chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 2-month-old female patient who experienced heart rate of 224 and temperature elevation to 104 degrees F. The patient received the first dose on 01-Nov-2006. The patient also received the first dose of Daptacel, the first dose of Rotateq, the first dose of Ipol and the first dose of Act-Hib on 01-Nov-2006. Within a few hours of receiving Prevnar on 01-Nov-2006, the patient developed a temperature elevation to 104 degrees F and a heart rate of 224. The patient was treated with Tylenol. The fever and tachycardia resolved within 24 hours. The child was taken to her cardiologist for evaluation. See related case HQWYE084208MAR07 for the report of the same events occurring to this same patient following receipt of the second dose of Prevnar. No additional information was available at the time of this report.
3/19 pt right upper arm became tender, warm to touch, redness/rash, itchy, w/edema on right deltoid, also, tenderness & swelling right axillary Patient did no self interventions (med/ice pack/or /inform/call PCP)   Contacted and left message to SPHD on 3/21  3/22 - SPHD returned message - all symptoms are resolving with no continued issues
admitted to hospital 3/20 for weakness and increased WBC to 70K, started on hydrea due to concern for progression of CMML
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing); "rotator cuff surgery" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization.The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "Vaccine Booster Dose this evening"; ARTHRALGIA (non-serious) with onset 22Oct2021, outcome "recovering", described as "severe shoulder pain"; PYREXIA (non-serious) with onset 22Oct2021, outcome "recovering", described as "fever"; MALAISE (non-serious) with onset 22Oct2021, outcome "recovering", described as "malaise".Additional information: Complaints of severe shoulder pain (worse than rotator cuff surgery), fever, malaise lasting 24 hours post dose. The symptoms were significantly worse than the first or second doses of the vaccine received previously. The patient might had COVID before receiving the first vaccination series. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pt developed numbness in fingers and toes shortly after receiving Hep-A vaccine. Symptoms have persisted to this date.
pt recv vax 17JUN97 & morning of 25JUN97 mom noticed sl rash on child's neck & face;thought it was heat rash;27JUN97 mom noticed a rapid & sudden change in the rash;rash became more reddened, lumpy, & itchy if covered the child entire body
102 fever from around 11 am until around 6 pm on 02/04/21.  Headache from 10 am on 02/04/21 until morning of 02/06/21.
Red spot that turned into scab; Red spot after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SCAB (Red spot that turned into scab) and VACCINATION SITE ERYTHEMA (Red spot after vaccination) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SCAB (Red spot that turned into scab) and VACCINATION SITE ERYTHEMA (Red spot after vaccination). At the time of the report, VACCINATION SITE SCAB (Red spot that turned into scab) and VACCINATION SITE ERYTHEMA (Red spot after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication provided.  No treatment information provided.   Reporter did not allow further contact
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 patients' current conditions, concomitants therapies or medical history provided. On unknown dates, patient were administered unspecified number of improperly stored doses of GARDASIL 9, lot # M003659 expiration date 20-SEP-2017 (dose was not reported). There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion of 29 degree Fahrenheit for 1 hour on an unknown date. Data logger was involved. This is one of several reports reported by the same reporter. Additional information is not expected because there was no consent to contact physician.
I first noticed symptoms for COVID-19 on 06/14/2022. My wife tested positive that day with a PCR test. I tested negative. on 06/15/2022, I was experiencing runny nose, coughing, and diarrhea so I tested again and was positive. We were on a cruise ship at the time. We departed on 06/11. We were placed into isolation on board the vessel. Under guidance for international travel, they recommend a 10 day isolation. So we did 3 days of isolation on the ship and departed from the ship where we completed our isolation. We came out of isolation on 06/25 and returned home. While onboard the ship, we saw the ship's doctor who prescribed pseudoephedrine and Tussin DM for symptoms. My runny nose lasted roughly 2-3 days while the cough lasted a bit longer, but by the time we left the ship my symptoms were declining and they were basically gone after 2 more days in the hotel. Overall though, it just felt like a cold or a mild case of the flu.
