chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a healthcare professional concerned a 51-year-old male. No medical history, height, weight, concomitant medications or concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number not reported), dose not reported, administered Apr 5, 2021, for immunization. The batch number requested. Age at time of vaccination: 51 years old. On Apr 5, 2021, Janssen COVID-19 vaccine refrozen and administered to patient. On an unspecified date, patient experienced product storage error. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of the the Janssen COVID-19 vaccine refrozen and administered to patient and product storage error:  not reported. This case, involving the same patient linked to 20220538347. This case, from the same reporter linked to 20220537683, 2005084289, 20220537356, 20220538238, 20220537444, 20220537507, 20220537532, 20220537688, 20220538146, 20220538210, 20220538292, 20220538297, 20220538379, 20220538316, 20220537341, 20220538573, 20220538437, 20220538428, 20220538425, 20220538411, 20220539045, 20220538480, 20220538149, 20220540435, 20220538666, 20220540611, 20220538693, 20220540524, 20220538758 and 20220538210.
pt recvd vax & w/in 8hrs p/vax exp sweating & itching;
maculopapular rash within 1-2 hours, vomiting x2 within 4 hours, chronic diarrhea for 7 months beginning the night of the vaccine
Moderna vial was placed in fridge on 01/01/22. The Moderna vial with lot number of 041J21A has not undergone a temperature excursion. Moderna booster (0.25ML) was administered to the patient on 02/17/22 at 8:15AM. Patient has not reported to the Clinic with symptoms at this time.
Fully vaccinated, no booster with COVID breakthrough infection and admit to an inpatient hospital unit
Pt received flu shot in thigh and from his knee to hip was swollen and red and warm to touch. Positive fever. Use BENADRYL and MOTRIN.
The night after the vaccination, I woke up with extreme anxiety.  I had a week of panic attacks (I am not at all prone to panic attacks - very usual for me), high blood pressure, and a pounding heartbeat with a high heart rate.  On April 7th (two days post vaccine), I developed a vibrating "pins and needles" sensation in my feet and legs, and some transient pins and needles and numbness in my hands and face.  On April 12, I developed a terrible headache in the  back of my head (base of my skull).  There is a squeezing sensation in the back of my head that comes and goes.  I contacted my doctor, and was advised to take antihistamines and advil to try and reduce inflammation. I saw my doctor in person on April 14th, and was given a prescription for Meloxicam, and gabapentin to help calm the nerves.  On April 15th, I visited the ER because the headache had not resolved, even with Meloxicam.  They preformed a Head CT which came back normal, and gave me a shot of Torodol and  antihistamines.  Today, (April 16th), I am finally starting to feel some better, but I still have a mild headache at the base of my skull and some lingering pins and needles sensation.
pain in his arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in his arm at injection site) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O11M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in his arm at injection site). At the time of the report, VACCINATION SITE PAIN (pain in his arm at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-061126 (Patient Link).
After the vaccine throughout the day and for two days my right leg has tingled and difficult time with circulation. It happened to the left leg too but not as often. It became worst at night.
diarrhea; headache; felt tired, with fatigue; throwing up for 4 hour; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA, HEADACHE, FATIGUE, VOMITING, and CHILLS in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA, HEADACHE, FATIGUE, VOMITING, and CHILLS. At the time of the report, DIARRHOEA, HEADACHE, FATIGUE, VOMITING, and CHILLS outcome was unknown.            No concomitant or treatment information was reported.   This case was linked to MOD-2021-044352.
Red, warm, arm at site of injection: very hard area pt received treatment at urgent care received antibiotic, cortisone and ZYRTEC.
From top of leg to bottom turned red. No itching or burning. Skin is blotchy and red. Still occurring.  County came in and administered the vaccine.
Patient developed a generalized erythema multiforme-like eruption following vaccination with no other identified factors precipitating.  This required high dose systemic corticosteroids transitioning to cyclosporine to suppress.  The eruption was limited to the skin with no mucosal involvement. Treatment continued over 2 months and at the last visit in July he had postinflammatory hyperpigmentation.
