chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event noted - was instructed to report as an error; pt should have received Td and IPV separately but since the dtap was considered valid the combination vaccine was administered.
Started with base of my spine being stiff than became very rigid/rapid heart beat/weakness/nausea/fever/uncontrollable shaking from inside out
generalized splotchy rash over trunk area & arms;no local rxn;21NOV94 f/u completed series w/o further incident
Started taking oral typhoid tabs on 02/05/2006 - had onset of rash on 02/07/2006 - began at antecubital space, moved down inner arms, then back of neck, chest, trunk and inlet ankles/calves.  Rash was fine, red, and itchy.  Duration approximately 3 weeks - almost fully resolved at this time.  No treatment.
Large red rash at site, approximately 6? diameter. Hot to touch. Sore and slightly itchy.  Diarrhea Nausea
Left arm (where pt received injection) warm yesterday and today red and indurated. Took benadryl this AM with no effect. ER evaluation: redness and reaction on L upper arm 8 days post COVID vaccination.  Cellulitis of left upper extremity with Vaccine reaction.  Treated with Cephalexin 500 MG  4 times daily  and discharged.
A territory representative reported that the patient received the vaccination and subsequently developed a fever which resolved within 1.5 weeks. He then developed a rash which spread over his entire body. Additional information received from the physician on 12/22/2000 indicated that the rash resolved.
Information has been received from a physician concerning a 12 year old male who on an unspecified date was vaccinated with the first dose of VARIVAX (Merck) injection. Concomitant therapy included acyclovir. Then the patient obtained the chickenpox shortly after. The patient sought unspecified medical attention. At the time of report, the patient's outcome was unknown. No further information is available.
had a sore arm that lasted 2 days; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be 86 or 87 years. The patient had a sore arm that lasted 2 days after vaccination. The reporter consented to follow up. For tolerance to 2nd dose, refer case US2020009814.
DEAD IN SLEEP; This spontaneous report received from a consumer via a company representative through media concerned a 26 year old male of unspecified race and ethnicity. 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, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis. The batch number was not reported. Per procedure no follow-up will be requested for this case. Age at time of vaccination 3 decade old. No concomitant medications were reported.  On an unspecified date, two weeks after Janssen vaccine, the patient died in his sleep. It was reported that "My 26 year old nephew dead in his sleep 2 weeks after J and J jab". On an unspecified date, the patient died from an unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221119726-Dead in sleep. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient became nauseated, and light headed. Patient was offered some apple juice and was encouraged to stay seated. After 20 minutes he still looked pale. The pharmacist called 911 and EMS arrived 15 minutes later. Patient was taken away in a stretcher.
Chronic diarrhea with mucus. Blood in stool two weeks after the injections. Red inflamed circle around injection site on right thigh two weeks after injection. Diarrhea has not improved for 2.5 months. Persistent diaper rash that will not go away with any treatment
injection was given 12 hours after punctured exp time  Vial was opened at 9:02am on 11/22/2021 and given on 11/23/2021 9am  Patient had no adverse reactions
Patient seen in clinic for travel vaccinations, patient did fine while receiving vaccinations. Patient mother had patient put on coat and as we started to leave noticed patient looked pale, I asked patient if he felt ok patient stated " I'm ok and started to walk down hall. I followed beside patient and noticed that he still did not look good, so I had patient sit down in chair and elevated feet.  Patient started to cry and I reasured patient that he was ok; placed ice pack behind patient neck, gave some orange juice, and peanut butter crackers. After sitting for fifteen minutes had patient relax feet and then stand. Patient still felt light headed, placed patient in recliner in room three. Patient stayed in recliner for another twenty minutes took patient BP 98/60. Patient stated that he felt better, had patient slowly stand and walked patient out.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease, but no treatment required right now" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tagamet, reaction(s): "Known Allergies: Tagamet". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) Negative; (20Oct2022) Negative; (22Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Anti-viral details included for COVID-19 treatment (brand: PAXLOVID), treatment start date was on 13Oct2022 and treatment stop date was on 18Oct2022. Patient tested negative on Wed 19Oct and Thursday 20Oct. Patient then tested positive on Sat 22Oct but felt ok. Patient started developing a stuffy nose and fever again on Sunday 23Oct and feel crummy.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Bleeding and quarter size bump formed immediately after injection. Swelling did not increase after 5min. Patient stated she felt fine and was instructed to keep an eye on it as well as how to recognize the signs of anaphylactic reaction. Followed up with a phone call 2 hours later and patient was feeling fine.
