chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a pt (age and gender not reported) who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot651321/1036P). Subsequently, the day after vaccination, the pt developed severe arm soreness, high fever, nausea, vomiting and weakness. The pt sought unspecified medical attention. At the time of this report, the outcome was unk. The physician requested a lot check of lot 651321/1036P. The physician felt that the pt's severe arm soreness, high fever, nausea, vomiting and weakness were disabling. Additional information has been requested.
6/2/21 A 1/2 inch long bump/rash appeared on the right side of my scalp. It didn't itch or hurt. 6/3/21 I woke up with a headache on the right side of my head. Felt like a sinus headache, behind my eyes and sinus cavity. 6/4/21 Still had headache and bump on scalp. The right side of my face from my forehead to my eyelids had a painful burning sensation when even lightly touched, almost like a pins and needles feeling but painful. A linear rash appeared on my right middle forehead. 6/4/21 1:20 Doctor diagnosed shingles. By 3pm I had started a 7 day course of Valacyclovir 1 GM 3 times a day. By evening my head hurt to the point of taking 800mg Ibuprofen for relief every 8 hours. Extreme fatigue for the next 3 days. 6/5/21 Head pain continued, with rash spreading throughout right side of scalp and down right side of face, even on eyelids. 6/7/21 Symptoms began to lessen, but head pain in spurts. 6/8/21 Visit to Ophthalmologist at 11:20 am. No lesions on eye. Prescribed Steroid eye drops 2x a day for 1 week. No pain in eye. Head pain almost gone. Energy returning.
Patient had flu vaccine on 10/14/03. On 10/26/03, she developed numbness and tingling in feet which gradually moved up legs to waist. On 11/5/03, developed progressive weakness in legs and back spasms. On 11/3/03, she was unable to walk and had urinary retention, and was admitted. She could still move feet on admission. She was started on IV Solumedrol. Was completely paraplegic on 10/10/03. Now plasma exchange for transverse myelitis. The medical record received on 3/23/04 states burning pain. She is still paraplegic and has no movement or sensation in her legs. It is uncertain if the myelitis is due to the flu vaccine. Per annual report she remains completely paraplegic with no movement or sensation in her legs. Her last MRI 06/21/2004 showed very significant atrophy of the lower thoracic spinal cord.
25AUG97 pt mom called & reported pt had a fever 104 ax; fever dec nl;mom felt fever may d/t vax 14AUG97;no rash no sz reported;26AUG97 mom reported t103.3 a;
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 05/26/2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-MAY-2021, the subject experienced administered expired vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered expired vaccine was not reported. This report was non-serious.
An attorney alleges that a 2 month old male, now 7 years of age, received an injection of DTAP vaccine on 3/30/94, as part of routine childhood immunizations. In 1999, the reporter alleges that the child was dx'd with mercury poisoning. It is alleged that as a result of the mercury poisoning, the child developed permanent neurological injuries, resulting in "his regression from a normally developing child into a severely impaired individual". The reporter attributes the events to the presence of Thimerosal. No further information was available at the date of this report.
After the vaccine Pentacel lot C3278AA my son started to convulse (I'm not sure if it was a seizure or not) in the car on the way home. He also threw up/dry heaved as he had nothing left. I pulled over and called Dr.'s office. He was "zombie like" eyes glazed over and not responding to his name. Dr. said he was probably was just still upset and I could come back in but she didn't think it was necessary. I called office again when I was home and spoke to nurse to get lot number of vaccine. Son ran a fever of over 102 for 4 days and was listless not responding to his name. I regret listening to the Dr. and not taking him to the ER. I don't know if this has anything to do with his developmental delays or not but thought I should report it. His caretaker and I started to notice changes in his behavior directly after the vaccine.
