chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient states that he began to have blurry vision in the evening on 6/23/20. The next day his vision was worse and the eye was painful. He saw Dr. on 6/24/20 and was told he has a corneal abrasion. Patient states that he could not see for 3 days. He says his vision and the pain have improved, but he is not 100% back to normal yet. Patient also states that he did not have any trauma to the eye to cause the corneal abrasion.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 at 10:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 09Mar2021 at 09:00 as dose 1, single (Lot number: 032M20A), in left arm, on 07Apr2021 at 10:00 as dose 2, single (Lot number: 016B21A), in right arm and on 18Nov2021 at 09:00 as dose 3 (booster), single (Lot number: 039F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Celebrex, reaction(s): "Known allergies: Celebrex". No other medication in 2 weeks.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound 3-4 days after last dose with increase nasal congestion and cough. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received anti viral treatment Paxlovid (lot number: 00079-1085-30) from 29Jun2022 to 03Jul2022 for treatment of COVID-19.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
At about 11:30 AM, I had extreme stomach cramps and then diarrhea. At the time, I hadn't eaten anything since 8 AM. At about 3 PM, I felt mild muscle pain. At about 5:30 PM, I experienced body aches (sort of flu-like symptoms) and fairly extreme shivering. The same thing happened around 2:30 AM (middle of the night). At both 5:30 PM and 2:30 AM, I took 1000 mg acetaminophen and 600 mg ibuprofen to combat the symptoms - they worked after about 15 minutes. I did not seek the help of a medical professional. It's now 8:30 AM the next morning and I'm feeling OK - and am hopeful the symptoms won't come back.
Case number PHEH2014US025003, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 74 year old female patient. Historical conditions were not reported. No concomitant medications was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 25 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Patient arms and face were red and hot to the touch.  No temperature was noted.  Temp was 97.9 degrees.  She complained of a metallic taste in her mouth and that her throat felt funny.  Given 25 mg of dissolvable Benadryl at 9:45 AM.  Within five minutes the said they felt improved.  Within 15 minutes of the first dose the patient noted they still had the metallic taste in their mouth an another 25 mg of Benadryl was provided at 10:00 AM.  She was instructed to remain for observation at the nursing home where she works so that she could be monitored, notify her supervisor, and call her primary care provider.  The patient left the facility and she was contacted to return.  The patient then stated her tongue was feeling numb and her throat was tightening.  Staff then proceeded to have patient return to the facility while they called 9-1-1.  At approximately 10:23 AM, 0.5 mg of epinephrine was administered IM to the left deltoid.  Vitals after two minutes were O2 98%, Pulse 67.  There was no stridor, lung sounds, or wheezing.  Patient expressed relief in throat but still had metallic taste in her mouth.  Vitals checked and were O2 100% and pulse 74.  Ambulance arrived between 10:40 -10:45 AM.  Patient transported to Hospital.
PERMANENT SORE ARM--HAS BEEN A MONTH OR SO SINCE GETTING THE VACCINE AND THE ARM IS STILL SORE.
Starting 05/24/2022, I had a heart attack. I eventually went to the hospital because it wasn't the worst pain. They diagnosed me with having had a heart attack that was stress induced and contributable also to hypertension. They admitted me and did a catheterization to see if I had heart disease but didn't find any. They changed my medicine regimen and they discharged me on 05/26/2022.
