chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After all 3 vaccines I did experience increased menstrual flow and decrease between menstruation, as well as paresthesia in fingers, feet, legs, abdomen, and back. After the 1st I had vaccine site soreness that last months in my left arm.
Dizziness - Day 1 Dizziness, nausea, vomiting - Day 2 and Day 3  0.9% sodium chloride Ondansetron (ZOFRAN) Meclizine (ANTIVERT)
Mom called 2 days later. C/O site "itchy -  rash". Mom called on 11/9 - said had itchy -  slight rash. Mom rubbed her down with the alcohol.
Pt recv vax on 1/28/99; on same day pt exp swollen left thigh w/redness
Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Achy). At the time of the report, PAIN (Achy) outcome was unknown.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 3/26/2023 ACUTE MESENTERIC VEIN THROMBOSIS
sick for about a week; felt like she had the flu; low grade fever; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (sick for about a week), INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (low grade fever) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No treatment information was provided by the reporter.  Concomitant products included ROPINIROLE HYDROCHLORIDE (REQUIP), CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), TIZANIDINE, OXYCODONE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 01-Feb-2021, the patient experienced MALAISE (sick for about a week), INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (low grade fever) and CHILLS (chills). At the time of the report, MALAISE (sick for about a week), INFLUENZA LIKE ILLNESS (felt like she had the flu), PYREXIA (low grade fever) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medicines include Requip, Carbidopa/levodopa, Tizanidine ,Oxycodone, Symbicort, ProAir  Treatment medicines were not include  Action taken with mRNA-1273 in response to the event was unknown   This case was linked to MOD-2021-040719 (Patient Link).
The day after the shot: My arm was red, swollen and very hard at the injection site and hurt. I had fever all day from 98.9 to 100.8 at 11:00 pm. My body was very achy and felt like the flu. My lips developed fever blisters. Completely raw and peeling. Dry mouth and very thirsty.  Very very tired
3rd Shingrix administered.; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number CS2ZE, expiry date 10th September 2023) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On 14th September 2022, the patient received Shingrix. On 14th September 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 28-Nov-2022 Reproter;'s comment: The vaccine administration facility was the same as primary reporter. The reporter gave consent to follow up via phone. Additional supportive information: The patient received the third dose of Shingrix vaccine, which led to extra dose administered.
Patient develops hives on the legs, back and both sides of the back of the forearm on July 14 2017. When patient call back in the afternoon at around 3pm the same day, patient reported his lower lip was swollen. Patient went to ER and was given a steroid shot in the hospital. For discharge medications, patient has prednisone, Benadryl and Nexium.
Per Aunt, noticed the next morning that patient's right arm was swelling, redness, warm to touch and was getting worse throughout the day.   Per provider, Benadryl 5ml q 6 h for the next 24 hours, local cold to the area, start AB (Kelflex) in 1 day if continues to be swollen/redness. Follow up in 3-4 days, or sooner if needed.
first shingles vaccine on 1-8-2020. I got shingles 6 months later.; I had my first shingles vaccine on 1-8-2020./ I got my second shingles vaccine today; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2020, the patient received the 1st dose of Shingrix. On 20th July 2021, the patient received the 2nd dose of Shingrix. On 20th July 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced Shingles 6 months later. The patient received 2nd dose today (day of reporting), which led to drug dose administration interval too long. The pharmacist recommended a third vaccine but GlaxoSmithKline information did not. The reporter confused at the time of reporting.
after returning home from visit, felt warm to touch. no temperature taken. then approximately 24 hrs after administration of Influenza vaccine, developed bilateral eyelid swelling and hives. was given Benadryl, Tylenol and Advil. seen in clinic 2 days after administration of vaccine. T101.1. still with bilateral eyelid swelling and erythema. no rash present. discharged home to continue symptomatic treatment.
