chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergic reaction; continuous headache; nausea; lack of appetite; joints, muscles, and nerve endings in my body were painful; joints, muscles, and nerve endings in my body were painful; joints, muscles, and nerve endings in my body were painful; rash developed around the injection site; it covered my whole forearm, a solid-red rash; area was hot; Area was sore; This case was reported by a consumer via call center representative and described the occurrence of drug allergy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hashimoto's thyroiditis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain. On an unknown date, the outcome of the drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain were recovered/resolved.   It was unknown if the reporter considered the drug allergy, headache, nausea, appetite absent, joint pain, muscle pain, nerve pain, rash, red rash, skin warm and pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was reported. The age group was selected as adult as per vaccine indication. The patient had prolonged and possibly allergic reaction to it, so the patient was hesitant about getting the second dose. The patient had the non-life-threatening reactions.  The patent experienced continuous headache and nausea or lack of appetite, and it was as if all of to the joints, muscles, and nerve endings of the body were painful. A rash developed around the injection site, and it grew and covered whole forearm, a solid-red rash, not hives, and the area was hot and very sore. These effects lasted for about 5 days, the rash lasted for 6 days. The patent thought that the patient might be allergic and should not get the second shot because of strong reactivity, particularly the spread of the rash, which was over the 100mm mentioned somewhere in documentation.  The patient was concerned because the patient Hashimoto's Thyroiditis, that could be contraindicated.  The patient asked if GSK was doing a specific study for specific disorders, including thyroid.
Day of vaccine:  within a few hours of receiving the vaccine (around 12:00pm or 1:00pm), I developed a headache, body aches, pain at the injection site, and brain fog.  The brain fog was such that I could no longer work, so I laid down.  Late in the afternoon (around 4:00pm), I developed numbness and tingling in my finder tips.  This continued to get worse, particularly when walking around, so I continued to rest.  Around 9:00pm, I was also getting dizzy when walking.  I went to bed, and awoke symptom-free in the morning.  Treatment included bed rest, ibuprofen, applied heat, and increased fluid intake.  Day after vaccine: I had the first HSV-2 outbreak I've had in 5 years.
the vial was initially stored in the refrigerator on 23Sep2022 and administration of vaccine on 24Oct2022; No adverse event; Patient received a dose of Moderna Covid-19, Bivalent 1 day past the beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna Covid-19, Bivalent 1 day past the beyond use date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23Sep2022 and administration of vaccine on 24Oct2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna Covid-19, Bivalent 1 day past the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23Sep2022 and administration of vaccine on 24Oct2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna Covid-19, Bivalent 1 day past the beyond use date), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23Sep2022 and administration of vaccine on 24Oct2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna Covid-19, Bivalent 1 day past the beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 23Sep2022 and administration of vaccine on 24Oct2022).    No concomitant medications were reported.  Individual vials or unbroken cartons was 1 dose. Vial size was 2.5 mL The vial was initially stored in the refrigerator was 23-Sep-2022 The vial did not undergo any temperature excursions.  No treatment medications were reported.
This is a spontaneous report from a contactable consumer (patient). This 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581), via an unknown route on 09Feb2021 at 13:00 (at the age of 75-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history included: For allergies the patient takes Loratadine unknown dosage started unknown date, did not think he took Loratadine on 09Feb2021 but he can take it daily if he wants to. The patient injects self every 2 weeks with Dupilumab (Dupixent)started around over a year ago for Chronic dermatitis-further dosage details unknown. The patient had flu shot unknown date, maybe 6-8 months ago. Family medical history included: The patient wife died of Lupus, his dad had heart problems and emphysema from smoking. His mother had leukemia. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unknown route on 19Jan2021 at 12:00 (at the age of 75-years-old) at single dose on the right arm. Concomitant medications was not provided. After the vaccination of first dose (19Jan2021), the patient had sore arm to lay on for that night. After second dose of vaccination (09Feb2021), the patient was laying in bed around. On 10Feb2021, (at 00:30-01:00), the patient had chills, shaking from being cold and body temperature was above normal. His bedroom was warm, like 80 degrees Fahrenheit. Body temperature above normal. Temperature recorded during this event include 100.3 degrees Fahrenheit about a half hour ago. His body temperature was normally like 97.8 degrees Fahrenheit this time of the day. Right now his body temperature was 100.4 degrees Fahrenheit. His body temperature was never high like that. It was rare if he had a day with a 99 degrees Fahrenheit body temperature. Chills and shaking from being cold lasted about a half an hour. The patient had some warm clothes on and turned the heat up a little bit. He recovered with possible lasting effect of being tired. But the patient always feels tired in the morning so not sure if it was from him not sleeping well last night. Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s) was none. Adverse event following prior vaccinations was none. Physician office or emergency room visit was not required for any event. Outcome of the events While he was laying in bed around 00:30-01:00 10Feb2021 he got chills, shaking from being cold and cold was recovered with sequel. Outcome of the remaining events was unknown. Follow-up attempts are completed. No further information is expected.
