chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report from contactable consumer. The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single, on 21Apr2021 as dose 1, single, on 20Oct2021 as dose 3 (booster), single and on 02Apr2022 as dose 4 (booster), single at the age of 65 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medications (other medication in 2 weeks) included: METFORMIN; FLONASE ALLERGY RELIEF; CLARITIN ALLERGIC. The following information was reported: vaccination failure (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19 test: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19: Paxlovid from 11Sep2022 to 15Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received 2nd vaccine on 5/9/2021at 4:15 pm and became light headed after leaving the location.  A few hours later I began to see a small line forming in my eye and it went away.  The next day 5/10/2021 I woke up and the spot in my eye had gotten even bigger.  I contacted my eye doctor and they scheduled and appointment for me on May 21st.   I woke up on May 11th and my eye was even worse and I notified my eye doctor and they had me to come in immediately.  I saw a Doctor who then referred me to a different eye doctor and I went back to my eye doctor on May 13th and saw Dr. I am now 4 weeks out and I still have no vision in my right eye.  I am now under the care of  that Dr.
Stain of blood visible every once in a while I blow my nose; My lips were badly dry and cracked; Sense of smell and taste off; Sense of smell and taste off; soar throat; Soar nose; muscle weaker; fever; chills; headache; Weak bones; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of RESORPTION BONE INCREASED (Weak bones), MIGRAINE (Migraine), EPISTAXIS (Stain of blood visible every once in a while I blow my nose), LIP DRY (My lips were badly dry and cracked) and ANOSMIA (Sense of smell and taste off) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sleep apnea.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced RESORPTION BONE INCREASED (Weak bones), MIGRAINE (Migraine), ANOSMIA (Sense of smell and taste off), AGEUSIA (Sense of smell and taste off), OROPHARYNGEAL PAIN (soar throat), NASAL DISCOMFORT (Soar nose), MUSCULAR WEAKNESS (muscle weaker), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). On 05-Sep-2021, the patient experienced EPISTAXIS (Stain of blood visible every once in a while I blow my nose) and LIP DRY (My lips were badly dry and cracked). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, RESORPTION BONE INCREASED (Weak bones), MIGRAINE (Migraine), ANOSMIA (Sense of smell and taste off), AGEUSIA (Sense of smell and taste off), OROPHARYNGEAL PAIN (soar throat), NASAL DISCOMFORT (Soar nose), MUSCULAR WEAKNESS (muscle weaker), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) had not resolved and EPISTAXIS (Stain of blood visible every once in a while I blow my nose) and LIP DRY (My lips were badly dry and cracked) outcome was unknown.            No Concomitant Drug was provided Treatment Drug: Ibuprofen
Significant hives within 5 days of vaccinations required ER visit x1 and office visit.
passed out; Blood sugar was 60; A spontaneous report was received from a consumer concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out and blood sugar was 60.  The patient's medical history included diabetes and high blood pressure. Concomitant medications included human insulin(Novolin 70/30).    On 19Feb2021, the day before the onset of the events, the patient received first of two planned doses of mRNA-1273 (Lot: not reported) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20Feb2021 at approximately 1 am, the patient experienced a blood sugar of 60. He drank orange juice and ate half an orange but passed out in the kitchen. He got up but passed out again.  He states that he took his insulin  and passed out due to his insulin and not the vaccine. and  his health care provider switched him to dulaglutide.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, passed out and blood sugar was 60 were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, since the patient is known diabetic and is on  insulin may remain a contributing factor to this event. Further information is requested.
patient presented rph with imz card at dropoff which showed last covid imz was 04/06/2022, so i gave him the bivalent today, and stapled the new card i made him to the old card.then he later showed a card which only had 1st line filled  out from local pharmacy 09/07/22 showing he got pfizer bivalent. he was confused and asked me if i worked at Pharmacy because the card said that specific Pharmacy, and i had to explain to him that my card was stapled to the only card he had shown me at dropoff and that this vaccination onthe new card was given 09/2022 and he then stated it was 09/23, patient was confused and did not present me with this card until after he had left imz room. after being presented with this new information, i looked up cdc guidelines to see that only one bivalent is recommended at this time, so i tried to reach patient and phone # on file been disconnected.
