chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15:30: MMR/Hep A administered within 5 minutes, dad returned to office with patient opon noting hives around mouth/lips and left cheek. RN call doctor. 15:45: 2 tsp. Benadryl administered PO. Patient swallowing easily, speaking clearly, no swelling of lips or neck or tongue. No difficulty breathing. no hives at injection site. BP and pulse monitored. Cold pack applied to face. 16:30: Patient released by doctor with instructions to take 10mg Claritin after dinner and instructed dad to call office if hoarseness or lip swelling occurs and call 911 if difficulty breathing occurs. Hives had decreased significantly by time of release.
administered post excursion to a patient; Initial information received on 14-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 20 years old male patient to whom diphtheria -2/tetanus -5 adsorbed toxoid NO preservative adult [Tenivac] was administered post excursion, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 06-Dec-2022, the patient received an unknown dose of suspect diphtheria -2/tetanus -5 adsorbed toxoid NO preservative adult, Suspension for injection, post excursion (poor quality product administered) (strength-standard) ( lot U7189AA and expiry date - 30-Sep-2023) via intramuscular route in the left deltoid for Immunization.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 guidelines 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.
Pt recv vax on 4/13/99; on same day pt exp fever (102), edematous eyes, hives face, trunk, chest, neck, back
Uncontrolled shivering. High fever 103.9 (my regular core body temp is consistently 98.6). Weakness. Fainted twice - once in bed and once crawling to bathroom. Back area (felt like kidneys but most likely just back muscles) sore and aching. Moving in bed between sore left arm at injection site and back muscles acutely uncomfortable. Headache, muscle ache, fatigue. 2 days after injection, site is still red and warm, BUT improving. Handout stated: "About 12 out of 6 people who got recombinant zoster vaccine experienced side effects that prevented them from doing regular activities." COULD not do anything but stay in bed. Improving 2 days later.
Arm very painful after vaccination. Rash developed over injection site/red, not raised, covering proximal 1/3 of upper arm, was resolving on 12/9/19.  Developed dizziness the following day which has been persistent from day 1 after vaccination until seen in the office on 12/9 and it had not resolved yet. No LOC. Also reported numbness and decreased sensation in toes 3-5 on left foot. 5th toe had resumed normal sensation by time of f/u visit on 12/9, but still with decreased sensation on toes 3 and 4. Normal neuro exam otherwise. No s/s GBS. Pt was also concurrently reporting 3 days of low grade fever 99-100, sore throat and headaches, mild congestion following vaccination. Unclear whether this was related to vaccine or viral illness
Moderna COVID-19 Vaccine EUA  3in x 2in size inflammation around the injection site, patient reports slight irritation and injection site is warm to touch and tender
contracted COVID-19, 8-9 days after vaccination; This is a spontaneous report from a contactable consumer. A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medication were not reported. The patient experienced contracted covid-19, 8-9 days after vaccination (sars-cov-2 test positive) (non-serious) on an unspecified date Mar2021 with outcome of unknown. The patient underwent treatment with Ly-CoV555 injection which he also referred to as Bamlanivimab injection. He explained he was medically recommended to wait 90 days between this antibody therapy and the second dose of the vaccine. He asked if the second dose could be delayed. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Swelling, redness, tenderness over Left upper arm of injection site with systemic chills, rigors, nausea, vomiting and weakness worse over 48 hrs.
SORE BACK; HEADACHE; FEVER; NOSE BLEEDS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A, expiry: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced nose bleeds. On 02-APR-2021, the subject experienced sore back. On 02-APR-2021, the subject experienced headache. On 02-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on APR-2021, and the outcome of sore back, fever and nose bleeds was not reported. This report was non-serious.; Sender's Comments: V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Moments after receiving the vaccine, while walking to the post vaccine area, patient reported right sided headache and generalized weakness. Weakness became progressively worse over 30-40 minutes, progressing to difficulty standing. Weakness generalized, not  noted to be focal/unilateral. Speech slow and soft but clear. 911 called, transported to Emergency Department . Vital signs 121/76 hr 69 O2 100% rr 18. Denied pain at the time of transport.
Patient was inadvertently given ZOSTAVAX vaccine, should have been given varicella. No adverse reactions. Received 0.5 mL not the 0.65 mL.
