chrisvoncsefalvay/vaers-outcomes huggingface dataset:
could not breath; chest pain; Really sick; This is a spontaneous report from a contactable consumer or other non hcp.     A 63-years-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, (Batch/Lot number was not reported) dose 1 via an unspecified route of administration on an unspecified date 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. It was Reported that, she got her first shot of the Pfizer Covid 19 vaccine 3 weeks ago and got really sick after that and also, she was taken to the ER as she could not breath and experienced chest pain. The outcome of the events was unknown on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Possible administration of expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received DTPa-HBV-IPV (Pediarix) (batch number BF722, expiry date 27th February 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 28th February 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-Oct-2022 Reporter's Comments: The nurse called and asked for information about the possible administration of an expired dose of Pediarix to a patient.  The reporter wanted to verify the lot number of the vaccine administered since she realized that in her records it was written that the expiration date. The lot number she reported was BF722 but this number did not match with Pediarix lot number. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Pediarix, which led to expired vaccine used.
Patient presented after receiving vaccine complaining of loss of vision and hearing. After being seated, she realized that her throat was closing up. Oral diphenhydramine 50mg was given, she reported slight relief of symptoms soon after. Vision and hearing returned as well. EMS was contacted and reported to the scene and transported patient to hospital.
mental dullness; Severe fatigue; muscle aches; body heaviness; This is a spontaneous report received from a contactable consumer reported for himself and a other healthcare professional. A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EW0170) at left arm on 26Apr2021 13:00 at single dose for COVID-19 immunization in Hospital. Medical history and Concomitant medications were none. No Known Allergies. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. the patient did not receive within 2 weeks of vaccination. It was reported nothing that made him feel in danger. Severe fatigue, mental dullness, body heaviness, muscle aches, all on 27Apr2021, 06:00 AM. Received shot at 1pm. Bicycle ride that late afternoon. No side effects until next morning. Major effects lasted until about 2pm the next day. All was back to normal the following morning after a normal night's sleep. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has note been tested for COVID-19. No treatment received for the events. Outcome of the events was recovered on 28Apr2021.  Batch/Lot number has been obtained. further information has been requested.
Narrative: Received 1st dose of COVID-19 vaccine (Pfizer) on 6/7/21. Had bilateral eye swelling/irritation the next day and arm soreness x1 mo. Patient states she has also been sleeping significantly more since she received the vaccine.
PATIENT INITIALLY HAD DISCOLORATION AROUND INJECTION SITE AND BACK OF LEFT ARM.  DISCOLORATION PROGESSED DOWN LEFT SIDE SO PATIENT WENT TO ER.  PATIENT WAS TOLD AT EVALUATION, REACTION TO SHINGRIX VACCINE AND ADVISED NOT TO RECEIVE SECOND DOSE. BLACK AND BLUE DISCOLORATION PROGRESSED ON LEFT SIDE INCLUDING HER EYE.  AFTER RETURNING HOME FROM ER, AROUND MIDNIGHT PATIENT BEGAN TO FEEL MUSCLE WEAKNESS THAT PROGRESSED OVER THE NEXT  2 DAYS.  PATIENT DESCRIBED AS FEELING PARALYZED ALTHOUGH SHE COULD STILL MOVE BUT THE EFFECTS WERE SUCH THAT SHE WAS UNABLE TO WORK FOR 2 DAYS AND JUST LAYED ON THE COUCH.  SHE ALSO REPORTED FEELING "WEIRD" AND HAVING ANOREXIA.  ON THE THIRD DAY THE PATIENT FELT BETTER AND RETURNED TO WORK
I became Very flushed in the face. This remained for about five-6 hours. I took pictures.
Approximately five minutes after the shot was administered my heart started to race, my ears begin to ring, my vision blurred I tried to wave to the pharmacist, sat down in the chair and passed out. The pharmacist and technician came out and woke me and stayed with me for the next 20 minutes.  They did not say anything else and let me go.
Pt came into office at 11:15am with reddened warm to touch 4" diameter area on LVL at site of Hep A injection. Local reaction. Given 12.5mg Benadryl injection in office.
