chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. The report concerns a 19-24 year old, male patient who was administered ADENOVIRUS TYPE 4 AND TYPE 7 LIVE VACCINE (Tablet, Oral) on 15-Jun-2012, batch: 34600029. The patient experienced OTHER ANAPHYLACTIC SHOCK, NEC on 20-Jun-2012. On 20-Jun-2012, patient received Epinephrine IM, Diphenhydramine IM and IV, Methylprednisolone IM for Anaphylactic Reaction. On 21-Jun-2012, the patient received Loratadine po, Methylprednisolone po, for Anaphylactic reaction and Hydrocortisone topical and Clobetasol propionate topical for dermatitis. Lab tests were not reported. The outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: recovered/resolved. Action taken with suspect drugs: ADENOVIRUS VACCINE - Not applicable. The patient's medical history was not reported. The patient's concomitant medication included INFLUENZA VACCINE (since 15-Jun-2012); DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS (since 15-Jun-2012); MENINGOCOCCAL POLYSACCHARIDE (since 15-Jun-2012); POLIOVIRUS VACCINE. The patient's past medication were unspecified. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). Medical Monitor Assessment of Events: The medical monitor assessed the causality between OTHER ANAPHYLACTIC SHOCK, NEC and ADENOVIRUS VACCINE as having No Reasonable Possibility. "Event occurred 5 days after vaccine. Even though no other cause evident, a 5 day delay would be highly unlikely." ICD-9 event is confirmed.
Patient  stated that her arm swelled up and was "super red" and she could not use it or touch it.  Patient stated that she had a fever of up to 103 F.  She stated that initially the swelling was from her shoulder to her bicep muscle on her left arm, and that she could not move her arm.  Patient stated that her blood sugars were very high, up to 300, despite following her DM plan of care.   The swelling has gone down, it is not as red or big.  She stated that the swelling has gone down, but she is still sore.  She stated that she does not feel feverish today.   Today she is feeling much better, but she is still feeling tired and weak.
Family member stated that pt experienced headache the afternoon she received the vaccination then complained to home health nurse that she did not feel well the next day.  Patient was admitted on 04/19/2021 with diarrhea and possible pneumonia.
child was given 0.25 mL of Bivalent booster - should have received 0.5 mL. child will return in 2 months to receive full dosage.
RINGING IN EARS; FINGERS TURN BLUE; PAIN IN KIDNEYS; FEVER; THIRSTY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included penicillin allergy, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 97.3, 101.5. On 21-MAR-2021, the subject experienced thirsty. On 22-MAR-2021, the subject experienced ringing in ears. On 22-MAR-2021, the subject experienced fingers turn blue. On 22-MAR-2021, the subject experienced pain in kidneys. On 22-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ears, fever, fingers turn blue, thirsty, and pain in kidneys. This report was non-serious.
warm arm after receiving 2nd dose of Covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp via pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced warm arm after receiving 2nd dose of covid vaccine on an unspecified date. Caller stated that there was some kind of chemical in the delivery of vaccines that causes her daughter anaphylactic shock. She said the same chemical was in the Covid vaccine. She was wondering if Pfizer was working on a pill or something for people who could not take the regular vaccines as her daughter would like to be immune to Covid too. Caller then stated that she got a warm arm after receiving 2nd dose of Covid vaccine. Consumer calling on behalf of her daughter who recently finished up chemotherapy treatment for breast cancer, was now on radiation, and wanted to receive the Pfizer-Biontech Covid19 vaccine. The oncologist believed that her daughter had an allergic reaction to the 'vehicle' that the chemo was being delivered in, not the chemotherapy drug itself, which caused her daughters face and throat to swell up. The caller stated the fluid used to deliver the medication might have been called "technol". Did Pfizer had plans to develop a different delivery system so that her daughter could get the vaccine. Caller stated she was "So grateful for what Pfizer had done for them. Her husband and mother and she received their 2nd dose last week with no reaction. Their friends who got the other shot could not say the same. They were so grateful. Seriousness of the event was non serious. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient received COVID vaccine at 6:16pm and began having symptoms post vaccination at 6:28pm.  Patient reported feeling dizzy and "things went black," he then got up to go to observation nurse to notify her and did experience a fall but was caught by observation RN.  Patient was cared for by observation RN and paramedic on staff.  Patient was given fruit snacks and juice and began feeling better.  Patient was monitored for additional time and was able to leave on his own, patient did not drive/got a ride home.  No medications were given to patient.
