chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose of the Pfizer Covid 19 vaccine on 21 March 2021/Her second dose is due this Saturday, 3 April 2021; first dose of the Pfizer Covid 19 vaccine on 21 March 2021/Her second dose is due this Saturday, 3 April 2021; She has a   rash that has not gone away; This is a spontaneous report from a contactable consumer (patient) via a pfizer sponsored program. An 88-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection); Lot/batch no: unspecified) via unspecified route of administration, as 2nd dose, single dose on 03Apr2021 for COVID-19 immunization (at the age of 88-years). The patient medical history was not reported. Concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 on 21Mar2021, had no reactions or anything for COVID-19 immunization. Patient previously took tofacitinib citrate (XELJANZ XR) for Rheumatoid Arthritis. Patient has been taking Xeljanz XR (11 mg) for Rheumatoid Arthritis for about 3 years, but the patient was not sure if took Xeljanz while having first dose of vaccine. The patient took Pfizer covid 19 vaccine on 21Mar2021 and second dose on 03Apr2021 after which she had a rash on an unspecified date in 2021 that has not gone away. The clinical outcome for the events was unknown except the event rash which was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was given FLUZONE vaccine 3/2/16 at 9:30 am. She made a return office visit on 3/3/16 at 1 pm to report swelling of the upper lip. She was treated for angioedema as an outpatient with steroids and antihistamine.
17-year-old was administered the vaccine; A spontaneous report was received from a physician concerning a 17-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273), resulting in the event, 17-year-old was administered the vaccine.  The patient's medical history was not provided. Concomitant product use was not reported.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the mRNA-1273 vaccine was administered to a 17-year-old. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The event, 17-year-old was administered the vaccine, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a 17 year old, male patient.  The patient's medical history is not provided.  The event occurred on 06 Jan 2021, during administration of the first dose of the mRNA-1273(Lot number: 012L20A). This report refers to a case of medication error where mRNA-1273 has been administered to the patient of inappropriate age.
Received vacine on October 5 at 9:30 AM by a visiting nurse.  At 11:30 A.M. became very dizzy and light-headed, broke out in a sweat and became very pale and weak.  I sat and rested and the symptoms subsided in about 15 minutes.
approx 2 days p/vax pt noted redness & swelling @ inj site 3 inches in diameter;area hot to touch;hot packed, didn't go to MD; resolved in 2 days;4 days p/inj;
No additional information provided; she received a dose of ROT ATEQ after ROTARlX; This spontaneous report as received from a medical assistant, referring to a 6 months old female patient. The patient's concurrent conditions, medical history or concomitant medications were not provided.     On unspecified dates in November in 2021 and January in 2022 (also reported at 2 months old and 4 months old), the patient received two doses of rotavirus vaccine live oral 1v(ROTARIX) (dose regimen details, lot #, expiration date and indication were not provided) separately.  On 22-MAR-2022 (also reported as at 6-months old), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral for prophylaxis (interchange of vaccine products).  No additional adverse events were reported.
extreme itchiness; Splotches from elbow to shoulder; Pink area on arm/extremly discolored; Elevated blood pressure; condition aggravated; COVID Arm; Nose bleed; Fever; Chills; Headache; Aching muscles; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pink area on arm/extremly discolored), HYPERTENSION (Elevated blood pressure), CONDITION AGGRAVATED (condition aggravated), VACCINATION SITE REACTION (COVID Arm) and EPISTAXIS (Nose bleed) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21M and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Cipro), Drug allergy (statins), Hypertension since April 2019, Hypercholesteraemia since April 2019 and Allergy (fiberglass). Concomitant products included EVOLOCUMAB (REPATHA SURECLICK) for Cholesterol, CARVEDILOL, LISINOPRIL, CLOPIDOGREL, ACETYLSALICYLIC ACID (ASPRIN) and CLONIDINE for Hypertension, MULTIVITAMIN [VITAMINS NOS] 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 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Aching muscles) and PAIN IN EXTREMITY (sore arm). On 02-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pink area on arm/extremly discolored), HYPERTENSION (Elevated blood pressure), CONDITION AGGRAVATED (condition aggravated), VACCINATION SITE REACTION (COVID Arm), EPISTAXIS (Nose bleed) and RASH (Splotches from elbow to shoulder). On 05-Apr-2021, the patient experienced PRURITUS (extreme itchiness). At the time of the report, VACCINATION SITE DISCOLOURATION (Pink area on arm/extremly discolored), HYPERTENSION (Elevated blood pressure), CONDITION AGGRAVATED (condition aggravated), VACCINATION SITE REACTION (COVID Arm), EPISTAXIS (Nose bleed), PRURITUS (extreme itchiness), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Aching muscles) and PAIN IN EXTREMITY (sore arm) had resolved and RASH (Splotches from elbow to shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood pressure measurement: 197/99 mmHg (High) 197/99 at 5 am.         For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) , reporter did not provide any causality assessment.   This case was linked to MOD-2021-108741 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: patient demographics, concomitant medications, medical history, lab values, description of events, treatment information On 29-Jul-2021: NNI FU - No new information was provided.
