chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Events second day. Swollen, red, "hot" at site of injection. Lethargy, feeling of hopelessness, headache, general feeling of not being well. Husband had injection at the same time on the same date. We both had to lay down the next day. General feeling of headache, tiredness, and "don't care" about anything anymore attitude.
1 week after shot developed an area of redness slight swelling and itching just below the injection site on the right upper outer arm - erythema is 5cm x 3cm. Unchanged for 3days so far.
skin:pale, warm, cyanotic, mottled, ashen. GI: stomach pain, vomit. Neuro: collapse but no LOC, Weak, tremor, lethargic, slow to response. vitals: hr elevated 108, bp 98/60, rr 16.
Posterior vitreous detachment, left eye Sympoms: flashing and floaters in left eye Treatment: exam, but no treatment necessary
Pt came in 4 days after vaccine with an rx for an antibiotic to help with rxn.  Area looked red and swallowen to most of deltoid area on left arm.
the patient may not have received a 3rd dose because of this; whose insurance would not cover their 3rd dose of GARDASIL 9; No additional AE; This spontaneous report was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. The patient's insurance would not cover the patient's third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) since the patient would be over 45 years old by that time (insurance issue). The patient had the possibility not to receive the third dose due to the insurance issue (inappropriate schedule of product administration). No additional adverse events (AE) were reported (no adverse event).
Extremity weakness   Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 78y.o. female with a PMHx significant for Hypertension, CVA, PFO and COPD that presented to the ED for worsening generalized weakness. Although patient was alert and oriented ×3, she is not a great historian. Patient was able to contribute some to HPI but I also obtained information form ED Note and Transition of Care note. According to transition of care note, the patient's sister stated that the patient has been sick for more than a month with cough, loss of appetite and decreased oral intake. It appears to have worsened since the loss of her son. During my encounter patient did endorse that she has had increased generalized weakness and decreased appetite. She stated that she has not been eating or drinking because she is too weak to take care of herself. In regards her cough, she stated that she has had whitish sputum production, but is unsure of how long it has been going on for. Contrary to other documentation, patient denied any abdominal pain, and did not have any pain to palpation on exam. At this time patient denied chest pain, shortness of breath, abdominal pain, nausea vomiting or diarrhea.
My regular Liver Enzyme test results came back elevated. I usually maintain pretty low. The AST is elevated. Alkaline Phosphatase - that was elevated. ALT - also went up. The doctor doesn't have an explanation for the cause. Nurse Practitioner ordered an abdominal ultrasound - showed liver is normal. Bile ducts - are normal. Will do more routine blood tests. With the last test - it came down a little bit but it's still on the top of the normal range. And that is elevated for me. If it goes back up again they may order biopsy on Liver. Another contact number to reach - Nurse Practitioner. Tinnitus - now and starting after the first vaccine I started feeling pressure in my right ear and I started high pitch noise constantly. That high pitch sound still remains in right ear right now. I had also experienced vertigo symptoms sometimes after the first vaccine and I went to ENT March 25 before my 2nd vaccine- ENT did some hearing testing - lost some - had Cortisone shot behind the ear drum - on April 9th and second one was April 16th. After those treatments - I don't have the vertigo anymore. I am on a online group with those who have the Liver Transplants and there are others who had liver transplants who have experienced the high pitch pressure in ears and the vertigo as well.
fine rash on upper torso (mainly chest). Slightly itches. Started the second night after injection
Lymph node in my neck by my collar bone (left side) enlarged and very tender.  (supraclavicular lymphadenopathy)  Began the day following administration of COVID-19 booster at Pharmacy. Tenderness in lymph node and swelling lasted for several days.  Back to normal in about one week from onset. No treatment administered. Did not contact pharmacy or doctor.
