chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; We had patients who were administered the vaccine that underwent temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 4:55 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 4:55 PM, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had patients who were administered the vaccine that underwent temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.  280 patients received Moderna Covid 19 stored at minus 82 degrees Farenheight.  Excursion duration was 1 month.  On 19 Nov 2021 is when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator.  70 vials are still in the ultra cold freezer, 8 vials are in the refrigerator,78 vial were impacted.   No vaccine state changes were noticed. The vaccine was never refrozen.   This case was linked to MOD-2021-402935 (Patient Link).
Two weeks after the second dose of the vaccine I felt winded suddenly. I had a cold feeling in the middle of my chest. I was very uncomfortable and I went to the ER the next morning. I was diagnosed with a Heart Attack. I was told I had 90% Occlusion and I was treated immediately. I was hospitalized for five days and I had to go back after 10 days because I had chest spasms. I had another Angioplasty and they said my blood flow was slow. I am still taking blood thinners and having some chest spasms.  I was experiencing some tiredness and then I got body aches. The body aches were very bad in my muscles that came and went for 5 days. . I was extremely tired. I got mouth lesions five days after I felt the tiredness. on my tongue and on the roof of my mouth. I had light headaches and I did not loose my sense of smell or taste. I tested positive for Covid-19 07/23/2021.. Since then I have developed a persistent cough and nasal drip which is lingering at the moment. It has been four weeks and I did not have this cough during the first 14 days.
Sore arm; This is a spontaneous report from a contactable consumer.   A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), dose 2 via an unspecified route of administration on 04Mar2021, at 13:15 as single dose for covid-19 immunization.  Medical history included Crohn's disease from an unknown date. Concomitant medication included adalimumab (HUMIRA AC) taken for an unspecified indication, start and stop date were not reported.  The patient previously took codeine and experienced allergy and BNT162B2  for covid-19 immunization on 11Feb2021.  On 04Mar2021, the patient experienced sore arm approximately six hours after injection. Prior to vaccination, the patient had not been diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The outcome of sore arm was recovered in Mar2021.
Clinical Summary Patient is a 82 y.o. female with a history of severe emphysema on home O2, anxiety, and dyslipidemia with recent positive COVID test on 11/2/22 who presented to hospital 11/6/2022 with 2-4 days of increased dyspnea and cough found to have COVID-19 Pneumonia. CTPE showed patchy irregular masslike densities in lower lobes; likely inflammatory with enlarged mediastinal and bilateral hilar lymphadenopathy. Improved with steroids. Discharged to home w/ HHC 11/9/22.   1. COVID-19 Pneumonia: exposed on 10/30/22; symptom onset 11/2/22 with mildly increased dyspnea and decreased appetite; tested positive on 11/2/22 at home x 3 tests and then again at wellness center on 11/4/22. Prescribed paxlovid on 11/4/22 bt pt refused to take it. Initially very reluctant to take higher doses of prednisone, then agreed with worsening respiratory status and more SOB on 11/7/22. Given decadron for 10 day course end date 11/16/22.  2. Advanced Emphysema with Chronic Hypoxic Respiratory Failure: On 4L O2 via NC at baseline and 5mg prednisone daily. Follows with Dr. (pulmonary) and recently started on spiriva and PRN lasix. At baseline O2 requirement on admit. Continued home regimen. 3. Abnormal CT: CTPE on admit showed new patchy irregular mass-like densities in lower lobes; likely inflammatory with enlarged mediastinal and bilateral hilar lymphadenopathy. Likely due to viral infection. Repeat CT in 1 month recommended to ensure resolution of infiltrates and lymphadenopathy. Discussed findings and follow up CT with patient extensively on admit; she stated she can get in with her pulmonologist to get repeat CT.  4. Elevated Troponin: 26 on admit, downtrended to 21. EKG nonacute. Likely due to above. No further testing indicated.