2-3 days p/vax pt c/o heart palpitations & not want to be hugged because chest hurt;pt was also being treated w/Biaxin for ear infect;21AUG96 pt vomited & had been fatigued w/mild fever but had not been seen by MD in regard to sx;
This literature-non-study case was reported in a literature article and describes the occurrence of VACCINATION FAILURE (vaccine response impaired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Non-ischaemic cardiomyopathy (cause or organ failure) and Solid organ transplant since an unknown date. Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (vaccine response impaired) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to VACCINATION FAILURE. At the time of the report, VACCINATION FAILURE (vaccine response impaired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: positive (Positive) Diagnosis of COVID-19 was confirmed in all patients with polymerase chain reaction (PCR) of nasal swabs..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION FAILURE (vaccine response impaired) to be possibly related.    Baseline immunosuppression for solid organ transplantation was achieved with basiliximab. Patient was hospitalized for 5 days and treated with Remdesivir and Convalescent Plasma. The patient was discharged on 2 Liters of oxygen. "The clinical presentation and course of these patients were comparable to those of SOTs who had COVID-19 infection and have not been vaccinated. This finding suggests that SOTs are still at risk of acquiring COVID-19 infection even after vaccination..."  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-094284, MOD-2021-094289, MOD-2021-094295 (E2B Linked Report). This case was linked to MOD-2021-094325 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-094284:Same literature article_Patient 3 MOD-2021-094289:Same literature article_Patient 3 MOD-2021-094295:Same literature article_Patient 5
Feel tightness in throat; its my sinus; I was just fatigued for 2 days; slight headache; Feel tightness in throat; its my sinus; an allergic reaction and I want to know if it is reported for people to have that tightness in their throat after that shot after this long; This is a spontaneous report from a contactable consumer or other non hcp.  A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) dose 2 via an unspecified route of administration on an unspecified date (Age at vaccination is 46 years) (Batch/Lot Number: EL9267, expiration date: 30 Jun 2021) as 2nd DOSE, SINGLE for covid-19 immunisation. Historical Vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. Medical history included autoimmune thyroiditis from an unknown date (Hashimoto's thyroiditis). Concomitant medication included levothyroxine sodium (TIROSINT) taken for thyroid pain, start and stop date were not reported. Patient stated that she was wondering if it is a side effect like 5 or 6 weeks after your second Pfizer shot to feel tightness in throat some say maybe it is an allergic reaction. Patient took Tylenol, in his second shot she was just fatigued for 2 days and had a slight headache and then took Tylenol and it was gone away and after that she was fine. In 10 days, she had this tightness in his throat, and she is thinking it an allergic reaction and she went to doctor and they are saying it is sinus give antibiotics (Unspecified medications) that did not help so that tells it is not that doctor asking me to go to allergist because they think it is an allergic reaction and she want to know if it is reported for people to have that tightness in their throat after that shot after this long. . The patient underwent lab tests and procedures which included blood work done but was  waiting for report. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Constant headache strong, dizziness, nausea. Blurry and double vision, no body equilibrium or disbalance, flabby and weak legs and body. White matter disorder.
Headache; Fever; Muscle pain; Joint pain; Chills; A spontaneous report was received from a 58 year old female consumer who was participating in the mRNA-1273  Program and experienced headache, chills, fever, muscle pain and joint pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Jan 2020 (pending clarification), the patient received their first of two planned doses of mRNA-1273 (Lot# 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 02 Jan 2020 (pending clarification), at 18:00, the patient experienced a headache, chills, fever, muscle pain and joint pain.   Treatment for the event included paracetamol.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, headache, chills, fever, muscle pain and joint pain were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
02/13/2021  sore muscle and tender around injection site.   02/14/2021 small red spots on upper arm and itchy similar to a minor rash.  Spots were spread out within 3 inch radius of injection 02/19/2021  still itchy and had red bumps size of mosquito bites spread out about 2 inches of injection site..  Muscle still sore.
vaccinatins given 3PM; 4PM pt became cranky which escalated quickly to inconsolablity no fever no swelling or redness @ site fell asleep @ 730PM;noted papules covering tongue, cheeks, lip mucous membranes;
Previously reported AE from first Pfizer COVID shot on 3 June 2021, VAERS temp report number 54613 reporting numbness of right arm lasting 3-4 weeks.   After receiving my second Pfizer shot on 7 June 2021 I developed severe soreness of my right arm and hand.  I also developed a dark brown discoloration on the top of my right hand that lasted approximately 5 days.   My right arm still  remains week and sore, especially below my elbow and on my hand (6 months after the first dose received)
Red rash at injection site that has gotten larger in surface area as time has passed. Around midnight I started having trouble breathing. Breaths were shallow and spaced out and had chest pain. None of these symptoms have resolved but my primary care doctor was notified via telephone.
UNEXPECTED THERAPEUTIC BENEFIT (WART ON LEFT THUMB THAT IS CLEARING UP AND NEW SKIN GROWING IN THAT AREA); This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: wart on the left hand. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced unexpected therapeutic benefit (wart on left thumb that is clearing up and new skin growing in that area). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit (wart on left thumb that is clearing up and new skin growing in that area) was not reported. This report was non-serious.
Patent was given Adacel at incorrect site (not IM). Experienced pain, very red, sore and swelling in left arm.
