chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HOSPITALIZATION; This spontaneous report received from a consumer (cousin) via a company representative concerned a patient of unspecified age and sex. 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) frequency 1 total, dose, start therapy date were not reported 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.  Consumer reported that ,on an unspecified date, the patient got the J&J vaccine and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalization was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210500098-covid-19 vaccine ad26.cov2.s-Hospitalisation. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
pt reported lightheadedness and dizziness after receiving 1st dose of pfizer vaccine. pt helped to floor and reported feeling better, pt placed in Trendelenburg position on litter, VSS, pt rested and was released with no further symptoms after 30 minutes
This case was reported by a physician and described the occurrence of not responding to therapy in an approximately 53-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  There were no concurrent medications.  The subject's previous medical history included receiving a series of three doses (1st, 2nd, and 3rd doses) of Engerix-B on unspecified dates and not responding to therapy.  See related case id A0656984A.  On unspecified dates, about one year after receiving the first three dose series of Engerix B, the subject received an additional series of three doses (4th, 5th, and 6th doses) of Engerix-B (20 mcg, unknown).  At an unspecified time after vaccination with 4th, 5th, and 6th doses of Engerix B, the subject experienced not responding to therapy again.  At the time of reporting the event was unresolved.
65yr old) had pain in his whole body after Pfizer Covid19 vaccine 2nd dose, his muscles shut down, he couldn't move, they put him in hospital; 65yr old) had pain in his whole body after Pfizer Covid19 vaccine 2nd dose, his muscles shut down, he couldn't move, they put him in hospital; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 65 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, Primary Immunization completed, Dose 1), for COVID-19 immunization. The following information was reported: MUSCLE DISORDER (hospitalization), PAIN (hospitalization) all with onset 25Mar2021, outcome "not recovered" and all described as "65yr old) had pain in his whole body after Pfizer Covid19 vaccine 2nd dose, his muscles shut down, he couldn't move, they put him in hospital".   Clinical course: Given dose at 10:30 that should have been discarded at 04:30.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 52-year-old male patient who received FLULAVAL QUADRIVALENT (batch number AE735, expiry date May 2017). On 8th September 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 8th September 2016, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site warmth and injection site erythema were recovering/resolving. The reporter considered the injection site warmth and injection site erythema to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The patient received the vaccine on left arm. On 10th September 2016, the patient informed pharmacist about an injection site reaction. One inch below the site of injection, the patient had redness radiating to the underside of the arm all the way to the elbow, and arm hot to the touch. The reporter referred the patient to healthcare provider, the pharmacy declined reporters offer to email the PI.
Edema, erythema + warmth to left anterior thigh.  Hydroxyzine syrup 10 mg/tsp 1tsp three times a day PRN.
Patient past out after flu and Tdap vaccination happened 1 min. after vaccination after past out we went to pt and grab him. Few seconds later he said he is fine now. About to call 911. He refuse to call 911. Waited 1/2 hr at pharmacy ask his roommate to take him.
At 11:15 vaccinated, fell asleep and when he woke up 2 hours later, I discovered that both legs were covered in hives which rapidly became one giant hive covering each leg. Instructed by physician to give benadryl every 4-6 hours until symptoms disappeared. Hives were mostly gone by 4 PM. Continued Benadryl through noon the next day, hives reappeared at 5 Pm (01/07/05), receded after Benadryl given and continued until 1/8/05.
Had vaccine 11/11/15. Soreness 11/12. 11/15, felt achy all over. 11/16, arm swelling, diarrhea. 11/17, weak and still achy. Pt starting to feel better.
Intussusception-surgery, hospitalization 6 days after vaccines patient with abd pain, emesis.
Sept 20 my facial muscles started to twitch and I had consistent migraines with lasting over 8 hours. Icing or taking medication only reduced the severity of migraine but it did not go away.
Information has been received from a female concerning her 13 year old granddaughter with no pertinent medical history and no history of drug reactions or allergies who on unspecified dates was vaccinated with the complete series of GARDASIL.  There was no concomitant medication.  Subsequently, in April 2008, the patient experienced severe pain on the bottom of her stomach on both sides and she was having blood clots.  Because of these symptoms, the patient was hospitalized for 4 days.  The patient also developed cyst.  Ultrasound was performed (results not reported).  As of 16-JUL-2008, the patient was at home but still complaining about severe pain in the lower part of her stomach and still has blood clots.  This is one of three reports from the same source.  (WAES: 0807USA03551 and 0807USA03552).  Additional information has been requested. 8/21/08-ER records for DOS 4/2-4/4/08-presented with C/O abdominal pain and cramping. Menses began 3-4 days prior. Pale diaphoretic.  Impression:abdominal pain, syncope. Temperature elevated. Urine culture E. coli. Seen in OB/GYN office 4/8/08-C/O continuous bleeding and abdominal pain. Follicular cyst of ovary. 6/4/08-continues to have heavy bleeding with cramps.Prescribed Ortho Nuvum 1/35. Seen on 7/15/08-last period without problems no longer taking birth control pills. Office did not administer Gadasil to client.