On 3rd or 4th day my bottom lip felt a tingle (I though was a scratch) and it continued for couple more days until it developed into a canker sore. Strong burning and finally top tissue peeled. Also had similar sores on my tongue. Followed by (what seemed to be Rosacea). The sores on lip and tongue have cleared up but the ones on my nose continue to appear more often. Peroxide packs and calamine lotion are my best treatment. The treatment Dr had me on for Rosacea was not working. This has been my problem following each Flu shot. Did not take a flu shot in 2010 and I didn't experience any of the symptoms I described. Metronidazole 500 mg and Metronidazole Top O cream didn't help the skin eruptions. These were in 2006 that really became very noticeable.
Patient experienced upset stomach, loose stools and general GI upset beginning 10-12 hours after injection.  Lasted 2-3 days.  No local injection site problems.
Experiencing the same rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:   A 91-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Experiencing the same rash".  Additional information :  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pregnancy 2 years post Covid vaccine adverse reaction ie. Cardiac arrhythmias post cardiac inflammation, parsonage Turner syndrome, optic neuritis in the mother. Infant born with significant heart murmur female, 39 weeks gestation, 6lbs 13oz
Pt after being administered 2 dose of Moderna, became dizzy/lightheaded. Pts vitals WNL. Pts blood sugar on lower end (64). Pt was initially given water, then ems assessed patient, to find patient had low blood sugar and was given orange juice to bring up. Pt was evaluated in the 30 minute observation after refusing the need to go to the hospital with ems. Pt left with symptoms resolved and patient left with mother whom brought her here.
This spontaneous case was reported by an other health care professional and describes the occurrence of MENOMETRORRHAGIA (she still had irregular bleeding. As of 18MAY2021 she started bleeding more heavily) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J20A) for COVID-19 vaccination. The patient's past medical history included Colonoscopy on 18-Jan-2021. On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced MENOMETRORRHAGIA (she still had irregular bleeding. As of 18MAY2021 she started bleeding more heavily). At the time of the report, MENOMETRORRHAGIA (she still had irregular bleeding. As of 18MAY2021 she started bleeding more heavily) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. In May she did a biopsy which was benign, but her uterus was swollen. They can see that is probably where it (the bleeding) is coming from. She had to do a sonogram or xray for her uterus. Now it's (the bleeding) still getting worse. No concomitant medication information was provided. No treatment medication information was provided. This case was linked to MOD-2021-328691 (Patient Link).
Muscle soreness, low-grade fever, chills, nausea.  Lasted all day, treated with rest and fluids
3-5min of tunnel vision, +diaphoresis while outdoors 6hr p/vax;c/o low back pain today w/+1 flushing-mild & resolving;tx w/DPH & motrin;f/u PRN;
12/19/2020 130  vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue.  Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.
SORENESS IN BACK; SEVERE CHILLS; SEVERE HEADACHE; SWEATING IN BACK; DOESN'T REMEMBER ANYTHING PAST; CONFUSION; FEVER; PARANOID THINKING; SORE THROAT; UNABLE TO SLEEP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced unable to sleep. On APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced confusion. On 12-APR-2021, the subject experienced doesn't remember anything past. On 12-APR-2021, the subject experienced paranoid thinking. On 12-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 104 degree F. On 13-APR-2021, the subject experienced sweating in back. On 13-APR-2021, the subject experienced severe chills. On 13-APR-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 102 degree F. On 14-APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.9 degree F. On 16-APR-2021, the subject experienced soreness in back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confusion, unable to sleep, doesn't remember anything past, sweating in back, paranoid thinking, sore throat, severe chills, and fever on APR-2021, and had not recovered from severe headache, and soreness in back. This report was non-serious.
inconsolable crying, fever, stopped talking & cooing for quite some time p/vax (approx 3wk);
rt arm began swelling early evening; by the next morning arm was swollen to med forearm, painful & erythematous, saw MD when recommended take Naprosyn for several days & recommended not receive any more pneumonia vax
prolonged fever X 2 1/2 days, (probably more?) than explained by concurrent URC/LRI.
Post vax, pt experienced redness on cheeks and headaches. On 8/4/98, pt became sluggish, her reflex's slowed down, she experienced severe chronic headaches, severe stomach cramps, nausea, vomiting, uncharacteristic mood swings, very irritable, joint pain in knees, elbows, and ankles, excessive lingering bruising and swelling, ringing in ears, tongue red with swollen taste buds, disrupted sleep patterns, fatigue, disrupted menstruation, constipation, shortness of breath, flu like symptoms, and blurry vision. Pt symptoms worsening over the next year and she underwent multiple lab tests. On 5/11/99, pt was dxed with autonomic disorder, postural orthostatic tachycardia syndrome, and hypotension. She is currently being treated with Adderall.