they gave a 5 year old child an expired QUADRACEL with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female child patient who received expired diphtheria-15/tetanus/5 Hybrid AC Pertussis/Ipv (Mrc5) Vaccine [Quadracel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Jul-2023, the 5 year old child patient received a dose 1 at a dose of 0.5 ml (TOTAL) of suspect diphtheria-15/tetanus/5 Hybrid AC Pertussis/Ipv (Mrc5) Vaccine suspension for injection (Frequency: once, Strength: standard, expiry date: 06-Jul-2023 and lot C5916AA) via unknown route in unknown administration site for immunization and (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt developed a 5 inch red circle the day after receiving ZOSTAVAX. Also had a band-aid-sized area in the middle of red circle that was hard and swollen. Reaction was decreasing slowly on its own over next several days. Told pt. to use hydrocortisone cream if needed.
SWELLING, REDNESS AT SITE. NO PAIN OR ITCHING. PT SELF MEDICATED W/ BENADRYL, APPLIED COLD PACK TO AREA.
Patient c/o feeling itchy, a little rash, and tension in the back of neck. Vital was taken BP:130/88, HR:71, Oxygen:100. Patient reported allergic to penicillin and spicy food. Patient reported she also received Tdap and IPV-Polio today at  clinic. Patient was given 1 Benadryl and observed another 15 mins and retake vital BP: 126/86. Oxygen 100. HR:72. Patient felt better and cleared by nurse. No EMS.
This spontaneous prospective pregnancy report was received from 31 year old female patient with no medical history, drug reactions allergies or concurrent conditions. On 06-FEB-2015 the patient was vaccinated with an unspecified varicella virus vaccine live (manufacturer unknown) (dose, frequency, indication, lot number and expiration date were not reported). The consumer reported that she received a dose of an unspecified varicella virus vaccine (manufacturer unknown) and subsequently, she discovered that she was 6 weeks pregnant. She took a pregnancy test and the results were positive. The patient last menstrual period (LMP) was approximately on 29-DEC-2014, the estimated date od conception and estimated date of delivery were 12-JAN-2015 and 12-JAN-2015 respectively. The patient contacted her physician and made an appointment. Additional information has been requested.
pt recvd vax; persistent high pitch cry w/ inc t of 104; cry was "sick"
FEVER; This spontaneous case was reported by an other caregiver and describes the occurrence of PYREXIA (FEVER) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced PYREXIA (FEVER). At the time of the report, PYREXIA (FEVER) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
7 days after the injection I experienced itching at the injection site. After 8 hours the itching turned into burning. Arm is still itching and swollen/red 2 inches around the injection site.
pt recvd vax & 3-5 mins later pt crying & stiffening & pale w/quick return to verbal stimuli; VS BP 86/?; pulse 128-130; referred to ER for f/u no local MD could see;
Information has been received from a physician concerning a 13 year old female who on 19-Jul-2007 was vaccinated intramuscularly with the second dose of Gardasil.  It was reported as on "19-Sep-2007" the patient experienced severe headache and high grade fever about an hour after being vaccinated.  The patient sought unspecified medical treatment by being treated with ibuprofen.  The patient recovered at an unspecified time.  Additional information has been requested. Follow-up received 04/16/2008. Patient is (90 lbs. 58 in.) The patient had a history of a rash when exposed to Cefzil. No additional information is expected.
4 days after shot, immune system kicked, body aches, lethargic, tired,  no appetite,  abdominal muscle pain.  Day 4-5 where bad,  stayed in bed.  Day 6 about 50% better Day 6 woke up with tinnitus in left ear- never had previous to shot.  Tinnitus is continuous.  Day 7 about 75% better Day 8 & 9  still not 100%
Information has been received from a nurse concerning a 77 year old male who on 07-FEB-1997 was vaccinated with PNEUMOVAX 23 (manufacturer unspecified, lot # not reported). On 28-NOV-2008 the patient experienced pneumonia described as involved in "left lower lobe". On 25-AUG-2010 the patient experienced asthmatic bronchitis. The patient had a chest X-ray on an unspecified date (result not reported). History of other pneumococcal vaccination was not available at the time of the report. The outcome of the events was not reported. The patient contacted office. Additional information has been requested.