Achy; Injection site began to swell; Oblong shaped redness 2-2.5 inches in diameter/ Mark on the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Achy), VACCINATION SITE SWELLING (Injection site began to swell) and VACCINATION SITE ERYTHEMA (Oblong shaped redness 2-2.5 inches in diameter/ Mark on the injection site) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     The patient did not had any complex allergies nor had any flu shot last year.  Concurrent medical conditions included Immunocompromised (Put it as "legally disabled but these illnesses are not life threatening") and Disability NOS (Put it as "legally disabled but these illnesses are not life threatening").    On 29-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced PAIN (Achy), VACCINATION SITE SWELLING (Injection site began to swell) and VACCINATION SITE ERYTHEMA (Oblong shaped redness 2-2.5 inches in diameter/ Mark on the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Achy), VACCINATION SITE SWELLING (Injection site began to swell) and VACCINATION SITE ERYTHEMA (Oblong shaped redness 2-2.5 inches in diameter/ Mark on the injection site) outcome was unknown. No concomitant medications were reported.NPatient received first dose on 20-Apr-2021, second dose on 18-Jul-2021 and first booster dose on 18-Nov-2021. The patient received bivalent booster dose at around 4:30pm, EST and at around 10:30-11:00pm, patient's arm where she got the injection (left arm) began to swell and had a mark on it.  Initially, reporter described it as a "hard baseball" which was 2-3 inches in diameter but later changed the description as oblong shaped redness 2-2.5 inches in diameter. On and off cold compress on the area was placed and patient took Tylenol. Reporter asked if it was a normal reaction to the vaccine especially the patient being immunocompromised.   This case was linked to US-MODERNATX, INC.-MOD-2022-653965 (Linked Report). This case was linked to MOD-2022-654324, MOD-2022-654320 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2022: Live follow-up received contains no new information.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-653965:MOD22-025207 (Husband 's case/ Same reporter).
patient received doses more than 12 hours post-puncture and stored in room temperature; patients received doses more than 12 hours post-puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses more than 12 hours post-puncture) and PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature) in a 69-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses more than 12 hours post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received doses more than 12 hours post-puncture) and PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that the Moderna vial was set to the counter on 31-Mar-2022 at 12:10 PM. The vial was first punctured on 31-Apr-2022 at 12:25 PM. It was stored at room temperature post puncture. Total amount of time the vial was exposed to room temperature range was a little over 25 hours and 20 minutes before the first dose was administered. The vaccine was administered on 01-Apr-2022 at 1:30 PM, 2:15 PM, 2:30 PM, and 3:30 PM. The vial was stored at room temperature post puncture.  No treatment information was provided.   This case was linked to MOD-2022-532655, MOD-2022-532656 (Patient Link).
This spontaneous report was received from a physician refers to a currently 17 years old female patient with drug reactions/allergies: gluten who on 31-AUG-2012 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL and on 06-SEP-2012 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The Physician reported that the patient's mother stated her daughter was having several fainting episodes a week. However, physician stated that the fainting episodes started to occur on 05-AUG-2012, before patient was vaccinated with GARDASIL. Patient's outcome was reported as not recovered. Patient sought medical attention, her mother called the office. The relatedness between the event and GARDASIL was unknown. Additional information has been requested.
