chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client completed 15min observation after vaccine and went out to her car. She noticed a rash on chest, and a dull headache so she came back in. Client was given 50mg of Benadryl PO and was observed for another 15min. Nurse observed a rash on chest that looked like hives and some redness on her right arm. Client's rash decreased but she did complain of a feeling of thickness in her mouth. There was no difficulty swallowing or breathing. Client was released to leave clinic site at 4:06 pm by RN.
It was reported that a 45 year old male received Fluzone SV 98-99 USP on 10/15/1998. Reportedly 6 hours after getting injection the pt developed shaking chill lasting off and on for 12 days. Reportedly the pt was seen by a physician. From additional information received on 11/23/1998 it was reported that the pt recovered from this experience.
She developed new onset acute psychosis. Was admitted to hospital for management and monitored overnight with head imaging, labs and an EEG that did not show any seizure activity. Psychosis appears to have resolved over past 24 h (several days after injection) - d/c from hospital last night 2/25.
from 2nd shot i had 103 fever for 3 days and  then had an increase in migraines, fatigue formonths and saw changes in my period. i felt pms all the time and bleed every 2 weeks. booster- relatively fine flue symptoms and 7 days later 3 days of migraines 10 days later full-body rash (very very itchy and burns if I scratch, very red and feels and looks like topographic map, huge bumps, lumps psoriasis looking patches, that is literally head to to feet. right arm swelled up left ankle swelled up. I am in day 3 of itchy turmoil.
Received injection 3-8-06 called 3/10/06 with c/o redness, warmth at site.
Swelling itching, fever, possible infection of injection site, sweats, chills, Tx Antibiotic given, patient doesn't know the name of it.
I was 35 weeks pregnant at the time of my second dose of Moderna COVID vaccine. Approximately 15 hours after receiving the vaccine, I developed a fever.  Approximately 18 hours after receiving the vaccine, my water broke and I went into preterm labor (baby and I are fine).
After my second dose Pfizer vaccine and about two weeks later I experienced  soreness to my left arm at the injection site. I also experienced fatigued, tiredness, body aches and started to have a urinary problem. To this day I am still having urinary problems and am seeing a doctor for treatment.
expired dose of Infanrix was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received DTPa (Infanrix) (batch number KG4M7, expiry date 6th February 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th April 2022, the patient received the 4th dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 20th April 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: Registered nurse (RN) stated that an expired dose of Infanrix was administered to a patient on the day of reporting. The reporter consented to follow-up via mail. Additional Supportive Information: On 20th April 2022, patient received dose of Infanrix that was already got expired on 6th February 2022, which led to expired vaccine used. Note: As per the structure field, dose no 4 was captured.
weak; dizzy; swelled bump about half a inch; chills; couldn't raise arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), LIMB DISCOMFORT (couldn't raise arm), DIZZINESS (dizzy), VACCINATION SITE SWELLING (swelled bump about half a inch) and CHILLS (chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M2OA) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included Vertigo. Concomitant products included SIMVASTATIN, MULTIVITAMIN & MINERAL and COLECALCIFEROL (D-3) for an unknown indication, ZINC.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 10-Feb-2021, the patient experienced LIMB DISCOMFORT (couldn't raise arm), VACCINATION SITE SWELLING (swelled bump about half a inch) and CHILLS (chills). On 11-Feb-2021, the patient experienced ASTHENIA (weak) and DIZZINESS (dizzy). At the time of the report, ASTHENIA (weak), LIMB DISCOMFORT (couldn't raise arm), DIZZINESS (dizzy), VACCINATION SITE SWELLING (swelled bump about half a inch) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Lips are numb), THROAT TIGHTNESS (throat tightened up), LIP SWELLING (her lips swollen up like she had bad Botox), FEELING HOT (she felt hot all over (she felt like she drank the contrast prior to a scan)) and PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included EZETIMIBE (ZETIA) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Lips are numb), THROAT TIGHTNESS (throat tightened up), LIP SWELLING (her lips swollen up like she had bad Botox), FEELING HOT (she felt hot all over (she felt like she drank the contrast prior to a scan)), PAIN (pain) and PYREXIA (fever). At the time of the report, HYPOAESTHESIA ORAL (Lips are numb) had not resolved and THROAT TIGHTNESS (throat tightened up), LIP SWELLING (her lips swollen up like she had bad Botox), FEELING HOT (she felt hot all over (she felt like she drank the contrast prior to a scan)), PAIN (pain) and PYREXIA (fever) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment information was unknown. It was reported that the family doctor told the patient not to get the second dose. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up information was received from the initial reporter: The reporter contact details were added.
patient received a fluzone high dose quadrivalent today, patient did have the same shot two weeks ago and the patient forgot, with no reported adverse event; Initial information was received on 12-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional via Regulatory authority (under reference:00809230).  This case involves a 77-year-old female patient who received a INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] today, patient did have the same shot two weeks ago and the patient forgot (extra dose administered).   The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 12-Oct-2021, the patient received a second dose of 0.7mL suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ733AA and expiry date: 30-June-2022) via intramuscular route in the right deltoid for prophylactic vaccination.  This was an actual case of medication error due to extra dose administered (same day latency).  It was reported "medical assistant is calling to report that a patient received a FLUZONE HIGH DOSE QUADRIVALENT today in the office. The patient did have the same shot two weeks ago and the patient forgot. The husband called the doctors office today to advise."  At time of reporting, 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 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.
