chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A fever started this morning; Right sore arm; Aches; I have relatively good health all my life, I can't stand to feel this way; Bad muscle soreness; Chills/ On and off chills; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0178 and Expiration Date: unknown), via an unknown route of administration, administered in right arm on 07Jul2021 at 13:30 (at the age of 75-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included unspecified blood thinner. The patient previously took first dose of bnt162b2 (Lot number: EW0168), administered in right arm on 16Jun2021 at 12:30 PM (at the age of 74-years-old) for covid-19 immunisation and experienced sore right arm and a passing twingy headache on an unknown date in Jun2021. The patient reported that she received her 2nd covid-19 vaccine dose yesterday on 07Jul2021 at 1:30 PM. She saw there were somewhat common side effects for the covid-19 vaccine. Her side effects were really bad muscle soreness and aches, on and off chills started on an unknown date in Jul2021 and a fever that started morning on the day of reporting on 08Jul2021. On 08Jul2021, her first temperature was 99.6 degrees Fahrenheit, and her temperature went to 100.6 degrees Fahrenheit. She took Tylenol at 10:00 AM morning on 08Jul2021 and now at the time of reporting the time was about 3:45 PM. She would like to take a second Tylenol dose and wanted asked if it was OK for her to take the second dose of Tylenol for her side effects. Her right sore arm had eased up with her first vaccine dose, as well as today on an unknown date in Jul2021 with her second covid-19 vaccine shot. Patient reported that, she had relatively good health all her life, she could not stand to feel this way. She did not do anything today (as reported) on an unknown date in Jul2021. The case was assessed as non-serious. Therapeutic measures were taken as a result of aches, bad muscle soreness, chills/ on and off chills, a fever started this morning (pyrexia) and right sore arm. Outcome of events was unknown.  No follow-up attempts needed. No further information is expected, batch/lot.no. has already been reported.
Case number PHEH2015US002051, is an initial spontaneous report from a medical assistant (MA) received on 27 Jan 2015 and with a follow up report received on 23 Mar 2015. This report refers to a 16-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Her vaccination history included administration of MENVEO (batch number: not reported), on 24 Mar 20101 which was well tolerated. She was administered incorrectly with only MenA powder component of MENVEO (batch number: M14044) reconstituted with sterile solution instead of Men-CYW-135 intramuscularly on 12 Jan 2015. No adverse event was reported following the administered errors.
I woke up March 19th thinking I was having a heart attack and also muscle spasms on left side and on trunk of body only. I called my doctor's office. They called me in a Muscle relaxer/prescribed on March 19th. Lasted less than 24 hours.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-OCT-2016, the patient was vaccinated with a dose of improperly stored VARIVAX lot # M027343, an expiration date 10-JUN-2018 (dose, frequency, route of administration were not reported). The vaccine was exposed to temperature of 8.8F for 3 hours and 26 minutes and to temperature of 30.2F for 1 hour and 54 minutes, the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Amoxicillin).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Jul-2020 and the estimated date of delivery was 17-Apr-2021. On 06-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 06-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Blood glucose: normal (normal) Normal. In March 2021, Ultrasound scan: normal (normal) normal. On 08-Oct-2021, Pregnancy test: positive (Positive) Positive.         Lab test : Ultrasound on 03/03/2021 was normal                 Glucose test was normal. Estimated date of conception was 25 Jul 2020. No relevant concomitant medications were reported. No treatment information was provided.
My upper left arm is very sore. The pain goes down to my elbow. It's a throbbing kind of pain and the injection site is still sore also. It is going on 2 weeks that I've had the injection.
booster given instead of second dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (booster given instead of second dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A and 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 12-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (booster given instead of second dose). On 12-Feb-2022, ACCIDENTAL UNDERDOSE (booster given instead of second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: pt stated that she is experiencing vertigo. has not taken anything to help symptoms
Around 7pm on 2/3/07 the pt was c/o pain in his left arm to his father. Father just thought he was c/o pain from having his shots the day before. On 2/4/07 at 4:30pm the mother noticed a problem with the pt' arm when bathing him. Mom noticed arm doubled in size, hard to touch with warmth and redness. She noticed a large bruise to left deltoid of 2-3cm. Mom called 24hr nurse hotline and was instructed to take to ER. At 5:30 pt was taken to ER. ER Dr. told mom it was a local rx with some "damage to tissue". Dr. instructed mom to observe arm for further problems. Dr. prescribed Keflex for 5days TID. Dr. instructed to apply ice prn and to make appt. with PMD in 2-3 days.
Improper dilution of vial resulted in 15 microgram dose.  Parent informed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 19Sep2023 at 09:00 as dose 6 (booster), single (Lot number: 3030342) at the age of 69 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: tested positive again; (03Oct2023) negative, notes: Tested negative two days in a row; (04Oct2023) negative, notes: Tested negative two days in a row; (05Oct2023) positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 27Sep2023 to 02Oct2023.
