chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st January 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was received as follows: The case was reported by the husband of the patient. The patient received Shingrix on her left arm and experienced sore arm that had not resolved.  The reporter did not consent to follow-up.
Mother stated that patient suffered from hallucinations.  She was seeing her friends in her house, however they were not physically present. She was speaking with pressured speech
On 3/26/21 it was reported that this pt had fallen in her apt., EMS responded and transported her to Medical Center.  On 3/29/21, I followed up with hospital staff, then family and was told she tested positive for Covid via rapid test & PCR.
pt recv vax 30SEP96 & 10OCT96 pt devel a rash;
COVID hospitalization,  vaccinated with chronic immunosuppression due to CLL Covid related acute hypoxic respiratory failure resulting in hospitalization. Vaccinated with Pfizer  3 doses (9/27/2021, 3/27/2021, 3/6/2021)   Developed symptoms of covid jan 23 and tested positive at home jan 24, received Evusheld 1/21/22 and had completed 5 day course of molnupiravir 1/2022   Admitted to hospital on 3-4-2022 for 2 week history of shortness of breath, cough and fever. Found to have acute on chronic sinusitis. He underwent sinus surgery 3/6/22. CT scan showed multifocal groundglass infiltrates-suspected to be post COVID. Discharged 3/8/22   3/10/22 received mab infusion (sotrovimab) and found to be hypoxic and had shortness of breath so sent to ED  Admitted to hospital 3/11/2022 with worsening shortness of breath, fevers and hypoxia. Hypoxia secondary to COVID lung injury. Improved on IV steroids (dexamethasone) and discharged on 8-week prednisone taper  Discharged 3/15/22  Acute hypoxic respiratory failure-resolved
Patient said that she had sneezing and coughing for about 24 hours after the vaccination. She said that she has developed a rash around the site of the injection and that it is spreading.
Patient called clinic to report subjective fever, chills, shakiness, and emesis x2. RN recommended evaluation in urgent care clinic.
My arm got sore; Body ache; Low grade fever; I kind of lost my appetite; Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283, Expiration Date: 30Apr2021), via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation.  Medical history and concomitant medications were none.  Patient had second Pfizer vaccine last Wednesday morning (13Jan2021) and went to work that day and was fine. Her arm got sore but that was fine and that night around like 10:00 pm, patient got like body ache and low-grade fever and patient was kind of lost appetite and that went on for about a day and a half. But patient had continued extreme fatigue and patient was wondering if that was part of the (sentence incomplete), several days later, it was four days later. Patient just expected it, but it was a little way more. Patient received paracetamol (TYLENOL) as treatment. Outcome of extreme fatigue was unknown. Outcome of other events was resolved after about a day and a half.
This spontaneous case, initially received on 08-Sep-2016, was reported by a Non-Health Professional and concerns a 79-year-old male patient. Weight: not provided: Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA (trivalent influenza vaccine thiomersal) on 08-SEP-2016. Dose: 0.5 ml, Route of administration: Intramuscular. Batch number: 13049331A. No additional suspect drugs. Adverse reactions/events and outcomes: On 08-Sep-2016, the vaccine has been administered that had particles in the vials - no adverse event (outcome: unknown, special circumstances: poor quality drug administered).
We had some friends visiting, they did not know they were exposed, we went with them for the weekend, on Monday they called and recommended to be tested, I tested Positive on Tuesday, it lasted for about a week; very leaky nose and eyes, sneezing, coughing, felt warm. I called the doctor, and it was recommended to take Paxlovid.  I took it according to directions, by the 5th day I felt better, by the 8th day I was okay.
Information has been received from a registered nurse concerning a 22 year old white male patient who on 09 JUN 1997 was vaccinated with the first dose of varicella virus vaccine live (lot #621199/0081E). On 09 JUL the patient was vaccinated with the second dose of varicella virus live (lot # 622684/0343E). On 1 OCT 2001 the patient had a titer drawn twice and the titer did not show seroconversion. No further information is expected.
PATIENT DEVELOPED AN URTICARIA ALL OVER THE BODY. NO OTHER SYMPTOMS.
Patient had mild injection site reaction swelling, not much pain reported besides the mild under the muscle pain from the vaccine. No redness detected from the swelling. I advised patient to observe and take Benadryl one dose 10mg and Tylenol 500mg 1 dose if needed one to two days as needed.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (Jan2023) came down with COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300044987 Same reporter/ drug/ event for different patients;
REDNESS AT SITE, FEVER OF 101 NEXT DAY.  MUSCLE ACHES. Follow up on 11/17/2003: "Both vaccinations given in same arm; unable to determine which caused reaction."
