chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist in on 18 June 2015. A 30-year-old female patient whose medical history was reported as none and concomitant medications were not reported had received a dose of ADACEL (batch number U5213BA, expiry date 2 December 2015) via intramuscular route in right deltoid on 30 May 2015. On an unknown date, after vaccination, the patient experienced soreness in her right deltoid. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was recovering. Documents held by sender: none. Follow up information received from a pharmacist on 3 August 2015. It was reported that, patient had unnoticeable soreness on an unspecified date. On 26 June 2015 patient had an appointment with her regular family physician (FP) at that time some muscle firmness was noted. Patient was advised to use hot and cold packs with weight lifting exercises. It was reported that, approximately ten days after appointment event soreness was resolved down from a "six". On an unspecified date, patient had recovered from above reported events. Documents held by sender: none.
I'm freezing and all kinds of things on a daily basis; pain; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265 and Expiration date: unknown), via an unknown route of administration, in left arm on 03Feb2021 (at the age of 77-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension, internal bleeding and take special medications to keep her CBC where it needed, thyroid cancer, cancer, cholesterol, rheumatoid and osteoarthritis from an unknown date, she bruise all the time, depression and PTSD since her husband has committed suicide. Concomitant medications included methotrexate taken for neoplasm malignant; folic acid taken for blood cholesterol, start and stop date were not reported. Patient took chemotherapy for rheumatoid arthritis. She was feeling like she had covid all her life because she was in pain, has chills and freezing and all kinds of things on a daily basis. She bruise all the time, but did not get bruise from the vaccine. The first dose of event was very uneventful. Patient had intramuscular injection before and the pain she had was just terrible. She don't want any more pain in her life. She wanted to ask what are the risk of bleeding with the vaccine and also wish to know the information about risks and blood thinners was in the fact sheet so she could read about that before getting the shot. She goes back on 21Feb2021 for the second dose. She made it clear that, she has a autoimmune disease of rheumatoid arthritis and did not want to take a shot in the muscle. She would have an adverse in next two weeks. She does not told anything about the second dose. The man that gave her the shot said that the side effects depended on her immune system. It could be nothing. She has a headache from holding the phone. She wanted to ask if she takes a blood thiner when she got the vaccine. She does not take a blood thinner. She has a internal bleeding and has to have routine CBC's. As long as her count is at a certain point she does not have to have an operation. The patient underwent lab tests and procedures which included full blood count: unknown results on an unknown date. Outcome of events was unknown.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
PATIENT FELT HOT AND QUEEZY. VOMITED HER LUNCH. THEN VOMITED AGAIN A SMALLER ANOUNT. SHE WAS DIZZY, SWEATY, AND CONFUSED. PATIENT WAS SEATED AT A TABLE TO REST HER HEAD. SHE REPORTED A MIGRAINE. SHE CALLED HER MOTHER AND WAS DRIVEN HOME. THE LEFT ARM WAS NOT RED, SWOLLEN OR TENDER TO TOUCH.
Patient bitten by unvaccinated cat on 6/22/16. Received rabies immune globulin + vaccine series 6/27, 6/30, 7/4 and 7/11. Patient received final vaccine in series on 7/11. Presented to ED approx. 5 hrs later with rash & itching at injection site. No acute symptoms causing distress. Prescribed prednisone 30mg x 2 days, 20mg x 3 days, then 10mg daily x 3 days. Also prescribed famotidine 20mg po BID x 5 days. Patient followed up with PCP on 7/14/16. Reported improvements in rash & itching. Pt requested DC of prednisone which was okay'd by PCP with instructions to restart if symptoms returned.
BODY ACHE/ EVERYTHING HURTS; CANT SLEEP; SICK; FELT SO BAD; FEELING COLD; SHAKING CHILLS; VOMITED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 17-OCT-2021 14:00 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 18-OCT-2021, the patient experienced body ache/ everything hurts. On 18-OCT-2021, the patient experienced cant sleep. On 18-OCT-2021, the patient experienced sick. On 18-OCT-2021, the patient experienced felt so bad. On 18-OCT-2021, the patient experienced feeling cold. On 18-OCT-2021, the patient experienced shaking chills. On 18-OCT-2021, the patient experienced vomited. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cant sleep, sick, felt so bad, feeling cold, vomited, body ache/ everything hurts, and shaking chills. This report was non-serious.
Fifteen days post vax the pt developed two red puffy spots near the injection site. The areas were not oozing or painful, but were hard to the touch.
hard at the vaccination site; red lump at the vaccination site; lump at the vaccination site; red at the vaccination site; Initial information received on 24-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a female patient (age unknown) who experienced hard red lump at the vaccination site (vaccination site induration), (vaccination site inflammation), (vaccination site swelling) and (vaccination site erythema), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  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 USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious hard red lump at the vaccination site (vaccination site induration), (vaccination site inflammation), (vaccination site swelling) and (vaccination site erythema) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  (Other relevant tests included no lab data.)  Final diagnosis was vaccination site induration, vaccination site inflammation, vaccination site swelling and vaccination site erythema.   It was not reported if the patient received a corrective treatment.  The event outcome was not reported for the events.  Information on the batch number was requested.