Pfizer COVID-19 vaccine administered on 03/13/2023 that expired on 03/09/2023.
Information has been received from an office manager (health professional) referring to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VAQTA (lot # L028666, expiration date 04-NOV-2016, strength, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Reports "tongue and throat feels swollen and tightening"  BP 147/100, PR 76, O2 sat 100%
Arm pain and nausea day of shot, this lasted 3 days.  Subsided and on 12/5 developed sore and red throat, fever of 100.3 and enlarged tonsils.  Tested for strep and covid on 12/6, both negative.  Fever broke by end of day 12/8, sore red throat and swollen tonsils continued and cough and runny nose began.  Throat culture collected on 12/9, and repeat strep test on 12/10.  Strep test was again negative.  Throat culture results tested positive for haemophilus influenzae on 12/12 - began 10 day antibiotic of Cefdinir on 12/13.  Cough has slightly improved and tonsil swelling has gone down some since starting medication.  Currently on day 2 of medication.  Unsure if this is related to vaccine, as could be community spread. PT was immunized for HIB as an infant.
Nerve pain affecting left-side of body; Left-side of body tingling; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain affecting left-side of body), PARAESTHESIA (Left-side of body tingling) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     The patient's past medical history included Sciatica (Patient reports as becoming exacerbated after appearance of AE.).    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced NEURALGIA (Nerve pain affecting left-side of body), PARAESTHESIA (Left-side of body tingling) and HEADACHE (Headache). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at a dose of UNK dosage form. On 22-May-2021, HEADACHE (Headache) outcome was unknown. At the time of the report, NEURALGIA (Nerve pain affecting left-side of body) and PARAESTHESIA (Left-side of body tingling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, Fibrin D dimer: negative (Negative) Negative. On 06-Jun-2021, Full blood count: negative (Negative) Negative. On 06-Jun-2021, Magnetic resonance imaging: negative (Negative) Negative and negative (Negative) Negative. On 06-Jun-2021, Magnetic resonance imaging head: negative (Negative) Negative. On 06-Jun-2021, Metabolic function test: negative (Negative) Negative. On 06-Jun-2021, Rheumatoid arthritis: negative (Negative) Negative. On 06-Jun-2021, Troponin: negative (Negative) Negative.     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.   No concomitant medicines were reported.
approx 4yrs p/vax pt devel fever 1st night, broke out w/chickenpox over back, face, arm & legs lasting 5days
A non-serious spontaneous report of "29 patients received expired FLUMIST" was received from a physician concerning a four-year-old female.  The patient's medical history included no history of asthma.  Concomitant medications were not available.  On 06-Jan-2009, twenty nine patients (26 children & 3 adults) were vaccinated at a military base and administered expired FLUMIST; the product was expired by 11 days (expiration date: 26-Dec-2008).  The reporting physician was concerned regarding efficacy and loss of potency due to the expired product.  Since the facility only administered the immunizations and does not care for the patients, they had limited medical history information (i.e. screening questions to confirm history of asthma, no detailed medical history to include all their concomitant medications).  There were no adverse events associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.  This case is being submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. This is in follow-up to report(s) previously submitted on 02/05/09. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. On 05-Feb-2009, the physician confirmed that there were no adverse events associated with the medication error. Additional information was received on 31-Mar-2009 and incorporated into the narrative: product complaint investigation results.
pt recv vax;exp pain & swelling at inject site;f/u info fr MD:pt exp immed redness,swelling at inj site;addl f/u fr RN:devel palpable nodule at inject site;tx w/ ice packs,sx lasted x 15 mins;RN expressed concern about lot;
ShoT was given in UPPER Left Arm -close to shoulder - when I got home - 2 Hrs after couldn't move my left arm & pain was horrific for 4 days. Couldn't Do Anything - my daughter had to help me dress etc. Couldn't even hold a phone eTc. my daughter is a P.T. & was Try to make sure arm didn't freeze. I have Trouble with that arm Anyway & this Just agitated iT. My arm still bothers me. Developed Tendintes - Hoping iT will Get Better.
Skin red, swollen everywhere with tiny itchy hard bumps. Eyelids were red and swollen, hot and hard to open.  Body aches and fingers partially numb.
Rash over whole body with red bumps that were relieved by BENADRYL. Patient also complained of itching. This was patient's 2nd flu shot in lifetime.
Patient reports itching, burning, redness and some hives to left upper arm site of injection. Patient refused Benadryl offered to her by EMS stating it makes her drowsy. Symptoms improved, cleared by EMS.
had a very sore left shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shoulder soreness. On an unknown date, the outcome of the shoulder soreness was recovered/resolved.   It was unknown if the reporter considered the shoulder soreness to be related to Shingrix.  Additional details were reported as follows: The reporter was  the patient's wife. The patient received his first dose in the week of November 25th 2020 in the left arm. He had a very sore left shoulder for a week following that dose. For tolerance of 2nd dose refer case US2021AMR053866. This is 1 of 4 linked cases reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021053253:same reporter (wife´s case) US-GLAXOSMITHKLINE-US2021AMR053770:same reporter (wife´s case US-GLAXOSMITHKLINE-US2021AMR053866:same patient, same reporter, 2nd dose
Patient came to the facility with a CDC card with the 1st dose information of 02/07/2021, and no information in the area for the 2nd dose.  We asked her if she was here for her 2nd dose she said yes. We administered the vaccine. When we went to process the 2nd dose we discovered that she had already received the 2nd dose on 03/17/21
Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022; Administered dose of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered dose of expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12May2022 and Exp: 02May2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported. The vial did not undergone any temperature excursions.
