chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received Moderna Bi-Valent 0.5mL on the left deltoid and after approximately 5-6 minutes. Pt started to c/o vertigo and stated "I'm about to passout" pt complained of lips feeling numb, feeling  faint, chills, and stated she had a hx of anxiety and  insomnia.  Patient takes Quetiapine 25mg HS and Clonazepam 0.5 PRN. Emergency medical personnel called pt evaluated by emergency medical personnel EKG NML.  Last BP per emergency personnel was 121/78. Pt cleared to leave per emergency medical personnel. Refused Ambulance Transport.
Day following vaccination the injection site and surrounding area were very swollen, red and hot to the touch.
Facial numbness (left nare, left side upper lip) started approximately 20 min post vaccine and lasted approximately 45 minutes. Headache, Fever (Tmax 101.8), aches, chills started at 0330 day after vaccine given 1400 day prior to symptoms , ended by 2100 day after vaccine.
Achy bones; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Achy bones) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced BONE PAIN (Achy bones). The patient was treated with PARACETAMOL (TYLENOL) for Bone pain, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Achy bones) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up information was received on 16 Jun 2021 : outcome of the event updated from unknown to recovering/resolving.
Miscarriage; This is a spontaneous report from a contactable consumer (patient herself). A 30-year-old female patient. A 30-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right deltoid on 14Apr2021 (Batch/Lot Number: Ew0162) as 2nd dose, single for COVID-19 immunisation. Patient had no relevant medical history. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS) received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She received an unspecified vaccine on 14Apr2021 (same date) in right arm. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced miscarriage on 27Apr2021. At 6 weeks there was a heartbeat detected. Patient received her second dose and at 8 weeks there was no heartbeat. Abortion pill was reported as treatment. Event result in Doctor or other healthcare professional office/clinic visit. Patient had not been tested for COVID-19 since the vaccination. Outcome of event was recovering.
Blisters and rash on injection arm, a little at injection site, more between elbow and wrist. Pharmacist thought it was probably related to the injection.
C/O hallucinating about 12 hrs after receiving vaccine. Had taken TYLENOL w/codeine x 2 in past 48 hrs. Parent feels like reaction was not related to medication (?).
Diffuse itchy erythematous  urticaria, onset ~3 hours after administration of vaccine. Improved with PO Benadryl, topical Calamine. Recommended pt be treated with continued Benadryl or Zyrtec until fully resolved.
This spontaneous report was received from a medical assistant referring to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 19-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011133:
Hospitalization: 5/12/2023 - 5/15/2023 (3 days) Presentation to the ED: fever  COVID + date: 5/12/2023  Treatment: supportive care Discharge to: home.  011L20A 1/6/2021 012M20A 2/2/2021 939901 939901
Patient reported that the area swelled, was red and hot to the touch. The area was still tender 4 months later. Patient was working with massage therapist to resolve tenderness and reported improvement.
High fever of 102.7 Deg. F Chills, Nausea Vomiting 400mg Ibuprophen given at 4 hour internals.  Symptoms resolved without medical care in 36 hours.
nerve pain in calf; This spontaneous case was reported by a patient and describes the occurrence of NEURALGIA (nerve pain in calf) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (nerve pain in calf). At the time of the report, NEURALGIA (nerve pain in calf) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.
Tetanus Diphtheria given 09/16/2005.  Fever on 09/17 to 103 degrees, plus chills, weakness, Cellulitis at injection site.  On 09/19, started on Augmentin 875 mg twice a day for 10 days.
Ezcema on hands, reactions to several foods that I used to eat.  For example tomatoes, eggs, shellfish, peanut butter, oranges, sugared donuts, BBQ sauce, and several other items. I've had hives since the end of March.  Saw Dermatologist in May 14th and gave me salve to use.  Currently, am seeing an Allerigst and they have me on Allegra 180 mg.  I started taking Allegra just at night and did help.  My hives have gotten worst in the past month.  I take now Allegra three times a day to keep my hives down. I have been following the ezcema diet since May.
