chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 30-SEP-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
pt died at home; no medical records; pt had a positive post mortem COVID test on 8/19/21; DC sent per VAERS request
pt recvd vax in approx 1986 & devel atypical MS-type sx;
The following morning after patient received the vaccine, she developed a severe headache and sensitivity, dizziness, weakness and fatigue, body aches, and developed an elevated temperature with a temp of 100.7*F. She also described herself as having "brain fog". She reports these were all of the same symptoms she experienced in October when she was previously positive with COVID19.
FEVER; Shaking chiills; Body aches; doesnt feel well; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER), CHILLS (Shaking chiills), PAIN (Body aches) and FEELING ABNORMAL (doesnt feel well) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 PYREXIA (FEVER), CHILLS (Shaking chiills), PAIN (Body aches) and FEELING ABNORMAL (doesnt feel well). At the time of the report, PYREXIA (FEVER), CHILLS (Shaking chiills), PAIN (Body aches) and FEELING ABNORMAL (doesnt feel well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Redness of left 3.0 cm x 6.5 cm, warm to touch at injection site of either Tdap or flu vaccine given to left deltiod on Monday immunization clinic.  Contacted/reported to Dr. (LM). Instructed parents to take benadryl and to apply cortisone cream to the site.
Dizziness, lips went numb, sides of mouth went numb, tongue began to swell.
Fever, nausea, inflammation at injections sites edema at site, redness, itching, size 13 3/4 cm x 12 cm R thigh
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that, there was no power outages that would have impacted the Moderna vaccine. However, the healthcare professional reiterates that because her facility was unable to download the digital data logger, they needed to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the state at this time. It was also reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
Body ran hot and cold; shaking; Thirsty; Excessive urinating; Blurry eyes; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 08Apr2021 at 14:30 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and sulfonamide allergy (sulfa). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) all started from an unknown date taken for unknown indication and unknown if ongoing. On 10Apr2021, the patient reported that her body ran hot and cold, shaking, thirsty, excessive urinating, blurry eyes, nausea and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body ran hot and cold, shaking, thirsty, excessive urinating, blurry eyes, nausea and diarrhea was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Severe left upper arm pain for 3-4 days after getting injection. Continued left upper arm for 4 weeks since injection. Left upper arm pain in triceps, worse with abduction and superior movements.
Numbness around the lips and the chin area; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration on 17Mar2021 at 10:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma (currently no treatment), chronic bronchitis (lifelong, prior to giving up cow's milk 15+ years ago- no problem since). Concomitant medications included XYZAL, EXEDRIN, BENADRYL, Probiotics(MANUFACTURER UNKNOWN) and triphala(MANUFACTURER UNKNOWN). Any allergies to medications, food, or other products were reorted to cow's milk (not an anaphylactic reaction),  some fragrances (asthma) and insect bites (excessive itching and swelling compared to others). The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 17Mar2021 at 10:45, the patient experienced numbness around the lips and the chin area, similar to the feeling when numbed at the dentist, but it had almost worn off. There did not seem to be any swelling. The tongue might have been affected, but less than the lips. The patient did not receive any treatment for the event. The clinical outcome of event numbness was recovering.   No follow-up attempts are needed. No further information is expected.
Patient was unsure which vaccine he was given on 4/22/2021. Patient experienced cough, slurred speech, and was incoherent.
Erythemanous indurated irreg. rash on anterior thighs, Right 8 X 1 cm, left 3 X 2 1/2 cm. Looks like hives.
Patient received 0.5mL Flulaval to right deltoid, IM, at 1:25 PM. At 3:30 PM, participant approached nurse with complaints of localized itching at left forearm. Light, red rash observed on inner left forearm. Patient denied SOB, HA, cough, chills, chest tightness. No facial swelling noted. Benadryl PO given at 4:45 PM.
pt recvd vax & w/in 24 hrs exp urticaria which lasted 1 day; treatment included DPH PRN; event occurred 30MAY90;
Chills, body aches, headache, metallic taste in mouth right after injection, flushed face
Approx 5 minutes after receiving the vaccine she started getting blurry vision. She says the next thing she knew she was lying on the floor and there were 2-3 people standing around her. She has a swollen lymph gland under her left arm. feels fine now. Dr gave her promethazine RX to take prior to her next dose.
