chrisvoncsefalvay/vaers-outcomes huggingface dataset:
72 people received 79 doses of expired vaccines that did not experience a temperature excursion and were thawed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (72 people received 79 doses of expired vaccines that did not experience a temperature excursion and were thawed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A, 039K20A, 039K20A, 039K20A, 039K20A, 039K20A, 039K20A, 039K20A, 039K20A and 039K20A) for COVID-19 vaccination.     no patient identifier no patient medical history was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 6 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 5 dosage form. On 02-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 5 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 6 dosage form. On 09-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 18 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 12 dosage form. On 16-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 11 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 7 dosage form. On 30-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 7 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (72 people received 79 doses of expired vaccines that did not experience a temperature excursion and were thawed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (72 people received 79 doses of expired vaccines that did not experience a temperature excursion and were thawed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was updated.  They used the same day as per Moderna guidelines.   No treatment medication was updated.   This case was linked to MOD21-126826, MOD21-126827 (E2B Linked Report). This case was linked to MOD-2021-278071 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Significant follow up; Sender's Comments:  MOD21-126826: MOD21-126827:
Patient returned day after vaccine administration having visited MD regarding pain and immobility of left shoulder.  Patient states that vaccine was administered too high in the shoulder per MD.  MD prescribed anti-inflammatory for discomfort and is sending patient to Physical Therapy for the shoulder immobility.
My left arm where the shot was administered felt as if I had been punched in the arm and had a severe bruise.  I was unable to lift my arm  for 36 hours without extreme pain.  The pain was also going up my neck.  I took tylenol to help.  On 3/25/21, the second day after the shot, the pain is not as bad but it is still there and I am able to lift my arm without as much pain.  I haven't ever had this kind of pain with any other vaccines that I have had in the past so I thought I would report just as an fyi
This is a spontaneous report from a contactable consumer. A 79-years-old female patient received BNT162B2 (COVID-19 Vaccine, Solution for injection, Lot number: EM9809), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date, 10:00 (at the time of 79-years-old) as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The vaccination facility type was hospital. The patient previously took prolia for her bones and osteoporosis and historical vaccine as bnt162b2 (Lot Number: FF1283) on 25Jan2021 administered via unspecified route, in arm left as first dose for covid-19 immunisation. The patient had first COVID-19 shot this past Monday. Gets the next one in three weeks. The patient was told information by someone and wants to see if that information was correct. The patient would get Prolia shot on a Monday and that Wednesday would get the second COVID-19 Vaccine. The patient gets Prolia every six months for her bones and osteoporosis. The patient had sore upper arm- put ice on - gone melt day. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.
Patient received Moderna first dose on 07/06/2022. Second does given was Pfizer.
Reports face and neck swelled, no difficulty breathing or swallowing, face remained swollen x 5 days, seen by PMD, prescribed steroid medpack but declined to take it, reports she instead took Benadryl x 5 days with resolution of symptoms.  She does report her face and neck had significant swelling.
Adverse reaction in form of swelling, redness, warmth R upper deltoid and fever 102.2 oral. Inoculations given at 10:00 on 06/14/2005. Swelling, pain and temperature 7 hours later. Recovering. The Stanislaus Co Public Health Dept, Immunization Unit, received this report via mail from one of our county clinics. I am forwarding this to you for your review and consideration. Please disregard if your department has already received this report.
pt was in mom's arm, looked pale, devel peri-oral cyanosis, poorly responsive x 5 minutes; then recovered;
Client reports within 20 minutes of the vaccine she developed dizziness, severe HA and facial swelling. Client called the hotline at local hospital but was never seen. Does not have private physician at this time.
I administered the vaccine, around 30 seconds later his wife tells me he's having trouble breathing. He is red and appears to be sweating. I have 911 called and prepared EPI pen. Pt then begins to recover and is ok by the time EMS arrives.
The booster I had no reaction, other than my arm was a little sore. 04/26/2023, low grade fever and slight congestion and a slight cough. I probably would not have known that I had it, but my husband had it and he had it much worse than I had it. I took a COVID-19 nose test on 04/26/2023, there was a slight 2 lines, it was negative. The next morning, on 04/27/2023, I took another COVID-19 nose test and the result was a bright line, it was positive. Within an hour and a half, I went to see my doctor, and he prescribed Paxlovid. My symptoms were very mild prior to taking the Paxlovid and they never got any worse. My symptoms got better, and they started to improve. I am on my final day today, 05/01/2023, of taking the Paxlovid. My temperature is still a little bit high. It fluctuates from 98 - 99, which is unusual for me, otherwise I feel fine.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of Zostavax. Subsequently the patient experienced localized swelling, redness and pain at the injection site. Unspecified medical attention was sought. The patient was given an antibiotic and it helped with the pain and swelling. There was no product quality complaint involved. Additional information has been requested.
Patient has a Mirena IUD and has not experienced any menstrual cycles for 2.5 years. One day after receiving the Covid-19 Vaccine, patient started period and has continued to bleed on and off for appox 2.5 weeks (From time of vaccine until present.)