PATIENT RECEIVED MODERNA VACCINE DOSE # 2 TO LEFT ARM AT 1:13PM, DIRECTED TO THE OBSERVATION AREA TO BE MONITORED FOR 15 MINUTES AND STARTED HAVING RIGHT UPPER QUADRANT ABD PAIN 10/10 AT 1:23. VITAL SIGNS OBTAINED, PATIENT WANTED TO GO TO URGENT CARE, PT TAKEN VIA WHEELCHAIR TO URGENT CARE.
Tachycardia began at approximately 9:45 am on 11/01/2021 while patient was sitting upright at a table after finishing breakfast. Tachycardia was accompanied by shortness of breath and dizziness for duration of event. Event lasted approximately 2 and a half hours. Patient went to urgent care to be assessed.
Patient received a 3rd booster Pfizer covid vaccine but the first 2 vaccines given were Moderna.
weakness; Loss of appetite; Thought "was going to die"; Laid in bed and couldn't get out of bed; Flu reaction; This case was reported by a other health professional via call center representative and described the occurrence of weakness in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced weakness, appetite lost, impending doom, bedridden and flu like symptoms. On an unknown date, the outcome of the weakness, appetite lost, impending doom, bedridden and flu like symptoms were unknown.   It was unknown if the reporter considered the weakness, appetite lost, impending doom, bedridden and flu like symptoms to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccination was not provided. The health care professional stated that, unsure what Flu vaccine received last year. The patient received dose of Flu vaccine last year and experienced flu reaction of weakness, loss of appetite and thought was going to die and laid in bed and not getting out of bed. The reported asked, for any information or recommendation on getting flu vaccine. The reporter consented to follow up.
red area on skin surrounding vaccine, began day after administration and now (two days after administration) is still present. patient states arm is sore but that redness and soreness is improving compared to yesterday.
One day after receiving second dose vaccine had a seizure. The caller had two more seizures since having first seizure.; lost weight; Brain is foggy since having last two seizures on 30Mar2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 28Jun2021 as dose 2, single (Lot number: EW0187) at the age of 46 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (First dose: 07Jun2021, lot: EW0177, NDC: unknown , Expiration: Unknown , route of administration: left arm , Time the Vaccination Was Given: First dose: early in morning, The caller received first dose Pfizer Covid Vaccine and had no reactions, everything was fine, Expiration: Unknown , route of administration: left arm), administration date: 07Jun2021, when the patient was 46-year-old, for Covid-19 Immunization. The following information was reported: SEIZURE (hospitalization, medically significant) with onset 29Jun2021, outcome "unknown", described as "One day after receiving second dose vaccine had a seizure. The caller had two more seizures since having first seizure."; FEELING ABNORMAL (non-serious) with onset 30Mar2022, outcome "unknown", described as "Brain is foggy since having last two seizures on 30Mar2022"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost weight". The patient was hospitalized for seizure (start date: 29Jun2021, discharge date: 30Jun2021, hospitalization duration: 1 day(s).  Clinical course: The caller received first dose Pfizer Covid Vaccine and had no reactions, everything was fine. One day after caller received second dose Pfizer Covid Vaccine, the caller had a seizure. The caller had two more seizures since having first seizure. Caller clarifies the Pfizer Covid Vaccine was the adult dose. Brain was foggy since having last two seizures on 30Mar2022. Caller's brain was all foggy since having the last two seizures on 30Mar2022. The caller doesn't remember what the caller did three days ago. Since having the last two seizures on 30Mar2022, the caller can't hardly remember anything. Everything previous to the last two seizures on 30Mar2022 the caller can remember but doesn't remember anything after that. The caller can't type, everything in brain was foggy and what not.  One day after receiving second dose vaccine had a seizure. This occurred on 29Jun2021. Caller clarifies weight loss occurred after receiving Pfizer Covid Vaccine. Had two more seizures since having first seizure: Caller clarifies the last two seizures occurred on 30Mar2022. Caller states discharge date was either 01Apr2022 or 02Apr2022, caller doesn't remember. Caller had two seizures and was in hospital for about three days. There was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Follow-Up (23May2022): Follow-up attempts are completed. No further information is expected.
