chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave 11 patients Moderna Covid-19 Vaccine doses on 6Oct2021 from a vial that had been moved; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses on 6Oct2021 from a vial that had been moved) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses on 6Oct2021 from a vial that had been moved). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses on 6Oct2021 from a vial that had been moved) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.
Pulmonary Embolism; Clot in her left artery and lung; Didn't receive second dose; Wasn't feeling well; Shortness of breath; Chest pain; having a panic attack; This spontaneous case was reported by a nurse and describes the occurrence of PULMONARY EMBOLISM (Pulmonary Embolism) and PULMONARY THROMBOSIS (Clot in her left artery and lung) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Blood pressure high.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced MALAISE (Wasn't feeling well). In April 2021, the patient experienced DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain) and PANIC ATTACK (having a panic attack). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary Embolism) (seriousness criteria hospitalization and medically significant) and PULMONARY THROMBOSIS (Clot in her left artery and lung) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Didn't receive second dose). The patient was hospitalized from 24-Apr-2021 to 08-May-2021 due to PULMONARY EMBOLISM and PULMONARY THROMBOSIS. The patient was treated with RIVAROXABAN (XARELTO) for Pulmonary embolism, at an unspecified dose and frequency and OXYGEN for Pulmonary embolism, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Pulmonary Embolism), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), PANIC ATTACK (having a panic attack) and MALAISE (Wasn't feeling well) outcome was unknown, PULMONARY THROMBOSIS (Clot in her left artery and lung) had not resolved and INTENTIONAL DOSE OMISSION (Didn't receive second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Oxygen saturation: low (Low) went down to 70% in Apr-2021..     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This is a case of Intentional dose omission for this 52-year-old female. Regarding events Pulmonary embolism, Pulmonary thrombosis, Dyspnoea, Chest pain, Panic attack, and Malaise, a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the events.; Sender's Comments: This is a case of Intentional dose omission for this 52-year-old female. Regarding events Pulmonary embolism, Pulmonary thrombosis, Dyspnoea, Chest pain, Panic attack, and Malaise, a causal relationship cannot be excluded based on the current available information and temporal association between the use of the product and the start date of the events.
This spontaneous report was received from a pharmacist referring to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 03-NOV-2016, the patient was vaccinated with GARDASIL (route, dose, dose number, frequency, lot # and expiration date were unknown) for prophylaxis. Subsequently, on 14-APR-2017 after the dose of GARDASIL the pharmacist reported that the patient went into the pharmacy  to received a dose of GARDASIL 9 (route, dose, dose number, frequency, lot # and expiration date were unknown) for prophylaxis. No adverse effect were reported. This is one of two cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA007031:
Pt requested to get bivalent Pfizer vaccine and was given monovalent Pfizer vaccine. Pt was notified and she will return to get her bivalent dose in 2 month. Pt did not have any adverse reactions.
I got my 3rd dose; I got my 3rd dose; heel of my hand and my little finger felt numb/My left hand up to my little finger have numbness,; I feel achy; felt ill; I got a little bit sick; felt weak/I am feeling kind of weak. I just didn't feel really good; I just couldn't pay attention like I should; tingling and still bad/I have some numbness in my right hand; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 75-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number FC3181), via an unspecified route of administration, administered in Arm Right on 23Aug2021 (at the age of 75-years-old) as DOSE 3, SINGLE for COVID-19 immunisation. Medical history included rheumatoid arthritis and pulmonary fibrosis from an unknown date and unknown if ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. Concomitant medications included atenolol, warfarin, rosuvastatin taken for an unspecified indication, start and stop date were not reported. The patient got his 3rd Pfizer COVID shot on Monday and the patient thinks he might have had a reaction but not sure he had a reaction at all. On an unspecified date, the patient got a little bit sick yesterday, felt ill, felt weak, felt like he needed to lay down, his hand this morning-heel of his hand and his little finger felt numb and didn't know if that could be a side effect or something. The numbness in the heel of his hand and it's never happened before but he don't think it was-it's probably the way he slept, he thought. His left hand up to his little finger have numbness, tingling and still bad; he was wondering and worried if it could be symptoms of something concerning. The patient was feeling kind of weak. He just didn't feel really good ok and again that morning when got up he have some numbness in right hand. It is like his hands are little numb and it was still kind of numb feeling. He just wanted to know if that could be a reaction from the corona virus shot. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
My head felt very foggy. I was very tired. I was in bed more than I was up. I could not function. I did not general feel well. I could not eat anything. This went on for 6 to 8 weeks. My doctor did a COVID-19 test, negative. Then they gave me amoxicillin. I don't feel the same as I was before the vaccination.