Covid positive; Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Aug2021 (Lot number: EW0196) at the age of 43 years as dose 2, single and administration date 27Jul2021 (Lot number: EW0196) 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: VACCINATION FAILURE (medically significant) with onset 31Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 31Dec2021, outcome "recovering" and all described as "Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab.  Clinical information: The patient was not receiving any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
outbreak of herpes on her lip; Herpes AE: states it is getting worse, it started as one now she has seven to eight.; tching around the site of injection, spots of itching, no pattern, little tiny red raised dots, one arm, one near ankle, bunch on her back. So small remind her of tiny insect bites.; Flu Like Symptoms; Low Grade Fever; This is a spontaneous report from a contactable consumer. A 59-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0164) via an unspecified route of administration in the left arm, on 22Apr2021 at 18:00, as 2nd dose, single dose for COVID-19 immunization. Historical vaccine included the patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EW0150) via an unspecified route of administration, as 1st dose, single dose for COVID-19 immunization. Medical history included oral herpes. Concomitant medications were not reported. On 23Apr2021, the patient experienced herpes outbreak, Arm, Itching around the site of injection, spots of itching, no pattern, little tiny red raised dots, one arm, one near ankle, bunch on her back. So small remind her of tiny insect bites, flu Like symptoms and low Grade Fever. The patient stated nothing happened with the first vaccine. The patient stated that she wanted to self report, and she had some drive time, so she was calling to self report a side effect. The patient also stated she doesn't know how common it was but she read shingles was something that was reported in rheumatology. She had an outbreak of herpes on her lip and used to getting one spot once or twice a year, usually with extreme weather changes. The patient reported that 8-12 hours after the shot, she had multiple outbreaks, 7-8 outbreaks where the lip meets the skin. The patient had called her physician to order Valtrex. The patient also stated what she saw on the websites, there have been reports of shingles outbreaks. Stated she had shingles before, but not the shingles vaccine. The patient received treatment Benadryl and Valtrex. Additional vaccines administered on same date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was both doses of the Pfizer Covid Vaccine. The outcome of the event oral herpes was not recovered. Outcome of the event condition aggravated was unknown. Outcome of the event vaccination site pruritis was recovering. On 24Apr2021, the outcome of the event flu like symptoms and pyrexia was recovered.  No follow-up attempts are needed. No further information is expected.
Patient developed an exanthem which developed within 48 hours of receiving #1 COVID vaccine. Rash was raised, and pruritic and started  near her ankles. It spread to full-body rash within 24 hours, associated with low grade fever, angiodema of her lips.  She treated herself with Benadryl , topical hydrocortisone and her daily Zyrtec. She was treated by healthcare professional with oral steroid for a 5 day course
No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown gender and age. Information of the patient's pertinent medical history, concomitant therapy, concurrent condition and drug reactions/allergies was not reported.  On 08-MAR-2023, the patient with vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (1 dose, lot #w008711, expiration date: 14-MAR-2024, strength and route were not reported) for prophylaxis. The vaccine was improperly stored at the temperature of -3.2 degree Celsius, and the time frame was 3 hours (product storage error). No previous temperature excursion. No additional AEs were reported (no adverse event), no further information provided.
Fever highest of 100.6, headache, fatigue, and body aches all onset about 4 hours following the vaccine. Symptoms were resolved within 40 hours of the vaccine.
March 8th Body ache, tired,  congestion, chills.  I  Left work at 5pm, went to bed at 6pm,  Took ibuprofen PM.  Slept until 10:30pm, had some water, went back to bed.  Woke up at 4:30am (March 9th), wet from sweat/fever, difficulty breathing through nose.  Took two more ibuprofen PM.  Slept until 11:30 am.  Felt better, but stayed home.
I woke up around 10 pm with a high fever, bone pain, headache, chills, nauseas, followed by days of fatigue. After those symptoms went away I had random low grade fevers and bone fever. My doctor feels triggered autoimmune. I have seen infectious disease doctors, Internist, Allergist, and my PCP.
Client experiencing short term memory problems, cognitive issues, trouble understanding speech- aphasia, stool continence issues that started a few days after receiving the 3rd dose of Moderna.  She states she did NOT have any of these issues prior to receiving Moderna on08-27-2021.
Generalized itching. Relieved with  benadryl 25mg PO x1
Patient stated the evening after receiving the immunizations her arm became painful and she had chills during the night. The next morning she took TYLENOL and stayed in bed. She reported on 10/13/18 her arm seemed to be more swollen, red and hot so she decided to go to the urgent care. The provider at urgent care gave her a prescription for Cephalexin 500 mg to take four times daily for 5 days.
After being on menopause for two years (no menstruation), I started with all signs of ovulation: vaginal secretion, breast sensitivity and pain, acne. And after almost two weeks I had the feeling I was going to start my period. And I noticed pink after urinating and apparently a period is starting (menstruation). After 3 years of no menstruation.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age (not pregnant). On 14-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose and lot# not reported) intramuscularly. The patient stated injection hurt and burned at the time of administration (14-MAY-2013). No treatment was given and the patient did not seek medical attention. Therapy of ZOSTAVX continued. On 16-MAY-2013, the patient recovered. Additional information has been requested.
Severe pain.  As of today, pain is less, but still present, particularly when arm is raised above head.
Employee states she developed left arm symptoms the day after receiving an influenza vaccine that was administered on 10/11/2017. She went to Urgent Care 10/12/2017 after noticing discoloration of her left hand and was told to report to ED. She has otherwise well without fever, chills, nausea and vomiting. Denies decreased range of motion or weakness in the extremity. She otherwise has no complaints.
Patient was feeling faint after receiving the COVID vaccine so she was placed flat on the floor with feet elevated.  Placed cool clothes on the forehead and nape of the neck.  Vitals were taken - B/P: 130/80, Pulse: 63.  Patient remained in the clinic for 30 minutes after the incident and vitals were taken again.  B/P 122/77, Pulse: 74.  Patient had complete recovery and was released.