TIRED; SPORADIC LOW GRADE FEVER; BAD TASTE IN MOUTH; 102 DEGREE FEVER; This spontaneous report received from a patient concerned a 63 year old white female with unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included: left bundle branch block for heart and was not on pacemaker. The patient will be visiting cardiology in march. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802072, expiry: 31-DEC-2021) dose was not reported, 1 total, administered on 06-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced 102 degree fever. (Dose number in series 1). Laboratory data included: Body temperature (NR: not provided) 102 degree Celcius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 102 degree fever was not reported. The patient received additional booster non-company suspect vaccine mrna 1273 (Dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 23-OCT-2021 in right arm for prophylactic vaccination.  On 24-OCT-2021, next day after moderna, the patient experienced bad taste in mouth. It had happened several times. On an unspecified date, the patient experienced tired, and sporadic low grade fever (all events in dose number series 2). The patient was not sure if she was immune enough because they said if patient got 2 doses of vaccine so will get immunity. She asked doctor if she need another dose, but he did not respond. Before christmas trip she called to health Department and the man said she would not be eligible for next shot till 23-JAN-2022. She got PCR tests negative The patient lay on couch for a minute and after 3 minutes get back up from couch. The patient was going to visit cardiology in March The patient had not recovered from tired, bad taste in mouth, and sporadic low grade fever. This report was non-serious.
NO SLEEP; TINGLING IN HANDS, FACE AND LEGS; NUMBNESS; CHRONIC URTICARIA  ALL OVER BODY; THROAT FELT LIKE COLD COMING SORE-CLOSING UP; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no history of asthma, eczema or food allergies. Patient never had hives or angioedema before receiving vaccine. The patient experienced palpitation when treated with levofloxacin for drug used for unknown indication. 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 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced chronic urticaria all over body. On 07-AUG-2021, the patient experienced throat felt like cold coming sore-closing up. On 07-AUG-2021, the patient experienced tingling in hands, face and legs. On 07-AUG-2021, the patient experienced numbness. On 28-SEP-2021, Laboratory data included: Complete blood count (NR: not provided) not reported, Differential WBC count (NR: not provided) not reported, Erythrocyte sedimentation rate (NR: not provided) not reported, Liver function test (NR: not provided) not reported, Platelet count (NR: not provided) not reported, Thyroglobulin antibody (NR: not provided) not reported, Thyroid peroxidase antibody (NR: not provided) not reported, and Tryptase (NR: not provided) not reported. On an unspecified date, the patient experienced no sleep. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic urticaria all over body, numbness, and tingling in hands, face and legs, and the outcome of throat felt like cold coming sore-closing up and no sleep was not reported. This report was non-serious.
Heart attack; A spontaneous report was received from a physician assistant, concerning a 54-year-old adult male patient who received Moderna's COVID-19 vaccine and experienced heart attack/myocardial infarction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 25 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis.  On 07 Mar 2021, after first dose of vaccine, the patient had chest pain and shortness of breath. On 12 Mar 2021, patient had a heart attack and was airlifted to hospital. He was hospitalized from 13 Mar 2021 to 14 Mar 2021. Patient did not have history of heart condition nor was taking any medications prior to having the heart attack. During hospital stay, he had angiogram done, stents were placed.  Treatment also included cholesterol lowering medicine, blood pressure medicine and acetylsalicylic acid.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, heart attack was resolved on 14 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of myocardial infarction, a causal relationship cannot be excluded.
Woke up around 3a and was sweating like crazy but freezing. Pounding headache. Intense muscle aches. Fever. Continued throughout the day on Saturday but definitely got better at around 10pm.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium
Injection site slightly swollen, tender, achy for 3 days. Within 5 hours of inoculation headache, fever, achy muscles and joints for 2-3 days.
