chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inconsolable crying per mom after 1st immunization (Never given DPT again-Continued other vaccinees DT) Pt diagnosed with autism. Now per mom (have moved out of state) Parents request report to VAERS.
Left arm with redness and small rash around injection site. Patient A/Ox3 denies S.O.B./ Numbness/ or additional swelling beyond injection site. Daughter wants to give Benadryl. Advise daughter only if her mother cannot tolerate the itching & as long as she is not allergic to it's components. Observe site, if itching increases in intensity & additional swelling occurs or her mother become short of breath, she is to take her mother to E.R. for further evaluation.
After 5 minutes from vaccine administration, patient developed localized rash to left thigh at site of injection. Benadryl was given. Patient was observed for another 15-20 minutes, was released to mom's care with rash resolving.
Patient reported pruritus at the injection site on left arm. Denies generalized pruritus.  No shortness of breath or difficulty in breathing. No swelling at the injection site., and no other cutaneous symptoms. Patient instructed to notify medical of worsening symptoms or difficulty in breathing. Patient reported feeling better after 5-10 minutes and left vaccine site.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant therapy, drug reactions/allergies and medical history was not provided. On an unspecified date in January 2016, the patient was vaccinated with PNEUMOVAX 23 (indication: prophylaxis; strength, dose, route, lot # and expiration date were not reported). On an unspecified date in April 2016, the patient was vaccinated with PREVNAR 13 by her unspecified physician. No adverse effects.
Felt fine after injection.  About 4 hours later, developed a hacking non-productive cough, SOB when talking, low-grade temp (100 or so), and fatigue.  At first some of the symptoms reminded me of my atypical GERD, so I increased the pantoprazole 40 mg from once daily to BID.  Symptoms continued. - with the additional of a bronchospasm.  Currently I am treating myself at home with an albuterol nebulizer and Advair inhaler treatments, Advil and Tylenol for fever.  I have supplemental oxygen for use as needed - am continuing to monitor O2 sats.  Pushing fluids.  After one week, I'm not really improving.
I got COVID my symptoms was nasal congestion, cough and extreme fatigue. I was sent to Hospital for the Monoclonal antibodies for Omicron within 24 hours my symptoms had subsided.
Rash on left and right biceps, left and right inner thigh, right lower back and injection site. Rash was red and itchy for two weeks. Still visible, faintly without itchiness on 12/13/2009. Injection site looked like red circle size of a half dollar, iritation was above the skin surface and a red dot at injection point. Some dizziness the morning after the injection, only lasted briefly.
1 day p/vax pt exp gen itching;eyeballs & ears also itched;pt stated that felt as though bugs were inside her;
About 12 hours after the vaccine I started to get a fever that got up to 101.2 degrees, headache, body aches and flank pain. I took Tylenol, which helped break the fever and body aches but still have a low grade fever and headache. I believe I have COVID antibodies from a previous infection back in September so think that having the antibodies already could have caused this.
Large swelling to left arm, measuring 3"x1 1/2".  24 hour injection.
After receiving my first COVID shot I was ok,  aside from a really sore arm. The next morning 9/23 I wake up with sever migraines, which I never suffer from and low back pain.  Two days after my shot, 9/24 I was in the shower and while showering, I felt a huge lump under my left armpit, which was the same arm  I received the injection.  The lump was so big that I couldn?t even see my armpit to shave.  The lump was soft not hard, definitely round, was sore to the touch but not painful. The lump went away in about 1.5 weeks after my first shot.  I was going to call urgent care, but after going on line, I noticed  that some others had also experienced this and that it would go away within 2 weeks, which mine did.  If it didn?t, I would have taken the necessary steps to seek out a professionals opinion.
