chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received most recent dose on 09/08/2020; she has a negative titer; This is an AE for an ineffective vaccination; This is an AE for an ineffective vaccination; This spontaneous report has been received from a pharmacist concerning a currently 30 years old female patient. The patient's concurrent conditions, historical drugs and medical history were not reported. The patient's concomitant therapies were reported as none. The patient has no known drug allergies.  On 03-JUL-2020, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection for prophylaxis (Lot # and expiration date were not reported).   On 08-SEP-2020, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneous injection for prophylaxis (Lot # and expiration date were not reported).   On an unknown date in 2020, the patient still presented a negative titer (antibody test negative) after having the aforementioned 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The pharmacist considered this was an ineffective vaccination (drug ineffective and vaccination failure).    At the time of reporting, the outcome of negative titer, drug ineffective and vaccination failure were not reported. The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the events was not reported.
No additional adverse events reported; improperly stored dose of GARDASIL 9 was administered; This spontaneous report was received from a medical assistant referring to a 12-year-old female patient. No information regarding the patients' medical history, concurrent conditions or concomitant medications was provided.  On 21-JAN-2021, the patients were vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (0.5 milliliter, lot # 1621929, expiration date 23-APR-2021 intramuscularly in left arm; conflicting information, previous dose was 3) for prophylaxis (product storage error). The administered dose was exposed to the temperature of 10.13 degrees Celsius (C) for 1 hour. There were previous temperature excursions reported as 9.17 C for 15 minutes and 8.59 C for 15 minutes. The call was because of a digital data logger. The patient did not experience an adverse reaction.  This is one of several reports received from the same reporter. Combination product report: Yes; brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp.; device lot number: 1621929; expiration date: 23-APR-2021; device age and unit: 0 ; operator of device: Health Care Professional; malfunction: Unknown; device usage: Initial; reason for non eval: 81 Other; follow up additional info :Yes; labeled single use device: No; mdcp reportability: No; mdcp rep rationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA006855:
24hrs after FLUMIST given developed melena and hematemesis. Went to ER found anemic, rc'd blood transfusion. EGD done to find source of bleeding. Admitted to hospital w/ GI bleed.
Severe lower back pain.  I am an otherwise healthy 23 year old.  I am 5'1" and 115 lbs.  In the 4 hours that passed after receiving the vaccine I did not do any heavy lifting or bending.  The pain happened gradually and I first noticed it at 11pm, just 4 hours after receiving the vaccine.  I haven't been able to stand or sit for long periods of time.  The pain radiates from my lower back to my hips and sometimes down my legs to my knees.  It is now March 4th, and I still have severe back pain. I have not been to the doctor about this, because I know there is probably nothing they could do about a vaccine adverse reaction and I have no health insurance.
DOSE OF JANSSEN VACCINE GIVEN ONE DAY AFTER PFIZER DOSE; This spontaneous report received from a health care professional (nurse) concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with Pfizer biontech covid-19 vaccine (Tozinameran) (dose number in series 1) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown), was administered on 31-MAY-2022 for prophylactic vaccination. It was unknown whether the patient had any adverse events following vaccination with first dose of Pfizer biontech covid-19 vaccine (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 26-JUL-2022) dose was not reported, 1 total administered on 01-JUN-2022 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2022, The nurse gave a dose of the Janssen covid vaccine to a patient thinking it was his initial dose. After vaccination she discovered that patient had gotten a initial dose of Pfizer mrna vaccine one day prior. She called back to confirm, and the patient agreed that he had Pfizer the day before (Inappropriate schedule of product administration) (dose number in series 2). The patient was kept for approximately 30 minutes after receiving Janssen vaccine and the nurse had not noticed any issues (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose of janssen vaccine given one day after Pfizer dose was not reported. This report was non-serious.
During evening of June 12, 2021, noticed itching in my left arm.  The area was exactly were I received my first COVID vaccination.  Shortly after, a rash appeared and pain accompanied it.  Also, there was a noticeable difference in the arm as the area was hard and hot to the touch.  About 30 minutes after this started, the rash took on a square type figure on my arm.  I would estimate approx 3 in x 3 in area that, again, looks like a reddish square,
1145: Patient complained of minor left eye swelling.  Vital signs 99%, 83, 141/80. 1155: Vitals rechecked 1155 100%, 79, 112/80.  Patient has new complaints of itchy ears, facial "heat", and slight tingling in fingers.    1200: 25 mg of oral Benadryl given. 1211: per RN, patient states symptoms are resolving. 1230: Patient still feels slight eye discomfort, all other symptoms have resolved.  Patient states she feels comfortable leaving vaccination clinic, her son will be taking her home.
sharp pain in right shoulder; Headache; Chills; Fever; This is a spontaneous report from a contactable consumer (reported for herself). A 73-years-old female patient received BNT162B2 (BNT162B2, Solution for injection, Lot Number: ES9261), via intramuscular route of administration in left arm on 02Feb2021 at 08:45 am as single dose for COVID-19 immunization. There were no medical history and concomitant medications. Patient had pain in her right shoulder hit her, then it went up into her head and it was horrible. The pain in her right shoulder in her joint went away when the pain moved to her head. Between 430-5pm the pain started in her head. It was the worst headache she ever experienced. She could not even clear her throat since it felt like the top of her head was going to come off. By 9pm her headache was subsiding, and she had a good night's sleep and had fever and chills. The patient received Tylenol. The outcome of the events sharp pain in right shoulder and Chills was recovered on 05Feb2021.The outcome of the other events was unknown.
