chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Taste alteration; Funny taste; This is a spontaneous report from a contactable Pharmacist.  A 51-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, on 28Dec2020 at 03:15 PM at single dose for COVID-19 immunisation. Vaccine location was right arm.  The patient was vaccinated at workplace clinic, age at vaccination was 51-years-old (reported also as 49-years-old, to be clarified). No other vaccine was received in four weeks. Medical history included thryoid disease, and current tx for pulmonary embolism (PE, 3months). Concomitant medications included levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS). On 28Dec2020 at 03:15 PM, the patient experienced taste alteration - funny taste upon injection. Transient. Lasted 10 seconds or so. The event was reported as non-serious. Outcome of the event was recovered on 28Dec2020. No treatment was received for the event. Information on the lot/batch number has been requested.
The day following vaccine administration he began to develop acute diffuse pain in the shoulder region radiation both up toward the neck and down toward the elbow associated with limb weakness/numbness. Describes pain as persistent and weakness sufficient so as to not be able to hold a cup of coffee.
Headache,; Chills; Body ache; Muscle cramps; Pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication were not reported. The patient previously 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 an unknown date in 09Apr2021 at 17.45 hours (at the age of 39-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 23:00, the patient experienced headache, chills, body ache, muscle cramps and pain. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event headache, chills, bodyache, muscle cramps and pain were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Rash left thigh times 2 days. DX Zoster. Treated with Acyclovir.
Pt felt dizzy, 10 min after receiving immunization. Rested and given juice. Recovered and left clinic. 4 hrs later symptoms returned and he was advised to go to ER. Pt did not see another MD but recovered at home.
Hives. Pt called us, and doctor, both counseled her to take Benadryl . Later, pt came in with rxn for prescriptions for Benadryl 50 mg and Prednisone 20 mg from ER at 11:00 on 10/01/2003
Breakthrough COVID infection. Symptoms of cough, shortness of break, and fever beginning approximately 07/12/2022. Tested COVID positive 07/14/2022
Numbness in sole of feet. Unable to walk, develop high fever, resp failure resulting in intubation, acute kidney injury
Pt developed a fever of 104.3 approximately 8-12 hrs after shot administered. Shot injection site tender with 1 inch x 2 inch induration and underlying edema.
Shortly after receiving the Pfizer booster developed pain in right leg, which then lead to extreme shortness of breath, requiring hospitalization Jan. 6-8, 2022.  Diagnosis at that time was DVT right leg, and bilateral PE.
expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient is immunocompromised.
pain from shoulder down to elbow that persisted 1-2 months , inability to move left arm to full capacity, when moving left arm experienced sharp pain
pt went limp for approx 45seconds, 1 day p/vax;pt had a tactile fever (not documented) prior to episode;no tx;
This vaccine made me skip my menstrual cycle for a month and and came back over a month late. This was very unusual for me and only ever happens to me when I am pregnant. I was not pregnant and had not been in a relationship over a year. I looked it up online and see that women had reported this happening after the COVID vaccine. I have never had a reaction like this to a vaccine before and have not been vaccinated for COVID since.
10 mins p/receiving vax lt thigh had 25x25 area reddened, swollen & firm; no breathing difficulty; ice pack applied & pt observed x 1/2 hr; reddness feding p/ 1/2 hr;
I developed severe back and muscle pain, chills and fever the first day. As the days are going by I am having light headedness, fatigue, confusion, blurred vision, joint pain, muscle pain, mental  difficulty with my moods, nerve pain, severe allergy feeling .
SHE REPORTED FEELING SICK AFTER LUNCH TIME WITH NAUSEA, SOME SWEATING AND VOMITED ALL HER LUNCH.
Bright red rash started on my neck 1 day after vaccine. It is spreading over my chest, torso, and sides. The rash is becoming brighter and itchy now in the 3rd day. It is not responding to hydrocortizone cream or oral doses of Benadryl.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a female of unspecified age, race and ethnicity. 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 (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 15-MAR-2021 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 27-OCT-2021, the patient received additional non-company suspect vaccine Comirnaty (tozinameran) (dose number in series 2) (form of admin, route of admin were not reported, batch number: FH8020 and expiry: Unknown) dose was not reported, administered on 27-OCT-2021 for prophylactic vaccination. On an unspecified date, the patient had fever, sore throat, fatigue and body aches (coded as suspected covid-19 infection) (dose number in series 2). The patient tested positive for covid-19 infection with a home test (coded as suspected clinical vaccination failure) (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20220434768-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Kept leg straight, did not like bending it to try and push up or crawl. Still does it sometimes.
