chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received 13 September 2011 from a health care professional. A 56-year-old female patient who had known allergies to seafood, penicillin and statin drugs, had received a first dose intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number UH459AC on 12 September 2011, and on the day of vaccination she developed a stiff neck, fever of 103F and a headache. The patient called her physician's office to report the symptoms and was instructed to go to the emergency room. She had not received any other vaccines during the four weeks prior to vaccination and she had no concurrent illness at the time of vaccination. Additional past medical history was not reported; however, the patient had been taking 15 concomitant medications which were unknown by the reporter. Outcome was not recovered. Documents held by sender: None.
Shortness of breath and severe Chest pain. Ended up being a pulmonary embolism. Placed on Eliquis.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (0.65 ml, SUB-Q, lot # 670755/0622AA) on 31-JUL-2012 and it expired on 26-JUL-2012. No adverse effects reported. No other co-suspects were reported. No concomitant medications were reported. No treatment information was reported. Additional information has been requested.
sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR004600  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient had a sore arm for a day or two after the shot. The patient commented like, but this pain beats the years of heaving nerve pain. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR004601:same reporter - other patient
This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with RECOMBIVAX HB, lot number L018500, expiration date 13-APR-2017 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as improperly stored doses of RECOMBIVAX HB were administered to the patients. No adverse event was reported. It was unknown if the patients sought medical attention. The outcome of the incorrect product storage was unknown. Additional information has been requested.
This spontaneous report was retrieved from webpage Sanevax, Inc. where the patient's mother reported on her daughter, a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. In approximately February 2014, the patient was vaccinated with a dose of GARDASIL, (dose, route of administration, lot number and expiration date were not reported). On an unknown date in approximately 2014, the patient experienced Lyme disease and chops migraine pathway for which she was treated with unspecified medications. It was reported that the patient was supposed to see a specialist for postural orthostatic tachycardia syndrome (POTS) in October. The outcome of the events was unknown at the time of the report. The relatedness between the events was unknown at the time of the report. The relatedness between the events and GARDASIL was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
at 9pm I couldn't speak. my wife called ambulance and I was taken to the hospital and it was confirmed that I had a minor stroke.
Pt presented with redness, swelling of right arm. Pt's arm had yellow crusting. When band aid removed a small area of skin bled and oozing occurred. Treated for cellulitis. Ibuprofen and antibiotics issued.
104.7 temperature for 4 days.  Fatigue for 1 month  Heavy clotting  (May 2021) period extremely LAST period  (Day 46, usually get my period at day 29 or 30). My periods are on target and regular  Heavy cramping with period (I never cramp) extremely painful.  Next period (June 2021) was regular 32 days  Next  period (July 2021) lasted 15 days of bleeding. Lots of cramping.   I almost never go to the doctor as I am quite healthy.
Started  experiencing fainting spells, muscle cramps, cold extremities, missed menstrual cycles
Already reported tinnitus which occurred after the first dose of the Covid vaccine.  This report is for a longer-term issue of joint inflammation and pain that occurred over time after the second shot.  All tests ruled out autoimmune disease, rheumatoid arthritis, lyme disease and everything else.  Joints are painful and thumb joint is now disfigured.
Fever the night of the shot (101.3) and fever the next night (102.0) but no fever during the day.
No additional AE; the patient was inadvertently administered a dose of VARIVAX by intramuscular injection instead of subcutaneous injection; Information has been received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 19-FEB-2020, the patient was inadvertently administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail and frequency were not reported) (lot # S010298, expiration date 03-APR-2021) with sterile diluent (STERILE DILUENT) by intramuscular injection instead of subcutaneous injection for prophylaxis (incorrect route of product administration). No additional adverse event was reported.
28 year old was administrated Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 28-year-old male patient who received Men B NVS (Bexsero) (batch number abxa95aa, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The pharmacist reported that the 28 year old patient was administrated a dose of Bexsero, which led to inappropriate age at vaccine administration. No further events were reported.  The reporter consented to follow-up.
Pain from waist down so excruciating; Throwing up; Could not lay down/sleep; loss of mobility; Could not lay down/sleep; Could not stand up/walk; Completely disabled in lower extremities; Could not walk w/o holding on to chair/counter; Something else going on with nerves; This is a spontaneous report from a contactable consumer(patient). This 57-year old female patient (not pregnant) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0153) at single dose on 14Apr2021 13:00 via an unknown route in left arm for Covid-19 immunization. Medical history was "none". Patient was completely healthy, no known allergies. Patient did not have covid prior vaccination.   No other vaccine in four weeks, prior to the COVID vaccine, no other medications in two weeks. Within 24 hours after Shot#1, patient could not walk without holding on to chair/counter. Within 48 hours, patient could not stand up/walk, pain from waist down so excruciating, patient began throwing up (lasted 3-4 days), could not lay down/sleep (for at least 3 weeks). Patient went to Emergency room, got x-rays, CT scans, blood workup, etc. All results normal.  Patient experienced undetermined cause of loss of mobility. 5 weeks later, patient was still unable to stand up on own, pain unbearable. No pain pills provided, just ibuprofen, Chiro adjusted her 3 times/week since, ice every 1-2 hrs, but it only able to alleviate some of the pain. Patient also reported something else going on with nerves. Patient needed to see a Nerve specialist. She was completely healthy/running/walking on day of shot and next day forward, completely disabled in lower extremities. Patient reported that she knew Shot 1 had done something damaging to her nerves. Adverse event start date was reported as 15Apr202110:00 AM, which resulted in Doctor or other healthcare Professional office/clinic visit, Emergency room/department or urgent care. Other treatment information was unknown. Patient did not have covid tested post vaccination. The report was assessed as non-serious. Outcome of the events was not resolved.