Redness and inflammation at injection site 2 in. diameter as well as redness and itch on legs, arms and stomach and under breasts. Patient referred to MD for evaluation.
The patient was vaccinated on approximately 08/28/2000. Subsequently in September of 2000, the patient developed 6 lesions on her chest and abdomen. The patient sought unspecified medical attention. Additional information has been requested.
Patient had a vasovagal syncope rxn.  He had it marked on his questionnaire.  I asked him and he said it only happened once and was due to being nervous getting the J 7 J 1st dose.  I talked to him for a minute to see how he was feeling and he said anxious but thought he would be fine this time. I tried to get him to focus on something other than the shot.  I told him to count to 10.  As soon as he started counting as a distraction, I gave him the shot.  He seemed fine, but I asked to make sure.  He said he was fine, we talked for a moment and I asked him was doing ok, which he said he was.  I asked if he was ready or wanted to wait a minute.  He said he thought he was fine.  I told him no rush.  He then said he was feeling a little light headed, so I got him a water. Then he passed out and stiffened up and had tremors.  I tried talking to him and he was unresponsive.  I had Employee call Emergency.  It took about 2 minutes before he seemed to gain his wits.  A manager came in and was talking to him.  I told them we called Emergency.  We asked if he wanted medical attention.  Initially he said no, but when they showed up he decided to let them check him out.
Information has been received from a RN concerning a pt who on 15Au1996 was vaccinated with a dose of varicella virus vaccine live (lot 617265/0566D). Subsequently, on 06Nov00, the pt developed chickenpox. The pt was seen in the office. The reporter also indicated that 30 other pts were vaccinated with varicella virus vaccine live and developed chickenpox (WAES0409USA00600, WAES0409USA01045, WAES0409USA01046, WAES0409USA01047, WAES0409USA01048, WAES0409USA01049, WAES0409USA01050, WAES0409USA01051, WAES0409USA01052, WAES0409USA01053, WAES0409USA01054, WAES0409USA01055, WAES0409USA01056, WAES0409USA01057, WAES0409USA01058, WAES0409USA01059, WAES0409USA01060, WAES0409USA01062, WAES0409USA01063, WAES0409USA01064, WAES0409USA01065, WAES0409USA01066, WAES0409USA01067, WAES0409USA01068, WAES0409USA01069, WAES0409USA01070, WAES0409USA01071, WAES0409USA01072, WAES0409USA01073, WAES0409USA01074). No further information is expected.
Initial information received from a consumer on 22 Jan 2010: This pregnant patient was vaccinated with S-OIV FLUVIRIN (lot no 1008131P) on 29 Oct 2009. The patient delivered a stillborn on 14 Jan 2010. The reporter stated that the doctor believed that the baby died on 31 Dec 2009. It was reported that chromosomal testing was performed to investigate the causes, however the cause remains unknown. It was also reported that the doctor did not identify any outward deformity. No other adverse reaction occurred.
after receiving both Moderna primary doses, he got COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (after receiving both Moderna primary doses, he got COVID-19) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (after receiving both Moderna primary doses, he got COVID-19). At the time of the report, COVID-19 (after receiving both Moderna primary doses, he got COVID-19) outcome was unknown.            No concomitant medications were reported. No treatment  medications were reported.  Company comment: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious AESI of COVID 19 , unspecified days after receiving the second dose of mRNA-1273 vaccine. No details regarding the vaccination dates or COVID 19 test were available in the report. The outcome of the event was 'unknown'.The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-525740, MOD-2022-525891 (Patient Link).; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious AESI of COVID 19 , unspecified days after receiving the second dose of mRNA-1273 vaccine. No details regarding the vaccination dates or COVID 19 test were available in the report. The outcome of the event was 'unknown'.The benefit-risk relationship of mRNA-1273 is not affected by this report.
