chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She denied further AE; Patients were administered MMRII that underwent multiple temperature excursion since 12-MAY-2020; This spontaneous report was received from a registered nurse concerning an unreported age and gender patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 28-JUL-2020, the patient was vaccinated with 0.5 milliliters (ml) of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) as prophylaxis (lot number R028526, expiration date 04-OCT-2020, which was determined to be valid) (formulation, dose number, vaccination scheme frequency, route and anatomical location of administration were not reported) (product storage error).   The involved vaccine underwent multiple temperature excursions; the warmest reported temperature was 21.6 grades Celsius (C) for a cumulative time of 15 hours and 30 minutes, as recorded by a data logger. No additional adverse events (AE) were reported.  This is one of 14 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000261: US-009507513-2108USA000260: US-009507513-2108USA000263: US-009507513-2108USA000259: US-009507513-2107USA008497: US-009507513-2108USA000262: US-009507513-2108USA000271: US-009507513-2108USA000264: US-009507513-2108USA000265: US-009507513-2108USA000266: US-009507513-2108USA000267: US-009507513-2108USA000268: US-009507513-2108USA000269:
Pt recvd vax 25JUN93 & 26JUN93 devel urticaria; No further details were provided;
Pain under left breast that come and go; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Pain under left breast that come and go) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included AMLODIPINE and LISINOPRIL for an unknown indication.    On 05-Mar-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 BREAST PAIN (Pain under left breast that come and go). At the time of the report, BREAST PAIN (Pain under left breast that come and go) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test negative: negative negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment included Tylenol.    Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Lab data attached
Shoulder Pain, Stiffness, Soreness, Immobility, Treated with Ibuprofen 800mg with no effect.
red, hot,  round, raised circular lesion in arm that was vaccinated. +itchy but no pain. No fever.
RASH ON FACE/RASH ON BODY; rash is pimply; This case was reported by a nurse via sales rep and described the occurrence of generalized rash in a 13-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12BA, expiry date 28th February 2021) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) (batch number RO24271 ?, expiry date 8th May 2021) for prophylaxis and MENACTRA (batch number U6521AA, expiry date 26th January 2021) for prophylaxis.   On 27th August 2019, the patient received the 1st dose of Bexsero, HPV vaccine and MENACTRA. In August 2019, less than a week after receiving Bexsero and HPV vaccine, the patient experienced generalized rash and papular rash. The patient was treated with doxycycline and prednisone. On an unknown date, the outcome of the generalized rash and papular rash were recovered/resolved.   It was unknown if the reporter considered the generalized rash and papular rash to be related to Bexsero and HPV vaccine.  Additional information received were as follows: The licensed vocational nurse stated that received Bexsero and Menactra a week before the reporting date and experienced a rash on their face and body that was not itchy. The reporter had had 3 patients that had experienced a rash after having Bexsero, not itchy, on the face and body. First they thought it was giving the menectra and bexsero together the other had them both. On the reporting date, the third person and she did not had any other vaccine called complaining of the same rash. The healthcare professional stated that they assumed the rash was due to Bexsero since one of the patients experienced the rash received no other vaccine.  All patients reported the rash appearing within 2 days of vaccination.  The rash was pimply in appearance on face, arms, and neck. The rash lasted for 3 weeks where she saw the doctor again on 4th September 2019 and was given doxycycline and prednisone. The patient was told to see the doctor again in 10 days. The MSL confirmed that patient had not yet been back to the office on the reporting date. For the other 2 patient's, it is unknown how long the rashes lasted and if they were treated because they only called in to report the adverse event. The reporter consented to follow up. No additional details regarding patients or product were available but licensed vocational nurse was agreeable to follow up recontact. This case is 1 of the 4 linked cases, reported by the same reporter.
Fever; Muscle pain; Body aches; Sweats; Chills; Severe headache; Injection site pain; Entire lymph area on left side (arm pit, outter side of breast) painful to touch; This is a spontaneous report from a contactable other healthcare professional, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 01Aug2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 01Aug2021 at 22:00, the patient had fever, muscle pain, body aches, sweats/chills, severe headache, injection site pain and entire lymph area on left side (arm pit, outter side of breast) painful to touch. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, muscle pain, body aches, sweats, chills, severe headache, injection site pain and entire lymph area on left side (arm pit, outter side of breast) painful to touch was resolving at the time of this report.
p/vax pt exp measles;6/11/99 began spiking fevers;6/12 rash, cough,conjunctivitis both eyes,& dec activity.6/16 koplik spots, very low oral intake;hosp for rehydration, pneumonia,tachycardia, tachypnea, on O2
soreness /and pain; dizziness; swelling; This case was reported by a other health professional via sales rep and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, dizziness and swelling. The patient was treated with morphine. On an unknown date, the outcome of the pain, dizziness and swelling were unknown.   It was unknown if the reporter considered the pain, dizziness and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and had soreness, dizziness, swelling and pain. The patient went to Emergency room and received morphine as a treatment. The reporter consented to follow up.
