chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt fainted right after I gave her flu and prevnar immuniztions , We  gave her water ,called store manager and also called 911. I did hold the pt  while she was sitting on the chair until she waked up;  so pt was on the chair for the whole time. No fall. I did check her blood pressure until paramedic gets here. pt's heart rate was very low 49 but her blood pressure was fine. The paramedic offered pt to take her to the hospital but pt refused . She wanted her daughter to pick her up. I was with the pt until her daughter picked her up around 1.38pm. Pt was feeling better when she was leaving pharmacy ,she walked her self .
Temperature 94.7°F for 14 hours after 2nd dose. Blurred vision. Swollen fingers every morning since 2/19/2021.  March 2021 extremely heavy period causing me to miss a day of normal activity. Low iron levels now anemic.  Night sweats cause  me to wake up, change sheets and pjs every night. Anxiety and mood swings. Confusion and at times I cannot recall words. Temperature remains under 97°F. Chills, aches, joint paint, pale and dry skin despite drinking water. Recently a large hemorrhoid has appeared requiring me to see doctor. My finger and toes are painful and red and it feels as if my vascular system is ?off?.  Hence, the hemorrhoid. I have been out of work for 5 days and cannot stop sleeping.  I have almost gone to the ER just to get peace of mind with what is wrong with me. I get out of breath quickly. I?m starting to feel very frustrated with physical pain and am becoming very weepy.
Woke up in middle of the night very dizzy/light headed.  Difficultly standing or keeping balance.  Lasted into the night.  Woke up the next morning with no further symptoms.  Also had sore arm at injection site for about 4 days.
Patient called several hours later and said she had heartburn/chest pain. Pt was told to seek medical care immediately. Most likely not caused by vaccine.
Pt reports that after receiving Hep. B vaccine, she developednausea, vomiting, and dizziness. Was given ANTIVERT and ZYRTEC and ER. Pt reported improvment with medications but not resolved. Pt called Clinic again 10/24/06. Reports mild dizziness, but stated that she felt much better.
Pt vaccinated w/OPV/DTP developed fever 104.8, upper arm red & edematous & painful, crying a great deal.
Information has been received from a nurse practitioner concerning a 25 year old female, who on 19-NOV-2007 was vaccinated with a first dose of Gardasil (Lot# 654539/0742U). On 20-NOV-2007 the patient developed red lumps on her face. The patient was advised to take BENADRYL. On 24-NOV-2007 the patient still was not recovered and went to the emergency room where she received steroids. The patient was advised to receive the second and third dose of Gardasil. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/7/2008. Initial and follow-up information had been received from a nurse practitioner concerning a 25 year old female, who on 19-NOV-2007 was vaccinated intramuscularly in the right deltoid with a first dose of GARDASIL (Lot# 654539/0742U). There was no illness at the time of the vaccination. On 20-NOV-2007 the patient developed pruritic red lumps on her face, hands, and upper body. There was no shortness of breath, and no swelling. The patient was advised to take BENADRYL. On 24-NOV-2007 the patient developed swelling of face and hands. The patient still was not recovered and went to the emergency room with no relief from BENADRYL. The patient was given "steroids for 5 days." The patient was advised to receive the second and third dose of GARDASIL. On 26-NOV-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Shakiness-Medium
The first symptoms were runny nose, congestion, cough, fatigue, light headaches, and night sweats. I didn't lose taste or smell or get a sore throat. The fatigue was the most extreme. I don't think I have had a fever. I just felt so run down that I tested for COVID-19 at home and it was positive. I called my doctor and he prescribed PAXLOVID. It helped with the major symptoms though I did experience metal mouth with it. I still have a swollen uvula and I need to clear my throat and cough a lot. My parents and husband also tested positive. I tested negative 14 days after first testing positive.