Flu-like symptoms started 12 house after receiving the vaccine. Chills, fever, joint pain, felt like all my muscles were spasming. I took Tylenol and ibuprofen, These symptoms last about 4 hours. I continued with weakness and overall feeling of weakness for the next 12 hours. Back to normal after 3 days.
Information has been received from a health professional concerning a 16 year old female who on 10-AUG-2007 was vaccinated with a first dose of Gardasil vaccine (lot# 658222/0927U) IM in the deltoid. On 10-AUG-2007, the patient experienced immediate tingling in the arm and moved to the whole side of the body which lasted 15 to 20 minutes. The patient recovered from the tingling on 10-AUG-2007. On 05-OCT-2007, the patient was vaccinated with a second dose of Gardasil vaccine (lot# 658558/1061U) IM in the deltoid. On 05-OCT-2007, the patient experienced immediate tingling in the arm and it did not spread past the arm this time. The tingling lasted for 10 minutes. The patient recovered from the tingling on 05-OCT-2007. Additional information is not expected.
Tdap was ordered (ADACEL); dtap was given (DAPTACEL).
This case was reported by a nurse and described the occurrence of stiff neck in a 31-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. There were no concurrent medications. The subject had no pre-existing medical conditions. On 05 October 2005 the subject received 1st dose of Engerix-B in the right arm (lot 131AA-incomplete lot number) At an unspecified time following the administration of the 1st dose of Engerix-B, on an unspecified date in October  2005, the subject experienced a stiff neck. The stiff neck resolved on an unspecified data before the 2nd dose of Engerix-B. On an unspecified date in November 2005, before 17 November 2005, the subject received the 2nd dose of Engerix-B. At an unspecified time following the 2nd dose of Engerix-B, on an unspecified date in November 2005, the subject again experienced a stiff neck. The subject was hospitalized. At the time of initial reporting, 17 November 2005, the stiff neck was ongoing. The nurse considered the stiff neck to possibly be related to vaccination with Engerix-B.
Rash arms - back itching chest - neck - body fine papular, erythematous, pruritis.
no adverse event; HCP states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23) and NO ADVERSE EVENT (no adverse event) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (states a dose was administered to 3 patients on 22JAN2023 after the 30 day use by date/ Moderna lot 044C22A BUD 1/22 used on 1/23 and Lot 215K22A BUD 1/20 and given on 1/23).    This case contains information for the 1st infant patient out of 3 patients (2 infants and 1 adult) described by the reporter.  No concomitant information was reported. Reporter wants to know if there was any stability information for this invalid dose and reporter states that the patients could had possibly been 2 infants and 1 adult impacted by this invalid dose. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706707, US-MODERNATX, INC.-MOD-2023-706711 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2023: Follow-up received contains no new information On 31-Jan-2023: Live significant Follow-up contains Product information and narrative updated. On 31-Jan-2023: Follow-up received contains no new information On 15-Feb-2023: Significant follow-up: Patient details, Reporter details and lot number updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706707:Master Case US-MODERNATX, INC.-MOD-2023-706711:Master Case
This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 07-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. No adverse events were experienced. This is one of several reports from the same reporter. Additional information has been requested.
inadvertently administered the Fluzone Quadrivalent to a 2 months old instead of prevnar/no ae; inadvertently administered the Fluzone Quadrivalent to a 2 months old instead of prevnar/no ae; nurse preparing the product withdrew a Fluzone Quadrivalent dose from a "blue box", where Prevnar is also stored and inadvertently administered the Fluzone Quadrivalent/no AE; nurse preparing the product withdrew a Fluzone Quadrivalent dose from a "blue box", where Prevnar is also stored and inadvertently administered the Fluzone Quadrivalent/no AE; Initial information received on 15-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)  (PREVNAR). (PT: Product administered to patient of inappropriate age, Wrong product administered, Product selection error, Product commingling)  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 15-Apr-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6713LA via intramuscular route in the right thigh.  It was of actual medication error due to Inappropriate age at vaccine administration, Wrong vaccine administered, Wrong product selected, Wrong product and correct product in same container. On 15 APR 2020, a nurse reported a 2 month old female patient was expected to receive a dose of Prevnar. The nurse preparing the product withdrew a Fluzone Quadrivalent dose from a "blue box", where Prevnar is also stored and inadvertently administered the Fluzone Quadrivalent.  It was unknown whether adverse event was noted.  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.