This is a serious spontaneous case, initially received from a physician on 19-Oct-2018, concerning a female infant patient of unspecified age. The mother was a 31-year-old female, whose historical drug included Metrogel for vaginitis and historical condition included multigravida, two spontaneous abortions and 4 full term live births. The concomitant medications included Ferrous sulfate for anemia and Prenatal vitamins [minerals nos, vitamins nos] for pregnancy. The estimated delivery date (EDD) was 12-Jan-2019. The pregnancy was without complications. At approximately 28 weeks gestation, on 19-Oct-2018, the patient's mother received FLUCELVAX QIVc vaccine [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, batch number: 252664, dose, route of administration, expiry date and anatomical location: not reported) (explicitly coded as fetal exposure during pregnancy) for an unknown indication. On an unspecified date, the mother developed hypertension, pericardial effusion, anemia, diagnostic ultrasound abnormal (Echogenic foci) and vaginitis. On 26-Dec-2018, the mother vaginally delivered a full term female infant at 37.6 weeks gestation. The infant's birth weight was 2155 grams, her length was 45.7 cm and head circumference was 30.5 cm. The APGAR scores were 8 (one minute) and 9 (five minutes). The infant had low weight at birth and was observed in the normal nursery. The outcome of the event was not reported. This case is linked to (201900313), the corresponding maternal pregnancy report.; Reporter's Comments: A female infant had a full term delivery with low birth weight (2155 gms), after FLUCELVAX QIVc vaccine exposure during pregnancy. The maternal history during pregnancy included hypertension and anaemia. The event low birth weight can be attributed to maternal history (hypertension, anaemia) rather than suspect vaccine. Hence, causality of the event low birth weight was assessed as not related to suspect vaccine. The company assessed the event (low birth weight baby) as serious (medically significant).
I GAVE THE INJECTION AND BLOOD SQUIRTED OUT. STOPPED THE BLEEDING BY PRESSURE. WAITED UNTIL HER DAD GOT THE SHOT. PATIENT FEELING NORMAL AT THE TIME SHE LEFT THE STORE. FOLLOWED UP AND ALL GOOD.
patient was possibly given 6 doses of undiluted pfzier.  chest pain dizzy headache red sore fever
17 year old female who received her first dose of the Moderna COVID-19 vaccine by accident; A spontaneous report was received from a parent concerning their 17 years-old female daughter, who received Moderna's COVID-19 vaccine (mRNA-1273) which resulted in the event: 17 year old received first dose of the Moderna COVID-19 vaccine by accident/ Product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the Moderna COVID vaccine was given to a 17- year old patient. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, 17 year old received first dose of the Moderna COVID-19 vaccine by accident, was recovered on 28 Dec 2020.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
on 4/8/21 at left upper arm at site of shot reports had a lump, soft, tender not red or warm 5 cm diameter and raised about 1 cm  Resolved after a week, and recurred 4/15/21 but smaller size of quarter, raised,  same texture, sore not red or warm  Came in for eval 4/21/21 and now is very small today 1.5 cm diameter , flat, mildly tender.
Patient presented to ER 13 days following receipt of Zostavax complaining of itchy, edematous eyelids with onset around 10 August. No distinctive lesions. No joint pain. No respiratory symptoms. No urticaria or generalized rashes. No visual changes. Treated with steroid burst with significant improvement of symptoms. See Attached
healthy pt recvd Acellular DTP, OPV/Hep B 27OCT92 & exp fever starting that evening; febrile 28OCT92 & 29OCT92 breif sz 29OCTPM t104.9; viral s&s started 29OCT92;
Injection site swelled up and turned red and started itching. The next day there was a hard lump at the site and the redness spread further outward from the site. Arm was painful and hurt to lift it over then next six days.
"I" had not menstruated in almost a year prior to "my" second vaccine. Since then, "I" had light bleeding, twice, about 3 weeks apart.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 29Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, since the second dose, the patient experienced light bleeding, twice, about 3 weeks apart. The patient reported that she had not menstruated in almost a year prior to her second vaccine. She now had a period like she had years ago. Her first dose was on 29Mar2021 and second dose on 23Apr2021. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event had light bleeding, twice, about 3 weeks apart, had not menstruated in almost a year prior to the second vaccine was unknown at the time of this report.