On Monday night around 7PM I was having really bad chills and noticed that I was tired. By the 28th I was having a fever as well with a runny nose and was coughing. That led me to take a home COVID-19 test, and it was positive. Yesterday I reached out to my healthcare provider and since I am doing better, they said as long as I am continuing to get better that I should be good to go. I feel like I am about seventy percent better, I have a hoarse voice and I am easily tired while doing things but am getting better overall. I would like to note that I did get a flu shot on the same day that I got my Bivalent COVID-19 vaccine.
Left upper arm swelling, red, warm to touch, painful to move arm, nausea, fever 100 degrees after shot.
Information has been received from a nurse concerning a female patient who "within the last month" received her was vaccinated a first dose of with GARDASIL (Lot# not reported). Nurse reported that the patient stiffened up, her eyes rolled towards the back of her head and "seemed to have a seizure". The nurse stated that it was different from syncope. The patient was fine afterwards. It was unknown if the patient sought medical attention. Upon internal review, "seemed to have a seizure " was considered to be an other important medical event. Additional information has been requested.
Presented to ER at 1815 c/o shortness of breath and tightness in throat.  BP 154/97 P76 R20 T98.2  Pulse ox 100%.  Given benadryl 50mg IM with relief of symptoms.
I began with numbness on the left side of my face and neck about 15 minutes after the shot and it lasted about 6 to 7 hours. I began the expected side effects at about 10 hours after with fever, muscle aches, joint pain, fatigue, terrible headache. I thought I had to suffer through it so my body could react properly but at 22 hours post shot, I finally took 2 Aleve which helped tremendously. I felt great when I woke on Monday then Monday night began with the left side of face very mildly numb again. I'm not doing anything for it.
This case was reported by a consumer via call center representative and described the occurrence of injection site wheal in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 21st November 2018, the patient received the 1st dose of SHINGRIX. On 22nd November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site wheal, injection site warmth and injection site infection. The patient was treated with antibiotics nos and azithromycin (Z Pak). On an unknown date, the outcome of the injection site wheal, injection site warmth and injection site infection were recovered/resolved. It was unknown if the reporter considered the injection site wheal, injection site warmth and injection site infection to be related to SHINGRIX. Additional details were provided as follows: The patient woke up with a huge welt at the injection site and also hot to the touch at the injection site, the next morning of vaccination. She went to see a doctor and she got antibiotics and a zpack prescribed. The physician said that her injection site was infection. The patient clarified that the pharmacist did open a brand new needle and cleaned the site of injection before giving the vaccine. The reporter did not have additional information. The reporter gave consent to follow up. This case has been linked with case US2018225305, reported by the same reporter.
This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX Quadrivalent 2014/2015 season (batch number FS575, expiry date 30th June 2014). On 23rd October 2014, the patient received FLUARIX Quadrivalent 2014-2015 season. On an unknown date, an unknown time after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced expired vaccine used. On an unknown date, the outcome of expired vaccine used was unknown.   Additional information received: 18 patients were involved and investigation still ongoing. Caller did not have patient info. Maladministration caught on 10/23/2014.
Blood clot in right vertebral artery caused stroke to the brain.  Loss of balance and function of right side of body.
Vx given at 3 months instead of 6 months; This case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (received 1st dose 3 months prior to the vaccination).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix 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-Dec-2022 Reporter's comment: The reporter reported that if the 2nd dose of Havrix was mistakenly given at 3 months instead of 6 months. The reporter asked that they need to repeat the dose or the customer was still considered fully vaccinated. Lot and expiration date of the vaccine were unknown. Not all information was available. It was unknown if it was the adult or the pediatric formulation.  No patient information was provided.  No additional information was provided.  Reporter's demographics were unknown.  Pharmacy number was unknown. Phone number from pharmacy was unknown. Additional supportive information: The patient received the 2nd dose of Havrix earlier than the recommended interval, which led to shortening of vaccine schedule.