I had a 2in rash of blisters at the site of the injection, it resembled the shingles. I thought what had happened was because I got the influenza vaccine a week before COVID-19 booster. Days later, it started to ooze and blister/scab up and is now healing. I also had a mild rash and stiff neck. I called my doctor and informed her, but she said she couldn't prescribe me any antiviral medications due to waiting too long to report it.
Patient reaction after the vaccine was generalized anxiety disorder . Onsite EMS was called vitals were taken BP 132/92  98% O2 room air HR 74. General Malaise unknown cause . Patient refused evaluation/care. Left aginst medical advice.
pt devel flu sz-vomiting, diarrhea;went to MD 21APR97 t103;23APR97 t105.2;Friday PM mom stated acting nl @ present;mom gave APAP  & Motrin for fever;
COVID+ICU admission Patient received first COVID-19 Vaccination on 3/12/21. On3/18/2021, Was alerted that patient was COVID+ and admitted to ICU
Tired; weak; lymph node on left side is swollen; pain from lymph node to arm; pain from lymph node to arm; pain from lymph node to arm; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced tiredness, weakness, enlargement of lymph nodes, lymph node pain, radiating pain and pain in arm. On an unknown date, the outcome of the tiredness, weakness, enlargement of lymph nodes, lymph node pain, radiating pain and pain in arm were unknown.   It was unknown if the reporter considered the tiredness, weakness, enlargement of lymph nodes, lymph node pain, radiating pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported that the patient received her first dose of the Shingrix vaccine and since then she was tired and weak.   The patient had also reported the lymph node on her left side was swollen.   The patient was experiencing pain from the lymph  node that radiated to the back of her left arm. The reporter was inquiring if this was a normal adverse event and how long would it take to subside. The reporter provided medical advice disclaimer. No additional details were provided by the caller. The reporter did not consent to follow-up.
This spontaneous report as received from a licensed vocational nurse refers to a 16 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 02-NOV-2015 at 02:59 PM., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX (Merck) injection, lot# K026385, subcutaneously (dose and expiration date were not reported) that was improperly stored. The patient's concomitant vaccines given on the same day and time included HAVRIX, (manufacturer reported as GlaxoSmithKline, first dose, intramuscularly) and FLUARIX (first dose, intramuscularly). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all correspondence was received.
Patient reports receiving both vaccinations in her upper left arm on 9/7/17. On 9/9/17 she stopped by the pharmacy to ask if the redness and swelling she was experience was normal. It was not. It was on the inside of her arm not at injection site. Visually, it was nearing the level of her elbow  and she reported that it went all the way up into her shoulder. She was advised at that time to seek medical attention if did not respond to diphenhydramine and OTC pain relievers. Upon contacting the patient on 9/11/17 she reported that she had gone to an emergency room and had been treated and was responding to the treatment.  Upon further discussion, she disclosed that within 4 hours of the vaccinations she had woken up chilled and feverish, with pain and swelling in her vaccinated arm.
Today her arm is swollen; Today her arm is swollen, bruised; Today her arm is swollen, bruised and still hurts.; It appears it hurts in the bone; At the time of injection she got a lot of burning sensations; This spontaneous case was received on 09-Dec-2021 from other healtcare professional (the patient is a nurse) via agency (reference number: SEQW21-05966) and concerned a 54-year-old, female patient.  The patient's medical history was not reported. The patient's current condition included diabetes and hypertension. The patient's concomitant medications included Metoprolol (metoprolol tartrate), Lisinopril, Metformin (Metformin hydrochloride), allergy medication, all for unreported medications.  On 05-Dec-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml; route of administration: intramuscular (IM); anatomical location: deltoid) for influenza prophylaxis. The batch number and expiry date were not reported.  On the same day, at the time of injection the patient experienced a burning sensation from the minute the pharmacist, who administered the vaccine, went with needle.  On 9-Dec-2021, four days after vaccination the patient's arm was swollen, bruised ant it still hurt. As reported, it appears it hurts in the bone.  The reporter stated that the administration of the Flucelvax on her arm was very slow and hard to do. She felt these adverse reactions she was experiencing was probably due to the way the pharmacist administered the vaccine shot but still she wants to report it. She noticed the pharmacist expelled the air of the vaccine prior to administration and wants information about air in the vaccine shot.  The outcome of the events unknown.  The case was assessed as non-serious.  Company comment: A 54-year-old female patient experienced burning sensation, bone pain, arm swelling, bruise and pain in extremity within 4 days after vaccination with Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A 54-year-old female patient experienced burning sensation, bone pain, arm swelling, bruise and pain in extremity within 4 days after vaccination with Flucelvax Quadrivalent. Based on plausible temporal relationship, causality for the reported events is assessed as possibly related.
