chrisvoncsefalvay/vaers-outcomes huggingface dataset:
unable to get their 2nd dose of Moderna COVID19 vaccine within the 42 day window; COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose of Moderna COVID19 vaccine within the 42 day window) and COVID-19 (COVID-19) 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 13-Jan-2021, 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 (unable to get their 2nd dose of Moderna COVID19 vaccine within the 42 day window) and COVID-19 (COVID-19). At the time of the report, PRODUCT DOSE OMISSION ISSUE (unable to get their 2nd dose of Moderna COVID19 vaccine within the 42 day window) had resolved and COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment medications were provided by reporter.
pt recvd vax 1030AM on 11OCT93 fever started 4Pm all that noc no fever 12OCT; redness & swelling above elbow noticed 12OCT @ 5 PM; warm to touch;
Pt. received his second dose Moderna Vaccine and shortly after he stated that he felt tingling and tightness in the  throat and neck with warm sensation around neck. Pt also verbalized difficulty swallowing. NP?s assisted patient and assessed Pt status. Pt remained in ER observation for further monitoring and safety precautions.  Pt denied any reactions to prior vaccine (first dose Moderna).  Pt given hydration and was able to drink 8oz of fluid without any difficulty. Pt remained alert and oriented x3 and coherent, his initial v/s were 117/78 pulse 72, 129/81 P 76, o2 sat 99% room air. NP administered 25 mg Benadryl  PO and Pt was observed for an additional 30 mins. Pt verbalized that he felt better and the sensation subsided. Once Pt was stable,  and verbalized no further complaints of symptoms, he was discharged from ER observation into a taxi.
Immediate: pain at injection site Within 3 hrs: pain in abdomen- left side Next day: muscle and joint pain over whole body, pain at lymph nodes in both arm pits, fever, pain in left side persists, flushed/hot face, fever, fatigue, nausea
Three days after shot had fever and chills for 7-10 hours. Then fever and chills returned four days after that, which was a week after shot and has continued into the next day, today.  Low grade 99.9, but body sensitivity and slight aches with off and on chills. I started taking ibuprofen, which brought it down to 98.9. I am not sure if this fever a week out was result of the vaccine, but the initial reaction was delayed by three days, seemed to retreat and may be coming back again. My partner had Covid and got the vaccine the same day/time as me and he had chills and fever the evening of the shot and a bit the next day and nothing since. My delay and on/off/on symptoms seem strange and unexpected. I'm not sure whether to wait a couple more days or go get checked out by the doctor.
Injection pain and headache patient took some of Tylenol. This pain lasted for a few days. On the second shot patient was fatigued and slept all day. Only fatigued for one day and went back to normal
Hives, itching on torso, thighs, groin and arms,; swollen lips. Awakened at 02:30am with intense itching. Hives noted. Benadryl 50 mg po. Itching subsided at approximately 04:30.  Closest hospital 45 min. On rural roads. Didn?t want to chance getting caught in desolate area needing emergency med tx. Chose to stay home and manage.
4 hours after the shot I was feeling like someone beat me up, dry cough for 3 hours. Body ache all night long. Saturday July 17, 2021 24 hours after the vaccine my right calf, ankle and foot started to swell. Body still felt like someone beat me up, felt like high fever but  no fever. Sunday July 18, 2021 I can hardly walk as calf ankle and foot are extremely swollen and very painful. Monday July 19, 2021 went to Clinic and they referred me to the ER. Checked into ER they did Ultra Sound and stated that I had DVT blood clot total right leg. Follow up visit with clinic on July 29 they recorded the event and drew Blood. Stated that a lady who deals with blood clots will contact me. The ER wrote a prescription for Equilas  10 mg Bid for 7 days then 5 mg bid for 3 months. By Monday afternoon my body was feeling much better. Today is July 31 and my right calf ,ankle and foot remain swollen and very painful. cannot walk for any extended length.