No additional AE; MMRII with a labeled expiry of 5/29/2022 was administered; This spontaneous report was received from an office manager via employee, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, and concomitant therapies were not reported.  On 13-JUN-2022, the patient was vaccinated with one dose (quality: 1) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) subcutaneous injection, 0.5 milliliter, lot #T018669, expiration date: 29-MAY-2022 (strength, route of administration and anatomical location were not provided) administered for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).  This is the one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA006816: US-009507513-2207USA007188: US-009507513-2207USA007041: US-009507513-2207USA007043: US-009507513-2207USA007052:
At 1003, RRT was activated at the end of client?s post-vaccine 15-minute monitoring period. 64 y/o F complaining of head ?heaviness? in the back of her head, dizziness, and mouth dryness. Head-to-toe assessment completed and WNL. BP: 118/60, HR: 68, breathing even and unlabored on RA. Client in no acute distress. Throughout response time, client?s condition improved. Recommendation to client to be monitored for an extra 15 minutes by post-vaccination nurses. At 1030, client felt much better and left facility ambulatory, in not acute distress, breathing even and unlabored.
Significant swelling and soreness under arm pit beginning during night between 26th and 36th hours after Moderna booster shot, and continuing beyond 48th hour after dose. Early extension of soreness into chest area.
Large red swelling at the deltoid first it was small and continued to grow and became itchy still present although improved not as erythematous, petechiae in the abdomen 3 weeks after first dose
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6200), in right arm, on 22Oct2021 as dose 3 (booster), single (Lot number: FF2293), in left arm and on 26Feb2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 56 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Nov2022 at 18:30 as dose 5 (booster), single (Lot number: 05D22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "lupus" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "ckd stage 2B" (unspecified if ongoing), notes: ckd stage 2B; "obesity" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Sulfonamide allergy" (unspecified if ongoing). Concomitant medication(s) included: PROGESTERONE, start date: Mar2021; VITAMIN B12 [CYANOCOBALAMIN], start date: Sep2021; SPIRONOLACTONE, start date: Sep2021; EVENING PRIMROSE, start date: Feb2022; HYDROXYCHLOROQUINE, start date: Nov1998; GABAPENTIN, start date: Nov1998; DULOXETINE, start date: Mar2014; ZOLPIDEM, start date: Nov1998; VITAMIN D3, start date: Jan2020. Past drug history included: Keflex [cefalexin], reaction(s): "Allergy"; Tetracycline, reaction(s): "Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Nov2022 at 18:30, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 29Mar2023 to 03Apr2023 for COVID-19 treatment.
small line of redness and very itchy just below the injection site.  lasted for 2 days
Fever, over all body aches, headache, fatigue, pain and swelling at site of injection, red rash at site of injection ~1 inch diameter day 1: day 2 thru day 5 fever, severe body muscle and joint aches and pain, severe headache, chills, severe fatigue and muscle weakness, difficulty breathing: day 4 elevated heart rate to 165 BPM, for 48 hours: by day three rash around injection site covered back of arm from shoulder to elbow and around both sides: day 6 arm rash gone but large hard lump on arm at injection site ~ 4" diameter: day 8 body fatigue resolved and other symptoms resolved but hard lump on arm persistent ~  4" diameter.
Not immune compromised and I accidently gave her the 0.5 ml booster dose of Moderna
After the second dose. I am a nursing mother and I noticed that my breast milk production decreased. I have been breastfeeding for 10 months and two weeks and it has never happened to me.
Patient received Shingrix on 4/17/21 on Monday following administration. Patient broke out into a rash with shooting pains. She states she is experiencing nerve pain 2-3 weeks later. Pt states she had shingles outbreak before.
administered a pediatric dose instead of the adult dose; administered a pediatric dose instead of the adult dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18th May 2023) for prophylaxis.   On 9th June 2022, the patient received the 1st dose of Engerix B pediatric. On 9th June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 09-JUN-2022 Reporter's Comment: Medical Assistant (MA) reported that a patient was administered a pediatric dose of Engerix-B-vaccine instead of the adult dose in the left deltoid. The reporter consented to follow up. Additional Supportive Information: The adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Currently breastfeeding. Toddler (2.5 years) had marks/allergic reaction to vaccine the morning after booster shot. Reaction was small compared to the reaction after the 1st dose of pfizer (ew0162 4/16/21).   1st dose the next morning face was covered with red spots. Benadryl helped until the second day when it was needed again. By day 3 better.   2nd dose, no reason.   Booster similar reaction as the first. But nursing much less and the red spots were less.