1st sz 7/9/99 went area hosp & sent home;2nd sz went hosp;hospitalized;fluid lt ear: ATB given;tests run for sx-all nl;released 7/11/99;
Felt nauseous and his mouth felt itchy, gave Benadryl and monitored.
Left arm where shot was administered was painful for 2 days. I could not lift arm. Seemed to get better then a week later my arm was very sore. Pain when I lifted above (elbow) shoulder. I feel discomfort and am aware of pain throughout the day. Seems to get worse at night. Pharmacist said to apply heat and take ibuprofen. Arm still hurts after 28 days. I have no previous injuries and have not exercised my arm. The pain is in the muscle 4 in. below top of shoulder inside of arm.
Hives noted on Rt wrist, on left arm adjacent to vaccine site, left elbow & on arm below vaccine site hives started 1 hour after vaccination
"spinning sensation" Patient reported having a sensation that the room was spinning, one week after receiving her first dose of the vaccine. The sensation resolved the same day. She was evaluated by her primary physician who advised her to receive the second dose of the vaccine as scheduled.
3RD DOSE MODERNA COVID VACCINE GIVEN 8/28/21, #025L20A; 4TH DOSE MODERNA COVID VACCINE GIVEN 4/4/22, #002M21A; pt brought to the hospital 10/6/22 with dyspnea past 2-3 days; found to be positive for COVID; started on Dexamethasone; pt experienced worsening SOB; O2 supplementation; 10/9/22 pt went into cardiac arrest x 15 mins; ACLS protocol followed; ROSC achieved; intubated; transferred to CVICU; pt had another cardiac arrest; ACLS protocol followed; unable to achieve ROSC; pt passed away in the hospital
COVID Vaccine Clinic.  Staff member received 1st dose of COVID 19 vaccination and approx 15 minutes later c/o diaphoresis, palpitations, throat ""feeling thick/swelling"" and tingling in fingers. She was able to speak clearly, no increase in salivation, breathing calm. She was moved via wheelchair to the hallway for privacy. Vitals 123/77,  HR-76, RR 20. She was given sips of water. Staff observed her for 40 minutes and symptoms improved. Pharmacy was consulted and the staff member administered her own Claritin. She stayed for another 20 minutes without return of symptoms and was released. She was encouraged to contact her personal physician to discuss. She was also given the V-Safe information and encouraged to report her experience."
FATIGUE; HEADACHE; KNOT ON ARM; RASH AT INJECTION SITE; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced knot on arm. On 16-MAR-2021, the subject experienced rash at injection site. On 16-MAR-2021, the subject experienced sore arm. On 17-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from knot on arm, rash at injection site, sore arm, and fatigue. This report was non-serious.
soreness still flares up at the chest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (soreness still flares up at the chest) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (soreness still flares up at the chest). The patient was treated with PARACETAMOL (TYLENOL) for Chest pain, at a dose of UNK dosage form. At the time of the report, CHEST PAIN (soreness still flares up at the chest) outcome was unknown.            It was reported that the patient's concomitant medications included unspecified diabetes medications and unspecified blood pressure medications.   This case was linked to MOD-2021-220389 (Dose 1) (Patient Link).
