chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizzy/ Lightheaded; grey; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 29Dec2020 (Lot number: EL0140, Expiration Date: Mar2021) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia; "Urticaria" (ongoing), notes: Verbatim: Urticaria, Since 5-6 Year of Age; "Raynaud's disease" (ongoing), notes: Verbatim: Raynaud''s disease; "Tested positive for markers for Scleroderma" (ongoing), notes: Verbatim: Tested positive for markers for Scleroderma; "Rash from really hot shower or really constrictive clothes gets hives" (unspecified if ongoing), notes: AE(s) following prior vaccinations: Rash from really hot shower or really constrictive clothes gets hives.; "Rash from really hot shower or really constrictive clothes gets hives" (unspecified if ongoing), notes: AE(s) following prior vaccinations: Rash from really hot shower or really constrictive clothes gets hives. . There were no concomitant medications. Vaccination history included: Flu (Flu Vaccine; Rash and Got flu 3 times that year. Doesn't always happen , Onset Age: 30s NDC, Lot, Expiration: Unknown), for Immunization, reaction(s): "Rash". The following information was reported: DIZZINESS (non-serious) with onset 29Dec2020, outcome "recovered" (29Dec2020), described as "dizzy/ Lightheaded"; FEELING ABNORMAL (non-serious) with onset 29Dec2020, outcome "recovered" (29Dec2020), described as "grey". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts completed. No further information expected.
Fever; chills; stomach ache; body ache; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (chills), ABDOMINAL PAIN UPPER (stomach ache), MYALGIA (body ache) and DECREASED APPETITE (no appetite) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for an unknown indication.     The patient's past medical history included No adverse event. Concomitant products included ADALIMUMAB (HUMIRA), METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), TAMSULOSIN and ROSUVASTATIN.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (chills), ABDOMINAL PAIN UPPER (stomach ache), MYALGIA (body ache) and DECREASED APPETITE (no appetite). At the time of the report, PYREXIA (Fever), CHILLS (chills), ABDOMINAL PAIN UPPER (stomach ache), MYALGIA (body ache) and DECREASED APPETITE (no appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Concomitant drug included Humira -Injections every 15 days for Psoriasis, Metoprolol-For his heart, Rosuvastatin-For cholesterol Consent for safety follow up allowed.
Patients power of attorney called to let us know patient had received Janssen vaccine on 3/12/21 and on 3/26/21 was hospitalized due to a clot and stroke.  Patient had history of strokes in past.
Patient had vasovagal episode in which patient lost consciousness. Vitals remained stable, patient given ice pack, laid down, given PO fluids.
Vaccinee rec'd first inject-HIP on 3SEP90 & experienced fatigue, mild fever & malaise. P/2nd inject-hip on 23OCT90, experienced "greater" fatigue, mild fever & chills. No treatment given.
diverticulitis; sick; can't eat or drink; side pain; night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 18Apr2023 as dose 1, 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: FEEDING DISORDER (non-serious) with onset 2023, outcome "unknown", described as "can't eat or drink"; DIVERTICULITIS (medically significant) with onset 2023, outcome "unknown"; NIGHT SWEATS (non-serious) with onset 2023, outcome "unknown"; ILLNESS (non-serious) with onset 2023, outcome "unknown", described as "sick"; PAIN (non-serious) with onset 2023, outcome "unknown", described as "side pain".   Clinical course: Caller was asking how far apart the first Pfizer COVID-19 monovalent vaccine and the Pfizer COVID -19 bivalent vaccine should be administered? Caller provided that she received her first Pfizer COVID-19 monovalent vaccine on 18Apr2023 and then received the Pfizer COVID-19 bivalent vaccine three weeks later on 09May2023. Caller stated that the healthcare provider told her that during this time period between vaccines, the authorization had changed and only bivalent was available to be administered. Caller provided that she was "real sick from it, so sick that she can't eat or drink." Caller stated that she had "high fever, night sweats, chills, side pain, and what she eats comes right back out." Caller provided that her doctor stated she "has diverticulitis because of the COVID shot."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300198955 same patient/vaccine,different dose/AE;
large local rxn, poss cellulitis;tx w/ATB 4MAY94 f/u sore rt arm; red; tx Ceftin
Patient was admitted to hospital on 02/03/2022.  No symptoms or pre-existing conditions listed.  Patient died 02/09/2022
Pt received 6 mo. vaccines 09-25-2009 and 24 hours after vaccinations was admitted to hospital with seizures per Dr.
tendons in both hands kept making snapping/cracking sounds; severe pain in both thumbs, to the point I could not hold anything; severe pain in both thumbs, to the point I could not hold anything; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EN6205, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on an unspecified date in Mar2021 (at the age of 70-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included migraines, sulfa allergy, shellfish allergy and strawberries allergy all from an unknown date. Concomitant medications included tamsulosin, trimethoprim, bromelains, flunisolide (TURM) and MygranX all taken for an unspecified indication, start and stop date were not reported. The patient previously took DEMEROL and experienced allergy. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 08Mar2021, the patient experienced tendons in both hands kept making snapping/cracking sounds and severe pain in both thumbs, to the point i could not hold anything. It was reported that for 6 days the tendons in both hands kept making snapping/cracking sounds like if you crack your fingers and at times the patient had severe pain in both thumbs, to the point she could not hold anything. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are possible. No further information expected.
