chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in yesterday to pick up medication and was counsel to recieve the flu vaccination and pneumo. The patient elected to have both the vaccines however soon after recieving the injection later that night, she felt a burning sensation/swelling and put on a ice pack. This morning she noted that the swelling had gone down but there was a large rash that had been developed on the backside/tricep area of her arm. When speaking with the patient, patient stated that she had already been on Allegra once daily thus we suggested to add Benadryl liq for quicker onset and liberally apply Benadryl/Allegra cream/ung in place of physically scratching the area. The rash could not be determine from the long duration of ice therapy nor itching thus I suggested using  the cream in place of scratching and a towel to buffer the area with the ice with 20 on/off intervals to minimize possible skin irritation. Hydrocort was not suggested since the itching had minimized and if the scratching had lead to a small case of infection - it would proliferate the affected area. Furthermore we ask the patient to follow-up with us the following day to let us know if the skin rash continue to advance and seek urgent care for possible steroid therapy. To mark the development for the rash, we had told the patient to mark around the area and time/date it on the skin before seeing the provider to indicate growth of the rash.
Patient had no prior history of cerebrovascular accident. Life threatening Intracranial hemorrhage found on hospitalization 3 weeks post administration of Pfizer booster. Complications developed post CVA including status epilepticus, requiring re-hospitalization and admission to critical care with intubation and pressor support.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of expired RECOMBIVAX HB (dose, lot number and route of administration were not provided). Additional information has been requested.
On the 27th of March, the day after my second dose, I had a slight fever (99 degrees). It was mostly tiredness and a low grade fever.  I had another event later on May 1st that I do not think was related to COVID 19 vaccine.  I had a bought of diverticulitis. My doctor gave me antibiotics and I was fine after that.
Severe jt pain, Bronchial Pneumonia, headache, rash and fever.
Beginning 1/3/2021, patient noted her injection site and surrounding area becoming pink. On 1/4/2021, patient noticed redness at and around injection site measuring roughly 3 inches in diameter. By the next day, the redness has become more prominent and larger. She contacted her primary care physician who felt it was likely a delayed allergic response. 1/6/2021, the redness has become a lighter pink and patient reports the area to be "markedly improved" from days previous.
Vaccine hib 4, given in right thigh on 07/25/2005, complaint of fever, swelling, redness in right thigh; 2cm swelling with redness and pain with touch.
pt recv vax & 12 hr later had 4 sz;no further info was available @ the date of this report which was recv from Connaught;
Insomnia; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151) via an unspecified route of administration in the right arm on 02Apr2021 at 11:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to food, medications, or other products. The patient was receiving unspecified concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 12Mar2021 at 11:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Apr2021 at 21:00, the patient experienced insomnia. The event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event insomnia. The clinical outcome of the event insomnia was not resolved at the time of the report.   No follow-up attempts are needed. No further information is expected.
having glares it was something like glare or something on the screen it was like very faint glare; nauseous; headache; chills; vision issues/Vision thing is kind of weird; This is a spontaneous report from a Contactable consumer (patient). A male patient of age, 28 (Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number, UPC number and Expiry Date are unknown), via an unspecified route of administration on 25Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on an unspecified date as single dose for covid-19 immunisation. On an unspecified date in 2021, the patient experienced having glares it was something like glare or something on the screen it was like very faint glare, nauseous, headache, chills and vision issues/vision thing is kind of weird. The reporter stated that he had his second dose this morning of the Pfizer covid vaccine. He had an episode with his vision, like a glare on the screen, but it is better. He was also nauseous, headache and some chills. He looked at his monitor and there was like a glare, he was having a hard time focusing, weird glare, but got better, lasted about 10 or 15 minutes, never had vision issues before. The reporter asked, was this a side effect that has been reported? The clinical course was reported as follows: the patient got his second Pfizer vaccine this morning on 25Feb2021, everything was fine he wishes and then may be about an hour ago and he sat down, document with some patients and then he started having glares it was something like glare or something on the screen it was like very faint glare on the screen when I was typing little started having hard time focusing on screen and, so he got up moved monitor in case it was a glare and then it was still kind of happening it lasted about 10-15 minutes or something so he just does not know if that is a normal symptom or when he called the hotline here and they said it's kind of normal symptom going to make sure that about they recommended like "hadark" (not clarified), so he thinks his vision is better right now but now he has started having on top of that he was still kind of having nausea and kind of headache feeling going on right now, no just going to say on top of all that he just wanted to know all that to verify if it was reported before or something like that. The reporter stated, Right, mainly the vision thing and another thing is nausea and stuff that's normal thing but the vision thing is kind of weird. The outcome of event, having glares it was something like glare or something on the screen it was like very faint glare was recovered on an unspecified date in 2021 and vision issues/vision thing is kind of weird was recovering while other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions, allergies, concurrent conditions were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N034558, expiration date: 05-DEC-2019 and lot#: R002509, expiration date: 25-JAN-2020 (dose, anatomical location and route of administration were not reported) indicated for prophylaxis, which were reconstituted with properly stored sterile diluent (MERCK) (lot# and expiration date were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius to 25 degrees Celsius (15C) for 1 hour and 25 minutes on unspecified dates called by a data logger. There were no previous excursions reported.
