chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with Exocrine Pancreatic Insufficiency; Hemoglobin started going down like crazy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EW0186) 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; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: PANCREATIC FAILURE (medically significant), outcome "unknown", described as "Diagnosed with Exocrine Pancreatic Insufficiency"; HAEMOGLOBIN DECREASED (non-serious), 3 months after the suspect product(s) administration, outcome "unknown", described as "Hemoglobin started going down like crazy". The patient underwent the following laboratory tests and procedures: Haemoglobin: going down, notes: hemoglobin started going down; Positron emission tomogram: Diagnosed with Exocrine Pancreatic Insufficiency, notes: Had to pay to get a PET scan that wasn't covered. They were looking for endocrine tumors; Pancreatic enzymes: Pancreas stopped producing enzymes. Clinical course: Patient had to take pancreatic enzymes now for the rest of his life. Everything started 2-3 months after receiving the Pfizer COVID-19 Vaccines.
Pt had fever the day after vaccine was administered. On 9/23/00, he broke out with fluid-filled sacs on his groin area, face and chest and scabbed on his face.
Symptoms/side effects began about twelve hours after second dose vaccine injection. Symptoms began weak to mild and increased to severe over the next twelve hour period, then subsided with no apparent lingering affects. Symptoms and side effects included body chills - becoming severe, mild body aches, strong headaches, very vivid hallucinogenic dreams that included strong physical stimulus, poor sleep and awoke very confused and disoriented, and strong fatigue. Weak soreness around vaccination site, notable less so than first vaccine dose, and no noticeable underarm lymph node swelling like first dose.
flu shot gave the flu and it killed; Initial information was received on 08-Nov-2020 regarding an unsolicited valid serious case from a non-health care professional via media.  This case is linked to case 2020SA314784 (same reporter).  This case involves a female patient of unknown age who was vaccinated with INFLUENZA VACCINE and it gave flu (influenza).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE. This event was was leading to death.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  It was unknown if an autopsy was done and as per reporter the cause of death was flu.  Information on the batch number was requested.; Sender's Comments: This poorly documented media case concerns a female patient of unknown age who died due to Influenza, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, allergic history, autopsy result and laboratory investigations ruling out alternative etiologies are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: flu shot gave the flu and it killed
Pt developed generalized chickenpox with 20 lesions mainly on his trunk, head and legs. Pt was afebrile. The pt sough medical attention. The reporting physician expressed concern with the vaccine lot. At the time of reporting, the pt's condition persisted. Additional information has been requested.
She woke up on 11/21/2021 with swollen lips, hands and feet.  No other apparent symptoms.
5/13 vaccination, 5/14 Woke up, her bottom lip was swollen and darkened in color; almost purplish. Her upper lip had a rash between the lip and the nose. That night, I gave her children's Benadryl. 5/15 administered benadryl again. 5/16 She seemed better but as the day wore on, her rash got worse, she complained that her lips were itchy and that they hurt. 5/17 same symptoms. Her mouth got progressively worse and sought medical attention. The dr. stated he didn't really know what was happening, if it was related to vaccine? 'just keep monitoring', keep with the zyrtec morning and night, don't delay 2nd shot. 5/20 symptoms disappeared.
After the vaccination, patient proceeded to sit on the chair. After about few minutes, patient fainted. Patient eventually recovered after about 10 minutes. Upon my questioning afterward, before receiving the vaccine, patient felt dehydrated.
administrated subcutaneously with the second dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 9H3Z4, expiry date 27th August 2022) for prophylaxis.   On 29th April 2021, the patient received the 2nd dose of Shingrix (subcutaneous). On 29th April 2021, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional information was provided as follows: The patient received a dose of Shingrix subcutaneously instead of intramuscular route which led to intramuscular formulation administered by other route. No adverse event was reported. The reporter consented to follow up.
I have been having shortness of breath since the a few days after vaccination. Have been in Urgent Care twice and the ER once. They dismiss it as asthma because of my history but no asthma medication works plus it feela different. My regular Dr. said it was the vaccine.
Tea-cup size rash on left side of neck. Postules are grouped, itchy, and sore to the touch.