A year after 2nd shot, got shingles/suspected vaccination failure; shingles on arm - 2nd outbreak; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (refer link case US2023047361 for first outbreaks of Shingles). Additional patient notes included No prior history of a shingles outbreak.   On 24-FEB-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: A year after 2nd shot, got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on arm - 2nd outbreak). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023047361   Additional Information: GSK receipt date: 29-MAR-2023 The reporter was the patients husband. She had both Shingrix dose.  Shot number 2 was given on 24-Feb-2022.  The reporter did not have the exact date of Shingrix shot 1.  The reporter provided the pharmacy name and phone number where the shots were administered as the pharmacy would have the date of administration on file as well as the lot number, site, and route of administration.  After that now, like a year into (after) the (second) shots, it (shingles) came out on her other arm. The reporter confirmed that this was his wife's second shingles outbreak. The wife was in the room and did not object to her husband giving her MD contact information. The reporter was consented to follow up. This case was considered as vaccination failure as details regarding laboratory test confirming influenza were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2023047361:same reporter
High pitched screaming and crying for 6 hours. Gasping for air after crying ended. Next day there was a large hive on his left arm. He was exclusivly breast fed, there was nothing different except the vaccine that could have caused his hive. No juice, or solid foods introduced.
(R) thigh 24 hours after vaccines given noticed 2 inch round red area at site of vaccines, continued to enlarge. Seen at MD office 8/13, given IM dose ROCEPHIN, started on AUGMENTIN. Called office in AM 8/29 with increasing enlargement of cellulitis. Seen in office and decision made to admit for inpatient therapy (IV antibiotics). Had seizure in hospital, neg CT scan. Home on PO abtx.
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 received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, 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".  Additional information: The reporter enquired that if they recommend patients receive their second dose of the vaccine if they have had this type of reaction. The reporter stated all of the patients were older and immunocompromised and she does not think these were adverse reactions.   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-2021422098 Same reporter, event, product/ different patient;US-PFIZER INC-2021416973 Same reporter, event, product/ different patient;US-PFIZER INC-2021422098 Same reporter, event, product/ different patient
Patient states he got COVID while on Xeljanz. He received the first 2 COVID shots but not the booster.; Patient states he got COVID while on Xeljanz. He received the first 2 COVID shots but not the booster.; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 63 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single 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), outcome "unknown" and all described as "Patient states he got COVID while on Xeljanz. He received the first 2 COVID shots but not the booster".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
low grade chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain. Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced chills (Verbatim: low grade chills).  The outcome of the chills was not reported.   It was unknown if the reporter considered the chills to be related to Shingles vaccine.     It was unknown if the company considered the chills to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023. This case was reported by a patient via interactive digital media. The patient stated that first Shingles shot did not bother him/her at all.  The second shot gave some low-grade chills the next day.  The patient take that any day over the pain suffered through with shingles for a month. The follow-up could not be possible as no contact details were available.
Patient had rash and redness at injection site 1 day after administration. 2 days later had rash in chest area. Patient went to ER on 5/14/16 was told to take BENADRYL.
Vaccine administered 5/02/05; 5/4/05 OV with c/o pain, warmth, redness at injection site. C/o nausea. Right upper arm with 10 x 10cm round patch of erythema and warmth 3x3 cm central area of induration at site Claritin 10mg QD Prn, Medrol dose pack ice/cool compresses.
Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Body Aches Generalized-Mild, Additional Details: patient just felt under the weather adn achy on weekend and arm became red and slighley swollen, after several days she went to urgent care because red area got larger. was bout 4-5 inches long and 3-4 inches wide. urgent care prescribed oral and topical steroid and said it was an allergic response
Information has been received from a licensed vocational nurse (LVN) referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB lot # L016427, exp. date: 13-APR-2017; strength, dosage, frequency and route unspecified. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red spots on her left leg, Patient was asked to take BENADRYL 50mg by his PCP.
Employee reports after receiving H1N1 and seasonal flu vaccine on 10-21-09, 4 days later was treated in emergency room for fever, myalgias and HA.
Pt incarcerated, Health Department went to detention center to administer COVID vaccine. Patient received Pfizer vaccine. Per patient, patient had never received a COVID vaccine prior. Upon further investigation while putting records into system, patient had received 2 doses of Moderna prior to administration of Pfizer on 09/17--- First dose on 07/01/2021 and second dose on 08/05/2021. RN went to notify patient and give updated vaccination card. No adverse events noted.