16 x 16 cm large local reaction 24-48 hours after DTaP/IPV.
Information was received from a nurse practioner concerning a patient, who was vaccinated with varicella virus live (Oka/Merck). Subsequently the patient developed chicken pox five days after being administered the vaccine. The status of the patient was unknown at the time of this report. it is unknown if medical attention was sought. There was no product quality complaint.
Forgot to mention in previous report on Shingrix reaction...Numbness in index finger/thumb area (3/10 scale) in arm shot administered, lasting 3 days. Still have very slight numbness in same area (barely 1/10 scale) 3 weeks later
Myalgia Difficulty concentrating and fatigue resolved in 24 hours Narrative: She called into work for one day and rested
Information has been received from a pharmacist concerning a male patient who was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. Subsequently, the patient developed a rash that extended down his arm. Unspecified medical attention was sought. Additional information has been requested.
12/25/04 stated she had hives starting on head and traveling down. By 25th some blistering. Client thought it may have been nuts or possibly hair dye or vaccine.
no additional AE details or PQC.; Inbound call from HCP stating that an expired MMR-II was administered along with expired DILUENT inadvertently to a patient. No additional AE details or PQC.; This spontaneous report was received from Pharmacist and refers to a patient of an unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an 28-APR2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of 0.5 milliliter, lot #T034389, expiration date: 08-OCT-2022, administered for prophylaxis (strength, and route of administration were not provided); along with an expired sterile diluent (MERCK STERILE DILUENT) lot #T015779, expiration date: 02-DEC-2022 as diluent (strength, route of administration were not provided). No additional adverse event was reported.
Information has been received from a registered nurse concerning a 23 week old patient who on 20-DEC-2007 and 17-MAR-2008 was vaccinated PO with the first and second doses of ROTATEQ.  No problems were reported.  There was no product quality complaint.  Additional information has been requested.
I now have shingles from getting the shingles vaccine.  Prior reactions were hives, benign rash and nausea.
This spontaneous report as received from a healthcare worker (also reported as medical assistant) refers to unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL Lot # K006124 and expiry date of 02-FEB-2017 (unknown route, strength and dose). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Following receiving her first dose of GARDASIL 9 and third dose of Hepatitis B vaccines she complained of feeling light-headed and "needing to sit down." She was then witnessed to slump to her knees. She was awake but non-responsive for 15-30 seconds. She was then alert and oriented to person, place, and time. She reports being in her usual state of health today. She admits to not eating breakfast today. She denies prior adverse vaccine reactions but reports fainting after receiving prior vaccinations on one occasion. She denies rhinoconjunctival, cutaneous, laryngeal, pulmonary, and GI symptoms. She denies a history of seizures.
joint pain, muscle pain; pain in all joints immed p/shot (next day), which then changed to joint pain that travelled to different joints & muscle pain in calves, (for months) & finally pain that settled in thumb joints, toes & feet;
pt recv vax 13AUG97 & 15AUG97 pt exp a rash, temp of 100, & a h/a;sx resolved by 21AUG97;21AUG97 pt exp gen itching & required a visit to MD:tx w/zyrtec;pruritus is currently unresolved;
Delirious; Can barely move; arm, foot, hand and toe has been ach; Sweats; body aches; hip has been achy; Nausea; Fatigue/extreme exhaustion; 102 Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of DELIRIUM (Delirious) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), MOBILITY DECREASED (Can barely move), PAIN IN EXTREMITY (arm, foot, hand and toe has been ach), HYPERHIDROSIS (Sweats), MYALGIA (body aches), ARTHRALGIA (hip has been achy), NAUSEA (Nausea), FATIGUE (Fatigue/extreme exhaustion) and PYREXIA (102 Fever). At the time of the report, DELIRIUM (Delirious), MOBILITY DECREASED (Can barely move), PAIN IN EXTREMITY (arm, foot, hand and toe has been ach), HYPERHIDROSIS (Sweats), MYALGIA (body aches), ARTHRALGIA (hip has been achy), NAUSEA (Nausea), FATIGUE (Fatigue/extreme exhaustion) and PYREXIA (102 Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The event of delirium was assessed as serious by IME list. Further information will not be received as there is no contact information.   This case was linked to MOD-2021-289827 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The event of delirium was assessed as serious by IME list. Further information will not be received as there is no contact information.
