chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme fatigue for 4 days.  minor constant headache daily since and still. Elevated Hear rate for 10 days after 1st shot and again after 2nd ( I wear an apple watch so I can keep track)  Extreme anxiety, feeling of passing out. blackness coming from behind me. need to put my head down on my desk almost daily for 10 after 1st shot and still now sporadically.  Smelling cigarette smoke when there is none around.  Swollen lymph nodes in armpits, neck groin.
Aug 20, 2019 had the flu shot office Told Nurse it really hurt when she gave it. 3 weeks was bruised + swollen red. Thought it would get better. HuRt bad. Now JaN 11, 2020 Right arm aches constant - Goes into neck + hand gets numb. Had ultrasound, saw Dr. for pain, went to Therapy + helped overhead paiN. Ice it/rub BioFreeze after, take Tylenol + ibuprofen aches constant.
Information has been received from a consumer concerning his 8 week old son with no relevant medical history reported who on 12-DEC-2007 was vaccinated with a first dose of PEDVAXHIB (OMPC).  On 12-DEC-2007, the patient was concomitantly vaccinated with a dose of ROTATEQ, tetanus toxoid, poliovirus vaccine, and pneumococcal vaccine (manufacturer unknown).  During the evening of 12-DEC-2007, the patient developed a fever, diarrhea and was pale.  The patient received unspecified medical attention.  At the time of this report, the patient had not recovered.  Additional information has been requested. Additional information was received from a physician who reported that the patient was never seen nor was the office contacted regarding any type of adverse reactons from htis immunization. No additional information is expected.
Approximately 6 hrs after FLUZONE, patient developed redness, swelling in lower (R) arm extremity, no pain at injection site in upper (R) deltoid and no swelling in upper (R) deltoid.
chills; Fatigue; Headache; Minor patient of age 12 was administered with Moderna vaccine; The patient was administered with Moderna vaccine instead of Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Minor patient of age 12 was administered with Moderna vaccine), WRONG PRODUCT ADMINISTERED (The patient was administered with Moderna vaccine instead of Pfizer vaccine), CHILLS (chills), FATIGUE (Fatigue) and HEADACHE (Headache) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Minor patient of age 12 was administered with Moderna vaccine) and WRONG PRODUCT ADMINISTERED (The patient was administered with Moderna vaccine instead of Pfizer vaccine). On an unknown date, the patient experienced CHILLS (chills), FATIGUE (Fatigue) and HEADACHE (Headache). On 07-Jun-2021, WRONG PRODUCT ADMINISTERED (The patient was administered with Moderna vaccine instead of Pfizer vaccine) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Minor patient of age 12 was administered with Moderna vaccine), CHILLS (chills), FATIGUE (Fatigue) and HEADACHE (Headache) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Updated contact information of the actual vaccinator. On 06-Jul-2021: Added medical history Seasonal allergies. Added new Events Chills, Fatigue,Headache
Tested positive for COVID-19, symptoms included muscle aches, headache, fatigue, cough, and diarrhea
ROTATEQ given on 4/17/08. Refusal to suck began 4/19/08. No vomiting. Able to swallow saliva/cereal after vaccine given but will not suck. No mouth lesions noted. Had fever 101. Mother is convinced it had something to do with the ROTATEQ. 5/19-08-records received for DOS 4/20/08-DX: Pharyngitis Acute. C/O-Difficulty Swallowing. C/O not drinking. Fever 101, only 1 wet diaper.
something in his left leg/felt tired after walking a little bit and has pain to calf and inner thigh; felt tired after walking a little bit and has pain to calf and inner thigh; got a little worse; felt something in his left calf/ got a little worse; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (something in his left leg/felt tired after walking a little bit and has pain to calf and inner thigh), LIMB DISCOMFORT (felt something in his left calf/ got a little worse), GAIT DISTURBANCE (felt tired after walking a little bit and has pain to calf and inner thigh) and CONDITION AGGRAVATED (got a little worse) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thrombosis in 1999 and Thrombosis in 2017. Concomitant products included ENOXAPARIN SODIUM (LOVENOX [ENOXAPARIN SODIUM]) and APIXABAN (ELIQUIS) for an unknown indication.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 18-Jun-2021, the patient experienced LIMB DISCOMFORT (felt something in his left calf/ got a little worse) (seriousness criterion hospitalization). On 19-Jun-2021, the patient experienced CONDITION AGGRAVATED (got a little worse) (seriousness criterion hospitalization). On 22-Jun-2021, the patient experienced GAIT DISTURBANCE (felt tired after walking a little bit and has pain to calf and inner thigh) (seriousness criterion hospitalization). On an unknown date, the patient experienced PAIN IN EXTREMITY (something in his left leg/felt tired after walking a little bit and has pain to calf and inner thigh) (seriousness criterion hospitalization). The patient was hospitalized from 22-Jun-2021 to 23-Jun-2021 due to CONDITION AGGRAVATED, GAIT DISTURBANCE, LIMB DISCOMFORT and PAIN IN EXTREMITY. On 04-Jun-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, PAIN IN EXTREMITY (something in his left leg/felt tired after walking a little bit and has pain to calf and inner thigh), LIMB DISCOMFORT (felt something in his left calf/ got a little worse), GAIT DISTURBANCE (felt tired after walking a little bit and has pain to calf and inner thigh) and CONDITION AGGRAVATED (got a little worse) outcome was unknown.            Patient was admitted to the hospital on 22-JUN-2021 and discharged on 23-JUN-2021 with the diagnosis of a blood clot.  No treatment information was provided.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.
