chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Began having normal body aches; Armpits were a little bit swollen; A bit itchy in his chest area; A few hives and a little redness on his chest; A few hives and a little redness on his chest; Anxiety; This is a spontaneous report from a contactable consumer (patient). A 21-years-old male patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0173, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 04May2021 at 13:45 hours as dose 2, single (at the age of 21- years) for COVID-19 immunization. Patient had no medical history and had received no concomitant medications. Patient had no prior vaccinations (within 4 weeks). Patient had no family medical history relevant to adverse event. The patient had not received any additional vaccines on same date of the Pfizer suspect. Historical vaccine included patient received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EW0158, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 13Apr2021 at 13:45 hours as dose 1, single (at the age of 21-years) for COVID-19 immunization and experienced heat rashes or sun rash and itching. On 05May2021, patient began having normal body aches, noted his armpits were a little bit swollen and was a bit itchy in his chest area and noticed a few hives and a little redness on his chest, could be his anxiety getting the best of him right now, but he wants to know if it was okay to take Benadryl or if he needs to take more serious action but patient verified later in the call that he had not received any treatment for all the events. The outcome of all the events was unknown.   No follow-up attempts are needed. No further information is expected.
Patient received the vaccine on Friday and called the next day to ask if mild pain in the shoulder was a normal reaction to the vaccine. Pt was advised to wait until Monday to see if the pain subsides because mild pain at the site of injection is a normal reaction. Patient returned on Wednesday with a prescription for an anti-inflammatory medication and said although her symptoms were slowly subsiding, her pain was intolerable and decided to see her doctor.
Painful at site at time of injection and got worse as the day continued. Felt headache and nauseous same day for 3 days. Contacted Covid-19 8/15/2021 until 9/1/2021. Still have moderate pain at injection site in left arm to this day, 10/04/2021
patient received first dose of Moderna on 4/14 and was admitted to the hospital on 4/17 for acute CVA and was discharge from Rehab  to home on 5/7. Nurse contacted his provider  prior given the second dose of Moderna and provider thought the s/s are sound more indicative of a TIA versus vaccine reaction and it was okay to give.   Approximately 5-7 minutes after the second injection was given of MOderna, patient became pale and lethargic, patient reported not eaten all day,  vitals were in normal limits, juice was offered to patient and legs were elevated. However patient reported feeling better however his appearance and what he was reporting did not match.  Patient was wheeled to his provider team for further evaluation. Veteran was taken via EMS to the hospital due to hypotension.
my sister got the shot and it made her sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (176890).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "my sister got the shot and it made her sick". Additional information: Patient's age reported as "21" (no age units).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient complains of pain shooting from injection site in upper left arm to left hand. no left hand weakness. no left or right arm numbness or tingling, no left or right arm weakness.
I have had, up until getting the vaccine, my diabetic numbers were under control regularly. But once getting the vaccine, my diabetic numbers increased tremendously for about a week regardless what medications to took.
Myalgia, Fever, SkinRash, malaise Narrative:  Other Relevant History:
1st dose 05/13/21, 2nd dose 07/20/21 (over 42 days apart)
This spontaneous report was received from a nurse refers to a 65 year old male patient. The  patient medical history, drug reactions and allergies were not reported. The patient's current condition included diabetes mellitus, hypertension, arthritis and gastrooesophageal reflux disease. Concomitant therapies included NORVASC, aspirin, benazepril hydrochloride, CELEXA, diclofenac, LANTUS, metformin, omeprazole and simvastatin. On 17-DEC-2018 the patient was vaccinated with PNEUMOVAX 23, (dose, units, frequency, lot# and expiration date unknown) intramuscularly to prevent pneumococcal disease. On 19-DEC-2018, the patient developed a rash at the site of PNEUMOVAX 23. On an unknown date after this, the patient was started on ZANTAC, BENADRYL, and triamcinolone cream (manufacturers unknown) for the rash. The patient has not recovered. Causality of the event was not reported.
