chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joint pain/knee pain; trouble walking; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient).  A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, on 21May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received first dose of COVID vaccine on 21May2021 and due for next dose on 11Jun2021. On an unspecified date in 2021, the patient experienced joint pain, knee pain, trouble walking. Reporter seriousness for Joint pain, knee pain and trouble walking were unspecified. Patient informed everything when she was leaving the doctor's office and heading to work, he had no time to answer question. She would just like to know if she should get the second shot on Friday. She stated that she understands about giving the information in the hopes to collect more data because she works in the medical field, but she is just not a registered nurse or Practitioner. Patient wanted the number for Medical information, and she will call them at another time. The outcome of events was unknown.  Information about lot/batch number cannot be obtained.
Development of ? brief seizure activity with fine tonic/clonic movements the evening following the immunization.  Severe lethargy for approximately 2-3 days.  Full recovery thereafter.  No further immunizations have been given.
Headache, Body aches, fatigue, felt like I was developing a fever though I didn't have a high temp. Felt some discomfort in taking a deep breath.
Swelling, inching and redness at vaccination site on left arm. First occurred more than a week after vaccination. First noticed symptoms at approx 6:00 am this morning and have persisted all day. They still remain as of the completion of this survey, 2/12/21, 7:00 pm.
Among classic COVID-19 vaccine symptoms (fever, chills, body aches), chest pain showed up on 3/18/22.  Got worse and peaked on 3/19/22.  Felt well enough (with heavy aspirin and acetaminophen dose) to go skiing on 3/20/22, which must have aggregated it.  Felt much worse on 3/21/22 and felt bad enough to to into ER thinking it could be pericarditis.  Diagnosed as likely costochondritis likely caused by vaccine by physicians at ER.  Pain concentrated around sternum around to under left armpit.
PT. RECEIVED THE VACCINE AND AFTER 5-6 MINUTES HE PASSED OUT
Awakened at night, unable to stand up from bed to walk to bathroom for 45 minutes. Sweating, felt viremic due to Covid vaccine administered approximately 20 hours earlier. BP normal, temp normal, could move extremities but could not bear weight. Incontinent of using. Was able to walk after 45 minutes. Returned to bed, slept, next morning felt flu like symptoms, but largely ok. No more weakness in 28 hours since. Walking fine for last 24 hours.
Extreme high temperature-not taken-prob. 105 degrees (was at a local store) - profuse sweating, dizzy - ex. went extreme nausea-Almost passed out, employees almost carried me sit down-I thought I was having a heart attack-almost called ambulance. Came on slowly and then progressed rapidly. Vomiting in trash can. Very ill. I almost fell on floor. I should have called ambulance took 2 days to feel normal. This took place over course of approx 45 mins or 1 HR.
Mother noted erythema, exaggerated edema and tenderness of (R) thigh. Seen 11/21 elevated erythematic warm area at injection site. Treated for cellulitis and injection site reaction.
Immediately sore - as day progressed, pain progressed. Moderate pain, with red splotches at injection side - denies apply ice - took BENADRYL/MOTRIN denies fever.
Patient passed out, seizure like activity less than 30 seconds, approximately 15 seconds, patient diaphoretic and clammy.
woke up in the middle of the night sweating; whole left shoulder, arm and hand was very sore and achy; whole left shoulder, arm and hand was very sore and achy; This is a spontaneous report from a contactable consumer (patient).  An 81-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 at a single dose on the right arm to be inoculated against the virus. The patient has no medical history and there were no concomitant medications. The patient reported that she got the Pfizer vaccine shot last Thursday, 22Jan2021 and while she was there she didn't have any reaction. She had the vaccine in her right arm because she was left handed and by the time she got home, her whole left shoulder, arm and hand was very sore and achy. She had trouble with her left shoulder, she didn't know if it was the co-incident (as reported) or not and then it kind of then the patient took some Tylenol and it kind of eased up. The patient then reported that on 22Jan2021, Friday night, she woke up in the middle of the night sweating and that happened during the night and in the morning it went, but it is still there but she still has soreness in her left shoulder, arm and hand and it kept her up last night. She didn't know if this was going to be a symptom of the vaccine. She wanted to know that when she will get the second one, is it going to be worst and what she was supposed to do. The patient was scheduled to get the second dose on 11Feb2021. The patient reported unspecified labs with unknown results. The outcome of the events whole left shoulder, arm and hand was very sore and achy was not recovered while the outcome of woke up in the middle of the night sweating was unknown.   Information on the lot/batch number has been requested.