Fever; Very Weak legs; she could not move around and slept on the floor, normally moves around with one crotch but last night she could not; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Very Weak legs), HYPOKINESIA (she could not move around and slept on the floor, normally moves around with one crotch but last night she could not), CHILLS (Chills) and PYREXIA (Fever) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Very Weak legs), HYPOKINESIA (she could not move around and slept on the floor, normally moves around with one crotch but last night she could not) and CHILLS (Chills). On 20-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, MUSCULAR WEAKNESS (Very Weak legs), HYPOKINESIA (she could not move around and slept on the floor, normally moves around with one crotch but last night she could not), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Later that day patient felt joint ache all over, muscle aches especially in thighs, eye burning, chills--went to bed and felt better next day although thigh muscle still sore today 10/24/17. Injection site was red raised with whole arm red and sore days later. Today 10/24 arm not red.
vomiting; diarrhea.; still congested; shaking chills; coughing; nose running; low-grade fever; feverish; chills; headache; aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (feverish), CHILLS (chills), VOMITING (vomiting), DIARRHEA (diarrhea.) and NASAL CONGESTION (still congested) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (feverish), CHILLS (chills), HEADACHE (headache) and PAIN (aches). On 09-Apr-2021, the patient experienced COUGH (coughing), RHINORRHOEA (nose running) and PYREXIA (low-grade fever). On 10-Apr-2021, the patient experienced CHILLS (shaking chills). On 12-Apr-2021, the patient experienced VOMITING (vomiting), DIARRHEA (diarrhea.) and NASAL CONGESTION (still congested). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (feverish), CHILLS (chills), VOMITING (vomiting), DIARRHEA (diarrhea.), NASAL CONGESTION (still congested), COUGH (coughing), HEADACHE (headache), PAIN (aches), RHINORRHOEA (nose running), PYREXIA (low-grade fever) and CHILLS (shaking chills) outcome was unknown. Not Provided
TOOK THE SECOND DOSE OF VIVOTIF A DAY LATE; This spontaneous case report (PVX2019-2545) was received from a consumer on 11-Oct-2019. It described a 69-year-old female consumer who "took the second dose of Vivotif a day late" (PT: Inappropriate schedule of product administration), while being on Vivotif for typhoid prophylaxis.  Case report: The consumer did not take the doses of Vivotif according to the schedule. The doses were taken on day 1, 4, and 6.   Action taken with respect to the event was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took the second dose of Vivotif a day late" was considered as not applicable. .; Sender's Comments: Company's Comment: The causality of the event "took the second dose of Vivotif a day late" was considered as not applicable.
Narrative: Patient reported rash developing 1 week after dose 1 of Pfizer COVID vaccine. He received dose 2 Pfizer COVID vaccine and subsequently presented to primary care about two weeks after receiving with rash that he reported developed one week after he received dose 2. He was prescribed a methylprednisolone dose pack.
Cardiac arrest, patient passed away. ED visit and death within 6 weeks of COVID vaccine.
Fever Redness, soreness, itching @ injection site Narrative:  Volunteer reported chills- fever of 102.0 on 1/8. Fever 100.0 on1/9. 1/13 reported redness, soreness and itching at injection site.
Pt was fine prior to vaccines. After developed high fever 105, shaking, twitching, complained of severe head and neck pain, also chest pain. Symptoms lasted around 36 hrs. Gave pt Tylenol, Motrin, fluids. Tylenol and Motrin given around the clock to keep fever down. Also next day swollen neck glands and red throat was noted by physician.
9hr p/vax pt had swollen eyes, red spots on body & swollen tongue;pt taken to hosp tongue started swelling more & could not breathe;911 called;EMT to house & gave DPH;T100.4;pt seem better;
The vial of the vaccine was wrongly diluted in 0.8 ml NS 0.9% instead of 1.8 ml NS 0.9%.  Patient received 0.3 ml from this dilution ( Vial in 0.8 ml NS 0.9%)
Started getting heart palpitations. Feels like the blood is building up in my heart then shooting through. Kind of like taking a giant gulp of water.
Pt has a silver sized red area around the injection site area. The red rash a grown larger 9 inch, first noticed on 6/19/10. 6/18/10 No noticeable site incubation observed. Onset approx. on 6/19/10. Noticeable angioedema.
Moderna COVID-19 Vaccine EUA Lightheadedness, pale skin, low blood pressure, low heart rate Sweating in left armpit prior to adverse event, starting immediately after vaccination
Individual noticed hard knot approximately 1/2" in diameter at site of injection and localized itching beginning on date noted above. Knot is still present and localized itching is intermittent.