DELIRIUM; PAIN IN HEART; DIFFICULTY IN WALKING; COLD EXTREMETIES; BODYACHE; VASCILLATE BETWEEN HOT AND CHILLS; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 53 year old female The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies,no drug abuse. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, intramuscular, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered in left arm on 24-MAR-2021 at 19:30 for prophylactic vaccination. Concomitant medications included paracetamol for drug used for unknown indication.  On 25-MAR-2021, the patient experienced nausea, difficulty in walking, fever , cold extremities , delirium ,vascillate between hot and chills, pain in heart ,headache body ache . The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient recovered from delirium, and pain in heart on 25-MAR-2021, and had not recovered from nausea, difficulty in walking, fever, cold extremeties, vascillate between hot and chills, headache, and bodyache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350740-COVID-19 VACCINE AD26.COV2.S - Delirium. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
On 05/01/01, this patient's mother called. Complained of left leg being swollen and red. Per manual not usual side effect. Told to give Tylenol. On 05/02/01, the Grandmother called, the patient's leg was swollen down to the knee. Told to take the child to the family doctor. On 05/01, the ER PA stated it was a local reaction. The patient had a slight fever. The patient was given Keflex and Motrin.
The day after vaccines were administered, patient experienced intense "pulsing, grabbing pain" in head sporadically. Stated was not like a normal headache kind of sensation. This persisted for 2 days in a row, then ceased to occur since then.
This spontaneous report was received from a Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical condition was reported. On an unknown date the patients were vaccinated with an unspecified number of improperly stored (Oka/Merck) VARIVAX (lot # K020757, expiration date 31-OCT-2016 and Lot # L004649 expiration date 11-FEB-2020) (dose, route, and anatomical location were not reported). No concomitant medication was reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash around injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE RASH (rash around injection site). At the time of the report, VACCINATION SITE RASH (rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment details were not reported.
This spontaneous report was received from a pharmacy student referring to a 12 month old patient. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. Concomitant therapies included sterile diluent. On 20-MAR-2019, the patient inadvertently received first dose of PROQUAD 0.5 milliliter, lot # N02592, for prophylaxis; that was past its expiration date. The dose had expiry date on 18-MAR-2019; however, no adverse effects were reported.
SHORTNESS OF BREATH; HEADACHE; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and batch number: 1802072 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of chills and shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment is not required  according to standard operating procedure as the case is assessed non serious
During the next 60 hours I had the following reactions, though not all at the same time:   02/19/21:  10:00PM Nausea and extreme headache, 11:00 PM - 2 hours of uncontrollable shivering and headache 2/20/21:  2:AM Extreme headache (like Migraine), Nausea, Body aching for the remainder of the night. Tried Advil, then tylenol - didn't tough headache.  7:00AM - Headache, Body Aches, Fatigue, chills, mild diarrhea and dehydration throughout the day.  Slept, finally that night.  Advil helped the head and body aches finally.   2/21/21 - Left with body fatigue, mild diarrhea, dehydration.  Night sweats for most of that night. 2/22/21 - energy back, mild diarrhea left. 2/23/21 - good, except left with mild diarrhea  Leary of taking anything for the diarrhea, as I tend to block up.  Through this whole ordeal, I consumed tons of water, almost drinking nonstop due to the thirst.
This was my Covid booster due to being immune compromised. This time only after 4-5 hours my right arm broke out in a rash, first on my inner elbow that looked like hives, and  spread down my arm to my wrist as red pindots. It was very itchy. I used hydrocortisone cream and Benadryl on it that didn?t help much. On the 3rd day the area where I had the injection turned bright red and spread in a larger area of my upper arm. It was  hot to touch and I started feeling more allergic overall. I went back to the pharmacist and showed her my arm and she said to use Benadryl and report it.  It?s now 6 days since my shot and my arm below the elbow is slightly better and above my elbow it is still red and splotchy. I didn?t have any of this with my first 2 shots, just had a sore arm, headache and tired for a day or two and I also had that again this time but also the rash this time.
soreness in arm, Arm was noticeably sore especially upon lifting household items; Initial information received on 15-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves patient of unknown demographics who experienced soreness in arm for 10 days [Pain in extremity], while he/she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious soreness in arm for 10 days (pain in extremity) Unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Arm was noticeably sore especially upon lifting household items  Other relevant tests not reported.    Final diagnosis was soreness in arm for 10 days .  It was not reported if the patient received a corrective treatment.  Information on the batch number was requested.  The event outcome was reported as Recovered / Resolved on an unknown date for soreness in arm  for 10 days after receiving flublok vaccine.
Pain; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain". Additional information: The patient felt pain compared to the flu vaccine. Pharmacist mentioned this was common adverse reactions. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.