ANXIOUS, WARM TO TOUCH, HEAVY EYES AND SHAKES  Narrative: VITALS STABLE @1025 BP134/76 HR 88 02 96% @1045 BP SYMPTOMS MONITORED LONGER, CALLED FOR TRANSPORT TO ED PER PROTOCOL. PT WAS ALERT AND CONCIOUS
A rash around the injection site with a hard bump underneath.  He said it didn't itch or hurt.  Showed up a week after the injection. Looks to be getting better after day two of rash.
Felt immediate pain at injection site and continued soreness. Had pain with abduction of left arm and pain with lifting objects. Seen by PCP-did heating pad, Motrin, hot shower without relief. Seen by Ortho doc-MRI done with results of "hole in middle of rotary cuff."
This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 38-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline) while pregnant. Concurrent vaccination included ADACEL (Sanofi Pasteur) and PPD given 12 May 2011. On 12 May 2011 at 09:30 and 12 April 2011 at 14:00 the subject received 2nd dose and 1st dose of TWINRIX adult (1 ml, unknown, left deltoid). The subject experienced vaccine exposure during pregnancy. It was reported that the subject visited the emergency room presenting with pelvic pain, but was not admitted to the hospital. At that time, it was determined that the subject was 6 weeks pregnant. Her date of last menstrual period and estimated date of delivery were not known. The pregnancy was ongoing at the time of reporting.
Hard of hearing; Not feeling really well; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot number unknown) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter called to ask what needs to be brought on second schedule of Covid-19 vaccine which is on 24Feb on the vaccination card, first dose was given on 27Jan2021 which is past 21 days apart between the first and second dose. He wanted to know the time of appointment. He stated he had his 1st dose (27Jan2021) and 2nd dose (24Feb2021) it was more than the usual 3weeks interval. He was calling earlier to know the exact time for his 2nd dose. He had his vaccination card with him but there was no time showing. He stated he got my first shot of the vaccination (Covid-19 Vaccine) on the 27Jan2021 and then they give a card there and it said next shot would be the 24Feb2021. He got that right in front of him then it doesn't say at what time, so he thought he should call and find out at what time and then the young men that was talking to him said that was too longer period of time. It was supposed to be in 3 weeks and he thought why would he put, why would he do that, you can explain it to. He stated he was hard of hearing, not really, he was not feeling really well, and he didn't feel like doing it. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
I apparently had a break through covid case.  Severe coughing, fatigue, general syncope
Information has been received from a licensed visiting nurse concerning an 8 week old female patient with no known allergies reported, who on 16-APR-2008 at 10:30 was vaccinated intramuscularly into the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. It was reported that on 16-APR-2008 at 10:30 the medical assistant gave the pneumococcal 23v polysaccharide vaccine instead of PREVNAR. No adverse reactions were reported. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. No further information is available.
No additional AEs; expired vaccine V AQTA (...) was administered to a patient on 1/12/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 12-JAN-2021, the patient was vaccinated with an expired, 1 ml dose of hepatitis a vaccine, inactivated (VAQTA) intramuscularly, lot# S036494, expiration date 09-JAN-2021 (site of injection was not provided) for prophylaxis. Hepatitis a vaccine, inactivated (VAQTA) had no temperature excursions. No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036494; expirationdate: 09-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
2:00PM 01/22/2021 Neck is numb from right side; 8:00PM 01/22/2021 Right arm was sore, couldn't move it. Had a headache; 02:00AM 01/23/2021 Entire body was sore; 12:00PM 01/23/2021 Entire body was still sore, right arm hurt a lot. High temperature; 3:00PM-Currently 01/23/2020 High temperature, chills, sore body. Feeling lethargic and cannot get out of bed because of the pain.
Red, swollen, hot, painful and itchy, knot at site of injection. Mom took child to ER and was given BENADRYL and KEFLEX. Mom states they believe he had an allergic reaction. Mom went to ER since they have no primary care physician.
Dizziness, nausea, anxiety, uncontrollable crying beginning 1 hour following vaccine.
