chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pulled from the ultra cold on 13July2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (pulled from the ultra cold on 13July2022) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (pulled from the ultra cold on 13July2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (pulled from the ultra cold on 13July2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (pulled from the ultra cold on 13July2022).    No concomitant drug was reported. It was reported that the vaccine was pulled from the ultra cold on 13July2022 but there was no time listed. Used by day was 11Aug2022. Based on the count, they counted July13th as day 1. Date of administration of vaccine was reported as 12Aug2022 before 11 AM. No temperature excursion was reported. No Treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-628899, US-MODERNATX, INC.-MOD-2022-628903, US-MODERNATX, INC.-MOD-2022-628906 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-628899:Infant patient 1 US-MODERNATX, INC.-MOD-2022-628903:Infant patient 2 US-MODERNATX, INC.-MOD-2022-628906:Infant patient 4
mild fever; loss of appetite; malaise; the pain was excruciating and extended to both sides of neck up into occipital area of my head and to both shoulders; the pain was excruciating and extended to both sides of neck up into occipital area of my head and to both shoulders; severe left sided ache in my neck/This worsened throughout the day; severe left sided ache in my neck/This worsened throughout the day; This is a spontaneous report from a contactable nurse reported for herself. An adult non-pregnant female patient of an unknown age received BNT162B2 (Solution for injection, Lot number: EM9810) via an unknown route of administration (second dose) on 05Feb2021 at 8.45 AM at left arm for COVID-19 immunization. Relevant medical history included bee venom allergy and clostridium difficile (treated with Vancomycin 125 every 6 hours). Historical vaccine included (first dose) BNT162B2 with lot number EL3249 on 15Jan2021 at 9.45 AM at left arm. The concomitant medication included vancomycin from an unknown date at 125 mg, every 6 hours for Clostridium Difficile. Within 2 hours of vaccine administration at 10.15 AM, patient started to experience severe left sided ache in her neck. This worsened throughout the day 05Feb2021. On 06Feb2021, the pain was excruciating and extended to both sides of neck up into occipital area of my head and to both shoulders. I could not turn my head in a full range of motion. Today on 08Feb2021, the pain is lessened, but range of motion remains limited. Additionally, patient had mild fever, loss of appetite and malaise. The patient treatments included massage, heat and ice for reported events. The outcome of all the events were recovering.
This spontaneous report as received from a healthcare worker refers to a 17 year old female patient with no pertinent medical history. The patient was allergic to ZITHROMAX, AUGMENTIN, CEFZIL and penicillin. On 31-OCT-2014 and 03-DEC-2014, the patient was vaccinated with the first and second doses of GARDASIL (lot #, dose and route not reported0, respectively. On 11-MAR-2014 the patient was vaccinated with the third dose of GARDASIL, 120 Y injection, lot # reported as K000146, expiration date 16-AUG-2016, (dose and route not reported). There was no concomitant medication. On 21-MAR-2014, the patient developed a diffuse rash on her entire body after receiving a third dose of GARDASIL. The healthcare worker also mentioned the patient developed swelling of her hands and feet, puffiness under her eyelids and puffy lips, bronchospasm and wheezing, discoloration of her feet and "serum sickness to the unknown". The healthcare worker mentioned the patient was seen in the emergency room. The patient had no previous reactions to GARDASIL before receiving her third dose and the patient was sent to an unspecified allergist. BENADRYL, DECADRON and prednisone were given for adverse event. The outcome of the event was recovered on 03-APR-2014. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-SEP-2013 the patient was vaccinated with MMR II (lot # H015829, expiration date 24-AUG-2014). The vaccines was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes. No known adverse effects. This case is linked to case 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked. Additional information has been requested.
I don't have the vaccine record, but it was her second covid vaccine. She reports that she felt lightheaded about 30 minutes after getting the vaccine. Since then she continues to feel weak, dizzy at times. She complains of bloating, which is not new since the vaccine. She has had hot feelings and temperatures of 99.4 degrees since then.
Patient is fully vaccinated. 90-year-old male patient presented secondary to being sent in by his PCP for Covid. Patient was tested positive in the office. Patient admits to having congestion, cough, shortness of breath, and fatigue.  DX: shortness of breath, chronic kidney disease, elevated troponin, CHF, COVID. Acute hypoxic respiratory failure/COVID viral pneumonia treatment with Decadron and remdesivir. NSTEMI: elevated troponins, EGK shows PVC and AFib.  Heparin drip. AKI creatinine 2.73. Hemoglobin 8.4. D dimer 1,090.  Lung scan positive for pulmonary embolism. Eliquis and Medrol. Patient discharged.
Lightheaded, dizzy, short of breath, nervousness, hyperventilation. Rested, calmed down, hydrated.
I began getting sick on 10/17/2022 and they lasted a week, I decided to do some home COVID-19 test because I was not in my hometown and tested negative for COVID-19. I got to see my doctor the following week and he tested me and I was still negative for COVID-19 but I was still experiencing chest congestion, low grade fever, exhaustion, coughing.