Vaccine expired 1/20/2014; looked at vial but must not have registered the date - until writing down after given.
Narrative: COVID infections following completion of COVID vaccine series 06/23/21 COVID vaccine dose #1 (J&J) 08/02/21 Pt presents to screening reporting cough and congestion; COVID POSITIVE 08/03/21 Pt states chills, cough, fatigue, headache started 07/31; reports vomiting, diarrhea, and body aches at a level of 0/10; rx given for acetaminophen, vitamin C, vitamin D, DM/guaifenesin, ondansetron, zinc 08/04/21 Pt reports productive cough, loss of taste/smell 08/05/21 Pt reports symptoms improving but still dizzy 08/10/21 Pt reports doing much better and no trouble breathing
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. The medical assistant reported on an unknown date, unknown number of patients were vaccinated with a dose of ROTATEQ (lot #, dose/frequency and route unknown) which were improperly stored. No adverse effects reported. This is one of three reports (MARRS #: 1403USA008050, 1403USA009143) received from the same source. Additional information has been requested.
5 th day after the second dose, I was awaken at midnight with severe vertigo, cold sweat, nausea and loose stools. I had no serious side effects after the first dose. Did not go to the emergency room. Today I feel better if I do not make sudden moves.
Confirmed clinical diagnosis of shingles on 10/5/21. First symptoms appeared weekend of 10/2/21.
pt recvd vax & exp flu like sx & inc tiredness; no further details were provided;
A few seconds after immunizing patient (03:57 PM) on her second dose, patient indicated chest pain. Patient requested ambulatory services. While waiting for ambulatory services, patient was observed to have shortness of breath. Patient remained seated and conscious. Patient was observed speaking to her husband. Patient indicated to ambulatory services of having chest pain, which radiated toward the left side, and down the left side towards her abdomen. Patient's husband called a short time later (a little before 05:58 PM) and stated patient is doing fine, stated that doctors indicated it was "nothing life threatening", and (tentatively) panic attack.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 18 month old. The patient demographics were updated. On 05-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
School nurse called office stating child had temp of 101.9 deg, arm discomfort, redness and warmth at inject site, raised areas on arms and chest, no SOB, no facial swelling. School activated EMS and PT was transported to a hospital. This event occurred on 3/6/03. Back to school on 3/7/03.
I tested positive for COVID-19 on 11/24/22. I had an extremely bad sore throat, body aches, fatigue, cough, congestion, low grade fever, and a runny nose. I went to urgent care and was prescribed 5 days worth of PAXLOVID. I had to stop taking atorvastatin for about a week and half because my doctor told me I could not take atorvastatin with PAXLOVID. I started to feel better after taking medication for a week and then I started to get worse again. I tested negative on 12/01/22. Then, I tested positive again on 12/8/22.
Patient Given Pfizer dose for age 12 and up. Monitored for 30 minutes with no signs and symptoms of adverse reactions.  Patient and parent education on signs and symptoms of adverse reactions. Patient and parent verbalized understanding. A follow up call placed on 3/9/2022. Patient has no signs and symptoms of adverse reactions Parent will continue to monitor.
Started vomiting at 2:30 AM and allowed sleep at 4:00 AM then 8:00 AM got loose stools then somewhat better and in evening had nausea again at bedtime relieved by PEPTO BISMOL.