chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE SPOT; This spontaneous report received from a patient via a company representative via social media concerned a 73 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on MAR-2021 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 patient experienced sore spot (Dose number in series 1). Patient stated that, "My husband and I got the J&J last March. I was 73 and hubby insisted 80s. We barely had a sore spot. So glad we got that one. And so far no breakthrough covid. Recently had a Moderna booster. So far so good." The patient received additional non-company suspect vaccine MRNA 1273 (Dose number in series 2) (form of administration, route of administration, and batch number were not reported) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. No adverse events were observed following vaccination with MRNA 1273 (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore spot was not reported. This report was non-serious. This case, from the same reporter is linked to 20220212947.
Pt. comes in with  mom, low grade fever last night and seemed confused after immunizations yesterday Patient was his usual self prior to receiving vaccines yesterday. He received Hep A and MMR #2. She stated upon leaving him and when putting him in his carseat and seemed confused. He was saying things that were not making sense and he was acting out of it. He was asking her to bring him back in clinic and how much he liked it here. He felt warm to her and temp at home was 99. While driving he fell asleep so she pulled over and he immediately woke up. She stopped to feed him and he ate well and then he was his normal self again. He had a good breakfast morning of vaccines. When he got home he complained of feeling like he was going to vomit. She recalls speaking with his previous pediatrician about similar experience following his one year vaccines. She also recalls him having fever and rash 2 weeks after those vaccines. Reviewed his chart and called 2 days after his vaccines with fever. Then phone call couple weeks later on 3/11/16 with rash.
It was reported in a published article that a 14 year old white male who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. It was reported that the patient's initial presentation involved inflammation of the ear, costovertebral joint, epiglottis, and ball of foot. A diagnosis of relapsing polychondritis was made through a biopsy of the ear. The patient was eventually controlled on oral steroids and methotrexate. Simultaneously the patient's immune status was evaluated and a noted progressive decrease of the IgG2 occurred. Eventually the subclass reached 45mg/dl and functional responses to polysaccharide antigens failed. The occurrence of a pneumonia with multiple drug resistance pneumococcus inspired the use of monthly IVIG therapy. The patient has been stable from an infectious and autoimmune aspect since the initiation of IVIG. The current drug regime of methotrexate and IVIG has successfully placed the patient into a state of remission. Measurement of the patient's serum IgM and IgA reveal if this patient will progress to common variable immunodeficiency. Relapsing polychondritis was considered to be an other important medical event (OMIC). Additional information has been requested. A copy of the published article is attached as further documentation of the patient's experience.
Pt states she started feeling flushed, started getting hives around neck, and tightness of the right leg
Hives developed evening of shot. Still spreading. complained stuffy ear. When she eats goes straight thru. Will try diphenhydramine to see if this helps with hive. Will follow up tomorrow.
This spontaneous report was received from a other health professional (nurse) refers to a 7 year old male patient. Patient's current condition was reported as pneumonia and no drug allergies were reported. On 28-JAN-2009, the patient was initially vaccinated with M-M-R II dose 1 (lot # and expiry date unspecified) subcutaneous. On 02-DEC-2011 the patient was vaccinated with M-M-R II dose 2, .5 ml, (lot # J0005846, expiry date: not specified). Other suspect therapies included influenza virus vaccine (manufacturer unknown). Concomitant therapies included albuterol. On an unknown date, reporting nurse stated that she was notified by an unspecified nurse that patient was administered two vaccines too close together and the school was considering the vaccines invalid. On an unknown date, reporting nurse stated that patient had no adverse effects to report as a result of receipt of the two vaccines. On an unknown date, after she read patient's chart, she reported that patient had developed bacterial pneumonia, diagnosed on 10-DEC-2011. Patient had been experiencing cough for unspecified amount of time prior to diagnosis. On an unknown date, patient was treated with amoxicillin and was started on FLOVENT HFA 44, twice a day. Outcome of the events were not reported. No product quality complaint (PQC) was reported. On an unknown day, reporting nurse stated she does not believe these events to be connected. Additional information has been requested.