12/31/21 presents to EC ED " transfer from Hospital" "bilateral PEs w/ RV strain". PMHx of "hypertension and obesity"
Information has been received from a physician concerning a 6 year old female with asthma and seasonal allergies who on 18-MAY-2001 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccines included a first, second, third and fourth doses of diphtheria toxoid (+) tetanus toxoid pertussis vaccine (unspecified) on 29-JUN-2000, 08-SEP-2000, 03-NOV-2000 and 18-MAY-2001; a first, second and third dose of poliovirus vaccine live oral on 29-JUN-2000, 08-SEP-2000, 18-MAY-2001; a first dose of II measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 18-MAY-2001; a first, second, third and fourth doses of Hib conj vaccine (unspecified carrier) on 29-JUN-2000, 08-SEP-2000, 03-NOV-2000, 18-MAY-2001; a first, second, and third doses of hepatitis B virus vaccine (unspecified) on 02-MAY-2000, 29-JUN-2000, 03-NOV-2000; a first dose of varicella virus vaccine live (unspecified) on 18-MAY-2001; a first and second doses of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) on 08-SEP-2000, 03-NOV-2000; a first and second doses of pneumococcal conj vaccine (unspecified) on 06-FEB-2001, 18-MAY-2001. The physician reported that the 6 year old patient was due for her second dose of varicella virus vaccine live (Oka/Merck) next week but on 20-APR-2007 the patient experienced "breakthrough with over 200 lesions all over her body" after receiving the first dose on 18-MAY-2001. There is no plan to re-vaccinate the patient with the second dose due to the breakthrough. The patient was being treated with a topical cream such as calamine lotion and she was being hydrated. No lot number was provided. Unspecified medical attention was sought. No lab diagnostic studies were performed. There was no illness at time of vaccination. Adverse event(s) following prior vaccination included: chicken pox (none reported for the patient's sibling). No further information was provided. Outcome reported as recovered with 27-APR-2007 as recovery date. There was no product quality complaint. Additional information has been requested.
2/5/99-rt inguinal pain, prescription inc; 5/11/99 rt hip pain; 5/24/99-dx: osteoarthritis bilat; 6/15/99 h/a; 8/17/99- swollen joints; fevers; pain in hands, elbows, shoulder, knees; poss rheumatoid arthritis;dx cluster h/a;
Acute  nontraumatic pain in neck, left side, and upper left extemity(shoulder).    Acute left cervical lymphadenitis.    Still have discomfort in shoulder blade, some swelling yet of lymph node.   Tingling in two fingers on left arm, had swelling  over same two knuckles but that has receded just have like my hand is asleep, more at night time.   Fullness feeling inside of arm at bend, vein area.  Injection site is high - about 1 1/2 fingers down.   Have had no x-rays or tests. Went to Urgent Care  - prescribed Predisone for 5 days - no help.  Nec k, now, has less swelling. Mom
6:00 pm R arm became very sore, hard to lift.  Midnight woke up with chills, very nauseated, vomited. Next morning are swollen from shoulder to elbow, red itchy rash, continued to feel nauseated. Took 4-5 days to resolve.
most horrible heartburn he's ever had in his life overnight; felt like his whole throat was going to be burned out; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (most horrible heartburn he's ever had in his life overnight) and THROAT IRRITATION (felt like his whole throat was going to be burned out) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (most horrible heartburn he's ever had in his life overnight) and THROAT IRRITATION (felt like his whole throat was going to be burned out). At the time of the report, DYSPEPSIA (most horrible heartburn he's ever had in his life overnight) had resolved and THROAT IRRITATION (felt like his whole throat was going to be burned out) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.
Developed itching around throat/face area shortly after second vaccine.  She did not have any other complications, was monitored in the emergency department, and sent home in stable condition.
Near injection site is raised, red rash near injection site. Red marks above and below injection. Very hot to the touch.
Approx 5 fingers below injection site an indurated, reddened and warm to touch area approx 5 fingers wide appeared.  The area is very painful, swollen, and reddened with a definite hardened edge.  I have not been able to lay on this arm or have anyone else touch it due the pain.