began having severe cramping and heavy bleeding with clots the next day; Started menstrual cycle a week early a day after getting second dose; began having severe cramping; heavy bleeding with clots the next day; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (BNT162B2, Pfizer COVID 19), dose 2 via an unspecified route of administration, administered in left arm on 26Apr2021 08:45 (Lot Number: unknown) as single dose for covid-19 immunization. Medical history included Anemia, ulcerative colitis, intracranial hypertension. None allergies reported. Concomitant medications included iron taken for anaemia. The patient received dose 1 on 01Apr2021 07:45 in right arm for covid-19 immunization. The patient started menstrual cycle a week early a day after getting second dose. The patient began having severe cramping and heavy bleeding with clots the next day 27Apr2021. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient has not been tested for COVID-19. The outcome was recovering.  Follow up attempts are needed. Further information has been requested.
Hives all around the body; It is itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all around the body) and PRURITUS (It is itchy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced URTICARIA (Hives all around the body) and PRURITUS (It is itchy). At the time of the report, URTICARIA (Hives all around the body) and PRURITUS (It is itchy) outcome was unknown.            Concomitant product use included medication for anxiety but not all the time.  Treatment information included steroid and histamine.
Started about 24 hours post injection.  Injection site hard and painful.  Fever with bad body pain (skin, joint, muscles - mostly upper body).  Treated with Tylenol and sleep.  Symptoms gone at 48 hours.
7/23/2021: Admitted to the hospital Covid + on 7/23/21 with oxygen saturation at 60%. Placed on 15L non-rebreather with new oxygen saturation at 99%. 7/24/2021: started on remdesivir + dexamethasone 6mg daily for 10 doses for treatment of COVID PNA 7/25/2021-8/3/2021: supportive care until discharge
she had a fall; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FALL (non-serious) with onset Mar2021, outcome "unknown", described as "she had a fall". Additional information: The reporter wanted to know if she can take Tylenol or Ibuprofen because she had a fall. First dose was given 27Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SkinRash, UrticariaPruritus, numbness and tingling to arm, fatigue Narrative:  Per primary report, employee "had adverse drug reaction on 12/22/2020 (day of vaccination). Numbness and tingling to left arm (site of injection)." Employee reported arm numbness and hives from her shoulders to her face. Employee was transported to local hospital by EMS. Per notes received, employee had an abnormal EKG, which shows the possibility of a mild heart attack. Employee reports had a heart catheterization done while inpatient. Employee was given 1L NaCl via IV at clinic while waiting transport to hospital. Employee reports all symptoms have resolved since then. No record provided from hospital stay, only from medical support post-vaccine and while awaiting EMS.
MOTHER REPORTED THAT CHILD EXPERIENCED SEVERE REDNESS AND SWELLING IN LEFT ARM THAT BEGAN THE DAY OF RECEIVING VACCINES. THE REACTION RESOLVED OVER A THREE DAY PERIOD. MOTHER TREATED CHILD WITH IBUPROFEN AND DIPHENHYDRAMINE.
Information has been received from a doctor's nurse concerning a female patient who on an unspecified date was vaccinated intramuscular with the second dose of GARDASIL, 0.5 ml. The nurse reported that a couple days after getting her second dose of GARDASIL, the patient had her menstrual cycle and it was very heavy and abnormal. The patient's outcome was unknown was unknown. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician concerning a female who in August 2007, was vaccinated intramuscularly with a first dose GARDASIL (lot # not reported). There was no concomitant medication. It was reported that "two weeks after receiving her first dose of GARDASIL (lot # not reported), the patient presented with headaches and two weeks after that had an MRI done. Subsequently, the patient recovered from headaches a "couple weeks after the first dose." The patient still received her second dose of GARDASIL (lot # not reported) in October 2007 and had no adverse experience afterwards." No further information is available.