COVID BREAKTHROUGH CASE: Congestion, Runny Nose, lost of taste for 24 hour, lots of sneezing, Coughing, lots of thick drainage, fatigue. Amoxicillin decongestion
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hyperventilation-Severe, Systemic: Seizure-Severe
Massive headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "wheat allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Massive headache".  Additional information: After the 2nd dose the patient had a massive headache. She had been having a progressing wheat allergy and wants to make sure before she gets 3rd dose that this isn't the reason why she got the massive headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 65 year old female patient. The patient's current conditions and pertinent medical history were none. Drug reactions or allergies were none. On 03-JUN-2015, the patient was vaccinated with PNEUMOVAX 23 prefilled syringes (lot # L001311 and expiry date of 06-JUL-2016), intramuscularly. This was the only dose of PNEUMOVAX 23 the patient had ever received. Concomitant medications were none. On 03-JUN-2015, the same day, the patient experienced redness and cellulitis at the injection site. Lab diagnostics studies were none. The patient sought medical attention and came back to the office on 04-JUN-2015 (next day) and received doxycycline as treatment in response to the events. The outcome of the events was reported as recovering. Causality assessment for the events with suspect therapy was not provided. There was no product quality complaint involved. Additional information has been requested.
According to ME office next day after 7 AM bottle baby found dead. Post showed no trauma.  10/24/08 Autopsy report states COD as sudden unexpected death in infancy.  Manner of death is undetermined.  Report also states patient found unresponsive supine in bassinet.
Information has been received from an 86 year old female with blood pressure and a history of shingles in April 2006, who on 07-DEC-2007 was vaccinated with a single dose of series ZOSTAVAX (Oka/Merck) (dose, route and lot # not reported). Concomitant therapy included DIOVAN. On 16-DEC-2008 the patient went to see a neurologist and she thought the test she had was a molecular gram, and from that test she was diagnosed with neuropathy in her legs and feet. The patient was not recovered form the neuropathy in her legs and feet. No further information provided. Additional information is not expected.
Red eyes, slightly sore, beginning June 3, thought it was possibly beginning of pinkeye infection from getting spit in eyes. Visited doctor, he thought it could be slight infection or slight irritation or could just be allergies or dry eye; was prescribed 1 week course of Tobramycin eye drops. Symptoms mostly resolved after Tobramycin treatment but continued to be slightly irritated in eyes; visited optometrist for routine visit June 24 and discussed ongoing eye irritation, she thought it was dry eyes, suggested several strategies to manage chronic dry eyes including lubricating drops and daily warm compresses.
Swelling "the size of grapefruit" in left arm, sore to touch and vomiting on 08/20/20. RPh on duty advised to use ice and OTC pain reliever and monitor for improvement or more severe symptoms. Followed up on 08/21:patient used ice to bring down swelling and after vomiting stopped in the evening of 08/20 was able to use a pain reliever.  Swelling is down, "still a little swollen" and some pain upon touch, no redness reported.
Upon administering Janssen COVID19 vaccine, patient experienced vasovagal syncope approximately 5 seconds after administration.  This occured at approximately 11:15 am on 4/10/21.  After approximately 5 to 10 seconds, patient opened eyes, became alert and was assisted to a sitting position where she was observed for approximately 30 minutes.  Patient left pharmacy and was contacted at 1:10 pm to check up on condition.  Patient said she was feeling fine and was thankful for pharmacy's concern.  Patient instructed to contact pharmacy with any questions or change in status.
Pt vaccinated with DTP developed pertussis - culture & screen positive.  Received 3 DTP's - last one 19JAN90. Treated successfully w/Erythromycin.
