chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had more symptoms with this vaccine than the patient had with the other two; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had more symptoms with this vaccine than the patient had with the other two) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included GOLIMUMAB (SIMPONI) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had more symptoms with this vaccine than the patient had with the other two). At the time of the report, VACCINATION COMPLICATION (had more symptoms with this vaccine than the patient had with the other two) outcome was unknown.            Treatment information was not reported.  It was reported that, the patient had more symptoms with her third dose of  vaccine than the patient had with the other two. The events related to second dose were not reported.   This case was linked to MOD-2021-303360, MOD-2021-301320 (Patient Link).
Indicates "got sick" after a week, wife SARs-Cov-2 positive.  He was tested, also positive.; Indicates "got sick" after a week, wife SARs-Cov-2 positive.  He was tested, also positive.; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Wife) that of A unspecified age female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown, Expiration date; unknown), via unspecified route of administration on unspecified at a single for COVID-19 immunization. The patient medical history and patient's concomitant medications were not reported. Contactable consumer first dose on 03FEB2021, after a week Indicates "got sick", and SARs-Cov-2 positive. Contactable consumer was kind of sick for a whole week and I run a test, mine came out to be positive on unspecified date. Contactable consumer wife got sick for different reason she went to the hospital and one of the case came on was Covid 19 case and she end up being positive and the same time after that one week when she went she had positive (further clarification unknown). The outcome of events unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185205 same reporter, product and AE, different patient
burning at injection site immediately after injection,then scarring, an ice pack was applied at the direction of nurses at the facility at 8 pm Burn and scarring at injection with pain , skin peeling  Urgent care doctor prescribed Mupirocin 2%
Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6199), in left arm and on 12Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing), notes: allergies; "known allergies:penicillin" (unspecified if ongoing), notes: penicillin; "known allergies: sulpher drugs" (unspecified if ongoing), notes: sulpher drugs; "known allergies: strawberries" (unspecified if ongoing), notes: strawberries; "known allergies:grasses" (unspecified if ongoing), notes: grasses. Concomitant medication(s) included: SINGULAIR; CLARITIN [CLARITHROMYCIN]; QNASL; ALBUTEROL [SALBUTAMOL SULFATE]. Past drug history included: Ceftin, reaction(s): "allergies:Ceftin"; Avalox, reaction(s): "allergies:avalox"; Forteo, reaction(s): "allergies:forteo"; Tymlos, reaction(s): "allergies: tymlos"; Amoxicillin, reaction(s): "allergies: amoxicillin". The following information was reported: COVID-19 (medically significant) with onset 17Jun2022, outcome "recovered with sequelae"; VACCINATION FAILURE (medically significant) with onset 17Jun2022, outcome "recovered with sequelae". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: Tested positive on homevtest day, 5, 6 though Felt milder cold symptons day 5 and 6; (Jun2022) negative, notes: Day 7 Tested negative on rapid test though still heavy chest and coughing; (17Jun2022) Positive, notes: Pcr Tested positive for covid 17Jun pm; (24Jun2022) negative, notes: Felt fine and tested negative on rapid test on 24Jun; (30Jun2022) Positive, notes: Rebound with same cold symptons and positive rapid test 30Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19.  clinical course: To first shot flu like response. Other 2 shots no symptons.Pcr Tested positive for covid 17Jun pm.Treatment on paxlovid began am 18Jun.On paxlovid just heavy head and chest cold symptons first 3 days and symptons began easing.Felt fine and tested negative on rapid test on 24Jun.
Dermatographia (whole body): onset 12/08/2021. Saw physician on 12/14/2021. Taking daily Zyrtec to help control itching. As of this report, no resolution--problem persists.
pt recvd Hep vax 25AUG to 27AUG started feeling numb; lt side shaky just didn't feel good; sx contd thru 31AUG when seen in our office was started on Medrol dose pack;
After performing a yoga exercise stretch, which I've performed many times prior to the event, I could not lift my head without feeling like I might pass out.  Called 911 and was taken to the Emergency room.  After numerous tests, diagnosis was Vertigo. I've never experienced Vertigo  before.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 13-NOV-2015 the patient was vaccinated with oral, ROTATEQ (lot # L008057, expiration 01-DEC-2016, dose not reported), which was exposed to temperatures outside of the recommended temperature (incorrect product storage). No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Spotting, menstrual spotting; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Spotting, menstrual spotting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTERMENSTRUAL BLEEDING (Spotting, menstrual spotting). At the time of the report, INTERMENSTRUAL BLEEDING (Spotting, menstrual spotting) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.