PERSISTENT HEADACHE TOP OF SKULL AND FOREHEAD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced persistent headache top of skull and forehead. Laboratory data included: Blood test (NR: not provided) Seems fine, and CAT scan (NR: not provided) Seems fine. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache top of skull and forehead. This report was non-serious.
11/17/2021 My arm began to hurt with general soreness after the vaccine was administered, it continued to get worse up until I reached out to my physician group, they at first had me get x-rays and from there I was sent to physical therapy. After 6 weeks, I was referred to an orthopedic surgeon now and the diagnosis was adhesive capsulitis or frozen shoulder. The physical therapy has helped with range of motion however I am still unable to lift my arm over my head. Pain is still occurring included with the frozen shoulder diagnosis causing sleeplessness.
Welt like rash below the site of the injection, looks like a little island; A spontaneous report was received from a healthcare professional concerning a 36-year-old, female patient who experienced welt like rash below the injection site and looks like island / PT: vaccination site rash.   The patient's medical history was not provided.    Concomitant product use was not provided.   On 28 Dec 2020, prior to the onset of the symptoms, the patient received the first/second (not specified) of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    On date 07 Jan 2021, the patient experienced the event welt like rash below the injection site and looks like island.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event welt like rash below the injection site and looks like island was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The patient received his vaccine on Monday 2/1/21. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day he had a temperature of 101.7 F. Since the patient was febrile, he was given rapid COVID tests, which was negative. He was not in distress. He had no complaints otherwise.
2 years since first shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 13-May-2022 Reporter's Comments: This case was reported by a consumer via call center representative. The reporter stated that It had been 2 years since his/her first shot. The patient asked whether he/she should get both shots now or just the second. Additional Supportive Information: The patient did not receive 2nd dose till the time of reporting which led to incomplete course of vaccination.
Redness, slight swelling, pain at injection site that re-started after 7 days.  Original ache / redness went away after 3 days.
6/8/2021 - same low-grade fever, swollen arm, painful the whole area was red from the site to the elbow, headache. Experienced choking for 11 months before and got the vaccine. It swelled up again in April 2021, the size was that of a golf ball at least 6.27 by 9. They are in the chest and coming from the chest. Had the 1st fist vaccine 3 weeks.
Patient vaccinated by RN @ 3:07pm.  At 3:10pm, the patient called for help.  The patient reported that he briefly passed out.  This event was not observed by any medical staff members.  The patient was provided with water and an ice pack to his neck.  EMS called to our area for further observation.  BP 106/62.  The patient quickly recovered and stated he was 'feeling fine'.  Patient escorted to observation area by EMT for remainder of his observation time.
Pt had a cat bite and since it had been 30 plus years since her last tetanus vaccination, the pt opted to have the vaccine given. Approx 4 hours, post vax, she had numbness and tingling on the left side of her hand, palate, front of mouth extending into gum and 1 tooth. Resolved in 6 weeks. Partial numbness of upper lip remains. Pt did not seek medical evaluation. No local reaction at vaccination site. She had a reaction 30 plus years ago with general malaise, fever and diarrhea. No local reaction.
Developed urticarial rash, starting on the face and spreading to the trunk and arms by the time of appointment.  No associated respiratory or GI symptoms.  No other new exposures.  Treated with steroids and Benadryl.
Gave FLUVIRIN 0.5 ml IM at right deltoid - No adverse S/S at time - None reported by mom (who also works at clinic) - Called MD - who advised me to report this (in case any SE's/adverse Rx's).
Local itching, redness, swelling at site of injection (deltoid), then red rash across upper back.
15 minutes after receiving the COVID-19 vaccine from Pfizer, the patient became short of breath and dizzy. The EMS was called and she was transported to the ER
lt deltoid red, hot to touch, pt had T99.5;CBC nl no elevated WBC;
Pt recvd Engerix-B, MAY90, JUN90, & OCT90, respectively; Titers performed JUN91 revelaed the pt was a nonresponder; tx will give booster dose;
Received Flu vaccination on 11/4/02 around 13:00. At 19:00, that evening, she was feeling very cold, shaky and thirsty. She went to Urgent Care at 21:30 and was examined by MD. She was sent home with instructions to follow-up with her doctor. When she was at Urgent Care, she was told that a young man had came in with similar symptoms. Pt called her son, who is a doctor, and he told her the Flu shot may be a contaminated batch. Pt's symptoms subsided without intervention around 23:00 and she slept "like a log" for 8 hours. She stated that she did not eat anything from noon until 19:00 on 11/4/02. She drank a couple cans of pop when she was feeling very thirsty.