Rash; Felt tired; Chills; Nausea; Fever; swelling of axillary lymphnodes; Flushing in the face; High blood pressure; Increase pulse; Chest pain; Sweats; Chest discomfort; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing in the face), HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase pulse), CHEST PAIN (Chest pain) and HYPERHIDROSIS (Sweats) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included High cholesterol in 2007 and Acid reflux (esophageal) in 2018. Concurrent medical conditions included Hypertension since 2007 and Sulfonamide allergy. Concomitant products included LISINOPRIL and AMLODIPINE for Blood pressure high, ATORVASTATINE [ATORVASTATIN] for Cholesterol, OMEPRAZOLE for Reflux gastritis.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 16-Feb-2021, the patient experienced FLUSHING (Flushing in the face), HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase pulse), CHEST PAIN (Chest pain), HYPERHIDROSIS (Sweats), CHEST DISCOMFORT (Chest discomfort), FATIGUE (Felt tired), CHILLS (Chills), NAUSEA (Nausea), PYREXIA (Fever) and LYMPHADENOPATHY (swelling of axillary lymphnodes). On an unknown date, the patient experienced RASH (Rash). At the time of the report, FLUSHING (Flushing in the face), HYPERHIDROSIS (Sweats), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown and HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase pulse), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (arm pain), CHEST DISCOMFORT (Chest discomfort), RASH (Rash), FATIGUE (Felt tired), CHILLS (Chills) and LYMPHADENOPATHY (swelling of axillary lymphnodes) had resolved.            Treatment medication included Benadryl and Tylenol.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-015889 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Reporter details, patient details, concomitant medications and outcome was updated
Vaginal ulcers; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 25-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 06May2021 (at the age of 25-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient had no known allergies. The patient concomitant medication included ethinylestradiol, norethisterone acetate (MICROGESTIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four week. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced vaginal ulcers on 08May2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received Valtrex as treatment medication for the event vaginal ulcers. Outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Progressive SOB, dizziness, circular blotchy white/pink rash on chest, redness on arms. SOB got worse -> gave epipen, called ambulance. Pt got better 10 min later father pick up to go home. BP 140/80 HRPP following epi pt was seated which contributed to rxn (see back for more info). Pt returned to pharmacy 10 minutes after receiving flu shot (FLUVIRIN) complaining of dizziness and shortness of breath. I told pt to sit down, gave cold wet towel in ziplock bag to put on forehead, told to put head between knees. Also in few minutes I gave her icepack wrapped in teeshirt. I told her to take off coat to help breath - she said is getting worse. I noticed circles forming on chest and becoming more pronounced and redness on arms. Pt said he did not have those circles before. I told tech to call 911 and I was sitting with pt - she was getting worse - shaking, saying SOB getting worse. I administered epipen 1 dose in thigh - pt was sitting. Within 5 min ambulance arrived. They were going to give her BENADRYL but then few minutes later she was feeling better so they decided not to. They offered to take her to the hospital. 10 min later her father came to window and told me that pt was doing better, he said he saw this circular rash this morning but pt told me and paramedics that she did not have it before and that was why combining with progressive SOB and rash I thought it was allergic reaction. Her BP after epipen was 140/80 hr 80. After epi injection breathing slowly returned to normal. Pt was scared and I think it contributed to the reaction. Pt's father told me that pt was feeling ok and decided not to go to ER and just home to rest. I called pt home twice at 6 pm and 8 pm to check on her - she said she was back to normal. Pt stated that arm was not sore but a little sore at EPI pen injection site. I told pt to follow up with MD tomorrow in case reaction returns. I called and left message for supervisor regarding incident.
10 being worst pain ever experienced. Left shoulder pain (8+) started morning after injections. Pain continued that day and next day. Shoulder and arm weakness persist x 7 day. Improving slowly. Started having "shock like" feeling down down both arms on May 16th with sensitivity especially to cold. Improving slowly. Taking ibuprofen with some relief.
This spontaneous report as received from a nurse refers to an unspecified number of patients with unspecified demographics. Approximately in 2014 (reported as unspecified dates since 13-FEB-2014 and prior to 14-APR-2014), the patients were administered doses of GARDASIL injection which were improperly stored. Concomitant therapy was unspecified. No adverse events were reported. No product quality complaint was involved. Therapy with GARDASIL was continued. The outcome of improperly stored GARDASIL administered was unknown. No further information was provided. This case is linked with MARRS # 1404USA008845 and MARRS # 1404USA011761 as same reporter link. Additional information has been requested.