Severe fatigue and headache that is ongoing for past 4 days since vaccine was administered. Chills are also experienced.
pneumonia; something wrong with his kidneys; dry heaves; he won't eat; had dots all over his back like it had exploded; rash; got sick; rash/ got sick; This is a spontaneous report from a contactable consumer. This consumer (wife) reported for a male patient (husband) that a male patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 and got sick and rash. The reporter's husband had second shot and she knew he broke out in a red rash all over. He had the first one and got sick eight days later. He had been in the hospital. He saw his primary doctor when he got out of the hospital. He had dry heaves and he won't eat. He didn't want to drink any liquid. She was trying to make him drink. He didn't have a fever. His temp was 97.2. He might have had the rash with both doses. When he came home from the hospital he had a rash, but yesterday he was broken out all over. He got sick and had a test and didn't have it. It was on the twenty eighth when she put him in the hospital and he had pneumonia and something wrong with his kidneys. He was on an antibiotic. He got a rash anytime of the year. When he came home he had dots all over his back like it had exploded. She wanted to know if he could be allergic to this. The patient was hospitalized for the events pneumonia and something wrong with his kidneys. Treatment was received for the events pneumonia and something wrong with his kidneys. The outcome of the events was unknown.  Information about Lot/Batch number is requested.
Pt discharging to SNF- requested COVID booster to be given PT DC from ED -ED physician verbalized understanding. Booster was not ordered. 7/26- Facility is now requesting COVID booster documentation. After investigating booster was not ordered/given. Facility made aware. Facility reports that nurse giving report said pt got one.
11/3- redeness at site. 11/4- redness/swelling on entire back of right arm with pain. 11/5 and 11/6- redness moved down patients arm, and pain subsided. All symptoms localized to right arm, no other symptoms reported.
Over all body inflammation; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Over all body inflammation) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia rheumatica (Recurrence after 7 years of having disease under control) since 02-Jan-2012, Sulfonamide allergy, Glaucoma, Hypothyroidism and Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE) from 15-Feb-2010 to an unknown date for Allergy, LATANOPROST (LATANOPROST OPTIC) from 15-May-1990 to an unknown date for Glaucoma, LEVOTHYROXINE from 01-Jun-1965 to an unknown date for Hypothyroidism, VITAMIN D NOS from 01-May-2002 to an unknown date and FISH OIL for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced INFLAMMATION (Over all body inflammation) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency; IBUPROFEN for Pain, at an unspecified dose and frequency and PREDNISONE (oral) on 04-May-2021 at a dose of 5 mg twice a day. On 25-May-2021, INFLAMMATION (Over all body inflammation) and HEADACHE (headache) had resolved.            This case was linked to MOD-2021-057674.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant FU-ADR: event outcomes updated.
I began to get a rash on my side, this was later diagnosed as shingles. I began to feel increasingly sick, and for many years my doctors told me I'm ok and there was no correlation to vaccine. In December 2011 I was diagnosed type 1 diabetic.
No Adverse Event; Patient was supposed to get the 3rd dose of the Moderna vaccine but was administer the Pfizer vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was supposed to get the 3rd dose of the Moderna vaccine but was administer the Pfizer vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1414B) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Patient parents did not describe any medical History or Condition.    On 30-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2023, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 19-Jul-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was supposed to get the 3rd dose of the Moderna vaccine but was administer the Pfizer vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was supposed to get the 3rd dose of the Moderna vaccine but was administer the Pfizer vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was supposed to get the 3rd dose of the Moderna vaccine but was administer the Pfizer vaccine).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
lLeft arm red and swollen down to elbow. Pt had to go to ER night of injection. Arm very painful.
At site of Dtap child developed a 8cmx5cm area that was swollen and red.
Got the shot early afternoon, by night had a fever of over 100. By the next day climbed up to 102, but mostly hovered around 101. Excruciating pains in my legs, in my joints all up and down. Could not get any rest, was crying and moaning in severe pain all night long. I took as much ibuprofen as I could according to bottle direction, but that didn?t help much. That pretty much subsided after 12 hours. Complete exhaustion and fatigue that lasted for about a week, then a moderate fatigue for another few days.