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil.  Subsequently, after receiving the vaccination the patient fainted. The patient sought unspecified medical attention.  On 13-AUG-2007 the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
About 20 minutes after her vaccine she complained of chest pressure, tingling of her fingers, nausea (briefly) and lightheadedness.  She was monitored initially, and when the chest tightness did not resolve, she was given albuterol, which did not help.  She said that her joints began to hurt.  She was sent to the ER, where an evaluation was undertaken to assess for alternative diagnoses (EKG, chest X-ray).  The patient had experienced the same type of symptoms with her first COVID vaccine in July 30th, 2021.  The symptoms resolved in a few hours at that time.
No other AE; Caller reported an AE for PEDVAX HIB. The caller said they have a patient who received PENTACEL and PEDVAX HIB on the same day, 23JUN2022. Confirmed with caller no other AE occurred. AE letter sent to prescriber. No other AE. No PQC.; This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  Caller reported an adverse event for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB). The caller reported that have a patient who received first dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U026802 and expiration date: 03-SEP-2021 (dose, indication and route were not reported), and first dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), lot # UJ529AAA expiration date: 22-JUL-2022 (dose, route of administration and indication were not provided),  on the same date, on 23-JUN-2022. No other adverse event occurred.
Injection given in (L) deltoid. 24 hrs later. Pt had 6 1/2 cm x 6 cm red, raised area with shot mark noted in center
swelling at shot location for 4 days, fever at shot location 4days ,headache for 2 days . extreme pain 3days ,pain for 4 more days finally went away by August 4th. Could not do anything with arm for 2-3 days because of pain and swelling.
10pm mom noticed child bleeding from nose while breast feeding, she wiped blood away then child turned blue and stopped breathing. She performed CPR dad call 911. Child was taken to hosp via ambulance. Pronounced dead 10:50pm. The autopsy report states SIDS.
Shortly after first vaccine, developed stiffness in upper torso as well as general aches and pains, malaise. These continued and after second vaccine, back stiffness increased and I had a period of flu-like symptoms. I have also been diagnosed with a retinal problem; they are calling it presumed occular histoplasmosis.
Temp. 105 large swelling and pain at site (deltoid). Rx - prednisolone (2mg/kg).
NOTE: PATIENT IS 2 MONTHS OLD (the website would not allow me to correct the age). He was born at 34 week gestational age; Baby was seen here in well baby clinic, a day before symptoms, was given primary series (PENTACEL, Hep B, ROTARIX and PREVNAR 13). Mother reports fever of 101.5F at 5AM next day for which she gave no medication and presented at ER. Temperature in ED was normal; Fever was attributed to the vaccines, mother reassured and discharged home; Another fever was noted at 1pm, 100.7F which resolved after TYLENOL was given(2 ml). Mother describes 2 episodes of stiffening and discoloration. 1st episode was about 8hrs after the fever, 9pm when she was bathing the baby, she noted stiffening of the limbs, baby also appeared flushed and like he was not breathing, episode lasted few seconds and afterwards he let out a loud scream and was back to his baseline tone, color, breathing, responsiveness. 2nd episode was this morning while the baby was in the crib (on the back), also had stiffening, cessation of breathing and facial blushing with associated eye deviation, also few seconds; Baby was admitted for full sepsis workup and other investigation including, EKG, Echo, EEG and Observation; All test results were benign.
30 minutes after getting Flumist and TDAP on 12/16 developed redness on soles of feet, palms of hands very itchy, rash on UE, thighs, felt constricted airway, difficulty swallowing, but still able to breathe, better now. Still very itchy arms and legs, taking Benadryl for children with not much help. Pt not allergic to eggs. No fevers. No URI sx. No prior rxns to IZs.
Sudden dizziness and fell out in floor three days later.  Followed by fatigue, diarrhea, headaches and hot cold sessions
This spontaneous report has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On or after 28-MAY-2017, the patients were administered improperly stored doses of GARDASIL 9 (lot# N002720, expiration date 12-MAY-2019; lot# N004798, expiration date: 31-OCT-2019; lot# M032650, expiration date: 31-MAR-2019) (dose and route were not reported) for prophylaxis. The vaccine (lot# N002720, expiration date 12-MAY-2019; lot# N004798, expiration date: 31-OCT-2019; lot# M032650, expiration date: 31-MAR-2019) were exposed to temperature excursion of 32 Fahrenheit (F) to 35 F cumulative for 165 minutes (85 minutes on 28-MAY-2017, 130minutes on 29-MAY-2017, 20 minutes on 30-MAY-2017, 20 minutes on 31-MAY-2017, and 10 minutes on 01-JUN-2017); exposed to temperature excursion of 47 F to 77 F cumulative for 205 minutes (65 minutes on 15-JUN-2017 and 140 minutes on 12-JUL-2017). The data logger was involved. There was no previous temperature excursion. No adverse effect were reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1709USA000641: US-009507513-1709USA000645:
2 hrs p/inject pt rt arm was painful to touch w/movement; large induration & erythema; states felt had a fever but is undocumented; assessed by MD next day was given Atarax; states arm sore only;
Potassium levels are elevated; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD POTASSIUM INCREASED (Potassium levels are elevated) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BLOOD POTASSIUM INCREASED (Potassium levels are elevated). At the time of the report, BLOOD POTASSIUM INCREASED (Potassium levels are elevated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Right arm reddened, with 20 mm area of swelling and induration, numbness and tingling.