A spontaneous report was received from a physician, whose patient (age and gender are unknown) received Moderna's COVID-19 vaccine and experienced to feel ill. The patient's medical history was not provided. No relevant concomitant medications were reported. On Unknown date prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) for prophylaxis of COVID-19 infection. After receiving the vaccine, the patient started to feel ill. Treatment for the event is unknown. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the event is unknown. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
1- Mild cough became severe associated with  shortness of breath starting from second day. Since the symptoms were progressively worsening, on doctors advice took one course of Z Pack (Azythromycin) starting from Wednesday04/14. 2- Still having  mild cough. 3- Having dry upper respiratory passages leading to choking sporadically (once or  twice on some days  day). 4- Vision getting poor noticeable  with watery eyes,  started to feel 3 to 4 days after getting first doze COVID19 vaccination.  Consulted an eye specialist on 04/24, who believes the vision issue is due to cataract  getting progressively worse. As far as I know, cataract does not gets worse over period of 3 to 4 days, so there is likely hood of  some adverse effect of the COVID vaccination.
11 hours after vaccine developed very high fever 39.3 C, chills, feeling nauseous
1 - 2 HRS AFTER INJECTION, PT EXP DIFFUSE RASH, VERY PRURITIC. PRURITUS LASTER MORE THAN 2 WEEKS.
Constant crying started @ 315PM APAP given 11AM & 3PM (time of report 445pm) unable to console has not eaten or slept since vax recvd; mom states pt will not move rt leg; swelling noted;
first dose in January of 2021; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received in January 2021).   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 details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist inquired about if it was okay for the patient to receive their second dose on the day of reporting and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter did not consent for follow-up. No additional information was provided.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (reported as RECOMBIVAX) (dosing details were not reported) lot# L044694, expiry:04-FEB-2018. There were no product quality complaints (PQC) involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT RECEIVED HER 1ST SHOT ON 1/2/21. SHE HAD SOME MUSCLE PAIN THAT WENT AWAY. HOWEVER ON THE 10TH , IN THE SAME AREA SHE STARTED HAVING REDNESS IN THE AREA THAT HAS SPREAD UPTO HER ELBOWS AS OF 1/17/21. PT IS UNSURE IF IT IS VACCINE RELATED OR IF SHE HAS DEVELOPED CELLULITUS . RPH RECOMMENDED THAT SHE TAKE BENADRYL TODAY AND FOLLOW UP WITH HER DR TOMORROW
Patient was administered Pfizer as their second dose. But should have gotten Moderna. Patient was contacted by the pharmacist and has no symptoms 6 hours post administration
Child recv'd 1st dose of Hep A vax on 12/1/99.Awoke after napping & compl. of a sore throat & generalized itching.Child had a very large red area to back & arms;described as looking like a sunburn Tx w/Benadryl;itching & redness stopped.
This spontaneous report as received from a registered nurse refers to a 7 month old patient of unknown gender. Medical history and drug reactions/allergies were not reported. On 26-JUL-2014, the patient was vaccinated with an expired ROTATEQ lot # J002356 expiry date 17-JUL-2014, third dose, oral (dose not reported). Concomitant medication was not reported. No adverse effects reported. This is one of two reports from the same source (1408USA003108). Additional information has been requested.
4 a.m. woke up feeling awful - nauseous - pain in both arms, joints, fever - out of it - vomited - couldn't move for an hour - came to get me at 5 a.m. (my bedroom is close) - fever was rising and quickly climbed to 102 from 100 (less than 30 minutes) - called doctor on call to ask whether ibuprofen or paracetamol/acetaminophen were more appropriate/contraindicated - gave 3 ibuprofen to reduce fever - finally fell back asleep at 7:00+ keeping a close eye out as it's still within 24 hours
Got the shot and it came back.more than once; Came back.more than once; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but selected as an adult as per vaccine indication. The patient reported that got Shingrix shot and it came back more than once. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown at the time of reporting. The information regarding consent to follow up was not reported.