Afebrile Intussusception on 2/20/11. Pt started with vomiting on 2/20/11. He was seen in the office and later he continued to vomiting and became more lethargic. Pt was seen at hospital. Abdominal Xray showed abnormal bowel gas pattern. Pt transferred. Air enema reduced intussusception. Pt observed x 1 day. Pt recovered 2/23/11 pt seen in office feeding well.
Temp 100; malaise; body aches; very sore arm; This is a spontaneous report from a contactable nurse (patient herself). A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK5730), via an unspecified route of administration (left arm), on 22Dec2020 19:00, at single dose, for covid-19 immunization. Medical history included asthma and; Covid (prior to vaccination). The patient has no known allergies. Concomitant medications included niacin; colecalciferol (D3); cyanocobalamin (B12); loratadine and; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient was also taking ginger. The patient experienced temp 100, malaise, body aches, and very sore arm - all on 23Dec2020 10:00. The patient recovered from all the events on an unspecified date. No treatment was received for all the events reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccination and; have not been COVID tested post vaccination.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided.  On 14-NOV-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L043702 with expiration date 03-NOV-2017 status albumin: RHA) . Concomitant medications were not reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. Data logger was involved. No adverse effects reported. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerns a 69-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F. On 13-Sep-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported) which underwent temperature excursion. The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804106 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
3-13-21 Shot, soreness in arm and knot nothing else notable except maybe mild headache 3-23  start with itchy rash mid back,  arm still sore knot smaller 3-24  Rash continued to spread up back extremely itchy  3-25 Rash continue to spread to stomach area , major head ache, vomiting (one time) temperature 97.1 3-26  Rash continue to spreading to  left breast headache, no appetite  3-27 Rash continued spreading to buttock cheeks, apatite improving  3-28 Rash continued to spread arms,  Knott in arm getting small feeling itchy all over. 3-29 Rash continued to spread to lower limbs. knot in arm almost gone, visit to doctor . Prescribed steroids for 7 days follow up in one week.
A nurse reported the occurence of injection site soreness in a 34-year-old female who inadvertenly received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix).  The medical history, concurrent conditions, and concurrent medications were not specified.  On 05/28/2002, the vaccinee inadvertently received a "booster" injection of Infanrix (lot DTPA542A2; expiration date 09/24/2003), rather than tetanus toxoid..Subsequently, she experienced a sore arm.  The outcome of the event was not stated.
Local and systemic symptoms. Fever, chills, malaise, body aches, joint pain, large painful bruising and erythema left upper arm at injection site.
This spontaneous report was received from a nurse and refers to a male 4 years old patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 25-JUL-2017 at 12:58, the patient was inadvertently administered PROQUAD Therapy type rHA (recombinant human albumin), first dose, intramuscular (lot #M042500, expiration date, dose and schedule were not provided) instead of M-M-R II (lot #, expiration date, dose and schedule were not provided). On 25-JUL-2017 at 12:03, the patient also received VARIVAX second dose intramuscular (lot # M014309, expiration date, dose and schedule were not provided). Concomitant therapies included sterile diluent. The patient did not experience any adverse event.