Same issues as with the first shot Lot 010A21A given on 3/2/21 by the Health Dept. And I was advised by my dr to not get the 2nd but my job gave me zero option. Right after the shot I had a migraine headache which has not gone away, extreme soreness and swelling in my arm, arm was purple now it is bright red and itches. My entire skin itches. Fever, chills, nausea, vomiting. Not being hungry, extreme fatigue. Today is 1/24/22 and the symptoms are still going. Lymph nodes swollen, sore throat, cough. Can't taste. I was negative for covid before this. I absolutely disagree with the forced vaccination to keep my job. I have been sick for weeks and ringing in my ears. Can't concentrate, This is outrageous. Dr. won't see me because I have symptoms of covid without testing for it because of this shot. Exactly what happened the first time. If this continues I will have to find a doctor or emergency room
felt warm; headache; body aches; nausea; Vaccines 52 days apart; felt so sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt so sick), FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-1021, the patient experienced MALAISE (felt so sick). On 02-Oct-2021, the patient experienced FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccines 52 days apart). On 04-Oct-2021, FEELING HOT (felt warm), HEADACHE (headache), MYALGIA (body aches), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccines 52 days apart) had resolved. At the time of the report, MALAISE (felt so sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: positiive (Positive) Her second injection was scheduled but she had a positive Covid-19 test 4 days before her shot was scheduled 4Sep2021..         Concomitant medication was not reported. Treatment information was not reported.  Patient called to report that she had her first Moderna injection on 8Aug2021.  Her second injection was scheduled but she had a positive Covid-19 test 4 days before her shot was scheduled 4Sep2021.  She had her second injection 1Oct2021 Lot# 048B21A  52 days after first injection.   This case was linked to MOD-2021-340751 (Patient Link).
This spontaneous report as received from a Licensed Practical Nurse refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (unknown strength and route) lot # K005881 and expiry date of 14-JAN-2017. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
4-5 days after receiving PNEUMOVAX 23, while patient was on vacation, her left arm became edematous, erythematous and somewhat indurated. This spread to her forearm the next day. She reports of her left face also becoming swollen 2 days later, however, as the swelling was not continuous between her arm and her face (neck was not involved) it is unlikely that the 2 events are related. Patient self-treated on vacation with BENADRYL. Swelling has resolved since.
p/vax pt exp greater than 50 lesions;seen by MD who determined that child was exp pityriasis rosea and not chickenpox;
Hard time going down, almost felt like it was restricted; during the night very dry throat; very sore throat; Almost felt it was closing up; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (during the night very dry throat), OROPHARYNGEAL PAIN (very sore throat), THROAT TIGHTNESS (Almost felt it was closing up) and DYSPHAGIA (Hard time going down, almost felt like it was restricted) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included CPAP.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DRY THROAT (during the night very dry throat), OROPHARYNGEAL PAIN (very sore throat) and THROAT TIGHTNESS (Almost felt it was closing up). On 11-Mar-2021, the patient experienced DYSPHAGIA (Hard time going down, almost felt like it was restricted). The patient was treated with PARACETAMOL (TYLENOL) for Sore throat, at a dose of 2 dosage form. At the time of the report, DRY THROAT (during the night very dry throat), OROPHARYNGEAL PAIN (very sore throat), THROAT TIGHTNESS (Almost felt it was closing up) and DYSPHAGIA (Hard time going down, almost felt like it was restricted) outcome was unknown.            Concomitant medications details were not reported by the reporter.
This is not a report of an adverse event, but instead an administration error. My patient is a medical doctor, colleague and employee. The patient arrived on the first morning boosters were recommended and the first day offering flu shots to employees. We were swamped and overwhelmed. She stated she received her influenza vaccination at another clinic in the right deltoid earlier in the week. I screened her, and had no concerns. I administered and documented a COVID-19 vaccine in the left deltoid IM on 9/24/21. The pt tolerated the injection well and waited the 15 minute post-vaccination time period without problem. HOWEVER, she returned after the wait period to ask if the covid syringe was glass. This was an odd question. She recalled seeing me grab a glass syringe from a white tray in the fridge and screw on a needle and adjust the bubble. This is NOT consistent with the covid vaccine, which is pre -drawn in plastic syringes with the needles already attached. The covid vaccines are in a basket in the fridge, but NOT in a white tray. The white trays hold flu vaccines. She wondered if she received a flu shot and not the COVID vaccine. All documentation was done on paper and not interactively on the computer. I could not recall that exact vaccination in my memory, as I had given shots for hours. We discussed at length and decided there was a potential administration error, with the pt receiving and additional dose of flu vaccine instead of covid vaccine. With shared clinical decision making and a discussion of the risks (reactogenicity, no boosted coverage for covid as a HCP)  and benefits (ensured coverage as a HCP), we decided to administer covid vaccine IM in the right deltoid. We did discuss that the ACIP meeting did not initially vote to offer boosters for HCPS and likely the coverage remains high for severe covid disease. We also discussed increased potential for reactogencity and Nonetheless, she wanted to proceed with an additional vaccination and I agreed. I f/u on 9/27 and she had anticipated mild to moderate side effects, including aches/chills, fever of 101, and sore arm (right delt) over the weekend of 9/25-9/26. Her side effects were similar to her 2nd dose of Pfizer vaccine.
Patient was given a peds/adol dose of hepatitis A vaccine instead of an adult dose.