Local reaction to injection site. Periorbital and perioral reaction on right side within 10 minutes of injection. Give 50mg BENADRYL and swelling went down.
Information has been received from a physician concerning a 42 year old female with asthma, glucose intolerance, elevated blood sugar and allergic reaction to Quinolone antibiotics who on 06-JAN-2011 was inadvertently intramuscularly vaccinated with a first 0.5ml dose of GARDASIL (Lot #: 1560Z, expiration date: 28-APR-2013), a Pregnancy Registry Product. At that time, the patient stated her last menstrual period was 17-NOV-2010. Concomitant therapy included PULMICORT, RHINOCORT, VENTOLIN and BENADRYL. The patient was in the office for a routine OB/GYN visit for her pregnancy, and she was supposed to receive the flu vaccine. However, GARDASIL was administered by another physician instead. No adverse effects reported. The patient sought an unspecified medical attention. Blood tests were performed but no results reported. The patient's last menstrual period was reported as 17-NOV-2010. The estimated delivery date would be 24-AUG-2011. Follow up information was obtained stating that this was a case of wrong product grabbing off the shelf by mistake. There was no product confusion involved. Additional information is not expected.
20 minutes after injection of vaccines, patient was noted to have first some redness around the site of PENTACEL injection and then urticarial like reaction around the sites of both sets of injections and on his abdomen. Positive dermatographia with these noted. He was given 3mL BENADRYL in office. Lips and tongue normal. Breathing normal. Normal pulses. Repeat BENADRYL 3mL every 6 hours as needed.
4 days after vaccine she developed hives and itching on her face, chin and the back of her neck.
Arm red from elbow to shoulder w/lump, hot to touch-temp up to 104; hallucin-and surg 29JUL92 sterile abcess;
Postive COVID-19 case after being fully vaccinated, breakthrough infection. Patient developed COVID-19 on 11/3. Patient has not recovered from COVID-19 infection. Symptoms began on 11/1 and patient tested positive for COVID-19 on 11/3. Symptoms include severe fatigue, severe headache, nausea, vomiting, chest pain, upper respiratory infection, difficulty breathing, sinus infection,  cough and nasal congestion. Symptoms have persisted since 11/1 until the date of this report, 11/9. Patient continues to have severe headaches, fatigue, and vomiting. Patient  is also experiencing loss of taste and smell.
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 44-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 29Apr2021 as dose 2, single (Lot number: EW1075), in right arm and on 03Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 44 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Severe sleep apnea" (unspecified if ongoing). Concomitant medication(s) included: FLUTICASONE PROPIONATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Tested negative on days 6,7,8; (2022) Positive, notes: Tested positive on days 9, 10. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Fever - started night after vaccine. Fever lasted 16 days. Parainfluenza type B sputum. Lt lower lobe pneumonia with positive rise in mycoplasma antibodies. Pt well @ time of shot.  8/6/09 Hospital records received DOS 5/15/09 to 5/24/09. Assessment: Mycoplasma pneumonia. Patient initially dx'd with urinary tract infection and viral infection Admitted to another facility. Patient then transferred from that facility due to left lower lobe pneumonia. Patient presents with fever, chills, headaches, nonproductive cough, posttussive emesis, and decreased appetite. Back pain.
This spontaneous report has been received from a licensed vocational nurse and referred to an unspecified number of patients of unknown ages and genders. The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ orally (strength, doses, and frequencies were not reported; lot number M032641 and expiration date 07-MAY-2018) for prophylaxis. There were no adverse effects reported. The vaccine data logger measured a temperature of 0.3°C for a total time frame of 15 hours. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Pt received Tdap vaccine left deltoid at appx 3pm on 1/17/2007.  By 10:00pm, left arm had become extremely painful.  On 1/19/2007 pt began having headache on left side of head, arm continued to be painful.  Pt experienced minimal relief with OTC Ibuprofen.  By 1/20/2007, redness at site began developing, headache, and arm pain continued.  Today 1/22/2007 redness persists;  covering area from shoulder to elbow.  Area is hot to touch.  No lymph node enlargement is noted.  Arm remains extremely painful with movement and is tender to touch.  HA persists but has improved.  Pt has been advised to see family MD tomorrow.