The client was vaccinated on 7/28/2022 with an expired Moderna vaccine. The vaccine was thawed and accidentally used 1 day following the marked B.U.D. date of 7/27/2022.  Pt tolerated vaccination well. The vaccine administration error was not realized until after vaccination clinic ended and RN returned unused vaccine to Pharmacy. Safety event completed in Pharmacy, team leadership aware. Additional safety checks and protocols put into place to mitigate future risk of administration errors in both the Pharmacy as well as on our Mobile vaccination team.
I observed in irregularly shaped raised, red, warm, and firm shape at the injection site this morning after my shower. I am also noticing a bit more soreness as I use my left arm at the injection site
10JUL98 child sitting on floor playing & went limp, eyes rolled up & perioral cyanosis, shallow resp nl heart rate;spell lasted 15-20seconds, sleepy afterwards;mom took child to MD; Annual follow-up states the pt has developed mental delays, does not talk and is starting a pre-school for special needs children.
Generalized aching; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized aching) and HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Ankylosing spondylitis.    Concurrent medical conditions included Psoriatic arthritis and Ankylosing spondylitis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN (Generalized aching) and HEADACHE (Headache). At the time of the report, PAIN (Generalized aching) and HEADACHE (Headache) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.
pharmacist called to inform that a dose of Arexvy was administered by error to a pregnant woman; 30 year old patient; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 30-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3N3CT, expiry date 29-JAN-2025) for prophylaxis.   On 04-NOV-2023, the patient received Arexvy. On 04-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 30 year old patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pharmacist called to inform that a dose of Arexvy was administered by error to a pregnant woman). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester  Pregnancy Details (Neonate 1):  Pregnancy Outcome: Pregnancy was ongoing Delivery Notes: around 32-36 weeks gestation   Additional Information: GSK Receipt Date: 08-NOV-2023 The reporter stated a dose of Arexvy was administered by error to a 30-year-old pregnant patient, the patient was around 32-36 weeks gestation, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Reaction at the injection site; Occasional itching over the whole body; Arm itchy; Arm swollen; Little bit of nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NAUSEA (Little bit of nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced NAUSEA (Little bit of nausea). At the time of the report, NAUSEA (Little bit of nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Presented 20 days s/p MMRV with varicella - like - rash. Diagnosed with vaccine induced varicella.
Right arm pain, myalgia,malaise, tiredness x 2 days. Sleeping all the time. tingling in finger pads
Muscle weakness in limbs, Guillain-Barre Syndrome-diagnosed. Treated by Plasmapheresis, 5 times. About 80% recovered weakness ongoing in legs. Was completely paralyzed at peak of condition and near death.
Patient stated vaccine was given "way up in the shoulder" and that she was "black and bruised" from it. She also stated that it was swollen and took approximately eight days to resolve. As of 12/11/22, patient states the site is "all fine now" and does not seem to be concerned.
This is in follow-up to report(s) previously submitted on 9/17/2007. Information has been received from a healthcare professional and a physician concerning a 4 month old patient with no pre-existing medical history or allergies who on 16-AUG-2007 at 09:15 was vaccinated with the second oral dose of ROTATEQ (lot# 657291/0669U). There was no illness at the time of vaccination. No adverse events were following prior vaccination. Concomitant vaccination administered that day included the second dose of COMVAX (lot# 655552/0002U) in the right thigh, a second dose of PREVNAR (lot# B70145E) in the left thigh and the second dose of DAPTACEL (lot# C2650AH) in the left thigh. On that same day (also reported as 17-AUG-2007), the patient experienced forceful vomiting and decreased appetite.  Medical attention was sought through the patient's physician.  The patient had no fever but the vomiting and decreased appetite persisted. The patient experienced vomiting every other day. The emesis had blood tinge in it for 2 episodes only but has since resolved. The patient's bottle nipples were changed which may have contributed. The patient's exam was normal. No other labs or diagnostic studies were performed. On 04-SEP-2007 the patient recovered. There was no weight gain. There was no product quality complaint. No further information is available. Additional information has been requested.
increased blood pressure after first 2 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERTENSION (increased blood pressure after first 2 doses) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination.     Family history included Blood pressure high. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included LOSARTAN for Blood pressure management.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (increased blood pressure after first 2 doses). At the time of the report, HYPERTENSION (increased blood pressure after first 2 doses) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Increased.     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 Treatment Medications details were provided.   This case was linked to MOD-2021-420124, MOD-2021-420138 (Patient Link).
