chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was sore, tired and nauseous; cannot take the smell; arm was sore, tired and nauseous; arm was sore, tired and nauseous; This is a spontaneous report from a contactable consumer (patient). This consumer reported about herself that: A patient of an unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, NDC/UPC number and Expiry Date: Unknown) via an unspecified route of administration on 22Mar2021 11:40, as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm was sore, tired and nauseous and cannot take the smell. The patient stated that on last Monday 22Mar2021, received the Pfizer COVID Vaccine at 11:40 and had no problems, but at night arm was sore and was talking about the side effects now was tired and nauseous. But the real call was that cannot take the smell, the consumer asked if it was that part one of the side effects. The consumer also asked some questions about the vaccine that did you know anything about this vaccine side effects. Consumer was informed about Pfizer Medical information department and was provided with the number. Product details (LOT#, NDC#, UPC# and Expiration date) and Pharmacy details were not available over the call as the consumer hung up the call abruptly. The clinical outcome of all the events was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
This spontaneous report was received from a pharmacist via a company representative concerning a 50 year old female patient. The patient's concurrent conditions included diabetes. Other pertinent medical history, drug reactions/allergies or concomitant medications were unknown by the reporter. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 for diabetes and age (Strength, dose, route, lot # and expiration date were not reported).  On an unknown date, the patient experienced "a really bad reaction, the patient's arm swelled up" (peripheral swelling). No treatment was given for the event. It was unknown if laboratories diagnostics studies were performed to the patient or if she did seek medical attention. The outcome of peripheral swelling was unknown.    The reporter did not provide the causality between peripheral swelling and PNEUMOVAX 23. Additional information has been requested.
Severe stomach cramping, decrease in temperature.  Difficulty breathing.  Patient reports he had a severe allergic reaction that needed emergency room evaluation that he treated at home with benadryl.  Reports that his reaction was the same as with his food reaction to milk.
Had vaccine 10/9/23. By 3:00pm muscle pain starting. By 10/10/23 muscle pain was extreme in upper arms, back, hands. Bending right elbow still very painful by 10/19/23. I do have arthritis but knuckles increased in size/pain not subsiding. Cannot get ring off of wedding finger. Back muscles staying very tight/painful. Pain still remains in upper arms.
Injection site infection 5/13/17 patient came back to store with a prescription for BACTRIM DS due to injection site infection from PREVNAR 13 on 5/6/17. KEFLEX from PCP and shot of antibiotic still under MD care.
Since receiving COVID-19 vaccination Moderna dose #2, constant pain (pulling in nature) in left upper arm and shoulder. Limited mobility and decreased strength in affected extremity. Denies numbness or tingling or other symptoms. Visual assessment of affected extremity unremarkable.
My daughter developed a rash to her inner arms, inner legs, and hands.  Warm to touch.  Raised rough textured rash.  The skin that is affected is swollen.  Benadryl taken orally did not help decrease the rash, nor did topical Benadryl. She also complains of pain to her left leg from her hip to her knee that intermittently bothers her starting 4/30 and still continues to bother her.   The day after the vaccine was given she had injection site pain, tiredness, extreme headache, fever of 101.8, nausea, chills, body aches.  No swelling or redness to injection site.  No lymph node swelling.
pt recv vax & 8APR94 pt devel an elevated temp & a generalized rash; pt recovered; No further details were provided;
I had a histamine response to the vaccine and have to take anti-histamine everyday, twice a day. I have been prescribed Zyrtec for treatment.
A subject (age and gender not reported) received the following vaccinations: On 06 August 2012 an injection of ACAM2000 (lot number not reported); On 20 July 2012 an injection of ANTHRAX (manufacturer and lot number not reported); On 05 August 2012 an injection of Tdap (manufacturer and lot number not reported). On 19 August 2012, the subject was diagnosed with acute myocardial infarction of inferolateral wall. This study case was received from the investigator on 26 October 2012. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Patient received a Prevnar-13 vaccination on 10/16/15 in her left arm.  She presented at the pharmacy on 10/22/15 with an rx for cephalexin.  She stated her arm felt sore and swollen around 10/18.  The arm was red and warm to touch around 10/21/15.  Went to the doctor and the doctor gave her an rx.
