chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Sep2021 11:45 (Lot number: FE3592) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "hashimotos" (unspecified if ongoing), notes: hashimotos; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: Sulfa. Concomitant medication(s) included: LORATADINE. The following information was reported: DIARRHOEA (non-serious) with onset 22Sep2021 07:00, outcome "recovered" (Sep2021), described as "diarrhea"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2021 07:00, outcome "recovered" (Sep2021), described as "pain at injection site". Therapeutic measures were not taken as a result of diarrhoea, vaccination site pain.  Additional information: It was reported that, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
24 hours after receiving  vaccine there  was no adverse outcome, based on phone call with parent. Child was given Pfizer 5-11yr BV instead of monovalent vaccine as first dose.
Shortly after receiving vaccinations, pt. went to check out with her mom and stated that she felt "funny" and weak. She became pale and diaphoretic; nursing and her mother aided her to a patient room to lay down. She remained diaphoretic with mildly elevated heart rate. The patient was given Pedialyte and water and allowed to rest. Blood pressure and pulse ox were within appropriate range. Patient stated she felt numbness on her jaw, her legs were tingly, she had a HA and felt her head felt off. Pt was emotionally distressed and crying. Her neuro exam was appropriate, no sign of seizure. Heart rate returned to appropriate range. Pt was frequently reassessed.  All symptoms resolved by 45 mins later.
Patient reported extreme fatigue, pain in legs, and generally not feeling well a few hours post vaccine administration. Patient also reported chills but no fever. This was the first year patient got the High Dose and thinks it was due to the higher concentration.
REDNESS, SWELLING AND ITCHING TO LOCATION OF VACCINE; SHORTNESS OF BREATH AND TINGLING DOWN LEFT ARM.
17 year old female patient received Flublock, with no reported adverse event; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case from a Physician via other health care professional via non-healthcare professional via Medical Information (Reference number- 00844192).  This case involves a 17-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], (product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 06-Nov-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ725AA and expiry date: 30-Jun-2022) (Frequency: once) via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (latency on same day).  It was reported "nurse requests counseling regarding FLUBLOK; on 06NOV2021, a female 17 year old patient received FLUBLOK; caller would like to know adverse events to look out for and counseling regarding dosage meant for adults".  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 the 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.
covid vaccine breakthrough case dose 1 Pfizer 3/31/21  ER8733 dose 2 Pfizer 4/21/21  EW0158
Information has been received from a male consumer who "a couple of months ago" in 2007, received  a dose of zoster vaccine live (Oka/Merck). He reported that 4 or 5 days after he got the shot he developed pink spots on his stomach, hands and face. He reported that one spot got big enough where he drained it (blister), and still had a few spots left on his face. The patient was part of a shingles prevention study and spoke with a physician that had been monitoring his reaction from the vaccine. Specific medical treatment and further current patient status was not reported. A product quality complaint was not reported. Further information was not available. Additional information has been requested.
Associate received the vaccine and experienced exacerbated symptoms related to her IBD and arthritis for 5 days as well as a change in their menstrual cycle. The  associate also stated that her menstrual period, "came earlier than expected and the amount of bleeding was abnormal" to the associate. She also stated that her arthritic pain was severe and she had an increase in diarrhea that was abnormal to her chronic conditions. All of these lasted 5 days.  Associate had to stay home from work and  self managed her symptoms.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium
Initial and follow up information has been received from a licensed visiting nurse concerning an 80 year old, white, retired female whose reported weight was 140 pounds with allergy to penicillin, clarithromycin (BIAXIN) and rofecoxib (MSD) with osteoarthritis, osteoporosis, hypertension, hyperthyroidism, high cholesterol and hyperglycemia, who on 22-SEP-2005 was vaccinated in the left arm, intramuscularly (previously reported subcutaneously) with her third dose of pneumococcal 23v polysaccharide vaccine (Lot#649977/0706P).  It was reported that the patient had no illness at the time of vaccination.  It was reported the vaccination was routine due to the patient's age.  On 23-SEP-2005, it was reported the patient presented with a red, swollen arm (deltoid region), the area the size of an orange or grapefruit and previously reported that, the patient developed a local reaction arm became very red and inflamed, area was about 4 inches by 5 one half inches.  The patient was treated with heat and ibuprofen (ADVIL), the patient sought unspecified medical attention.  It was reported that the patient was previously vaccinated with pneumococcal 23v polysaccharide vaccine in 1984 and 1997.  At the time of the report, the patient had recovered.  Additional information has been requested.