Inside of mouth had blisters inside of cheeks and developed a very large fever blister on the right side of my chin below my lip.  I have a history of fever blisters but never had one in this area and this large.  Note**I had taken Phizer for the previous 3 vaccines, this was my first Moderna vaccine received.
nausea, vomiting after 15 hours, headache, joint aches, muscle aches, chills, hot flashes after 24 hours, exhaustion, shaking
Local reaction at site of Varivax vaccination.  Redness (3cm) and small vesicles.
I have Multiple Evanescent White Dot Syndrome that started 6 days after my Pfizer Covid booster vaccine
no adverse event; The patient was inadvertently administered a dose of VARIVAX, that had been improperly stored; This spontaneous report was received from the immunization coordinator concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 04-DEC-2019, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck) (VARIVAX), lot # S020464, expiration date 02-JUL-2021 for prophylaxis (dosage schedule, anatomical location and route of administration were not reported) (product storage error). The vaccine was reconstituted with properly stored sterile diluent MRK (lot number and expiration date were not reported). The administered dose of the vaccine experienced a temperature excursion of (-2.1C) for 4 hours and 30 minutes, as recorded by a data logger. There was no adverse effect reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: 1920150A) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course included: The patient not received other medication in 2 weeks. Received Paxlovid treatment from 09Nov2022 to 13Nov2022. The patient allergies and other medical history reported as none. The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162b2, BNT162b2 omi ba.4-5 immunization is considered ineffective of BNT162b2, BNT162b2 omi ba.4-5, and the Company cannot completely exclude the possible causality between the reported events and BNT162b2, BNT162b2 omi ba.4-5  administration.
p/vax pt devel neutropenia, fever of 101, hypotension, gen malaise & myalgia & was hosp;
Pt exp bronchospasms & bronchoconstriction approx 16 hrs p/vax; went to ER; treated w/Tagamet, steroids & DPH; no Epi was administered; pt recovered;
pt recv vax & devel positive test consisting of 10-11mm area of erythema when given tuberculin PPD skin test the same day;devel a smaller rxn 1wk later;reporter also indicated pt had a negative x-ray;
Client was in the clinic to receive his 4 year old vaccinations.  Client was given DTaP in his right deltoid muscle.  Within 5 minutes after receiving the vaccine the client developed redness, warmth, swelling and hives at the injection site.  The swelling and hives was noted to be from his deltoid muscle to his elbow.  The client did not have any signs of breathing difficulty or respiratory distress during this reaction. Ice was immediately applied to his deltoid and the pediatrician was called and recommended the client head immediately home for a full pediatric dose of Benadryl.  Pediatric Benadryl dose sheet was given to the client's mother.  In addition to calling the pediatrician, the county health officer for the clinic was also notified of this event and how the event was managed. The client left the clinic approximately 20 minutes following the administration of this immunization.
5 to 6 days p/inject pt ran high fever (temp not taken by mom) x 3 days; fever dropped on 20JUN93 red spotted rash started on stomach, spread to back groin, legs, face; pt appetite dec; 21JUN93 pt taken to MD rash dx as roseola;
Adult patient received the dose after its expiration date 13-Jul-2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received the dose after its expiration date 13-Jul-2022).    This case contains information for the 27th of 56 patients described by the reporter.  Concomitant medication was not provided.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Doses were administered after 30-day use by date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial did not undergo any temperature excursions.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Medication misadministration - client should not have received nasal H1N1 due to age.
- First day after vaccination, I had a mild fever, pain in chest near armpit area, pain in muscles, joints especially in shoulders, elbows and feet - Second day after vaccination, the chest pain was gone but I have a sever pain in my elbows, feet and toes. I had to take an Ibuprofen 400mg one time so I can be able walk and tolerate the pain. - Third day after vaccination, the pain in toes was gone. - Fifth day after vaccination, I had a severe pain in both shoulders, I couldn't raise my shoulders up.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 05-MAR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
I had my first shot at 10:00 AM and At 4 AM the following night I went to the bathroom was diarrhea 17 times it's been two months and a half and I'm still having diarrhea head a lot of test done nothing came positive was right after my first dose of my Covid vaccine I had to go several times to the ER get some hydration because it was severe dehydrated
Fever of 104.3F. Treated with 325mg acetaminophin, repeated 4x dose. Cold compresses and other physical cooling applied.  Fever dropped from 104.3 to 102.5 immediately before taking patient to emergency department, so did not transport. Continued dropping so no further treatment sought. By following morning temperature returned to normal.
This spontaneous report as received from a other health professional refers to a 12 month old female patient. On 14-JUL-2017, the patient was vaccinated with VARIVAX, (lot # was reported as M046926, expiration date 28-NOV-2018, 0.5 ml, intramuscular in the left thigh for prophylaxis. Other suspect therapies included sterile diluent (lot # M015993, expiration date 03-DEC-2018). On 14-JUL-2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. This is one of two reports received from the same reporter.
Itchy rash on abdomen, back, and buttocks. Afebrile.