chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing); "Known allergies: Nut allergy" (unspecified if ongoing), notes: Known allergies: Nut allergy. Concomitant medication(s) included: ALLEGRA; CALCIUM; CRANBERRY; FLONASE [FLUTICASONE PROPIONATE]; VITAMIN B 12 [CYANOCOBALAMIN]; VITAMIN D [COLECALCIFEROL]; ZINC; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had taken other medication in 2weeks.Treatment start date provided as 23Jun2022 and treatment stop date 27Jun2022. Vaccine lot unknown reason were not available/provided to reporter at the time of report completion. Adverse event reported that Patient had diarrhea for 5 days and patient recovered. Reported as treatment adverse event. Adverse event treatment given as Imodium.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
myocarditis based on chest pain and elevated troponin. also with chills, frontal headache, nausea and vomiting
This spontaneous report as received from a pharmacist via other company Pfizer, refers to a 41-year-old female patient with asthma. Patient had no other pertinent medical history. On 26-SEP-2015 around 12:00, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # K009107, expiry date 21-JAN-2016, 0.5 ml, intramuscularly in the left deltoid for asthma. Other suspect therapy included the second dose (the first dose was given 1 year before, in 2014) of FLUVIRIN lot# 15721P, expiry date 30-MAY-2016, intramuscularly, into the left deltoid (dose not reported), administered at the same time. Concomitant medications were not reported. There was no illness at the time of vaccination. In October 2015, the patient experienced pain in hand and arm, where the vaccines were administered, and had trouble lifting it. The patient sought medical attention via doctor's visit. No laboratory studies were performed. The outcome of pain in hand and arm was reported as improved (recovering), but the patient still had trouble lifting her arm (not recovered). Causality assessment was unknown. Additional information has been requested.
Bilateral pulmonary embolism which was diagnosed on 4/14/21 after 2 days of severe shortness of breath. Associated with hypoxia requiring supplemental oxygen. Patient is morbidly obese which is only other risk factor for pulmonary embolism. He denies history of increased sedentary activity, denies recent travel, denies known history of a hypercoagulable disorder or family history of blood clots. No other causative factors for the pulmonary emboli have been identified.
Clt called & c/o "splotches" on his neck & head. No c/o SOB, or other complaints (per secretary). Advised to go to nearest E.R. (since client does not have a private physician). Also advised to take BENADRYL (per MFGTR directions).
I had bad chills, shooting pain up the tendon and a headache. I took Tylenol.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine administered 10 days after 1st punctured. No concomitant medication information was reported. No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information was received include no new information. Sender's Comments: This report refers to a case of Expired product administered for mRNA-1273, lot # 037C21A with no reported AEs. Causality for the medication error is not applicable.
Inadvertent administration to wrong patient. Patient was identified by mother as being her other daughter. After the vaccine was given. the nurse asked for patient and was informed by the mother that patient had received her sister's vaccine.  Mother notified that the vaccine was given based an her identification of the child as well as when next dose would be due if she wanted to complete the series since the timing of the vaccine was off.  Patent received her other vaccines and was observed for 20 minutes. Patient was released without any symptoms of reaction or distress.  Followed up with patient's mother on 10/1. Stated that the patient was "doing fine."
This spontaneous report was received from a medical assistant refers to an unknown number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored RECOMBIVAX HB (dose, lot # and route of administration were not reported). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient was receiving Pfizer vaccine dose #2, at end when the LVN went to remove syringe, syringe came out and needle stayed. Manually needle was successfully removed, No bleeding occured. Needle was intact. Small amount of vaccine did splash out when the syringe came out. LVN believes possibly 70-80% of dose received by patient. Patient was ok following the event. No symptoms. Was contacted 1hr later and no symptoms reported.
FEVER; HEADACHE; SHAKING CHILLS; FEELING HOT AND COLD; SWEATY; BODY CRAMPS; This spontaneous report received from a patient concerned a 50 year old male. 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 admin not reported, batch number: 1805020 expiry: 25/MAY/2021) dose was not reported, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced feeling hot and cold. On 15-MAR-2021, the subject experienced sweaty. On 15-MAR-2021, the subject experienced body cramps. On 15-MAR-2021, the subject experienced headache. On 15-MAR-2021, the subject experienced shaking chills. On 16-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature increased (NR: not provided) High. On 21-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97 F. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling hot and cold, fever, headache, sweaty, body cramps, and shaking chills. This report was non-serious.