(L) leg red and warm to touch, small hard lump at injection site dtap. Child took nap areas improved mom thought about cancelling.
31JUL92 @ 1130AM pt had emesis x 1 & t101.6 oral w/APAP;1230PM mom noticed maculopapular pink rash; pt had sz activity followed by postictal state lasting few mins; dx febrile seizure; viral exanthem secondary to MMR; less energetic than nl
Narrative: Patient developed headache and elevated BP. Patient did not require any additional intervention and was able to able to leave following normal monitoring period.
Pt received the 12 month vaccinations. Mom states that pt had change in temperment. He becaume more irritable after getting the 12 month vaccines for at least a week. He also stopped breastfeeding that same day of the vaccinations. Pt ws not talking at 12 month visit. Pt still does not talk at 20 months of age.
Severe headache (worst of life), neck pain/nuchal rigidity, back pain, fever measured at 101.8°F, chills, nausea, dizziness, tachycardia to 130 bpm, diffuse myalgias. Worsening symptoms over the course of the night requiring Emergency Department evaluation in the morning, due to patient being a physician working in an emergency department. Head CT, lumbar puncture, CBC, chemistry performed.  Medication given for severe headache. Headache improved with medication. Patient continued with fever, myalgias, neck pain, back pain until 06/17/2017.
Induration (palm sized) and heat at site (back of left arm). Swelling, pain and chills radiating to shoulder.
After warm bath following the vaccine he experienced dysequilibrium, confusion, poor coordination of right hand, possible slurred speech.  Symptoms resolved after 4 days.
No adverse event; Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml).    Patient received Moderna bivalent booster dose.  No concomitant medication information was provided. No treatment medication were provided.
Hard to breathe, bad shortness of breath, rapid heart rate, tired, sore arm, which lasted for a month.
headache started on 4/8/21 evening. Progressed into ocular migraine (both eyes) and migraine headache in the afternoon of 4/9/21. Another ocular migraine in the left eye on 4/10/21 followed by fever of 102.1  along with nausea and vomiting during the night into 4/11/21. Ocular migraines have been a constant of at least 1, sometimes 2 per month since injection. I also developed a very painful swollen lymph node in my left clavicle area on 4/10/21 that was the size of a dime and hard like a marble that lasted for 3 weeks post injection. I suffered with a stiff left shoulder and trapezius for 4 weeks post injection.
There is swelling, redness, and itchiness around the injection site. It feels like I was stung by a bee. The site is much warmer to the touch than the surrounding area. This is occurring about 7 days after the initial similar symptoms. The itchiness and feeling like I was stung are new.  I took 500 Ibuprophen to help with pain and swelling. It doesn't seem to be helping. after an hour and a half.
Severe dizziness and unable to function. Severe headache. Fatigue and pain in arm at injection site. Burning on the front of the forehead. This is her second injection.  1/14/09 Reviewed GYN medical records of 12/22/2008. FINAL DX: candida vaginitis; uti; (+) Chlamydia & trichomonas 10/08, resolved. Records reveal patient tx for UTI on day of vaccination.  Parent stated previously via voicemail message that patient not seen by PCP or ER for treatment & has fully recovered from HA following HPV vaccination of 12/22/08.  Has back spasms couple of times/wk only & treats w/OTC meds.
Two days post vax, the patient developed a reddish brown sandpaper-like rash on bilateral anterior thighs. The patient had no other problems and the rash did not seem to bother him.
Chills; Joint pain; Headache; soreness in her arm injection site; A Spontaneous case report was received from a consumer who was a 68 year old female patient who has received first dose of Moderna COVID-19 Vaccine(mRNA-1273) on her right arm on 20-JAN-2021.She experienced chills,joint pain,headache and soreness in her arm. at injection site.No past medical history  and treatment was provided.The outcome of the patient is unknown.
