chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inflammatory arthritis caused by the BNT162b2 COVID vaccination; This is a literature report for the following literature source(s):  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: ARTHRITIS (medically significant), outcome "unknown", described as "inflammatory arthritis caused by the BNT162b2 COVID vaccination".; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202201280037 Same article/drug/event and different patients.;US-PFIZER INC-202201280036 Same article/drug/event and different patients.;
SWOLLEN KNEES; LOOSE JOINTS; CHARLEY HORSE; HIGH FEVER (3 DEGREES OVER NORMAL); SEVERE FATIGUE; MUSCLE SPASMS; SEVERE MUSCLE CRAMPS; DIFFICULTY WALKING/BARELY MOBILE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 180898L (or a 2 for last digit)) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced muscle spasms. On 06-APR-2021, the subject experienced severe muscle cramps. On 06-APR-2021, the subject experienced difficulty walking/barely mobile. On 06-APR-2021, the subject experienced charley horse. On 06-APR-2021, the subject experienced high fever (3 degrees over normal). On 06-APR-2021, the subject experienced severe fatigue. On 12-MAY-2021, the subject experienced swollen knees. On 12-MAY-2021, the subject experienced loose joints. On 04-JUN-2021, Laboratory data included: Blood test (NR: not provided) No blood clots detected., and X-ray (NR: not provided) No diagnosis. The action taken with covid-19 vaccine was not applicable. The patient recovered from high fever (3 degrees over normal), and severe fatigue on 14-APR-2021, and had not recovered from muscle spasms, severe muscle cramps, difficulty walking/barely mobile, swollen knees, loose joints, and charley horse. This report was non-serious.
Site of injection became, red, swollen, and itchy.  My right thumb became very red and swollen.  Both occurred the evening of the 6th day..  Both areas slightly better on day 7.
Patient received un-diluted dose of Pediatric covid-19.  No untoward events, when realized patient contracted via phone and advised of VAERS filing
Drug ineffective; Got covid after shots; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP. The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "Got covid after shots". Clinical Course: Patient also reported that she had 2 shots and she still got covid twice.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hallucinations; Headache; sharp pain through arm come and go and arm sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 04Mar2021 10:00 (Batch/Lot Number: EN6200; Expiration Date: Jun2021) as SINGLE DOSE for COVID-19 immunization at the doctor'ss office. Medical history included arthritis and was diabetic. Concomitant medications were not reported. It was reported that right after the first dose probably first, second, or third night in Mar2021 the patient had hallucinations. The patient also had headaches and sharp pain through arm/arm sore a couple of days after the first dose (probably started the next day or even the same day) which come and go. The patient recovered from the events in Mar2021 (a week or week in a half maybe two weeks before getting second dose).    Follow-up attempts are completed. No further information is expected.
About 24 hours after receiving my first dose of the Moderna COVID19 vaccine, I developed two quarter-sized rashes on my left arm (the arm that was injected). Neither is exactly at the place of injection - one is below it in the middle of my bicep, and the other is above it closer to my shoulder. The size of each rash has not grown since I noticed them 13 hours ago. They are a little bit raised and firm, they are not itchy at this time. Other effects aside from the rashes is a very sore arm, which I understand to be typical with the vaccine.
Severe pain ,swelling ,redness ,rash and itching at the injection site. This occurred 8 days after the initial injection. When to physician and they administered an antibiotic Clarithromyc 500 mg. Every 12 hours. Also apply cold compress and take 25mg. Of Benadryl for the itching.  Diagnosed as Cellulitis. Follow up appointment Thursday February 4th.
fever of 102.6, chills, body aches, fatigue, nausea for 36 hours
Mother in for 2nd Prevnar. Told us that child started having irritability and fussiness early the next morning. She stated that the child cried often, very fussy and would only sleep about 2 hours at a time, at night. Symptoms lasted 3 days. No fever. Due to the extent and length of the irritability, she deferred 2nd immunization.
Erythema and edema +1 20cm x 11cm around vaccination site on L upper arm.
Pt recvd Hep B vax about 5 yrs ago for Hep B; MAR92 neg titer drawn;
PT recd a series of 3 Engerix-B vaxs, 1cc, IM, deltoid, on 6FEB90, 5MAR90, & 14AUG90; PT did not develop antibodies p/3 injects;
The pt fainted and had a seizure then recovered. The pt was examined by MD. The event lasted about 2 minutes.
