chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE.; the vaccine sprayed into his face/eye; the vaccine sprayed into his face/eye; the vaccine sprayed into his face/eye; At time of exposure, the barrel came away from the needle and a small amount of the vaccine made contact with his face and eyes.; At time of exposure, the barrel came away from the needle and a small amount of the vaccine made contact with his face and eyes.; This spontaneous report was received from an unknown aged pharmacist referring to himself. His pertinent medical history, concomitant drugs and drug allergies were not reported.    On 09-NOV-2020 at 5:45 pm, he got the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot number was R036581, expiration date was 17-DEC-2020, dose was 0.5 milliliter, strength and route was not reported) sprayed into his face and eye when the needle came off of the syringe. He confirmed the exposure to the vaccine on his face and eye did not occur while drawing up the medication from the vial. The pharmacist stated the exposure occurred at the end of administration. At time of exposure, the barrel came away from the needle and a small amount of the vaccine made contact with his face and eyes. The pharmacist went immediately to the eye flushing station and flushed his eyes. No further information provided. No other adverse events (occupational exposure to product, product leakage, product container issue, exposure via eye contact, exposure via skin contact and no adverse event). The pharmacist wanted to know if there were any precautions that needed to be taken.
Patient General Malaise  unknown cause . Onsite EMS was called vitals were taken BP 168/66 100% O2 room air HR 72. Patient refused evaluation/care , and released aginst medical advice.
fatigue; This is a spontaneous report from a non-contactable ICU nurse (patient) via a Pfizer sales representative. A 64-year-old female patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via unspecified routes of administration, on unspecified dates, at single doses, for COVID-19 immunization. The patient had no known medical history/ health issues. Concomitant medications were not reported. The patient experienced extreme fatigue lasting weeks after taking dose 1 of COVID-19 vaccine, then continued after dose 2. The patient underwent lab tests and procedures which included weight: slightly overweight. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
intense rash both arms, neck and upper torso. Treatment: steroid injection by provider, benadryl, Pepcid  Outcome: next morning symptoms gone.
covid vaccine breakthrough case  dose 1 Pfizer  4/9/21  ER8729 dose 2 Pfizer  5/1/21  ER8735
She went to the living room and fell and couldn't get up; She went to the living room and fell and couldn't get up; tiredness; She has a sore throat and fever blisters on her mouth; lost almost 18 pounds in the last week with all this stuff; severe headache; muscle pain in the back of her neck and back; She has a sore throat and fever blisters on her mouth; violent chills; sick with diarrhea; Dry heaves; This is a spontaneous report from a contactable Consumer. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported) via an unspecified route of administration to left arm on 25Jan2021 at single dose for covid-19 immunization. Medical history included Crohn's disease and Type II Diabetes. The patient experienced sick with diarrhea on Jan2021, dry heaves on Jan2021, she went to the living room and fell and couldn't get up on 27Jan2021, tiredness on Jan2021, she has a sore throat and fever blisters on her mouth on Jan2021, lost almost 18 pounds in the last week with all this stuff on Jan2021, severe headache on Jan2021, muscle pain in the back of her neck and back on Jan2021, violent chills on Jan2021. The patient underwent lab tests and procedures which included weight: lost almost 18 lbs on an unspecified date (lost almost 18 pounds in the last week with all this stuff). She received the first dose of the vaccine a week ago on Monday. For two days she was absolutely normal and fine. The night of the second day she had fallen asleep on the couch and when she woke up it was midnight. She knew immediately she was going to be sick with diarrhea. She had dry heaves. She never vomited. The dry heaves were longer than she has had in her life. The diarrhea kept going and going. She went to the living room and fell and couldn't get up. She is 80 years old (as reported). She has never had that happen before. She slept on the floor until six in the morning. When she woke up she managed to get up. She had so many of these side effects. She has tiredness, severe headache, muscle pain in the back of her neck and back, violent chills. She has never had chills so violent before. She has a sore throat and fever blisters on her mouth. There must be 9 or 10 of them. It is a never ending list. She has lost almost 18 pounds in the last week with all this stuff. The symptoms have not stopped. Outcome of the events was not recovered
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergy.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 15Aug2023 to 20Aug2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I26.92 SADDLE PULMONARY EMBOLISM 3/31/2023 CAD (CORONARY ARTERY DISEASE) WO ANGINA
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 3-year-old female subject who was vaccinated with Engerix B for prophylaxis. Concurrent vaccination included HIB, IPOL, Prevnar, and DTaP. On 25 April 2005, 4 September 2004 and 3 August 2004 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B (unknown). In September of 2006, the subject was diagnosed with an enlarged spleen. A titer for hepatitis B antibodies was drawn on 24 July 2007 which showed 7mIU/ml for antibodies. This was considered to be a decreased therapeutic response to treatment with Engerix B. This case was assessed as medically serious. At the time of reporting the outcome of the events was unspecified.
Shingles has developed on the right half of the torso from the navel to the spine.
