chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Fever; Feel really sick / feel very poorly; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 30-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced general body pain, fever and sickness. On an unknown date, the outcome of the general body pain, fever and sickness were unknown.   It was unknown if the reporter considered the general body pain, fever and sickness to be related to Flu vaccine.  Additional details were provided as follows: The patient received flu vaccines and had body aches, fever and to feel sick afterward. The reporter stated they were all years ago, from hospitals and during Army enlistment. The reporter stated would previously receive flu vaccines and the night of and for a few days after feeling very poorly and then the symptoms would resolve. The reporter did not consent to follow up. The reporter has no other information for this case. No consent to follow up. This case linked with US2019187025, reported by same reporter.
mild pain after first shot, as soon as she got the shot, she kept exercising her arm; mild pain after first shot; This is a spontaneous report from a contactable consumer(patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736, Expiration date: Unknown), via an unspecified route of administration in left arm, high up in arm on 03May2021 around 10:30 or 11:00 (at the age of 79-year-old) as a single dose for COVID-19 immunization. Medical history included diabetes (under control, under 7), high blood pressure and knee surgery (her knees have been bad, so she is going for steroids. So many of her friends and relatives had knee surgery and it was botched so, she has continued with the shots and her knees hurt so bad), thyroid condition, blood pressure abnormal, chronic back condition from car accident, depression and she doesn't have a lot of energy. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride, manganese ascorbate (COSAMIN) taken for joint health, for her knees and it doesn't work right away, have to keep taking it. Has been taking a while and starts and stops taking it when she needs to, hydrocodone taken for chronic back condition from car accident and started quite a few years ago. Only takes a half of one, depending on the rate of pain. It was powerful stuff. Gets the prescription from the pain doctor and was monitored, sitagliptin (JANUVIA) taken for diabetes mellitus and has not been taking that long. Was on Metformin for two years. Has been taking maybe 6 months, just refilled the second time, and it was every 3 months, metoprolol taken for blood pressure abnormal and has been taking quite a while, about 10 years, maybe not that long, so 5 years, vitamins nos (MULTIVITAMINS), curcuma longa (TURMERIC), ascorbic acid (VITAMIN C), fish oil (OMEGA-3 FISH OIL) and still ongoing, cyanocobalamin (B12 ) taken for thyroid condition and sometimes, the doctor gives her a shot that has multivitamin and B12, gives her a boost. Patient takes vitamins for depression and she doesn't have a lot of energy because of her thyroid condition, she was on B12. Patient has blood work every 3 months for diabetes and have been normal. The patient did not receive any vaccine, within 4 weeks prior vaccinations and not had any vaccines in a while, at least 6 months. On 03May2021, the patient experienced mild pain after first shot, it was awful. As soon as she got the shot, she kept exercising her arm. With the first one, she just kept putting ice on it when it hurt, then it went away. Events did not result in emergency room or physician office. The outcome of the event mild pain after first shot was unknown, rest of the event was recovered on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Dosages expired on the 20Jan2022, initially stored in the refrigerator on 20Jan2022, The vial unerwent temperature excursions; Received dosages in January with the same lot number, 045L21A that expired on the 20Jan2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dosages in January with the same lot number, 045L21A that expired on the 20Jan2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dosages expired on the 20Jan2022, initially stored in the refrigerator on 20Jan2022, The vial unerwent temperature excursions) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 20-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dosages in January with the same lot number, 045L21A that expired on the 20Jan2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dosages expired on the 20Jan2022, initially stored in the refrigerator on 20Jan2022, The vial unerwent temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received dosages in January with the same lot number, 045L21A that expired on the 20Jan2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Dosages expired on the 20Jan2022, initially stored in the refrigerator on 20Jan2022, The vial unerwent temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no allergies. It was unknown if patient ever had COVID positive test or diagnosis. Patient had no Acute and Chronic illnesses at the time of vaccination. No concomitant drug was reported. The reporter stated that she received dosages in January with the same lot number, 045L21A that expired on the 20-Jan-2022 and they were put in the freezer and from 23-Feb-2022 until the 12-May-2022 they administered them to 13 patients, all booster dosages, after they expired. Date the vial was initially stored in the refrigerator: 20-Jan-2022. No treatment drug was reported.