After the vaccine, around 1am that evening, I woke up and did not feel well and I started sweating and throwing up.  My temperature was 101. I was throwing up on and off until 9am the next day. I had chills and felt very hot and cold.  I was unable to keep anything down. I had no energy, no appetite and feeling lethargic. It took about 3-5 days to resolve. A day or 2 later, I went to the Urgent Care and was diagnosed with an ear infection. I was prescribed oral antibiotics and ear drops. I am fully recovered after completing the medications.
a homeless person who received 1st dose and missed 2nd, more than 42 days have passed; 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 PRODUCT DOSE OMISSION ISSUE (a homeless person who received 1st dose and missed 2nd, more than 42 days have passed) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (a homeless person who received 1st dose and missed 2nd, more than 42 days have passed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a homeless person who received 1st dose and missed 2nd, more than 42 days have passed) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
She had a L knee injury on 7/8/21 and was seeking medical care for that.  She presented to this clinic for evaluation of L knee pain and was given Covid vaccine at that visit per her request.  She was observed for 30 minutes after due to allergy history without incident.  Pt presented to ER on 7/31/21 with complaints of cough, bloody sputum, L sided rib pain.  She was diagnosed with L popliteal DVT, positive D-dimer with suspected PE.
I contracted COVID-19 on 06/07/2022 with symptoms runny nose, congestion, sore throat, and fatigue. I was prescribed PAXLOVID on 06/08/2022 via a telemedicine visit. I was ill for 2 days before my symptoms began to improve, and it was a very mild case. I am fully recovered with no lingering symptoms.
lot of pain in the arm of the injection site; Warm; Can't lift arm; Muscle spasms; Doesn't let her sleep; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm), MUSCLE SPASMS (Muscle spasms), INSOMNIA (Doesn't let her sleep) and PAIN IN EXTREMITY (Pain in the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (EUTHYROX) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm) and INSOMNIA (Doesn't let her sleep). 04-May-2021, the patient experienced MUSCLE SPASMS (Muscle spasms) and PAIN IN EXTREMITY (Pain in the arm). On an unknown date, the patient experienced INJECTION SITE PAIN (lot of pain in the arm of the injection site). The patient was treated with NAPROXEN at a dose of 500 mg. At the time of the report, FEELING HOT (Warm), LIMB DISCOMFORT (Can't lift arm), MUSCLE SPASMS (Muscle spasms), INSOMNIA (Doesn't let her sleep), PAIN IN EXTREMITY (Pain in the arm) and INJECTION SITE PAIN (lot of pain in the arm of the injection site) outcome was unknown.            Treatment included Warm compresses   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received on 30-JUN-2021 contains NNI
12/08/16 -patient reports left deltoid injection site became red; swollen; painful & hot to the touch. Went to ER. ER MD advised heat compresses & follow up with MD 12/09/16 patient came in for OV left deltoid injection site: 3cm x 3cm swollen, hot & painful to the touch. MD eval: Local swelling & tenderness; + joint & back pain.
Patient reported itching sensation on upper arm, lower back, thighs and shin but no rash.
Headache; Injection site pain; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non HCP).   A 50-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 09Dec2021 at 12:30 (Lot number: 1620) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot Number: 6955, Anatomical location: Left arm, Administration time: 11:00), administration date: 08Apr2021, when the patient was 49 years old, and Bnt162b2 (DOSE 1, SINGLE, Lot Number: 6955, Anatomical location: Left arm, Administration time:13:30), administration date: 18Mar2021, when the patient was 49 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 at 12:30, outcome "unknown", described as "Dose number: 3"; HEADACHE (non-serious) with onset 10Dec2021 at 09:00, outcome "not recovered", described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2021 at 09:00, outcome "not recovered", described as "Injection site pain". Therapeutic measures were not taken as a result of headache and vaccination site pain.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a male consumer who experienced a cough and runny nose.  The pt received a dose on 12/13/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/13/03.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The pt experienced a cough and runny nose several days following administration of Flumist on 12/13/03.  His wife experienced a similar reaction after receiving Flumist (see related case HQWYE887823DEC03).  The reporter declined to provide additional information and declined to grant permission for follow-up investigation.
Patient began complaining of severe left arm pain and diziness approximately thirty minutes after injection. Patient was evaluated by EMS and DOH nurse, vital signs were found to be stable, patient remained alert and oriented and appeared to be without overt signs of distress. Patient maintained mobility of her arm and was able to grip firmly. Respirations were even and non-labored, no wheezing noted. Patient was assisted to sit down and was provided with juice and a snack. Mother was instructed to follow up with medical professionals if symptoms persist or become worse, no further medical care needed at this time.
pt rcvd vax; pt dx w/ arthritis & brachial; plexitis of unknown etiology; some decreased mobility;
No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No concomitant medications was provided. No treatment medications was provided. Vial size was 5.5 mL  Date the vial was initially stored in the refrigerator was on 31Mar2023. The vial did not undergo any temperature excursions
Narrative: Patient passed away due to COVID-19. He was hospitalized and received a COVID-19 vaccine.
Awoke 13th day after flu shot paralyzed from waist down. Never recovered. In wheelchair; perfectly healthy before this. In 11/91 13 days after a flu shot, I awoke paralyzed from the waist down. Went to our doctor then to hospital ER. Called it acute ideopathic polyneuropathy fter x-rays and cat scan. Finally went to the hospital and then to another clinic where they thought it was GBS. Later transverse myelitis. From there to nursing home where I've been in a wheelchair ever since. Completely paralyzed from waist down with incontinence. The hospital discharge summary received on 1/2/04 states congenital malformation, spasticity, and neurogenic bladder.
