chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious initial spontaneous case was received on 13-Sep-2017 from a pharmacist, concerning a 58-year-old adult female patient. On 13-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, batch number: 179603P (as reported), expiry date: Apr-2018, route of administration: intramuscular and anatomical location: not reported). The administered vaccine reached 60-degree F for no longer than 24 hours instead of storing at 36-46-degree F, which was considered as incorrect product storage and drug administration error. It was reported that, power went for about 24 hours, FLUVIIRN was in the refrigerator and "they did not have a temperature that it reached". It was reported that, no adverse event was occurred after the administration of vaccine. At the time of this report, the outcome of the events was not reported. The reporter assessed the report as non-serious. Follow up received on 18-Sep-2017: It was reported that, no adverse event was occurred after the administration of vaccine. Route of administration of vaccine was updated. Batch number was confirmed by the reporter. The narrative was amended accordingly.
Patient has had severe headache since vaccine - starting day after - "worst headache of his life". Now has loss of smell, shortness of breath and nasal drainage
Patient experienced episode of severe leg cramping on 12/22/2020 that began in early AM and lasted until noon. Patient experienced another episode on 12/24/4040 of cramping that began in the legs and went up to the head that felt like muscle tension. This episode also began in the early AM and lasted until noon. However, patient did have residual minor leg cramping. Patient did follow-up with his PCP, who obtained bloodwork on patient. On 12/28/2020, patient states all symptoms have been resolved.
9/7/22 pt found minimally responsive by family; EMS brought to ED with low BP; had fallen in last few days; slightly confused; found to be positive for COVID; AKI; Atrial Fibrillation with RVR; not hypoxic on RA; Atrial Fibrillation treated with medication; dc'd to home in fair condition on 9/9/22; pt passed away at home
This case was reported by a nurse via call center representative and described the occurrence of fever in a 19-year-old female patient who received BOOSTRIX (batch number K5F5R, expiry date 3rd April 2021) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis. On 30th November 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, the patient received Flu vaccine at an unknown dose. On 30th November 2018, unknown after receiving BOOSTRIX and not applicable after receiving Flu vaccine, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced fever, injection site tenderness, headache, light headedness and product packaging confusion. On an unknown date, the outcome of the fever, injection site tenderness, headache and light headedness were recovered/resolved and the outcome of the wrong vaccine administered and product packaging confusion were unknown. It was unknown if the reporter considered the fever, injection site tenderness, headache and light headedness to be related to BOOSTRIX. Additional details were provided as follows: The nurse reports that BOOSTRIX vaccine was accidentally administered to the patient instead of a flu vaccine, which led to wrong vaccine administered. The nurse who administered the vaccine commented that the flu vaccine box and the BOOSTRIX box look the same this year, which led to product packaging confusion. Less than a week after receiving BOOSTRIX vaccine, the patient experienced a slight fever for one day, tenderness where the vaccine was administered, headache and was light headed. The nurse did not know what brand of flu vaccine their office uses.
Pt got flu vaccine Rt deltoid 10/19 numbness developed in rt arm x 9 days, got better but returned on 11/5. Forearm to fingers feels asleep. Fine motor control of thumb, index and middle fingers seems decreased. No pain at time of injection. No pain in arm.hand. Problems with counting holding utensils; No weakness.
Next day after second dose of Pfizer vaccine, she developed hives over her whole body. Lasted 1 week.
I received the shot at 8am. By noon, the injection site was very sore. By 2pm, I could not move my arm without excruciating pain from my shoulder all the way down to my left ring and pinkie fingers. I was not able to lift my arm on my own, it was as if my muscles were not recognizing the brain signals. If I lifted my left arm using my right, I could move it about an inch. Anything more than that was so painful that it brought tears to my eyes. Pain relievers did not help. It took almost 5 days to regain function of my arm, and I am still experiencing muscle pain when I try to stretch my arm or lift a heavy weight.
Got COVID four day after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID four day after getting the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID four day after getting the vaccine). At the time of the report, COVID-19 (Got COVID four day after getting the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: covid-19 positive (Positive) COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter  As per client, MI error in DOB.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26MAY2021, no new information
Patient received 1st dose of pfizer bivalent covid vaccine on  09/16/2022 and received 2nd dose 01/09/2023. Pt showed no s/s of reaction to vaccine immediately after administration. Upon finding that the 2nd dose was administered pt notified over the phone by provider and manufacturer alerted for guidance.
vaccine admin 03/22/2023 @ 8:28am on right arm, mother states she noticed patients  right arm being swollen the next day on 02/23/2023 early morning along with redness and right arm being warm to touch,
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after 4 temperature excursions. This case contains information for the 27th of 43 adult patients described by the reporter. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the worldwide unique case identification number.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:master case
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no symptoms of fever, cough, congestion, chills. The patient previously received covid-19 vaccine ad26.cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 31-MAR-2021 for covid-19 prophylaxis It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received booster on covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 03-DEC-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JAN-2022, the patient tested positive for covid-19 (Dose number in series 2). Laboratory data included: COVID-19 virus test Positive. On 01-FEB-2022,COVID-19 virus test Clear (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 test positive on 01-FEB-2022. This report was non-serious. This case, from the same reporter is linked to 20230157162.
