chrisvoncsefalvay/vaers-outcomes huggingface dataset:
five doses of the VARIVAX that underwent the temperature excursion were administered; This spontaneous report has been received from a physician  concerning a 12 months- old patient of unknown gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.  On 09-AUG-2020,  the patient was vaccinated with one of the five doses of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection 0.5 milliliter once for prophylaxis, that underwent temperature excursion.  Lot # reported as S026925 (Patient route of administration and expiration date was not reported).  The storage temperature was reported  to have been at -9.2° celsius degrees (C) and in between  -14° celsius degrees (C) to -10° celsius degrees (C) (-14.3) for 30 minutes.  There was digital data logger involved and  no previous temperature excursion was reported.  Lot #  S026925 is an invalid lot number for varicella virus vaccine live (oka/merck)  This is one of many reports received from the same reporter about related temperature excursion cases.; Sender's Comments:  US-009507513-2008USA011215: US-009507513-2008USA011215: US-009507513-2008USA011596: US-009507513-2008USA011473:
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX 0.5 ml, subcutaneously, lot # M023379 with an expiration date: 11-MAY-2018. Administered dose of VARIVAX experienced temperature excursion of 11.1 Celsius degree for 1 hour 40 minutes, on an unknown date. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
R arm became severely painful,warm, red, edematous from upper arm down to hand.  Accompanied by fever.  Sx began few hours after flu vaccine administered and wosened with time.  Presentation consistent with cellulitis.  Required IV antibiotics twice in ER as well as course of PO antibiotics.
heart rate racing; feeling faint; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate racing) and DIZZINESS (feeling faint) in a 65-year-old female patient who received mRNA-1273 (batch no. 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and ELDERBERRY [SAMBUCUS NIGRA] for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HEART RATE INCREASED (heart rate racing) and DIZZINESS (feeling faint). On 29-Apr-2021, HEART RATE INCREASED (heart rate racing) and DIZZINESS (feeling faint) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included black elderberry,arthritis topical cream. Treatment included Patient used a cold compress on her face and neck.
Patient received flu shot at 11 am on 9/2/10 in her left arm. On 9/3/10 afternoon she experienced left arm fingers starting to feel numb. By night she felt numbness in her palms also. The numbness went away on 9/4/10 morning. She completely recovered.
A spontaneous report was received from a nurse concerning a 47-year-old, male patient, received the 1st Moderna Vaccine on 01 Feb 2021, today the patient received the Pfizer vaccine (Wrong vaccine administered ). The patient's medical history was not provided by the reporter. No relevant concomitant medications were reported. On 01 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 043L20A) for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient inadvertently received the Pfizer vaccine (Wrong vaccine administered ). Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, Wrong vaccine administered was considered resolved.; Reporter's Comments: This report refers to a case of Wrong product administered of for mRNA-1273, the patient received the Pfizer vaccine, with no associated AEs.
Pt seen at ED for anaphylaxis after Moderna Vaccine pt received 1st Moderna COVID19 vaccine at pharmacy today, within 2 mins felt throat closing, itching, SOB. had slight hives on abdomen. received epi-pen and po benadryl at pharmacy. was given additional epi-pen , iv solumedrol, iv benadryl in ED.  discharged after improvement and 6 hr observation
patient was hit hard by another person at the sight which made the arm numb down to his left wrist. patient did experience at injection site pain, redness, swollen and fever. no gi issues. which had subsided by the day he reported this event (11/22/19).
Missed the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Pains in chest near heart. It?s not extreme pain, but it?s enough to notice quick, sharp stabs that are freaking me out. They come and go.  Day after vax felt kinda sick. Next day felt great, thought it was over. But the following day (day 3 after) I started noticing quick pains around heart. It?s continued until now, which is why I started researching it and saw I should report it.