no further AEs occurred from the concomitant administration; they gave PROQUAD and VARICELLA together to a patient; This spontaneous report was received from a medical assistant referring to a 1-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, one time, lot number T034613, expiraton date 10-APR-2021 (route of administration was not reported) for prophylaxis and varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, one time, lot number T031381, expiraton date 15-SEP-2022 (route of administration was not reported) for prophylaxis too (extra dose administered). Both vaccines were reconstitued with sterile diluent(STERILE DILUENT) 0.5 milliliters, lot number T020663 and U000171. No adverse event was reported.
patient is 63-year-old male, active smoker with no history of hypercoagulability or malignancy is admitted in hospital for DVT in left popliteal vein.  He received first dose of Pfizer vaccine for COVID about 1 week ago. Patient's PTT was high on presentation even before being started on heparin.  Due to sudden drop in hemoglobin patient's heparin drip was suspended since 4/12.  Mixing studies showed partial correction consistent with acquired factor inhibitor.  Factor VIII levels less than 1 consistent with factor VIII inhibitor. Patient was started on FEIBA at 100 units/kg every 12 hours, tolerated very well,  In order to eliminate the inhibitor immunosuppressive therapy was initiated: Will continue Solu-Medrol 80 mg daily and Cytoxan 2 mg/kg daily.  This treatment will continue until his clinical stability is achieved, at which point taper will be initiated.  Patient required 2 transfusion over the course of the hospitalization. Currently, he is stable but still hospitalized and receiving treatments. No signs of new bleeds.
rash on the face; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on the face on 25Dec2020 in the afternoon, it was  not bad, but it always happen in the afternoon. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Information has been received from a physician concerning a 62 year old white female who is a heavy smoker who on 03-OCT-2007, was vaccinated into the left deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (Lot# 659148/1382U). On 04-OCT-2007, the patient experienced elevated temperature of 101 and enlarged lymph nodes. These symptoms lasted for approximately 4 days. No laboratory diagnostic studies were performed. Subsequently, the patient recovered. Additional information has been requested.
Client complaining of urticaria.  However, the urticaria only occurs when exposed to cold.  Started 10 days after vaccine.  Benadryl has helped.  Avoiding cold and has not had any further symptoms.  No other complaints.
GI symptoms loss of taste and smell sinus congestion headache extreme fatigue post nasal drip leading to cough yellow and green flehm sinus chills and sweats diarrhea vomiting constipation
Pediatric dose of hepatitis A given instead of adult dose. CDC contacted 6/2/08 and instructed to give age appropriate dose. Will contact client.
Adm. vaccine that expired on 11-16-22 on 11-17-2022 not knowing the vial had expired at time of adm.  Realized same day after adm the vial lot number  was not in the registry and review the time  vaccine was received to date  and noted the vaccine expired 1 day prior.   Notified Vaccine program Administrators.  Also notified Pfizer of the incidence and was advised since within 2 days of expire time the vaccine would not have to be readministerd.  An email was sent from Pfizer with the following info to verify that there is 2 additional days for expire time but the vaccine over all expire date has not had any extension time.   Total Time: 72 days = [10 weeks (70 days) labeled time described in the Prescribing Information plus 2 days excursion time)] ? No additional excursion time is allowable for vials reduced to 1 week of storage at 2°C to 8°C (35ºF to 46ºF) due to excursions at -50°C to -15°C (-58°F to 5ºF). The vials do not have printed expire dates and when the shipment is received the staff have to determine the expire date and then COVID vaccines are constantly having extended  expire dates, making it very confusing for staff to monitor.    No treatment was needed, no injury occured  to the vaccine receipent (patient) and all staff have met and will place visible expire labels on each box upon recieving and monitor expire dates daily to prevent further occurances.