Sore arm; Ball under arm; Body hurts when arm is supported; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Ball under arm) and MYALGIA (Body hurts when arm is supported) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced LYMPHADENOPATHY (Ball under arm) and MYALGIA (Body hurts when arm is supported). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Ball under arm) and MYALGIA (Body hurts when arm is supported) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Patient developed infection of eye, untreatable with antibiotics. Belief is that it was shingles/zoster virus and related to vaccine. Recommended by MD to not receive second dose.
After 1st shot, I start feeling soreness in my left breast, and after the 2nd shot an1/2" increase in size and soreness.; After 1st shot, I start feeling soreness in my left breast, and after the 2nd shot an1/2" increase in size and soreness.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 57-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 08:00 (Lot number: EP7534) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE; SPIRONOLACTONE. Past drug history included: Celebrex, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (lot number Ep7534, administration time 09:00 AM, dose 1, single, vaccine location Left arm), administration date: 25Mar2021, when the patient was 57 years old, for COVID-19 immunisation, reaction(s): "soreness in my left breast". The following information was reported: BREAST PAIN (non-serious), BREAST ENLARGEMENT (non-serious) all with onset 2021, outcome "not recovered" and all described as "After 1st shot, I start feeling soreness in my left breast, and after the 2nd shot an1/2" increase in size and soreness.". Therapeutic measures were not taken as a result of breast pain, breast enlargement.  Additional information: Prior to vaccination patient was not tested with covid-19 and not been tested since the vaccination. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks: Amlodipine 10mg, Spironolactone 50mg.   No follow-up attempts are possible. No further information is expected.
Redness and soreness below the injection site the size of a fist.  Patient choose to go to walk in clinic to have assessed by a provider.
Pain at injection site lasting 4 hours. Soreness in injection arm lasting 4 days.
Patient reports Vertigo the day after receiving vaccine. Patient has never had vertigo in the past.
48hr p/vax lt arm, devel itchy @ site inj w/soreness, swelling, chest tightness, cough;responded to DPH & albuterol treatments;
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent condition or medical history was unknown. On unknown dates, the patients each were vaccinated with a dose of improperly stored ROTATEQ (lot # M041181 with expiration date 31-MAY-2018, dose unknown) orally for prophylaxis.    No adverse effects were reported. The vaccines were stored under temperature 9-25 degrees Celsius with time frame 2 hour and 31 minutes. There was no previous temperature excursion. No data logger involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008913: US-009507513-1707USA009010: US-009507513-1707USA009011: US-009507513-1707USA009012: US-009507513-1707USA009014.
I developed a COVID-19 infection the following month and an upper respiratory infection after that.  Diagnosed 01/03/2023 with URI.  I had a sore throat and next day I had a cough and nasal and sinus congestion.  Small fever 98.0 degrees and body aches.  I was able to get Paxlovid on day zero of positive COVID-19 test.
LITTLE LETHARGY; FEELING LIKE COMING DOWN WITH SOMETHING BUT NOT REALLY; LITTLE TIREDNESS; LESS PAIN WITH BOOSTER DOSE THAN THE FIRST SHOT; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, and other pre-existing medical conditions included: The patient took her unspecified diabetes medicines as usual. The patient received covid-19 vaccine ad26.cov2.s (manufacturer unspecified, series 1) (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. On 14-MAR-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced pain at injection site. The patient was recovering from pain at injection site.  The patient received covid-19 vaccine ad26.cov2.s (series 2) (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, administered on 04-NOV-2021 for prophylactic vaccination. Concomitant medications included metformin, and metoclopramide hydrochloride.  On 04-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced less pain with booster dose than the first shot, little lethargy, had feeling like coming down with something but not really, sleepless and little tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome for the events of the little lethargy, less pain with booster dose than the first shot, feeling like coming down with something but not really, sleepless and little tiredness was not reported. This report was non-serious. This case, involving the same patient is linked to 20210330610.
swollen lymph node under armpit on the same arm vaccine was administered which has gotten worse as time goes by. This symptom started Wednesday  (March 31) morning. Yesterday (April 2) the injection site started to itch and this morning it was swollen.
