chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 10:46 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 10:46 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days expiry date vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine administration time was given as 02-Apr-2022 at 10:46:21   No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
I thought I had a sinus infection, went to the doctor and the dr. gave me an antibiotic (amoxicillin). The next day my son came home and said he tested positive for COVID-19. I then went back to the doctor and told him that my son had tested positive and that I think we need to test to be sure. I was tested for COVID-19 and was positive for that and the Flu. I was trying to get the prescription, but the doctor told me it was no need. I then called my PCP and she called in the PAXLOVID and the flu medication. My symptoms were the same as sinus infection things such as postnasal drip and stuffy nose. This all lasted for about three or four weeks. I did drink plenty of water.
2-3 weeks after the booster shot my hands swelled up and then my knees after some days and then my feet and ankles. All my joints (wrists, fingers, elbows, shoulders, jaw, knees and ankles and feet became very painful. By the end of the year (2021) the pain was so much that I started taking Advil to cope. That helped. The joint condition did not a bare and in February I had a video interview with Dr. He diagnosed me with Rheumatoid Arthritis. I have had no such problems before. He had me take a blood test and a week or two later when the results came in, he said the inflammation markers were very high, but the rheumatoid factor was normal. One subsequent blood test (a month or two later) confirmed the above. Dr. prescribed Prednisone at 40mg per day. I started that and it alleviated the pain and visible swelling. Problem is - 8 months later I have been unable to wean off the Prednisone. I have tried twice and whenever I get to the level of 10mg per day the pain in my joints comes back full force. I have tried Prednisone substitutes to no avail. The Prednisone causes side effects which I cannot tolerate (mainly problems breathing which disappear at the lower dosages ie 15 mg per day which I am now taking) At 15 mg the joint pain is high but somewhat tolerable, though I have difficulty walking and have reduced my work hours so as to get more sleep. 8-9 hours per day.
had swollen lymph nodes on my second vaccine.It was quite painful; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Apr2021 11:00 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1; Anatomical Location: Arm Right;  time:at 11:00 AM), administration date: 16Mar2021, when the patient was 55 years old, for covid-19 immunization, reaction(s): "covid". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Apr2021 21:00, outcome "recovered" (Apr2021), described as "had swollen lymph nodes on my second vaccine.It was quite painful".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021491217 same reporter/ product/ patient, seperated doses
Rash on arms starting 2-2-19 and spread to face and legs - itchy. Treatment calamine lotion, oatmeal baths.
9/27/22 Got annual flu shot manuf sequirus lot as1594B exp 6/30/2023 0.5ml right arm. influenza vaccine flucelvax quadrivalent 2022-2023 formula. normal arm itch and redness incur for a week plus normal. but 5 days later on 10/1/22 i use a ointment triamcinolone acetonide 0.25% usp ointment ndc 00168-0005-80 for vaginal itch as prescribe by skin dr. been using this ointment for a long time. at about 915pm 10/1/22 at bathroom tissue wipe after ointment apply find vaginal bleeding its been about 7 days now current tiny spotting to nothing at bathroom wipe. reported triam to medwatch 10/6/2022 now i am reporting in the flu shot to go with the problem. victim is female 66. unknown what cause the bleeding. i still have box to triam i uploaded wtih my fda complain yesterday. as to the flu shot i only have printout dr gave me about the rx no box no bottle no anything on it.
The afternoon of my first vaccination, I had four hours of nausea, followed by vomiting. For the next few days, I had headaches, fatigue, and a low-grade fever (101 degrees max). I also had constipation that lasted five or six days. I did not see a doctor in person, but got his email advice for the constipation.   In August, I had virtually identical symptoms unrelated to any vaccination (nausea, headache, fatigue, low-grade fever, and constipation). This time I went to an urgent care facility, where I was tested for covid-19 (negative) and the doctor there diagnosed my problem as a gastrointestinal virus.    My hypothesis is that what I thought was a vaccine reaction in January was instead a gastrointestinal virus that I contracted around the same time as the vaccination.
sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection). The patient was treated with AMOXICILLIN for Sinus infection, at a dose of 1 dosage form. At the time of the report, SINUSITIS (sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Diagnosed positive of COVID-19 after receiving the first dose of the Moderna COVID-19 Vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19 (diagnosed after receiving first dose of vaccine) since 22-Jan-2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Diagnosed positive of COVID-19 after receiving the first dose of the Moderna COVID-19 Vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Diagnosed positive of COVID-19 after receiving the first dose of the Moderna COVID-19 Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test positive: positive.         No concomitant medications reported by investigator  No treatment medications provided by the reporter.