Information has been received from a female consumer who is a certified medical assistant and paramedic with a mitral valve problem, migraines, and allergies to yeast, sulfa, Metrogel, Imitrex, and Daypro, who on an unspecified date in 1995 was vaccinated with an initial dose of hep B virus vaccine. The consumer stated, she had a severe anaphylactic reaction. The consumer reported that this happened in another state, and post vaccination she experienced kidney shut down, hives all over her body, damaged heart muscle, and diarrhea for a week. She reported that her immunologist sent him to "sauna and physical therapy treatments to sweat out the vaccine." The consumer stated that her immune system was "shot" after that. It was noted that a prescription drug was required. Additionally the consumer reported the nurse who administered the vaccine "knew she was allergic to yeast and gave her the injection anyway." There was no product quality complaint reported. Unspecified medical attention was sought. Upon internal review severe anaphylactic reaction, kidney shut down, hives all over her body, damaged heart muscle, and immune system was "shot" were determined to be other important medical events (OMIC). Additional info has been requested.
Event: new onset severe debilitating left pelvic pain, heavy menses, irregular cycle (earlier than regular cycle), back pain, migraines
After 1 week lips became very dry, within a day I had a canker sore appear on my inside bottom lip. This has grown to 3 canker sores and lots of pain
Injection site started to get red, firm and warm to touch the evening of 10/4/2021, mother took pictures, area was about 2 inches by 2 inches morning of 10/5/2021. As of 1540 on 10/5/2021 the area has become more swollen, still warm to the touch and red as well as approximately 6 inches by 6 inches. Pt reports some pain but is able to still play.  Instructed mother to apply a cold/ice compress and childrens Benedryl to help with swelling as well as monitor it and if it continues to get worse then see the local clinic.
Moderna COVID 19 Vaccine EUA : 3 of 4 vials used to administer booster doses were punctured 21 times, instead of the max limit of 20. Vaccine storage, handling and draw were all performed with integrity. Vaccine was stored between 2 degree C and 8 degrees C until time of draw. Each vial was drawn with sequential punctures, and batched for administration. Syringes and vials were inspected prior to moving to administration table. No defect identified. Each of 3 vials where 21st dose was extracted, has all 21 doses extracted within 15-20 min.  It is not known if any patient received any of the 3 "21st' doses". 29 Patients were identified as receiving a booster dose from one of the 3 vials, where a 21st dose was drawn. However, we are not able to verify if any of these 3 "21st" doses were in fact administered.
COVID; COVID; This is a spontaneous report from a non-contactable Other HCP. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included HIV positive and concomitant medications were not reported. The Other HCP reported that patient died recently after receiving COVID vaccine, since he got COVID, but he was HIV positive, it just seemed like he died after he got the shot and it's just, is like, uh, and he got COVID as well. Causality: Not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective (Fatal) and covid-19 (Fatal) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: COVID; COVID
I have stage 4 Hodgkin Lymphoma.  I will begin chemotherapy  on 8/5/21. My prognosis is unknown at this time.
sharp bone pain in R knee, just off the knee cap; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in left arm on Mar2021 as a single dose for COVID-19 immunisation. Medical history included obesity. The patient was allergic to tetracycline-drug allergy and succinyl choline from choline estray deficiency. Concomitant medications included cymbalta (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and ferrous (MANUFACTURER UNKNOWN) for unknown indications from an unknown duration. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. On Mar2021, the patient experienced sharp bone pain in R knee, just off the knee cap developed a day or two after the shot. About a week or so after the shot, the patient thought she had heard a popping noise from her knee and the pain got much worse. The clinical outcome of sharp bone pain was not recovered at the time of report.   Information about lot/batch number cannot be obtained. No further information is expected.
About 5 minutes after receiving  the vaccination patient fainted and was unconscious for about a minute.  Patient's eyes remained open even though he was not conscious.  Patient was transported by paramedic to the emergency room
Myalgias, Rigors, Syncope, Hypoglycemia, Nausea, Fever
Pt had a Tdap vaccine (L) upper arm on 7/10/14 that resulted in severe upper arm pain for > 3 mos. No evidence of infection.