19JAN97 pt spiked temp to 103 temp ranged between 100-103 for next 3 days;unable to retain oral or liquid APAP;was able to retain food & other liquids;also slept well;temp nl by 27JAN97;
Patient had pulmonary  Embolism  after receiving  2nd dose of COVID 19 vaccine
Tested positive with immediate strong test line in rapid antigen test on day 12 and day 14.; Tested positive with immediate strong test line in rapid antigen test on day 12 and day 14.; 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), on 13Apr2021 as dose 1, single (Lot number: EW0161) and on 04May2021 as dose 2, single (Lot number: EW0173) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 08Dec2021 as dose 3 (booster), single (Lot number: 018F21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Apr2022, outcome "recovering" and all described as "Tested positive with immediate strong test line in rapid antigen test on day 12 and day 14.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test positive: (23Apr2022) Positive; (May2022) Positive, notes: Tested positive with immediate strong test line in rapid antigen test on day 12 and day 14; (May2022) Positive, notes: Tested positive with immediate strong test line in rapid antigen test on day 12 and day 14. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; No further information is expected.
the son felt like he was gonna pass out and was pale; the son felt like he was gonna pass out and was pale; This is a spontaneous report from a contactable consumer. A 15-year-old male patient (reporter's son) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 15-years, on 03Jun2021 18:25 (Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date as single dose for covid-19 immunisation. The patient experienced felt like he was gonna pass out and was pale on 04Jun2021 01:00. Events outcome was unknown.  Information on the lot/batch number has been requested.
Fever first 4 days not exceeding 100.4 then diarrhea for next 3 days. Began to develop rash, that is all over body per mom, on 8/1/11. No respiratory problems noted. Referred to PCP. S/S cleared up by 8/3/11.
The next day my arm from my shoulder to my elbow turned black and was warm to the touch and hurt bad it was like this for 3 weeks
Pt was treated at Hasbro ER.  Awaiting reports 10/18/09 Spoke with reporter's office.  Seen for allergic rxn of facial swelling and itchy tongue and released on Benadryl
This spontaneous report received from a registered nurse referred to a 9 weeks old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 07-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
The needle and syringe used for administration were not securely tightened. During administration the vaccine spilled outside the needle and the syringe detached from the needle. Needle and syringe were discarded. Vaccine on patient's arm was wiped up with gauze and a bandaid given over the site of the needle puncture. Patient was informed of what had occurred and consented to receiving a repeat dose in the other arm. The repeat dose was given successfully. Patient stated she was feeling well. Patient completed a standard 15 minute wait period before leaving the vaccine clinic.
Patient was given vaccine at 17 years 10 months instead of 18 years of age. Patient had no adverse reaction to vaccine.
pt returned to clinic shortly p/vax 8SEP98 rxn to immun;rash around mouth & on forehead;no distress rash resolved a/leaving clinic;no medication given;
pt reported the evening following vax became ill, n/v, chills, unk fever (didn't have thermometer) lasted7PM-2A;doing fine next day;
Flublok vaccine intended for 18 yo and older administered to pt, no side effects, treatment required
Case number PHEH2014US024684, is an initial spontaneous report from a physician via Merck National Service Center (reference: 1-12953477015) received on 09 Dec 2014. This report refers to a patient of unknown demographics. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: unknown) in Nov 2013. On an unknown date, after vaccination, the patient experienced erythema, swelling, pain and warmth at the injection site. The outcome, seriousness and causality of the events were not reported.