False positive HIV blood test; This spontaneous case was reported by a pharmacist and describes the occurrence of HIV TEST FALSE POSITIVE (False positive HIV blood test) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) and SPIRONOLACTONE for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HIV TEST FALSE POSITIVE (False positive HIV blood test). At the time of the report, HIV TEST FALSE POSITIVE (False positive HIV blood test) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Administered Tdap, Hep A, and then HPV4.  Within 5-10 seconds following the HPV4 client fainted, was unconscious for approx 15-20 seconds, woke up with ammonia inhalents.  Color pale but pulse at approx 60/min and resp from 12-14/minute.  Assisted to exam table, remained in clinic for 30 minutes under observation.  Grandmother with client--states has hx of being "woozy". Menactra given after recovery.
Initial listed reactions began an hour after receiving injection on 9/4/2021. One side affect I experienced that was not listed was an extreme hunger and strong food cravings which is very out of the ordinary for me. I have a small appetite and eat extremely healthy, avoiding most salt, all fried foods, oil, and sugar that does not come naturally from fruit and vegetables. After a few days of extreme fatigue, nausea, and body aches, I began to feel normal again. On 9/13/2021, 9 days after receiving the vaccine, I began experiencing extreme stomach pain, nausea, severe diarrhea, extreme fatigue, headaches, and nasal and chest congestion. All of these symptoms except for the diarrhea, which lasted for about 12 hours the night of 9/13,  have continued for a week. I am due for my second dose on 9/25 and I am still very ill from the first one.
Two days after injection patient developed cellulitis from shoulder to elbow. MD treated with cephalexin 500mg four times daily for 7 days.
expired Ipol was given to a male, no adverse event; Initial information was received on 08-May-2020 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 47 year old male patient who was given an expired IPV (VERO) [IPOL] (Expired product administered).  Medical history, medical treatments, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB); HEPATITIS B VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 07-May-2020, the patient received a 0.5 ml dose of suspect IPV (VERO) lot P1A371M, expiry date 27-Apr-2020 via intramuscular route in the left deltoid for prophylactic vaccination  It was a case of an actual medication error due to Expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Fever; shaking; flu-type soreness all over; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, tremor and flu-like aching. On an unknown date, the outcome of the fever, tremor and flu-like aching were recovered/resolved.   The reporter considered the fever, tremor and flu-like aching to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 58 or 59 years. About this time in last year 2018, the patient received vaccine. The reporter stated that his wife received the second shot of Shingrix around this time last year and experienced fever, shaking, and flu-type all over soreness.  These events fully resolved within 48-72 hours. The reporter gave permission to follow up.
15min p/vax pt devel papular rash (2mm) on lt arm x 20, forehead x 15, no resp distress;
After my second doze of Moderna vaccine which was in June 2021. Starting July 2021 I have been experiencing severe hives, doctor recommended taking Zyrtec which pauses for a few hours and then they appear again. I have never had any allergic reaction in my life up until now.
Swelling and itchy rash at injection site. No breathing difficulty, no SOB. Advised use of diphenhydramine and MD referral if worse.
During the first & second week I was fatigued. After a week of recieving dose 1 my arm started to hurt where I recieved the shot.  It became swollen, warm to touch, it was hard and bruised.  This lasted about a week & half and into the 3rd week my arm was left with a black & blue for another week & slight pain when touched.
Onset redness and swelling on (R) deltoid at site of DTaP vaccine (#5) about 24 hrs after vaccine. No fever/ V/D/chills/exudate/resp distress. In clinic today, pat with 3 3/4" x 2" area erythema, warm, blanching, nontender, swollen on (R) deltoid. NO purulent fluid, no exudate.
Lt. Mid. arm has 4" circular redness + swelling at injection site - with a 1.5 cm. round area in middle of redness that appears to have had a peeling effect there is warmth in area. This occurred 48 m after injection.
Information has been received from a physician concerning a female patient, with no pertinent medical history and no known drug allergies/drug reactions, who was vaccinated with the first dose of GARDASIL intramuscularly. There was no concomitant medication. The physician reported that a couple of weeks after vaccination. The patient developed "a couple of warts" on the extremity. None laboratories diagnostics studies performed. The patient was seen by the physician. The patient's outcome was not recovered. Additional information has been requested.
pt recvd vax & t 101-102 (ax);APAP did not bring down T; 12Oct94 7am pt OK
"A mother reported that her 2 month old son, post vax 1 to 2 weeks later, developed constipation and was irritable. He recovered.
Patient felt wasted', foggy, exhausted, and hungover within 2 hours.  Occipital headaches began that evening, then the next day fever, body aches, and head pain worsened.  Blurred vision has been steadily worse since the day after the injection, and breathing is aggravated, requiring more gasping for air.  Extreme fatigue has been present since the evening of the injection.  GI symptoms including nausea, lack of appetite, and diarrhea, and gurgling upset' stomach have been present since the day after the injection.  Severe trembling of the hands was observed on video, and body tremors were present in office.  Patient reports feeling unwell', exhausted, nauseous, and in pain. It won't let me continue.
Initial healthcare professional report received on 25 Mar 2010: This patient vaccinated with S-OIV FLUVIRIN (batch 10073803), IM, on 29 Oct 2009. The patient experienced being on-edge or jittery for about 4-5 days on an unspecified date. The outcome of event was not reported.