as per d/c plan nurse/MD said parents felt pt had fever of 104 & a sz @ home; none witnessed in hosp; no fever;
Injection arm (left) was itchy when we left facility. But other than that, no pain, no feelings of illness. So, didn't think much of it. After about three days, the patient developed (not sure of the technical term), large blood blotches beneath the skin. On both arms and on her back. The itching has subsided. Five days later, the blood blotches are still there but seem to be slowly improving.
Sick after booster; Light headed when lie down and when getting up after booster; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after booster) and DIZZINESS (Light headed when lie down and when getting up after booster) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 037A21B and 011A21A) for COVID-19 vaccination.     The patient's past medical history included Vertigo (Used to get vertigo and the last time felt vertigo was in 2018.) in 2018. Concurrent medical conditions included Hypertension (Blood pressure under control with medications.). Concomitant products included BENAZEPRIL, AMLODIPINE and SPIRONOLACTONE for Hypertension.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced ILLNESS (Sick after booster) and DIZZINESS (Light headed when lie down and when getting up after booster). On 02-Jan-2022, ILLNESS (Sick after booster) had resolved. At the time of the report, DIZZINESS (Light headed when lie down and when getting up after booster) outcome was unknown.            No treatment medications were reported.   This case was linked to MOD-2022-480662, MOD-2022-480672 (Patient Link).
Pt related pain for approximately 10- 11 days when seen on 12/06/02. Related a deep aching in arm from shoulder to elbow left arm, middle of area especially.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), NAUSEA (nausea) and HEADACHE (severe headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (severe headache). On an unknown date, the patient experienced MALAISE (feeling sick) and NAUSEA (nausea). At the time of the report, MALAISE (feeling sick), NAUSEA (nausea) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided.  Treatment Medication provided was common pill that accelerates digestion.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Non-Significant follow up appended to AER
facial flushing; eyes were bloodshot; dizziness and weakness; dizziness and weakness; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 21Feb2021 12:30 (lot number: EN6200; expiry date: unknown) at the age of 77-years-old, as dose 1, single for Covid-19 immunisation. Medical history included allergic to penicillin (did not experience any swelling or trouble breathing). The patient had no relevant family history. The patient was not taking concomitant medications. The patient previously received influenza vaccine many years ago and got sick. The patient did not receive other vaccine on the same date or within four weeks prior to the first administration of Pfizer vaccine. The events did not require emergency/ physician visit. The patient stated that she and her husband got the first Pfizer shot yesterday, 21Feb2021. Both of them got real flushed in their faces (facial flushing), stated their eyes got blood shot. She also experienced dizziness and weakness, her husband did not. The patient recovered from the events on 21Feb2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021211948 same reporter/events, different patients
Initial report received from a non healthcare professional on 24 August 2012. This is a cluster case of 4 patients (same reporter, events after receiving ADACEL lot number: C4104AA) 4 patients (age and gender not specified), whose medical history and concomitant medications were not reported, received a dose of ADACEL (lot number: C4104AA, site of vaccination not reported) intramuscularly on an unspecified date. It was reported that the patients developed large lump at the site of injection with swelling, redness, tenderness and hot to touch area of deltoid, and tenderness going down the arm on an unspecified date. Laboratory investigations and corrective medication were not reported. The outcome of the event was unknown at the time of this event. List of documents held by sender: none.
After first dose I had cramping and a heavy period.  After second dose started having severe abdominal pain and after ultrasounds was found to have inflammation of the uterus and adenomyosis.  No history of any uterine issues prior to HPV shot.  Scheduled for hysterectomy since no other cure for adenomyosis.  Received third and final dose and ended up going to ER for rebound pain and found inflammation had spread to fallopian tubes.