Nausea, Dizziness, Chills/Hot Flashes, general tiredness.
Patient received vaccine at an on-site flu clinic and experienced no symptoms at the time. Two months after the immunization, the patient passed away.
PATIENT PRESENTED WITH SWOLLEN RIGHT UPPER ARM BELOW THE DELTOID MUSCLE BUT ABOVE ELBOW. SHE HAD NOT TAKEN ANY TREATMENT, COUNSELLED TO TAKE SOME BENADRYL AND IF SYMPTOMS PERSIST SEEK MEDICAL ATTENTION.
WAS NOT GIVEN COVID DOSE 1.  It was reported that I had received it.  Error on the part of the volunteers.
This spontaneous report as received from a Medical Assistant refers to a 4 year old patient. On 25-JUN-2014 the patient was vaccinated with (Oka-Merck) PROQUAD (lot # K004418, expiration date 25-SEP-2015, dose not reported) subcutaneous. There was no concomitant medication reported. The Medical Assistant reported that the (Oka-Merck) PROQUAD administered to the patient was improperly stored, it was exposed to 18F for two hours. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
immediately after the injection the injection site was sore. The injection site still remains sore 3.5 days later. Approximately 7 hours after the injection (6:45pm), physical exhaustion set in; mental state was wide awake (thinking about everything/mind racing), however. Approximately 1 hour after the exhaustion began, slight fever and chills started.  By 9 pm the fever and chills increased to the point of teeth chattering and touch to the body felt raw.  Throughout the night, the fever and chills continued.  Sleep was mixed with pain in the legs and restlessness, coupled with a mild headache.  In the morning, the headache increased, but the chills subsided and the fever had broken (8am); slight nausea.  Eating food seemed to keep the nausea at bay; body exhaustion still existed.  headache subsided by the evening. no further chills/fever symptoms.  1.5 days for major adverse symptoms.  Soreness at injection is still continuing (no discoloration or lump, just soreness).  no vomiting, diarrhea, migraine  perhaps related, but not sure...my right leg had a broken fibula a month prior, but was ~98% healed.  The evening of the injection, that ankle was swollen to the size when the injury first occurred.  Earlier that day, the ankle had no visible signs of injury (no swelling, discoloration, etc).  In the morning, the ankle appeared as it had the day/week before.
The caller states he still has pain around the head and what not and underneath the caller's jaw; tongue:gave the numbing sensation not a tongue pain.; got a headache, an all around headache; What is more concerning is the tongue has tongue pain; This is a spontaneous report from a contactable consumer or other non hcp.  A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, in Arm Left on 09Jun2021 10:35 (Batch/Lot Number: EW0217) as single dose for COVID-19 immunisation.  The patient medical history were not reported.concomitant medications included Repatha  for cholesterol, start and stop date not mentioned.09Jun2021, the patient had all round headache, tongue pain. The tongue pain lasted for an entire day. the tongue pain had subsided, when he woke in the morning. On an unspecified date, the patient felt like a distant pain around the tongue area. He had pain around the head and underneath the jaw. The pain around head and underneath jaw is not as severe as it was on 09JUN2021. The patient still had pain in his tongue. The patient had Repatha shot for cholesterol earlier in the year and it went straight to the tongue and gave the caller a numbing sensation not a tongue pain. The physician had advised not to take after that first time, suspecting tongue swelling.10 minutes after the vaccine the patient felt tongue discomfort and he had to wait 15 minutes after vaccine and he started to feel the pain in tongue and headache all round. Th patient second dose was scheduled in coming weeks and he was wondering whether he should take a the second dose. The patient also stated that the tongue pain had improved but still has like as if the caller has connected like a sinus kind of pain around head and it is connected with the tongue. The patient's headache started about an hour after receiving the first dose Pfizer Covid Vaccine.  The headaches are ongoing but are not as severe as 09Jun2021.  The outcome of the events headache and tongue pain was recovering and other events outcome was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Woke 08/19/2011 - red "bumps" on hands, leg, buttock. Took child to physician - stated probably reaction from varicella shot. Told parent to keep child out of school until 08/22/2011. Low grade fever.
