chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dosage: 0.25 ml; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Dosage: 0.25 ml) and NO ADVERSE EVENT (No adverse event) in a 50-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Dosage: 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Dosage: 0.25 ml) 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 ACCIDENTAL UNDERDOSE (Dosage: 0.25 ml). Concomitant Medication use information was not provided by reporter. The patient initial was reported as 1 patient. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.
This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored GARDASIL (dosing details were not reported) (lot # K007264 with an expiry date of 02-MAR-2017 exposed to 31.8 F for 8.75 hours) and (lot # K009482 with an expiry date of 06-MAR-2017 exposed to 31.8 F for 10.75 hours). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sore Arm; Headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), HEADACHE (Headaches) and CHILLS (chills) in a 77-year-old female elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) , while the parent received the product for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Food allergy and Iodine allergy. Concomitant product exposures included ATORVASTATIN for an unknown indication.    On 27-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 05-Feb-2021, the elderly was diagnosed with PAIN IN EXTREMITY (Sore Arm), HEADACHE (Headaches) and CHILLS (chills). The elderly was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 12-Feb-2021, PAIN IN EXTREMITY (Sore Arm) and HEADACHE (Headaches) had resolved. At the time of the report, CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Follow up received . Patient details , patient history, product batch number , event outcome, start date stop date new event are added
Arm soreness one day after received immunization-swelling noted 24 hours post vaccination.
This spontaneous report as received from a nurse refers to a male patient of unknown age. The nurse reported that the male patient was due for his 3rd dose of GARDASIL. The patient might have received VAQTA (lot number and expiration date not reported). There was no concomitant medication reported. No adverse effect reported. Additional information has been requested.
This spontaneous report was received from a medical assistant (also reported as nurse practitioner) via a company representative referring a 12 year old female patient. The patient's concurrent conditions and medical history were not provided. On unknown dates, the patient was vaccinated with three series of GARDASIL 9 (route, anatomical location, lot number and expiration date were not provided) for prevention of HPV. Concomitant therapies were not provided. On an unknown date after the second dose of GARDASIL 9, the patient experienced bright red legs and pain. Subsequently, she was diagnosed with erythromelalgia. The patient sought for medical attention with rheumatologists, a blood test was performed (results were not provided) and steroids were used for treatment. Nevertheless, on an unspecified date 3 days after the third dose of GARDASIL 9, the symptoms were exacerbated. At the time of this report, the outcome of erythromelalgia was unknown. It was reported that there was no intervention to prevent serious criteria, the case did not involve cancer or overdose, the patient did not die, there was no hospitalization and no significant disability and none of the events were life-threatening. There was no product quality complaint (PQC) involved. The reporter did not provide a causality assessment between erythromelalgia and GARDASIL 9. Additional information has been requested.
Patient fainted 2 min after receiving the vaccine.  She fell into her fiance, who let her down softly onto the floor.  Regained conciousness after 1 min.  Was checked out by EMS 5 min later and all vitals were normal.  Left on her own.
I slept until almost 5pm with exhaustion and trouble breathing.; I slept until almost 5pm with exhaustion and trouble breathing.; severe migraine, muscle pain, weakness, high fever over 100; severe migraine, muscle pain, weakness, high fever over 100; weakness; high fever over 100/on and off light fever; cold sweats; nausea; difficulty moving; coughing/Mild cough; dizziness/ some dizziness; and coming home before 12pm, I slept until almost 5pm; inability to stand; This is a spontaneous report from a contactable consumer (patient herself). A 24-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0178; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 24May2021 10:45 (at the age of 24-years-old) as DOSE 2, SINGLE and patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0178; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 03May2021 10:45 (at the age of 24-years-old) as DOSE 1, SINGLE both for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included rheumatoid arthritis, anaemia and drug hypersensitivity; sulfa medications from an unknown date and unknown if ongoing. Concomitant medication(s) included ferrous sulfate (FERROUS SULFATE) taken for an unspecified indication. The patient previously took Enbrel and Indomethacin [indometacin] and experienced drug hypersensitivity. 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. It was reported that, after receiving the vaccine and coming home before 12PM on an unspecified date in May2021 patient slept until almost 5pm with exhaustion and trouble breathing. Symptoms subsided and after a hot shower around 10Pm patient experience a severe migraine, muscle pain, weakness, high fever over 100, cold sweats, nausea, difficulty moving, coughing, and inability to stand until 8Am. Patient did not receive any treatment for adverse event. This report was not serious. Since the vaccination, patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: over 100 on an unspecified date. The outcome of all events was resolved with sequel.  Follow-Up (25Jun2021): Follow-up attempts are completed. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 21-year-old male patient who received MENVEO. Previously administered products included Tdap vaccine with an associated reaction of injection site pain. On 1st June 2016, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On 1st June 2016, less than one day after receiving MENVEO, the patient experienced injection site muscle pain and injected limb mobility decreased. On an unknown date, the outcome of the injection site muscle pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain and injected limb mobility decreased to be related to MENVEO. Additional details were provided as follows: This case was previously reported to a manufacturer. The reporter stated that, after vaccination with MENVEO the patient was still experiencing deep muscle pain on the inside. There were no injection site symptoms. The patient stated that, it was hard for him to move his arm when he wakes up in the morning and it took him time to where the pain loosens up. The morning was the worst. The patient is pretty athletic and active, but had not been able to perform regular exercises, like a push-up. His arm feels like day two or three and had not improved. The reporter, also stated that patient compared this experience to when he received the Tdap vaccine, in which he only experienced tenderness for two days before it subsided.