first developed tingling in both hands, then developed numbness and tingling in lips, then palate, then throat. She was given water, and while she could swallow, the water felt thick and her swallow felt off/weird. she was given IV benadryl and taken to the ER. There she was given steroids and H2 blockers. She felt her symptoms resolve about 20 minutes later.
my arm still hurts a lot; Drug dose administration interval too short; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm still hurts a lot) and drug dose administration interval too short (Verbatim: Drug dose administration interval too short). The outcome of the pain in arm was not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUN-2023. This case was reported by a patient via interactive digital media. The patient received first dose of vaccine on unknown date. The reporter reported that thank you that he/she just got vaccinated.  The patient was told to take the second one after 2 months but patient had to give it after 3 days and patient arm still hurts a lot which led to shortening of vaccinations schedule.  The follow-up could not be possible as no contact details were available.
Localized redness and swelling and induration on right leg at site of either varicella or hep A.
This spontaneous report as received from a practice manager (health worker) refers to a 55 year old female patient with allergy to penicillin. The patient's pertinent medical history included fatigue, heart murmur, obesity, osteoarthritis, vitamin d deficiency. On 09-JUL-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J011548, expiration date 19-DEC-2014, subcutaneous). Concomitant therapies included ADVIL and vitamin d (unspecified). The practice manager stated that the patient called in to the office today, 15-JUL-2014, to report that after receiving a dose of ZOSTAVAX she developed a reaction. The patient reported to the practice manager that on "Saturday" (on 12-JUL-2014) the injection site was swollen "to the size of a soft ball", red, itchy and burning. The patient reported that "by Sunday (13-JUL-2014) it was almost done". The patient reported that to the practice manager that she placed ice and BENADRYL cream on the injection site for treatment. The practice manager stated "as of today, it was completely gone". No lab diagnostics studies were performed. Additional information has been requested.
Chills; Excessive heat; water bumps to left arm; itching; swelling under the arm; red blotches that have since healed; The red blotches in my arm left black spots, not red, and blue; This is a spontaneous report from a contactable Nurse who reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 28Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced chills, excessive heat, water bumps to left arm, itching, swelling under the arm, and red blotches that have since healed. The patient reported that, "the red blotches in my arm left black spots, not red, and blue" additionally occurred on an unspecified date in 2021. The patient wanted to know if as a result of the reaction, should she take the second dose of the vaccine. The outcome of the event "red blotches that have since healed" was reported as resolved on an unspecified date in 2021. The outcome of other events was unknown.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Redness, swelling, induration, warmth at site of MCV - 7.75cm x 7cm and TDAP 3cm x 5cm. (Seen on 3/23/12).
Client was given HPV & MCV4 vaccinations at 10:30 am at PHO, 1 hour later began to have intermittent dull pain in her wrists and ankles, the pain moved up her legs into her knees and in the upper extremities it moved into her hands/fingers and up into her elbows. Returned to PHO at 1 PM to inform of above, wrists and ankles appeared swollen and felt warm to touch. Client had not experienced any fainting or lightheadedness. CDC and State DOH Epi dept contacted for guidance.  Client referred to PCP for evaluation. M.D. from PCP clinic called RN at PHO with update on client's condition. M.D. sent client home at 2:30 pm with instructions to take Ibuprofen prn and return to clinic if pain or swelling increases.
The patient was administered the vaccine which was in transit to long/no AE; The vaccine was in transit to long/no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00325681) and transmitted to Sanofi on 21-Oct-2020..  This case involves a 71 year old male patient who was administered 0.7 ml INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ546AA, expiry date: 30-Jun-2021) via intramuscular route in the left arm for prophylactic vaccination on 19-Oct-2020 (product storage error and product distribution issue)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Still painful; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Still painful) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Still painful). At the time of the report, PAIN (Still painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
feeling bad/worse; This case was reported by a consumer via media and described the occurrence of feeling bad in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. It was reported that after receiving Flu vaccine the patient felt worse. Some other people also said the same.