IT WAS THE PATIENT'S SECOND meningococcal DOSE.   I injected Trumenba. The pharmacy was busy. I did not Realize that the patient had received Bexcero for the first shot.  The patient's mother called. She informed me that I had made a mistake. She was very upset . She requested to speak to my manager. I called the Manager at home. informed him of the situation and gave him the phone number of the Mother. to call.
One day later leg was a little red and a quarter size knot on left leg.  Was not fussy and did not cry when touched.  Today knot pea size.
Localized swelling (30 x 40 cm), tenderness, redness, itchiness, pain.
Immediately after receiving vaccines went from being a baby who rarely cried to being inconsolable, developed golf ball size knot on left side of head, lost facial symmetry on left side of face and weakened muscles on left side also. Has been seen by multiple Dr's and has been declared to have motor development delay by his neurologist. Ongoing testing scheduled to determine if neurological damage was done.
pt recv vax; 1 wk later, devel hives & swollen joints which lasted 3 days; to ped; no tx done but MD felt rxn to hep B;
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On multiple unspecified dates the patient was vaccinated with improperly stored GARDASIL 9 (lot # reported as K011562 with expiration date 08-APR-2017, lot # reported as K010215 with expiration date 05-MAY-2017, lot # reported as K007828 with expiration date 02-MAR-2017, lot # reported as L040459 with expiration date 16-APR-2017, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age whose child was vaccinated with VARIVAX (Merck). The patient was enrolled in a program with Merck vaccine strain. Reporter stated that he learned about the VZVIP program from a colleague. He explained that he had a sample that their lab found was positive for varicella zoster virus (onset date was not reported) and they were interested in strain identification through our program. On 29-MAY-2014 specimen (swab from vesicle) was obtained and on 12-JAN-2015 was sent to laboratory. On 13-JAN-2015 the specimen arrived to laboratory, VZV DNA amplified and the VZV strain identification showed wild type strain (final polymerase chain reaction (PCR) specimen result). He did not have any additional case information but stated that he would fill out the patient with additional information. It was also reported that secondary transmission occurred on unknown date. The outcome of the events was unknown. The relatedness between the events and vaccination with VARIVAX (Merck) was not reported. Additional information has been requested.
p/vax pt exp swelling & tenderness at inj site; also nausea & D; tx w/tylenol
SUSPECTED COVID-19 INFECTION; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION; This spontaneous report received from a patient concerned a 36 year old male of unspecified ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: Unknown) dose was not reported, dose number in series 1, 01 in total was administered on 08-JUL-2021 to left arm for prophylactic vaccination. On an unspecified date, following administration of covid-19 vaccine ad26.cov2.s, he had symptoms of corona virus disease (COVID) (suspected covid-19 infection and suspected clinical vaccination failure) (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection and route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, dose number in series 2, 01 in total was administered in mid of SEP-2021 for prophylactic vaccination which was off label use and inappropriate schedule of drug administration (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following administration of covid-19 vaccine ad26.cov2.s, the patient had symptoms of corona virus disease (COVID) (suspected covid-19 infection) (dose number series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, off label use and inappropriate schedule of drug administration was not reported (dose number series 2). This report was non-serious. This case, involving the same patient is linked to 20220140123.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Only had arm pain initially.; Bilateral knee pain; This is a spontaneous report from a contactable consumer (Patient's mother). A 13-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration, on an unknown date (reported as: 2 weeks ago, as of tomorrow) (at the age of 13 years old)as 1st dose, single dose for COVID-19 Immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced Pain in arm initially, Knee pain started about 2 weeks after getting vaccine, it was like bilateral knee pain mostly with exercise. She did not have it the first few days of the shot like she would expect she normally would. She did not have it until last week. It was only when running last week and now she is still having it. Reporter reported that she was concerned about getting her daughter the second dose of vaccine and would like to know if this has been reported. Reporter does not know whether this was related to the first vaccine. She does not know how to know if it was related to the vaccine. Reporter stated that she does not know, and how does somebody know if it was related or not. Reporter also stated that her daughter was not having problems before and she does not know. Reporter stated that she would like to wait at this time and see, she was not sure she should report this or not. The outcome of the events was not recovered. It was reported as the Reporter stated that she thinks that she was not sure if it was related to the Covid vaccine or not  Information on Lot/Batch has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug hypersensitivity (the patient was generally sensitive to medicines). On 15th October 2018, the patient received the 2nd dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, nausea, headache, appetite absent, tiredness, shivers and diarrhea. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the nausea, headache, appetite absent and tiredness were not recovered/not resolved and the outcome of the shivers and diarrhea were unknown. It was unknown if the reporter considered the injection site pain, nausea, headache, appetite absent, tiredness, shivers and diarrhea to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced mild injection site pain after the dose. The next morning, she felt tired and nauseated and had shivers and diarrhea. She had not been able to eat or drink. She contacted her physician and was instructed to wait another day. She was feeling a little better on the day of reporting.
Pt received Pfizer vaccine though patient was previously vaccinated with Moderna, Moderna was given about a month ago