Postive test on a Sunday; PCR positive; Postive test on a Sunday; PCR positive; exhausted; head cold; fever lifted almost miraculously; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown), on 09Feb2021 at 17:00 as dose 2, single (Batch/Lot number: unknown), in right arm and on 10Sep2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Haemochromatosis" (unspecified if ongoing); "Food allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022 at 01:00, outcome "recovered" and all described as "Postive test on a Sunday; PCR positive"; FATIGUE (non-serious) with onset 26Apr2022 at 01:00, outcome "recovered", described as "exhausted"; PYREXIA (non-serious) with onset 26Apr2022 at 01:00, outcome "recovered", described as "fever lifted almost miraculously"; NASOPHARYNGITIS (non-serious) with onset 26Apr2022 at 01:00, outcome "recovered", described as "head cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) faintest pink, notes: 4 days later Binax test faintest pink; (unspecified date) solid pink, notes: 6 days later cold symptoms coming on Binax sold pink; (06Apr2022) Positive, notes: PCR positive with 38 viral load; (07Apr2022) Negative, notes: Negative on binax. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had rebound effect. Positive test on a Sunday. Started Paxlovid Sunday night. Within 5 hours she was 50% better, by the next day 80 % better, just exhausted. head cold, fever lifted almost miraculously. 4 days later, Binax test faintest pink, 6days later cold symptoms coming on. Binax solid pink. terrible cold. On 04April still testing positive. 06Apr PCR positive with 38 viral loads. Positive on Binax, Negative on Clear Vue, on 07Apr negative on Binax. Patient was allergic to Some food.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from medical assistant refers to a patient of unknown age. On 23-JUL-2013 the patient was vaccinated with M-M-R II (lot # H010133, epx. 17-MAY-2014), 0.5 ml, subcutaneously. The vaccine was exposed to 79F for a maximum of 45 hours and was unsupported due to stability data not being available. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Patient currently admitted at (5) days inpatient admission.  H & P : 64-year-old male who presents with COVID-19 pneumonia.   64-year-old male presents after 10 days of symptoms.  Patient had a Covid test done outpatient at hospital.  Today patient was found to be 85% on room air and came in for evaluation.  Patient has had the Pfizer vaccine but no booster.  Hospitalist service was asked to admit patient for further management of his COVID-19 pneumonia.   At the time of this providers exam patient is resting quietly in ED stretcher.  Patient has had symptoms for 9-10 days. Patient has had fever, chills, dyspnea, diarrhea 3 times a day for past 3 days (non-bloody, non-tarry), patient states his mouth feels dry but improved over yesterday.  Patient currently feels better then on arrival in ED.   Patient pfizer vaccine in July, but no booster.   Patient states he had some mouth and tongue swelling at the start of his covid symptoms.  However nothing currently.  Patient took benadryl and that resolved it.  Did not have to use Epi pen.   Patient denies  chest pain, falls, syncope, abdominal pain, nausea, vomiting, constipation,  dysuria, headaches, numbness, tingling, one-sided weakness, vision changes, skin rashes, homicidal thoughts or suicidal thoughts.   ED course: Tylenol, Decadron,  Assessment and Plan: Sepsis secondary to COVID-19 pneumonia -patient on room air baseline and currently required 6 L nasal cannula -patient was febrile, tachycardic, hypoxic, and had leukocytosis. -patient has had symptoms for 10 days and is not a candidate for remdesivir -continue Decadron -supportive care with Tylenol and antitussives -obtain CMP, complete blood count, CRP, and D-dimer -pronating as able -telemetry and continuous pulse ox -given the duration of patient's symptoms will add a procalcitonin -trend blood cultures -vascular congestion noted on chest x-ray.  Patient denies any history of heart failure.  Patient states that he actually still feels slightly dehydrated.  Will hold off on Lasix tonight as patient has no crackles and mouth feels slightly dry.  Reassess need for Lasix in a.m..    Leukocytosis -patient's white blood cell count was 11.34 in the emergency department -see plan above for 1.    Hyponatremia -sodium 131 in the emergency department -encourage orally intake -trend with a.m. labs   Hypertension -hold patient's home amlodipine for tonight   History of alcohol abuse -noted.  No alcohol in over a week.   History of anaphylaxis secondary to unknown source -noted.  No recent use of epinephrine CT -continuous pulse ox and telemetry as above   DVT prophylaxis -subcu lovenox   Patient wishes to be a DNR   Addendum 11:40 p.m.:  Patient's D-dimer was elevated at 1410. Given patient's high oxygen needs and D-dimer elevation will obtain a CTA of the thorax.
