chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient was not pregnant. Medical history was not reported. On 24-OCT-2014, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot number was not reported). Secondary and concomitant therapies were not reported. Pharmacist reported that on the same day patient was vaccinated, on 24-OCT-2014, patient experienced inflammation and a blister-like, fluid filled lump at the injection site. Pharmacist reported that he did not assessed the patient, but patient was going to pharmacy on 30-OCT-2014 for assessment. At the time of the report, patient had not recovered from the events. Additional information has been requested.
Pt recvd 1st MMR vax in 1981 & on 29MAY91 recvd 2nd dose of MMR & the next morning exp h/a, dizziness, weakness, & nausea; pt recovered w/in 24 hrs;
Rash  Narrative:  + Area of erythema slightly raised was noticed on 1/8/2021 at 5:30am. Reports she is atopic and is pregnant with 20 week fetus. Aware she was pregnant when she received the vaccine. Area of redness measures 3.5cm x 4cm. Denies itching.
1. Chronic itching. 2. Breaking out (hives). 3. Rapid heart beat. 4. Severe drop in glucose level. 5. Profuse sweating. 6. Passed out. 7. Bowel movement. 8. Paramedic return and transport to hospital. 9 . Hospitalized 3 days.
Pt received DTAP on 5/30/06, was seen in the office on 6/1/06 for severe local reaction. L thigh and knee were swollen and painful. Started on Zyrtec and has had gradual improvement and nearly resolved.
2/4/21- nothing 2/5/21- chills and numbness in fingertips of left hand. Slept from 8:30am-10:30am tingly went away but not congested 2/6/21 - no chills, no numbness but still congested, plus sore are which is expected
Moderna 4/22/21, 5/20/21. Positive on 2/1/22
Pt received BEXSERO vaccine and MENACTRA  on 5-19-2017.  No adverse reaction occurred.
Patient presented with a blistering rash on the left arm beneath the deltoid. Rash appeared 2 days following vaccine. Patient is scheduled to see his PCP 11/27/18 at 8:30AM.
Patient stated that the day after the vaccination he developed bruising at the site of injection and redness and swelling on the left arm. He sought medical attention and was diagnosed with cellulitis.
type 4 delayed reaction severe rash, welting severe itching, redness on all extremities of body
dark pink discoloration at the site of injection; heat at the site of injection; itchiness at the site of injection; slight pain at the site of injection; sense of slight fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (dark pink discoloration at the site of injection), VACCINATION SITE WARMTH (heat at the site of injection), VACCINATION SITE PRURITUS (itchiness at the site of injection), VACCINATION SITE PAIN (slight pain at the site of injection) and FATIGUE (sense of slight fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LOSARTAN for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (dark pink discoloration at the site of injection), VACCINATION SITE WARMTH (heat at the site of injection), VACCINATION SITE PRURITUS (itchiness at the site of injection), VACCINATION SITE PAIN (slight pain at the site of injection) and FATIGUE (sense of slight fatigue). At the time of the report, VACCINATION SITE ERYTHEMA (dark pink discoloration at the site of injection), VACCINATION SITE WARMTH (heat at the site of injection), VACCINATION SITE PRURITUS (itchiness at the site of injection), VACCINATION SITE PAIN (slight pain at the site of injection) and FATIGUE (sense of slight fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.
After about 2 or 2 1/2 hours pt came back to pharmacy, feeling  dizzy, just not right, heavy breaths (winded while walking). Monitored patient, gave water.  pt called family member to come pick her up. pt left on own accord and seemed to feel better when she left. I  went over  info sheet and encouraged her to set up the app.
Within the first 24 hours the patient manifested symptoms of headache, persisting fatigue and pain in the joints of the arms and legs noting the elbows and wrists as particularly irritating.  Within one day of appearance the symptoms of headache and fatigue resolved, but joint pain remains and patient has developed a 3-inch radius rash without elevation centered at the site of injection which the patient reports to be painful.
This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 23-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M020103, dose, frequency, expiry date were not reported) for prophylaxis. The patient was vaccinated under Vaccines for Children Program (VCF). The vaccines underwent a temperature excursion of -0.3 C for 22 hours. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. Digital data logger was involved. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, lot #L037924, expiry date 22-JUN-2016 (dose was not reported). Concomitant therapies were not provided. Additionally, it was reported that improperly stored doses PEDIARIX (reported as "PEDIRIX"), (lot number, dose, route and frequency were not reported), were also administered. According to the reporter, the vaccines were stored at a temperature of 13.1 degrees Celsius for 1 hour and 16 minutes. There was no previous temperature excursions reported. No adverse effect was reported. No product quality complaint (PQC) was involved. It was also reported that GARDASIL 9 was also improperly stored, however, it was not administered to patients. This is one of several reports received from the same reporter. Additional information has been requested.
