chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; chill; aches; underarm swelling and ache; underarm swelling and ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Nov2021 11:00 (Lot number: F63527) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 01Mar2021, when the patient was 54 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3248, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 22Mar2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 06Nov2021 21:00, outcome "recovered" (09Nov2021), described as "Fever"; CHILLS (non-serious) with onset 06Nov2021 21:00, outcome "recovered" (09Nov2021), described as "chill"; PAIN (non-serious) with onset 06Nov2021 21:00, outcome "recovered" (10Nov2021), described as "aches"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 06Nov2021 21:00, outcome "recovered" (09Nov2021) and all described as "underarm swelling and ache". Therapeutic measures were taken as a result of pyrexia, chills, pain, swelling, axillary pain.  Additional information:Patient had no known allergies. The patient had not received any other vaccine within 4 weeks. Patient had not received other medications the patient received within 2 weeks of vaccination Patient received treatment with Advil (took every 6-8 hr) for the events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination .no name of the drug and allergic reaction was reported.  No follow-up attempts are possible. No further information is expected.
Client received first dose of Moderna on 2/26/21, she is age 17. Per guidelines her 2nd dose was given on 3/2/21. She was monitored for 15 minutes with no initial reactions.
Patient should have received the second dose of Moderna vaccine instead of the Janssen.  Medical records indicated on the first page that the patient should receive Janssen.   Patient was monitored for 15 minutes with no ADR.
Within several minutes of receiving flu vaccine, client came to nurse with hives on neck. BP at the time was 180/90.  Client chose to take PO benadryl from her purse and her symptoms started to improve. Client remained with the nurse for 45 minutes and felt much better. Client was advised to inform her PCP.
He developed a 101F fever the next day after he receive the vaccine on  4-3-21. He took some tylenol and it went down then went back up, then after some rest, the day after, the fever went away.
itchiness on the injection site; rash on the injection site; swelling on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness on the injection site), VACCINATION SITE RASH (rash on the injection site) and VACCINATION SITE SWELLING (swelling on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchiness on the injection site), VACCINATION SITE RASH (rash on the injection site) and VACCINATION SITE SWELLING (swelling on the injection site). At the time of the report, VACCINATION SITE PRURITUS (itchiness on the injection site), VACCINATION SITE RASH (rash on the injection site) and VACCINATION SITE SWELLING (swelling on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported
pain under her arm; pinched nerve in my neck and blood pressure went up to 182/98; I have pinched nerve in my neck and blood pressure went up to 182/98; arm where she got the shot hurt like it was very tender; left breat hurt/then right breast hurt; having a little bit of trouble with asthma; congested and sneezing; congested and sneezing; bumpy rash on her chest and arms; puffiness/swelling in the neck; This is a spontaneous report from a contactable consumer, the patient.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration on 14Jan2021 (at the age of 66-years-old) as a single dose for COVID-19 immunization.   Medical history included ongoing asthma and high blood pressure unknown if ongoing; both from unknown dates.  Concomitant medications included prednisone (MANUFACTURER UNKNOWN) for asthma, unspecified vitamins and an inhaler for asthma. On 14Jan2021, the patient received the vaccination. She had a reaction to the vaccine almost immediately within 15 minutes of receiving vaccine. First, she had a pinched nerve in her neck and blood pressure went up to 182/98. Then about an hour later, the arm where she got the shot hurt like it was very tender. Then, her left breast hurt, followed by her right breast hurt. A few days later on 17Jan2021, she had breast pain and also pain under her arm.  In Jan2021, she was also have some trouble with her asthma, was congested and sneezing. She had bumpy rash on her chest and arms. It was like tiny little bumps but it was not painful. She also had puffiness/swelling in the neck. The clinical outcomes of the pinched nerve in her neck, blood pressure went up to 182/98, arm where she got the shot was tender, breast pain, pain under arm, trouble with her asthma, congested and sneezing, bumpy rash, and puffiness/swelling in the neck were unknown.
I developed a racking cough and difficulty breathing including an onset of what felt like a very terrible flu.
Patient given 2 doses (.5cc) of Novartis lot #102125P1 within 10 minutes. CDC notified; CDC stated localized reaction may occur. Child observed 30 minutes.