No adverse event; Patient has received 2 primary and 3 booster doses by intramuscular injection to the deltoid; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has received 2 primary and 3 booster doses by intramuscular injection to the deltoid) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22-2A, 042J21A, 061E21A, 012L20A and 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has received 2 primary and 3 booster doses by intramuscular injection to the deltoid). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has received 2 primary and 3 booster doses by intramuscular injection to the deltoid) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has received 2 primary and 3 booster doses by intramuscular injection to the deltoid). Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a physician (Rheumatologist) via other company (Pfizer). This case involves an unknown age and gender patient who experienced allergy to immunisation with vaccine INFLUENZA VACCINE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to immunisation with influenza vaccine (allergy to vaccine) with unknown latency. Lab data was not provided. Final diagnosis was allergy to immunisation with influenza vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to immunisation with influenza vaccine. List of documents held by sender- none.
I received the Pneumo vax on Wednesday, November 5, 2003 at 11 AM and by 2 PM, experienced a feeling of exhaustion. Symptoms are typical of what once was called the 'grip', i.e., Fever (102D Fahrenheit), shaking chills, exhaustion, arthralgias, nausea, with loss of appitite. I slept all day Thursday. I also have a very red, inflammed, tennis ball size swelling at the vaccination site on my left deltoid, with swelling and tenderness extending to my left axila.
Patient reported fever of 102.6 F on 8/17. Patient reports that she fell due to ataxia on 8/16, 8/17, 8/24 and 8/26. States that she started falling more after the vaccination on 8/16. Patient states that she almost falls every day since the Shingrix vaccine on 8/16/22.  Patient has not sought medical treatment for these falls. Reports skinned knees, elbows and shoulder. Today fell and states that she hurts all over.
had an allergy to the yellow fever vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "had an allergy to the yellow fever vaccine". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.  Additional information: Patient calling for Prevnar 20 and the patient said he had an allergy to the yellow fever vaccine. He wanted to know more about this or ask for more information.
Patient was given both vaccines and told to wait in waiting room.  The patient felt dizzy and light headed, and may have slightly passed out. The patient told the pharmacist she had skipped breakfast and may have low blood sugar.  The pharmacist gave her a bottle of water and a glucose tablet.
Patient had swelling and redness from elbow to shoulder. Patient also stated site is warm to touch.
At 6pm the evening of my 2nd dose I started feeling nausea. Within an hour later I had a slight fever of 99.8 degrees and had terrible headaches like I suffered when I had the Covid back in 12/04/2020. My symptoms from the 2nd shot lasted until Sunday. June 27th, 2021 up till 6:30 pm
vomiting, headache, chills, body aches, low back pain that feels like menstrual cramps, weakness
A small allergic reaction at the injection site; Itches a lot at the injection site; A little red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (A small allergic reaction at the injection site), VACCINATION SITE PRURITUS (Itches a lot at the injection site) and VACCINATION SITE ERYTHEMA (A little red at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-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 SITE REACTION (A small allergic reaction at the injection site), VACCINATION SITE PRURITUS (Itches a lot at the injection site) and VACCINATION SITE ERYTHEMA (A little red at the injection site). At the time of the report, VACCINATION SITE REACTION (A small allergic reaction at the injection site), VACCINATION SITE PRURITUS (Itches a lot at the injection site) and VACCINATION SITE ERYTHEMA (A little red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  No treatment details were provided    Reporter did not allow further contact
pt recvd vax;8 days p/ dose 2 was fully jaundiced & had rt upper quadrant pain;41 days p/ dose 2 had pos ABHBC;pos HBS;1 day later, was found to have elevated liver func tests which were resolving by 15dec93;
Patient received all three vaccines and as nurse turned her back fainted and fell off exam table. Immediately came to and color returned after resting a few minutes, hit arm and head on floor.
pt recv vax 21SEP95 & devel rash on groin & stomach;22SEP MD changed Verelan to Cardizem pt awakened 23SEP w/h/a,swollen tongue,conjunctivitis,pt to ER -near syncope
Information has been received from a registered nurse concerning her 78 year old father with an allergy to AMBIEN, Parkinson's disease, and peripheral neuropathy who on 20-JAN-2007 was vaccinated with a dose of Varivax. Concomitant therapy included Carbidopa - levodopa (manufacturer unknown), an unspecified blood pressure medication, and NEURONTIN. The patient has had Parkinson's disease for seven years and a day after the vaccination, on 01-FEB-2007, he seemed off balance and confused. On 07-FEB-2007, he was falling numerous times and profoundly confused. He needed full time care and he fell on his head many times. He "cannot be left alone for a minute." He was noted to be up all night and walking and hallucinating. He went to a neurologist and was diagnosed with Lewy body disease. An MRI was performed (results not provided). At the time of the report, the patient had not recovered. A product quality complaint was not involved. The Patient's experiences were considered to be disabling by the reporter. No further information is available.