rash on torso, resolved after 10 days,  very sore arm 4-5 days, felt "unwell" for 3 days.  did not seek medical treatment/report until today when asking about getting 2nd dose  of shingrix.  dose deferred until consults with pcp
This spontaneous report was received from a nurse concerning to an 8 weeks old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Shot received at 11:15 a.m. Saturday.   Fever of 102f at 7:00 pm same day.  Took 350 mg Tylenol at 8:30 pm, very strong chills throughout night, low fever into  Sunday.   Had low grade fever until about 4:00 pm Sunday.  Overall flu like body soreness, extreme tiredness and overall not feeling well all  day Sunday until about 7:00 pm.  Body soreness all through Monday.  Tuesday - fine.
burning pelvic Nerve pain; burning pelvic Nerve pain; diagnosed with pudendal neuralgia; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: Er8732) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MIRENA. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 1,, Product: COVID 19,, Brand: Pfizer,, Dose brand unknown: False,, Dose lot number: En6198,, Dose lot unknown: False,, Dose vaccine location: Left arm), administration date: 05Mar2021, when the patient was 33 years old, for Covid-19 immunization. The following information was reported: BURNING SENSATION (disability), NEURALGIA (disability) all with onset 27Mar2021, outcome "not recovered" and all described as "burning pelvic Nerve pain"; PUDENDAL CANAL SYNDROME (disability) with onset 27Mar2021, outcome "not recovered", described as "diagnosed with pudendal neuralgia". The events "burning pelvic nerve pain", "burning pelvic nerve pain" and "diagnosed with pudendal neuralgia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of burning sensation, neuralgia, pudendal canal syndrome.  Clinical course was reported as: The patient had not received other vaccine in 4 weeks. Within 24 hours of patient vaccinated dose 2 and started having burning pelvic Nerve pain. It has gone on since then and not gone away. Patient have been diagnosed with pudendal neuralgia and it has not subsided since it began. Patient had received AE treatment with antibiotics, steroids, pain meds, nerve blocks. The patient had received covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the events of burning sensation, neuralgia and pudendal canal syndrome and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Heavy and painful period on 1/19/2022 after receiving the booster shot for COVID-19 on 1/8/2022. My cramps were very painful and debilitating to the point that I could not sleep. This also led to diarhhea for several hours and throwing up twice (once around 4 AM on 1/19/2022 and again at around 6 AM on 1/19/2022). The cramps subsided after a combination of a hot shower, taking two pills of ibuprofen around 9:30 AM, one gummy of magnesium citrate, and a cup of peppermint tea. During this time, I could barely eat one slice of toast without almost throwing it up. Later in the day I had to take an additional two pills of ibuprofen @ around 2 PM because the cramps returned and I feared they would get worse. Then I took one more pill of ibproufen at around 6:30 PM while eating dinner along with my final magnesium citrate gummy.  As of 11:04 PM on 1/19/2022 the cramps have returned.  Compared to my period last month, my bleeding is much heavier and I have had more severe cramps along with back pain. My legs also hurt along with the center of my knees. This has made it difficult to work and move around.
Mild body aches in both arms and both legs; Mild headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Mild body aches in both arms and both legs) and HEADACHE (Mild headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 026L20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Mild body aches in both arms and both legs) and HEADACHE (Mild headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache and Ache, at a dose of 1 dosage form. At the time of the report, PAIN (Mild body aches in both arms and both legs) and HEADACHE (Mild headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Pt developed a red, raised, warm area 8 X 8 cm on right leg at injection site. Pt was treated with warm compresses and Benadryl.
DRUG ERROR, PATIENT ALREADY GOT FLUZONE HD 9/19/22 AND CAME IN AND GOT FLUBLOK 11/16/22
This case was reported by a health professional on 04 September 2007.  A female patient with no reported medical history received injections of Decavac, Fluzone, IPOL, Menomune, Typhim Vi, and hepatitis A (manufacturers and lot numbers not reported) on 20 December 2006.  "Almost immediately", the patient reported that she experienced "dark circles under my eyes, bags under my eyes, a permanent tired line on my face, and hair loss".  Per the reporter, the events were ongoing.  The patient's husband also reported experiencing dark circles under eyes, bags under eyes, and a permanent tired line in the face after receiving the above vaccines; this information is captured in case number 2007-02806.
the patient was given an extra dose of MMRV accidentally instead of Menactra/No AE; Based on information received on 15-Jul-2020, the report previously considered as non-case became valid: reason: wrong vaccine administered (medication error).   Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves an 11-year-old patient (gender not reported) who accidentally received MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE [MMRV] instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (wrong product administered).  Medical history, medical treatment(s), vaccination(s) and family history and concomitant therapies were not provided.  On an unknown date, the patient accidentally received a third dose of suspect MMRV not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site for prophylactic vaccination instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (formulation: Solution for injection).  It was a case of an actual medication error due to wrong vaccine administered. Reporter wanted to confirm how soon can before the patient can get the Menactra vaccination.  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.  Follow-up information regarding an unsolicited valid non-serious case was received on 15-Jul-2020 from a nurse.  The report previously considered as non-case became valid: wrong vaccine administered (medication error). Entire narrative was updated accordingly.