After receiving her third booster for HPV in her left upper arm she began feeling dizzy, nauseated and c/o of a headache at 9:46 am & seen by physician.
lethargic, like a big fog hit me, loss of energy, loss of balance heavy red ichy rash developed over arms, chest, waist,   REALLY ITCHY Prescriptions taken:  Levocetirizin E5 mg --1 tablet daily;  Hydroxyzine HCL 25mg --two tablets at bedtime, 1 tab every 8 hours as needed
mom states pt had fever of 104 ax for approx 6hr on evening of 21NOV96 p/vax;inc temp cont for approx 2 days;
01/03/22: RN, CONGESTION, DIARRHEA, COUGH, KIDNEY PAIN, AND SOB.
For the first 2 vaccinations, I had headaches swollen under arm glands. Headaches lasted for about 3 days, and head cold headaches and sleepiness that lasted for about 24 hours. The third vaccination, I got it on a friday evening, about 2 hours later, I started feeling warm and tired. I woke up and felt like a truck ran me  over with bad head congestion. I just wanted to sleep. The next day I woke up with a fever of 103, and that fever eventually broke, but it took a lot of tylenol to make that happen. From friday to that tuesday, I was in pain, and like I had a cold with head congestion when I cough. Arm was heavy and hurting. Friday my arm started hurting, and was heavy. I had both underarm glands swollen. Saturday, I woke up and had a fever the whole day reaching 103 degrees. Even today, My under arm glands are still swollen and it hurts to cough, and my arm still feels heavy. I feel warm on and off .
Headache HA. Lethargic. body ache. Narrative:  HA.  Lethargic. body ache.
This literature report (initial receipt 10-Dec-2011) concerns patients who were vaccinated with 2009-2010 seasonal influenza or 2009-H1N1 inactivated or live attenuated (WAVES 2011030534) vaccines from 01-Jul-2009 through 31-Jan-2010 and reported to VAERS (Vaccine Adverse Event Reporting System). There were 48 deaths with reported cause of death category after record review of cardiac, infectious, multiple systems, neurologic, motor vehicle accident, pregnancy complication, respiratory and unknown. Results of clinical review of death, cardiovascular conditions were the most common reported cause of death (22 reports). Underlying medical conditions and risk factors for cardiovascular disease, were present among 94% (45/48) of the patients who died. In some cases the cause of death was clearly unrelated to vaccination (e.g. meningococcal sepsis, ruptured aortic aneurysm). Molecular testing did not identify vaccine strain virus in lung tissue for the three individuals tested and who received live, attenuated 2009-H1N1 vaccine. No deaths from anaphylaxis were reported. There were 8 death reports where the patient also received seasonal influenza and H1N1 vaccination on the same day. There were 99 verified reports of GBS (Guillain-barre syndrome), 24 had received seasonal influenza vaccine on the same day or within 30 days of the 2009-H1N1 vaccine (live attenuated or inactivated). The author also verified 117 reports of anaphylaxis, 15 had received seasonal influenza and H1N1 vaccine (live attenuated or inactivated) on the same day. The event outcome was not reported. The adverse event profile after 2009-H1N1 vaccine in VAERS was consistent with that of seasonal influenza vaccines.
1/19/2021 Injection given.1/25/2021 Redness and itching at injection site. Began using Benadryl cream on area 3 times a day. 1/29/2021 Shoulder cleared.
thought my heart was going to explode; can't raise my arm over my head at all; Initial information received on 20-Feb-2022 regarding an unsolicited valid Social Media non-serious case from a patient.  This case involves an adult patient of unknown demographics who thought my heart was going to explode and cannot raise my arm over my head at all while receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza vaccine (dose, form, route, strength, batch number and expiry dates: unknown) and one other booster dose all in unknown administration site for immunization. Information on batch number has been requested.  It was reported that the 2 shots didn't hurt the patient, but when the patient took the booster shot 2 myths ago still down can't raise the arm over the head at all (injection site pain) and patient thought his/her heart was going to explode (heart rate increased) (onset and latency: unknown).   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (heart rate increased and injection site pain).  At time of reporting, the outcome was Unknown for the events (heart rate increased and injection site pain).