Pt came to pharmacy after receiving vaccine and stated that she still had a sore arm and was having some difficulty lifting her arm.  Rph on duty asked pt if she would be willing to try an Nsaid and ice pack for a couple of days to see if it helped and that Rph would follow up with pt.  Pt later contacted pharmacy (on May 6th) and stated that her arm soreness had worsened and that she had visited her orthopedic doctor on May 5th due to the pain.  Prescriber wrote several prescriptions for the patient.
Patient tested positive for Covid19 after being vaccinated with Pfizer vaccine EUA 4/11/2021-5/14/2021
Received Menactra 08/23/2005, left deltoid began to swell that evening - skin in office 08/24/2005, left deltoid swollen, red and painful - 11cmx14cm induration - prescription Benadryl, Advil and ice pack - 08/26/2005 less painful, swelling down but persists.
Fatigue, mild fever (99.2-99.7),  muscle aches, headache
little itchy; Redness from top of the shoulder to arm; little warm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (little itchy), ERYTHEMA (Redness from top of the shoulder to arm) and FEELING HOT (little warm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRURITUS (little itchy), ERYTHEMA (Redness from top of the shoulder to arm) and FEELING HOT (little warm). At the time of the report, PRURITUS (little itchy), ERYTHEMA (Redness from top of the shoulder to arm) and FEELING HOT (little warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from a consumer refers to his female friend of unknown age. On an unknown date the patient was vaccinated with GARDASIL (route, dosage, dose no. and lot number unknown). On an unknown date the patient experienced she was having decreased hearing possibly stemmed from taking the GARDASIL. The outcome of she was having decreased hearing was unknown. Upon internal review decreased hearing was considered to be medically significant. Additional information has been requested.
This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On  21-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Arm sore for day or two and tired immoedially after first shot On day 9 left arm sore, red rash around shot area and itching.
No additional effects reported; a patient received her first GARDASIL 9 on 10-FEB-2019, second dose of GARDASIL 9 on 04-DEC-2019, and her third dose of GARDASIL 9 on 03-FEB-2020; Information has been received from a medical assistance, referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 02-OCT-2019, the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot # and expiration date were unknown) for prophylaxis. The patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail, route, lot # and expiration date were unknown) on 04-DEC-2019. On 03-FEB-2020, the patient was vaccinated with her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose detail and route were unknown) (lot # R028656 had been verified to be a valid number; expiration date was reported as 27-JUL-2021) (inappropriate schedule of product administration). No additional effects reported.
PT C/O NAUSEA, ANXIETY, DIAPHORETIC. PT WAS PROVIDED WITH WATER AND SEEN BY PARAMEDICS, SYMPTOMS IMPROVED AND REFUSED MEDICAL TRANSPORT, AMA SIGNED.
Information has been received from a physician, referring to three unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot M007764 (strength, dose, administration route, anatomical location and expiration date were not reported) for prophylaxis. No adverse effects were reported in any patients. The vaccine had an unspecified temperature excursion (reported as greater than - 70 Fahrenheit (F) and below of 32 F) with a time frame of 40 hours. It was reported that no previous temperature excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004743:
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 23-DEC-2014, the patient was vaccinated with M-M-R II (route, dose, frequency and lot # not reported) which underwent an excursion (on an unspecified date). This is one of several reports from the same source. Additional information has been requested.
Information has been received from a nurse concerning to unspecified number of patients (ages and genders not reported) who since 29-FEB-2016, were vaccinated with doses of PROQUAD (Lot No. L002420, exp. 23-JUL-2016) (sites not reported), which were exposed to a temperature of -14.94C, for 6 hours. Vaccines had not been previous to temperature excursion. The reporter was not aware of any adverse effects. No PQC was involved. This report is linked to MARRS 1603USA004021 from the same reporter. Additional information has been requested.
Feeling dizzy and pale, felt weak  vital signs monitored all WNL, was given water and laid on cot for 15 minutes felt better and left on own
Pt vax w/ 3 doses hepta B. + devel cronic elevated liver enzymes.  dx of non-A and non-B hepta was made.  screening panel was neg.