severe headache; feeling very tired; has a sore arm; A spontaneous report was received from a consumer concerning a 58-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe headache, feeling very tired, has a sore arm.  The patient's medical history was not provided. Concomitant medications reported were Cholesterol medication, Diabetes Medication, Hypertension Medication for drug use for unknown indication.  On 2 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event(s) severe headache, feeling very tired, has a sore arm.  Treatment details included tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), severe headache, feeling very tired, has a sore arm was unknown.
During observation, after her first dose, developed chills, scratchy throat.  High blood pressure present. Had history of hypertension,  and stated she had taken her med earlier in the day.  No problems breathing at that time.  Benadryl (50mg) administered by facility.  Called 911. Patient escorted by wheelchair to front door of building, where emt were to arrive.  About that time there, patient developed problems breathing,  and was adminterested epipen,  by immunizing RN and facility staff member. Given epipen about 1 to 2minutes before emt's arrival.  Checked out by fire department emt's and they were waiting for another unit to arrive.  She appeared to be doing much better then, after the epipen.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Chest pain pressure on right side, cold shakes, nauseous, light headed, body aches
Vaccine was administered to left deltoid on Tuesday May 26, 2009.  Came to office today to show me his left arm which was reddened around the entire arm at the deltoid area and warm to touch. Arm was not hard.  No other symptoms. Suggested physician visit however patient is unsure as to whether he will seek.
Swollen, hard, painful bicep muscle extending 4 inches x 6 inches, painful with any arm motion.  Headache for 3 days.
Injection delivery-pain upon injection. Pain at injection site for approx. 8 hours, interrupting sleep. 12 hours after injection, awoke with nausea and joint pain severe enough that just getting out of bed and walking to the bathroom was painful. Because of nausea, could not take any pain medication. Headache approx. 14 hours after injection. Again, because of nausea, no pain medication could be taken.
scattered red areas, some itching (since resolved) no redness or bruising local to injection site, some pain in arm some areas pt indicated had no visible redness. pt stated it was "under the skin"
This case was reported by a consumer via call center representative and described the occurrence of weakness of arms in a elderly male patient who received SHINGRIX for prophylaxis. On 27th December 2018, the patient received the 1st dose of SHINGRIX. On 1st January 2019, 5 days after receiving SHINGRIX, the patient experienced weakness of arms (serious criteria hospitalization) and walking difficulty (serious criteria hospitalization). In January 2019, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the weakness of arms and walking difficulty were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the weakness of arms, walking difficulty and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's cousin. The patient's concomitant medication included unspecified cholesterol medication. The age at vaccination was not reported but the patient could be 67 or 68 years old. The patient at around 1st January 2019, began to experience weakness in his arms and legs and found it difficult to walk. The patient was seen in the emergency room, and various laboratory and imaging tests were done, but not specified which type. The results were negative. The patient went home and about 2 days later, the symptoms remained, and the patient went back to the emergency department, and was admitted. Nothing remarkable was noted on testing. The physicians thought an unspecified cholesterol medication might be the cause of the weakness and was discontinued, but symptoms did not improve. The patient was limited in daily activities and was in a wheel chair. The reporter consented to follow up. Lab Comments: Various laboratory and imaging tests were done, but not specified which type. The results were negative.
Local inflammatory skin reaction warm, pink, indurated, tender no fever (+) chills 11 cm x 8 cm left upper extremity no SOB no edema.
Vaccine was expired on 07 Apr 2022 and continuously stored in stable freezer environment and only stored in fridge on date of administration for thaw period; On 18 Apr 2022 one patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 18 Apr 2022 one patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 07 Apr 2022 and continuously stored in stable freezer environment and only stored in fridge on date of administration for thaw period) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 18 Apr 2022 one patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 07 Apr 2022 and continuously stored in stable freezer environment and only stored in fridge on date of administration for thaw period). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 18 Apr 2022 one patient received expired vaccine) and PRODUCT STORAGE ERROR (Vaccine was expired on 07 Apr 2022 and continuously stored in stable freezer environment and only stored in fridge on date of administration for thaw period) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.
No adverse effects were reported; patient was inadvertently administered an expired dose of VARIVAX; This spontaneous report was received from a medical assistant concerning to a 31 year old male patient. The patient's historical conditions, concurrent condition, and concomitant medications were not provided.  On 29-MAY-2019, the patient was inadvertently administered an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) by subcutaneous route (strength, dose and anatomical location were not reported; Lot number N014631 and expiration date 11-MAY-2019) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion.