Patient couldn't sleep at night because of the pain and inflammation in arm. He put his arm in cold water to relieve pain. It got a little better but still some redness and inflammation exists.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA lot # M036459 with expiration date of 28-OCT-2017 and lot # M036459 with expiration date of 18-JAN-2018 (doses, route of administration and anatomical location were not provided). No adverse effects were reported. Administered doses of vaccine underwent a temperature excursion of 48.7 degrees Fahrenheit (F) for 13 hours which was detected by a data logger. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA009410: US-009507513-1704USA009408: US-009507513-1704USA009409.
My son completely fainted/passed out about 2 minutes after both shots. After the first shot, they said that due to his age group, he may have been anxious, but we both feel he was not. We took extra precautions like drinking extra water and Gatorade before and after the second shot, but it happened again.  This is not normal for him. He has never passes out from any other vaccination shots or flu shots ever. So he must have had a bad reaction to whatever ingredients are in the vaccine itself.  If a booster shot is mandated in the future, he will NOT be getting. Besides him fainting after both shots, other side effect he had was a headache and sore arm after the first shot. And after the second shot, he had a headache, a very sore arm, and was very tired and had some foggy COVID brain for a few days after.
Client received 2 doses of Moderna  at a different facility and then presented as a first dose at the health department in order to receive $100 gift card incentive (per her statement:  "I needed the money.".   Moderna dose #1: 05-10-2021;  Lot # 033B21A; RIGHT deltoid at  Moderna  dose #2: 06/07/2021; Lot # 033B21A; LEFT deltoid at  Pfizer dose:  08/24/2021:  Lot EW0172; RIGHT deltoid at
Patient contracted with covid-19 infection week after 1st dose; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Patient contracted with covid-19 infection week after 1st dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hypothyroidism. Concomitant products included LOSARTAN for Product used for unknown indication, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) and LEVOTHYROXINE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (Patient contracted with covid-19 infection week after 1st dose). The patient was treated with DEXAMETHASONE for Product used for unknown indication, at an unspecified dose and frequency and AZITHROMYCIN at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient contracted with covid-19 infection week after 1st dose) outcome was unknown.        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.    Second dose was scheduled on 04-FEB-2021
slept for 4-5hrs p/inj when awoke febrilet105 per mom 104 per ER; slightly cranky, exam nl;fever resolved in 2-3hrs
lymph node on his left side was swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node on his left side was swollen) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph node on his left side was swollen). At the time of the report, LYMPHADENOPATHY (lymph node on his left side was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. No treatment details were reported.
No adverse event; The patient was inadvertently administered a dose of VARIVAX (Lot#N034558/Exp: 12/5/2019), that was expired; This spontaneous report was received from a certified medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not reported.  On 08-JAN-2020, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # N034558 (expiration date: 05-DEC-2019) for prophylaxis (strength, route and anatomical location not reported), that was expired. The patient had no additional adverse event. No product quality complaint (PQC) was involved.
Shooting pain in arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2019, the patient received the 1st dose of Shingrix. On 5th July 2019, 2 days after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had experienced shooting pain in his arm since two days after the injection. The pain shoots down the patients left arm when he raises the arm. The reporter stated that the pain resolves when the arm is lowered, but returns when arm is raised again. The patient had not sought treatment from a physician as of the time of reporting. The reporter consented to follow up.
ABout 25m after shot, patient felt significant itching in throat. Was coughing and clearing throat a lot. Denied respiratory distress though. Able to swallow, so given 50mg Benadryl PO. Symptoms improved after 20-25m. Evaluated by both NP and Paramedic at clinic. Picked up by supervisor and transported to  ER for observation. Symptoms never worsened and was released after a few hours of observation. Patient contacted by phone 48h later and said she was still feeling well and not allergy symptoms. Advised not to get shot #2.
Pt wasn't feeling well, said she was feeling dizzy 5 minutes after getting shots.  She said she had anxiety and believed the 3 shots was too much for her and making her bloodpressure goes up.
Pt vaccinated with DTP and experienced screaming fit for 4-5hrs on 29JUN90.