This case was reported by a nurse via patient support programs and described the occurrence of fever in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (a dose received in 2012). On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever, pain, allergic reaction, erythema of extremities, swelling arm, intramuscular formulation administered by other route, drug administered in wrong device and pharmaceutical product complaint. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, pain, allergic reaction, erythema of extremities, swelling arm, intramuscular formulation administered by other route, drug administered in wrong device and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the fever, pain, allergic reaction, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient was registered nurse working in a travel vaccine clinic. The age at vaccination was not reported. The patient went to received SHINGRIX vaccination because she could use her health insurance to help cover the cost. The registered pharmacist who gave her the shot used a TB syringe, which led to vaccine administered in wrong device. The patient did not see the size of the needle. The SHINGRIX was given well below the deltoid area, so the patient was sure that it was administered subcutaneously instead of intramuscularly, which led to incorrect route of administration. The patient stated that it was very painful the first night and she thought she had a fever during the night. The patient had been taking Tylenol for 2 days to reduce the discomfort. Less than a year after vaccination, the patient experienced allergic reaction, a site reaction that was really red and swollen for approximately one week. The patient was asking if this was truly SHINGRIX that she was given subcutaneously; the dose would be considered a valid dose or not. The patient also stated that her manager wondered if the patient was given ZOSTAVAX, but the paperwork the patient received said SHINGRIX.
This spontaneous report as received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-NOV-2014 the patients were vaccinated with an improperly stored dose of ZOSTAVAX (strength, route of administration, dose and lot # were not reported). The reporter was not able to provide a cumulative time frame of these excursions, so the total time out of range was not known at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 3/3/2023 Discharge Date:  03/06/2023  PRESENTING PROBLEM: Acute hypoxemic respiratory failure due to COVID-19 (HCC) [U07.1, J96.01] Pneumonia due to COVID-19 virus [U07.1, J12.82]  HOSPITAL COURSE: Patient did well.  He was weaned off supplemental oxygen during the daytime, ambulating with minimal difficulty.  He was treated with Zosyn initially which was transition to Augmentin to complete a 7 day course for suspected aspiration pneumonia.  He was started on Decadron for COVID-19 pneumonia, switched to prednisone with slow taper for COVID-19 pneumonia.  Patient's weakness improved.  He will continue on a modified diet as before for dysphagia.  He was tolerating his diet while here, all cultures remain negative, inflammatory markers improved.  Patient is stable for discharge.  Recommend he follow up with primary care provider next week, repeat chest x-ray in 4 weeks.
12/04/2021 presented to ED for "vulvar pain, UTI and lightheadedness."  PMHx of "partial hysterectomy and FIGO stage 1B squamous cell carcinoma of the vulva s/p radiation."
Headache, nausea, heart racing, shakes, chills, vomiting, dizziness, fatigue and general malaise that lasted for 3 days
Fever over 101 for 3 days - fever broke and a fine macular rash on trunk seen. Dx as Roseola by doctor - parents felt the reaction was from immunization given on 8/24/07 Prevnar and Hib.
Fatigue after 1st and 2nd dose; Headaches after 1st and 2nd dose; Soreness at injection site after 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after 1st and 2nd dose), HEADACHE (Headaches after 1st and 2nd dose) and VACCINATION SITE PAIN (Soreness at injection site after 1st and 2nd dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History was provided.  Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), GABAPENTIN, ESZOPICLONE (LUNESTA), MULTIVITAMIN [VITAMINS NOS] and CALCIUM for an unknown indication.    On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue after 1st and 2nd dose), HEADACHE (Headaches after 1st and 2nd dose) and VACCINATION SITE PAIN (Soreness at injection site after 1st and 2nd dose). At the time of the report, FATIGUE (Fatigue after 1st and 2nd dose), HEADACHE (Headaches after 1st and 2nd dose) and VACCINATION SITE PAIN (Soreness at injection site after 1st and 2nd dose) outcome was unknown.            No Treatment Medications were provided.   This case was linked to MOD-2021-294441, MOD-2021-294519 (Patient Link).
After injection, developed immediate soreness and swelling to site of injection. Symptoms resolved within 3 days. On day 7, developed redness, swelling, and mild itching. Also developed mild tingling to left arm.