Information has been received from a physician concerning an 82 year old white female pt with no known medical history who on 11/6/01, at 09:30, was vaccinated SC, in the left arm, with the 1st dose of pneumococcal vaccine 23 polyvalent (lot 641115/1159L). There was no illness at the time of vaccination. On 11/6/01 (previously reported as 11/7/01), the pt experienced a bad reaction which included severe swelling and redness. The pt was seen in the ER. There was no relevant diagnostic tests or lab data. The reporter expressed a concern with the lot number. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. The pt's husband (WAES 01111065) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. F/U information received on 5/9/02, stated that the pt recovered, on an unspecified date. There was no disability or long-term adverse effect noted. No further information is available.
Patient was diaphoretic with hives around neck, face, and back. Breathing fast. Indicated that she had the vaccine (shot) a few minutes before. Also felt dizzy and light headed. An Epi Pen was prepared ("yellow" as requested by patient and as indicated by patient's weight). Paramedics were called as patient felt like she was going to pass out. She was placed on the floor. The hives improved soon after the Epi Pen was administered and her breathing slowed. Blood pressure was 164/40. Paramedics started O2 and took her to ER.
Headache; Dry mouth; Light headed or Dizzy; Not able to fall asleep; lost 11 pounds; Anxiety; This is a spontaneous report from a consumer (patient). A 55-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in an left arm on 06Feb2021 14:00 (lot Number: EL9263) for COVID-19 Immunisation. Patient medical history included allergy to Sulfa (Sulfonamide allergy) from an unknown date. Patient was not pregnant at the time of vaccination. Patient received concomitant medications (unspecified products) . Patient previously received the first dose of BNT162B2 on 16Jan2021 (lot number: EL1283) in the left arm at single dose for COVID-19 Immunisation. List of other medications the patient received within 2 weeks of vaccination was said available but not reported. Prior to vaccination and since the vaccination the patient was not tested with COVID-19. The patient experienced anxiety, lost weight (lost 11 pounds), insomnia (not able to fall asleep), lightheaded or dizzy, dry mouth, headache on 09Feb2021 03:00. The adverse events resulted in doctor or other HCP office/clinic visit. Treatment was not received for the events. The outcome of the all the adverse events was not recovered (still ongoing at the time of reporting).   No follow-up attempts are possible and no further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reporter information was updated (name was added, county removed, updated reporter phone number format and Email address added). Patient details were updated (name, patient race, patient address added). Relevant Med History and historical vaccine were added. Suspect product was recoded as BNT162B2 as a company product. Start time of vaccination added and dose number updated to 2. Vaccine Facility Information details captured. Physician Office Visit was reported for all events. Event onset time added. Treatment received captured as no. Concomitant Therapy updated as yes in corresponding data field. Anatomical location of vaccination was updated as left arm. Narrative was updated to reflect that events resulted in doctor or other HCP office/clinic visit. Stop date and time of vaccination was populated with 06Feb2021 14:00.
immed hive @ inj site;took DPH & topical cortisone cream;some chest tightness about 4hrs later; resolved;only some soreness as of 15NOV94;
PT FAINTED FOR A VERY SHORT PERIOD OF TIME AFTER RECEIVING BOTH DOSES OF VACCINE. TOTAL TIME APPROXIMATELY 30-45 SECS. PT RECOVERED PROMPTLY, WAS GIVEN WATER AND SENT HOME AFTER A PERIOD OF OBSERVATION.
