chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 hours after administration mom called.  the patient was on the floor " too weak to move" felt terrible listless, proufoundly fatigued.  no paralysis, but lethargic, weak.  he was not confused, just too fatigued to get up.  Symptoms resolved in 12 hours  (24 hours after administration).  They were advised to go to the ER  but they did not he resolved wit hno treatment or testing.
1st Shot was J&J 3/29/2021 -No side effects.  BOOSTER on 10.25.2021. On 10/26/2021 I started experiencing severe headaches, and Pulsative Tinnitus (as well as fever & chills).  Fever and chills subsided after 24 hours, Pulsative Tinnitus and sever headaches have not gotten better in terms of frequency and severity.
PATIENT PRESENTED TO CLINIC WITH COMPLAINTS OF LEFT ARM PAIN AND SWELLING THAT BEGAN TWO DAYS AFTER RECEIVING VACCINATION. PATIENT STATES HE FIRST NOTICED A KNOT UNDER THE SKIN AT INJECTION SITE, AS WELL AS MILD DISCOMFORT. HE STATES THE SWELLING AND PAIN BEGAN TO WORSEN WITH EACH PASSING DAY, AND THE REDNESS AND WARMTH TO THE SKIN STARTED SOON AFTER. TODAY, PATIENT WAS NOTED TO HAVE MILD ERYTHEMA TO LEFT UPPER ARM AND SKIN WAS WARM TO THE TOUCH. RECOMMENDED THAT PATIENT SEEK FURTHER EVALUATION AND TREATMENT AT NEARBY WALK-IN CLINIC. PATIENT VERBALIZED UNDERSTANDING AND STATES HE PLANS TO FOLLOW-UP TODAY WITH WALK-IN CLINIC.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 4-months-old patient of unknown gender. On 25-APR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
my period was delayed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 3 (booster), single (Lot number: GH9703) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: EW0162, Prev dose lot unknown: False, Prev dose administration date: 20Apr2021, Prev dose dose number: 2, Prev dose vaccine location: Left arm), administration date: 20Apr2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "Drug ineffective", "Suspected COVID-19"; BNT162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Is bivalent: False, Prev dose lot number: ER8733, Prev dose lot unknown: False, Prev dose administration date: 31Mar2021, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 31Mar2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "Drug ineffective", "Suspected COVID-19". The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 09Oct2022, outcome "recovered", described as "my period was delayed". Therapeutic measures were not taken as a result of menstruation delayed.  Additional information: No other vaccine in four weeks. Other medications in two weeks included Zyrtec and multivitamin. After her booster shot in Sep2022, her period was delayed by 6 days. She used [Name withheld] to track her period and she was extremely regular 28 day cycle and have been for 3 years of tracking. After being delayed, then her cycle was right back on track. This was extremely concerning. She had covid prior vaccination and she was not covid tested post vaccination. Known allergies included penicillin and Other medical history: no.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300162028 same product, patient, different AEs, different dose;
Pt. received MMR and Varicella vaccine in outer (R) thigh on 10/6/14. On day 1 after vaccine developed erythema, tenderness area 15 cm in diameter. Day 2 after vaccine given developed blistering lesion over both sites and temp of 102. Resolved by 10/10/14.
Information has been received from a licensed practical nurse concerning a 23 year old female with no medical history and drugs allergies, who in November 2007, was vaccinated with a first dose of GARDASIL. The second and the third dose were given in January 2008 and May 2008 respectively. There was no concomitant medication. On 28-MAY-2009 the patient had an abnormal Pap test. The Pap test revealed "atypical cells of undetermined significance with high risk HPV to include HPV types 16 and 18". The nurse added that this was the patient's first abnormal Pap test. The patient sought medical attention through an office visit. At the time of this report the patient had not recovered. Additional information has been requested.
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 21 March 2007 from a healthcare professional. A 54 year old female patient received on 28 February 2007 intramuscular first dose of Adacel (lot# C2690AA) and immediately developed facial swelling including eyelids and generalized hives on face and chest. Treated with Benadryl, Tagament and prednisone. The event resolved and the patient recovered. No other vaccines were given concomitantly. At the time of vaccination the patient had vertigo. Received Fluzone on 11 October 2007 and experienced generalized hives and lump on elbow (case 2007-00862). The patient medical history included multiple environmental life threatening allergies and asthma. Concomitant medications included: ASA, fish oil, Spironolactone, Terbutaline prn, Benadryl prn, singulair, Combavent, Adver. The reporter is the same as in case 2007-00862.