Seizure. He has continued to have them as well.  11/23/09 Medical records recieved for DOS 10/11/2009.  Final DX: Generalized tonic clonic seizure, new onset.  30 Sec GTC seizures. perioral/central cyanosis. Dazed s/p sz for 2 min, then sleepy.  back to baseline @ 1hr.  EKG and blood glucose WNL. Refer to neuro. D/C to home.  ICD9 Code: 780.39
Patient presented to pharmacy at 7:00 pm complaining of soreness in left arm. Small (quarter sized) red patch at site of injection. Having difficulty lifting arm. Patient said she was an asthmatic and she need to use Albuterol inhaler today.
Fever spiked at 102.6 then broke after 6am and tylenol 1200 po, blotchy red raised rash to rt side of body( harlequin in nature) only mainly torso and back extending to some anterior upper thigh and neck region went away around 1300 on 29th, severe HA, shakes, N/V, dizziness, severe body aches especially to neck amd ankles, injection site swollen x4 camaraderie to rt arm with heat for 12+ hours.
Patient was given a vaccine that was over the allotted time frame from being opened. The vaccine had been opened and drawn up yesterday and stored in the refrigerator and was given this morning.
The day of receiving vax pt developed a "significant" local reaction characterized by swelling, redness, itching, and hives at the Prevnar injection site. Pt was treated with Benadryl and Keflex 250 mg tid for 10 days for possible cellulitis. The pt recovered.
The pain at the injection site was immediate. 24 hours later, I felt like I was hit by a truck. My entire body ached and was extremely sore. I had a low-grade fever of 100°. I took advil and put cold packs on my arm sporadically. I was not able to go to work the second day after the shot because I felt so miserable. I slept almost the entire day (9/8/22). I had the fever all day, and the body aches all day. I took advil every 4 hours to help alleviate the arm pain. It wasn?t until the morning of 9/10/2022 that I felt better. The body aches and fever were gone. The arm pain is still there.
Vaccine vial was opened at 9:34am on 6/28/21. Dose was drawn out of vial at 4:52pm on 6/28/21 and given immediately. Vial had already expired at 3:34pm that day but was left in the refrigerator, and dose was inadvertently drawn and given out of the expired vial.
L upper arm reddened/ warm approx 4 x 5 cm X 1/2 mm height. Child had received 2 vaccines 1 s/c; 1 IM on 8/26/13. Child was very anxious; moving and tightening arm while mother held her. Treatment: prescribed by NP Tylenol q 6 h ATC 3-4 days. Cool compresses qid X 10 minutes until redness clears. PHN will follow up with 2 phone calls to mother over next 7 days. Mother will call PHN if s/s worsen.
One week after receiving vaccines, this infant had 2 blisters, the 2nd week after the patient broke out all over. She had a temp of 101, that responded to Tylenol. The doctor also diagnosed with impetigo. Gave Cephalaxin and Bactroban cream.
pt had diff breathing & confusion immed p/vax;pt was transported by ambulance to ER; MD stated pt had vasovagal rxn but not d/t vax;
Diagnosed shingles on upper left back, prescribed Valtrex and as of 09/21 rash is still present, fatigue is still present.
i got them on my side about 3 years after getting the shot /Suspected Vaccination Failure; i got them on my side about 3 years after getting the shot; was painful enough.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got shingles on his/her side about 3 years after getting the Shingles shot and that was painful enough. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided.
Injection Site reaction (hardness, redness, warmth, itching). Inflammation has gone down after 2 days but still itching and red mark the size of a fist around injection site.
Shortly after the vaccine, I had a small, raised red bump around the injection site.  As the day went on, it grew larger and swelled a bit.  By the next morning (2/25/21), it was swollen, red, and warm.  It increased in size during the day and was still the same size this morning (2/26/21)..about 2" long by 1 1/2" wide.  The big change today is that my arm became itchy.  It has itched on and off through the day.
Three days later, Pt heavy loose stool, Diarrhea, low grade temp. Treated for diarrhea.