This is a spontaneous report based on information received by Pfizer from GlaxoSmithKline (Manufacturer Report Number: A1025426A). This case was reported by a physician via sales representative for a child patient (age and gender unknown). On an unspecified date, around 4 months of age, the subject received second dose of ROTARIX (oral), second dose of PEDIARIX (unknown details), second dose of PREVNAR (unknown details), second dose of PEDVAXHIB (unknown details). It was not specified as to which vaccination was co-suspect to the events. No dates of administration were provided. The second dose of ROTARIX was administered around 4 months of age. On an unspecified date, 4 days after vaccination with second dose of ROTARIX formulation, PEDIARIX, PEDVAXHIB, and PREVNAR, the subject experienced diarrhea and rotavirus infection. Relevant test results included a stool sample of the diarrhea. The stool sample showed child was positive for rotavirus. At the time of reporting the outcome of the events were unspecified. Follow-up (16-AUG-2013) Follow-up attempts completed. No further information expected.
DIZZY; RUN DOWN; FEVERISH; HEADACHE; WEAK; TIRED; SORE ARM; BRUISED ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sinus issues.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 14:30 for prophylactic vaccination. Concomitant medications included fexofenadine hydrochloride for sinuses. On 07-APR-2021, the subject experienced bruised arm at injection site. On 07-APR-2021, the subject experienced sore arm. On 08-APR-2021, the subject experienced weak. On 08-APR-2021, the subject experienced tired. On 01-MAY-2021, the subject experienced dizzy. On 01-MAY-2021, the subject experienced run down. On 01-MAY-2021, the subject experienced feverish. On 01-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from bruised arm at injection site, and sore arm on 09-APR-2021, and had not recovered from tired, feverish, dizzy, headache, run down, and weak. This report was non-serious. This case, from the same reporter is linked to.
Patient reported a bruise and soreness at site and fever, chills, and malaise starting at 9 pm, lasting 24 hours.
Patient had a sore arm and was tired; Patient had a sore arm and was tired; diarrhea; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Patient had a sore arm and was tired), DIARRHOEA (diarrhea), HEADACHE (severe headache) and PAIN IN EXTREMITY (Patient had a sore arm and was tired) in an elderly patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030536) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Moderna (As a booster dose lot number 034F21A and expiration date is not known) on 09-Nov-2021, Moderna (As a booster dose lot number 034F21A and expiration date is not known) on 09-Nov-2021 and Pfizer. Past adverse reactions to the above products included Diarrhea with Moderna; No adverse event with Pfizer; and Tiredness with Moderna.    On 14-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 15-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced HEADACHE (severe headache). On 21-Oct-2023, the patient experienced DIARRHOEA (diarrhea). On an unknown date, the patient experienced FATIGUE (Patient had a sore arm and was tired) and PAIN IN EXTREMITY (Patient had a sore arm and was tired). At the time of the report, FATIGUE (Patient had a sore arm and was tired), DIARRHOEA (diarrhea), HEADACHE (severe headache) and PAIN IN EXTREMITY (Patient had a sore arm and was tired) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   This case was linked to MOD-2023-746827 (Patient Link).
Moderna COVID-19 Vaccine EUA dose given 2 days after the BUD for refrigeration
Day after receiving vaccine I woke up with headache, had nausea, and was dizzy. This lasted 3 days. My arm was red and sore day after vaccine . Sunday night, 1/16/21 the injection site became itchy, continued to be red .  Monday, 1/17/21 injection site was swollen, hard, red and warm. I work at a SNF as a Licensed Physical Therapist Assistant, I had an RN look at site and trace it. It continued to stay swollen after taking Motrin and A 24 hr Claritin. Went to Urgent Care to have Dr look at it and was put on Bactrim  for possible infection to injection site. I do not take many antibiotics or any other medications, so I do not always react well with medicine.
Patient called the following day stating she was having tingling and numbness in both her legs, with dark toenails, and some pain.  Feet were not discolored, just toenails.  Patient states this did not happen after her 1st dose, and she did not hurt her lower back or legs any time during the past 24 hours.  Patient started to feel better the following day, but still had symptoms so went to the ER and is being tested for COVID with results pending.  Still having some leg pain.
Major rash on face that started in May. I felt light headed and discovered that my blood pressure had elevated noticeably while in 15 minute waiting period. Staff at vaccine facility did not allow me to leave until blood lower, but it did not lower. Doctor on call asked that I go to hospital. My cardiologist advised hospitalization unnecessary. Cardiologist advised me to go home, take another dose of blood pressure medication and rest. This resulted, after a period of rest, in my blood pressure returning to normal. I also developed a higher temperature and fever along with body aches within a 24 hours.