Follow up information from the pediatrician provided the site of the reaction as the injection site. A pediatrician reported that a nine month old female received her first dose of Prevnar (pneumococcal 7-valent conjugate vaccine) on 08-MAY-2003. On 09-2003, one day post immunization, she developed a quarter sized water blister lesion at the injection site. The lesion ruptured ad skin peeled for two weeks. Treatment included supportive care for two weeks. The child recovered.
pt recv vax 4NOV96 & pt c/o sore muscles, heavy arm, denies SOB, swelling anywhere else;6NOV96 lt deltoid nickel-sized erythematous area, sl warm to touch, larger, tender nodule;pt demonstrates good grip;neuro exam nl, ROM nl;
This spontaneous report was received from a pharmacy technician, who referred to a patient of unknown demographics. On 17-AUG-2017, the patient was vaccinated with the expired dose of PNEUMOVAX23 lot # M007769 and expiry date of 27-JUN-2017 (indication defaulted to prophylaxis; dose and route of administration were not reported). The patient experienced no adverse effects. No product quality complaint was involved. The outcome of expired product administered and no adverse event was unknown. The reporter considered expired product administered and no adverse event to be not related to PNEUMOVAX23. Additional information has been requested.
3hrs p/vax chills,fever (t99.3),h/a;APAP-IV NaCl,heparin lock
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 33-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "heart problems" (unspecified if ongoing); "over weight" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (08Jun2002) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had received Anti-viral as a treatment for COVID-19 which included Paxlovid, treatment start date: 30May2022 and stop date: 03Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fever of 103.3, soaking wet by the time pt got home. Fever continued and dr recommended pt to go to hospital same evening. . fever fluctuated and remained high. MS flared up. Put pt on IV meds a couple of days later. pt hospitalized for 2 weeks.
No additional AE reported; M-M-R-II expired was administered on may 6th 2021; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.       On 06-MAY-2021, the patient was vaccinated with expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHa), at a dose of 0.5 milliliter for prophylaxis (strength, route of administration and anatomical location were not reported, lot # S013536  had been verified to be a valid number; expiration date 02-MAY-2021). It was reported the use of sterile diluent (STERILE DILUENT VACCINES). No additional adverse event reported.
Pt. called pharmacy 2 days after receiving vaccine complaining of "egg size" swelling, pain, redness, heat at injection site.
Patient received first dose of the Moderna Vaccine on 2/15/2021 and second dose on 3/15/21. He initially developed minor flu-like symptoms and then developed chest discomfort accompanied by chest pain. Patient has history of cardiac stent placement and DVT. Patient contacted cardiologist, they initially believed he developed angina. Patient had an ECHO that was normal. Chest pain continued and cardiologist brought patient in for cardiac catherization where 3 stents were placed on 4/9/21.  Patient still experienced  chest discomfort post-stent placement. Severe pain began to develop after catherization. Pericarditis was diagnosed by cardiologist 12 days after catherization.  Patient has been taking colchicine and pain was fully alleviated.
Two days after getting the flu shot, Patient had a very bumpy and red rash covering his entire upper arm. He only complained of itching. He gets his flu shot every year with no problems in the past.
This spontaneous report as received from a physician refers to a patient of unknown age. On 07-AUG-2013 the patient was vaccinated with a doe of PNEUMOVAX 23 (lot # H012650, expiration date: 27-FEB-2014) (dose, route unknown) which was improperly stored. No adverse event reported. This is one of several reports (1403USA000875; 1403USA001194; 1403USA001195) from the same reporter. Additional information is not expected.
nickel size round itchy patch rash near injection site does not go away any tropicals raised lesion came suddenly months after 2 doses of moderna vaccine thus has not increased in diameter or color
This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown.  On an unknown date the patient was vaccinated with a dose of GARDASIL 9 INJ, (strength, lot# and expiration date unknown) subcutaneously (incorrect route of drug administration). No adverse effect was reported. No product quality complaint was reported.
Chronic urticaria. Red, itchy, swollen skin. Irritated and inflamed when scratching, all over the body.
Large red patch surrounding injection site has appeared.  Small this am on waking but as of 5:30 pm quite large.  Hot to the touch.  Itchy.  No pain.  No fever.
c/o arm pain, swelling, redness, numbness in finger tips; fever 20OCT93 7PM 103; pulse 100; resp inc; felt bad x 2 days;