chrisvoncsefalvay/vaers-outcomes huggingface dataset:
long term fatigue beyond 4-5 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient in her 70's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 8 decade as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "long term fatigue beyond 4-5 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021422097 Same reporter, event, product/ different patient;US-PFIZER INC-2021416973 Same reporter, event, product/ different patient; US-PFIZER INC-2021422097 Same reporter, event, product/ different patient
an adult received a pediatric dose of Engerix-B; an adult received a pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-year-old patient who received HBV (Engerix B pediatric) (batch number MB744, expiry date 01-MAR-2024) for prophylaxis.   On 15-AUG-2023, the patient received Engerix B pediatric. On 15-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced inappropriate age at vaccine administration (Verbatim: an adult received a pediatric dose of Engerix-B) and underdose (Verbatim: an adult received a pediatric dose of Engerix-B).     The outcome of the inappropriate age at vaccine administration and underdose were unknown.   Additional Information: GSK receipt date: 17th August 2023 The nurse reported that nurse reported that an adult received a pediatric dose of Engerix-B, received inappropriate age at vaccine administration and underdose. The reporter consented to follow up.
A nurse reported that 2 unidentified children developed a rash following the administration of Prevnar. No further info was available at the time of this report. These pts were 2 of 4 children from the same facility reported to have developed a rash subsequent to Prevnar. See related cases HQ2329820JUN2001 and HQ2389221JUN2001 for the reports on the other two children.
Crankiness at 10:30. Fell asleep, woke approx 3am screaming and crying, face looked like a balloon, very irritable, screamed at the touch of the shot site, warm feeling but no fever. Gave MOTRIN at 4. He calmed down and fell asleep at 6:30am. Eczema flare up & itching.
Zoster Vaccine Recombinant - Second Injection. I experienced dizziness, nausea, fever, extreme body aches and headache and some congestion starting the evening of the day I received the injection, and lasting almost three days.
I had fever nausea extreme fatigue and arm soreness and high heart rate. All in one day, I could hardly get out of bed. I called my PCP on the phone, the doctor had me take a few medicines. I awoke the next day, and my arm was just sore, but I felt normal.
Four days after receiving DTaP #4 and MMR #2, this pt. developed cellulistis on her right upper arm. she was given a ten day course of Keflex.
Information has been received from a physician concerning a 22 month old female patient who on 30-SEP-2009 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported). The patient concomitantly received on the same day a dose MMR II, a dose of RECOMBIVAX HB (manufacturer unspecified) and concomitant vaccine included a dose of DTaP on the same day (manufacturer unspecified) (doses, routes and lot numbers unspecified). On 04-OCT-2009 the patient presented to ER with seizures and fever. The patient required several anticonvulsants and then intubated due to respiratory depression secondary to anticonvulsants. The patient was hospitalized on an unspecified date. Magnetic resonance revealed enhancing lesion of cerebellum thought to be consistent with vascular abnormality. On 08-OCT-2009 the patient was extubated, remained somewhat ataxic, but was improving. At the time of the report the final diagnosis was still pending. Upon internal review, seizure was determined to be an other important medical event. No further information is available.
Left arm-Lower deltoid area turned red and warm on 04/03/2003 24 degrees after receiving DTAP & IPV.  Can see injection site where DTAP given.  Just below this site is a large area-warm to touch-slight induration noted.  3in in diameter.  Appears area reddened where IPV given SQ.
Very tried the first day and then second day good.  Went for a 5 K run. Right after the run my right knee starting hurting so bad that I couldnt walk on that leg.  Still today I have a knot on the back on my knee and pain when trying to stretch or pull the knee into my chest.  I cant pull the leg around to my side to stretch or sit on my knees with excessive pain.  Before the shot there was no pain in my right knee.   2nd shot dead tired the first day.  The next day hot and cold chills for two days, weak, head ache for one week and stomach pain.  Kneed still is hurting.
Bell's Palsy; This is a spontaneous report from a contactable physician (patient). A 62-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on left arm on 19Dec2020 19:00 at single dose for COVID-19 immunisation. Known allergies: No. Other medical history: None. No other vaccine in four weeks. No other medications in two weeks. The patient experienced bell's palsy on 03Jan2021 21:00 and required visit to physician office. Covid test type post vaccination: Nasal Swab (PCR) on 29Dec202: Negative. Therapeutic measures were taken as a result of bell's palsy included Prednisone, Valtrex. Outcome of event was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on a compatible association, causality between event Bell's palsy and BNT162B2 vaccine cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Subsequently following vaccination, the pt experienced a slight fever, which resolved within two days with treatment with acetaminophen. The infant did vomit and had decreased intake for two to three days also. The reporting physician attributed the vomiting to the mother giving the infant prune juice and increasing his Enfamil feeding from 4 ounces to 6 ounces. A dime-size lump remained at the injection site as of 10/20/00. All events resolved within three days. As of 1/23/01, the outcome of the events was resolved.