adjuvant only, forgot  powder portion; only adyuvant administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2022, the patient received Shingrix. On 2nd September 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-SEP-2022 Reporter's Comment: The reporter reported that, a patient was given only adjuvant of Shingrix and forgot the powder portion. The vaccine administration facility was the same as primary reporter. No other details were available. The reporter did not consent to follow-up. Additional Supportive Information: The patient received only adjuvant of Shingrix and forgot the powder portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
feel ache and achy, during the day like all my world, I felt like I have been  hit with, from my head to toe; Lymph node underneath my armpit going into my breast is swollen and enlarged; Bad headache; I have a rash; I have a knot where the shot was; my arm that I have the shot is really being aching; I was really Fluish/still felt very Fluish; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 52-year-old patient of an unspecified gender received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0191) via an unspecified route of administration, administered in arm on 07Jun2021 (at the age of 52-year-old) at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Reporter stated, Yes. What I need today, I called the number yesterday. I had my first shot of the Pfizer vaccine on Monday afternoon. Tuesday, well Monday evening, I was kind of feel ache and achy but right Tuesday, during the day like all my world, I felt like I have been hit with, from my head to toe and yesterday morning, All into the evening my arm that I have the shot is really being aching and I have a knot where the shot was and then I have a rash up above it and then the lymph node under meet my armpit going into my breast is swollen and enlarged. Needless to say, I am a pretty miserable person right now and have bad headache also. Reporter stated, Yes, I was still feeling that Tuesday also, I was really Fluish, then yesterday not as that but still felt very Fluish and then that's when the rash started and then then lymph nodes under my arm into my breast started swelling. Age: Reporter stated, Okay. When I started feeling it, was have been Monday evening. It could have been 8 I Believe. Start date: Consumer stated, I started showing that on Monday June 8. UPC and NDC: Reporter stated, I do not have it. It is the LOT number they gave me and the date. I had it. First shot: Monday, 07Jun2021 and then I have to return on 28Jun2021 also. Condition of event: Reporter stated, they had improved a little, not much. Treatment: Reporter stated, I have just been taking Tylenol. Outcome of the events was resolving.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Patient was given the vaccination and then waited seated for 15 minutes.   At 15 minutes patient started to stand and then fainted. Patient was breathing and had a pulse. Patient  was placed on back and feet elevated and 991 was called. Patient was coming too as paramedics arrived.  paramedics checked vitals.  Eventually patient was able to walk out on her own and did not want to go to hospital.
Pain, redness, warmth upper arm - responded promptly to course of cephalexin.
about a year ago a young female patient fainted after receiving a GARDASIL 9 shot; This spontaneous report was received from a pharmacist referring to a young female patient of unknown age. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was unknown.  In approximately 2018 (reported as about a year ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. In approximately 2018 (reported as about a year ago), the patient fainted after receiving a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) shot. The patient was not hospitalized. It was unknown if the patient sought medical attention, performed any lab diagnostics/studies or given any treatment. The pharmacist reported that the patient was fine at time of the report. The dechallenge was reported as yes. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, faint was determined to be medically significant.
This spontaneous report was received from a registered nurse and refers to a 4 month old female patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 26-OCT-2018, the patient was vaccinated with improperly stored doses of LIQUID PEDVAXHIB first dose, intramuscular in the left vastus lateralis lot number R004964. Other suspect therapies included PEDIARIX first dose, intramuscularly, in the left vastus lateralis, lot number 9A2KC, PREVNAR 13 first dose, intramuscularly, in the right vastus lateralis, lot number W11304 and ROTARIX first dose, orally, lot number 557R9 all of them for prophylaxis (expiration date was not provided). No adverse events reactions thus no treatment was prescribed. Data logger was involved. The vaccine was exposed to a temperature excursion in the refrigerator below 2°C. The reporter stated that the refrigerator had been checked and the temperature was stable. The reporter spoke with a company representative and the vaccine was considered viable as it was not exposed for a too long period that affect the vaccine adversely. This is one of several reports received from the same reporter.  Sender's Comments: US-009507513-1901USA011370: US-009507513-1902USA002412: US-009507513-1902USA002413.
This initial spontaneous case, was received on 02-Nov-2017, from a consumer, concerning a 31-year-old adult female pregnant patient. The patient had no relevant medical history and the concomitant mediations included prenatal vitamins. It was reported that the patient had not used any contraceptives and her husband was not on any medication prior to the conception. The last menstrual period was reported as 06-Sep-2017. On 02-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). It was reported that the patient was vaccinated at 8 weeks and 1 day of pregnancy (first pregnancy) and developed mild soreness at the site. There was no adverse event reported for the foetus. The estimated date of delivery was reported as 13-Jun-2018. The reporter assessed the events as non-serious.
This spontaneous report was received from a healthcare professional concerning a patient of unknown gender and age. The patient pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot # L040415, expiration date: 13-APR-2017) (route not provided). No adverse effects were provided. This is one of two reports received from the same source. Additional information has been requested.
About two weeks after getting my first Moderna Covid-19 vaccine, I broke out in a mild case of shingles on my back.  I have had all 3 shingles vaccines - the original one I received at age 55 and then  two doses of the Shingrix .  I perhaps had 3 blisters but I am left with some post herpetic neuralgia.
October 27 pain in leg noticed in afternoon October 28 pain worse -- went to ER at 2:00 AM  - leg swollen, pain
This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness/slight warmness in arm size of a half dollar) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concurrent medical conditions included Glaucoma and Blood pressure high. Concomitant products included HYDROCHLOROTHIAZIDE for Blood pressure high, ATORVASTATIN for Cholesterol, DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT) and BIMATOPROST (LUMIGAN) for Glaucoma. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  the patient experienced TENDERNESS (Tenderness/slight warmness in arm size of a half dollar). TENDERNESS (Tenderness/slight warmness in arm size of a half dollar) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. This case was linked to MOD-2021-254179. Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up document was received. Patient's demographics, medical history, concomitant medication, adverse event outcome were updated. It contains significant information.