chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received 17 April 2008 from a consumer, who is the patient's parent. A 16-year-old male patient had received a right arm injection of MENACTRA (lot number and route of administration not provided) and a left arm injection Tetanus Diphtheria vaccine (manufacturer, lot number and route of administration not provided) on 15 April 2008 and within 24 hours after vaccination, he experienced a fever of 101 degrees Fahrenheit, diarrhea, generalized body aches, flu-like symptoms, dysuria and testicular pain. On 17 April 2008, the following day, the fever elevated to 103 degrees Fahrenheit, body aches worsened and the patient was lethargic. The patient also experienced wheezing for a few hours but no chest tightness and he did not need to use his inhaler. The patient's medical history included Asthma and seasonal allergies and they had been taking Tylenol concomitantly at the time of the vaccination for pain from cutting a wisdom tooth. According to vaccination visit records received, the patient had active medications which consisted of NASACORT, ALLEGRA, ALBUTEROL SULFATE and BENZAMYCIN (Gel). At the time of the report the patient had not recovered from the event. No further information was provided. Follow-up information was received 21 April 2008 from a consumer, who is the patient's parent. The vaccines received by the patient were confirmed to have been MENACTRA, lot number U2613AA and DECAVAC, lot number U1963DA, both manufactured by Sanofi Pasteur. According to the reporter, the patients symptoms resolved by 19 April 2008. No further information was provided. List of documents held by sender: Doctor vaccination summary. This patient experienced two other events which have been captured in cases 2008-01109 and 2008-01110.
The morning after my vaccination I awoke with bodily aches (primarily back and hip), severe headache,  neck pain (stiff and sore) fatigue, some achiness at injection site.  These were somewhat alleviated with acetaminophen but returned just as severe when medicine wore off. The second morning I still had head and neck pain and fatigue
sore; Muscle pain; Joint pain; Low grade fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Low grade fever) and CHILLS (Chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, High cholesterol, Depression, Arthritis and Enlarged prostate. Concomitant products included MELOXICAM for Arthritis, ATORVASTATIN for Cholesterol, CITALOPRAM for Depression, TAMSULOSIN for Enlarged prostate, ACETYLSALICYLIC ACID (ASPIRIN 81) for Hypertension.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Low grade fever) and CHILLS (Chills). On 16-Jan-2021, VACCINATION SITE PAIN (sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), PYREXIA (Low grade fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-099943 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Patients demographic details updated. Additional info AE outcome and recovery date updated. Concomitant medications updated and medical history updated. Patients 2nd dose details also updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
This spontaneous consumer report (initial receipt: 12-Nov-2012) with sparse information concerns a patient, who had adverse effects from the flu shot (influenza virus vaccine, manufacturer, brand name and batch number were not provided) received. The patient was admitted to hospital for medical treatment. The date of the event was 21-Oct-2012.
Headache, Fatigue, swollen, red, itchy patch the size of a baseball at the site of shot. Shot site-Hot to the touch. Called doctor. Cold compress and Silvershield (natural antibiotic).
No additional adverse events; Medical assistant reporting AE for improperly stored vaccine administered. No additional AE information reported. No PQC reported. See TE case 02244271. Names of vaccines involved: VARIVAX (U015685 11/03/2022) Temperature: 9.3F; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U015685, expiration date reported as 03-NOV-2022, but upon internal validation was established as: 18-MAY-2023, administered as prophylaxis (strength, and route of administration were not provided) (product storage error).   It was reported that the vaccine was stored at a temperature of 9.3 Fahrenheit degrees (F) for 5 minutes. There was a previous temperature excursion at 14F up to 46F (25.9F) lasting 1 hour and 20 minutes.   This is one of three reports received form the same source.; Sender's Comments:  US-009507513-2209USA004839: US-009507513-2209USA004342:
feeling dizzy, nauseous, faint, flu sx, fever, aching, sore throat, stopped up head & throat, swollen arm where shot was administered;almost had to go to ER
Patient had some swelling, slight blistering near local site of injection.  Was given 1 tab, po, 25mg of benadryl, and directed to go to the emergency room, and f/u with the employee health department on 10/12/2007.
ACUTE RESPIRATORY FAILURE 8/27/2022 ACUTE RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/30/2022 ACUTE RESPIRATORY FAILURE  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/8/2022 ACUTE RESPIRATORY FAILURE  ACUTE RESPIRATORY FAILURE 8/27/2022 BPH (BENIGN PROSTATIC HYPERPLASIA)  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/30/2022 BPH (BENIGN PROSTATIC HYPERPLASIA)  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 9/8/2022 BPH (BENIGN PROSTATIC HYPERPLASIA)
Approx 45 min p/inject of vax into rt deltoid, c/o tingling, weakness, & loss of strength in rt arm;
Starting around 11pm I felt extreme nausea, I had a fever, chills, body aches, and a migraine.  Those lasted until about 4pm the following day.  The body aches were very bad, I felt like my back was being ripped in half.  The migraine was very bad, light sensitivity,  noise sensitivity.  When I would stand up, my vision would start to go dark.  It is now the 28th, and 9:50 am.  I still feel nauseous,  my arm is still sore, and have a slight headache.  I also feel achy all over, but it is very mild now.
