the subject received unspecified dose of BOOSTRIX in an unknown arm. The subject went back to the office on 31 July 2009 and a red raised area about 3 to 4 inches in diameter was noted at the injection site. The official onset date was not known. At the time of reporting the outcome of the event was unspecified.
Nurse administered Tdap Vaccine as requested for school entry. Provider order to administer vaccine. Allergies assessed NKA , VIS and consent given. Tdap administered IM at LD at 1710. Nurse back into to room at 1720 patient reports slight rash to chest, patient assessed denies SOB no difficulty swallowing. Vital signs assessed, WNL Provider notified and in room with patient. Patient in room for 20 min, rash appeared to resolve and patient had no further complaints. Patient to discharge with medications ordered by provider.
The patient became clammy, sweaty and pale. Patient almost passed out. Basic symptoms of syncopy. Patient laid to floor with knees up and hands behind head. The patient came to rather quickly. The EMS squad was called and they took over with blood pressure and portable EKG machine. The patient had a gatorade and rested for about an hour and his wife drove him home. I called him 2 days later to check in on his status and he said he got a good nights sleep and felt much better with just a sore arm.
Pt. has local reaction with large area of erythema on injection site. Start more than 12 hours after. Seen on day 6. No evidence of abcess, erosion or cellulitis.
circular, inguinal rash; suspicious for shingles rash; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On 9th October 2019, less than 2 weeks after receiving Shingrix, the patient experienced rash and shingles. On an unknown date, the outcome of the rash and shingles were not recovered/not resolved.   It was unknown if the reporter considered the rash and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by a physician assistant in a gynecology office. The patient received 1st dose of Shingrix approximately 2 weeks ago and presented today, at the day of reporting, with a circular, inguinal rash that developed on Wednesday 9th October 2019 and appeared to be suspicious for shingles rash. The outcome reported for all the events in the structured field of XML is recovering/resolving instead of not recovered/ not resolved (outcome uploaded).
Patient contracted COVID after being fully vaccinated. Muscle Aches, Fatigue, Body Aches, Cough, Headache, Sore Throat, Runny Nose, Sneezing
Very sore Arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 30Jan2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies to adhesive" (unspecified if ongoing). Concomitant medication(s) included: METROGEL, start date: Jan2020, stop date: 30Jan2021; ASCORBIC ACID, start date: 2015 (ongoing); COLECALCIFEROL, start date: 2015 (ongoing); MEGARED OMEGA 3 KRILL OIL, start date: 2015 (ongoing); CYANOCOBALAMIN, start date: 2015 (ongoing). Past drug history included: Triple antibiotic ointment, reaction(s): "allergy". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE at 11:30 AM in left arm), administration date: 11Jan2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Slight tenderness at injection site", "Extreme fatigue". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 30Jan2021 20:00, outcome "recovered" (2021), described as "Very sore Arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red circle on arm, size of half dollar. It itches and is slightly sore to touch. Not sure if related: but muscle under that same armpit close to vaccine site is also very sore.
Area indurated, red, hot, swollen 6 1/2 inches long by 5 1/2 wide.  Taking Tylenol and applying cold compresses.
The needle wasn't latch on tightly to the syringe, vaccine was leaked out about 2/3 of the volume during administration. Syringe removed and patient was given another injection without complication.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Mar2021 at 08:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Mar2021 at 08:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 03Nov2021 at 11:00 as dose 3 (booster), single (Lot number: FH8028), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2023) Positive; (11Jan2023) Negative; (15Jan2023) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.