After the first shot I began to feel a pressure in my neck. A few days after the second shot, I was walking across a street and my neck began to choke and my jaw locked up for about 10 seconds. It released a bit but was still very uncomfortable. I sought immediate medical help and was given steroids. The medical professional on staff said it was from the vaccine, but that I would be fine. I am now three weeks out from my second vaccine and my neck (rt side) is still stuck in spasm, and there is a growing numbness with a few painful spots growing up the right side of my face up to my eye. My Dad is an ophthalmologist, and he examined me. Confirmed the spasms in my neck and diagnosed the cheek numbness as infra-orbital neuralgia. He said he "strongly believes it is from the vaccine". I went back to the original facility the next day  (5/17/21) and am now being referred to an ENT.
DTAP/IPV QUADRACEL given IM left thigh on 7/22/2019. Swelling extends to knee on 7/24/2019.
Left arm pain, swelling, itching. Arm was swollen, red and hot to the touch.
Patient stated on Wednesday 10/26/22 that she awoke early Sunday morning with a rapid heart beat that lasted a few hours . She also stated that as of today she was better but still "woozy"
During observation period, the patient began to get shakey and stated he did not feel well.  Post vaccine became slow to respond, diaphoretic, felt lethargic and weak with noticable tremors.  BP 164-102; P: 98; O2 99%.  Discharge note states reaction to the vaccine.
Perfectly healthy until vaccine. Developed dermatomyositis. I had a skin rash without a few days of the first dose. After the second dose muscle weakness set in and I couldn?t perform basic life duties. I seemed medical advice for the rash by a dermatologist that referred me to a rheumatologist
I noticed around 930 pm I started to have chest tightness. The next day I took an at home Covid test that came back positive. I went in to an urgent care and was tested for Covid, and it came back positive. I was prescribed antiviral medication. I had a slight cough but no other symptoms. My symptoms lasted for 3 days and have completely subsided.
I had both vaccines. I am currently dealing with shingles / suspected vaccination failure; shingles, in my mouth; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had both vaccines and currently dealing with shingles in mouth. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
This spontaneous report as received from a pharmacist refers to a patient of unspecified age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The pharmacist reported that on 27-APR-2016, the patient was inadvertently administered an expired dose of ZOSTAVAX with lot # J010447 and expiration date 22-APR-2014 (strength, dose number, dosage and route unspecified). No adverse effect was reported. Product quality complaint (PQC) was involved. No further details was provided. Additional information has been requested.