Initial information received on 25-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a two months old female patient who received a 0.5 mL dose of QUADRACEL (lot number: C5325BA, expiry date: 14-Nov-2019) in left thigh in error instead of PENTACEL (lot number and expiry date not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was reported that QUADRACEL given to 2 months old patient in left thigh today in error and also received MMR and Varicella vaccines (right thigh). Intended vaccines to be given today were: PENTACEL, PCV 13, ROTATEQ, Hep B and none of those were given. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Pain in left arm near injection site, headache, fever, flu- like bodyaches, chills, tiredness
Pt developed a 2x3 inch egg shaped lump. Became hot, red, itchy spreading redness in length 5 inches long 2 inches wide. No treatment, resolution w/in 1 week.
Patient was administered the 2nd dose for SHINGRIX on 02-16-19. Patient came back a couple hours later having swelling at the injection site and sore arm.
Rehab facility patient under the age of 50 and not known to be immunocompromised was given a second booster shot.
Hives started 1 hour later, lasted 3 days. Tolerated second dose.
09/11/22 presents to EC ED for "shortness of breath, corona virus concern". PMHx of "autism, bipoloar disorder, hypothyroidism"
Felt tired; C diff/took a year to heal; C diff/took a year to heal; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4272984-00 (Agency).  A 63 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 05Aug2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriasis; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CLOSTRIDIUM DIFFICILE INFECTION (medically significant), IMPAIRED HEALING (non-serious) all with onset 2020, outcome "recovered" (2020) and all described as "C diff/took a year to heal"; FATIGUE (non-serious), outcome "recovered", described as "Felt tired". The action taken for adalimumab and risankizumab was unknown.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of C DIFF/TOOK A YEAR TO HEAL onset in 2020, C DIFF/TOOK A YEAR TO HEAL onset in 2020 and FELT TIRED with HUMIRA(ADALIMUMAB) was a reasonable possibility. Causality for SKYRIZI(RISANKIZUMAB) The reporter's causality for the event(s) of C DIFF/TOOK A YEAR TO HEAL onset in 2020, C DIFF/TOOK A YEAR TO HEAL onset in 2020 and FELT TIRED was not provided. Drug: PFIZER BIONTECH COVID-19 Causality as per reporter (Drug/Vaccine): Not Related  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
the patient was contracting Covid (Coronavirus disease) last month; the patient was contracting Covid (Coronavirus disease) last month; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 41-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose 2 (initial pfizer dose), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in 2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL unknown taken for rheumatoid arthritis, start date: Sep2019, stop date: 2020; ENBREL unknown; PREDNISONE [PREDNISONE ACETATE] unknown; SULFASALAZINE unknown. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "the patient was contracting Covid (Coronavirus disease) last month". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: the patient was contracting Covid (Coronavirus disease).  Clinical course: The patient was contracting Covid (Coronavirus disease) last month and got a Pfizer booster today on 15Jul2022. It was clarified the patient received third COVID vaccines prior to this in the span of three months. first dose was the Moderna vaccine, second and third doses were the Pfizer vaccine.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201019611 same patient, different doses of vaccine different AE;
Patient complained of new rash that appeared in a cluster on the upper back right arm.  They appeared like blisters, and then they unroofed.  He also had itching of the scalp.  The rash on his arm was not itchy or painful. The rash is slowly resolving
patient passed out; patient became stiff; This spontaneous report was received from a nurse via company representative regardin a 11-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 09-FEB-2021, the patient was vaccinate with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and other dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) in the opposite arm (dose, route, anatomical location, lot number and expiration date were not reported for both vaccines); all for prophylaxis.  On the same day immediately after received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient became stiff and passed out (stiffness and loss of consciousness). The patient was monitored in the office for about 30 minutes and then released home. The did not seek medical attention and no treatment was given for the events.  At the time of the report, the patient had recovered from the events on 09-FEB-2021.  The relatedness between the events of stiffness and loss of consciousness and therapy with received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  Upon internal review, loss of consciousness was determined to be medically significant event.