BNT162b2 was administered on same day when Flu vaccine was administered; BNT162b2 was administered on same day when Flu vaccine was administered; dose number=3 administered; Fever; Tired; Aches; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 3 via an unspecified route of administration, administered in Arm Left on 11Oct2021 17:00 (47-year-old at the time of vaccination) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration from 11Oct2021 (Batch/Lot number was not reported) to an unspecified date, at DOSE 1, SINGLE for immunisation. The patient medical history was not reported. The patient previously received first dose of bnt162b2 (BNT162b2 solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Feb2021 (47-year-old at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation and received second dose of bnt162b2 (BNT162b2 solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 18Mar2021 (47-year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation; both as a single dose for COVID-19 immunisation. Concomitant medication(s) included levothyroxine sodium (TIROSINT) taken for an unspecified indication, start and stop date were not reported. 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 COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Oct2021, the patient experienced fever for more than 24 hours and felt tired and had aches. The clinical outcome of the events fever for more than 24 hours, tired and aches was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
the next morning, it was very strange, there were places that looked like worms and round rashes on both arms and identical, from the palms up to the elbows on the inside. It looked like poison Ivy and with the blisters. Both itched, went to 2 doctor. the vaccinated area was round and hot to touch. Gave steroids and antibiotic. 9/3/2021  Urgent care and 9/7/2021 normal healthcare. Its gone but there are some scars.
Pt was given a dose of the Pfizer COVID 19 vaccine from a vial that had been diluted over 24 hours ago (27.5 hrs exactly) and had remained refrigerated within a medical fridge between (8`C - 25`C).    At this time family has been notified, and patient is showing no adverse effects at this time.   Facility has been in contact with vaccine manufacturer for further discussion of course of action.
Hypothermia 94.3 body temp on 10/27/2020 5:00 pm took two Ibuprofen (400 mg) thinking she had fever
I had issues after taking both doses. I experienced hives and large swelling - which worsened after taking the 2nd dose. I developed Edema. I took Prednisone. I will be seeing an allergy immunologist specialist on January 21, 2022.
All over body rash and redness with some welts, tachycardia. Given epinephrine injection and a script for a steroid taper as well as antihistamine.
Headache, Myalgia, Fever & NauseaVomiting Narrative:  Headache 2 hours after injection. Nausea and vomiting started 9 hrs later with fever x 3 days
Sore arm initially into shoulder then red and swollen and hot notable reaction appeared 5-6 days later.
(Note has had flu vaccine twice previously reported with no reaction). Pt c/o rash which started after FLUZONE vaccine - child says same day, not observed by parents till several days post. Present today for eval and found to have petechiae over legs (approx 2 inches apart), and more widely separated on arms and torso, not on palms or soles of feet. No other symptoms. No itching, no malaise, "rash" is flat.
Severe edema and redness in upper left deltoid, febrile (101 temperature), required doctor and ER visit, discharged with 10 day course of two separate antibiotics. Patient reporting successful completion of antibiotic course and being stable.
hives all over the body; lip swelled up as well as the right eye; lip swelled up as well as the right eye; This is a spontaneous report from a contactable healthcare professional (patient) received via agency. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm, on 14Jan2021 at 11:30 AM (Batch/Lot Number: EK5730) (at the age of 20 years old) as dose 2, single for COVID-19 immunisation in a workplace clinic. The patient has no relevant medical history. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known drug allergies. The patient was not pregnant at the time of vaccination. Concomitant medication included ibuprofen 600mg tablet, taken as needed for unspecified indication. The patient was previously administered the first dose of BNT162B2, via an unspecified route of administration, administered in right arm, on 23Dec2020 at 11:45 AM (Batch/Lot Number was not reported) (at the age of 20 years old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 at 19:30, 8 hours after the second dose of vaccination, the patient experienced hives all over the body and lip swelled up as well as the right eye. This has been happening since the second vaccine on 14Jan2021 until today, 03Apr2021. These episodes of hives and swelling happened at least 3 times a week. The healthcare professional reported the events as non-serious. The patient received no treatment for the events. The outcome of all events was recovering.  No follow-up attempts are needed. No further information is expected.
Apnea and cyanosis on/off x 20 minutes. Called 911, suctioned nose, normal pulse ox. Saw PCP next day -> admit to hospital for apnea monitoring, blood/urine studies.
Hives began 5 minutes following injection, located on upper arm at site of injection.  This spread to opposite arm within 5 minutes.  BP at this time was 148/98, HR 90, no difficulty breathing, chest pain, SHOB, headache.  Over following 45 minutes this spread to patient's back, abdominal area, then to upper legs, then lower legs.  25mg Benadryl chewable given to patient at 15 minutes following start of hives.  No change in level of itching associated with hives, or progression of hives to other parts of her body.  Additional 25mg Benadryl chewable given to patient 15 minutes after initial dose.  30 minutes after second dose of Benadryl, patient experienced reduction in itching in upper body.
Information has been received from a male patient of unknown age who was also a retired physician concerning himself. The patient had no pertinent medical history or drug allergies. On 28-MAR-2015 the patient was vaccinated with a single dose of ZOSTAVAX (dose and frequency not reported), subcutaneously in the left arm. There was no concomitant medication. On 29-MAR-2015, the patient developed a vesicular rash on the posterior aspect of the right leg and burning and stinging in the area of the rash. The patient also experienced low-grade fever, headache and significant malaise. The patient did not seek medical attention but self-treated with NAPROSYN. No lab diagnostics studies were performed. At the time of the report, the fever and headache were reported as resolved on unknown dates in 2015. The lesions were crusted, and the patient was recovering from the rest events. Additional information is not expected since the physician is not allowed to be contacted.