No adverse event; Received Expired Monovalent Booster; Received Monovalent Booster instead of Bivalent; This spontaneous case was reported by a phlebotomist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster), WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster) and WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster), WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received Expired Monovalent Booster) and WRONG PRODUCT ADMINISTERED (Received Monovalent Booster instead of Bivalent).    No Concomitant medications were provided.  No treatment medications were provided.  This case contains information for the 1st of 2 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-661317 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661317:2nd adult patient case
Fever beginning four hours after administration. Fever of over 103 for the next 52 hours. Severe upper arm pain, unable to lift arm past 90 degrees. Rash appearing on entire upper left arm on 4/15/19. Symptoms improved the afternoon of 4/15/19 after doctor prescribed steroids to stop reaction.
Reporter has observed more local reactions with this particular lot than with previous lots. Local erythema seemed to be more severe with this control number.
PATIENT CAME TO PHARMACY ON 08/17/21 FOR SECOND DOSE OF PFIZER.  PATIENT REPORTS BODY RASH ALL OVER HER BODY. TOOK BENADRYL TO HELP WITH SYMPTOMS (ITCHING). HAD DIFFICULT SLEEPING THAT NIGHT. DUE TO REPORTED SIDE EFFECTS, SECOND DOSE WAS NOT GIVEN.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this patient (gender not specified) was reported to be  1) 22-JUL-2016.  [Date as reported.] No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
First vaccine given on 1/21/2021. The local Pharmacy. Moderna. Lot: 041L20A. Given Intramuscular in Left arm
headache, muscle aches, pain at injection site, sensitivity to touch--prickly skin, severe elbow and shoulder pain--both sides, insomnia, 100 degree fever approximately 18 hours after shot, treated successfully with acetominophen.  Symptoms still present 24 hours
Initial reaction after the injection: Sore left shoulder, stiffness that continued for 2 days 04/12/2021 The patient went to the ER  for left chest pain 04/15/2021 Chest CT obtained with pleuritic chest pain diagnosis CTA report: several pulmonary emboli in the left lower lung with lingular infiltrates; 04/15/2021  - 04/16/2021 admission to Hospital ER for pulmonary embolism and infarction 04/15/2021 admitted to hospital for observation for pulmonary emboli with hemoptysis He was started on Eliquis which he has tolerated.  There was hemoptysis during this time and after admission.  He experienced an increase in left-sided pleuritic pain followed by improvement after being on the Eliquis for several days.  He continues to have discomfort with deep inspiration however asymptomatic with regular breathing and has been able to return to many of his routine activities.  Started Eliquis 10mg twice daily x7 days, followed by 5 mg twice daily
could not breathe; Wheezing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medication(s) not reported. Patient stated had a bad reaction to the vaccine (Unspecified vaccine) got. Patient had the real problems, sated had to go to the Emergency Room and they gave patient prednisone and Aleve as treatment and they did whatever they could because patient could not breathe and afraid to take the second shot that required. From that time patient had been wheezing and had to take inhaler. Patient doctor said actually taking the prednisone depresses the immune system, so patient did not get lot of effects of it because used prednisone every time to breather. The event outcome for events was unknown.
Pt walked in day after vaccine to show local reaction: 5x7 area of firm redness, not overly tender or warm, do not suspect infection.  Arm is very sore but not with reduced range of motion use. Unknown how quickly the redness developed as patient did not see it until the Band-Aid was removed today.  Upon review of administrating provider's note, the pt was informed of all possible reactions and advised to wait in clinic area for 15 min for observation.
Pt recvd 2nd dose of Hep B vax 11APR91 & approx 30 mins p/vax pt became flushed & devel rash across chest; also felt wheezy & had a cough; over the next 25minutes given meds; pt adm to hosp & d/c following day; 18APR91 readmitted to hosp;
Patient was given the Meningococcal B vaccine earlier than the recommended age. She did not have any adverse reactions.
itching on wrist; rash behind his left wrist; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th October 2020, 2 days after receiving Shingrix, the patient experienced pruritus and rash. On an unknown date, the outcome of the pruritus and rash were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed a rash behind his left wrist with itching which has not resolved. The reporter consented to follow up.