Moderna COVID?19 Vaccine EUA  Raised red itchy rash @4cm diameter at injection site
This non-serious initial spontaneous case was received on 09-Oct-2017, from other Health Professional, concerning a 31-year-old, adult, female patient. On 09-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195220, expiry date: Apr-2018). It was reported that the vaccine which was exposed to 68F for 8 hours/ temp excursion above 46F was administered and the patient had no adverse effect. The outcome of the events was not reported. Follow-up received on 13-Nov-2017: It was reported that the patient  had no adverse effect. Narrative amended accordingly.
Left deltoid area. Local reaction around injection - redness - not confluent - gave 25 mg BENADRYL -> and resolving in 15 min - down to 2 inches.
I reviewed patient Consent Form and patient stated that she was going to look away and  to tell her when it was all over. After administration,  patient became limp and her head fell backwards.  I took the patient's mask off, nudged and called her with no response.  Patient loss consciousness in chair and her body became rigid.  Patient had a series of convulsions and recovered in chair. Emergency services was called and took over the scene.
Shortness of breath and tightness in chest beginning 3 days after vaccine and persisting 3 weeks later. Inability to take a deep breath and feeling as though I?m not getting enough oxygen.
Left arm pain described as "muscle soreness" and "pulling" in days to weeks following injection, possibly due to fluvirin administration.
10 minutes after receiving the vaccination patient started to become itchy all over her body. Per patient had hives on legs and back. Her tips of ears were also itching. Patient stated that she has an Epipien with her and if difficulty breathing or throat/lip swelling didoccur that she was going to use it. I advised her to call an ambulance if difficulty breathing occurs. Patient was advised to take benadryl and patient did take benadryl and her symptoms improved to the point where she did not feel an ER visit was necessary. Patient still has residual itchiness but symptoms have improved. I advised patient to take benadryl again before bed if symptoms are still there.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant follow up: Added age group and updated narrative.
Irregular heartbeat / premature ventricular contractions that persisted for several months until I ultimately went to the emergency room and then a cardiologist who diagnosed the condition and prescribed daily medication that I must still take to manage the condition
BUD date excursion. BUD was 4-7-23 and vaccine was administered 4-21-23.
Red area around sq injection site which 3 days after vaccine was larger than softball. Center of redness was hard and painful. No c/o fever at this time. Dr examined client on 3/1/19.
AFTER THE VACCINATION, PATIENT WALKED TO THE OBERSERVATION CHAIR AND HE FAINTED WHEN HE GOT TO THE WAITING STATION. PATIENT FELL AND HIT HIS HEAD, HE WAS UNCONSIOUS FOR ABOUT 10 SECONDS THEN WOKE UP AFTER BEING HELPED BY THE PHARMACIST AND LOCAL MEMBERS. HE WAS AWARE OF THE DATE, DAY, MONTH, AND WHERE HIS LOCATION. PT HAS NO DIFFICULTY IN BREATHING OR SPEAKING. HOWEVER, PATIENT HAD HIT HIS HEAD AND HE WAS TAKEN AWAY WITH THE PARAMETIC.
Well my experience was just flu like symptoms like fever, chills, body aches etc on the night of my vaccine on 2/9/2021. But then I started getting very nauseous, and I started vomiting and that lasted for several hours. The nausea lasted for about 12 hours. And then when that subsided I wasn't able to keep anything down, eventually I was able to keep a Pepcid down. From there I just recovered from the general weakness and that in total lasted probably about 24 hours. It was the vomiting that was concerning to me, not the other things. I had a telehealth with a DR the morning following my symptoms around 9 or 10AM. Then the following day on 2/11/2021, I got a COVID test.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillins" (unspecified if ongoing). There were no concomitant medications. There were no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: Product: Product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 19May2022, lot number: Ga2279, indication: Treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Problems with her heart; Shortness of breath; Pain the chest; Low blood pressure; Passed out; Started shaking "like a seizure"; Started shaking "like a seizure"; Dizziness; Tiredness; Stomach pain; Chills; Fever; Sweats; Nausea; Vomiting/throwing up; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Inflammation in the chest, muscle or maybe heart inflammation; Pain in the heart; Not feeling well; Had a severe allergic reaction; Headache; Weak; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169; Expiration date was not reported) on the left arm on 20Apr2021 as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. On 20Apr2021, the patient had passed out; started shaking "like a seizure"; dizziness; tiredness; stomach pain; chills; fever; sweats; vomiting/throwing up; and nausea. The patient was brought to urgent care/emergency room (ER) due to the reported events. On 21Apr2021, the patient had shortness of breath; pain in the chest; and low blood pressure. On 22Apr2021, the patient had problems with her heart. The patient was brought to urgent care/emergency room (ER) due to the reported events, and for cardiac work up. On an unspecified date in 2021, the patient was not feeling well; had a severe allergic reaction; headache; and was weak. In Apr2021, the patient had "inflammation in the chest, muscle or maybe heart inflammation". The patient received treatment for the events, pain in the chest and "inflammation in the chest, muscle or maybe heart inflammation" (double dose of naproxen. The patient's laboratory tests included normal blood pressure on 22Apr2021; chest x-ray on 21Apr2021 (results were not provided); echo sonogram on 22Apr2021 (results were not provided); electrocardiogram (EKG) was normal on 21Apr2021, 22Apr2021 and 23Apr2021. The outcome of the events was not recovered for tiredness; was recovered on an unspecified date in 2021 for chills, sweats, vomiting/throwing up; was recovering for pain in the chest; and was unknown for all the other events. The patient's primary care provider was writing a doctor's note recommending that she not receive the second dose based on her reaction to the first dose, and the PCP recommended that the mother call Pfizer as well.
Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  No other issue reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Pt recvd Engerix-B on 9SEP91, 17OCT91, 17MAY92 & 12MAY92 pt's antibody titer results were neg;
1 week after second shot, major rashes on elbows and itchy spots in other parts of body.  Shortly after I noticed unusual bruises popping up and not remembering hitting that spot. Recently had my blood taken and I have huge bruising from the needles which normally I don?t have any.  The skin rashes mostly went away but I?ve had extreme flaky dandruff on my scalp which I?ve never had, and excema-like itchiness.  Not 100% sure if this is all from the vaccine but the side of my neck where I got the shot has had knots and pain since I got it.
Patient got the shot from the vial that has been thawed more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got the shot from the vial that has been thawed more than 30 days) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038821A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got the shot from the vial that has been thawed more than 30 days). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient got the shot from the vial that has been thawed more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered with a vial that was thawed from the freezer more than 30 days ago and the expiration of vaccine is  on 25-sep-21 and the administration was done on 15-sep-21 .However the vials were removed from the freezer to refrigerator storage on 08-april-21.
vial was initially stored in the refrigerator on 08Oct2022, vial was first punctured on 08Oct2022 around 9 AM, administration of vaccine on 10Oct2022 at 12 PM; no adverse event; received a dose 12 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose 12 hours after puncture), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 08Oct2022, vial was first punctured on 08Oct2022 around 9 AM, administration of vaccine on 10Oct2022 at 12 PM) and NO ADVERSE EVENT (no adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7164B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.   On 10-Oct-2022 at 12:00 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022 at 12:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose 12 hours after puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 08Oct2022, vial was first punctured on 08Oct2022 around 9 AM, administration of vaccine on 10Oct2022 at 12 PM) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose 12 hours after puncture), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 08Oct2022, vial was first punctured on 08Oct2022 around 9 AM, administration of vaccine on 10Oct2022 at 12 PM) and NO ADVERSE EVENT (no adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received a dose 12 hours after puncture) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 08Oct2022, vial was first punctured on 08Oct2022 around 9 AM, administration of vaccine on 10Oct2022 at 12 PM).    Concomitant medications were not reported.  Vial size was 2.5 ml. The vial stored at room temperature post puncture and did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range for 48 hours. Treatment medications were not reported.
Case previously recorded as MA2009-3683. Consumer reported the following information via MedCom, on 3 NOV 2009: A female patient with a known history of Parkinson's disease (diagnosed about one year ago) was vaccinated i.m. with S-OIV FLUVIRIN (batch no. 101716P1A) on 26 or 30 OCT 2009. When returning to her car shortly after vaccination she developed a tingling sensation in her left foot lasting for approximately ten minutes. She had fully recovered on 26 or 30 OCT 2009. MedCom Ref. no.: NA09-007532. Addendum: We received the following additional information via MedCom on 5 NOV 2009: Tingling sensation resolved and had not yet returned. No change in assessment.
Two days after receiving the dose client felt "stabbing pain" on inhale and continues to have a cough with deep inhale.