Chills at 12:30 PM lasted all night and into Tuesday until evening.  My period came at 12:30 PM after vaccination - still present at 3/4/2021 My arm was very sore I took 1 ibuprofen tablet at 10:00 PM  on 3/1 At 12:30 PM I began to feel very confused. This continued on and off and on 3/2 in the morning my head was very foggy all day long.  On 3/2/2021 at 1:45 am I woke up to all of my bones feeling like they were going to shatter and I could not move without being in tears. This lasted all night and the pain is still present on 3/4/2021 I slept all day on 3/2/2021 A fever of 99.9 happened on 3/2/2021 at 9:00 PM.  The fever was gone by morning of 3/3/2021 with the help of 2 Tylenol tablets.  My body felt extremely weak and still is on 3/4/2021
Pt inadvertently received a subcutaneous injection of Tetanus and Diptheria Toxoids Adsorbed, Purogenated instead of PPD. The pt developed an erythematous wheel at the injection site. The pt reportedly popped it like a pimple and then had a 3mm scab. The pt reported that the injection site was scarred.
looked like sunburn; skin is bumpy; Reddish spots appeared at injection site; COVID Arm; red arm; swollen arm/bumpy arm; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), PAIN IN EXTREMITY (arm was sore), RASH ERYTHEMATOUS (looked like sunburn), SKIN SWELLING (skin is bumpy) and ERYTHEMA (red arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypercholesterolemia and Hypertension. Concomitant products included ATORVASTATIN for Hypercholesterolemia, METOPROLOL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 07-Apr-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm), ERYTHEMA (red arm) and PERIPHERAL SWELLING (swollen arm/bumpy arm). On an unknown date, the patient experienced RASH ERYTHEMATOUS (looked like sunburn), SKIN SWELLING (skin is bumpy) and VACCINATION SITE ERYTHEMA (Reddish spots appeared at injection site). On 14-Apr-2021, VACCINATION SITE REACTION (COVID Arm), ERYTHEMA (red arm) and PERIPHERAL SWELLING (swollen arm/bumpy arm) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore), RASH ERYTHEMATOUS (looked like sunburn), SKIN SWELLING (skin is bumpy) and VACCINATION SITE ERYTHEMA (Reddish spots appeared at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included ice packs several times a day.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional information received on 14-May-2021 added medical history, concomitant medications,new events and second dose details
To left arm apprx 10 cm area of erythema, warm to touch, induration. fever lasting and symptoms started yesterday.
TERRIBLE PAINS; SEVERE DIARRHEA; HEAVY FEVERS; This spontaneous report received from a consumer concerned multiple patients.  No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced terrible pains, severe diarrhea, and heavy fevers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe diarrhea, heavy fevers and terrible pains was not reported. This report was non-serious.
I recently have covid after I had a two doses of Pfizer; I recently have covid after I had a two doses of Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; acetylsalicylic acid (ALKA-SELTZER), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I recently have covid after I had a two doses of Pfizer". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for acetylsalicylic acid was unknown. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included 2 weeks. COVID-19 treatment of Paxlovid from 05May2022 to 09May2022. 9 days after onset of COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
not enough diluent was withdrawn  to reconstitute the pfizer vaccine as a result patient received higher concentration of the vaccine than the normal dose no unusual side effects were reported
I was awakened at 1:00 am Sunday, February 9th.  I was throwing up, chilled, and had a terrible headache.  The rest of that day I had a terrible headache (a 9-10), nauseous, and consequently couldn't take any pain reliever.  I was finally able to take some in the mid afternoon. I could not work on Monday and finally found relief around 1 pm.  If this had been my first shot I would not be getting my second dose.  I only had some chills and body aches with the first dose.
Developed a rash in area of vaccine shot, upper arm, then it spread over next few weeks down my right  arm, then rash or welts appeared on left arm after that. My doctor diagnosed as psoriasis which I never had in my life (I realize it is an immune disorder and is related to Chrones disease). Dermatologist confirmed diagnosis. Being treated currently with triamcinolone cream.  Now welts showing up on my legs past few days.