Generalized tonic clonic seizure at night in bed witness by family.  Patient had received flu vaccine 8 days prior.  Additional terms added from DIS. Summary rec'd 10/30/2005:WBCinc, BP inc, Magnesium inc, platelets inc./sr Discharge summary states confusion. msv
This case was reported by a consumer, the subject's mother, and described the occurrence of swelling in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.   Concurrent medications included CORTISONE TOPICAL, BENADRYL and Ibuprofen.  The subject had no relevant medical history or any adverse events following previous vaccinations.  On 31 March 2009 at 15:30 the subject received unspecified dose of KINRIX (.5 ml unknown, right arm).  No other vaccines were given on 31 March 2009.  On 31 March 2009, approximately 2 hours after vaccination with KINRIX, the subject experienced swelling, hives, redness and itching in his right arm.  The subject had not experienced any problems with prior PEDIARIX and RECOMBINANT and inactivated POLIOVIRUS vaccine combined) injections.  Medical attention was required at a physician's office.  The mother of the subject planned to continue follow-up with her son's physician on an unknown date.  On an unspecified date, the swelling on the subject's right arm improved.  On an unspecified date, the hives, redness and itching on the subject's right arm resolved.  The consumer reported that the events were clinically significant or requiring intervention. This case was reported by a consumer, the subject's mother, and described the occurrence of swelling in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Cortisone, BENADRYL, and IBUPROFEN. The subject had no relevant medical history or any adverse events following previous vaccinations. On 31 March 2009 at 15:30 the subject received unspecified dose of KINRIX (.5ml. unknown, right arm). No other vaccines were given on 31 March 2009. On 31 March 2009, approximately 2 hours after vaccination with KINRIX, the subject experienced swelling, hives, redness and itching in his right arm. The subject had not experienced any problems with prior PEDIARIX and RECOMBINANT and POLIOVIRUS vaccine combined injections. Medical attention was required at a physician's office. The mother of the subject planned to continue follow-up with her son'ts physician on an unknown date. On an unspecified date, the swelling on the subject's right arm improved. On an unspecified date, the hives, redness and itching on the subject's right arm resolved. The consumer reported that the events were clinically significant or requiring intervention. Follow up received from the physician on 03 August 2009: The subject had previously received 3 DTaP vaccinations on unknown dates. KINRIX was the 5th in the vaccinatin series. The events were reported to be a local reaction and resolved on 05 April 2009. The physician considered that the events were not serious.
LUNG INFLAMMATION/ SEEMS LIKE LUNG INFECTION; SHORTNESS OF BREATH/HARD TIME BREATHING; CHEST PAIN/BURNING IN THE CHEST; SINUS INFLAMMATION; THROAT INFLAMMATION; INTERNAL BURNING DOWN HER ARM TO THE WRIST; SHOULDER BLADE AREA PAIN; ARM PAIN; INTERNAL BURNING AT THE  INJECTION SITE; 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 covid -19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-APR-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included meloxicam for drug used for unknown indication. On 12-MAR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 09-APR-2021, Laboratory data included: Antibody test (NR: not provided) Positive. On 13-APR-2021, the subject experienced lung inflammation. On 13-APR-2021, the subject experienced shortness of breath/hard time breathing. On 13-APR-2021, the subject experienced chest pain/burning in the chest. On 13-APR-2021, the subject experienced sinus inflammation. On 13-APR-2021, the subject experienced throat inflammation. On 13-APR-2021, the subject experienced internal burning down her arm to the wrist. On 13-APR-2021, the subject experienced shoulder blade area pain. On 13-APR-2021, the subject experienced arm pain. On 13-APR-2021, the subject experienced internal burning at the injection site. On 15-APR-2021, Laboratory data included: Blood test (NR: not provided) Unknown, Chest X-ray (NR: not provided) Unknown, and EKG (NR: not provided) Unknown. Treatment medications included: ibuprofen. On 29-APR-2021, Laboratory data included: Blood test (NR: not provided) Lymphocytes and Eosinophil numbers changed. On MAY-2021, treatment medications included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath/hard time breathing, lung inflammation, chest pain/burning in the chest, internal burning at the injection site, shoulder blade area pain, sinus inflammation, throat inflammation, internal burning down her arm to the wrist, and arm pain. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
63 year old vaccinated female was admitted for GI symptoms related to Covid-19 infection. She was dehydrated and in renal failure. These symptoms resolved with IV fluids. She also received Remdesivir and steroids. She will be transferred to facility today for rehab in stable condition
Swelling surrounding injection site; Erythma surrounding injection site; This case was reported by a physician via other manufacturer and described the occurrence of injection site swelling in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 15-AUG-2022 Reporter's comment: The patient had symptoms which were centered around the injection site and started less than 24 hours after vaccination.  The patient had swelling and erythema surrounding injection site.
Lightheadedness; 1243 lightheaded BP 154/90, HR 100,resp 16, sats 98% 1258 expressed lightheaded resolved left ambulating for home. First Vaccine.