Patient presented redness in the area within 1 to 2 days after administration of the vaccine and later a bruise formed. The first days I had fever and diarrhea.
Information was received from a female consumer who reported she received the ZOSTAVAX. The penetration of the needle in her arm irritated her skin and started to swell. No additional information was reported at that time. Later in the day the consumer called back. She received ZOSTAVAX and INFLUENZA (unspecified) on 25SEP2012. Later that night, she experienced itching and redness on her ZOSTAVAX shot arm. The redness was the diameter of a tennis ball, slightly raised, and felt like "fire ant bites". The next morning, the injection site was 8 inches long and 4 inches half wide. Half was bright red, half was a paler red and it was warm to the touch. In addition she described itchy prickles on hands and face. She said we could contact her HCP. No further information was provided. Additional information has been requested.
EventsPatient experienced segmental and subsegmental pulmonary emboli without other preceding no evidence for DVT, no history of inherited thrombophilia or previous pulmonary embolism, no underlying cancer, surgery, or stasis.  The only other complicating factor would be that she has been taking estrogen therapy prescribed by gynecology which she discontinued the day prior to her vaccine.
I feel weak; ache on the back of my right shoulder; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I feel weak), ARTHRALGIA (ache on the back of my right shoulder) and CHILLS (chills) in a 70-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 ASTHENIA (I feel weak), ARTHRALGIA (ache on the back of my right shoulder) and CHILLS (chills). At the time of the report, ASTHENIA (I feel weak), ARTHRALGIA (ache on the back of my right shoulder) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported  No treatment information was provided
Information has been received from a physician concerning a 10 year old male pt who was vaccinated with the 2nd dose of Hep B. On 7/11/99, the pt experienced symptoms progressing towards urticaria. He sought unspecified medical attention. No further information is available.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 67-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient did not report any symptoms or received any known treatments.
apporx 10 mins following vax pt reported tingling in mouth & up to bridge of nose; just don't feel nl; BP 140/90;
Got the shot at 9:30 am on the 27th.  Soreness at injection site, pain in joints, headache and dizziness when turning head by 8:00 pm. Overnight had minor chills, fever of 100.5, neck ache, severe headache and joint pain.  Took 400 mg Advil. Fever passed by 28th in the morning. Had joint pain, neck pain and headache all day and night. By morning of 29th neck pain mostly gone and joint pain receding. Headache still there.
10/2/21-Patient received high-dose influenza vaccine at drive through clinic.  Next day, developed arm pain that continued to worsen over several months. At first intermittent and then persistent.  Weakness when pain is worst, but no loss of ROM.  Interferes with sleep.  Sought treatment 2/28/22- Exam: Palpation: Significant point tenderness over posterior border of the deltoid approximately 5 cm from humeral head ROM: Intact throughout, significant pain with internal rotation Strength: 5 out of 5 however patient unable to tolerate liftoff
This afternoon, I was given a version of the vaccine that CDC specifically states should not be given to pregnant women.  The staff failed to advise me in any way that I should not get the LAIV.  It was only after contacting the facility to inquire about another issue that it was revealed to me that I should not have been given this vaccine and that the staff should have informed me at the time. Person at the CDC informed me that VAERS would want to keep track of this sort of event, though I have no physical problems at the moment. Current time is 3:22 pm, 11-14-09.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown ages and genders. On multiple unspecified dates, the patients were inadvertently administered with improperly stored GARDASIL (lot # L038135, expiry date: 27-MAY-2017) (route of administration: intramuscular). The vaccine was stored at a temperature of 9.9 degrees C at an unknown time frame. Data logger was involved and there was no previous temperature excursion. No adverse effect reported. The outcome of the events was not reported. Additional information has been requested.
Patient developed unspecified pneumonia which led to extremely high troponin levels.  Patient died due to cardio pulmonary disease due to complications from COVID vaccine.