Patient had severe unilateral sudden sensorineural hearing loss upon waking morning after vaccination. Seen here at ENT and is being treated with oral high dose steroids as well as intratympanic steroid injections
Mild sore throat; Arm pain at injection site; Muscle soreness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 12:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 13:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15May2021, the patient experienced mild sore throat, arm pain at injection site, muscle soreness and fatigue. It was reported that the events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events mild sore throat, arm pain at injection site, muscle soreness and fatigue were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse refers to patients (clients) of unknown age. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (strength, dose, route of administration and indication were unknown). No concomitant medications were reported. No adverse effects reported at the time of report. No product quality complaint was involved. The outcome of events was unknown. No further details provided. This report is linked to 1405USA009522, 1405USA010571, 1405USA010572 by the same reporter link. Additional information has been requested.
COVID vaccine, 2nd dose, unaware of manufacturer, patient denies being given immunization record; reports reaction as aching, headache, joint pain, falls
Flu vac 10/12/10. 10/12/10 Back pain/malaise/muscle aches x5d. 10/15/10 Tachycardia, dizziness/difficulty speaking x 3-4 min while driving - had to pull of to side of road.
had a flu shot / got the flu/ suspected vaccination failure; flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 57-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The case was reported by patient him/herself on interactive digital media. The age at vaccination was not reported. The patient received flu vaccine and had flu. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Information has been received from a physician concerning a 69-year-old female with a codeine allergy and gastroesophageal reflux disease and a history of rhinitis allergic who on 14-Nov-2005 was vaccinated in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 651524/0605R). Concomitant therapy included rabeprazole sodium (Aciphex), estrogens, conjugated (Premarin), and a baby aspirin daily. On approximately 15-Nov-2005, 36 to 48 hours post vaccination, the patient experienced a cellulitis like reaction of swelling, redness, warmth. She was treated with a methylprednisolone (Medrol) dose pack. The outcome was reported as not recovered. Unspecified medical attention was sought. No lab diagnostic studies were performed. There was no product quality complaint involved. The reporter considered the event to be an other important medical event (OMIC) and disabling.
Tremors, shacking of hands and face; Teeth chattering; Tiredness and Fatigue; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of tremor in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-MAY-2023 10:00, the patient received the 2nd dose of Shingrix (right arm). On 03-MAY-2023, 1 days after receiving Shingrix, the patient experienced teeth chattering (Verbatim: Teeth chattering), fatigue (Verbatim: Tiredness and Fatigue) and headache (Verbatim: Headache). On 03-MAY-2023 14:00, the patient experienced tremor (Verbatim: Tremors, shacking of hands and face). The patient was treated with paracetamol (Tylenol). The outcome of the tremor and fatigue were not resolved and the outcome of the teeth chattering was resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the tremor, teeth chattering, fatigue and headache to be related to Shingrix.     It was unknown if the company considered the tremor, teeth chattering, fatigue and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-MAY-2023. The reporter was the spouse of a patient.  Patient also reported some information during the call.  Patient received the 2nd shot of Shingrix vaccine at a local pharmacy in the right arm.  Patient reported he had the vaccine around 10 am and at 2 am the next day, he reported having tremors in his entire body up to the head.  Patient reported having shacking hands, shacking face, Teeth chattering, tiredness, fatigue and headache.  Patient reported that his symptoms had improved.  Reporter stated that even though he was shaking, patient did not have chills, fever or felt cold.  Patient stated that he had less tremors on the day of reporting, but he still felt tired.  Patient reported of taking 2 Tylenol tablets.  Not all information was available. Lot and expiry were unknown. Consent to follow up with HCP was not provided.
Information has been received from a physician concerning a 12 year old female who was vaccinated with all three 0.5 mL doses of GARDASIL (lot # not reported). After the third dose was administered a small growth of facial hair was noted under her chin within a month. The patient's status was not reported. No laboratory diagnostic test was performed. No additional information is expected.
A high fever of 102.3F, chills, body aches, headache, fatigue, and sore throat. The chills and body ache started at 11pm. Prior to going to bed, I took 1000 mg Tylenol. I woke up at 1am with symptoms getting worse. At 4am I woke up to take my temp and it read 102.3F. I took another dose of 1000 mg Tylenol. I drank pedialyte and kept taking Tylenol while lots of rest. At 12 pm I got up to take a shower. At that point it seemed to get better.
This case was reported by a consumer and described the occurrence of influenza in a 75-year-old male subject who was vaccinated with influenza virus vaccine (Influenza vaccine, manufacturer unspecified) for prophylaxis.  A physician or other health care professional has not verified this report.  The subject's medical history included asthma, four heart attacks, high blood pressure and type II diabetes.  Concurrent medications included Advair, Metformin, Singulair, Losartan, Simvastatin, Felodipine, Metoprolol and Salbutamol sulphate (Albuterol).  On 10 October 2007 the subject received unspecified dose of Influenza vaccine (1 injection, unknown, right arm).  On 17 October 2007, 7 days after vaccination with Influenza vaccine, the subject experienced influenza and lack of efficacy.  The subject noted that he also experienced nasal symptoms.  The subject noted that no medical attention was required.  The subject reported that he was feeling better but still had nasal symptoms.  The subject consulted a healthcare professional regarding his event.  At the time of reporting the events were unresolved.