Shortness of breath, light headed, rapid pulse, fatigue on and off for 3 days.
This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.  No treatment information was provided.
A 0.25mL booster dose of Moderna Copvid-19 vaccine was given to a patient 24 hr 32 min post puncture.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A 0.25mL booster dose of Moderna Copvid-19 vaccine was given to a patient 24 hr 32 min post puncture.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A 0.25mL booster dose of Moderna Copvid-19 vaccine was given to a patient 24 hr 32 min post puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A 0.25mL booster dose of Moderna Copvid-19 vaccine was given to a patient 24 hr 32 min post puncture.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Booster dose was given to patient after 24 hr 32 min post puncture. No concomitant medications details were reported. No treatment medications details were reported.
patient husband had covid and thought patient also had it but was not tested, first dose of covid vaccine had a really bad reaction; patient husband had covid and thought patient also had it but was not tested, first dose of covid vaccine had a really bad reaction; Achy Arms; patient husband had covid and thought patient also had it but was not tested, first dose of covid vaccine had a really bad reaction; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), VACCINATION COMPLICATION (non-serious), outcome "unknown" and all described as "patient husband had covid and thought patient also had it but was not tested, first dose of covid vaccine had a really bad reaction"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Achy Arms". The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's causality for the event(s) of patient husband had covid and thought patient also had it but was not tested, first dose of covid vaccine had a really bad reaction and achy arms related with humira was not provided. The reporter's causality for the event(s) related with Pfizer BioNTech Covid-19 Vaccine for patient husband had covid and thought patient also had it but was not tested and first dose of covid vaccine had achy arms was not provided and for the events first dose of covid vaccine had a really bad reaction was not related.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Suspected COVID-19, Pain in extremity and Vaccination complication and the use of suspect product BNT162B2 cannot be fully excluded.
Tinnitus, ringing in the left ear started 2 to 3 months after 2nd vaccine.
I did not have an adverse event after receiving the vaccine. I began not feeling well with a fever, extreme sore throat and nasal congestion. I went to the doctor and tested negative for multiple illnesses. I was sick for two weeks. I contacted my doctor and was advised to treat it like it was cold.  I did test positive COVID-19 in May 2022.
The day of the shot - pain at site of vaccination, traveled from there to the neck, prominent headache, body aches, chills. Symptoms continued for 48 hours, with one episode of vomiting, completely emptying the stomach, overnight after 36 hours.
ECCHYMOTIC AREA LEFT DELTOID REGION AND BELOW 5 BY 3 CM PATCH OF SKIN, REDNESS WITH ILL DEFINED BORDERS, ITCH X GEL TID AND PAIN. CONTINUE TYLENOL PRN
Moderate symptoms after administration occurring between 24 hours and 48 hours post administration including fatigue and headache. 8 days post administration, numbness and tingling to right side of face developed. 11 days post administration, right flank pain and itching causing severe discomfort developed.  14 days post administration, sever right ear pain developed including vertigo and hearing loss. 19 days post administration, blistering and painful rash appeared on right flank. Following medical evaluation, etiology was determined to be herpes zoster - shingles outbreak. Blisters  also visualized in right ear canal during medical evaluation. Anti-viral therapy initiated.
Initial unsolicited report received from a physician on 13 October 2015. This case is linked with 2015SA163125 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number, route and site of administration not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date after the vaccination the patient had experienced encephalitis and was also hospitalized. Laboratory investigations and corrective treatments were not reported. The event outcome was not reported. Documents held by sender: none. Sender's Comments: Encephalitis is listed with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. Time to onset is not reported; however, alternative autoimmune or infectious etiologies, the most frequent being viral infections, were not excluded. Based on the available information, a role of the vaccine cannot be established.
Received expired third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired third dose) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 031L21a and 031L21a) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired third dose). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Reporter contact information was updated   This case was linked to MOD-2021-346406, MOD-2021-346331, MOD-2021-346347, MOD-2021-346608, MOD-2021-346268, MOD-2021-346421, MOD-2021-347067, MOD-2021-347112, MOD-2021-347368, MOD-2021-346981, MOD-2021-347368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Non-Significant follow up appended-Email ID updated
Severe fever, vomiting, lasted 3-4 days. Extremely lethargic, weird behavoirs followed. He was a totally diff baby never has been the same since these shots. Showed video footage to infant toddler program and they had seen the difference in my baby. Set him up with evals. that was the first episode we also had him get more shots in Feb of 2011 and same reactions occurred brought him to the docs and then was sent to developmental specialist. He is now diagnose with autism, and mental retardation!!!!
none. Patient received bivalent COVID vaccine instead of (grey cap) COVID vaccine dose #1.