Body aches; Injection site swelling; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and PAIN (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and PAIN (Body aches). At the time of the report, INJECTION SITE SWELLING (Injection site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and PAIN (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
Initial report was received 26Aug2010 from a health care professional. This case is a cluster of 35 unidentified patients' who experienced similar adverse events following vaccination with ADACEL. A group of 35 unidentified patients' (ages ranged from 11 years to 64 years) received on an unknown date(s) an injection (route and site not reported) with ADACEL, lot number not reported. Following vaccination on an unknown date(s), the patients' experienced confirmed pertussis diagnosis. The outcome was not reported. Follow-up information was received from a health care professional on 28 September 2010 who clarified that there were 9 cases (previously reported as 35). The 9 cases occurred in children who had been fully and recently immunized. The vaccines were given out by local doctors participating in the Vaccines for Children Program. The State Health Division was contacted and did some research. The State Health Department did not find any patterns: no breakdown of the cold chain in any of the provider's offices, no concentration of cases at one provider. Follow-up information received from a health care professional on 25 October 2010 reported that this was not an adverse event. Follow-up information was received from a health care professional on 01 November 2010 reported that there were no cluster of 35 patient's with pertussis. The intent was to acquire information and not to report any adverse event. There were 35 cases of pertussis in which many of these patients never were vaccinated or were partially vaccinated. The reporter did not vaccinate these patients and does not have any lot numbers. The reporter had no further information at this time and does not want any further contact. Documents held by sender: None.
Seen 2 days after immunization. Had approximately 14x14cm area of tender, warm, erythema on left lateral arm, with 2-3cm diameter area of small blisters at the injection site.
Pt presented to COVID vaccination clinic on 10/13 for Pfizer booster dose. Pt reported that he had hives with both 1st and 2nd dose.  No difficulty breathing or SOB reported.  According to pt, he took Benadryl and hives went away.  Pt was administered 3rd dose on 10/13 and was asked to stay for 30mins observation.  Called pt for f/u on 10/22.  Pt reports that he did not have any reaction after the 3rd dose.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 04-FEB-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to three temperature excursion, one for a sum of 216 hours with a lowest temperature recorded as 34 degree F (1.111111111 degree C); other for a sum of 24 hours with a lowest temperature recorded as 33 degree F (0.555555556 degree C) and another for a sum of 144 hours with a lowest temperature recorded as 31 degree F (-0.555555556 degree C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complain involved. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 62 year old female physician who on 25-JUN-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # 656609/0015U). Concomitant therapy included several unspecified medications (the patient was not taking any immunosuppressive therapy). On 01-JUL-2007 the patient called the reporting physician and stated that she had a shingles rash on the left side of her chest. Medical attention was sought, the patient expressed interest in VZV analysis though at the time of reporting no lab studies had been performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.  This is in folow-up to report (s) previously submitted on 9/24/2007. Initial and follow-up information has been received from a pphysician concerning a 62 year old female physician who on 25-JUN-2007 at 15:00 was vaccinated SC in the left posterior arm wiht a 0.65 ml dose of ZOSTAVAX vaccine (Merck) (lot # 656609/0015U).
02/17/22 presents to ED for "Vision changes, blurry vision". PMHx of " HIV"
A non-serious spontaneous report of FLUMIST given to person older than 49 years of age was received from a health professional concerning a 51-year-old female. On 14-Oct-2011, FLUMIST was administered to the patient who was older than 49 years of age. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse reaction). At the time of the report, VACCINATION COMPLICATION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided. Treatment information was not provided.
Dizziness, diaphoresis, bradycardia (47), momentary loss of consciousness, fell forward to floor, hit head. - woke quickly to verbal commands. Close monitoring, vital signs checked. EMS were called and transported Attendee to local hospital.