Guillain Barre syndrome. Hospitalized at hospital. Still no reflexes in ankles and knees bilaterally. Discharge summary states paresthesia, pain. msv Medical records state myasthenia, accidental injury. msv
Has not yet received second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 05th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not consent to follow up.
Information has been received from a physician concerning a 5 year old male who in approximately 2003 (at 13 months of age) was vaccinated with varicella virus vaccine live. In September 2006, the patient was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). On 11, Jan 2007 the patient experienced a very mild outbreak of chicken pox. The patient sought unspecified medical attention. Additional information has been requested.
n/v, diarrhea for sometime;dehydrated & transported to hosp by paramedic;
03/20/21 - Patient was scheduled to receive 2nd dose of Moderna COVID vaccine.  EHR was working very slow (at times it was down completely), and MA was unable to fully review patient?s chart prior to vaccine administration. All patients scheduled that morning were scheduled to receive 2nd Moderna dose, which is why the MA felt comfortable administering vaccine after patient verbalized that she was coming in for the second dose of the COVID vaccine. After vaccine was administered, MA asked the patient for the COVID vaccine card to update the information. It was then that he noticed that the first vaccine administered on 02/20/21 was Pfizer, not Moderna. Provider was notified right away and Dr. went into room to speak with patient, explain situation, and offer reassurance. Upon chart review, it was determined that on 02/20/21, Pfizer vaccine had been administered.  Per CDC website "Interchangeability of COVID-19 vaccine products" ?In exceptional situations in which the vaccine product given for the first dose cannot be determined or is no longer available, any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series.? The situation that occurred is not what is described above, but it is helpful to know as it is the same outcome ? two different products used, although not ideal, not necessarily harmful. This was discussed with Medical Directors for medical input. All agreed that there is nothing else to do medically for patient as long as she is doing well. She has completed COVID vaccine series, no need to restart series or get a 2nd Pfizer vaccine. 03/26/21 ? Dr. was updated with information above.  03/29/21 -  Writer spoke to patient and updated her on situation. She denied having any adverse effects to COVID vaccines. Patient was grateful for the follow up phone call and relieved to learn that the COVID vaccines are valid. Questions and concerns were addressed to patient?s satisfaction. MAs involved are being followed up with by Nurse Educator.
Area around injection and injection site became swollen/warm to touch/developed cellulitis requiring antibiotic treatment.
Septic shock due to urinary tract infection. ED visit and hospitalization. These visits were within 6 weeks of receiving the COVID vaccine.
This spontaneous report as received from a health care professional refers to a patient of unknown age and gender who on 13-APR-2015 was vaccinated with an improperly stored dose of ROTATEQ lot # K011663 which was under 12 hours excursion. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Had my 2nd Moderna shot on 4/7/21. Approximately on 4/21/21 (it may have been sooner and I didn't pay attention) I noticed I could not taste. I can smell. I also have a salty, briney taste in my mouth. It is now 5/10/21 and these symptoms still persist.  I called my doctor to report these things and she told me to report it to you. I hope I get my taste back.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included mononucleosis. Concurrent medical conditions included diabetes. On 26th September 2018, the patient received the 1st dose of SHINGRIX. On 27th September 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, injection site itching, injection site erythema, injection site swelling, appetite lost, taste metallic, headache, facial pain and fatigue. On an unknown date, the outcome of the pain in arm, injection site itching, injection site erythema, injection site swelling, appetite lost, taste metallic, headache, facial pain and fatigue were recovering/resolving. It was unknown if the reporter considered the pain in arm, injection site itching, injection site erythema, injection site swelling, appetite lost, taste metallic, headache, facial pain and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient experienced arm soreness, itching, redness, and swelling at the injection site, loss of appetite, metallic taste in mouth, and her face hurt. The patient reported that the events began to resolve after 2 days. This is 1 of the 3 linked cases reported by the same reporter.
This spontaneous report as received from a medical assistant refers to a 31 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 28-JUN-2018, the patient was vaccinated with an adolescent/pediatric formulation of RECOMBIVAX HB, lot # M003658, expiry date: 02-JUN-2018, once, intramuscularly for prophylaxis. The patient was given an additional 0.5ml of the pediatric/adolescent dose. The patient experienced no adverse event.
Gave MMr with Biojector, Td by injection. Pt's color turned pale, c/o dizziness and abdominal pain. Put pt's head on knees, had him breathe deep and slow. gave pt juice after 10 minutes. Pt left feeling WNL. Mom fed him chicken nuggets and milkshake at McDonalds, pt got ill in evening, vomited times 2, had temp 101, c/o headache and abdominal pain. ER nurse told her to treat with Advil and Tylenol.