Joint pain; Inflammation; Redness in her knees; This is a spontaneous report from a contactable consumer (Husband to the Patient). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included interstitial cystitis, an autoimmune disorder that affects her bladder, she has had flair ups in her knees in the past. Concomitant medication(s) included pentosan polysulfate sodium (ELMIRON, 100mg) taken for cystitis interstitial; fluoxetine hydrochloride (PROZAC 20mg) taken for an unspecified indication, for 1-2 decades. The patient previously took first dose of vaccine. It was reported that the patient received the second dose of the Pfizer Covid 19 vaccine several weeks ago. Now, she has been having joint pain, inflammation, and redness in her knees. She saw a Rheumatologist yesterday (28Apr2021) who scanned her knee, which found "no water in the knee", and drew labs that were pending. She has had flair ups in her knees in the past. Stated that his wife took the booster shot of the Covid Vaccine several weeks ago. Stated his wife takes other prescription medications as well. They wanted to know if Elmiron was considered an immunosuppressant medication or not, whether her medications could interact with the vaccine and cause the symptoms she is experiencing. Referred caller to HCP for guidance. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Tested positive for COVID virus; Tested positive for COVID virus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), 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 immunization. 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), outcome "unknown" and all described as "Tested positive for COVID virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 4-5 days after that she felt funny and went to the drug store and bought a home testing kit. Hers was positive; unknown; unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. Clinical course was reported as, Received call from reporter who bought product from Pfizer - Paxlovid for the COVID 19 virus. He got phone call from Pfizer and said Reference #. He took Paxlovid for 5 days. Somebody called him back. He clarified that he had just left a message for medical information and had not completed a safety report before. He did not wish to provide an address, phone, email or date of birth. He said he just wanted to speak to someone who could answer his question. Reporter asked about, After you take it for 5 days, what do you do. It is like a doctor should have the answer. They just tell you don't do anything and test negative. He then stated his wife (patient) tested positive and took the pills also. This report is to capture information for his wife. In Feb (year not provided), they got COVID 19 shots. They got Pfizer 2 shots and the booster and then everything was ok and then his wife went traveling and they were tested when they get out of the plane and ship. She came back and got tested in # and came back to #. 4-5 days after that she felt funny and went to the drug store and bought a home testing kit. Hers was positive and his was negative. They don't know how she got it. He was surprised because they got the 2 shots and the booster. She wore the mask. He then asked what is the use of taking the shots. Does it just not make it as bad. She took the 5 pills and wants to know what is the next step. He took them took because he did not want to take any chances and thought it will not hurt him to take the Paxlovid. On his, it tested negative and the next day positive and the next day negative. He did not know what to make of it.  He is an old man and doesn't have time to talk. He did not wish to complete report on himself or his wife and requested to be transferred to have his questions answered. No further details provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had soreness and swelling to my left arm after my vaccine.  I had covid after two vaccines and after one booster. I did contact my doctor, but a different doctor issued the prescription and that doctor prescribed Monopunovair medicine. My also had a 4th booster as well.
Loss of appetite, swelling and rash at injection site, tired, lower back pain, headache, flu-like symptoms.  I called the Dr. office and the nurse told me that my symptoms weren't adverse reactions to the shot and that I should move my arm like she told me to.  Onset of symptoms were that evening with the worst being two days later.  I had to miss work because I couldn't keep my eyes open and was too achy all over to make it out of bed.