Swelling around right eye Looks like "got stung by a bee"; This spontaneous case was reported by a consumer and describes the occurrence of PERIORBITAL OEDEMA (Swelling around right eye Looks like "got stung by a bee") in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (dermatological fillers around both her eyes and lips.). Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PERIORBITAL OEDEMA (Swelling around right eye Looks like "got stung by a bee"). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at a dose of 180 milligram. At the time of the report, PERIORBITAL OEDEMA (Swelling around right eye Looks like "got stung by a bee") had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient awoke several times in the night with abdominal pain.  We treated with Pepto Bismol (antacid) and saw no relief.  In the morning the pain continued and worsened, becoming overwhelmingly severe.  It was painful to walk.  She was carried to the pediatrician's office at 10:15AM.  The pediatrician observed that patient was tender on palpation and advised that we take her immediately to Hospital's outpatient radiology for a sonogram to determine whether she had appendicitis.  In the car on the way to the sonogram she began to feel much better.  By around 12:25pm the pain had completely gone away.   The sonogram at around 1PM  showed no abnormalities.  She ate a light lunch and was fine thereafter.
No symptoms until day 8, when my arm starting itching and I noticed a lump and a rash--reactive area around 3 inches wide. On day 9, rash is worse and the reactive area is around 5 inches in size.
I21.4 ACUTE NON ST ELEVATION MI 2/13/2021 DM 2 W HYPERGLYCEMIA
Shingles; This is a spontaneous report from a contactable nurse, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER2613) via an unspecified route of administration in left arm on 17Mar2021 at 14:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included eosinophilic esophagitis (EOE) and the patient was allergic to sulfa and penicillin. Concomitant medications included multivitamin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6202) via an unspecified route of administration in left arm on 24Feb2021 at 14:30 (at the age of 33-years-old). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 24Mar2021, the patient underwent COVID-19 nasal swab test and the result was negative. On 28Mar2021 at 10:00, 10 days after the second dose of vaccination, the patient experienced shingles. The adverse event resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient received treatment with antiviral and lidocaine patches for the reported event. The clinical outcome of the event shingles was not resolved at the time of report. No follow-up attempts are needed. No further information is expected.
Localized reaction to DTaP vax. Developed erythema, swelling, and mild tenderness over left deltoid area. No history of fever. Advised to treat with Tylenol and supportive care as needed.
Information has been received from a healthcare worker concerning an unknown number of patients who were vaccinated with improperly stored GARDASIL (Lot #, dose and route not reported). The GARDASIL was exposed to 30 degrees F. No adverse effect was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. All telephone attempts to obtain follow up information have been unsuccessful. Follow-up information was received from a Medical Assistant concerning a 12 years old female patient. The patient was vaccinated with a dose of GARDASIL lot# (670048/0963AA), IM right deltoid on 29-DEC-2011 at 03:51 PM. No other co-suspects were reported. No concomitant medications reported. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was store at a temperature of 32 degrees F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
Flu shot given on 1/10/13 high on arm at shoulder. 1/10/13 Pain in arm from shoulder to elbow began - muscles in arm severe pain - worse at night when laying down - throbs. Unable to raise arm. Saw Dr. following week - thought nerve may have been hit. Reported to pharmacy - twice. Just had X-rays and will be going to specialist soon.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Child complains of injection site pain, redness, swelling, and heat. Also complains of fever, headache, chills, and nausea. Inspection of injection site reveals a one centimeter blister over the injection site with redness and induration spreading another centimeter out from the blister. Patient was treated with Cetirizine and Amoxicillin-potassium clavulanate.
Lt arm very sore two hours after the injection- then at 4 hours after started not feeling well achy and headache.  Went to bed woke up with sever pain in all joints. Tylenol taken when went to bed at 6 hours after injection.  Woke up after three hours of sleep with the severe pain in all the joints and sever headache.  Took another Tylenol. Up most of the night with severe headache, nausea, chills, severe pain in bones and joints. Took Tylenol and then waited three hours and took Ibuprofen.  Took both medications at three hour intervals through out the early morning and up until 28 hours after the injection.
Rash on upper right and left thigh, r/L buttocks, r/L thigh behind leg, rash on R palm. Itching, raised. 7 days post injection. No treatment as of yet