I ran fever and my whole arm was sore that night and the next day and after the fever subsided, my shoulder kept hurting. It has been weeks and it is still very sore and a little swollen, which is right above where I received the injection. It is causing my shoulder to lock up, I cannot move it in certain direction or lift items at times. I have taken ibuprofen every day since then. I finally went to the doctor and they has me taking  2400 mg of prescription ibuprofen and on flexeril muscle relaxers for 2 weeks to see if I get any relief.
No other AE; HBP calling to report the administration of an expired dose of ROTATEQ and PEDVAXHIB to a patient on 11/03/2023.  Caller confirmed no previous temperature excursions for these products and stored in the recommended range until the time of administrat; This spontaneous report was received from medical assistant and refers to a patient to unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-NOV-2023, the patient was vaccinated with expirienced dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W010331, expiration date: 01-NOV-2023, administered orally for prophylaxis (strength was not provided); and  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U024090, expiration date: 28-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Case number PHEH2016US027535, is an initial spontaneous report received from a consumer on 21 Oct 2016. This is also a quality complaint report (QA reference number: 1017591). This report refers to a 50 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1620501, expiry date: Jun 2017) at a dose of 0.5 ml intramuscularly on 05 Oct 2016. On the same day after vaccination, within 12 hours, the patient began to suffer numbness in face. He visited his physician and was diagnosed with Bell's palsy, which was attributed to the flu vaccine. The outcome of the event numbness in the face was reported as condition improving and for the event Bell's palsy it was not reported. The seriousness of the event numbness in face was reported as non serious by the consumer and for the event Bell's palsy it was not reported. The causality of the events was not reported. Seriousness of the event facial paralysis was upgraded to serious as per the Novartis Important Medical Event list. Non significant follow up report received from Quality Assurance department (QA reference number: 1017591) on 01 Nov 2016: QA reference number (1017591) added.
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient was administered with expired FLUMIST. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious.
Patient to be evaluated for rash. This has been a problem for the past one to two days. The rash has not occurred previously. It is located primarily over the left leg and the right leg. He describes the rash as red and distributed in irregularly shaped patches. The rash has been essentially asymptomatic. He denies any associated symptoms. Possible contributing factors include received 2 vaccines yesterday (PCV and Hib). Pertinent past medical history is unremarkable.
Patient received second dose of COVID-19 vaccine (Pfizer) on 11/30/21. He did not have any notable local or systemic reactions and was in his usual state of health, even participating in his tae kwon do classess until 12/4/21, when he developed new back pain. On 12/5, pain worsened to the point that he had difficulty walking as well as worsening urinary retention, prompting admission to the hospital for further workup. He underwent extensive workup from 12/5-12/12 (summarized in Item 19), all of which was inconclusive. However, his clinical exam improved while inpatient, so he was subsequently discharged with supportive care and outpatient PT.  Repeat MRI 3/7/22 demonstrated a substle T2 hyperintense signal abnormality at the left lateral cord from C6-T1 as well as a tiny C5-C6 annular tear, most suggestive of a spinal cord infarct. Underwent cryptogenic stroke evaluation with repeat head/spine and vessel imaging as well as serum studies, that were not suggestive of other underlying cause of spinal stroke. Leading suspicion is that his presentation was due to a fibrocartilagenous embolism.  He clinically continued to improve over the next several months to the point where he no longer had urinary retention and no weakness was detectable on his neurologic exam as of 03/2022. He does continue to have hyperreflexia.
RECEIVED MODERNA AS A SECOND DOSE; This spontaneous report received from a health care professional concerned a 56 year old male. 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: 041A21A,expiry: 21-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination.  On 14-SEP-2021, the patient experienced received moderna as a second dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received moderna as a second dose was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006342.
swelling both thigh (did not walk x 24 hrs), t102.5 3-4 hrs p/shots dec appetite; OK p/2 days
The day following vaccine administration the pt. developed "a blotch rash at the left deltoid region and more slightly distal to the injection site." She also reported nausea and vomiting.
Red  itchy rash both arms chest abdomen and back  Itchy scalp started on Saturday morning after receiving  vaccination on Wednesday 3/24/21  Taking  Benadryl called local health dept
pt recvd vax & had small swelling; ice applied immed; swelling went down in 5 min;
It has been almost 5 months and my injection site On my right arm is absolutely excruciating pain all the time it is so much more worse at night my arm is completely sore in that spot it hurts and I?m not sure what the problem is. It is not getting any better it is actually getting worse. At the point where sometimes I want to cry I cannot raise my arm up in my arm is just all the time in pain.
L arm warmth, erythema, tender and mild edema since 7/4/13. Area is 10x12 cm.
tiny rash; little pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (tiny rash) and PAIN (little pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (tiny rash) and PAIN (little pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] ongoing since an unknown date at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (tiny rash) and PAIN (little pain) outcome was unknown.            no concomitant medications reported.   This case was linked to MOD-2021-016861 (Parent-Child Link).   See case MOD-2021-016861 for details regarding the child case.