chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a nurse (subsequently medically confirmed), describes the occurrence of injection site erythema (arthus reaction: very red, swelling), injection site swelling (arthus reaction: very red, swelling) and injection site discolouration (some darkness 3x3cm on injection) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 for COVID-19 immunization. No medical history reported. On Dec 28, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Dec 28, 2020, patient experienced injection site erythema (arthus reaction: very red, swelling) and injection site swelling (arthus reaction: very red, swelling). On Jan 11, 2021, patient experienced injection site discolouration (some darkness 3x3cm on injection). At the time of the report, injection site erythema (arthus reaction: very red, swelling), injection site swelling (arthus reaction: very red, swelling) and injection site discolouration (some darkness 3x3cm on injection) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. No concomitant medication provided. Treatment included Motrin.
Yes and it made me sick an put in Hospital; Initial information received on 28-Nov-2022 regarding an unsolicited valid Social Media serious case received via consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who stated yes and it made me sick an put in hospital after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for immunization. Information on  batch number and expiry date was requested.  On an unknown date the patient had an event of yes and it made me sick an put in hospital (illness) (unknown latency) following the administration of influenza vaccine.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.  Seriousness Criteria: The event caused hospitalization.; Sender's Comments: Sanofi company comment dated 01-Dec-2022: This case involves an unknown age and unknown gender patient who stated yes and it made me sick an put in hospital after receiving influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
adverse event; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for prophylaxis. On an unspecified date, the patient experienced unspecified adverse event. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) 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 EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medications were reported. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. 77 Monovalent doses administered after the BUD to patients 12 and up. It was reported that 37 doses from Lot 059H21A, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A were administered. No treatment information was provided.
A couple of weeks after getting the vaccine, I noticed ringing in my ears.  It has continued off and on since.  I went to an ENT who suggested it is a reaction to the COVID-19 vaccine, since it started shortly after my second dose, and there is no other cause that he can determine.
Painful large hard lump formed at injection site with large red area that was itchy. The area became very hot and peaked the following day. Area is still itchy, red, and painful today (11/7/2021)/
I never had a fever I felt very tired I also had a cough it felty like I had the flu. I didn't lose my appetite which lasted for about a week to 10 days. Then I started the Paxlovid. After five days I was no longer testing positive for COVID-19. The cough did last for about 4-5 weeks after I tested negative.
10/9/12 left arm slightly red, itchy and slightly painful. 10/10/12 positive fever, increased redness and warmth to (L) deltoid area, still itchy. Started on BENADRYL and cephalexin for questionable cellulitis.
I received my second Moderna shot on Sun 05/23. Immediately following the injection I noticed that it was high on my shoulder and I showed my wife where the shot was given. I also felt a swoosh sensation down his arm when it was injected. Now I am in terrible pain and can?t move my left arm. The pain started maybe an hour after and increasingly got worst. I searched this online and learned about shoulder injury related to vaccine administration (SIRVA).  It?s when the shot is delivered into the sub-deltoid bursa instead of the muscle.  I think this is what happened to him but I am not certain. I did consult with my primary care physician on Monday 05/24 and he recommended me to an orthopedic specialist.
Was seen in clinic 9/15/06 with temp follow up from ER 9/14/06. Was admitted to the hospital on 9/16/06 with temp 104.  10/12/06 Received medical records from provider which reveal patient had mild wheezing & candida rash on day of vax.  RTC 2 days later with fever, cough & congestion.  Bilateral TMs had tubes.  Treatment for symptoms advised.  On 9/19 was notified by MD that patient was hospitalized with temp 104 which MD felt was due to AE from immunizations.  Note indicates elevated WBC./ss  10/27/06 Received medical records from hospital which reveal patient had throat infection & OM approx 12 days prior to AE.  Completed 10 day course of antibiotics 2 days prior to receiving vax.  On 9/15 had left eye redness & drainage, decreased appetite & was very fussy.  Temp max 104.4.  Exam showed congested nose, clear lungs.  Admitted to hospital on 9/16-9/19/06 & started on IV antibiotics. Afebrile by next day & continued to progress well.  Final dx: fever, probable s/p immunizations.