Vaccine more of a brownish color/discoloration/Brownish yellow honey colored; Wasn't that much in the syringe; Injection site feels "warm to touch"; Got feverish like a normal shot would do; A spontaneous report was received from a consumer, who was also a 70-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that the vaccine was not white or clear, more of a brownish yellow/honey colored /product color issue, she got feverish/pyrexia, there wasn't that much in the syringe/accidental underdose and injection site feels warm to touch/vaccination site warmth.  The patient's medical history was not provided. She had no allergies. No relevant concomitant medications were reported.  On 06 Feb 2021 at 8:30 am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 013M2014) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection.    The patient reported that the vaccine administered was not white or clear, but more of a brownish yellow (also reported as honey colored).  There was a discoloration but had already been administered.  When the patient looked at the syringe on television, it was clear.  She stated that the website said it should be white, but this was more of a yellowish brown.  The patient also reported that there wasn't much in the syringe but knew it was supposed to be the 0.5 ml.  The patient also reported that she didn't even feel the shot being given when it was administered.    As the day went on, the patient got feverish like a normal shot would do, which she said lasted a couple of days and through this week.  She did not contact her primary care physician about her concerns because she doesn't really go to the doctor.  The patient felt comfortable that the vaccine was administered the right way, intramuscularly.  She was not sure if the vaccine was spoiled at that color.  In addition, the patient reported that the injection site felt warm to touch. No treatment was provided for the events.  Action taken with mRNA-1273 in response to the events was not reported.   The events, vaccine was not white or clear, more of a brownish yellow/honey colored and wasn't that much in the syringe were considered resolved on 06 Feb 2021.  The event, got feverish, was considered resolved on an unknown day in February 2021. At the time of this report, the outcome of the event, injection site feels warm to touch, was unknown.  Follow-up Follow-up received on 24 Mar 2021 included vaccination date details and events.; Sender's Comments: This report refers to a case of (Product discoloration issue and accidental underdose  for mRNA-1273, lot # 013M2014  with associated AEs vaccination site warmth and pyrexia. 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. US-MODERNATX, INC.-MOD-2021-012063:
No additional adverse event; the patient was inadvertently administered a dose of VARIVAX on 6/16/2020, that had been improperly stored; This spontaneous report has been received from a nurse, referring to a 19 months old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 16-JUN-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S028925 with expiration date: 16-SEP-2021; dose, strength and route were unknown) for prophylaxis, that had been improperly stored (product storage error). The lot of varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent (unknown lot# and expiration date). No additional adverse event.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion below 7.2 degrees Fahrenheit (F) for 30 minutes. On 05-JUN-2020, the previous temperature excursion was 6F to 14F for 1 hour and 15F to 46F for 4 hours. On 08-JUN-2020, the previous temperature excursion was 6F to 14F for 1 hour 50 minutes. On 15-JUN-2020, the previous temperature excursion was 6F to 14F for 20 minutes. The digital data logger was involved to capture the temperature excursion.
Patient was given a Kinrix vaccine today.   aprox 1030am.   Patient left the clinic and went to school.  The patient's mother called stating the patient had a "seizure" at school.  She was seated at a table in the cafeteria and the lunch attendant noticed her "wobbling" in her seat.  When the attendant walked over, the patient fell backwards and was caught by the attendant.   Her arms and legs were shaking and she was unresponsive for aprox 10 seconds.   After regaining consciousness, she was walked to the nurse who checked her temp which ranged from 99.6-100.0F.   The patient's mother called the clinic and was referred to the ER for evaluation.   The mother stated that when the patient was 18mo old, she was given 6 vaccinations and had a fever and vomiting for 4-5 days after.  Today was her fist vaccination since she was 18mo old.
body aches; arm pain from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and VACCINATION SITE PAIN (arm pain from the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pfizer (dose 2 of Pfizer) and pfizer (dose 1 of pfizer). Past adverse reactions to the above products included No adverse reaction with pfizer and pfizer.    On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced MYALGIA (body aches) and VACCINATION SITE PAIN (arm pain from the injection site). On 22-Dec-2021, MYALGIA (body aches) had resolved. At the time of the report, VACCINATION SITE PAIN (arm pain from the injection site) outcome was unknown.            No Concomitant product use was reported.  The reporter was calling on behalf of their daughter who was the patient. The patient got their 1st 2 doses of Pfizer and on 20-Dec-2021 got the booster dose of the Moderna Covid-19 vaccine. On 21-Dec-2021, the patient had body aches, until 22-Dec-2021, The patient also had arm pain from the injection site.  No treatment information was provided.   This case was linked to MOD-2021-424245 (Patient Link).
Within 25 minutes experienced increased HR-see vital signs: 0930 HR 120 BP 140/80, 0932 88 118/70; 0935 72 110/70; 0940 68 112/68; 0945 64 110/62, 0950 68 110/60, 0955 60 108/60.
Patient had no issues with 1st shot. After 5 minutes of injection pt fainted. He revived right away but pupils were dilated and he had trouble staying conscious. After a few more minutes pupils were normal but he was pale and sweaty. He drank some water and felt better. EMS were called and said he was ok. All happened within 30 minutes.
first booster was a full dose but she was not really immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (first booster was a full dose but she was not really immunocompromised) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 32L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Asthma.   On 04-Feb-2011, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2021, 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OVERDOSE (first booster was a full dose but she was not really immunocompromised). At the time of the report, OVERDOSE (first booster was a full dose but she was not really immunocompromised) outcome was unknown.            Treatment details was not reported by the reporter.   This case was linked to MOD-2022-593848 (Patient Link).
Headache, Myalgia, Fever, Tachycardia, Chills, injection site soreness Narrative:
He hadn?t felt well, with flu like symptoms, he took an at home covid test to be sure which came back negative. He called his PCP and they sent in a prescription for dexamethasone 4mg and Azithromycin 250mg, and he died within 24 hours of treatment. He was having trouble breathing in prior conversations with him and flu like symptoms, starting Friday April 1st, and died on Tuesday April 5th.
Left knee joint clicking and mild discomfort started mid to end of January 2021. Similar symptoms in right knee but very mild. Not sure if it is related to vaccine or not.
Intense abdominal cramps Wednesday 05/28.  Early irregular period 07/31.