SARS-CoV-2 RdRp Resp Ql NAA+probe~COVID-19 rapid diagnostic test performed on 7/24/21. Test done at a Pharmacy most likely in one state or other state as the patient recently traveled to. Test came back positive. Case investigation completed and case manager stated, "started having symptoms on 7/22 - cough, runny nose.
tested positive for COVID after getting the Pfizer COVID vaccine; tested positive for COVID after getting the Pfizer COVID vaccine; This is a spontaneous report from a program from a non-contactable consumer.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced tested positive for covid after getting the pfizer covid vaccine on an unspecified date with outcome of unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Persisting nausea, diarrhea; night sweats; dizziness; sensory changes (auditory)
Patient experienced likely vasovagal syncope.  Felt "woozy, dizzy," then momentary syncopal episode, then slight nausea and dizziness.  VS monitored Q 5 mins x 35 mins, incl orthostatics.  Patient assisted to gurney with head raised, given bottle of H2O to drink.  Pt states had eaten Taco Bell immed prior to vaccine appt and was well-hydrated.  Pt states that she experienced a similar event in Oct 2020 after a blood draw.  Pt felt back to normal within 10-15 minutes, this RN continued to monitor and provide support for an additional 20 mins.  Pt reported feeling "completely normal" at discharge.  Conversing and ambulating well.
NEUROPATHY (NO ONE KNOWS IF SHOULDER WILL EVER GET BACK TO  NORMAL); This solicited report received from a patient via Janssen  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 initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced neuropathy (no one knows if shoulder will ever get back to normal). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy (no one knows if shoulder will ever get back to normal). The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and neuropathy (no one knows if shoulder will ever get back to normal) was related.  This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 24-OCT-2021. Upon review the following information was amended: case level seriousness and previously reported non-serious event of neuropathy was updated to serious. Company causality was updated to related.; Sender's Comments: "No one knows if shoulder will ever get back to normal"  PT Neuropathy peripheral. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are no other factors more likely to be associated with the event(s) than the drug. Therefore, this event(s) is considered related to COVID-19 vaccine ad26.cov2.s.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 09-FEB-2016 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # L024250, expiration date 30-JUN-2017, dosage and route not specified). It was reported that the vaccine was stored at -13.7 degree Centigrade for 15 hours. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a healthcare worker referring to multiple, unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with improperly stored (temperature: 32 F and time frame: 75 hours (5 cycles of 15 hours each)) doses of ROTATEQ (dose not reported, lot # L004466 with expiration date 02-AUG-2016 and lot # L013203 with expiration date 28-JAN-2017) orally. No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1603USA000576). Additional information has been requested.
w/in 24hr pt had a sl fever & wheezed occasionally;by 48hr pt had devel a rash of red bumps, 2 inches in diameter @ the site of inj;the rash lasted about a wk;
I mentioned at the time that it seemed to hurt more than the other two shots. I took ibuprofen following the shot, again that night and again the next morning. The ibuprofen doesn't seem to be helping and I've developed other symptoms as well. When I move my arm even the slightest amount, I have shooting pains on the outside of my arm as well as on the underside. I feel like my shoulder is frozen and now I have pain on the outside of my shoulder socket? (sorry, I don't know all of the technical/medical terms). I also have troubles sleeping. Perhaps this has to do with the angle of the arm when lying down?
Started with swelling at 8 pm - by AM red, swollen, took ALEVE. Swelling down to elbow.
Information has been received from a pharmacist referring to 3 newborns (numbered 174, 175 and 176). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 07-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
At 12:24 on 5.6.21 I became extremely nauseated & fatigued...that has last through today May 9. At 6:30 p.m. on 5.7.21 my tongue felt odd. I looked in the mirror and it was white and smooth....I have bot been able to taste since.
Pt had swelling  in right foot and was instructed to go to emergency room for an ultrasound.  She had a calcified, non-occlusive blood clot in her right thigh.  She started eliquis 5mg twice daily.   She followed up with PCP and cardiology Pt with atrial fibrillation on  7/8/2021
arm was itchy; became more swollen; hardness; little bit of a sore arm; redness on the site of the injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (little bit of a sore arm), VACCINATION SITE ERYTHEMA (redness on the site of the injection), VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (became more swollen) and VACCINATION SITE INDURATION (hardness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (little bit of a sore arm) and VACCINATION SITE ERYTHEMA (redness on the site of the injection). On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (became more swollen) and VACCINATION SITE INDURATION (hardness). On 11-Feb-2021, VACCINATION SITE PRURITUS (arm was itchy), VACCINATION SITE SWELLING (became more swollen) and VACCINATION SITE INDURATION (hardness) had resolved. At the time of the report, PAIN IN EXTREMITY (little bit of a sore arm) and VACCINATION SITE ERYTHEMA (redness on the site of the injection) had not resolved.        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.   Thyroid medication and Hydrochlorothiazide 25mg used as a Concomitant medication  baking soda paste used as a Treatment medication.