Date of Admission: 4/26/2023 Discharge Date: 5/1/2023  PRESENTING PROBLEM: Generalized weakness History of dementia COVID-19 virus infection  COVID-19    HOSPITAL COURSE: 84-year-old man with a past medical history of atrial fibrillation on Xarelto, diastolic heart failure, vascular dementia presented with weakness and was found to have COVID-19 infection.  Patient was admitted to the hospitalist service due to concerns about safety returning home. Was living in independent living apartment with his wife who feels that she can no longer take care of him.  She was working on setting up memory care placement for patient in the same place where she has her independent living apartment.   Patient worked with physical therapy it was initially felt to be too weak to return home.  Family did not want patient to go to a subacute rehab facility while awaiting the end of his quarantine period for COVID.  Eventually the patient was able to become strong enough and the family was able to arrange private duty service as well as adult children to stay in the home so that patient and his wife have 24 hour care until diet is able to go to memory care unit.   Electrolytes were monitored and repleted throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up. Patient's wife voiced understanding was agreeable with plan of care discharge
After getting the vaccine at 11:30am on March 2, 2021, I noticed tinnitus in my ears at about 9pm that night.  It has not gone away since then.
Diarrhea; Stomach cramps; It was really hard to close left hand - can now close it but with a lot of pain; Little bit of pain throughout my system/Pain; Siick to my stomach; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), PAIN IN EXTREMITY (It was really hard to close left hand - can now close it but with a lot of pain), PAIN (Little bit of pain throughout my system/Pain) and NAUSEA (Siick to my stomach) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included ADALIMUMAB (HUMIRA), METHOTREXATE, DULOXETINE and FOLIC ACID for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), PAIN IN EXTREMITY (It was really hard to close left hand - can now close it but with a lot of pain), PAIN (Little bit of pain throughout my system/Pain) and NAUSEA (Siick to my stomach). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), PAIN IN EXTREMITY (It was really hard to close left hand - can now close it but with a lot of pain), PAIN (Little bit of pain throughout my system/Pain) and NAUSEA (Siick to my stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient came to pharmacy to ask about pain in her arms following Moderna vaccine. Patient received first dose 9/3/21 in right arm, Pt received second dose 10/1/21 in left arm. Pt stated that she has had pounding, pulsating pain that comes and goes - like there is a bruise but there is not bruise evident. Pt states effect is worse in right arm than left
had a swollen, red reaction at injection site; had a swollen, red reaction at injection site; This is a spontaneous report from a contactable physician via Pfizer Sales Representative. This Physician reported for similar events for three patients. This is 1st of three reports. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history and concomitant medications were not reported. Patient had a swollen, red reaction at injection site on an unspecified date. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020307304 Same reporter/drug, different patient;US-PFIZER INC-2020307303 Same reporter/drug, different patient
Nausea; headache; temperature; feeling hot; Chills; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (Nausea), CHILLS (Chills), HEADACHE (headache), PYREXIA (temperature) and FEELING HOT (feeling hot) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (temperature) and FEELING HOT (feeling hot). On 17-Apr-2021, the patient experienced NAUSEA (Nausea) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 2 pills to alleviate symptoms. At the time of the report, NAUSEA (Nausea), CHILLS (Chills), HEADACHE (headache), PYREXIA (temperature) and FEELING HOT (feeling hot) outcome was unknown. Not Provided          No concomitant medications are provided .
Patient was given the Moderna Bivalent instead of the Moderna monovalent by our nurse.  Should have been the monovalent since it was the second dose of the primary series.
Headache, Myalgia, Arthralgia, chills, injection site pain Narrative:
Injection site soreness, erythema and swelling of all arm, induration, and mild to moderate itch. Lymphadenopathy is palpable on axilla.
Very lethargic, no appetite of energy, fever, cough, restlessness, and body aches
Pt was inadvertently adm MMR  in lateral thigh IM instead of SC on 05AUG90; @ time of report, there was no adverse response;
This initial spontaneous case, was received from other non-health professional (consumer) on 25-Oct-2017, concerning a 41-year-old, adult, female pregnant patient. The patient's historical drug included doxycycline, ENDOMETRIN, ESTRACE, LUPRON, MEDROL, METROGEL vaginal gel, PROMETRIUM, Progesterone in oil injection prior to pregnancy. The patient's medical history included an unspecified fertility treatment. The patient had two ablation (unspecified) as contraceptive method. The patient had 3 previous pregnancies and had no stillbirth or miscarriage, birth defect or congenital anomaly occurred in any previous pregnancy. The patient had no relevant maternal and paternal medical history relevant to pregnancy. Medications taken by father prior to conception was lisinopril. The patient's concomitant medication included Prenatal vitamins and baby aspirin for an unknown indication. The patient's last menstrual period date was 19-Jun-2017. There was no evidence of a defect/adverse finding from a prenatal test. The patient was permitted to enroll in the pregnancy registry. On 20-Sep-2017, at gestation age of 13 weeks (2nd trimester), the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular route, batch number: 195225A, expiry date: Apr-2018). The patient received the vaccine during pregnancy and no adverse event was reported in the pregnant patient and fetus so far. The estimated date of delivery was reported as 06-Mar-2018. The reporter assessed the event as non-serious.