Red, blotchy area left thigh area 2in around, mottled boarders, central "bulls eye" apparent at injection site. Elodel cream BID
AFTER pain at injection site, mild headaches, mild nausea, malaise for two days, at about 4 AM (36 hours after injection), I woke up to terrible, sharp pain on left upper portion of back. Too uncomfortable to lay back down. Took 400 mg of Ibuprofen. Felt 80% better, enough to go back to sleep. Pain returned before ibuprofen ran out.  Husband discovered red rash with line of small dots, rash like where pain was indicated. Redness was gone after a few hours and bruising of yellow and blueish colors with small dots remaining. Next day, Tue 2/16/21, symptoms improved, but still present, pain still sharp and shooting into left side back neck and left shoulder, down left back. That evening, at 10:30 PM, thinking it was muscular, husband put Biofreeze on affected area and just his touch resulted in excruciating pain. He had a history of shingles and wondered if I had it. I made an appointment with Dr.  for Wed. 9:00 AM. Symptoms had improved even more, but rash dots still present and shooting pain into neck and shoulder still present.
another bad reaction to part 2 / side effects from second shot; chills; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix. On 20th August 2020, 1 days after receiving Shingrix, the patient experienced fever, chills and headache. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever, chills and headache were recovered/resolved.   It was unknown if the reporter considered the fever, chills and headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had reactions fever chills headache. As the day went the fever got higher and higher up to 103.4. The reporter Doctor told to take Ibuprofen and slowly the fever went away. The patient asked would had the same reaction to the second shot. For tolerances of 2nd dose, refer case US2020AMR169942, reported by same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR169942:same reporter
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). Patient had no known drug allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 20Apr2023 to 25Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182760 same patient, different product and event;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 24Aug2023 to 29Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291329 same patient, different drug/event;
symptoms of heart attack; chest pain; hands and fingers tingly; dizzy; blurred vision; Vision decreased; extreme tiredness; lethargic; hurting all over; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EN6198) intramuscularly in left arm on 01Mar2021 05:45PM (at the age of 70-year-old) at single dose for COVID-19 immunisation. Relevant medical history included 5 back surgeries, Barrett's esophagus and H. pylori. Known allergies included Eliquis. Concomitant medications included dexlansoprazole (DEXILANT), hydrocodone, atorvastatin (LIPITOR), famotidine and chondroitin sulfate sodium, glucosamine hydrochloride (TAZAN). For 4-5 days after vaccine the patient had extreme tiredness, was lethargic and hurting all over. On day 5 chest pain started, hands and fingers tingly, dizzy, blurred vision both eyes off and in, vision decreased by 50% right eye. He experienced all symptoms of heart attack. Onset date for extreme tiredness, lethargic and hurting all over was 02Mar2021, while all the other events occurred on 06Mar2021. The patient was hospitalized for 1 day. No treatment was received. The patient underwent COVID test post vaccination, nasal swab on 07Mar2021 and it was negative. The events resolved in Mar2021.
3 hours after vaccination patient had a fever of 102.5 degrees Fahrenheit, she felt achy all over, and weak. She had a fever for 3 days then slowly started to feel better.
Patient feeling pain/tenderness in her wrist. Tingling feeling has spread down to her fingers. Patient did feel soreness in arm the day after the shot but that has since subsided. About one week after the shot is when her wrist started to bother her.
pt recvd vax & exp t103 @ 730- 102 @ 1-PM 1-3-2AM 104-530AM 104.6 gives APAP & cool bath ea time; pt is weak & jerky twitch movements arm sl swollen; mom called MD 530AM;
After receiving immunizations, pt immediately developed fainting symptoms. Pale, faint, bluish face, lethargic acting, mild upset stomach / coughing up mucous.
pt recv vax;exp fever,HA,sore throat,back pain,neck,muscle pain;fingers were red/swollen;w/in 6days SGOT=104,GGT=131,SGPT=131,LDH=312 & serum alkaline phosphatase=145;trace protein & bili in urine;throat culture pos for staph aureus;amoxil
My tongue felt tingly when I was sitting for the 1st 15 minutes but I figured that was nerves. Around 2 hours later I felt the inside of my lips started mildly swelling.  It is the same now  no better no worse.