Patient came in today 12-11-15, and said that she had tightness in her chest, and pressure, and that she was very cold (shaking).  She said she went to bed. Got up the next morning, felt better. Got a shower, and felt much better.  Had gotten a flu shot 20 yrs ago without any problems.  Patient said she is fine, and will check with allergist to determine if this is an allergy.
joints ache, arthritis, high blood pressure, loss of concentration, high cholesterol, depression, loss hair, continuous headaches, insomnia, memory loss, mood: angry, sinusitis, libido decrease, weight gain
the product leaked from the needle while it was being administrated; patient reported that they felt like they did not get the vaccine; no additional AEs; This spontaneous report was received from  a nurse and refers to a 55-year-old female. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-JAN-2022, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered subcutaneously for prophylaxis (strength, lot #, and expiry date were not provided). When the vaccine was being administrated, they sawit leaking from  the needle. The patient felt like she did not get the vaccine, receiving less than the recommended dose. No other adverse events were reported.   A causality assessment was not provided.
Worst headache ever had,  fever, sever coughing, red swollen face,  felt like  a semi truck ran over ,tired
Patient received an expired Dose of Pfizer vaccine on 9/2021 at pharmacy. Per patient she was told that she will need to get Covid vaccine as she received an expired dose at their facility. Patient received a Moderna vaccine on 10/18/2021.No adverse reactions reported by patient
4/5 (Day of vaccine)- slight headache.  4/6- worsening fever, chills, flu- like symptoms, excruciating headache. 4/7: resolving symptoms, but small (grape sized) lump under Right Axilla.  4/8- Lump size of an apple.  Contacted the facility.  In for examination (internal medicine)  (infectious disease):  Reactive lymphadenitis. soft, moveable, non-tender, not red/inflamed.  recommended ice and tylenol as needed and to contact clinic of not resolving within a week.
For 3 days post vaccination, their was numbness and tingling in the arm and hand that had received the injection.  The emergency room MD said the shot had been given too high and the brachial nerve had been hit with the needle.  Symptoms reversed after 3 days without treatment.
No AE ocurred; An expired dose was administered to a patient; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. Concomitant therapies were not reported.  On 29-MAR-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliters (lot #U018309 with an expiration date on 08-JAN-2023), administered for prophylaxis (strength, and route of administration were not provided) (expired product administered).  No adverse event occurred.
Reporting due to vaccination administration error. The Moderna COVID-10 vaccine, Bivalent administered today expired yesterday on June 01, 2023. The patient has not experienced any adverse events at this time of reporting.
Pain hurting very badly; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain hurting very badly) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. MOD011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (Pain hurting very badly). At the time of the report, PAIN (Pain hurting very badly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication includes Aleve.
significant/visible amount of blood and protein in urine; significant/visible amount of blood and protein in urine; mild fever noted "of 100"; chills; headache; This is a spontaneous report from a contactable consumer (mother) reported for her son from a Pfizer-sponsored program.  An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced significant/visible amount of blood and protein in urine, mild fever noted "of 100", chills, headache. The outcome of the events was unknown.  The visible blood in urine prompted mother to take son in for HCP evaluation.  Finally, she explains he is due for second dose of vaccine in a couple of days and would like to know if he is a candidate.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient of an unspecified ethnicity started to receive PREVNAR 13 (Lot # R33239, Expiry Date Mar2018, NDC # 0005-1971-02, UPC # 30005-197105) via an unspecified route of administration at single dose at left arm on 02Mar2017 for immunization. The patient medical history was not reported. Concomitant medication included BOOSTRIX at right arm on an unknown date for immunization. Seven days later, on 09Mar2017, she had a knot at the injection site and it started to itch, with outcome not recovered, and she was dizzy, with outcome unknown, and on an unspecified date she got kind of fainted, with outcome unknown. The pharmacist mentioned he/she did not know that's associated with anything having to do with immunization or not, but it did happened and she was questioning. Pharmacist in response to causality mentioned "On injection site reactions yes it was due to PREVNAR 13 as far as dizziness he/she called to ask that question, so I don't know if it was or it isn't, the patient also in her other arm received the BOOSTRIX.
This spontaneous report as received from a health care worker refers to a 36 year old adult male patient. No information about medical history, concurrent conditions was reported for the patient. On 18-MAR-2015 the patient was vaccinated with pediatric dose of RECOMBIVAX HB (2.5/1.5), 0.5 ml, intramuscularly instead of an adult dose. No adverse effects were reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
BP rose to 200/100 in 12 minutes after injection. Was held for observation for another 30 minutes. Began to have random muscle spasms, lip twitching/contortions, trembling. BP fell to 178/96. Went straight to hospital ER and was monitored for3 hours. Had bloodwork and EKG, all normal. Respiration and oxygen always normal. Given 1L IV saline. BP was 148/95 at dismissal from ER with metallic taste in mouth. BP has been elevated and erratic since. I do not have high BP history. Was prescribed 1mg clonidine by family NP to take as needed. On 3/29/21, developed joint and muscle pain in left elbow up to left shoulder. My age is 62 yr, 0 month (field 6 won't allow me to enter numerals).