This spontaneous report has been received from a medical assistant referring to a 10 patients of unknown age and gender. Information regarding medical history, drug reactions, allergies and concomitant therapies was not provided. On an unknown date, the patients were vaccinated with an improperly stored, RECOMBIVAX HB  (dose, strength, route of administration and frequency were not provided), lot # M018625 and expiration date 11-AUG-2018 for prophylaxis. The reporter stated that the temperature range  of the vaccine  was 0 Celsius (C) and 2 Celsius (C), the time frame was 15 hours and 42 minutes, also stated that there was no previous temperature excursion, this information was registered in a digital data logger. No adverse effect was reported nor product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007990: US-009507513-1701USA013143:
Patient was admitted on 1/15/2022 because of acute hypoxic respiratory failure likely multifactorial .  Patient was found to have positive COVID-19 infection as well as evidence of volume overload both of which contain should be due to his hypoxic respiratory failure.  Patient was started on the usual regimen for COVID-19 infection including Dexamethasone and also was treated for possible secondary bacterial pneumonia. Patient was cleared for discharge and he was comfortable going home with home health care.  A
low energy; low temperature on third day; I had very bad back pain the next day; then felt lethargic for four days after; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via Intramuscular, in Arm Right, on 21Jul2021 at 15:30 PM (age at vaccination: 53 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included ongoing vertigo only (I have ongoing protentional vertigo and reduced occasionally) and known allergies: dairy products. Family history included gallbladder surgery (I had gallbladder surgery 1991), hernial surgery in 1997, and tonsils comrodin past 1972. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via Intramuscular, in Arm Right, on 22Jun2021 at 03:30 PM (age at vaccination: 53 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that she felt fine with first shot but her second day of second shot on 22Jul2021 at 01:00 PM, felt intense back pain and bit low energy, then on 22Jul2021 at 12:30 PM, she felt lethargic for four days after and low temperature of 96 degree on third day on 24Jul2021 at 02:30 AM which was low and low energy at least five day. She was not told of when booster was and if protect against variants and shot needs to best improved if they people to got booster noone. beats to safest throughout the first shot is not one symptoms but others did. The patient did not receive any treatment for the events. The patient underwent lab test and procedure included temperature with 96 degree (I had a temperature of 96 degree which was low) on an unspecified date. Outcome of the event I had very bad back pain the next day was recovering, then felt lethargic for four days after was recovered on an unspecified date, low temperature on third day was recovered on 26Jul2021, and low energy was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Hives started less than 48 hours after 2nd shot. Came and went for several weeks then became daily on arms, legs, trunk, feet, hands... Self treated with antihistamines. Later started occasional swelling of lips, toes, fingers, feet and hands. Pain in feet and legs. Still having these symptoms as of 12/29/2021
pt recv vax;c/o itching at site;redness; 1" diam; ice packs to site;to MD;inc redness 5x4";MD said ok to adm diphenhydramine;inc swelling;BP 122/72;P=88;swelling,redness dec;advised to go to er if redness/swelling inc;
Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) with a lot # L030586, expiration date of 10-FEB-2017 and lot # L023111, expiration date of 24-DEC-2016, (strength, route of administration and dose were not provided). The vaccines were exposed to excursion -13.4 centigrade for 3 hours and 3 minutes, the previous temperature excursion was -13.4 centigrade for 2 hours and 21 minutes and -`3.7 centigrade for 4 hours and 26 minutes. There was no concomitant therapy reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.