Initial report was received 16 January 2009 from another manufacturer; document number 927258.  The other manufacturer received the report from a health care professional.  A 16-year-old male patient had received a left deltoid injection of MENACTRA, lot number U2728AA (route not reported) on 19 December 2008 at 12:15am and shortly afterwards, the patient complained that they could not breathe.  The patient's mother had been present at the time of vaccination and the patient was fine.  According to the reporter, the patient was quiet so the nurse asked the patient if he felt okay.  The patient replied "yes".  The nurse then left the patient to wait for the doctor to perform a physical exam.  An unspecified amount of time later, the patient's mother came out of the room yelling for help.  The nurse went in the room and the patient "was grabbing at surrounding cords".  The patient's mother stated that the patient couldn't breathe.  The nurse told the patient to relax and had him lay down; then went to get ice and report to the doctor.  Oxygen sats were 98% on room air.  The patient recovered from the event on 19 December 2008 (duration of the event and time of recovery were not reported).  No additional information was provided at the time of the report.  Documents held by sender: None
now I have red itchy bumps to both forearms and on my knees and behind my knees; my elbows were itching really bad; This is a spontaneous report from a contactable consumer.   A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation .Age at vaccination:44 years. The patient medical history was not reported. The patient received first dose of bnt162b2 on unkonwn date. The patient's concomitant medications were not reported.  The patient stated she received her second Pfizer covid vaccine on Tuesday and last night "my elbows were itching really bad and now I have red itchy bumps to both forearms and on my knees and behind my knees".Onset date of events was reported  on 26Feb2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained
Large red patch that went down to elbow, significant swelling. Started on same day. Still has redness down to elbow, but swelling has gone down. Tender/sore to the touch.
Allergic reaction to smallpox vaccination. Red streak going from vaccine area to the underarm. "Keflex" for skin infection.
arpound 3:00 i felt like a truck hit me. Every muscle ached, my neck, back. ears. eyes muscles ached for approximately 24 hours and i couldnt even drive to the emergency. I would never take this medicine again. it is 5:00 on 9/6/23 and i feel fine
fully vaccinated and boosted but still had a breakthrough case of COVID where the patient was very ill; fully vaccinated and boosted but still had a breakthrough case of COVID where the patient was very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic Lyme disease, Epstein Barr and babesiosis" (unspecified if ongoing), notes: chronic Lyme disease, Epstein Barr and babesiosis. The patient's concomitant medications were not reported.  The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "fully vaccinated and boosted but still had a breakthrough case of COVID where the patient was very ill". Therapeutic measures were taken as a result of suspected covid-19, drug ineffective, illness. Paxlovid saved the patient. The patient believed it knocked other virus out because he/she had chronic Lyme disease, Epstein Barr and babesiosis. Recently the patient had been pale and tired. The patient was not sure what else the drug treated but felt better than he/she had in years. The feet no longer hurt when he/she walked in the AM and energy had tripled.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Varicella, MMR, HIB, PCV-13 given on 8/20/10. Developed rash on 8/31/10. Accompanied by bilateral ear infection with fever.
heart palpitations and shortness of breath - especially when exercising limb discomfort - especially in legs where I have numbness and restless leg issues brain fog - decrease in ability to think clearly
Temperature excursion and administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 11th April 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 14-Apr-2022 Reporter's comments: The healthcare professional reported that Boostrix had undergone a temperature excursion and the vaccine was administered to the patient on the same day. The patient had not experienced any adverse events.  The reporter was with provided telephone number for Medical Information for future reference. The reporter disconnected call whilst transferring to Medical Information. Additional Supportive Information: The patient received Boostrix which undergone temperature excursion, which led to incorrect storage of drug. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065218:Same reporter. US-GLAXOSMITHKLINE-US2022065221:Same reporter. US-GLAXOSMITHKLINE-US2022065222:Same reporter.
I'm so tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I'm so tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (I'm so tired). At the time of the report, FATIGUE (I'm so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were not provided.
pt recvd vax;subsequently was noted that vax was expired;at time of report no problems noted
RASH STARTED IN THE ANTERIOR WAIST , AND BIALTERAL LOWER LEGS ABOUT 30 HOURS AFTER VACCINATION. THE RASH EXTENDED TO THE ANTRIOR PELVIS, THIGH , UPPER ABDOMEN, ANTERIOR NECK AND FOREARM, AND EXTEND TO THE UPPER ARM IN 48 HOURS. THEN  ABDOMINAL RASH DESAPPERED. NO-MINIMAL ITCHING, NO FIEVER , NAUSEA OR DIARRHEA. MINIMAL HEADACH AND ABDOMINAL PAIN. NO TREATMENT.