Shingles (herpes zoster) developed 18 days after first injection. Visible rash on lower right abdomen area with itching and burning. Took antiviral medication for 1 week and rash gradually cleared.
No additional AE reported; patient was administered an expired dose of VAXNEUVANCE; This spontaneous report was received from a nurse via Pfizer referring to a 63 years old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.   On 17-NOV-2022, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, lot #U029559 (also reported as package batch #), expiration date: 16-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided; fill batch 0001335181 had an assigned expiry of 21-NOV-2023, inconsistent information) (expired product administered). No additional adverse event (AE) was reported (no adverse event).
Patient's parent brought patient in to receive a COVID-19 Pfizer vaccine on 09/18/2021.  The patient?s caregiver filled out a consent form on behalf of the patient and listed the date of birth and signed and consented on the official Pfizer-BioNTech consent form.  The nurse verified the name and date of birth with the patient and the patient?s parent.  Guidelines were followed, and the parent received the up-to-date Pfizer-BioNTech EUA and the vaccine was administered.  In the patient?s 15-minute wait there were no adverse reactions.  Upon entering the vaccine into the system it was discovered that the patient's true DOB and therefore this was an unauthorized vaccination.  A nurse asked the parent why the DOB on the consent form did not match the DOB in the state system and the mother told us that the state was wrong and once again said the other was correct. The date of birth was then confirmed and verified in the system.  The Health Department Chief Medical Director was notified.  In addition, the patient's parents were notified per protocol.
Reports severe headache, nausea, and weakness.  No temperature.  Saw MD either on 6-7-21 or 6-4-21.  She says MD advised a vaccine reaction to covid vax
Jynneos vaccine administered at a dose of 0.1 mL; Jynneos vaccine administered intradermally; Case reference number US-BN-2022-002283 is a spontaneous case report initially received on 07-Sep-2022 from other healthcare professional via Communication (reference number: USBAV22-1300) and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown), at a dose of 0.1 mL (explicitly coded as 'vaccine underdose'), intradermally (explicitly coded as 'inappropriate route of vaccination'), at an unknown site, for monkeypox prophylaxis. As reported, the patient did not have a bubble under the skin after being administered with Jynneos vaccine.  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 08-Sep-2022 included local BN case ID number.; Reporter's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at a dose of 0.1 mL, which is considered as vaccine underdose, intradermally, which is considered as inappropriate route of vaccination, at an unknown site, for monkeypox prophylaxis. As reported, the patient did not have a bubble under the skin after being administered with Jynneos vaccine. No associated adverse events have been reported with the reported medication error. Underdose and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose and incorrect route of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of Jynneos, at a dose of 0.1 mL, which is considered as vaccine underdose, intradermally, which is considered as inappropriate route of vaccination, at an unknown site, for monkeypox prophylaxis. As reported, the patient did not have a bubble under the skin after being administered with Jynneos vaccine. No associated adverse events have been reported with the reported medication error. Underdose and incorrect route of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose and incorrect route of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Patient reports she received both vaccines yesterday, 9/29/21. Reports she began with an urticarial rash as well as puritis shortly after. Patient followed up today, 9/30/21, for treatment.
Patient is a 79yo WF with h/o COPD recently on 8L with nocturnal BiPAP, HTN, PE who presents from LTC with hypoxia. Patient is a modest historian, she is vague on most details. I have called her facility and got more details today. Briefly, she was at local hospital with PNA and respiratory failure (COVID negative) in December/January, then sent to alternate clinic location in February. During that time she has been on 8-10L of O2 with BiPAP QHS. Apparently was on a steroid taper and cannot wean below 20mg daily without worsened hypoxia. She has been diagnosed with a PE at some point, she thinks recently but Dr. shows Eliquis since 9/2021. Ultimately she was felt to be at new baseline and sent to local health and rehab last week - COVID negative daily there, was exposed to her husband who was positive after his visit 3/4. She tells me she has had some occasional SOB and cough with clear sputum during this time, with indolent night sweats per her report. Today she was acutely SOB and sats were in 60s despite BiPAP, EMS was summoned and gave solumedrol along with updrafts. Patient arrived here on BiPAP, ABG showed pO2 66 but sat 94% and normal PH. Her CXR shows some chronic changes but no obvious infiltrate, unfortunately she has tested positive for COVID today. She is now weaned to 5L O2 NC and is no distress. Labs show WBC 18k with a left shift but again no infiltrate. She denies any CP, dysuria (chronic incontinence), N/V/D, constipation. We have been asked to admit for care. PATINT REMAINS INPATIENT AT THIS TIME.