Received both Pfizer injections at satellite site setup by the Mall on February 10 and March 10, 2021.  At the end of March noticed excessive itching on back.  Observed a ?horse shoe? rash in the middle of my back.  Visited Urgent Care twice before getting an appointment at Dermatology .  Visited this facility twice where they conducted a biopsy on my back and under both arm bits.  Results of biopsy reflected  Tumid Lupus Erythematosus on my back and Eczematous Dermatitis under both arms.
administration error; gave regular quadrivalent flu vaccine;  age 68 - should have given high dose quadrivalent vaccine
diagnosed with Covid; cough; diarrhea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing dementia. The patient's concomitant medications were not reported. About two weeks ago, the patient's son came home and he had some coughing and fever for a day and shortly after, the patient husband starting having symptoms. The patient had diarrhea and a cough and because he had dementia, his wife called the ambulance and they put him in the hospital and he was diagnosed with COVID. He had been there since last Sunday and they want to release him on 01Mar2021. The patient was supposed to get his second vaccine on 05Mar2021. The outcome of events was unknown.                 She had a cough but no fever. She has had a test but no results yet but she is in quarantine until the 7th and they are supposed to get their second vaccine on March 5.  She needs to reschedule her appointment.  They gave her a card with the time but she doesn't have a phone number of the place she got it. How does she reschedule?  DSU: filing AE/PC  age  69 for (name).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swollen at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen at the vaccination site) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen at the vaccination site). At the time of the report, VACCINATION SITE SWELLING (Swollen at the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Brief seizure - pallor, fussy, gagging the brid "shaking" followed by eye rolling and sleepiness (post-ictal state).
Fever, headache, body ache, shivering. Taking ibuprofen and acetaminophen. Still experiencing side effects at 24 hours post vaccination.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age and medical history. The patient was vaccinated with ZOSTAVAX on 27-SEP-2012. Dose and route were not reported. No other co-suspects were reported. No concomitant medications were reported. In approximately September 2012, the patient experienced local injection site reactions including pain, swelling, redness and warmth around the injection site after receiving ZOSTAVAX. Treatment information was not reported. The patient's outcome was not reported. Additional information is not expected.
3 blotches with red dots.; Like a punch on the upper part of the arm, it was very sore; Headache; Strange rash on mid upper arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (3 blotches with red dots.), PAIN IN EXTREMITY (Like a punch on the upper part of the arm, it was very sore), RASH (Strange rash on mid upper arm) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included NATALIZUMAB for Multiple sclerosis, CLONAZEPAM, PAROXETINE (DAVOL [PAROXETINE]), TRAZODONE, PRAVASTATIN, ARIPIPRAZOLE, VITAMIN D3 and CALCIUM CARBONATE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (Strange rash on mid upper arm). On an unknown date, the patient experienced RASH MACULAR (3 blotches with red dots.), PAIN IN EXTREMITY (Like a punch on the upper part of the arm, it was very sore) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (3 blotches with red dots.), PAIN IN EXTREMITY (Like a punch on the upper part of the arm, it was very sore), RASH (Strange rash on mid upper arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: NNI
This case was reported by a consumer via other manufacturer and described the occurrence of swelling arm in a male patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm, inability to work and joint pain. On an unknown date, the outcome of the swelling arm, inability to work and joint pain were unknown. It was unknown if the reporter considered the swelling arm, inability to work and joint pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the field representative who is the patient's neighbour. The age at vaccination was not reported. The patient received initial vaccination of SHINGRIX. The patient's arm swelled up double its size and experienced severe pain in joints. The patient told that he still had joint pain so severe that he was unable to work. The patient had been referred to a Rheumatologist. The reporter said that the patient received SHINGRIX vaccination from a Veterans administration clinician. No further adverse event information was provided.
Diagnosis -Transverse Myelitis numberness of right leg from hip to foot.  Numbness on left leg from knee to foot.   Unstable and inability to balance and stand without support. Difficult walking.  Pain in lower back and hip , legs and feet.   MRI x 2 upper and lower regions - Spinal Tap x 2
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's concomitant medication, medical history, concurrent condition and drug reactions/allergies were unknown. On an unknown date, the patient was vaccinated with M-M-R II via intramuscular route (incorrect route of product administration) (lot# and expiry date were not reported) for prophylaxis. No adverse symptoms reported (no adverse event). No product quality complaint was reported. No further information provided. This was non-valid case due to lack of patient identifiers.
Subsequently a patient who received the vaccine reported temporary paralysis at the injection site/The caller also describes the event as muscle soreness, not paralysis; This is a spontaneous report from a contactable two consumers. A 53-years-old female patient received bnt162b2 (Solution for injection, Batch/lot number: EL9262) via an unspecified route of administration from an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reporting on the COVID 19 vaccine and who explains they had 2 vials on Tuesday that had little black specks that were noticed in them after the diluent was injected. The nurse caught one of the vials and discarded it but the other vial, 1-2 doses were administered before the black specks were noticed. Subsequently a patient who received the vaccine reported temporary paralysis at the injection site. This patient might have been the recipient of the dose with the little black specks in the vial. They need to report this. The original caller is (name) with a phone number of (phone number). The call is then handed to the Reporter as he has the information on the even to provide. Reporter explains that they have not contacted the patient and would like to speak with the doctor before providing patient contact details. It is explained that think they are able to determine whether the patent received the dose from this vial but they need to do some research and that has not been done at this point. The do not want to provide any details for the patient at this time other than what is populated. The caller also describes the event as muscle soreness, not paralysis. The outcome of the event was unknown. .