Fever (102F); Body aches; Warm/painful injection site; Warm/painful injection site; Arm pain; limited arm mobility; This is a spontaneous report from a non-contactable consumer, the patient. A 31-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 arm right on 09Apr2021 at 19:00(at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications 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 10Mar2021 at 11:00 (at the age of 31-year-old) as a single dose for Covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 at 14:00 the patient experienced fever (102F), body aches, warm/painful injection site, arm pain and limited arm mobility. On 10Apr2021, the patient underwent Body temperature and the result was 102F. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event fever (102F), body aches, warm/painful injection site, arm pain and limited arm mobility was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
c/o lightheaded, diaphoretic, placed in recliner, BP 110/64 P 60, cold cloth to forehead and behind neck. Back to baseline post sitting BP 122/78 p 88, standing Bp 121/78 P 93, ambulated to exit with Mom
Drug ineffective; Suspected COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; SUSPECTED COVID-19 (medically significant), outcome "not recovered". Reportedly, Per agent, caller wants to know why she is "still having COVID after taking the booster dose".(After providing this information, call went silent and MI agent was unable to hear the rest of the call, call disconnected due to technical issue).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300110033 same patient/drug, different events;
When I woke up the morning after the Booster my vision was blurry and double vision.  Is the same and getting worse to this day.  I can hardly use the computer and I am a web site developer, so it is a big problem.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling, injection site erythema and injection site pain. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved. The reporter considered the injection site swelling, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist reported that several patients those received SHINGRIX doses at her pharmacy had local adverse reactions. The reporter reported that some had happened with first dose and some had happened with second dose only. Several patients were experienced a red, swollen and painful area around the site of injection. The patient was advised to use BENADRYL to treat. The reporter was unsure of the lot numbers involved with these cases.
Patient presented to the ED and was subsequently hospitalized for lactic acidosis within 6 weeks of receiving COVID vaccination.
brief leg paralysis episodes; acute small fiber sensory neuropathy; lost ability to control legs for under a couple of minutes with fall to ground; neuropathy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Lot number: EM9810) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT C; VIT D [COLECALCIFEROL]; MELATONIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Right), administration date: 01Apr2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset Jun2021, outcome "recovered", described as "neuropathy"; MONOPLEGIA (medically significant) with onset Nov2021, outcome "recovered", described as "brief leg paralysis episodes"; SMALL FIBRE NEUROPATHY (medically significant) with onset Nov2021, outcome "recovered", described as "acute small fiber sensory neuropathy"; FALL (medically significant) with onset Jun2021, outcome "recovered", described as "lost ability to control legs for under a couple of minutes with fall to ground". The events "neuropathy", "brief leg paralysis episodes", "acute small fiber sensory neuropathy" and "lost ability to control legs for under a couple of minutes with fall to ground" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: cardiovascular autonomic function test: unknown results; electromyogram: unknown results; magnetic resonance imaging: unknown results; x-ray: unknown results. Therapeutic measures were taken as a result of neuropathy peripheral, monoplegia, small fibre neuropathy, fall including gabapentin.  Course of the event: Developed noticeable symptoms of neuropathy within 8 weeks of vaccine. In Nov2021 diagnosed with acute small fiber sensory neuropathy. Symptoms have occurred in feet, legs, hands, arms including numbness, coldness, burning, tingling, pinching, brief shock sensations (all over body), displacement sensations in feet, as well as 3 very brief leg paralysis episodes (lost ability to control legs for under a couple of minutes with fall to ground). Symptoms started in Jun or Jul2021 with very minor burning in front of both thighs, symptoms seemed to peak in Sep2021 (with all of symptoms listed above). In Oct2021 symptoms seemed to diminish somewhat but still included burning in feet, pinching in side of right thigh, burning on front of both thighs. Started Gabapentin in Nov2021, symptoms seem to have diminished with Gabapentin but still have ongoing burning in feet and sometimes mild burning in legs and arms.  Follow up information has been requested