Left arm 3 1/2 X 2 3/4 area of inflammation. Right arm quarter sized red lesion. TX: anti- inflammatory, ice, BENADRYL.
Upon injection into LEFT deltoid, vaccine leaked out of syringe at barrel. Patient got minuscule amount of vaccine if any at all. Another Shingrix same lot # was reconstituted and injected into RIGHT deltoid without incident. Second attempt into right arm was successful.
8 days after injection,  widespread area  around injection site is, red, tender, slightly edematous and itchy.  No fever noted at this time.
150 pts recvd series of 3 vax" @ different intervals w/in last 6 months or so. "Of the 150, 3 pts did not seroconvert p/ last dose.
Patient received 2nd dose of Modena at 21 days instead of 4 weeks
For 3hrs pt c/o SOB, dizzy, sharp pains in head, shaking a lot. Sx went away when taking Clonazepam and COMBIVENT
Same noc p/inject pt had joint pain, fever & frequent urination-cont intermittant joint pain; 7APR92 severe chest pain, seen by MD hospitalized dx rheumatic fever;
56 hrs. after injection starting having pain in left shoulder. Pain became so intense, could not sleep, level 8 on 1 to 10. Responds to ice, but any movement of shoulder causes acute pain.
injected 0.2 ml of  Pfizer Bivalent instead of 0.3 ml.  Patient has not had any adverse reactions or events due to this immunization.
This report has been received from a nurse, reported that VARIVAX (merck) (lot# H020587, expiration date 13-NOV-2014) and PROQUAD (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 15-AUG-2013 the patient was administered the unsupported VARIVAX (merck) (dose and route not reported). This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312ISA003317). Additional information is not expected.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with a doses of VAQTA lot # L004743, expiration date 01-JUN-2017 (dose, route of administration and anatomical location were not reported), that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 17 year old female patient with no pertinent medical history. The patient was vaccinated with her first dose of GARDASIL, lot # 658271/0558X, on 16-JUN-2009 (route, site and dose not reported). The patient was vaccinated with her second dose of GARDASIL, lot # 662404/0312Y, on 18-AUG-2009 (route, site and dose not reported). No other co-suspects were reported. There were no concomitant medications. On 14-JUL-2009 and on 28-JAN-2011, the patient experienced severe fever blisters. On 18-AUG-2009, therapy with GARDASIL was discontinued. The adverse event improved after stopping therapy. The patient was seen in the physician office. The patient was given ZOVIRAX and amoxicillin and AUGMENTIN as a treatment for the adverse event. The outcome of severe fever blister was reported as recovered/resolved. The relatedness for severe fever blister and severe fever blister was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
It was reported that a 5 month old male patient received an IPOL, a Tripedia and a Comvax vaccination on 5/22/01. Reportedly within 12 hours the patient developed a local reaction of redness and swelling at the injection site (not specified). The next day, the patient developed a generalized rash over abdomen and back. Patient was seen in physician's office. From mailed correspondence received on 6/29/01, additional patient, vaccine administrator and responsible physician information was provided. From additional correspondence received on 9/05/01 the patient's birth weight, where the patient was vaccinated at and how the vaccine was purchased information was provided. No further information is expected. This case is closed.
Miscarriage. Bleeding started June 19. Lasted 2+ weeks. Pregnancy confirmed with urine sample and blood work and ultrasound at 5weeks 5 days at ER in Hospital June 22,2021. HHG the following week confirmed loss of pregnancy.
mild arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild arm soreness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LINACLOTIDE (LINZESS) and LISINOPRIL for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild arm soreness). At the time of the report, VACCINATION SITE PAIN (mild arm soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068789 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068789:crosslinked to Dose 1
MIGRAINE; VOMITING; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. 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 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced migraine. On MAR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine and vomiting was not reported. This report was non-serious.