Patient is feeling loss of sensation in bicep muscle. no tingling or pins and needles feeling. Not necessarily complete numbness but does not have the feeling in her arm like she thinks that she should. No treatment has been initiated
My son and I got the flu shot and still got the  virus; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from an consumer.  This case involves unknown age male patient who experienced flu (Influenza) while he received vaccine 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 lot number not reported via unknown route.  On an unknown date the patient experienced a non-serious flu (Influenza) following the administration of INFLUENZA VACCINE.  Other relevant tests included no lab data.  Final diagnosis was Influenza.  An unknown corrective treatment was received.  The event outcome was unknown.  There will be no information available on the batch number for this case.
pt had episode of cyanosis, grunting & became floppy; on arrival @ ER pt's color was dusky & did look better as was here a few minutes; pt was given DPH; chest-xray was obtained;
Erythematous warm circular area approx. 10 cm around injection site. Fever, angioedema and painful. Diphenhydramine 25 mg other.
I came home and I was feeling very dizzy. I have been having to watch my blood pressure very closely. I was pretty nauseated. I checked my BP and it was 88/44. It was odd because I have always been hypertensive but never hypotensive. It did that about 12-14 times in the days after. I was ranging high to low. My systolic number is more troublesome than the dystolic. I was shocked with my BP going that low. It was very unstable. I had to go to the doctor because I didn't want to take my medication with my BP being so low. We have been trying for the last week or so to take half of a tablet in the morning and half at night. It's not controlling my higher blood pressure. I took my meds and it seems to have stabilized. Today is looking really good. I just have to be very careful. My BP is still unstable. I normally have very high BP at the dentist and it was really low. It was 95/52. It did shoot back up after about half an hour. I have never had any of these issues prior to my vaccination. The drop happened within 4 hours after receiving the vaccine.
Urticaria 12 days following booster shot. Went to see an allergist today, possibly urticaria related to booster shot. Will start on prednisone and antihistamines.
Patient received a PNEUMOVAX 23 on 7/20/18. She went shopping after the injection and noticed pain in her right shoulder. After a few hours, the pain was so bad that it prevented her from making dinner. By 8pm she was having trouble breathing ? which the patient thinks was due to the pain she was having. She went to the ER. She was worked up for cardiac issues, but that came back negative. She states she was treated for an allergic reaction to the injection. The patient reports that her pain was so severe that she was unable to walk and describes pain as blinding pain. She did not have a fever and the site was not red or swollen. Her blood pressure was elevated in the ER. She said that she was unable to move her arm at all ? had no range of motion.  While in the ER she also had an ultrasound to check for a clot.
arm is sore where the shot was given; shivering; slight burning sensation in my arm; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In September 2021, unknown after receiving Shingrix, the patient experienced injection site pain, shivering and burning sensation. On an unknown date, the outcome of the injection site pain, shivering and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, shivering and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the Shingrix shot and was shivering at the time of reporting.  The patient's left upper arm was sore where the shot was given, and the patient had a slight burning sensation in the arm. The follow-up would not possible as no contact details were available.
Symptoms began 3-4 hours after flu shot. Vomiting, chills, hyperventilation. Went to Dr. in the ER, was admitted to hospital with lung infection and treated with LEVAQUIN. Doctor did not think it was related to flu shot.
Numbness, weakness, tingling, pain, and inflammation especially in the left side of my body, brain fog, light sensitivity, migraines. It began as normal symptoms like i had with previous boosters like a fever and chills/body aches. But by monday my whole left side hurt. I attributed it to my pre-existing condition (scoliosis) and tried to treat myself at home until Thursday the 22nd. Wednesday the 21st I felt confused and had a lot of brain fog and felt like I had a fever that night, with worsening numbness in the left side. The next morning I woke up and struggled to work, I had messaged my doctor wednesday night and she told me to go to urgent care. I went to the Clinic urgent Care, and the only diagnosis the physician provided for what was happening was "arthralgia" and I was told to go home and rest, even though the numbness in my left side left my hardly able to walk.   Since that time, i had to use a cane to support my left side while walking and was unable to drive or walk independently for 2 weeks. I missed over a week of running my private psychotherapy practice, which I own. I continue to have many of the symptoms I described, including nerve pain, what my chiropractor described as hypotonic in my left side muscles, light sensitivity, migraines, weakness, fatigue, rapid heart rate increase with activity, shortness of breath with increased activity, stomach problems. increased flare of my psoriasis which is being explored as psoriatic arthritis, and ongoing cognitive symptoms such as brain fog, reduced working memory, and increased difficulty in long term recall.
intermittent right throbbing headache, lasting one hour associated with nausea no vomiting. Headache recurs every 2 hours. He has a headache 5-6 days. During the headache he is warm, However, on 5-26-2021 when he woke up, he had same headache but at this time he also had pain in the right lower jaw on the right side of his neck. This is nondescript and persisted at this time
Administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after expiration date). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received expired vaccine, and the vaccines were moved from the freezer to room temperature on the day it was administered.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-407151, MOD-2021-407155 (Patient Link).