Information has been received from a physician concerning a 15 year old female patient who on an unknown day was vaccinated with a second dose of Gardasil. The physician reported that patient after getting second dose of Gardasil "felt dizzy and felt like throat was closing." Unspecified medical attention was sought by the patient. The patient recovered 'an hour after the dose". Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unknown number of patients (gender and age not reported). Since October 2014, improperly stored PROQUAD (Merck) (dose, lot number and route not provided) were administered to patients. No adverse effects were noted. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, patients were vaccinated with VARIVAX (dose, route and lot number were not reported) that in January of 2014 were exposed to 69.5F for 72 hours. No adverse effects reported. This case is linked to cases 1403USA014486, 1403USA014487, 1403USA014488 and 1403USA014486 via same reporter link. Additional information has been requested.
Positive COVID diagnosis 6/24/2021. Headache, congestion, fever, tiredness
Aches; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and PYREXIA (Fever) 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 PAIN (Aches) and PYREXIA (Fever). At the time of the report, PAIN (Aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No treatment information provided.    Reporter did not allow further contact
"Patient" was given Rabies vaccine and 1 hour later experience nausea, sweating, and dizziness. 45 min later, donor was better.
This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or MedWatch report may indicate in the appropriate field that it is an initial report. This is a report from a Pfizer sponsored interventional study. Follow-up received from the treating hospital provided a change in the wording of the event, additional medical history, event details, test results and consultant comments. Information regarding Pneumococcal Conjugate Vaccine, 13-Valent (injection) was received from an investigator regarding a 38-year-old female participant in a study who experienced severe headache consistent with migraine headache. The participant received the first dose on 04Jun2009. On day 6 through 12 following administration of Pneumococcal Conjugate Vaccine, 13-Valent the patient developed intermittent headaches resolved with over-the-counter analgesics. On the evening of 18Jun2009, post-vaccination day 14, the patient developed a severe headache that did not resolve after three hours. She was instructed to go to the emergency room where she was admitted for observation with the diagnosis of acute headache, nausea with no vomiting and hypertension. The patient reported her own blood pressure to be 150/110 prior to admission however at the hospital it was within appropriate range in the 110s-140s/50s-90s. Treatment included DILAUDID, ZOFRAN, DECADRON, PHENERGAN and IV fluids. No further episodes of hypertension were noted. On 19Jun2009 the patient was examined by a neurologist and discharged from the hospital with a final diagnosis of severe headache consistent with migraine headache. The outcome was reported as recovered. The neurologist commented that the patient clearly admits to a family history of migraine in her mother. He also stated that "whether or not this is related to her Pneumococcal experimental vaccine approximately two weeks previous to current evaluation will be very difficult to definitively characterize". On 22Jun2009 the patient reported that her headache was relieved in the hospital with DILAUDID and had not returned. No additional information was available at the time of this report. The investigator considered migraine possibly related to the study product. The medical monitor considered migraine not related to the study product. Follow-up (09Aug2016): This is a follow-up report from study. No further information provided.
tingling in hand and forearm; numbness in hand and forearm; pain in her right shoulder blade down through injection site, down arm muscle/down arm muscle; flu symptoms; chills; fever; weakness; could not lift her head; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (flu symptoms), PARAESTHESIA (tingling in hand and forearm), ASTHENIA (weakness), MOVEMENT DISORDER (could not lift her head) and HYPOAESTHESIA (numbness in hand and forearm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back pain and Pinched nerve.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Apr-2021, the patient experienced INFLUENZA (flu symptoms), ASTHENIA (weakness), MOVEMENT DISORDER (could not lift her head), CHILLS (chills) and PYREXIA (fever). In May 2021, the patient experienced PARAESTHESIA (tingling in hand and forearm), HYPOAESTHESIA (numbness in hand and forearm) and MYALGIA (pain in her right shoulder blade down through injection site, down arm muscle/down arm muscle). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. On 24-Apr-2021, INFLUENZA (flu symptoms) had resolved. At the time of the report, PARAESTHESIA (tingling in hand and forearm), ASTHENIA (weakness), MOVEMENT DISORDER (could not lift her head), CHILLS (chills), PYREXIA (fever) and MYALGIA (pain in her right shoulder blade down through injection site, down arm muscle/down arm muscle) outcome was unknown and HYPOAESTHESIA (numbness in hand and forearm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.         No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
An hour after administration of HPV and ADACEL, child developed focal twitching, shaking, dystonic posturing of the (R) leg, (R) hand, without loss of consciousness.
I had a thick head and which I tend to get with a sinus infection and facial pain with a lot of drainage going back in my throat.  When I noticed the facial pain I didn't think much of it but just thinking I had a sinus infection.  The second day everything was speed up with facial pain, headache, and body sweats.  No fever but my body was sweating and had that for several days and I also had a productive cough.  I took a home COVID-19 test and it was positive very quickly within 3 seconds.  I contacted my allergy doctor and they prescribed a Z-pack and Erythromycin antibiotic.
Information has been received from a registered nurse concerning a patient with no past medical history who "one to two weeks ago" was vaccinated with Pneumovax 23 (lot # 650541/1004P).  Subsequently, the patient experienced redness and soreness around the injection site.  Subsequently, the patient recovered.  This report also involved two other patients, for a total of three, and it was reported that "two of the patients developed a fever."  Additional information has been requested.