Pt reported was diagnosed by ER and PCP that he had allergic reaction to Moderna. Pt reports was hallucinating and passed out in shower twice causing 2 ER visits.  Previous VEARS report uncertain and felt information collected needed reporting
my daughter is in labor and they are talking about having to give her a C-section because of, what I believe is a false positive HIV test; had the Covid vaccine last week and she is now in labor; This is a spontaneous report from a contactable consumer (patient's parent). This consumer reported information for both mother and fetus. This is the maternal report.   A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. Medical history included having a baby two years ago (2019). The patient's concomitant medication was reported as none. The patient received the COVID vaccine on 03Feb2021 and was now (08Feb2021) in labor. The hospital protocol was that they do a rapid HIV test in which the patient has tested positive for, which was further clarified as false positive. They gave her a bag of ATZ (also reported as AVT), an antiretroviral intravenously, tested her again, and was talking about taking the baby by C-section if the rapid test comes back positive again. She was in labor and they have slowed down her labor. They were currently waiting for test results for the other HIV test. The patient has no other risk factors for HIV. Her doctor did not do a routine HIV testing during the pregnancy. She had a baby two years ago and she had an HIV testing done which was negative on an unspecified date. They were trying to find out before they cut her open for no reason. The consumer asked if there has been any information on false positive HIV testing and if the COVID vaccine could possibly cause it as the patient had the COVID vaccine last week. That way, they may less likely to cut the patient open. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021149068 fetal case
It was fine at first. I had no reaction then about 9-10 days out my arm felt bumpy in one little area and hurt to press on it. I did not look to see the exact spot the needle went in but I thought it was the injection site.  Then it was itchy. Then it became a red circle and felt warm to touch. I was scratching it so it looks worse than it felt. Now I think it going away. The red circle is far less, not itchy and I think it is going away. I did put Mupirocin 2 0/0 ointment on it. I think that helped it. It took about 5 days. Like I said I think the ointment helped it.
This spontaneous report as received from a pharmacy technician concerning a currently 9 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 01-MAY-2014, the patient was vaccinated with VARIVAX (Merck) lot #J003700; expiration date: 27-MAR-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Vaccine administered on 04/12/2002. Mother reported that on 04/13/2002 and 04/14/2002 child had softball size edema, redness, and warmth at IM site left arm. Pt recovered by 04/15/2002. Cool compresses used.
approx 3 mins p/vax pt got dizzy & fainted falling on floor & striking back of head causing large knot to swell;
8cm X 6cm - red, swollen (slightly), warm to touch patch on (R) thigh.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 02-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M031802 with expiry date: 09-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all the correspondence have been received. Narrative updated. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. Later in 2016, she sought subsequent treatment from another physician and a nurse practitioner for a blistering vesicular outbreak, which was then diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Within 24 hours of injection patient reported increased swelling, increased pain left arm and redness to entire body.  No itching, no difficulty breathing.  On return to clinic pain and swelling had improved, no redness seen to body.  Very slight swelling of injection arm - well below injection site with slight warmth - no redness to site.  Within 2 days no symptoms.
A report has been received from a physician concerning a 15 year old, male patient. The patient's medical history and concomitant medications were not reported. On 08-Oct-2013, the patient started receiving treatment with nasal FLUMIST (Intranasal). Patient began to have nasal congestion, cough, fever, body aches, two days ago (20-OCT-2013). Patient tested positive for flu on 22-OCT-2013. Action taken with FLUMIST was unknown. The outcome of the event of tested positive for flu, cough, fever, nasal congestion and body aches was unknown. Patient was on TAMIFLU as he was tested positive for flu. MD sent specimen of viral culture from his nose to see what kind of virus was the patient having. The report was considered to be non-serious by reporter.
Cutaneous hypersensitivity: Two-inch diameter circular welt, red and painful, at injection site less than 24 hours after shot.  I realize it isn't serious but want to report it since we are just beginning to collect data on COVID vaccine side effects. I fully expect to recover, but am marking "unknown" for recovery below simply because I don't know how long the welt will last.
Devel burning, pruritic type pain in arms following Recombivax inject; No SOB or swelling of throat; skin showed mild erythema over the arms; Given Epi & DPH;
After receiving vaccination, pt asked for ibuprofen for headache, then he went to church, then saw his attorney. When he came back, he sat down at a table, put his head down and reportedly had some spastic movements and fell over. They did CPR and used the AED without results. He coded at 3:25, was sent to the ED at 3:40 and passed at 4:10.