This spontaneous report was received from a physician via company representative concerning a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient received, as stated "GARDASIL 9 and MENACTRA concomitantly" (dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported). Other suspect therapies included MENACTRA (dosage schedule, route, anatomical location, lot number and expiration date were not reported), which was administered concomitantly with GARDASIL 9. On an unknown date the patient experienced prolonged menses. The outcome of the event was unknown. The reporter did not provide the causality assessment between menorrhagia and the suspect therapies. No further information provided.
This spontaneous report as received from a physician via a company representative refers to a 16 year old patient of unknown gender. Pertinent medical history and drug reactions or allergies were not specified. On unknown dates, the patient had either 1 or 2 doses of VARIVAX administered (frequency, route, anatomical location, lot numbers and indication were not reported). Concomitant medications were not specified. On an unknown date, at least 2 years later (after the vaccination) the patient developed zoster-like vesicles on the foot. The outcome of zoster-like vesicles on the foot was reported as recovered on an unspecified date. The relatedness between the zoster-like vesicles on the foot and VARIVAX was not reported. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 61 year old female patient. The medical history and concurrent conditions were not reported. Concomitant medications were none. On 12-APR-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. Approximately on 12-APR-2016, couple of hours later the patient developed redness at the injection site, nauseous, diarrhoea and loss of appetite. No treatment was rendered. No lab tests were performed. The outcome of the events were reported as not recovered/not resolved. The patient sought medical attention. Additional information has been requested.
Tachycardia, headache, fever 102.1, nauseated, chills, fatigue
Delayed injection site reaction that occurred 8 days post vaccination, erythema, increased warmth, and induration
This spontaneous report as received from a nurse practitioner refers to a 21 year old female patient who was not pregnant a the time of the report. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On an unknown date the, patient was vaccinated intramuscularly with the first dose of GARDASIL. On unknown dates 2 and 6 months after the initial dose, she received booster doses of GARDASIL (dose, lot# and expiration dates were not provided). The patient has all three doses of GARDASIL, but on an unknown date, she showed positive for either HPV 16 or HPV 18. The nurse could not remember which strain. No treatment was given for the adverse event. The patient sought medical attention via visiting the nurse on an unknown date. The nurse said that the patient had no intercourse prior to starting the vaccine. However it was not certain whether or not she became sexually active during the vaccination period. The outcome of the adverse event was reported as not recovered. Causality assessment was not provided. Additional information has been requested.
Day 1 - could barely lift arm it was so sore Day 2 - woke up with headache, dizzy, and really tired Day 3 - felt a little tired, went to a them park with rides and BLACKED OUT 4 times  My daughter is an extremely healthy super athletic 16 year old kid that just started her Junior year of High School. I am worried about her brain, blood clots, and what else the COVID vaccine may have done to harm my daughter vs protecting her from COVID. Please call me. Thank you,
gave a vaccine that had not been diluted yet. She stated she gave all 6 doses to the patient.; gave a vaccine that had not been diluted yet. She stated she gave all 6 doses to the patient.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown" and all described as "gave a vaccine that had not been diluted yet. She stated she gave all 6 doses to the patient.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My mother took the Pfizer vaccine on 08/28/2021 and complained about chest pains a few days after. It got so painful that she contacted EMS on 9/03/2021 and was transported to the emergency room at Hospital for chest pains. She was released later on that day but the pains persist. On the day of 9/04/2021 my mother was found in her bedroom deceased. I had an examination performed on her body and it was found that she passed away due to a heart attack. My mother has never had any heart conditions before, she was vaccinated and not even a week later she was found dead.
Increase hives, redness, swelling bilateral arms/shoulders radiating down arms.  Sites of Menveo and Adacel.