Patient presented for first COVID-19 vaccine. Requested the Pfizer vaccine. Inadvertently received the J&J vaccine. Patient informed. Management contacted and discussed event with patient. Apologized to patient, provided information on the vaccination he was given (including EUA patient fact sheet for Janssen vaccination), and provided patient with the phone number for patient experience as he requested to file a complaint. J&J vaccine was in the room from a previous patient no show. Both Pfizer and J&J vaccine were sitting next to each other. The J&J vaccine should have been removed from the room prior to the next patient. Usual primary system build to catch wrong drug error is barcode scanning prior to...
15 month old male with no significant medical history received Hib and DTap immunizations in clinic on 6/6 and subsequently developed difficulty breathing, stridor and rash approximately 1 hour administration. Was transported to ED via ambulance where he received IM Epinephrine, IV Benadryl, IV MPS, IV Famotidine. Respiratory distress improved after medication administration and patient was discharged home after a 4 hour monitoring period.
Sore arm; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and DIZZINESS (Dizziness) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included TADALAFIL (CIALIS), LISINOPRIL, GLIMEPIRIDE, METFORMIN, TIZANIDINE, TRAMADOL and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and DIZZINESS (Dizziness). At the time of the report, PAIN IN EXTREMITY (Sore arm) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unknown date the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) (dose, route, lot# and expiration date were not provided) which was improperly stored. No adverse effects reported. Additional information has been requested.
11 y/o female with Rett's syndrome, scoliosis, has had 2 recent spinal surgeries (1/31/12 anterior, 2/8/12 posterior).
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot # and route unknown) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 15-SEP-2015, the patient was treated at a medical center for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Received Moderna vaccine on April 7, 2021 and May 5, 2021. Have not received booster yet. Tested positive for Covid-19 on Jan 4, 2022. Sore throat, nasal congestion, headache and sinus pressure in forehead and  face, chills, fever up to 101, teeth pain, coughing and generalized body aches.
- Patient was given Covid-19 Bivalent (grey top) Vaccine which was beyond the usage date of 01/11/2023, lot #GJ6738. Patient has been notified. No adverse effects reported. Reports filed. -  ?Pulled a report of all administered vaccines by lot number and verified those that were administered past the BUD.  - Pulled all vaccines in fridge and placed a ?Do Not Use? sign on them while we completed investigation - Sat with each MA within the clinic going over the following: o Training on administration workflows to include ? entering vaccine information into database prior to administering vaccine, always having a team check which includes verification of vaccine, verification of patients age, timeframe between vaccines, BUD, dosage o BUD versus expiration date versus puncture expiration o Dosage of maroon top, orange top and gray top for monovalent and bivalent o The difference between monovalent and bivalent o Storage instructions o Workflow associated with what to do when clinic receives the vaccine o Training on lot manager and database reconciliation o Training on how to enter information into database when a provider places an order versus immunization clinic - Reached out to Pfizer who is recommending all patients who received an expired vaccine get re-vaccinated due to unknown efficacy - Clinic will reach out to all patients letting them know about the situation and offer to have them come into the clinic free of charge for re-vaccination or to a sister clinic if they prefer?
The child complained of bilateral leg weakness the day after vaccines and progressively worsen. He was admitted to hospital 11/10 - 11/15/12 and received 2 doses of IVIG. Symptoms improved.
w/in several hrs pt slept deeply would awake & cry out given APPA was moaning off & on 24 hrs; had mild encephalitic type react to DTP;
Patient admitted 5/20/21. Self reported vaccination > 14 days prior, however, reporter does not have access to vaccination dates
Received first dose of Pfizer vaccine @ 4:30PM 12/28/2020. Full body rash starting @ 7:30PM day of injection lasting until today (Jan 8th 2021) although much less severe.    Rash was hot to touch, not itchy, and very blotchy first few days. Dec 30-Jan 5 2021 low grade fever, chills, diarrhea, sore throat. Thought possibly COVID+; tested Dec 31 @ Hospital and was negative.   No other allergic reactions such as throat swelling, itchiness, eye irritation at all. Alough I did take one Benadryl at ~9PM 12/28.