I had stomach ache and headache. I have now being diagnosed with Pulsatile Tinnitus.
Systemic: Seizure-Mild, Additional Details: patient got vaccine and about 3 minutes after dose was experiencing feeling hot and excessive sweating. Patient then passed out and had seizure with loss of consiusness, convulsion, and clenched jaw. Patient regained consciousness in about 10-15 seconds and was disorriented ambulance was called and patient was taken to hospital. Hx of seizure 1 time in past year not currently on antiepleptic medication
Noticed a small rash under the injection site around 4:00 a.m. after initial injection. As the day progressed the rash became larger and still remains there today.  Arm has been very sore as well. I've had severe headaches and body aches for the past three days.  The headaches have subsided today and the body aches are much less, however, I still feel tired.
Son received his 4 year vaccinations. Dtap, mmr, varicella,  and IPV. Unsure of which shot was put in each let. His left leg started swelling and was red within an hour and has continued to spread. Its now across his entire thigh. Red and swollen and raised. I've outlined in pen each time it spreads. It's hard and warm to the touch. He complains that it hurts to touch. It is now Friday and it spread over last night and it looks bruised now as well.
Lymph node swelling in armpit of injection site arm, extending into right breast and down right side of rib cage with pain radiating down the inside of the right arm
Difficulty breathing, sinus drip, coughing 09:00 PM, head ache, body aches, chills, 10:00 PM, no fever. Tuesday, 09/17/2013; mild head ache, body aches.
Father reports temperature 103F with nausea and headache the next day following immunizations. Child was taken to an Emergency Clinic and seen by a physician. Pt was given Zyrtec with instructions to repeat dose at bedtime and PRN. Father reports fever had subsided several hours later and all symptoms gone by 9/29/00.
A non-serious spontaneous report of "administration of H1N1 with expiry date of 01/15/2010" was received from a health professional concerning a 40-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 15-Jan-2010. On 22-Jan-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
patient got booster dose today for moderna. He has no history of having adverse reactions to any vaccine, including no reaction to his first two doses of moderna which we gave here (which were 5/17/21 6/14/21). About 5 minutes after we administered the vaccine we could hear the patient on the bench making sounds like he was going to throw up (but never actually threw up). We went out and asked if he was okay, he said he felt fine, did not feel dizzy at all. He said that he all of a sudden was overcome with racing thoughts/anxiety which made him feel like he had to throw up. He stated this was a very common occurrence for him as an anxious person. Both wife and daughter with him confirmed this to be the case as well. We offered ice packs to him, or if he needed anything else. He stated no, he was okay, just was feeling anxious but nothing to do with the vaccine. I wanted to measure his blood pressure, but he was already so anxious, that even us talking to him made him more anxious.  We watched him for 30 minutes. During that time, he had one more episode of attempting to throw up after we had talked to him again (which made him anxious). Once again he stated he did not need anything from us, nor did he feel lightheaded or dizzy. He decided after 30 minutes to leave. He was escorted all the way to his car by wife and daughter, and the daughter was going to be driving home. We called later in the afternoon to check on him but he didn't answer
2/1 am chills with low grade fever (about 100F), GI discomfort with no vomiting, normal pain at injection site 2/1 pm developed red streak downward from injection site that developed into itchy raised rash by 2/2 Skin was "hot" 2/2 am rash continued to spread to area approximately 3 inches by 5 inches 2/3 Was checked by PA in Employee Health to r/o cellulitis and advised to report reaction.  Size of rash appears smaller
It depends on the person. Some people it works and some it doesn't. My Dad got the flu everytime; Initial information regarding an unsolicited valid non-serious case received from a non-health care professional (patients child) via social media on 27-Nov-2020.  This case involves a male patient of unknown age who got the flu every time it depends on the person. some people it works and some (influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, past vaccinations, family history and concomitant medications were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patients child informed that the patient got the flu every time (influenza) (non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE it depends on the person, for some people it works and for some it does not.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 30-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.; Sender's Comments:  US-009507513-2109USA000271:
For a day and a half she had the following reactions: stabbing left ear pain, body and joint aches, inflamed right arm and swelling (injection site). She was also in bed for a day and a half. Pt came in on 10/2/18 to recap her reaction and let me know she will not be receiving the second dose.  She said was ok on this date and the pain and swelling were gone.