Narrative: Pt is a 68 year old who presented to receive his COVID booster on 10/15/2021. he had no complications with this or any prior dose of the vaccine. HE presented to the ED with unrelated complications due to a nephrostomy tube. He was asymptomatic, but was found positive for COVID-19. Pt states he is doing much better and just glad his quarantine is over.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, drug reactions or allergies, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # M015290, expiry date 20-SEP-2017; lot # M022924, expiry date 24-JAN-2018; lot # reported as M03572, expiry date 11-MAR-2018; lot # M040421, expiry date 26-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 27 degrees Fahrenheit for 1 hour and 20 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent to contact physician. Sender's Comments: US-009507513-1704USA004640: US-009507513-1704USA004639: US-009507513-1704USA004638.
Pt recv vax on 2/3/99; on same day pt exp fever (102.7), diarrhea, runny nose
WRIST/HAND SORE TO TOUCH; JOINT, HIP, KNEE, ANKLE, SHOULDER  ELBOW ARE ACHY; SORE ARM; TIRED; FEVERISH; This spontaneous report received from a consumer concerned a 24 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 10-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 10-AUG-2021, the patient experienced wrist/hand sore to touch. On 10-AUG-2021, the patient experienced joint, hip, knee, ankle, shoulder elbow are achy. On 10-AUG-2021, the patient experienced sore arm. On 10-AUG-2021, the patient experienced tired. On 10-AUG-2021, the patient experienced feverish. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.9 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint, hip, knee, ankle, shoulder elbow are achy, wrist/hand sore to touch, tired, feverish, and sore arm. This report was non-serious.
Reddened and warm at site. Sore. Approximately 50 mm circumference Received 10/21/13 at 9am Patient to notify our office if she seeks medical attention.
Sore arm a few hours after getting the shot Next morning, sore arm, very sensitive skin, temperature of 99.7
Patient stated that her adverse symptoms started 6 days after she got the first vaccine, on 29 January 2021. It began as swelling, and redness at the injection site. She stated she had hives that were itchy and raised on her left arm around the site, and on 30 January 2021 the hives spread down her arm. She also noted that the lymph node in her left axilla was swollen.  On 6-7 Feb 2021 patient stated that the rash has mostly resolved, but that she started having neck pain, on the sides of her neck, near her collar bone. This pain leads to a headache, which she has been taking Ibuprofen for. The Ibuprofen only helps with the headache pain, not the neck muscle pain. She also stated that since the 6 and 7 of Feb in the evening her chest begins to feel "heavy, like something is sitting on it". Patient stated that she went to see her primary care provider at the end of January and was sent to an allergist, who did not believe it was an allergic reaction. She was not prescribed any medication.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On 12-JUL-2016, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L033543 with 30-MAY-2017 and L048854 with 31-AUG-2017), orally for prophylaxis after a reported temperature excursion on the same day. The time frame was 1.7 degrees Celsius for 2 hours. It was back in range. The vaccines previously were exposed to 1.9 degrees Celsius for 30 minutes, for a cumulative time out of range of 2 hours and 30 minutes. There were no adverse effects reported. No product quality complaint was involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004124.
No treatment has been received. Anxiety with very elevated heart rate and shortness of breath. Almost like panic attacks. Those happen regularly that didn't happen before. The really bad one (episode) happened once. But I'm still getting them at a moderate level about 2 or 3 times a week. I went to ER other than that I've ridden it out when it happens. I went to ER on May 29th. I have scheduled a mental health therapist appt.
No adverse event; Received the Bivalent Booster instead of Moderna's 1st primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received the Bivalent Booster instead of Moderna's 1st primary series dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received the Bivalent Booster instead of Moderna's 1st primary series dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received the Bivalent Booster instead of Moderna's 1st primary series dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received the Bivalent Booster instead of Moderna's 1st primary series dose).    Concomitant product use was not provided by the reporter.  The patient was not having side effects.  Treatment information was not provided.   Reporter did not allow further contact
Information has been received, for the Pregnancy Registry for GARDASIL, from a nurse practitioner concerning a 16 year old female with no pertinent medical history who on 03-JUN-2008, "while pregnant", was vaccinated with a first dose of GARDASIL. It was reported that the patient was hospitalized for delivery. On 14-SEP-2008 the patient delivered healthy, but premature twins. The babies were about 29 week gestation. It was reported that the babies were healthy, but had "typical premature problems". On 14-SEP-2008 the mother recovered. Follow-up information was received on 08-JAN-2008 via a telephone call from the N.P. in a pediatric practice where the mother was seen. On 03-JAN-2008 the mother received her first dose of GARDASIL (Lot #659180/1758U, expiration date 25-JUN-2010). The nurse was unaware if the patient received any subsequent doses of GARDASIL, there was no record of any further doses given in their office. The nurse did not have any specific information about the patient's obstetrical history, as the next time they saw the patient, she was there with the babies. The babies were born on 14-SEP-2008, both are male. There was no record of the mother's estimated conception date, but the babies were reported to have been delivered at 29 weeks gestation (delivery type was not reported). The nurse did not know if the patient's hospitalization was longer than a "typical" stay for a vaginal or C-section delivery. It was reported that baby "A" weighed 1420 grams and baby "B" weighed 1450 grams. Baby "A" spent one month in the Neonatal Intensive Care Unit and required one week on a ventilator. He had no bleeds, however was diagnosed with necrotizing enterocolitis, which resolved with a formula change. On 15-NOV-2008 baby "A" was re-admitted to the hospital for two days with pneumonia (no further details). Baby "B" was "OK" as far as the nurse knew, no ventilator and no bleeds. Upon internal review, "premature baby with 29 weeks gestation" was determined to be an other important medical event. Additional information has been requested.