He had a fever and chills later the night of the vaccine (6/5). The next day, he awoke with no fever, but later in the day he felt lightheaded and had general joint discomfort/achiness (6/6). The next day he had a headache (6/7). On 6/8, he had bloodwork done that showed very low platelet levels.
dead from second dose of Pfizer Covid 19 vaccine; This is a spontaneous report from a Pfizer-sponsored program by a non-contactable consumer. This report reported same event for two patients. This is the first dose of two reports. A 13-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 13-year-old for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) for covid-19 immunisation. A 13 years old female is dead from second dose of Pfizer Covid 19 vaccine. Both had no prior conditions with the heart and now are dead. The patient died on an unspecified date.  It was unknown if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101091793 same report/drug/AE, different patients; Reported Cause(s) of Death: dead from second dose of Pfizer Covid 19 vaccine
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose) on 10-Apr-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. On 30-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Vaccines were thawed on 28-Jan-2022. It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. It was reported that the patient did not experience any adverse event. Treatment information was not reported.
Pt recvd vax 12AUG92 & exp a dull intermittent pain underneath both knee caps w/more pain in the rt knee which travelled down to calf; also exp swelling & warmth in rt knee;
A 10 year old boy presented with a complaint of not hearing from left ear. He failed a hearing screen on that side (right is normal) and had a normal exam. ENT referral obtained and dx'd with sudden left sensorineural hearing loss. He had improvement with oral steroids but has residual drop in highest frequencies between 2000 to 8000 Hz. He has partial recovery.  F/UP report on 3/21/03: By phone conversation w/PT's mother (He has transferred out of reporting office's practice) he has regained "90%" of his hearing and does have some tinnitus at times.
So I brought patient in Wen. for his vac. and check up. Everything went great. We went home and that nite he started to run a fever. His 1st one ever! I gave him some tylenol and he went to bed. THe next morning his fever was back along with green diahriea ( I breastfeed so it should be yellow) So I called the doctor and left a message. Not 5 minuntes later patient went into convulsions his head was bouncing up and down off the bed. I picked him up and he was limp then he let out a cry and seemed ok. I nearly died in fear. I grab the carseat and fastened him in we were on the way to ER. I held his hand as I drove and could feel him start to shack again I went to pull over but it was over before I could get off the road. So I get to the ER they take us right back and it happens again in my arms his little eyes were bouncing around. The nurse ran to get the doctor but it was over. They keep us there four hours run some test his fever went from 102 to 99 and he didnt seizure again so they said to go home but come back if it happens again Duh right? I made a appt with our doctor for monday. He seems to think they were fever seizures and said we are going to spread out his shots next time 2 one week 2 the next week. Yesterday was by far the most horrifing day of my life. I hope this is the last I ever see him do that again. I pray it is only fever seizures and not somthing else. He still has a low fever but they assured me that it is from the shots and lots of babys get fevers.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 28-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
severe induration, erythema, tenderness surrounding inject site; area measures 11 x 12 cm & devel w/in 24 hrs of administration; pt will not flex knee or hip; had been intermittently febrile temp max 39.8;
Patient received Pediatric Pfizer 03.ml dose diluted with 1.8ml of Sodium Chloride.
Approx 2 days after receiving immunization pt started to have severe pain at the bra of back down to buttocks on posterior side also had some pain just above breast. Approx 9 days later pain is some better but still present.
Information has been received from a physician concerning a 74 year old caucasian male with no medical history or allergies who on 07-JUN-2007, was vaccinated in the right arm with a 0.65 ml dose of Zostavax. There was no illness at the time of vaccination. On 11-JUN-2007 the patient developed Bells palsy. Unspecified medical attention was sought. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been received from the physician who stated that on 19-JUN-2007 (previously reported as 11-JUN-2007) patient developed Bells palsy. No diagnostic laboratory tests were undertaken. At the time of report, the patient was improving. The physician considered patient's experience of Bells palsy to be an other important medical event. No further information is expected.
Pregnancy from approx. 04/19/22 with EDD of 01/09/2023. No abnormal ultrasounds or blood tests. Baby aspirin as preeclampsia preventative (purely prophylactic). Received primary Pfizer series in 2021 with first booster (Moderna) in November 2021. Moderna booster in august 2022 and Pfizer bivalent in November 2022. Baby boy born on January 14, 2023. No abnormal NSTs before or during labor (weekly monitoring and then continuous during labor). A few minutes later baby heart rate spiked. Diagnosed with SVT with likely WPW.  No family history and not caught in utero despite weekly NST.  Baby put on propranolol. SVT is unexplained and there weren?t other pregnancy complications. Also had a small PDA and PFO with some valve regurgitation at birth
A nurse reported the occurrence of vomiting in a 4 month old female who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The vaccine provider submitted this report directly to the local public health department. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 4/23/03, the subject received her second injection of Infanrix (lot DTPA592A9). During the evening of 4/23/03, the subject developed chills, fever, and vomiting. Comment: The reporter indicated that two additional subject experienced these events after receiving Infanrix lot DTPA592A9. However, these subjects are not presently identifiable.