2nd dose injection was roughly given at 10:30am Central time. Fatigue and headache started approximately at 12:30pm, was managed with OTC meds (ibuprophen) and rest. approx 2:00am central time Thursday morning 1/14/2021 I woke with very bad chills, and low grade fever (99.5). Chills continued for approx 10 hours, fever rose to 101.8 within a few hours, and came back down to 98-99 range by 1:00pm same day.  Headache, nausea, issues breathing deeply remained until the next day, after a good night of sleep. Following day no fever, some fatigue, low grade head pains continued for about another day.
Patient received first dose of Moderna on 8/10/21 and the seizure started 8/23/21, patient admitted to Hospital with tonic clonic seizure, underwent neurology work up including CT head EEG, patient started on Keppra. This writer contacted patient and spouse on 8/30/21 and they inquired about submitting a report. The other risk factors they mentioned were exposure to agent orange int he past, prior stroke.
some of the vaccine spilled from the syringe; pain at the injection site; This spontaneous report was received from consumer on 04-feb-2021, concerning a 84 year old male patient who was administered Moderna COVID-19 vaccine ( mRNA-1273). The patient experienced pain at the injection site and reported some of the vaccine spilled from the syringe down his arm.   The patient's medical history and  Concomitant  medication was not provided.. The patient received suspect product  mRNA-1273 on 04-feb-2021, prior to the onset event, the patient received their first dose of mRNA-1273 (lot number:029L20A)intramuscularly on the  right arm for prophylaxis of COVID-19 infection  On 11-FEB-2021 to complete his adverse reaction form and to update Moderna on how he is going to proceed. Patient will get his second injection and will have antibodies after the second Moderna Covid-19 at the direction of his Physician Action taken with the second dose of mRNA-1273  in response to the event was not reported; Reporter's Comments: This case report concerns a 84 year old male patient who was administered mRNA-1273 vaccine Lot# 029L20A and experienced pain at the injection site and reported some of the vaccine spilled from the syringe down his arm. (incomplete dose administered). The event of pain at the injection site is consistent with the known safety profile of mRNA-1273 and temporarily associated with the product use and a causal association cannot be excluded. The event of incomplete dose administered is assessed as not applicable.
Two raised itchy bumps, then they went away, and now there is swelling underneath, at the shot site. It is the same kind of swelling I had for the first three days after the shot. The swelling is about three inches in diameter and feels about as high as 1/4 inch.
pt recvd vax 12OCT95 2PM & exp leg rash that same day about 10PM-rash progressed w/swelling of hands, face & feet; taken to ER; day of inj pt could not walk
Information has been received from a pharmacist who reported that a patient had an unspecified reaction to Pneumovax 23 (Lot # 655053/0743F).  The pharmacist did not have any specifics.  The patient sought unspecified medical attention.  At the time of the report, it was not reported if the patient recovered.  Additional information has been requested.
Pfizer given as 2nd dose of primary series when Moderna was given as first dose. No adverse events with vaccine.
Started with Right ankle pain and swelling. Went to specialist MRI showed degenerative disease. Dr. Gave steroid injection and recommended Rheumatologist.  Hands swelled and  lost grip with pain bilaterally. Saw Rheumatologist failed NSAID therapy for Sero-negative  OA. ON DMARD and other medications therapy.   Will be doing ongoing therapy.
3/3/21 er to hospital admission:  81 y.o. female with a history of Parkinson's in previous stroke.  The patient basically is maintained in the nursing home in this state of being bed-bound and nonverbal.  She was recently transferred to Rehab after she developed a stage IV sacral ulcer at a previous nursing home.  The patient had been seeing wound care and doing very well.  Her stage IV sacral ulcer had been healed to a stage II.  She had been gaining weight.  Unfortunately, at her wound care appointment yesterday the wound had decompensated a little bit and had started to drain some purulent material.  It also enlarged in size a little bit.  I was called yesterday afternoon and the nursing home reported the patient was not wanting to eat or drink.  Lab work showed a sodium of 170 and creatinine consistent with acute kidney injury.  She also appeared to have a urinary tract infection.  Because of her critical labs she was sent to the nursing home.  The patient was evaluated in the nursing home and then admitted to the floor.  She was given Zosyn and vancomycin and started on IV fluids.  The emergency room physician did counsel the family that the prognosis was very grim.  The patient has done reasonably well overnight.  She has been grimacing quite a bit and the family has decided they just want her kept comfortable    comfort care during admission