No adverse effect; inadvertent administration of MMR II reconstituted with expired merck diluent; inadvertent administration of MMR II reconstituted with expired merck diluent; This spontaneous report was received from a pharmacy student regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On 23-NOV-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) (lot number S015284 and expiration date: 19-MAY-2021) reconstituted with expired diluent MRK (STERILE DILUENT) (lot number M009800 and expiration date: 12-SEP-2018) (strength, dose, route of administration and anatomical location were not reported) as prophylaxis (expired product administered and product preparation error). No additional adverse events were reported.
I received the first shot on Saturday, March 27, 2021. Out of the blue on  Monday, April 12th I woke and had developed a raised hive at the injection site. It was warm to the touch, sore and lasted for five days. I was exhausted during that entire time and had brain fog.  Within three hours of having received the second shot, I was in bed utterly exhausted - napped for three hour straight. I stayed in bed the rest of the day. I woke up on Sunday morning exhausted, I ate and took a two hour nap. When I woke up I had a fever of 100.9. My menstraul cycle completely stopped after receiving the first vaccine it finally started 46 days later on May 2, 2021. I took five pregnancy test all of which were negative. I've never had a late period in my life!
warm to the touch circle at the site of injection; sore circle at the site of injection; Red circle at the site of injection; Itchy circle at the site of injection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch circle at the site of injection), VACCINATION SITE PAIN (sore circle at the site of injection), VACCINATION SITE ERYTHEMA (Red circle at the site of injection) and VACCINATION SITE PRURITUS (Itchy circle at the site of injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch circle at the site of injection), VACCINATION SITE PAIN (sore circle at the site of injection), VACCINATION SITE ERYTHEMA (Red circle at the site of injection) and VACCINATION SITE PRURITUS (Itchy circle at the site of injection). At the time of the report, VACCINATION SITE WARMTH (warm to the touch circle at the site of injection), VACCINATION SITE PAIN (sore circle at the site of injection), VACCINATION SITE ERYTHEMA (Red circle at the site of injection) and VACCINATION SITE PRURITUS (Itchy circle at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not provided
Notice pain in right arm (injection site) upon waking up in the morning and before bed. Arm occasionally hurts during the day if I am carrying something heavy. Pain is similar to the aches of having gotten a vaccine.
Daughter (age 5) received VARIVAX (varicella vaccine) on 8/31/12. One week later, patient - father - developed clinical chickenpox with widespread typical lesions. He received valacyclovir and had no complications during recovery. This appears to be a case of vaccine associated varicella from a child (vaccinee) to parent.
Patient reports that she is still experiencing what was diagnosed  as glossitis and a random left foot sensation. It reportedly began around the time of vaccination and is still happening.
chills, headache, very sore arm at site of injection, fatigue, sweating treated with Tylenol
no adverse effects reported; Administration of 3 separate doses of an improperly stored vaccine of MMR II; This spontaneous report was received from a nurse concerning 3 patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 01-JUL-2019, the patients were vaccinated with improperly stored doses of 0.5 milliliter of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot# R029516, expiration date 14-OCT-2020, which had a temperature excursion of -8.37 C for 2 hours and 30 minutes, and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) of an unknown lot# and expiration date, which had an unknown temperature excursion for an unspecified time; both vaccines were administered once for prophylaxis (strength were unknown) and were reconstitute with properly stored sterile diluent. The reporter stated that the temperature excursions were detected by a data logger. The vaccines had no other temperature excursions and no adverse effects were reported.