Patient received Pneumovax injection.  Had immediate swelling/pain upon arriving home.  Used ice, heat, massage, NSAID's for the past 3 weeks with no improvement except decrease in swelling.  Continues to have limited range of motion and pain.
Severe fatigue; body aches; chills; rash; This is a spontaneous report from a contactable Other HCP (patient). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9261, on 17Jan2021 08:30 at single dose on right arm for COVID-19 immunization. Medical history included Insomnia. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The patient had no Known allergies. Concomitant medications included colecalciferol (VITAMIN D) and hydroxyzine. The patient previously received first dose of BNT162B2 lot number: EL0140 on 27Dec2020 11:15 via Intramuscular route of administration on right arm for COVID-19 immunization. The patient experienced severe fatigue, body aches, chills, and rash on 17Jan2021 22:00. No treatment was received for the events. The outcome of the events was resolving.
The patient broke out in rough purple-like rash approximately 22 hours after the vaccination. The patient had the rash on his arms, chest, back and buttocks. The patient did not have any breathing problems and was afebrile. The patient states she is very uncomfortable due to itching. The patient was treated with Zyrtec, Pforcone and Benadryl.
Initial and follow up information has been received concerning a 36 year old female, who is currently nursing, with no pertinent medical history, drug reactions or allergies who on 30-JUN-2007 was vaccinated subcutaneously with 0.5 mL of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot# 656428/0203U). Concomitant therapy included prenatal vitamins and thyroid medication. On 10-JUL-2007 (also reported as 09-JUL-2007), the patient developed a maculopapular rash on her stomach that spread to her arms and legs. The patient did not have any other symptoms. No lab diagnostics studies were performed. The patient recovered on an undisclosed date. No product quality complaint was involved. Additional information is not expected.
Patient is a recruit in basic training and received the smallpox vaccine. He then began experiencing a rash around 05 days later covering his trunk and arms. Antibiotic and steroid Tx had no effect on rash. Rash causes mild itch but no other side effects occurred.
While after receiving the first shingles vaccine only resulted in a sore arm, this second dose resulted in chills, body aches, headache, nausea, as well as a sore arm.
The very next day (10/28) I experienced severe heartburn which turned into chest pain. Soon, my arm (left) became numb. Next the left side of my face became numb and some of my left toes.
Patient experienced swelling starting the day after vaccine administration. Starting 1.5 inch by 1.5 inch square at 24hrs. At 72 hours most of the upper left arm is swollen down to elbow. Patient will try taking BENADRYL tonight 9/17/17.
has not received his second Shingrix vaccine yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 03 Sep 2022 of shingrix vaccine intramuscular in unknown arm).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date: 19-Jul-2022 Reporters comment: The reporter reported that the patient received his first Shingrix vaccine and did not received the 2nd dose of shingrix vaccine  The reporter did not consent to follow-up. The reporter not willing to shared any demographics except zip code and that was not correct Additional Supportive information:  The Patient did not received the 2nd dose of shingrix vaccine which led to incomplete course of vaccination.
ADVERSE EVENT, NOS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included down syndrome. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced adverse event, nos. The action taken with covid-19 vaccine  was not applicable. The outcome of adverse event, nos was not reported. This report was non-serious.
Pt received Pfizer vaccine on 1/30/21, 2/21/21, 10/6/21, 7/00/22 and he came in for his bivalent booster vaccine. Due to mix up of the Pfizer monovalent and bivalent vaccine- he may have gotten either the monovalent or bivalent Pfizer vaccine.
Headache; Body aches; Fatigue; This is a spontaneous report from a contactable consumer. A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 at 12:15 (at the age of 36 year) as dose 2, single for COVID-19 immunisation at Workplace clinic. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient was not pregnant at time of vaccination. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for COVID-19 immunisation. On 18Feb2021 at 09:00 AM patient experienced Headache, Body aches, Fatigue. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
diarrhea; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 92 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 20Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhoea on an unspecified date with outcome of unknown.    Information of lot and batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.