This spontaneous report was received from a health care professional refers to 2 unspecified patients of unknown demographics. On an unknown date the patients were vaccinated with improperly stored VAQTA 25/0.5 ml (lot # K005323; expiry: 10-FEB-2017) (dose # and frequency unspecified) (incorrect product storage). No concomitant medications were reported. No adverse effects reported. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
On approximately May 20, 1999, the pt developed rash with fever of 103F.
had swelling @ site rt deltoid, itching, joint aches (started in hips);pain @ site (rt deltoid) & drowsiness;still had itching sensation 12JUL98;
Moderna COVID 19 Vaccine EUA  I have fever, chills, sweating, body aches, fatigue, head ache, nausea, and vomiting.  My vaccine was administered at about 3:20 pm. I started to have a fever at about 2:30 am.  At about 4:30 I got up to take my temperature and it was 100.2 and I began to feel nauseous. I vomited at about 4:30am. My body aches which mostly includes back and neck ache were very sore and made me extremely uncomfortable.  Then at 7:00am I vomited again and my fever was 100.6 At 1:50pm my fever was 102.6 and I vomited for a third time.  At 3:40 my fever was 103.3 and I vomited for a forth time.  At that point I knew I was dehydrated so I went to prompt care and was given zofran. I was finally able to keep Tylenol in my stomach long enough for I to help. I feel better right now with the help of the Tylenol and zofran.
Information has been received regarding a case in litigation from a lawyer, an approximately 60 year old female patient, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-FEB-2010, at age 58, the patient was administered the ZOSTAVAX by a healthcare provider. On an unknown date in 2013, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Fever, chills, headache Fever and chills ended on 3/26 at 4:00 AM Headache is continuing.  It isn?t debilitating, just constant.
Daily Headaches; This is a spontaneous report from a non-contactable nurse (patient). A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration, on left arm, on 20Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included allergy to bacteria. The patient is not pregnant. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE]), colecalciferol (VIT D3), choline, ascorbic acid, pyrroloquinoline quinone, tocopherol (PQQ), and lavandula angustifolia extract, melissa officinalis extract, origanum vulgare extract (MELATON [LAVANDULA ANGUSTIFOLIA EXTRACT;MELISSA OFFICINALIS EXTRACT;ORIGANUM VULGARE EXTRACT]). The patient had no prior Covid vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Dec2020, the patient experienced daily headaches but did not receive any treatment. The patient underwent lab tests and procedures which included nasal swab PCR test on 30Dec2020 and on 08Jan2021, both showed negative. Outcome of the event daily headaches was unknown.
SHORT TERM MEMORY AFFECTED 3 TO 5 MONTHS AFTER SHOTS. IS NORMALLY FORGETFUL, BUT INCREASED. HAD GARDASIL #2 08-24-11. GUARDIAN FEELS IT IS DUE TO GARDASIL AND HAS REFUSED #3.
Tinnitus in left ear.  Used an antihistamine for several days but did not detect any change.  Ongoing for 5 weeks now with no change or resolution.
Five minutes after vaccine pt reported feeling very dizzy and "buzzed." VSS. Pt reported improvement in symptoms within 10 minutes and was able to walk out to go home.
Patient received Fluad at the doctor's office at 11am. Around 8pm that evening the patient developed fever, chills, and severe shaking. He took Tylenol and was able to warm enough to go to sleep. At 3am he woke up and went downstairs to the couch. He woke up again around 7am and went to the bathroom,  but was very nauseous and dizzy. He sat down on a chair and began staring off into space. He was staring and unresponsive for about 30 seconds. He became coherent again and wretched biled. He then moved to the couch and started sweating profusely (as much as if he had showered). His wife called 911 and the ambulance came to take him to the hospital. The hospital gave him Zofran and IV saline. He was in the hospital all day on 11/7 and went home after symptoms subsided and the hospital did not find any positive results.
This spontaneous report was received from a nurse and refers to a 19-year-old female patient. The patient did not have pertinent medical history and drug reactions or allergies. The patient did not take any concomitant medications. On 14-DEC-2018, the patient was vaccinated with a first dose of M-M-R II subcutaneous, lot # R000552, expiration date 08-JAN-2020, albumin status rHA (recombinant Human albumin) (exact dose was not reported) for prophylaxis. On 14-DEC-2018, the patient experienced a fever, diarrhea, weakness and a rash. The outcome of a fever, diarrhea, weakness and a rash was reported as recovered on approximately 18-DEC-2018 (reported as 3-4 days after vaccination). The relatedness between the events and M-M-R II was not reported.
"45 minutes after shot, felt hot, temp 100.4. Headache, leg numbness, swelling of fingers, eye twitching, heavy chest, back ache, lack of concentration."
At a routine checkup, I got a tetanus shot. It is now almost five months later, and I still have pain in the affected shoulder. It is not as severe or acute, but it is still painful and limiting at times.