Patient's arm/shoulder (where the shot was administered) became so sore that patient could not lift arm above head without severe pain.  The pain persisted for at least 2 weeks.  Patient couldn't dress without help, and couldn't sleep on that side at all.  The pain woke patient up whenever they moved at night.  Took ibuprofen to control the pain.
she had positive COVID test; she had positive COVID test; This is a spontaneous report from a contactable nurse. A 52-year-old female received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscularly in the left arm on 28Dec2020 16:00 at a single dose for covid-19 immunisation. The patient's medical history included tested positive for covid on 06Nov2020. The patient had recent physical in Dec2020,  patient did blood work. Twelve years ago (2009) she had a partial thyroidectomy and at the physical they noticed a lump. The goiter was enlarged on her neck. She doesn't know if it a result from COVID, but she has Hashimoto's disease in Dec2020. She has to have surgery to removed the goiter, but she can't because of COVID. She has looked it up and it is an autoimmune disease. She had a fine needle biopsy and it was negative and she had a full thyroid work up that was fine in the beginning of Jan2021.The patient's concomitant medications were not reported. On 14Jan2021, the patient's test came back positive for covid. It was further reported that the patient tested negative on the Friday after holiday. She has been getting tested twice weekly since that time and they had all been negative. Patient was scheduled to get her second dose of the vaccine today (18Jan2021). The outcome of the event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Copious Emesis x 4-5,  asso?d c/ watery diarrhea overnight. No hematemesis, nor blood in stool. Followed by HA, myalgia, loss of appetite the entire  next day. Chills, but I didn?t check temperature.  I suspect that if a fever were present, then it was low grade
muscles were sore; 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 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 70 years as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "muscles were sore". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4-5 urticarial lesions surrounding injection site. Tender. Prescribed hydrocortisone 2.5% ointment to be applied sparingly BID.
I started a week or two weeks after with an ear ache in my left ear and a sore throat.
Five minutes after receiving Moderna vaccine, patient became shortness of breath with chest pain(That went away), some tightness in low neck area and mild cough.
There was blood dripping down her arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "There was blood dripping down her arm.". Additional Information: The patient reported that she just received her second dose a few minutes ago. There was blood dripping down her arm. She wanted to know if the efficacy of the vaccine is going to be impacted.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This morning I gave  Moderna shot to patient. Once I finished giving the shot ask patient to wait 15 in one of the chairs. The patient came up to the window to tell one of my technician that he didn't feel well before we can go check on him he fainted and fell on floor. He lost conscious for a second by the time I got to him he was speaking with me. One of my technician was on the phone already calling 911. Made sure he didn't have any injuries, checked airway, put his feet up, applied cold compress on face, neck and wrists. Tried checking blood pressure but the paramedics arrived. The paramedics told us his blood pressure was low and didn't want him driving because he was alone in the store. They took him to the  hospital.
This spontaneous report has been received from a registered nurse, who reported that unspecified number of patients were administered RECOMBIVAX, which underwent supported excursion in December 2013. Dose and Lot information was not provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one o several reports from same reporter and case is linked to 1403USA010165, 1404USA001101,1404USA001102, 1404USA001100. Additional information has been requested.
Rash -upper left papulovesicular eruption in C6 C7, dermatome on the right.
Shortly after getting GlaxoSmithKline Fluarix Shot lot# NS755 at Pharmacy 11 year old female began complaining of itchiness beginning in her wrists. Within an hour her body was covered in red raised rash blotches on truck, neck and thighs. She was taken to urgent care where she was given a steroid and Benadryl and told to go to the ER of symptoms worsen.
After administering a dose of moderna to a patient the needle accidently stuck into the nurses thumb.
Approximately one hour post vaccine, I began to feel achy. By five hours post vaccine, my temperature was 101.2 and my entire body ached. The following morning, I had a minor headache which continued despite taking 600 mg of ibuprofen. I continued to take ibuprofen periodically over the next two weeks for a persistent low grade headache, at which point I contacted my physician. She advised me to continue taking ibuprofen and the headaches should subside. I continued to take 600 mg of ibuprofen for an additional week but the headache continued. I contacted my physician again three weeks post vaccine, and she requested that I come in to be evaluated. I received an injection of toradol in the physician?s office and a prescription for a seven day course of colchicine. The headache finally subsided the day after my appointment but returned briefly three days later for a day and then finally subsided for good.
Severe redness around where the shot was administered and swelling, redness was hot.  Muscle aches, sore throat, chills, arm pit soreness, headache. Pharmacist told me to take Benadryl.
Pt awoke to feed, was irritable, cried hard then became pale, limp & unresponsive; Brought to ER-normal exam; Admitted as poss apnea; Peds consult felt this represented a hypotonic-hyporesponsive collapse;
Parents noted red whelps to scalp shortly after immunizations.  Assessed infant by nurse and noted, skin reddened from thighs to lower legs bilateral, torso blotchy red, arms reddened and face.  Notified doctor of reaction, assessed by doctor, instructed to give Benadryl.
Monthly cycle started 4 days early, 2 days after vaccination. Have a history of irregular periods but they are usually late and have only been early one other time. Have not experienced this with any other vaccine. Have had all recommended vaccines with the exception of the HPV vaccine.  Other than coming early, the cycle was normal.