Janssen COVID-19 Vaccine EUA Received the shot at 11 am and started feeling tired with some muscle aches at 2:45 pm. I slept from 3:45 to 4:30 pm but was still tired and felt weak. I did feel hungry and made dinner over 30 minutes. However, this wore me out. I was even more tired and started getting dizzy. I almost fainted as I made my way to a chair to sit down. I couldn't eat because of slight nausea and cold chills. I was shaking for about 20 minutes. Eventually, I made it to my bed to lay down, but my legs were shaking as I walked up the stairs. At 6:00 pm, my temperature was 98.8 F. I was freezing a shivering for the next hour in bed under 3 blankets. My hands and feet felt like ice. At 8:00 pm, I had a fever of 100.2  F that lasted all night. My body ached all over, especially at the hips. I couldn't sit still and couldn't sleep until 4:00 am. I woke at 8:30 am with some milder aches and fatigue with a temperature of 97.6 F.
her armpit got swollen,it is getting worse and is radiating to her back; breast; her armpit got swollen,it is getting worse and is radiating to her back; The caller took the first vaccine on 24Apr2021 and pain started that same day on the same side she was vaccinated; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (consumer) of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), first vaccination dose via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Apr2021, the patient took first vaccine and pain started that same day on the same side she was vaccinated. After one day on 25Apr2021, her armpit got swollen and then yesterday it came to her breast and it is getting worse and is radiating to her back. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient presented with fever, Headache, swollen upper right arm, painful to the touch. After the events patient still have a "knot" in the site area. No other events. No muscular problems. Patient was not seen by a provider the day of the vaccine. Patient was seen by provider on 01/03/2018.
body aches; Swelling and pain at injection site; Swelling and pain at injection site; fever; chills; intense headache; nausea; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number and expiration date were not reported), dose 2 via an unspecified route of administration, administered in arm right on 02Feb2021 at 16:00 (26-years age at the time of vaccination) as 2nd dose, single for COVID-19 immunisation. Medical history included known penicillin allergies. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in right arm on 12Jan2021 at 16:00 for COVID-19 immunisation and experienced body aches, swelling of upper arm, muscle pain, headache, chills and slight fever. The patient had not received any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced vaccination site swelling and pain, fever, chills, body aches, intense headache, and nausea on 02Feb2021 at 23:30. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovered on an unspecified date.  Information on Lot /Batch Number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
feeling dizzy/lightheadedness; nauseous; got sick; This is a spontaneous report from a contactable consumer (patient).   A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262, Expiry date: not reported), via an unspecified route of administration on left arm on 23Feb2021 09:30 (at age of 63-years-old) as dose 2, single for covid-19 immunization at military facility. Medical history included ongoing cancer, heartburn and sick. The patient stated she had cancer and she had not been seen by her regular doctor. She saw her oncologist. Concomitant medication(s) included dexamethasone taken for sick from an unspecified start date and ongoing; omeprazole taken for heartburn from an unspecified start date and ongoing; talazoparib tosylate (TALZENNA) taken for cancer from an unspecified start date and ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL1283, Expiration Date: Not reported), via an unspecified route of administration on left arm on 02Feb2021 09:45 (at age of 63-years-old) as dose 1, single for covid-19 immunization and experienced vertigo which came on "all of a sudden" but resolved quickly. The patient had not received any other vaccine within 4 weeks. No additional vaccines administered on same date of the bnt162b2. No adverse events following prior vaccinations. Since receiving the second dose on an unspecified date in Feb2021, the patient reported dizziness, lightheadedness, and nausea. It was reported that since she got the shot she has been light headed and feeling dizzy. She does not know if it is part of the shot too. The patient got nauseous especially when she was about to eat dinner. The patient did not know if it was part of the shot too. It came out of the blue. She was sitting down and then all of a sudden it was like her head and world was tilted. It was like she was being shaken. This only lasted for like a minute. She got sick and threw up from this. Stated she is unsure if she recovered completely or recovered with lasting effects. Stated due to this event she was scared to get the second shot. She spent the rest of the day trying to take it easy. By the end of the day she was fine .This occurred about 7:30 AM. Of note, the patient was also being treated for cancer (not chemotherapy) but the patient stated that usually the pill did not bother the patient at all. The patient asked whether those symptoms be a result of vaccination, should the patient have waited longer before calling to see if symptoms would have resolved on their own. The events did not require visit to emergency room or physician office. The outcome of the events was not recovered. The outcome of got sick was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a healthcare administrator referring to a patient of unknown age and gender. On 27-JUN-2016 the patient was vaccinated with improperly stored oral ROTATEQ (lot # L048854, expiration date 31-AUG-2017, dose not reported) orally. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day 2,  Wednesday 3/24 at 5 am body aches, headaches, weighted down feeling. Day 3, weighted down feeling, Day 4, nausea, vomiting, diarrhea. Day 5,  weak and tired, Day 6, nausea vomiting, gassy, 102 temperature., Day 7 gassy, tired/rundown but feeling better.