About 30 seconds after the shot, became faint, dizzy, and ears started to lose hearing and became fuzzy. Sat down and drank some water, vitals showed lowered BP. Recovered after 15-30 minutes and some water.
aches, pains, diarrhea, & fever beginning 3 hrs p/vax; 12 hrs subsided & felt fine next day;
Pediarix given 02/05 mom states slight redness and swollen upper right arm02/06- worse 02/07- " rash" appearance of solid red and swelling  12cm x 9cm- gave topical Benadryl and then 2/6  PO Benadryl x2.
PERSISTENT STOMACH PAIN; CONSTIPATION; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and other pre-existing medical conditions included: The patient did not taken a birth control pill. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced persistent stomach pain, constipation, muscle aches, and fever. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, CT scan (NR: not provided) Not reported, and Diagnostic ultrasound (NR: not provided) Not reported. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from persistent stomach pain, and muscle aches, and the outcome of fever and constipation was not reported. This report was non-serious.
I have had new onset, severe hyperhidrosis which began within a day of the vaccine AND HAS LASTED FOR FIVE WEEKS, so far.
Information has been received from a physician concerning a 5 year old male who on 10/24/97 was vaccinated with Varivax. On 02/10/02, the patient developed a chicken pox rash (approximately ten pox) scattered on the torso and buttocks with no sequelae.  It was noted that the patient did not have any adverse events following previous vaccinations.
Erythema, swelling L arm near to vaccine site, warmth of arm, erythema spreading to elbow.
severe bilateral pneumonia; hypoxia; shortness of breath; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (severe bilateral pneumonia) and HYPOXIA (hypoxia) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tobacco user since an unknown date, Hyperlipidemia since an unknown date, Chronic pancreatitis since an unknown date, Hypertension since an unknown date and Diabetes mellitus since an unknown date. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), METFORMIN, OMEPRAZOLE, ESCITALOPRAM OXALATE (LEXAPRO), ASA, PROPRANOLOL and OXYCODONE for an unknown indication.    On 04-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DYSPNOEA (shortness of breath). On 10-Apr-2021, the patient experienced PNEUMONIA (severe bilateral pneumonia) (seriousness criteria hospitalization and medically significant) and HYPOXIA (hypoxia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 10-Apr-2021 due to HYPOXIA and PNEUMONIA. At the time of the report, PNEUMONIA (severe bilateral pneumonia), HYPOXIA (hypoxia) and DYSPNOEA (shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal wbc 17.3 with 79% neutrophils and 1.2 lymphocytes.. On an unknown date, Brain natriuretic peptide normal: normal normal. On an unknown date, Computerized tomogram: abnormal chest with collapse of the left upper lobe with dense consolidation with possible mass like density occupying much of the left upper lobe bronchus, diffuse ground glass opacities throughout the left lung are seen and ground glass opacities of the right upper lobe and right lower lobe are seen infectious/inflammatory. there is also mediastinal and hilar lymphadenopathy seen.. On an unknown date, Influenza: negative negative. On an unknown date, Procalcitonin: normal normal. On an unknown date, Productive cough: normal normal. On an unknown date, SARS-CoV-2 test: negative negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Client received CanSino COVID vaccine, outside of the US, no reaction. CanSino vaccine not approved by World Health Organization, Janssen given as an alternative on 09/15/21.
TESTED + AT HOME ON       2-6-22   ;DECEASED 3-4-22;  I DO NOT HAVE ANY FURTHER INFORMATION
Patient received vaccine on 4/16/2013. Returned to clinic with redness at inj site and low grade temp on 4/22/13. Dr. prescribed prednisone for reaction.
Swelling, painful,  limited arm movement, Purplish color where vaccine was placed.
patient has left shoulder swelling around the site of injection about the size and deviation of a tennis ball. it is sore,  mildly bruised. Does not impact ROM
The day after I got my shot, I woke up to my right eye being significantly bigger than my left.  It was swollen and extremely itchy.  It was swollen for a few hours until I remembered to take allergy medicine.  It subsided. Then today, January 19, 2021, it happened again.  It didn't swell as much, but was extremely itchy. My neck area and stomach area is itchy as well.