Significant lymph node swelling under left arm (left arm was injection site)/less severe lymph node swelling in jaw and neck; pain and discomfort; pain and discomfort; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in arm left on 17Feb2021 at 13:00 (at the age of 26-year-old) as 2nd dose, single for COVID-19 immunisation. Medical history included migraine and no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL); spironolactone; ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); isotretinoin (CLARAVIS). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 25Jan2021 at 13:00 (Lot Number: EL3249) for COVID-19 immunisation. On 18Feb2021, the patient experienced significant lymph node swelling under left arm (left arm was injection site). The lymph node under the arm was about the size of a small lemon. She also experienced less severe lymph node swelling in jaw and neck that caused pain and discomfort while chewing and brushing teeth. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was not provided in response to the events. The patient has not undergone COVID test post vaccination. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Sedation, Myalgia, Fever, NauseaVomiting, Chills, Insomnia, Leg twitches, Weakness, Dry eyes, intermittent low back pain, Altered sense of smell  Narrative:  Received 2nd dose on 1/20/21. Later that evening noted fever/chills, sore arm, fatigue and weakness. Despite significant fatigue, had difficulty sleeping that night. On 1/21/21, noted fever (up to 102.5), chills, aches and twitching in legs. Weakness and decreased energy continued through 1/25/21. Additionally noted nausea, dry eyes, intermittent back pain and altered sense of smell. Missed work x 2 days. No known prior COVID infection.    Other Relevant History:
Post vax, on 06/05/2000 the patient developed a rash of vesicular lesions. On 06/06/2000 the patient was seen by a physician. The physician felt that the patient "must have been exposed to natural varicella to have developed a rash so quickly." The patient's mother denies exposure to natural varicella. At the time of reporting the patient continued to develop 3-4 pox every day. Additionally it was noted that the patient's mother and father also developed similar experiences. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (So weak. could not get up), URINARY INCONTINENCE (pea in her pants), VACCINATION COMPLICATION (had a reaction), VACCINATION SITE INDURATION (it was hard to the touch) and HEADACHE (excruciating headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ASTHENIA (So weak. could not get up), URINARY INCONTINENCE (pea in her pants), VACCINATION COMPLICATION (had a reaction), VACCINATION SITE INDURATION (it was hard to the touch), HEADACHE (excruciating headache) and VACCINATION SITE PAIN (Injection Site hurt). The patient was treated with HYDROCODONE on 19-Feb-2021 for Adverse event following immunisation, at a dose of 1 dosage form. In February 2021, ASTHENIA (So weak. could not get up) had resolved. On 21-Feb-2021, URINARY INCONTINENCE (pea in her pants), VACCINATION COMPLICATION (had a reaction), VACCINATION SITE INDURATION (it was hard to the touch), HEADACHE (excruciating headache) and VACCINATION SITE PAIN (Injection Site hurt) had resolved.            No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant follow-up Telephone Contact Report received and event outcomes updated to recovered since the patient stated she was fine.
Employee developed itching in throat, itching all over body, throat closing within 15 minutes after receiving influenza vaccine.  Was taken to hospital - received Zantac 50mg iv, Benadryl 50mg iv, Solu-Medrol 125mg iv.
Noticed red blotchy rash around injection site 3cm in diameter; Noticed red blotchy rash around injection site 3cm in diameter; Her throat was feeling a little swollen without difficulty swallowing or breathing; This is a spontaneous report received from a contactable pharmacist (reporting for a patient). A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular in the left arm on 25Jan2021 13:15 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's medical history was unknown. The patient had no known allergies. It was unknown if the patient had COVID prior to vaccination. It was unknown if the patient was pregnant at the time of vaccination. The patient's concomitant medication was unknown. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscular in the left arm on 04Jan2021 12:45 (at the age of 31-years-old) as a single dose for COVID-19 immunization; the patient had no reaction to the first dose. On 25Jan2021, the patient noticed a red blotchy rash around injection site 3 cm in diameter at 13:15. She was treated with diphenhydramine hcl (BENADRYL) 25 mg orally one dose. Her throat was feeling a little swollen without difficulty swallowing or breathing (also at 13:15 on 25Jan2021). She reported similar reactions to bee stings. At 13:25, the rash was almost gone, her throat was feeling better, and she ambulated independently to her vehicle. The clinical outcome of the events was recovered on an unspecified date in 2021.
01-27) pm Started HA and fatigue 01-28) Sore arm, swelled and hot from deltoid to elbow. 103.4 temp, severe joint pain, nausea 01-29) Red streaks on deltoid towards elbow,continued HA and temp. Seen APN at clinic who recommended ice, OTC pain meds and benadryl. Temp 99 01-30) Severe arm pain all day and night. Fatigue and body aches 01-31) Red streaks continue but spread to chest and neck, body aches fatique and 102 temp 02-01-21) arm pain with sunburn feeling. 0 temp body aches 02-02-21) arm feels sunburned with itching. Red streaks better. Fatigue & body aches continue 02-03-21) feeling better. Arm looking better. Still has HA
I developed a sore arm. The next day I was very sore, extreme fatigue, muscle aches and feeling "out of it". Emotionally I felt very jumpy and irritable which is very much not like me. For two weeks I stayed in bed. I did not take anything to help elevate my symptoms.
The next day, just after the 24 hour mark, I began she ran a fever that elevated up to 103.7° for about 8 to 10 hours. The reaction caused severe joint pain. The joint pain has continued, a little less severely since then.Also, I have had to increase my basal rate buy three times as much to keep my blood sugar levels stable and down.
Information has been received from a licensed practical (vocational) nurse referring to  unspecified patients of unknown age and gender. There was no medical  history or concurrent condition reported. On an unknown date the unspecified patients were vaccinated with ROTATEQ (lot # K022993, expiry date 20-JUL-2016) (dosage, strength and route were not reported). There was a temperature excursion that resulted in the vaccinated being stored improperly. There was no concomitant medication reported. At the time of the report, no adverse event was reported. Additional information has been requested.