Presented to ED with shortness of breath on exertion and tachycardia.  Patient reported getting covid-19 2nd vaccine 4/11 (moderna)  Lot #037B21A. Patient found to have acute saddle pulmonary embolism and right leg femoral DVT.  Placed on heparin drip then transferred to hospital on 4/16/2021.  Converted from heparin IV to Apixaban PO.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 14:00 as dose 1, single (Lot number: EL3247), in right arm, on 15Feb2021 at 13:00 as dose 2, single (Lot number: EN6201), in right arm and on 10Nov2021 at 16:00 as dose 3 (booster), single (Lot number: ff2593) at the age of 76 , in right arm for covid-19 immunisation. The patient's relevant medical history included: "Small fiber sensory neuropathy", start date: Nov2021 (unspecified if ongoing), notes: Small fiber sensory neuropathy; "Known allergies: Microbic" (unspecified if ongoing), notes: Known allergies: Microbic. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR], start date: Jul2004; CALTRATE [CALCIUM CARBONATE], start date: Jan2000. Past drug history included: Septa, reaction(s): "Known allergies: Septa", notes: Known allergies: Septa; Ibuprofen, reaction(s): "Known allergies: Ibuprofen", notes: Known allergies: Ibuprofen. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) COVID Rebound, notes: COVID Rebound after Paxlovid Treatment"; (04Jul2022) positive, notes: I was positive until 04Jul and continued to have nasal congestion; (05Jul2022) Negative, notes: I tested negative again this morning ,05Jul; (21Jun2022) Negative, notes: I tested negative with home antigen 21Jun and 22Jun; (22Jun2022) Negative, notes: I tested negative with home antigen 21Jun and 22Jun; (26Jun2022) positive, notes: On 25Jun my symptoms returned and I tested positive on 26Jun with home antigen; (15Jun2022) positive, notes: I started Paxlovid after testing positive (PCR) 15Jun2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Started Paxlovid after testing positive (PCR) 15Jun2022 and completed 5 days 20Jun2022. My symptoms of nasal congestion were mild and I tested negative with home antigen 21Jun and 22Jun. On 25Jun my symptoms returned and I tested positive on 26Jun with home antigen. My symptoms of nasal congestion and mild cough were worse than original onset. I was positive until 04Jul and continued to have nasal congestion. I tested negative again this morning ,05Jul. I found the CDC Health Advisory distributed 24May2022 on line describing COVID Rebound after Paxlovid Treatment. I believe this is what happened to me. I notified my PCP when I tested positive on 26Jun and started the isolation period over .
Started feeling incredible fatigue and exhaustion about 7pm on the day of the vaccine. That night around midnight I started running a fever and throughout the night and the next day I?ve been running an off and on fever usually around 100.1°. Today (second day after vaccine) I?ve had a really bad headache.
I have redness approximately the size of a quarter maybe a little bigger with a little tenderness in the red area still 10 days later after the first dose. When my husband received his first dose he mentioned to the clinic he was at and they said I should report the side effect.
11 Sept 03 Smallpox (Primary)-Left arm Hep B #1-Right arm Anthrax #1-Right arm  Service member received the smallpox and anthrax briefings and tri-fold brochures.  She reports no contraindications to the vaccinations.  She also reports no complaints on this date.  13 Sept 03 Noted a golf-ball sized knot on right arm-deltoid area at site of anthrax vaccination.  Reports area was red and tender.  Did not seek medical attention as she remembered from her briefing that local reactions were common.  She describes peak redness and swelling on 14 Sept and reports that it started to resolve by 15 Sept.  Denies any drainage or odor from site.  No weakness, numbness, or tingling reported.  15 Sept 03 Began to experience some tenderness under her left arm.  No mass palpable at that time.  No other complaints except felt a little more tired.  16 Sept 03 Noted left axillary lymph node swelling and increased tenderness.  19 Sept 03 Presented with chief complaint of left axillary lymph node swelling and pain.  "Hurts to move my arm."  Otherwise feels fine except a little more tired. Smallpox vaccination site progressing as expected.    Denies any other lesions.  No chest pain or shortness of breath.  No headaches today but states she had a mild headache the day before.  No vision changes.  No neck pain.  Denies any weakness in extremities.    Does recall 1 episode of brief tingling in her left arm on 18 Sept and 1 episode this morning.  She describes it as a tingling sensation that started under her arm and traveled to her fingertips.  She estimates that it lasted several seconds to a minute.  She was lying in bed both times when this happened but has not noticed it since that time.  Denies any other numbness or tingling in other extremities.  No weakness in any extremity.States that she had experienced numbness, weakness, and tingling in both extremities over two years ago after an adverse reaction to Benadryl (taking for allergic rhinitis/sinusitis) and Prednisone (taking for a rash she experienced after taking a sulfa drug).  She describes the tingling she experienced today as nothing compared to her symptoms 2 years ago.  She developed those symptoms within 4 hours of taking the medications and states that the symptoms lasted 2 weeks.  She was evaluated by her family doctor (records unavailable) but states that no testing was done at that time.  Symptoms resolved on their own with no recurrence.  22 Sept 03 Service member reports L axilla area still tender.  Has full ROM in LUE but experiences discomfort in axilla area with movement.  Reports that she had 2 additional brief episodes of tingling that ran from L axilla area to finger tips and then back to L forearm area (19 Sept pm and 21 Sept am).  During both episodes, she was lying on her back and had raised her arms to a 90-degree angle.  The tingling sensation lasted several seconds.  No weakness noted in extremities.  No tingling in lower extremities or R upper extremity.