Covid arm: red, itchy,  hot rash.  Lightheadedness for a couple of days  Low grade fever  Headaches
Headache lasted 12 days and still have it. Blurry vision lasted 3+ days. Neck pain lasted 12 days still have it. Arm and shoulder pain lasted 10 days. Chest pain came and went for 3+ days. Blood pressure went up to 181/109 went to hospital ER in an ambulance. Nausea for 3 days. Low grade fever for 3 days. Medicine was given in ambulance. IV medication in ER and prescriptions. Nabumetone for headache, Tizanidine for neck pain/ stiffness. Ibuprofen for headache. Several follow up visits to hospital.
Sx began 01/19/2015, pt refused to nurse, bloody stool, inconsolable crying. resolved by intussusception reduction using air enema at hospital.
really hurt from injection site to wrist, and swollen; arm really hurt; Itchy around the injection site; Red 2-3 inch itchy circle around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy around the injection site), VACCINATION SITE ERYTHEMA (Red 2-3 inch itchy circle around the injection site), VACCINATION SITE PAIN (arm really hurt) and VACCINATION SITE SWELLING (really hurt from injection site to wrist, and swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE ERYTHEMA (Red 2-3 inch itchy circle around the injection site). On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm really hurt). On 12-Feb-2021, the patient experienced VACCINATION SITE SWELLING (really hurt from injection site to wrist, and swollen). The patient was treated with HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) at an unspecified dose and frequency and MENTHOL, METHYL SALICYLATE (BEN GAY) at an unspecified dose and frequency. On 26-Jan-2021, VACCINATION SITE PRURITUS (Itchy around the injection site) and VACCINATION SITE ERYTHEMA (Red 2-3 inch itchy circle around the injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (arm really hurt) and VACCINATION SITE SWELLING (really hurt from injection site to wrist, and swollen) outcome was unknown.            No Concomitant medications were provided Treatment information provided skin moisturizer   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Follow up received
improperly stored dose of GARDASIL 9 was administered; No adverse effect reported; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, current conditions, concomitant medications, drug reactions and allergies.  On 28-AUG-2019, the patient was vaccinated with a second dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot number 1614897 and expiration date on 20-SEP-2020 (dose, route of administration and anatomical injection site were not reported) for prophylaxis.  It was reported that on an unknown date, the vaccine was exposed to a temperature excursion of 48.5 Fahrenheit (F) degrees for 4 hours and 15 minutes. There were no previous temperature excursions. The call was placed because of a Digital Data logger report, because the alarm went off. No adverse effects were reported.
Initially started as feverish feeling, generalized weakness and fatigue. Went to local ED ~8 times and initially diagnosed with dehydration and hypokalemia. Came to Hospital on 7/24/21 for 2nd opinion. found to have severe orthostatic hypotension with palpitations meeting POTs criteria. seen by endocrine, neurology, cardiology and discharged after few weeks on potassium replacement and to increase hydration. Autonomic function test done in 9/2021 shows signs suggestive for POTS and autonomic dysfunction of sympathetic sudomotor fibers. Possible in small fiber or autonomic neuropathy.
Flu like symptoms. Headache, fever, chills, diarrhea, big red spot on arm. Sore arm.
He's had an adverse effect to the shot/They started on my leg's after my 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He's had an adverse effect to the shot/They started on my leg's after my 1st shot) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery (20 years ago). Concurrent medical conditions included Penicillin allergy, Drug allergy (Statins) and Allergy to chemicals (Sulfur).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (He's had an adverse effect to the shot/They started on my leg's after my 1st shot). At the time of the report, VACCINATION COMPLICATION (He's had an adverse effect to the shot/They started on my leg's after my 1st shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment details were reported.   This case was linked to MOD-2021-407399, MOD-2021-407221 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow up received contains no new information.