The skin on "my" entire face felt like it was on fire. "I" had to sleep with an icepack on it.; The rest of "my" body was cold and shivering.; Headache; Brain fog; Achy muscles; Swollen gland in "my" left armpit.; Trouble sleeping; The rest of "my" body was cold and shivering.; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0169) via an unspecified route of administration in the arm left on 20Apr2021 at 09:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The medical history included migraines, lasting effects from and flareups of mono when the patient was 17 and allergy to penicillin family. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8737) via an unspecified route of administration in the arm left on an unknown date in Apr2021 at 09:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 03:00, the patient's skin on her entire face felt like it was on fire and had to sleep with an icepack on it. The rest of her body was cold and shivering, headache, brain fog, achy muscles, swollen gland in left armpit and trouble sleeping. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events skin on entire face felt like it was on fire, rest of body was cold and shivering, headache, brain fog, achy muscles, swollen gland in left armpit and trouble sleeping were recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
LACK OF EFFECT; This spontaneous report received from a pharmacist concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine (Pfizer covid-19 vaccine) for drug used for unknown indication. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced lack of effect after vaccination. It was reported that, the patient had initially taken first dose Pfizer covid-19 vaccine, later Janssen Covid-19 Vaccine, and wants to take second dose of Pfizer vaccine for extra coverage. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lack of effect was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210666779 - COVID-19 VACCINE AD26.COV2.S- Lack of effect. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Within 1 minute of my injection of the 2nd Pfizer dose, my throat started feeling itchy and scratchy, I couldn't clear it, this was at 2:30.  I was given a Claritin 10mg, 1 1/2 hrs later the sensation seemed to have cleared up. But 20mins later around 4:10pm my tongue started burning and tingling and within 15mins that sensation traveled to the back of my throat. Within 20mins from that I broke out in a rash on my chest, this was around 4:40. I was taken to ER and given 50mg Benadryl through the IV. My rash on my chest started going away but my throat and tongue still felt tingly and burning. It started barely clearing up around 8:45pm but it did not go away entirely, it is still here today 1/22/21 1:54pm, but not bothersome. It seems to be fading away as time goes. I will continue to take Benadryl at home every night until symptoms completely resolves.
hives; itching on chest, neck started in the evening after receiving the vaccine; Initial information received on 29-Dec-2022 regarding an unsolicited valid non-serious case received from Patient.  This case involves a 68 years old female patient who experienced hives and itching on chest, neck started in the evening after receiving the vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac].  The patient's past vaccination(s) included COVID injection. The patient's past medical history, medical treatment(s) and family history were not provided. At the time of the event, the patient had ongoing allergy for sulfa (Drug hypersensitivity).  On 15-Dec-2022, the patient received 0.5 ml once of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (strength, expiration was not reported), lot U7679AA via intramuscular route in the left arm for Immunization.  On 15-Dec-2022 the patient developed a non-serious hives (urticaria) and itching on chest, neck started in the evening after receiving the vaccine (pruritus) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  The patient was treated with steroid dose pack on 17-Dec-2022 and it has not worked, levocetirizine dihydrochloride (Allegra) was currently given for Urticaria and Pruritus.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.
Reported by parent to school nurse child had lesions on trunk 11/12/2005. Not Dr confirmed. Lesions lasted for 4-5 days.
Approx. 12 hours after injection, experienced flushing, fever of 101.5 F, nausea/vomiting, erythema,  diffuse muscle soreness, frontal headache, dizziness, clammy skin, sweating. Treated w/ 600 mg ibuprofen t.i.d. for 2 days, symptoms resolved w/o further treatment in 48 hours.
pt recvd vax & devel soreness, swelling, warmth, redness, & induration @ the inject site; also exp fatigue
Shortly after receiving an MMR shot, patient became "dizzy" while walking down aisle #10 of our store. Patient then "fainted" and as he fell to the floor he bumped his head & side of face on the floor. Patient remained conscious throughout the event. Patient had no symptoms of tremor and no difficulty breathing. Paramedics responded within 10 minutes.
patient states 8 days after receiving her vaccine she developed itching and multiple raised approx pea-sized lumps around the injection/vaccine site.  states that she had a few red spots axilla area that weren't raised; were just 2-3 red spots.  she states that on Day 9 she developed a baseball sized lump at the vaccine injection site.  states was painful.  a little warm to touch.  was never really red but did itch terribly; felt itching it caused it to be red at times.  She states that every day it seems to be getting a little better; no itching now.  no redness.  states lump is still size of baseball.  No fever, chills, or sweats.  is able to use her arm as normal.  patient states did use both tylenol and advil post injection.  took advil x1 same day post vaccine and then 3 days later due to a headache.  states normally will use advil for her headaches.
not getting high enough IG and requiring boosting as they get sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "not getting high enough IG and requiring boosting as they get sick".  Additional information: Some kids [5 over the last few years] not getting high enough IG and requiring boosting as they get sick.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300202763 same drug and event with different patient.;US-PFIZER INC-202300204702 same drug and event with different patient.;US-PFIZER INC-202300204700 same drug and event with different patient.;US-PFIZER INC-202300204701 same drug and event with different patient.;
missed dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, 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 (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported
Patient said one week after vaccination he started to experience weakness, sweating, tongue swollen, increased saliva.