1030PM pt in crib wimpered; mom went in to give bottles & turned pt over arm came w/the head & was stiff then pt had sz; mom started CPR & drove to hosp w/pt because had no phone & no help;
On Monday, 05/17/2021 at approximately 3:30am, I had a seizure at home. According to my husband and daughter, it lasted a few minutes. When I came to, I remember being disoriented, dizzy, nauseous, sweating and headache in the back of my head. I was taken to the Hospital.
headache; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support.   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 12Feb2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021 patient  experienced headache. Patient was checking on the fact sheet and it does not say anywhere if she could take Excedrin for her headache.The final outcome of the event was unknown. Information on the batch number has been requested
My daughter had her 6 month shots DTaP, Hib, Polio, Hep B and PCV13 on 5/15/15 at 10am. At 9pm on 5/15/15 she had severe bloody diarrhea. In 30 minutes she pooped 5 times. The first of 5 times was 10% blood. The 5th time was 90% blood. I took her to ER and blood tests, xrays and lab work were done, but the drs could not figure out what was causing the blood in the diarreah. They discharged her. She had bloody diarreah for 24 hours. The next day her pediatrician ordered additional lab work. We are still waiting for those results. There were no other out of the ordinary happenings the day of the 15th or leading up to the bloody diarreah, except the 3 vaccines.
This form fails to ask about the second dose of the Pfizer COVID-19 vaccine.  My 2nd dose was given on 1/11/2021, Lot No, EK4176, IM, left arm.   About 2 weeks after my second dose of the Pfizer vaccine, I developed what has been called "COVID toes," tender, burning, numb, toes with splotchy areas of redness.  This waxed over a few weeks and then waned.  It was minimal by 6 weeks, and resolved completely in the following weeks.
Information has been received from a health professional concerning a 17-week-old male who was vaccinated with a first dose of Rotateq. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
VARlVAX was improperly stored and administered; This spontaneous report was received from a pharmacist referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 25-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T028306, expiration date 20-AUG-2022) at a dose of 0.5 milliliter once for prophylaxis (route of administration and anatomical site of vaccination were not reported).  The vaccine was stored in a temperature of 41 degree Fahrenheit (°F) for 24 hours. This was not recorded in a data logger. There was no previous temperature excursion reported.; Sender's Comments:  US-009507513-2107USA000237:01957053
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 31-MAY-2016, the patient was vaccinated with improperly stored M-M-R II  (lot # L003855 and expiration date 05-FEB-2017; lot # L026553 and expiration date 16-JUl-2017, albumin status therapy type, dose and route of administration were not reported), VAQTA (lot # M011116 and expiration date 17-JUN-2017; lot # K008333 and expiration date 10-MAR-2017, dose and route of administration were not reported) and VARIVAX (lot # L039092 and expiration date 06-OCT-2017; lot # L043622 and expiration date 03-NOV-2017; lot # M004326 and expiration date 25-JAN-2018, dose and route of administration were not reported). The maximum temperature of excursion of M-M-R II and VAQTA was 22.7 Celsius degrees with the time frame of 3 hours and 48 minutes and the minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 3 hours and 48 minutes and the minimum temperature of excursion was 0.2 Celsius degrees with the time frame of 31 hours and 1 minute. The maximum temperature of excursion of VARIVAX was minus 5.2 Celsius degrees with the time frame of 50 hours and 17 minutes. There were no known adverse effects. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Fever, chills, body aches, bpm over 100 entire night even while laying in bed
Stress; Unevaluable event; Inappropriate dose of drug administered; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), STRESS (Stress), UNEVALUABLE EVENT (Unevaluable event) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In January 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced STRESS (Stress), UNEVALUABLE EVENT (Unevaluable event) and INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered). In January 2022, COVID-19 (COVID-19) had resolved. At the time of the report, STRESS (Stress) and UNEVALUABLE EVENT (Unevaluable event) had not resolved and INCORRECT DOSE ADMINISTERED (Inappropriate dose of drug administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information on concomitant medication were reported. No treatment details were reported. Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of COVID with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. The reporter's causality for the event(s) of STRESS and SPOTS was not provided. The reporter's causality for the event(s) of RECEIVED SKYRIZI AND A PORTION OF IT WAS OUT with SKYRIZI(RISANKIZUMAB) was a reasonable possibility. 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.