The booster made me very ill and out for 4 days but I also now have a constant buzzing like a power line; The booster made me very ill and out for 4 days but I also now have a constant buzzing like a power line; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID: The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization complete), for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "The booster made me very ill and out for 4 days but I also now have a constant buzzing like a power line". Additional information: The patient was an NP who had 2 doses and one booster of covid vaccine. The booster made him very ill and out for 4 days, but he also now has a constant buzzing like a power line. His friend an NP also has the same thing. He thinks this happens more often than reported. He and others are very hesitant to get more vaccines and would like scientist's input. 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-202200836506 Same reporter/ drug/ event for different patient;
VERTIGO EXPERIENCED AT DAY 3 AND DAY 4; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer, right knee replacement, and skin cancers, and concurrent conditions included lymphedema, type 2 diabetes mellitus, asthma, worse pollen allergy, severe allergies, meniere's disease, mold mildew allergy, naproxen dust allergy, non alcoholic, non smoker, and migraine, and other pre-existing medical conditions included the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included fremanezumab for migraine.  On 06-APR-2021, the subject experienced lightheadedness. On 10-APR-2021 02:30, the subject experienced vertigo experienced at day 3 and day 4. Treatment medications (dates unspecified) included: dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness on 06-APR-2021, and was recovering from vertigo experienced at day 3 and day 4. This report was non-serious.
Experienced sickness after first dose; late second dose of Shingrix over 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness and incomplete course of vaccination. On an unknown date, the outcome of the sickness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that the patient experienced sickness after first dose and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  The pharmacist unable to provide full patient details. The reporter did not consented to follow up.  This case was 1 of 8 cases, reported by same reporter.
SEVERE menstrual bleeding!!  Cramping so painful that I have been throwing up non stop for 3 days. Haven't been able to sleep or eat because the pain is so severe. I've had my period for almost 30 years now and have never experienced anything like this.
Severe rhabdomyolysis with peak CK ~750,000, myoglobin >5000.  Severe life-threatening hyperkalemia, K up to ~7.5.  Renal failure including ~2+ weeks anuria, still on hemodialysis  5 weeks post onset with uncertain prognosis.  Respiratory (muscle) failure, on ventilator for  ~18 days with endotracheal tube, followed by tracheostomy ~1 week.  Hospitalized for 26 days including 19 days  in Intensive Care Unit, ~11 days in medically induced coma. Loss of swallowing function requiring retraining.  Profound diffuse muscle damage and weakness,  ~20 lb. loss of muscle mass, initially unable to move arms, legs or support head. Will require extensive physical therapy to achieve ability to care for self and function somewhat independently.
Large rash (+/- 7in x 4in) around injection site 10 days after vaccine was administered. Lasted 2 days. There was no pain, itching or discomfort-- they area just felt significantly hotter than the rest of my body.
This case was reported by a nurse via call center representative and described the occurrence of intussusception in a 7-week-old male patient who received ROTARIX (lyophilized formulation) (batch number YN47S, expiry date 9th November 2018). Concurrent medical conditions included umbilical hernia (finding at the baby visit on 26th May 2017). Concomitant products included PEDIARIX, Hib  vaccine and PCV-13 vaccine. On 26th May 2017, the patient received the 1st dose of ROTARIX lyophilized formulation (oral). On 5th June 2017, 10 days after receiving ROTARIX lyophilized formulation, the patient experienced intussusception (serious criteria hospitalization and GSK medically significant). The patient was treated with Barium Enema. In June 2017, the outcome of the intussusception was recovered/resolved. It was unknown if the reporter considered the intussusception to be related to ROTARIX lyophilized formulation. Additional details were reported as follows: The nurse stated that the patient received 1st doses of ROTARIX, PEDIARIX, Hib  vaccine  and  PCV-13 at a well baby 6 week old visit on 26th May 2017. The patient was hospitalized with intussusception on 5th June 2017. The nurse stated that there was no surgical intervention at the time of report. The patient received a barium enema which was successful in resolving the intussusception.
Patient fainted approximately 5 minutes after receiving his first Covid vaccine.  Patient regained consciousness with the smell of an alcohol pad, but our pharmacy staff did call 9-1-1.  EMT's arrived within a few minutes and ensure patient was healthy to leave the pharmacy/store.
after 4 days, the patient went to the hospital complaining of fever and not feeling well. He found out he got pneumonia and the patient stays at the hospital for about 23 days. He started getting better on 10/10 and left the hospital on 10/20
tiredness; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th December 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 18th December 2019, the patient experienced tiredness. On an unknown date, the outcome of the tiredness and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the tiredness and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.