Pt came in for a physical and received vax, pt returned on 8/25/2000 for PPD reading and mom states child had leg swollen for one day. Pt was prescribed Benadryl liquid.
slight fever (99.3); Chills; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the left arm 24Mar2021 at 13:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient was reported as no. The concomitant medications included ALEVE. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685) via an unspecified route of administration in the left arm 03Mar2021 at 10:00 (at the age of 61-years-old). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 25Mar2021 at 13.00(24 hours following the 2nd shot) the patient experienced chilled and slight fever (99.3) for about 4 hours and head ache but again only for about 4 hours then she was fine. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills and headache was recovered on 25Mar2021.   No follow-up attempts are needed. No further information is expected.
body aches; chills; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route in the left arm on 24Mar2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications with two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route in the left arm on 03Mar2021 at 14:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 22:30, the patient had body aches and chills starting about 12 hours after dose and this lasted through the night. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was treated with ibuprofen (MANUFACTURER UNKNOWN) for the events body aches and chills. The clinical outcomes of the events body aches and chills were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
Severe rash on one leg (blisters) treated by dermatologist. Patient says rash is cleared but is experiencing neuropathic pain in leg area. Being treated with analgesics.
erythematous rash; numbness in right arm radiating down to hand; Mild pain at injection site; Also had swelling of right hand; This is a spontaneous report from a contactable physician via Pfizer Sales Representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced numbness in right arm radiating down to hand. Patient also had an erythematous rash above the site of injection, mild pain at injection site and also had swelling of right hand on an unknown date after use of the product. The outcome of the events was unknown.  Information on the batch number has been requested.
Narrative:  PATIENT WAS VACCINATED IN A TIMELY MANNER IN JAN/FEB 2021 WITH PFIZER. PT WAS ADMITTED 8-17-21 AFTER PRESENTING TO ER WITH COUGH, CHEST CONGESTION, DIARRHEA AND TACHYCARDIA.  PT WAS PROVIDED O2 BRIEFLY FOR TACHYCARDIA AND FOR COMFORT WHILE SLEEPING (NO CPAP MACHINES AVAILABLE)
Patient reports a large welt and pain at the injection site. She has applied hydrocortisone cream, BENADRYL cream and NEOSPORIN to the site with some improvement.
about 2 years ago and has not yet received her second Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received by intramuscularly at unknown arm about 2 years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: about 2 years ago and has not yet received her second Shingrix vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-AUG-2023 The reporter reported that no other information was known. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023114896:Same reporter
Pt received SHINGRIX Vaccine manufactured by GlaxoSmithKline, the next day she noticed a baseball sized area of redness on that arm, not hot or tender, no other symptoms.
Headache, Myalgia, shoulder tightness, sweating, rigor, polyuria,  Narrative: N/A
Hx of Covid-19 previously in the year, diagnosis includes the following: Urinary Tract Infection, Pseudomonas, Pneumonitis d/t inhalation of food, dysphagia, protein malnutrition, muscle weakness, cough, adult failure to thrive, critical illness myopathy, chronic respiratory failure with hypoxia, dependence on supplemental oxygen, aphasia, anemia, chronic kidney disease
Burning pain in arm for 30 min post injection, very sore arm/injection site for 3 days. Severe Fatigue and weakness, nausea, sore throat and joints, fever for 4 days 101-spiking for hours at 103 for full 4 days.
At 3:28pm, flu vaccine was administered IM in patient's left deltoid. Bleeding was immediately noted from injection site, and within 10 seconds of administration, a lump began forming under the injection site and reached approximately 1.5cm in diameter. Patient at that time denied symptoms of anaphylaxis and was awake, alert and engaging appropriately in conversation. Light pressure was held to site to control the bleeding and second RN was called to assist. Within 1 minute of lump forming, it decreased in size and area of redness approximately 3cm in diameter around the injection site was noted. Bleeding stopped and gauze and a bandaid was applied. Cold pack was held to area for 20 minutes while RN continuously monitored patient. The only symptoms patient noted was feeling "a bit funny in my head" but she noted she had a bit of a headache prior. She sipped on approximately 12oz water during this time as well. Approximately 15 minutes after vaccine was administered, redness around injection site resolved and no further discoloration was noted at the injection site. Patient continued to deny symptoms of anaphylaxis (SOB, tongue/throat swelling, difficulty swallowing/talking, dizziness, feeling faint) and no change in level of consciousness was noted. Patient was advised to go to the ER if she or her husband who was accompanying her today notice any of the symptoms listed above.
RED BLOTCHES ON LEFT ARM AND RIGHT TEMPLE; HIVES ON LEFT ARM AND RIGHT TEMPLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 11:51 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021 17:30, the subject experienced red blotches on left arm and right temple. On 07-MAR-2021 17:30, the subject experienced hives on left arm and right temple. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red blotches on left arm and right temple, and hives on left arm and right temple on MAR-2021. This report was non-serious.
01/30/22 presents to ED for "back pain, leg numbness". PMHx of "DVT, Hypercholesterolemia, and partial thyroidectomy"
09/13/22 presents to Orthopedic Surgery for "Incision and debridement of right femur". PMHx of "no past medical history on file"
Pt has a history of HTN, HLD, and CAD s/p stent to RCA. She presented to the ED with shortness of breath and was found to be COVID positive. She had been having shortness of breath for several weeks and a productive cough with sputum.