Started as axillary pain on 4/30 On 5/1, large red area appeared and lasted for 48 hours Pain worsened and spread from elbow to breast tissue, no further erythema or swelling occurred however range of motion was drastically reduced. Pain peaked on 5/3 then gradually subsided.  Today, 5/14, I still cannot fully extend my arm without pain.
I inadvertently ordered vaccine in this 14 year old. Not currently approved under 16 years for booster dose. He had been extremely tired for 3 days after adminisstration. Developed fever too 100.6 the day after administration. He has persistent grogginess and global headache, described much like he felt during his Long COVID. The second night after administration he awoke from sleep speaking gibberish per his Dad and he also had no recall to what he had just said.
Extreme Chills and un-controllable sever body shaking for approx. 30 minute period.
Initial case was received on 30 September 2010 from a healthcare professional. A 66 year old female patient received on 29 September 2010 at 11:00 a.m., a left deltoid intramuscular injection of FLUZONE HIGH-DOSE (lot number U3609AA). The patient had nausea in the a.m. before and at the time of the vaccination. No pre-existing medical conditions were reported and she had no known allergies. She was taking "several" concomitant medication, but the names were not provided. After the vaccination on 29 September 2010, the patient ate lunch, vomited "the lunch then foam." She experienced body aches, then a sore arm and palpitations, which "kept her up until 1 a.m." It was unknown if the patient recovered. Documents held by sender: None.
Approximately 38 hours after my second does of the Pzifer COVID-19 vaccine, I started having menstrual bleeding. However the reason this is odd for me was the first day of my last period was on 4/1/21, nine days prior to my 2nd COVID vaccine. As a 39 year old whose had periods since I was 14, I've NEVER had this happen. I have had irregular periods in the past, but it's always been late, never back to back like this was. It seems odd to me that a vaccine would have this effect, but I wanted to report it because it was very bizarre for me and the only thing that was different was the vaccine.
Hives- stared out as a rash around the bottom of my back. I was covered everywhere on my body except for my face
Pt had redness, swelling and warmth at site starting Sun 9/8. Given Ancef 1gm.
The most painful shots ever, but worth it.; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date, refer case US2021AMR073665).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient reported that her shingles shot was painful but was worth it. No other information was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073665:same reporter, 1st dose US-GLAXOSMITHKLINE-US2021AMR073665:same reporter, 2nd dose
pt stated 2/22/2021 she woke up with a red itchy rash on the left arm.  On 2/23/2021 pt had rash on both arms and upper chest.  It has spread to neck, behind her ears and onto her shoulders.  On 2/24/2021 it spread to her left thigh.  Pt was putting Sarna cream on the rash.  Pt called her Dermatologist.  Since they told her they could not see her until 2/26/2021 and told her to go to he ER.  Pt ended up going to the hospital.  She was treated w/medicine and discharged w/ a prescription for prednisone, Epi pen and also told to take Zyrtec.  They told her not to use the Sarna cream any longer. She is going to FU w/ her PCP on 2/26/2021.
headache - began around 11:30am on 4/29/21 and was maintained until about 7pm on 4/30/21; fever - began around 12am on 4/30/21 and continued until about 4pm on 4/30/21; body aches - began around 12am on 4/30/21 and continued until about 7pm on 4/30/21
Tendonitis and shoulder weakness.  Pain persisted after initial muscle soreness faded 2-3 days after the vaccine was administered.  It has been constant for the last 6 weeks and has at times affected my sleep and has caused me to significantly reduce weight lifting exercises that I have been doing for more than 10 years.  It has also reduced my ability to do manual work & projects around the house and slowing the work that i still perform.  I have started physical therapy at home using shoulder stretches and exercises.  It is not clear to me if the minor improvement is because of the therapy or because my normal activity/exercise level has been significantly reduced due to the shoulder pain.
4 patients were administered with this expired vaccine/ we have administered a vaccine beyond the expiration date by 24 hours what is the recommendation; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered with this expired vaccine/ we have administered a vaccine beyond the expiration date by 24 hours what is the recommendation) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered with this expired vaccine/ we have administered a vaccine beyond the expiration date by 24 hours what is the recommendation). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients were administered with this expired vaccine/ we have administered a vaccine beyond the expiration date by 24 hours what is the recommendation) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.