My period is 3 days late since the shot. I have slight cramps as if it?s coming but it never shows up. My period has never been late like this maybe by a day. Never more than that.
her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red; face started tingling and feeling numb; really itchy; they were hot and red; feeling numb; they were hot and red; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: FC3180; Expiration Date: 31Oct2021), via an unspecified route of administration, administered in arm left (left upper arm) on 21Aug2021 (at the age of 69-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccine prior vaccinations within 4 weeks. On 21Aug2021, the patient experienced her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red, face started tingling and feeling numb, really itchy, they were hot and red. Patient got the shot the Pfizer biontech, name as provided by the caller. Patient got the shot on 21Aug2021, she ended up getting first dose. Patient felt fine, but then her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red. Patient would like to know if its a normal side effect or if she needs to go to the doctor. Patient signed up with safe. Patient got the shot on the front side of arm. It makes her afraid to get the second one. Hives, and they were hot and red. Half an hour after her shot, it was really itchy. Treatment - antiitch medication. Face started tingling and feeling numb: About 10 mins after her shot her face started tingling and feeling numb. It went away after an hour and a half. It was around her cheek. Patient recovered completely. The patient received antiitch medication as treatment for the event really itchy. Outcome of the events her arm on the backside at the top of her arm where she got the shot had hives, and they were hot and red was not recovered; really itchy, they were hot and red was unknown; face started tingling and feeling numb recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected .
Redness, swelling, burning, pain at injection sites. PNEUMOVAX was given SQ; IM vaccine.
Blurred vision; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision) and DIZZINESS (Dizziness) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced VISION BLURRED (Blurred vision) and DIZZINESS (Dizziness). At the time of the report, VISION BLURRED (Blurred vision) and DIZZINESS (Dizziness) outcome was unknown. Not Provided          No relevant Concomitant Medications were reported. No Treatment Information Provided.
Red area on arm at injection site with distinct borders, hot to the touch. Approx 5 inches by 4 inches at time of report. Area is painful and itchy.
Vaccinator gave a first dose Pfizer Ped 5-11 yr dose of 0.2 mL to a 3 year old female patient. No adverse symptoms noted during 15 minute wait period. Father was called after error was discovered and advised to watch for potential of increased side effects.
Continual Trouble breathing unexpectedly. Haven't been able to elevate my heart rate like prior to vaccine. This is ongoing since vaccination
after administering Pedvax HIB and applying Band-aid noted redness and swelling. Notified provider. Ordered 1tsp Motrin for children B 6.25 mg Benadryl-adm. @ 11:14 am-also applied ice. By 11:25 minimal swelling noted, no erythema warmth or bruising. Original measurement of swelling to LLMLT 8cm x 6.5 cm.
RN made vaccine error on 6/29/22 when patient received first boost dose of COVID-19 vaccine Pfizer pediatric vaccine (orange cap, age 5-11 yrs). RN inadvertently diluted vaccine w/ 1.6 mL 0.9% normal saline instead of recommended 1.3 mL on 6/29/22. Error due to misreading gradations on 5 mL syringe which was used for drawing up diluent. On Fri 7/1/22, RN realized vaccine error made, so contacted area point-of-contact Private. By Tues 7/5/22 morning, still no response received, so RN contacted Pfizer customer service / nurse / pharmacist which referred RN to CDC guidelines (repeat dose immediately w/ no minimum interval between error dose and following dose).  Pfizer internal reference # INT-702042. From Pfizer, RN spoke to (Pfizer Customer Service); RN (Drug & Safety Unit); and (Pharmacist) who provided direct line for medical unit / information: Private. Vaccine error report filed with Pfizer via phone call. Pfizer stated they cannot provide guidelines for specific patients, can only provide information based on Pfizer data only, leaves decision-making up to clinical judgment of clinic provider. RN proceeded to attempt patient contact starting 7/6/22. Private contacted RN via phone & email on 7/7/22 with similar guidance (as Pfizer/CDC) to repeat COVID vaccine dose given circulating variants.  RN successfully made contact with patient's mother via phone call on 7/7/22. Patient arrived to clinic on 7/13/22 for repeat dose COVID vaccine. RN attempted to re-explain situation to patient's mother who later expressed request for different nurse to vaccinate patient, stated "I feel traumatized by you" and "I cannot look at you." RN re-explained situation regarding vaccine error, provided opportunity for questions, successfully re-vaccinated patient. Patient and patient's mother were provided with plan for further COVID vaccines: none recommended at this time.