Yellow fever vaccine given @ 0830 at 0845 pt c/o itchy arm @ site of injection site, erythemanous and warm. Given benadryl 25mg PO and ice pack. At 0850 complained of wheezing and throat tightness + upper airway wheezing. Lungs clear thorough out benadryl 50mg IM given VSS: resp rate 20, at 0853 epinephrine 0.3mg IM L arm. Remained in unit another 60 minutes. Symptoms resolved after 10" of epinephrine. Vital sign stable.
Pt has DTaP 10/31/11 at hospital. Redness next day. 11/01/11 - 8 cm x 14 cm erythema (R) deltoid. No adenopathy. T 97.8. Pt rxn seen at hospital. Rxn (R) deltoid. Seen on 11/4/11.
A month after vaccination my menstrual cycle was early by 8 days every month until November of 2021. I feel it's important to note that My menstrual cycle is a textbook every 27-28 days for the last 14 years, and I have not been on any type of hormonal contraception. I also had symptoms of aching in both shoulders that started about two weeks after my second dose. This initially lasted about two weeks. I still have aching in my shoulders intermittently that lasts a day to a few days. This occurs within a week of my menstrual cycle.
Community outreach completed at local Nursing Home. Consents signed by Nursing Home administrators/guardians for patient to receive vaccine. Health Center staff thought nursing home had record of primary dose series of covid vaccine that was not entered to show me vax. Bivalent dose given as error that now, per CDC recommendations will serve as the "1st dose" and vaccine series will be completed correctly.
Administration of improperly stored PROQUAD (20.5F); No adverse event; Information has been received from a certified medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.  On 22-SEP-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (Lot # T015598, recombinant Human albumin (rHA), expiration date on 02-NOV-2021, dosage, route and anatomical location were not provided) for prophylaxis.   The dose was stored at 20.5 Fahrenheit degrees for 1 hour and 54 minutes. Previously the dose experienced a temperature excursion from 6 to 14 Fahrenheit degrees (12.3 Fahrenheit degrees) for 23 hours. The report was because of data logger. No adverse event was reported.
pt recv vax & in the evening mom noticed pt jerking & eyes rolling back; pt devel a diffuse rash over body; t101; also noted seizing; apnea was noted lasting 15 seconds p/2 episodes of sz;
wheezing, trouble breathing, coughing, swelling of vocal cords, throat, lips, face, numbness to face, tingling face, hands. ER treatment for anaphylactic shock 11/30/09 and 12/08/09 Medical records received for DOS 11/5/09. Final DX:  Grade 1 allergic reaction, controlled, Hypokalemia 20 min s/p vaccine developed cough, dyspnea, expiratory wheeze, transient laryngitis, lower lip swelling/angioedema.  Subsequent vasovagal reaction. Diuretic induced hypokalemia. improved. d/c to home.