Pt felt pain in right shoulder at time of vaccination and has continuously had pain in right shoulder since then to present.
After taking the 2nd dose, my sinus irritation/inflammation & post nasal drip worsened, which originally started after taking the first dose of Moderna. On 07/26/2021, I went into Afib and had blood clots in the brain. I had a stroke. I didn't have shortness of breath, lightheadedness, dizziness, or increased heart rate though. But I experienced loss of speech for 4 days. The blood clots still have not dissolved since being on the blood thinners. My sinus irritation/inflammation & post nasal drip has persisted.
Fever; chills; nausea; headache; pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 15:15 (Lot number: FE3592) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=FK5127, prev dose lot unknown=False, prev dose administrator route=Intra muscular, prev dose administration date=05Nov2021, prev dose administration time=03:30PM , prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 05Nov2021, when the patient was 12 years old, for COVID-19 Immunization, reaction(s): "The patient inadvertently received the pediatric dose for her first shot instead of the regular dose". The following information was reported: PYREXIA (non-serious) with onset 30Nov2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 30Nov2021, outcome "recovering", described as "chills"; NAUSEA (non-serious) with onset 30Nov2021, outcome "recovering", described as "nausea"; HEADACHE (non-serious) with onset 30Nov2021, outcome "recovering", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 30Nov2021, outcome "recovering", described as "pain in arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, nausea, headache, pain in extremity.  Additional information:The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient treated with Tylenol. No Other medications in two weeks.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101690899 similar report from same reporter
really bad body aches; Cough / awful, deep, rattily cough; awful, deep, rattily cough; Pneumonia/had xray, showed left lung pneumonia; This is a spontaneous report received from contactable consumer, the patient. A 74-year-old elderly female received the second dose of intramuscular BNT162b2 (solution for injection; Lot EN6199 and expiry information not provided) as a single dose in the right deltoid on 18Mar2021 (at 74-years-old) for COVID-19 immunization. Relevant medical history included diagnosed allergies, asthma, bronchial cough, pneumonia (not within since 2019), rheumatoid arthritis, compromised immune status, genetic/chromosomal abnormalities, and endocrine abnormalities. There were no concomitant medications reported. The patient previously received the first dose of intramuscular BNT162b2 (solution for injection; Lot EN6198 and expiry information not provided) as a single dose in the right deltoid (arm muscle) on 25Feb2021 (at 74-years-old) for COVID-19 immunization. The patient reported that she had a weird reaction in Mar2021 after second Pfizer vaccine. The patient explained that she had the second Pfizer COVID-19 vaccine on 18Mar2021 and was fine for two days and then she had the other symptoms, really bad body aches. States she has really bad rheumatoid arthritis already, but the pains/aches started the night of 21Mar2021 and were so bad she called the doctor. Was told that she cannot take any steroids because it will affect the vaccine and that the pain will go away after two days, and it did go away in two days. The patient also reported that although she had a bronchial cough, it got worse and was a deep cough. The patient reported that she already has asthma and a bronchial cough, but after ten days of still coughing she thought to get it checked out at a walk in clinic where she had an x-ray and was told there it was pneumonia. The patient stated that she guesses she had it all along over the asthma and bronchial issues. She has not had pneumonia in over 2 years. Denied having any fever or chills it was just this awful, deep, rattily cough and the x-ray confirmed that the left lung had pneumonia. Had the cough the 21Mar2021 and it was practically going away, but not completely. The doctor cleared her of pneumonia as of 04May2021, reported as last Tuesday, with another x-ray. States that one x-ray was a confirmation and she was put on a very strong antibiotic, which she did not improve and so she went for another x-ray on the 12Apr2021 and it showed there was no improvement. She had quite a time with it and was then put on a steroid taper and had a computerized assisted tomographic (CAT) scan and another round of antibiotics. Caller unable to provide names, NDC, Lot, or expiry for any of the antibiotics or steroids treated with. The outcome of the event really bad body aches was recovered on 23Mar2021 after two days. The outcome of the events cough/ awful, deep, rattily cough and pneumonia was recovering.   Follow up needed, further information has been requested.