Patient reports Fever, Chills, Body aches, and a little chest pain that started 8/5/21 at 3am
I started with being sensitive to bright lights and then anything could bring migraines on - 1, 2 to 4 or 5 a week. They mimicked that of a TIA (the migraines).Doctor has prescribed  A medicine injectable (Emgality)- I have to take it once a month. (My insurance doesn't want to pay for the meds that the doctor has prescribed but luckily there is a company where I can get coupon cards to help with the costs of the meds) I'm still getting them now  - so My nose will still go numb and twinge and I still have vision at most times - before the injectable  medication  I couldn't feel my arms, blurred vision, numbness in face (that numbness came first before the left side of my body) and it was almost like I was getting a stroke. Sometimes it felt like bright light brought the migraine on and sometimes it would come on out of nowhere. I used to have an issue of these years and years ago but it wasn't the amount of  having these like I was having every day - at most I'd get one or two a year - the ones after the vaccine may be slightly worse than what I got years ago but they were still very debilitating. I still get pain in the  Right back side of my head - pain -and that is controlled by Tylenol - so it still happens one or two times a week but it's tolerable compared to what it was doing.
This spontaneous report as received from a pharmacist technician refers to a 85 years old female patient with sulfa allergy, silver allergy and hypersensitivity to alpha blocker quinazolines. The patient was vaccinated subcutaneously with a dose of lot # (672612/1653AA; exp date 21-JAN-2013) ZOSTAVAX on 18-JUN-2012 (dose not reported). No other co-suspects and no concomitant medications were reported. On a subsequent date sometime before 29-JUN-2012, she had an outbreak of shingles on the right flank and abdomen (hospitalization). The patient was admitted to the hospital on 29-JUN-2012 for the shingles. She was discharged from the hospital on 03-JUL-2012. Treatment was given but the type of treatment was unknown. At the time of the report the patient was still recovering from outbreak of shingles on the right flank and abdomen. The relatedness for outbreak of shingles on the right flank and abdomen was not provided for ZOSTAVAX. Additional information has been requested.
Vaccinated three children, patient was last of three. Mentioned to parents the 15 minute recommended wait period. Parents and kids left towards area. Within about 5-10 minutes, parents brought patient because he had fainted in area. Patient was unresponsive and was turning blue. I asked a technician to call a code white and to call 911 after alerting management. I retrieved a Jr. Epipen and some benadryl and then checked for a pulse and breathing. I asked a member of management to grab some pillows so that we could lay the patient down and lift his legs. Luckily, EMS services arrived within minutes since they had been just outside the store. EMS took charge until a stretcher was brought out for the patient.
felt like throat was itchy, gave Benadryl, symptoms resolved gradually by 2:44 PM. Advised to go to ER if symptoms return.
Got the first dose and was contracted with COVID; Got the first dose and was contracted with COVID; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was contracted with covid on an unspecified date in Dec2020 (27Dec2020 or 28Dec2020) with outcome of unknown.    Information about lot/batch number has been requested.
Two hours after receiving the vaccine my face and lips started tingling. I felt super itchy all over my body but with no visual rash or hives. Three hours after receiving the vaccine my face was numb to where I could not lift my eyebrows or smile. This lasted for around 2 hours until I took Benadryl and went to bed. The tingling and numbness went away when I woke up the next morning. It has now been two weeks since receiving the Moderna booster and I now have intense itching on my hands and feet multiple times a day, especially in the middle of the night. I try to control it with Benadryl and Allegra. This has not let up and is only controlled with antihistamines around the clock.
48 hours post booster I got chills at the same time sudden onset of very loud tinnitus.  The chills subsided within 45 minutes. The tinnitus has never gone away. It seems to be worse at night watching tv and trying to sleep.
Flu like symptoms; This non-serious case was reported by a consumer via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix with an associated reaction of no adverse event (Shingrix first shot was okay for patient).  On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms). The outcome of the influenza-like symptoms was resolved (duration 24 hrs).  It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.  Additional Information: GSK receipt date: 03-APR-2023 The patent was over age 50 years. The reporter said that, the second shot had resulted in flu like symptoms which had lasted for 24 hours.  The reporter had denied to provide further contact details.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine past the beyond used date) and ACCIDENTAL UNDERDOSE (Accidental underdose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine past the beyond used date), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           Case included information of 4th patient out of 6 reported patients.  No concomitant product reported by reporter. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication reported by reporter.