12/03/09 Temp. 98.9-Flu vaccine given (Influenza) on 7-3 shift. 8:45 PM 12/3/09 Temp. 102.9, pulse 145-Dr. notified-CIPRO 500 mg via GT given as an order BID. Change to ROCEPHIN 1 gm IM x 7 days, TYLENOL given, cold compresses. 12:20 AM 12/04/09 resident ceased to breathe. 12/9/2009 Death certificate received. DOD 12/4/09. Cause of Death: Pneumonia. Traumatic Encephalopathy.
Information has been received on 10-JAN-2017 from a registered nurse regarding multiple unspecified patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date, multiple unspecified patients received doses of PROQUAD (lot number and expiration not reported) or VARIVAX (lot number and expiration not reported) for prophylaxis which underwent defrost cycles. No adverse effects reported. Additional information has been requested.
Report A0360871A describes headache in a 42 yr old male who received Lyme disease vaccine recomibinant OsPA (lymerix). This report was received from the vaccinee's wife and has not been verified by a physician. The subject's medical history included chronic low back pain since 1984. Concurrent medications included celecoxib (Celebrex). The subject received his first injection of Lymerix on an unspecified date. He received his second injection of Lymerix on 15 June 2000. He had no adverse experiences following those injections. He received his third injection of Lymerix on 09 June 2001. The subject's spouse reported that subsequently to the third injection of Lymerix, the vaccinee experienced nausea, fatigue, headache, and general achiness. He had not sought medical attention as of 27 Feb. 2002. The most recent information was received from the vaccine provider on 17 May 2002. As of 13 May 2002, the subject had not reported any adverse events to the vaccine provider. The adverse event headache does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28,2000 letter.
pt has milk allergy now has rash/cough;also exp diarrhea & abd pain;pt devel hives;pt emesis (mucous only);dx URI w/mild RAD;breathing hard, wheezing;dx flu w/underlying asthma;congested & can't sleep;yellow & green discharge;sleep problems
Large red raised area, upper arm swollen hot to touch very painful, treated at home with NSAIDS
He got his second Moderna Covid vaccine at the local HD on 2/21/21 at noon without immediate problems The next morning, around 6 am, he had swelllng of the left side of his lower lip. He took Benadryl 25-50 mg several times a day over the past few days, and thought the swelling may be improving. Stlll there today and wanted to be checked. No other vaccines or change in meds. Saw ENT on Tuesday to follow up tonsillar CA, s/p RT last fall. Responded well, with no evidence for cancer at this time. He is alert and oriented, and in NAD. VSS. He has mild sinus congestion which he states is normal, Pharynx- clear. No swelling or airway compromise.Neck supple. I do not feel any adenopathy. Lower lip- mild swelllng, about 2 cm along the lip from the midllne laterally. Buccal mucosa with what appears to be early canker sore, about 2mm In diameter, with slight blanching but no open sore. Mlld localized angioedema of the left side of the lower lip, noted about 18 hours after receiving second Moderna covid vaccine at a local HD. Continue Bendryl 25-50 mg q hours end begin Prednisone 40 mg q day x 3, then reduce by 10 mg q 3 days. Seek medical care immedletely for worsening symptoms. 24 hour recheck at this office. VAERS paperwork completed.
pt recv vax on10/95 & on 4/98 pt devel ``moderate'' chickenpox. seen by m.d. & @ that time pt ha 10 lesions.