Approximately one week after vaccine, my existing tinnitus ramped up significantly and has not changed; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 16Mar2021 at 12:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimotos, graves, asthma, allergies, tinnitus and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included azelastine (MANUFACTURER UNKNOWN), fluticasone propionate (FLONASE), fexofenadine hydrochloride (ALLEGRA) and fluticasone propionate (FLOVENT); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received cefuroxime axetil (CEFTIN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021, the patient experienced existing tinnitus ramped up significantly and had not changed (was still significantly more tinnitus than had before) and the patient could hear it over most noises now. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event existing tinnitus ramped up significantly and had not changed was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
After patient received the 1st dose of HPV-9 vaccine in the clinic, she fainted in the bathroom (postural dizziness with pre-syncope) while still in the clinic. BP 65/29 and patient was nauseous minutes later after she woke up. Patient stayed in the clinic for additional 20 minutes before being discharged with all symptoms resolved. No additional treatment given.
Less Than Approved Age/ a female patient aged 49 years received one dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old female patient who received Herpes zoster (Shingrix) (batch number YC5Y7, expiry date 25-OCT-2024) for prophylaxis.   On 15-MAR-2023, the patient received the 1st dose of Shingrix. On 15-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Less Than Approved Age/ a female patient aged 49 years received one dose of Shingrix).  The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: Receipt Date: 23-AUG-2023 The reporter reported that the patient of 49 years old received first dose of Shingrix vaccine. The reporter did not believed that the patient had any sort of immunodeficiency or immunosuppression. The reporter stated that at the time of reporting the second dose had not been administered. The vaccine administration facility was the same as primary reporter. The patient received Shingrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Fever 101F on Saturday 12/19/2020 Lost smell and taste Very tired
Alarming high potassium level; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD POTASSIUM INCREASED (Alarming high potassium level) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD POTASSIUM INCREASED (Alarming high potassium level). At the time of the report, BLOOD POTASSIUM INCREASED (Alarming high potassium level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium: (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were reported as a lot of medication for unknown indications. No treatment related information has been reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Chills and tremors for 1 hour accompanied by fever.  Severe headache, fatigue, and body aches lasted the entire day.  Fever reached a peak of 102.8 in the late afternoon of 3/24/21.  Loss of appetite.  Treated fever with Tylenol, liquids and rest. Chills returned in the evening around 7pm.  3/25/21 fever began to subside with a high temp of 100.8 and was treated with Tylenol at half the prior days, dose.  However pain in the left armpit began and has continued through 3/27/21.
Patient experienced immediate pain with injection.  Patient reports that she thinks it was injected into joint space.  Patient has had constant pain, limited range of motion ever since vaccination.
Mom reports redness, swelling and warmth to all (4) sites which started the same day and is continuous at the present time. She noted discoloration to both arms approx. 1 week, post vax, with left arm approx. (2 1/2"-3") and right arm approx. (1") with red/purple colored circled area around injection sites. Client was taken to the doctor on 8/3/01 and was treated with antibiotics. Discoloration continues to be rechecked by doctor on 8/31/01. Note: Diluent/MSD/1707R/SC/RA/1 previously.
4/9 Received JE #2/ Rabies #2/ Menomune/ Adacel and Twinrix #2 - called on 4/15/07. Left message c/o SOB, rash to upper extremities and torso, deep upper body aches from 4/11 on. Did not call till 4/15 - insisted to go to ER or MD ASAP. 4/16 Symptoms decrease.
10.21.23 Developed red 2 inch x 2 inch raised area where vaccine was given-warm, slightly itchy lasted ~3 days. Wed. 10/23 red small raised areas notice on right thigh and glutes, spread to left thigh and glutes by next morning. Currently spreading up trunk, down bilateral UEs.
Patient passed out after returning to work after vaccination. Ambulance was dispatched and patient transported to medical facility.  No further information known at this time
Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Additional Details: Symptoms have been ongoing for 9 days. Pt also reports experiencing arm swelling and incredible fatigue after Shingrix.