Rash as burning, itching, bumps; Rash as burning, itching, bumps; a couple of bumps, the size of two half dollars put together on his neck, there was a raised cluster of bumps; Rash on his neck; This is a spontaneous report from a contactable consumer (patient). A 49-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6201), via an unspecified route, administered in left arm on 18Feb2021 at noon (at the age of 49 years) as dose 1, single for covid-19 immunization at his work. The patient's medical history was not reported. The patient's concomitant medications were reported as none. There was no other Products. There was no history of patient. He had not taken any new medications and did not have any medications to include on this report. History of all previous immunization with the Pfizer vaccine considered as suspect was not applicable. There was no additional vaccines administered on same date of the Pfizer suspect. There was no any vaccine prior vaccinations (within 4 weeks). There was none adverse events following prior vaccinations. There were no relevant tests. Patient's Medical History (including any illness at time of vaccination): The patient declined being sick at the time of vaccination. The caller is calling about the COVID 19 Pfizer vaccine. The reporter said his first dose was on 18Feb2021 and, he never linked it, but on 19Feb2021 he woke up with a rash on his neck. He said his brother showed him article he had read and it said in a few cases there were some rashes. His brother said he should call doctor, the caller called his doctor, he could not get in until next week, Thursday. He described the rash as burning, itching, bumps, and said for some reason he did not link it to the shot. He said he woke up with the rash, it was in the morning, he got up at 5. It was a lot better, sometimes it itches, there were a couple of bumps, the size of two half dollars put together on his neck, there was a raised cluster of bumps. He might be messing with it, his brother gave him the article, the caller called his doctor, he was not getting in, then said it was not like he was dying, then says well maybe he was. The second dose said Pfizer BioNTech EN6205, that was on 11Mar2021. NDC/EXP for second dose was unknown. His first dose was on the left arm, the same side the rash was on, received at noon. His second dose was in his right arm and was at 10am. The adverse events did not result into emergency room and physician office. The outcome of events was unknown.   No follow-up attempts were possible. No further information was expected.
first day rash; super itchy; swollen; delayed rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (first day rash), PRURITUS (super itchy), PERIPHERAL SWELLING (swollen) and RASH (delayed rash) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (first day rash), PRURITUS (super itchy), PERIPHERAL SWELLING (swollen) and RASH (delayed rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) at an unspecified dose and frequency. At the time of the report, RASH (first day rash), PRURITUS (super itchy), PERIPHERAL SWELLING (swollen) and RASH (delayed rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PT was administered the Smallpox vaccine on 3 Mar 2008. This administration was the first vaccination of 15 jabs. PT was diagnosed with a rash surrounding the site of vaccination as well as Urticaria on the chest and stomach 12 Mar 2008. PT has not taken any medication and first noticed the urticaria 11 Mar 2008.
Patient falsified DOB when registering for vaccination, stating the minor was one year older. Guardian consented to the vaccination. Health department verified with statistical records that the patients actual DOB is (what is now on file) which made the vaccine a contraindication.  No known adverse reactions noted.
Upper (R) arm sore & red after Tdap 8-9cm diameter indurated area.
p/vax pt devel fever of @ least 102 w/cellulitis & swelling of the leg;
By bedtime the day of the booster of Pfizer I was already starting to get achy, during the night I woke up in pain, my whole body hurt so bad I couldn?t move without crying. I didn?t sleep much that night. Saturday my whole body continued to hurt, I had a 101 degree fever, my head hurt, I didn?t eat anything or take my medicine, I slept most of the day, I had chills and was sweating at the same time. Sunday 2 days after booster my body didn?t hurt as much but I still had a headache, low grade fever of 99 degrees, still not eating or taking meds, nausea started this day, still had a headache, chills and the profuse sweating started. Monday the fast heart rate started so a trip to the doctor
2AUG95 pt upset w/vax-immed p/vax vomited/felt poorly/tired; 7 days later devel rash that looked like measles has since devel white pustules lesions under arms spread down arm & in throat, tired, sore throat;
Patient received Tetanus vaccine 2 months prior. Patient went home and noticed that her crotch, armpits, elbows, and ears started itching. Patient looked herself in the mirror and noticed lips were swollen. Also noticed rash on stomach, chest and back. There was a little near injection site. Arm was sore for about 3 days at site of injection. Patient went back to pharmacist and was directed to doctor. Patient took Benadryl, it helped, and had rash for a couple of days. Patient called doctor when it was almost gone and told not to come in. Doctor told patient not to get next dose.