Patient complaint of flu like symptoms beginning approximately 12 hours after vaccine given.  Complaint of mid back ache, legs aching, temperature increased, complaint of left arm pain from elbow to shoulder and neck.  Noted reddened area of approximately 2x5cm below injection site.  Symptoms resolving approximately 60 hours after administration of vaccine.
A feeling of significant lassitude, pain at injection site and also the site opposite in the right shoulder.  I could not sleep after 3 am, awake until 7:30 am.  January 13:  in the morning, body aches, requiring bed rest.  After 12 pm, relief came with normal feeling.
patient has not presented an adverse reaction  patient had vaccine Moderna  and was administered third dose pfizer  by mistake patient did not bring in vaccination card at the moment and refers she had pfizer.
Patient developed rash to face and bilateral thighs where immunizations were administered; (B) thighs also were minimally swollen at injection sites.
TESTED POSITIVE FOR COVID ON 2/26 SYMPTOMS LOSS OF SMELL AND SOB.
Client called health department in mid Aug c/o numb tongue and mouth and weak, heavy, tired (Lt) leg. States symptoms started morning after the shot. Client was seen in clinic 8/13/08 and did not report any of these symptoms at that time. Client advised to see PCP for evaluation. Client saw PCP for 2nd time for symptoms. Client called health department reporting PCP advised her it was a reaction to the "tetanus shot" the previous month. Client's symptoms unchanged and she is requesting treatment to "cure" problem. Client advised no "cure" and if this is a reaction will resolve with time.  9/16/08 PC from client reporting mouth "is better" but leg is "the same". Again requesting treatment advised to return to PCP and reiterated previous information. Client had Td immunization in 4/05 in LAIM.
30 min to few hrs after Tdap, pt c/o numbness and tingling in fingers & hand. 3 days later c/o leg pains. Approximately 10-12 days later c/o nausea, emesis, dizziness, and blurred vision. Dx'd = optic neuritis. Required brain MRI, MRA. ER visit for CSF, LP done, then hospitalized.
Stuff nose; Sinuses"; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Stuff nose), SINUS DISORDER (Sinuses") and HEADACHE (Headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Stuff nose), SINUS DISORDER (Sinuses") and HEADACHE (Headaches). At the time of the report, NASAL CONGESTION (Stuff nose), SINUS DISORDER (Sinuses") and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided  As per client, MI error in DOB capture as --1-JAN-1900
25-year-old who lives with her partner and her roommate and who presented with disassociative phenomena and depression.
Felt like had torn muscles in shoulder--intense pain / sudden pain; Limited range of motion, withoutany muscles feeling tense or locked up; Sore arm; Pain and sensation continued to worsen in my arm and shoulder, until it spread to my spine; spine hurt more and more; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6202) via unspecified route of administration in left arm on 17Mar2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not received any other medications in two weeks prior to vaccination. On 18Mar2021, the patient started the morning after vaccine, with just a sore arm (pain in arm). The second day after the vaccine, it felt like the patient had torn muscles in shoulder--intense pain (shoulder pain) and limited range of motion, without any muscles feeling tense or locked up (movements reduced). The third day, pain and sensation continued to worsen in arm and shoulder, until it spread to spine (condition worsened). By the end of the night, arm started to feel okay but spine hurt more and more (pain in spine), feeling like it had a compression injury. It was reported that, the patient that if he had no memory, and someone told he had been in a car accident, or compressed his spine by jumping from 30 feet in the air, he would readily believe it. It was the fourth morning as the patient wrote, and spine still felt same way. No physical activity or other explanation for sudden pain, no prior history of injury/pain for these areas. It was unknown if the patient had received any treatment for the events. The outcome of the events shoulder pain, movements reduced, condition worsened, pain in spine was not resolved and for event pain in arm was resolving at the time of this report.   No follow up attempts are needed. No further information is expected
Syncopal event, sweaty,altered mental status 1 min. BP 120/73. HR 80. Resp 18. O2 sat 99 15:05. 132/74 P 78. RESP 99% HOME WITH FRIEND
pt recv vax & 4 to 6 days later pt devel an itchy rash w/small red spots on the inside of both arms,from inner wrist up to underarm & neck;poss petechiae;observed by MD & therapy w/chlor-Trimeton