Nausea, Fever 99.3, Chills Hot flashes, Sore arm in injection site 3" diameter, Post 48 hours still sore.
Typical tiny bit sore arm immediately after injection  that was relieved by Tylenol. whole body aches the next 2-3 days that also was relieved by Tylenol. All symptoms subsided by after the initial few days and I was back to normal. I am an athlete and was able to run and do my normal highly active routine after injection until 10 days later when I suddenly woke at 2:30 am unable to barely move. My whole body felt numb and super weak. I was severely dizzy and lightheaded so I went back to bed until 6:30 am and the symptoms persisted so much and scared my husband enough to stay home from work to keep an eye on me. I slept so much that day and severely lightheaded dizzy and body numbness even on 1,000mg Tylenol. I am a highly sensitive person and a red head. I waited this long to get the shot because I know myself so well and wanted to see everyone else?s reaction. My husband got the Johnson and Johnson a week after mine and he was fine. No reaction. I called the cdc immediately after my reaction, I also had an odd swollen arm at injection site that wasn?t there for 10 days that appeared out of no where and it was super tender and painful and hot and itchy. The CDC said to call my doctor who said they haven?t seen or heard of this reaction yet and I should go to the ER if needed. We don?t have health insurance and I wasn?t having troubles breathing and felt they couldn?t do anything for me so I decided to stay home and rest. I am 2 1/2 weeks out now and still dizzy and lightheaded but no swollen arm, that lasted day 10-12. I am concerned getting the second dose as I hear it way worse.
After vaccine was given, it was discovered that it was 18 days before patient was eligible for it. Management was notified of error, CDC guidelines were looked up (did not need to repeat dose) and voicemail was left for patient's father. Management spoke with facility physician and patient's father when he called back.  Dates of initial series were 12/2/21 and 1/27/22.
Light headed, fever, swelling and bruising around entire area where shot was given.  Severe soreness in entire arm.  Vertigo, nausea.
20 minutes after receiving flu shot c/o "throat closing". Given 50 mg Benadryl IM, after 10 minutes still c/o tightness, given 1:000 Epi. Transported via 911 to ER for observation and eventual discharge after several hours.
Felt sharp pain during administration. Tenderness and pain at injection site is continuous. Rates 7 on 1-10 scale. Pain 9 in the morning. Difficult to dress and apply deodorant and sleep on that side. Feels as if there is a lump at injection site. No redness/swelling or fever.
children received their first dose of the primary series with the Moderna bivalent vaccine booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (children received their first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse event) in a 10-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 WRONG PRODUCT ADMINISTERED (children received their first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (children received their first dose of the primary series with the Moderna bivalent vaccine booster) and NO ADVERSE EVENT (No adverse 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 adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (children received their first dose of the primary series with the Moderna bivalent vaccine booster).    No concomitant medication were reported.   The Pharmacist administered Moderna vaccine to a family and 3 of the children received their first dose of the primary series with the Moderna bivalent vaccine booster.       No treatment information was provided by the reporter.
My right arm about 5 inches spanning horizontal is hard, is red, and hot, has progressively gotten bigger since Saturday, its about 4 inches by 5 inches affected area
Patient stated he felt dizzy. Laid patient down on exam table. Patient stated felt better. BP 113/68. Patient sat up BP 100/67 and stated felt fine. Patient stood up BP 98/69 and patient stated felt fine. Walked patient to car and notified him to lay down if he feels dizzy again. Also if he does not feel better by laying down go to ER.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A, A0756485A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
3-4 hours, post vax, of Prevnar vaccine, the child spiked a fever to 103.5F which persisted for 3 days. She also developed a fine pinpoint red rash on her body.
Became hot, Blood pressure spike to 161/104, Cold Chills, teeth hurt, tongue tingling, Blood sugar 98, weak and tried, about 1-hour time course
Feel faint, Seen by EMS. Discharged home at 12:45. Recorded by Nurse.