Narrative:  COVID infection following COVID vaccine series 01/11, Pfizer, dose #1 02/03, Pfizer, dose #2 08/17 pt cc: fatigue, myalgias, dyspnea exposure: unknown 08/25 pt admit to medicine cc: fever, chills, body aches, fatigue, malaise, cough and some SOB dx: covid 19 pneumonia LOS: 6 days 08/25 ABG i-pH 7.48, i-PCO2 33.4, i-PO2 68, i-HCO3 24.7 08/25 SARS-COV-2 Variant Sequencing result: pending 08/25 DDIMER result: 0.63 08/25 COVID swab, result: detected 08/25 CXR impression: Patchy lingular opacity. Correlate clinically for pneumonia, including viral/atypical etiology and follow-up to resolution. 08/26 CTA PE impression: No pulmonary embolus. Bilateral groundglass opacity, suspicious for bronchopneumonia and viral pneumonia is within differential. 08/26 FIBRINOGEN result: 638 08/26 DDIMER result: 0.96 08/26 ESR result: 51 08/27 FIBRINOGEN result: 541 08/27 DDIMER result: 0.53 08/27 ESR result: 43 08/28 S.PNEUMONIAE AG Eval result: negative 08/28 LEGIONELLAAgUR Eval result: negative 08/28 ESR result: 24 08/28 FIBRINOGEN result: 399 08/28 DDIMER result: 0.51 08/29 DDIMER result: 0.81 08/31 FIBRINOGEN result: 317 08/31 DDIMER result: 1.07 08/31 ESR result: 23
1 day post smallpox vaccine patient developed severe headache, body aches, fever and loss of appetite.  Was hospitalized for 3 days and received lumbar punture, blood work, IV fluids, and brain MRI  60 day follow up states pt has not recovered. Continued chronic daily headache with photophobia.
1st dose 2 years ago, 2nd Jul2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received the first dose of Shingrix 2 years ago from reporting).   In July 2022, the patient received the 2nd dose of Shingrix. In July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: The reporter unable to provide additional details on patient or vaccine. The reporter did not consent to follow-up. Additional Supportive Information: The patient received the 2nd dose later than recommended time interval, which led to lengthening of vaccination schedule.
Information has been received from an office manager concerning a 14 month old female who on 13-JAN-2009 was vaccinated with a dose of MMR II subcutaneously. The patient broke out in hives immediately after receiving the vaccine. The hives were all over the patient's body and closer to the injection site and the patient had larger sized welts. The patient was given ZYRTEC orally and the symptoms improved and they sent the patient home that same day. The patient sought medical attention by visiting the physician's office. Follow up information was received from a physician who reported the patient with no previous medical history and drug allergies was vaccinated intramuscularly with the first dose of MMR II (rHA, lot #659879/1083X). On the same day the patient also was vaccinated with a dose of VARIVAX (Merck) (MSD) (lot #662196/1542X) subcutaneously and a dose of PREVNAR (lot #005852) intramuscularly. At 11:00 on 13-JAN-2009 the patient experienced acute onset of edema and hives at site of arms. Patient was given 10 mg ZYRTEC oral with improvement of hives within 15 minutes. The patient recovered on 13-JAN-2009. Additional information is not expected.
PATIENT REPORTS PAIN IN VACCINATED (RIGHT) ARM FROM SHOULDER TO ELBOW, ESPECIALLY WITH ACTIVITIES OF DAILY LIVING. DESCRIBES PAIN AS ACHY, NOT BURNING. TYLENOL AND IBUPROFEN NOT HELPING. ICE DOES TEMPORARILY RELIEVE PAIN. WENT TO MD AFTER SPEAKING WITH PHARMACIST ABOUT REACTION. MD PRESCRIBED KEFLEX AND PREDNISONE.
RHEUMATOID ARTHRITIS AGGRAVATED; INFECTION; SHINGLES; This spontaneous report received from a consumer via other manufacture (Abbvie) concerned a 65 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (NOV-2020), and another strain of covid-19 (FEB-2021), and concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced rheumatoid arthritis aggravated, shingles, and infection of other kind. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the shingles, infection and rheumatoid arthritis aggravated was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220506412-covid-19 vaccine ad26.cov2.s- rheumatoid arthritis aggravated. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Pt appeared clammy and ashen in face 5 min after receiving  1st Pfizer vaccine .  Had pt lay on floor in the event of passing completely out.  Elevated pt's feet on the chair.  Pt's hands where sweaty.  Pt continued talking throughout process while laying on the floor.  Pt stated she felt tired and tingly and hot.  Monitored pt for next 15 minutes until she felt well enough to sit up.  Pulse was normal and steady.  After 15-20min pt had color returning to face.  Pt felt well enough to sit up while still on floor.  Had pt sit 5 min on floor and texted on phone.  Pt felt well enough to sit on chair.  Pt sat 5 min on chair.  Pt felt well enough to stand and walk.   Mom and I monitored pt walking and doing well.  We sent pt home with mom.
Eythema - swelling, redness, pain to injection area SC area of lt. arm (4" x 4") symptoms increased from date of administration and was worse on 4-1-08 slightly reduced 4-2-08 but still consulted with Dr.