Oval bright red, lesion immediately adjacent to injection site over left deltoid with mild to moderate swelling.  Started app. 3"x1", over 3.5 days grew to app. 7"x2.5". Extremely severely itchy, not relieved by Benadryl cream or hydrocortisone ointment. Very temporarily relieved by applying ice. On day 4 lesion has mostly faded, swelling is reduced and itching is now mild and intermittent.
10:10am 14 year old male child after receiving PPD< TD, MMR, varicella and hep A fell on his back, was unresponsive, pale and clammy. Vital sings B/P 119/62, P 73; R 20.
resident (patient) tested positive for COVID, 10 days after the first dose of COVID vaccine; resident (patient) tested positive for COVID, 10 days after the first dose of COVID vaccine; This is a spontaneous report from a contactable physician via a Pfizer sponsored program Pfizer First Connect. A 29-year-old female patient received their first dose of BNT162B2 (lot number and expiry date not reported), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted to know how long they have to wait for the second dose of the COVID vaccine as her resident (patient) tested positive for COVID on 27Dec2020, 10 days after the first dose of COVID vaccine given to her on the 17Dec2020. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 27Dec2020. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE and SARS-CoV-2 test positive, based on temporal relationship.  There is very limited information provided in this report.   This case will be reassessed upon receipt of follow-up information.
Patient states that after the 2nd dose of Moderna 02/10/2021, started experiencing symptoms 02/17/2021 of swelling in the testicles lasting 5 weeks with slight pain. Left testicle swelling with tenderness and hard to the touch. No noted Primary visit.
Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 47 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose_number=1), for Covid-19 immunization; Bnt162b2 (dose_number=2), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.
12/98:Pt. was vaccinated w/ mumps vax.He was also taking an unspecified antibiotic at the time.Starting b/w Jan. & March '99 the pt. experienced bleeding disorders,a common variable immune deficiency & factor 12 def.No further info avail.60 day follow-up / no additional data.
pain around the injection site / between a 3 to 4 on the pain scale; hurts when he raises his arm; pain in the arm / wakes him up / about 2 to 3 times a week (difficulty sleeping); This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included stroke (had a stroke a year ago on his right side).   On 6th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 1 week after receiving Shingrix, the patient experienced pain in arm, pain upon movement and difficulty sleeping. On an unknown date, the outcome of the pain in arm and difficulty sleeping were not recovered/not resolved and the outcome of the pain upon movement was unknown.   It was unknown if the reporter considered the pain in arm, pain upon movement and difficulty sleeping to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left arm and week after receiving the dose had pain around the injection site that occurs intermittently and was still ongoing at time of reporting. The patient reported the pain was between a 3 to 4 on the pain scale and hurts when he raised his arm. The patient reported the pain in the arm around the injection site woke him up from sleep about 2 to 3 times a week (difficulty sleeping) and this was still ongoing currently.  The reporter consented to follow up.
devel swollen joints in hands & knees;eval by orthopedic MD w/? referred to 2nd rxn;no titers drawn;
2 seizure episodes occurred consecutively 15minutes post vaccination & during the observation period lasting 5minutes each. Patient caregiver take patient home once the seizures stop.
No other AE; Caller is a state vaccine coordinator who reports a vaccines were administered following a temperature excursion.; This spontaneous report has been received from a state vaccine coordinator concerning a 4-month-old patient. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 27-SEP-2022, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # W004501, has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and upon internal validation established as 20-APR-2023) (dose, anatomical location and route of administration were not reported) for prophylaxis. The vaccine was stored at a temperature of 8.6C for 18 minutes (Product storage error). The vaccine suffered previous temperature excursions (11.5C for 1 hour 6 minutes, 8.8C for 21 minutes and 9.6C for 6 hours 41 minutes).  No additional adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2209USA010872:
Patient was given vaccine and then sent to observation area for 15 minute observation. Patient appeared pale and diaphoretic when she got to the observation area and then suffered a syncopal episode. She was unconscious for several seconds. She did not hit her head or have any trauma. Patient complained of nausea, and dizziness when she regained consciousness. Patient appeared pale and diaphoretic. Patient then developed hives over her abdomen, upper torso, and upper arms. Patient never complained of difficulty breathing but was constantly pulling at the neck of her sweater.  Pt was a Type I diabetic and had a BG reading of 262. She was given 0.3 mL of epinephrine with an immediate positive response. Transported to local hospital emergency room.