This initial spontaneous report was received from registered nurse concerning a patient of unknown age and gender. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. In approximately 2015 (reported as about a year ago), the patient was vaccinated with the first dose in the series of GARDASIL 9 injection and on 21-JUN-2016, the patient received the second dose of GARDASIL 9 injection (dose, route, lot# and expiration dates were not reported). No adverse effect was reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
Persistent severe headache, onset 01/07/2021 following second vaccine dose on 01/06/2021, ongoing as of 1/19/2021
Broke out with itchy red rash all over; joints became swollen and painful; hands and bottoms of feet hurt very much; bottoms of feet had no rash but were very itchy and irritated. Bottoms of feet almost purple, hand bright pink/red. Tingling feeling in chest on day 2. Took Benadryl but itching did not stop.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's demographics were unknown. There was no information on pertinent medical history and drug reactions or allergies. On 19-AUG-2014, the patient was vaccinated with expired dose of PNEUMOVAX23 injection N/A 10 standard package syringe of 1 (dose 0.5 ml(milliliter), Product lot # H022172, Expiry date: 16-AUG-2014) subcutaneously. No adverse effects reported. There was no product quality complaint involved. The outcome of the event was unknown. Additional information has been requested.
muscle stiffness from injection site up through shoulder and neck on left side; This is a spontaneous report from a contactable other HCP. This 44-Year-Old non-pregnant Female Other HCP (patient) reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in arm left on 23Feb2021 11.15 (at the age of 44-years) as dose 1, single for covid-19 immunization. The patient relevant medical history asthma. Patient had known allergies sunflower seeds and topical steroids. Concomitant medication(s) included progesterone taken for birth control, start and stop date were not reported taken prior two weeks and montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines prior to the COVID vaccine. The patient did not test for covid post vaccination. On an 23Feb2021 20:00, the patient experience muscle stiffness from injection site up through shoulder and neck on left side. The patient did not receive any treatment for adverse event. The outcome of the event was recovered on an unspecified date of 2021.     Follow-up attempts completed. No further information expected.
Case number PHEH2014US025020, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 50-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 OCT 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error (incorrect storage of drug).
Rt hip/upper thigh pain that started when she woke up today (08-23-13). Able to walk but has to limp. Had MMR and VARIVAX in the form of PROQUAD on 8-13-13. Did run fever after vaccines for 1-2d. The Rt hip/leg pain started the minute she woke up. Her appetite has been good and she has been sleeping good. Dx toxic synovitis.
had previous admission to hospital with NSTEMI and stent placement, was dc'd to home; back to the hospital reporting fever and altered mental state; tested positive for COVID; metabolic encephalopathy; respiratory failure secondary to COVID PNA; treated with remdesivir and Decadron; poor oral intake; pt's condition worsened and he passed away in the hospital
pt recvd vax & devel a wheal & flare @ inject site which was described as white welts in a flat red area;
Feeling of being "hot" and "not normal" wasn't really wanting a lot of attention.
Throat is hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Throat is hurting". Therapeutic measures were taken as a result of oropharyngeal pain.  Additional information: Reporter stated, reporters daughter got the Pfizer, she was 11 years old So, that's the only part that's hurting it was her throat so I gave her some Ibuprofen (Treatment)." When probed to repeat the concern: Reporter stated, "That his daughter got the Pfizer vaccine and she was complaining of her throat." When probed if have a question regarding it or want to report: Reporter stated, reporter just want to know what he can do about it.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient got Pfizer covid 19 booster shot at our pharmacy Friday 12/24/21. He came this morning & complained that he started to have pain & felt there's "a little ball" under right arm (injection site) and inflammation since last night 12/25/21. Pt took 2 of Tylenol 500mg yesterday but not helping much. I recommended patient to see MD to have it examined for more details and take Ibuprofen OTC today.
admitted to hospital on 21 Jan 21 with Acute cystitis without hematuria; Cardiovascular disease; Diarrhea; ST segment depression; Syncope, unspecified syncope type   Discharged on 26 Jan 21
received two doses within about a week; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 6-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 14th September 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: The medical professional reported that a patient inadvertently received two doses of FluLaval within about a week.  The dose was intended for another patient.  The lot number was not available. Additional supportive information: The patient received 2nd dose of FluLaval earlier than the recommended interval, which led to shortening of vaccine schedule. The reporter consented to follow-up via email.
Pfizer-BioNTech COVID-19 Vaccine.  Pregnancy- 5w2d at time of vaccination.  Started to have generalized joint pain starting about 12 hours after vaccination. Developed headache, chills, sweating and nausea throughout the next day and fever, low grade between 100.3-101. Had mild dysuria. Improved about 36 hours out from vaccine. Now almost 48 hours out, I continue to have a headache and mild joint pain but otherwise feeling better.
The patient received the monovalent Moderna COVID-19 Vaccine rather than the bivalent Moderna COVID-19 Vaccine. It was supplied by the inpatient pharmacy and administered by the nurse. No adverse outcome was observed.