pt devel redness, induration, warmth & hardness @ the site of vax;LMD did not see rxn;
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No pertinent medical history or drug reactions/allergies were provided. On 18-SEP-2014, the patient was vaccinated with PNEUMOVAX 23 inj (lot # J005067, expiration date 17-JAN-2015), 0.5 ml dose, once, intramuscular in the deltoid. No co-suspect or concomitant therapies were provided. On 18-SEP-2014, after the administration of PNEUMOVAX 23 was done, the patient experienced soreness and swelling at the injection site. The pharmacist reported that they put an icepack on the injection site and provided ibuprofen and this treatment made the events improve. The patient sought medical attention while still at the office, the patient sought no further medical attention. At the time of the report, the patient was recovering from the adverse events. Additional information has been requested.
1st day itching , headache and swelling at site of injection . By night I was itching all over and my face was swelling . I took 3 Benadryl. Woke up with swollen shut eyes and pain like flu but took alieve and ice pack and went to church . By 2 night I was fevered, shaky and muscle aches and more swelling . Arm was more red and swollen . Couldn?t sleep but a few minutes off and on . Day 3 arm still hot and swollen and aches and pains like flu . Stayed in bed all day . Day 4 still swollen and fevered arm but went to pharmacy to see if this was normal . She said to call you and make a report  because she had not seen or heard of one like mine . Plus I have had diarrhea for 2 days now .
2wk p/vax bruises noted all over body took to ER was dx w/ITP;was tx w/2 doses of Gamma;
No additional AE information provided; HBP in charge of vaccine storage calling to report that MMR II and VARIVAX were administered to a patient today 3/4/2022; This spontaneous report was received from an other health professional referring to a 57-week-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 04-MAR-2022, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number U006485, expiration date 26-FEB-2023 and varicella virus vaccine live (oka/merck)(VARIVAX) lot number U022320, expiration date 15-JUL-2023 (doses and routes of administration not reported) both for prophylaxis (product storage error). No adverse event was reported.
I am constantly sick with either vomiting and diarrhea, or severe congestion, cough, fevers, chills and body aches.  I am unbelievably exhausted since the vaccine and have fallen asleep driving.  I've battled migraines and fibromyalgia for most of my life, however it was never constant. Since the vaccine I have a migraine almost daily, and every joint in my body aches constantly
Information has been received from a health professional concerning a "7 or 8 year old " male who on an unspecified date, was vaccinated with a second dose of varicella virus vaccine live (Merck) (lot# 659727/1771U). The healthcare worker reported that the patient developed an "anaphylactic reaction" to the VARIVAX vaccine(Merck). It was indicated that the patient developed a swollen tongue with difficulty breathing, and had hives all over his body. Treatment included epinephrine, BENADRYL, and observation for 3 hours. It was indicated that when the patient left the office he had recovered. A product quality complaint was not reported. The healthcare worker requested a lot check. This is one of 3 reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008. a standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements for the Center and was released.
COMPLETELY SKIPPED AN ENTIRE MENSES.  LMP WAS 2/19/21, THEN AGAIN ON 4/12/21.  UNSURE IF THIS WAS VACCINE RELATED???
Fever for 3 days and chills.  TINNITUS has not stopped  very loud ringing never had it before.
Patient called today.  Said on Aug 30th she started to develop a rash. On September she saw a physician and was diagnosed and treated for Shingles.
No adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report as received from a register nurse refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.  The nurse reported that on 01-OCT-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number R019237 with expiration date 04-JUL-2020 or lot number S005078 with expiration date 19-FEB-2021(the nurse did not knew which lot number was administered to the patient) (dosage, route and anatomical location were not reported) for prophylaxis, which was exposed to temperature excursion of  -14°C to -10°C (-9.74°C) for an unknown time frame, because of data logger. There was no previous temperature excursion. The varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effects reported.
Information has been received from a consumer concerning his daughter, an 11 year old female with no medical history or allergies who was vaccinated with a first 0.5ml and second dose of GARDASIL (lot # not reported) on an unknown date and a month ago, approximately in Sep 2008, respectively.  There was no concomitant therapy.  Subsequently the patient experienced injection site pain after both doses.  The patient sought medical attention.  She recovered on an unknown date.  Additional information is not expected.
SWELLING OF THROAT, DIFFICULTY BREATHING/SPEAKING.  ANAPHYLACTIC REACTION.  RECIEVED 0.3ML EPHRINEPHRIN, EMS CALLED AND PATIENT EVALUTAION WAS PERFORMED.  PATIENT WAS RELEASED ON OWN ACCORD. PATIENT DENIED FURTHER TREATMENT.