Pt received Tdap to (L) deltoid on 2/12/14. Pt called to report pain at 5 days had not subsided. Reported numbness on radial aspect of (L) hand. Pain w/ sleeping. Decreased functionality of (L) hand. Pt see by FNP on 2/19 and prescribed Abx for ? of abscess (7 day) pt stopped treatment on day 4 "not working". Referred to neurology/PT/ ok'd for acupuncture. Still having decreased function/numbness/pain.
chills; headache; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced CHILLS (chills), HEADACHE (headache), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Approximately 6 weeks after 2nd vaccine dose:  Outbreak of Shingles on left shoulder/neck  Outbreak of unknown rash, very itchy, small blisters on left forearm and upper arm, right arm (small amount) and small spots on rest of body.   Hives on face
I noticed a large red blotch on my left arm at the injection site a week after the initial injection.  It was swollen, itchy, and red.  It measured ~ 3 " x 3" in size.
Flu like symptoms for a week with a fever; Flu like symptoms for a week with a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunisation, reaction(s): "adverse event". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), PYREXIA (non-serious) all with onset Oct2023, outcome "recovered" and all described as "Flu like symptoms for a week with a fever". The event "flu like symptoms for a week with a fever" required physician office visit.  Additional information: Reporter asked where can she find the vaccine that was grown in a mammalian cell instead of an egg cell? She has had reactions in the past to the Pfizer BioNTech COVID 19 vaccine, which lasted a week or two, so her immunologist said for her to try and find a vaccine that has been grown in a mammalian cell. She thinks she would not have a reaction to it. She reported that that she has had reactions in the past to the Pfizer-BioNTech COVID-19 Vaccine which lasted for a week or two for her. Reporter stated, No, she did not know product details, she can told them the date. She think it was 10,20, something, last week, but she did not know the exact date. She did not know where it was, just a moment. Reporter stated she did not know where she got this one. Reporter will not be able to provide the facility details. reporter did not known time of vaccination. Reporter stated, she did not have diabetes and she was not taking any hypertension medications. Reporter further stated, she told her she had doctors appointment in a few minutes, she had to go to, she need to get off the phone.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
This spontaneous report was received from a health professional refers to patients of unknown demographics. No relevant medical history of the patients was reported. It was reported that on unspecified dates an unspecified number of patients were vaccinated with improperly stored VARIVAX (Merck) (Lot number reported as J013904) (strength, dose and route of administration were not reported). No concomitant medications were reported. It was reported that the stored VARIVAX (Merck) were exposed to temperatures of -11 degrees Celsius for 13 hours. There were no adverse effects reported. The outcome was unknown. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 01/15, Pfizer, dose #1 02/12, Pfizer, dose #2 09/16 pt cc: cough, diarrhea, headache, rhinorrhea, exposure: unknown 09/27 COVID swab, result: detected 09/27 SARS-COV-2 Variant Sequencing result: pending 10/01 clinically resolved
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. On 15-APR-2014 the patient was vaccinated with VARIVAX (Merck), lot # J006114, expiration date 19-MAY-2015, 0.5 ml once, subcutaneous (dose in series unspecified) that was improperly stored at 11.5F due to defrost cycling for an unspecified time frame. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Redness and flushing to face, neck and chest beginning 45 mins after receiving the vaccine.  Took benadryl with good effect.  Symptoms completely resolved by the following morning.
Dose 1 given 4/21/2021 Pfizer Lot # EW0172  Patient had a cardiac arrest at home and was pronounced dead at Emergency Room. Covid test was negative.
Around 10 minutes after getting the vaccine, the patient broke out in a red, itchy rash with inflammation all over her entire body from her face down to her feet. Patient stated the she had taken diphenhydramine 50 mgs approximately 15 minutes prior to getting the Covid vaccine due to a past experience where hives occured from a flu vaccine (which she believed to have occured due to her egg allergy).