I experienced one week after I had normal side effects for two days, the lethargic, not feeling well in general then it went away. About one week later, one of my hands, inside of palm felt itchy, I thought I was reacting to something. I went home and from my fingertips to palm , on the inside was hot and red all over my palms. I saw my doctor who tested my for kidney and bacteria  all my tests were negative. They gave me steroid topical cream and to take Tylenol. My skin peeled off over the course of two weeks, still sensitive to heat and dry. My skin on my skin was dry and also on my feet.  I dealt with these symptoms for three weeks.  As far of today my hands are much better, they are not red and some dryness but hands are very sensitive to heat.  I do not have the lot number to provide today.
16 years old patient received 1st dose of moderna vaccine; A spontaneous report was received from a physician concerning a 16-year-old patient who was participating in the mRNA-1273 Emergency Use Program and they gave first dose to a patient 16-years-old.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 07-Jan-2021 intramuscularly for prophylaxis of COVID-19 infection.   The reporter reported that the patient received the Moderna vaccine on 07-Jan-2021. He stated that the patient was 16-years-old. No adverse reactions were reported.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event they gave first dose to a patient 16-years-old was considered resolved on 07-Jan-2021.    The reporter did not provide a causality assessment for the event they gave first dose to a patient 16-years-old.; Reporter's Comments: This report refers to a case of 16- year-old patient who experienced non-serious unexpected event of first dose to a patient 16-years-old (product administered to patient of inappropriate age) for mRNA-1273, lot # unknown, Exp date-unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Information has been received from a physician concerning an 80 year old female with a history of thrombin who on 24-APR-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included gabapentin.  On 08-JUN-2007 the patient experienced tingling on the right side of stomach.  Medical attention was sought.  The patient's tingling on the right side of stomach persisted.  No product quality complaint was involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a physician concerning an 80 year old female with no known allergies and a history of "throbin" who on 24-APR-2007 was vaccinated in the right hip with a first dose of ZOSTAVAX (Oka/Merck) (Lot#652925/0621F). On 08-JUN-2007 the patient developed tingling on the right side of her stomach. Medical attention was sought. The patient's tingling on the right side of stomach persisted. No product quality complaint was involved. Follow up information from the patient indicated that on an unspecified date both of her hands started tingling and throbbing. Her physician prescribed gabapentin which was making her dizzy. Additional follow up information from the physician indicated that the patient's adverse events started on 14-MAY-2007, but the patient first complained to the doctor on 08-JUN-2007. It was noted that the patient's problems continued through 10-SEP-2007. An exam was performed and was "normal". There was no recent exposure to chicken pox or shingles, and no rash occurred at the site of injection or elsewhere within 42 days of vaccination. No further information was provided. Follow-up information was received from the physician which indicated that the patient's tingling, numb hands have persisted. On 08-OCT-2007, the patient underwent a nerve conduction study which revealed carpal tunnel. The physician did not feel the patient's symptoms were related to ZOSTAVAX. No additional information is expected.
Arm Pain; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), HEADACHE (Headache) and PYREXIA (Fever) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), HEADACHE (Headache) and PYREXIA (Fever). On 16-Jan-2021, PAIN IN EXTREMITY (Arm Pain), HEADACHE (Headache) and PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant Drug details were reported.  No Treatment information was provided.   This case was linked to MOD-2021-416954, MOD-2021-416977 (Patient Link).
Around 9:00-9:30pm on Jan 16th (vaccination date of Jan 8th), I noticed my arm in the area of the injection site had swelled, turned red/pink, and felt itchy. Area is approximately 8mm in length and 4-6mm in height, irregular shape. Area feels tight, hard, and significantly warmer than remainder of arm. No fever, but site registers approximately 98F, which is above forehead temperature. Given my history of delayed reactions to insect bites, I felt reporting may be necessary. No medical treatment sought as of 10:05pm on Sat Jan 16th, but I will call primary care provider/urgent care center if symptoms worsen or if taking over the counter loratidine 10mg does not improve swelling, itching, and redness.