PUSTULAR RASH WITH FIRM RED BASE ON CHEST,ABDOMEN,UPPER ARMS, NECK AND SCALP
She had nausea the evening and morning 12/2/09 after vaccine 12/01/09.
I tested positive for COVID-19.  Initially I started out with a dry that wouldn't stop on the next day 04Jan2023 I could not go to work due to headache and nausea and then my cough continued I did not test for Covid that day because I had tested negative on 01JAN2023 I continued to test positive for ten straight days. when I went to Urgent care my PCR test was negative all my rapid test wee positive very dark lines. I had a loss of appetite as well. My doctor said having a cough for a long time is expected.
Information has been received from a nurse practitioner concerning a female who was vaccinated with a dose of MMR II. Subsequently, the pt immediately developed redness and induration at the injection site. "About two weeks later," the pt developed a rash over her entire body "that turned into eczema." The pt sought unspecified medical attention. The nurse practitioner felt that the pt's redness and induration at the injection site, rash and eczema "was a reaction to the neomycin." Additional info has been requested.
Pt received 1ml DT vaccine intradermal to outer right forearm, developed induration, erythema, tenderness at site within 24 hrs, progressed to right wrist and elbow arthralgias, increased swelling, and red, streaking to elbow crease also with chills, body aches, nausea with emesis, malaise within 48 hrs, pt sent to ER where MD changed from Biaxin (Biaxin started 10/1 PM for abscess left arm with fever and systemic sx) Scheduled for re-eval later today.
Feeling weak and tired/achy about 12 hours after shot; woke up in the morning and went to work but couldn't get warm - cold & chilled all day, headache, muscle & joint achiness; took Tylenol for achiness and headache, felt better about 48 hours after shot, but still feel a bit "off" 4 days after shot
Slight numbness in hands, tingling in left hand, rheumatism-like sensations in lower left arm, occasional cough, occasional raspy throat, occasional memory and cognitive problems.  I'm also experiencing indescribable fatigue -- I've never had this kind of fatigue before.
A nurse prospectively reported that a 28 year old female subject was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) during an unspecified trimester of pregnancy. On an unspecified date in Oct 2005, the subject received 1st dose of Twinrix. The dated of the subjects last menstrual period and trimester of pregnancy were not reported. On the same day, the subject also received influenza virus vaccine (unknown manufacturer) and a Tuberculin skin test (unknown manufacturer). Follow up information received on 9/8/06 indicated that the subjects pregnancy was complicated by PSOL at 35 weeks. The subject was hospitalised for premature labor on 3/31/06 for less than 24 hours. She was also hospitalized on 4/1/06 and 4/2/06 for greater than or equal to 24 hours. The subject was successfully treated with IV hydration, oral terbutaline (2.5mg every four hours as needed) and oral hydroxyzine (50mg daily as needed). The etiology of the premature labor remains undetermined. Additional information indicated that the subject received multiple oral supplements during pregnancy including Henalmic formula (1 three times daily), enriching greens (1 three timed daily), vitamin A C E (1 two times daily) and prenatal vitamins 1 daily. The subject gave birth via spontaneous vaginal delivery to a normal, male infant on 5/23/06 (39 weeks gestation). The infant weighed 6 lbs and 13 oz's, was 19 3/4 inches in length with and APGAR score of 8 at one minute and 9 at five minutes. Oligohydramnios was noted during labor. No further details were provided.
None reported per patient phone conversation @ 1610 on 3-3-010 - stated had lightheadedness & bone aching yesterday.
Delay of my menstrual cycle. Today makes my period 8 days late. It was due on 2/12/22 and today is 2/21/22. My last period was on 1/15/22. My period has never been late by more than 2 days.
After the vaccine, I have all over the place including my face/Suspected vaccination failure; I have all over the place including my face, maybe was a reaction; Is to pain full; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine. It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles all over the place including face. For the last two months from the date of reporting, the patient was not having shingles. The patient went to saw his/her doctor and she told that, might be was the reaction from the vaccine. The patient asked if the worst thing could happen was too painful. The patient was praying for all those people who had shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting.
Information has been received from a consumer concerning her 15 year old female daughter with no pertinent medical history and no drug reactions/allergies, who on 20-MAR-2008 was vaccinated with the first 0.5mL dose of GARDASIL. There was no concomitant medication. On 26-AUG-2008 her daughter fainted after getting second dose of GARDASIL and on the same day patient recovered. The reported stated that her daughter did not experience any adverse event after getting first dose of GARDASIL. The patient sought unspecified medical attention. No further information is available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 22May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 52 years 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's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
12:00 Am Tuesday baby awoke from sleep screaming and was difficult to settle.  Tuesday morning 6:30 am fever 102.4 and was fussy and lethargic.  Wednesday morning had fever of 102.3, one liquid stool.  She was again fussy and lethargic.  Thurday fever of 102.3 and extremely irritable and crying, two liquid stools.  Brought her to the doctor, who suspected Roseola.  Friday fever broke.  Saturday pronounced red spots on trunk and neck.