Diffuse papular rash w/surrounding erythema/adema; she urticarial lesions & swelling of ears - unclear etology.
Red, induration at left shoulder.  Treated w/ TYLENOL PRN & cool compresses.
neck tightness; neck / pain; elevated blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (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: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 11Mar2021, outcome "unknown", described as "neck tightness"; NECK PAIN (non-serious) with onset 11Mar2021, outcome "unknown", described as "neck / pain"; BLOOD PRESSURE INCREASED (non-serious) with onset 11Mar2021, outcome "not recovered", described as "elevated blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Events was experienced two weeks after the vaccine. It was reported that elevated blood pressure goes sometimes, and was still experienced yesterday and today (day of the report).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tinnitus appeared over the past two months.  Not sure when it started, I just noticed it and it doesn't seem to go away.
Upset stomach; Headache; Cold hands; Sore back in the kidney area; This is a spontaneous report received from a non-contactable consumer, the patient. A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6207) via an unspecified route of administration in the left arm (at the age of 72 years) on 11Mar2021 at 14:30 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6201) via an unspecified route of administration in the left arm on 18Feb2021 at 13:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested with COVID-19. Concomitant medications included ELIQUIS 5 mg tablet, telmisartan and atorvastatin; all for an unknown indication since unknown date and unknown if ongoing. On 17Mar2021 at 12:00, the patient experienced upset stomach, headache, cold hands and sore back in the kidney area. The patient did not receive treatment for the reported events. The clinical outcome of the events upset stomach, headache, cold hands and sore back in the kidney area was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
PT fainted post vaccination. He was sitting in chair looked nervous conscious. He then fell out of chair and hit his head on the ground. When assessed he was rigged, eyes were flickering in head and was not responsive. Lasted for about 30 seconds. He then regained consciousness and was AxO times four. Felt cold and shaken.
Sore arm on day #1 & #2... expected with any injection.  Day 5 I got up from bed and fell into nightstand, thinking I just got up too quickly, I tried to slow down but fell into shower once in the bathroom. The dizziness has continued for past 3 days now, no past history of vertigo or dizziness before.
Gradual onset of itching, large hive on area of injection, raised, red - and warm - gradually worsening over five days - still arm pain 3/13/11 no rash (+) swelling.
Resident was fine Day of the vaccine. The pharmacist stayed after for 30 minutes to check the well-being of the residence. Three days later resident was feeling weak wasn?t able to stand so we had to get a chair for her to sit in which was unusual. We did rapid testing and it was the only positive in the facility.
Fainting, left sided weakness and tingling, double vision for 3 months, prolonged fatigue, rigors, hypersensitivity, unsteady gait. All symptoms continue to persist. Placed on steroids on and off for three months.  11/20/08 Received GYN office records of 3/24-10/06/2008. FINAL DX: none provided Records reveal patient had fibrocystic breasts on 3/24 & BCP changed.  US of breasts reviewed & WNL.  T/C 6/26 pt reported having been seen in ER x 2, ENT, Neuro & had EEG, CT scan & MRI.  Had faint feeling, numbnness in feet, visual changes x 1.5 mo.  RTC 10/6/08   12/8/08 Received ER medical records of 5/1/2008. FINAL DX: pre-syncope & palpitations Records reveal patient experienced intermittent pre-syncope & palpitations x 3 weeks now with same plus tingling around mouth & hands, nausea x 2 wks, dizziness.  No symptoms while in ER & d/c to home w/PCP f/u.  2/2/09 Received hospital clinic records for 6/25-8/8/2008. FINAL DX: none provided Records reveal patient w/lightheadness, fatigue, multiple episodes of felt faint, tachycardia, hand tremors, feeling foggy, intermittent tingling & weakness of legs, vision abnormal since 3/08 shortly after received HPV #1.   2/3/09 Reeived ENT medical records of 5/8/2008. FINAL DX: resolving sinusitis Records reveal patient experienced sinus infection s/s x 3 weeks of nasal congestion, malaise, HA, rhinorrhea, facial pain/pressure & dizziness.  2/9/09 Received ER medical records of 4/14/2008. FINAL DX: dizziness, etiology unknown Records reveal patient experienced dizziness & felt faint x 5 days.  D/C home w/neg exam.
Per daughter, patient, after uneventful vaccine administration and 15 minute observation period, returned home, and father had lunch with wife and daughter. At 1:30, father remained home while daughter and wife went grocery shopping. Upon return from grocery store, approximately 1 hr. 45 minutes later, daughter found father unresponsive in bathtub with small amount of water, faucet off, and father partially clothed. Per daughter, the shower chair had been removed from the tub by her father. Per daughter, an autopsy was planned. Results are pending.