Felt very hot; Fever of 101.6; Chills; Shaking; Really achy; Arm was sore; Did not sleep; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), PAIN (Really achy), PAIN IN EXTREMITY (Arm was sore), SLEEP DISORDER (Did not sleep) and FEELING HOT (Felt very hot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040H21A and 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced TREMOR (Shaking), PAIN (Really achy), PAIN IN EXTREMITY (Arm was sore), SLEEP DISORDER (Did not sleep) and CHILLS (Chills). On 11-Jan-2022, the patient experienced FEELING HOT (Felt very hot) and PYREXIA (Fever of 101.6). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Shaking), PAIN (Really achy), PAIN IN EXTREMITY (Arm was sore), SLEEP DISORDER (Did not sleep), FEELING HOT (Felt very hot), CHILLS (Chills) and PYREXIA (Fever of 101.6) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, Body temperature: 101.6 (High) High.         No concomitant medications was provided by the reporter.   This case was linked to MOD-2022-447941 (Patient Link).
pt recv vax & mom thinks may have gotten something from pt, choking, coughing, sneezing, sore throat;
Patient came to pharmacy 09/12 asking for otc treatment for painful/stiff arm following vaccination. Reported difficulty moving  arm(through husband as translator) and pain with moving. Treating with rest, ice, advil.
itchy; skin problem; redness; sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (itchy), SKIN DISCOMFORT (skin problem), ERYTHEMA (redness) and PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 0R2A21A) for COVID-19 vaccination.     The patient's past medical history included Gastrointestinal disorder NOS. Previously administered products included for Product used for unknown indication: Flu vaccine. Concurrent medical conditions included Hypertension. Concomitant products included LABETALOL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PRURITUS (itchy), SKIN DISCOMFORT (skin problem), ERYTHEMA (redness) and PAIN IN EXTREMITY (sore arm). The patient was treated with HYDROCORTISONE for Itching, at a dose of 1 dosage form and DIMETICONE, GLYCEROL (CETAPHIL [DIMETICONE;GLYCEROL]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchy), SKIN DISCOMFORT (skin problem) and ERYTHEMA (redness) outcome was unknown and PAIN IN EXTREMITY (sore arm) had resolved.            Patient does not have a working computer and requested letter be sent by regular mail to address on file.  Treatment information was included salpicon, antihistamine  by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow up document attached included no new significant information. Data correction made on initial relevant history information and treatment information, event start date were added.
Patient with history of ESRD on nightly peritoneal dialysis and diabetes. He was brought to the ED by EMS on 3/12/23 with shortness of breath and productive cough that has been present for the past three days. Notably, he lives with someone who was recently ill with COVID. When EMS arrived, the patient's O2 saturations were 30% on room air and increased to 80% after being placed on a non-rebreather mask. A COVID PCR test done in the ED also resulted positive. Ultimately, the patient was admitted 3/12/23 - 3/16/23 with discharge diagnoses including acute respiratory with hypoxia and COVID-19. Notably, the patient was on Decadron in the hospital. During admission, eh required BiPAP, but was weaned off oxygen by discharge. Of note, the patient has received the primary COVID vaccine series and one booster dose.
Patient stood up and became very nauseous, started to cough -airway was clear but patient started vomiting. patient vomited  liquid, refused ambulance. Stayed for an hour and before leaving returned to normal face color  and was able to stand and walk on her own with no staggering.
After my 1st vaccine I felt dizzy and experienced headaches. I tested positive for Covid 19 on 12-30-2020.
hyporesponsive episode 48hr p/vax;EEG, LT, LP nl;
felt really bad; nauseated; fever of 101 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt really bad), NAUSEA (nauseated) and PYREXIA (fever of 101 degrees Fahrenheit) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     No medical History was reported.  Concomitant products included MELOXICAM, VERAPAMIL, TOCOPHEROL, UBIDECARENONE, ZINC (COENZYME Q10+) and PRAVASTATIN for an unknown indication.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced FEELING ABNORMAL (felt really bad), NAUSEA (nauseated) and PYREXIA (fever of 101 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) for Pyrexia, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt really bad), NAUSEA (nauseated) and PYREXIA (fever of 101 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, Body temperature: 101 (High) Fever of 101 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had no known allergy.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow-up received significant information - Events Outcome updated.
extreme arm pain, decreased ability to move arm. Pain continued through the week, though less, but worsened 7 days later when hit on arm during sporting event
As soon as needle pricked skin I felt severe itching at injection site (I developed a large red weal after my 1st injection in january). Within 10 min my shoulder was so swollen and sore I couldn't lift it. Went home and took water + emergency for the rest of the day. Nxt morning my entire left side neck and shoulder were in spasm and I had HA. On tues (5 days later) I got acupuncture to try and relax muscles. The next day (wed) I started experiencing fever and chills accompanied by HA and nausea plus lack of appetite. Ibuprofen helps but still tired and achy and feverish today (thurs) if I do not take ibuprofen
57 YOM with h/o peanut allergy developed right hand swelling and redness, as well as facial swelling and "funny feeling in throat" within 1-2 hours of H1N1 injection. No shortness of breath or wheezing; + improvement with BENADRYL. No hospitalization required.
run a low temp 2 days after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (run a low temp 2 days after 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced BODY TEMPERATURE DECREASED (run a low temp 2 days after 2nd shot). At the time of the report, BODY TEMPERATURE DECREASED (run a low temp 2 days after 2nd shot) outcome was unknown. Not Provided          No concomitant medication was provided.  No treatment details were provided.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non-significant follow-up appended to AER