Within 5 minutes of injection, patient's shoulder was red and warm. Diphenhydramine 25 mg capsule given. In another 5 minutes pt stated she was nauseated and was "feeling like passing out". Pt developed red splotches on face and neck. RN administered epinephrine 1:1000 0.1 ml in left posterior upper arm subQ. Heart rate increased 124, then 136 BPM. Pt began shaking and developed pressure feeling in chest. Later pulse decreased to 100 and redness resolved.
first dose: pain on the side of injection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Feb2021 11:00 (Lot number: EN6200) at the age of 27 years as dose 1, single for covid-19 immunisation. Family history included: "Fibromyalgia", start date: 2020 (ongoing), notes: Diagnosed with mid year of 2020. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Feb2021, outcome "recovered" (2021), described as "first dose: pain on the side of injection".  Additional information: The Reporter was a consumer reporting unusual side effects after receiving the booster dose Adult Pfizer Covid 19 Vaccine. The caller had no side effects with the first and second dose Adult Pfizer Covid 19 Vaccine except for typical side effects. The booster dose Adult Pfizer Covid 19 Vaccine was unusual side effect. The caller did not call to report, wanted to let play out. Caller provides lot: FF2593 for Adult Pfizer Covid 19 Vaccine booster dose and describes at batch number. The Reporter had no side effects with the first and second dose Adult Pfizer Covid 19 Vaccine except for typical side effects: The caller clarifies the caller had pain on the side of injection after receiving both first and second dose Adult Pfizer Covid 19 Vaccine that lasted for a day or two for both first and second dose Adult Pfizer Covid 19 Vaccine. First dose: pain on the side of injection: Agent asks caller if pain at injection site recovered completely or with lasting effects and caller replies, the pain began 7 or 8 hours after receiving first dose and was a slow onset. First and second dose was pain on the side of injection: The pain went away after a day or two for both the first and second dose Adult Pfizer Covid 19 Vaccine.  Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6200 and ER2613 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6200 and lot ER2613, fill lot EN5332 and EP8678, and the formulated drug product lot EN5321 and lot EP8565. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/prevent ative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.
Information has been received from a health professional concerning a 7 year old male female who on 04-JAN-2000 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (lot# 631773/1033J). On 14-MAR-2006 the patient presented with 15 - 20 vesicular lesions on her trunk and face, nausea, itching and a headache. The patient was treated with over the counter acetaminophen (TYLENOL) as needed. unspecified medical attention was sought. At the time of the report, the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This information is in follow-up to report (s) previously submitted on 5/12/2006. Information has been received from a health professinal concerning a 7 year old white female with no allergies or medical conditions who on 04-JAN-2000 was vaccinated SC with a 0.5 ml first dose of VARIVAX (Merck) (631773/1033J). There was no illness at the time of vaccination. ON 14-MAR-2006 the patient presented with 15-20 vesicular lesions on her and face , nausea, itching and headache. The patient was treated with over the counter TYLENOL as needed. Unspecified medical attention was sought. At the time of the report, the patient was recovering. There was no product quality complaint involved. Follow up information received indicated that on 14-MAR-2006 the patient was seen with spots all over the body that were itchy. There were 15-20 spots on the trunk, scattered spots on the forehead and the arms and legs. There were spots in the mouth and throat that were causing her throat to be sore. She had headaches and nausea. It was noted that the patient had chicken pox. No labs were done and the patient recovered. Additional information is not expected.
Information has been received from a registered pharmacist concerning a 78-year-old with no known allergies who on 05-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On 07-NOV-2007 the patient developed a pruritic and erythemic rash on her arm.  The rash is on the same arm as the injection was administered; however, the rash is "away from the injection site".  On 08-NOV-2007 (the patient stated today) "the rash is no longer pruritic".  At the time of the report the erythemic rash on her arm was recovering.  The patient sought medical attention via a telephone call.  No diagnostic labs were performed.  A product quality complaint was not involved.  Additional information has been requested.
Menstrual cramping day or vaccine and menstrual cramping for a full week before cycle started
high fever for hr & wk p/ w/break through sz;adm to hosp for 3 days;fever persisted p/ now apparently recovered;
Injection site irritated / rush; Little bruise next to injection site; Injection site irritated / rush; Red spot around injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE IRRITATION (Injection site irritated / rush), INJECTION SITE BRUISING (Little bruise next to injection site), INJECTION SITE RASH (Injection site irritated / rush) and INJECTION SITE ERYTHEMA (Red spot around injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE IRRITATION (Injection site irritated / rush), INJECTION SITE BRUISING (Little bruise next to injection site), INJECTION SITE RASH (Injection site irritated / rush) and INJECTION SITE ERYTHEMA (Red spot around injection site). At the time of the report, INJECTION SITE IRRITATION (Injection site irritated / rush), INJECTION SITE BRUISING (Little bruise next to injection site), INJECTION SITE RASH (Injection site irritated / rush) and INJECTION SITE ERYTHEMA (Red spot around injection site) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.