Information has been received from a physician concerning a 10 year old female who on 11-APR-2008 was vaccinated with a 0.5 mL first dose of VARIVAX (Merck). On the same date the patient received a dose of MMR II (MSD). Concomitant therapy included influenza virus vaccine (manufacturer unspecified) on 12-NOV-2008. On the same date the patient received a second dose of VARIVAX (Merck) (lot #  661988/1190X). On 04-MAY-2009 the patient was broke out with 8 or 9 lesions and diagnosed with breakthrough chicken pox. No laboratories studies performed. The patient sought unspecified medical attention. At the time of this report the patient had not recovered. The patient was lost to follow up. No further information is available.
Myalgia, NauseaVomiting, fatigue, headache,  Narrative:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 05Apr2021 as dose 2, single (Lot number: ew0150) at the age of 26 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Sep2021 as dose 3 (booster), single (Lot number: 047c21a), in left arm and on 24Feb2022 as dose 4 (booster), single (Lot number: 027l21a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prothrombin G2" (unspecified if ongoing), notes: Other medical history: Prothrombin G2; "Asthma" (unspecified if ongoing); "Hidradenitis suppurativa" (unspecified if ongoing), notes: Hidranitis Suppertiva- being treated with Remicade,; "migraines" (unspecified if ongoing), notes: Other medical history: migraines; "environmental allergies" (unspecified if ongoing), notes: Other medical history: environmental allergies; "POTS" (unspecified if ongoing), notes: Other medical history: POTS; "PCOS" (unspecified if ongoing), notes: Other medical history: PCOS. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Took Paxlovid and was negative within 5 days. Tested negative the next day. Had a total of 3 negative tests; (unspecified date) Negative, notes: Took Paxlovid and was negative within 5 days. Tested negative the next day. Had a total of 3 negative tests; (unspecified date) Negative, notes: Took Paxlovid and was negative within 5 days. Tested negative the next day. Had a total of 3 negative tests; (unspecified date) Positive, notes: COVID 19 Treatment; (12May2022) Positive, notes: Today is my first day being positive "again". 12May2022. Therapeutic measures were taken as a result of covid-19 from 03May2022 to 07May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash around injection site of LD, with increased irritability and fussiness per moc.
ONGONING SYMPTOMS OF RASH RELATED ILLNESS SINCE IMMUNIZATIONS GIVEN ON AUGUST 29, 2003.  VARICELLA LIKE VESICLES, SCABS, FROM HEAD TO TOE STARTING 3 DAYS AFTER IMMUNIZATION, HAS BEEN TREATED BY FAMILY PHYSICIAN WITH ANTIBIOTICS FOR RELATED INFECTIONS, ONE URGENT CENTER CARE VISIT FOR EYE INFECTION PLUS MULITPLE DRS OFFICE VISITS.  "ONE PART OF BODY SEEMS TO CLEAR AND THEN HE BREAKS OUT AGAIN WITH CHICKEN-POX LIKE SORES."
itching of skin; dry skin; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching of skin) and DRY SKIN (dry skin) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PRURITUS (itching of skin) and DRY SKIN (dry skin). At the time of the report, PRURITUS (itching of skin) and DRY SKIN (dry skin) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRURITUS (itching of skin) and DRY SKIN (dry skin) to be related.    Concomitant medication was not reported.  It was reported that the patient had discovered a link between the vaccines and skin problems in 2021. Within 4 days caller has itching of skin which lasted for 4 months. The patient thought it was just dry skin and was sure it was from the shot. The patient took Moderna vaccine in October of 2022 and did not have any problems with that. Now it is 2023, they were worried what would happen if they get another vaccine from Moderna.  Treatment medication was not reported.   Reporter did not allow further contact
Mother states child with temperature of 100.9Ax on 11/13/2006.  RLE "swollen, red, tight" with no tenderness to touch. Child s/w 'fussy' today, with no temperature elevation. Recommended that child continue to receive Tylenol as needed and to apply ice to the site.  If no improvement within 2 days, child should be seen by physician.
pt states that on 31OCT97 had a h/a & gen achiness w/temp of 102 1-2NOV97 cont to feel tired & achy;3NOV97 vomited all day & had diarrhea;this cont through 6NOV97 when called family MD;pt remains tired 18NOV97;
Pt was given (2) immunizations and fainted. Mother had alerted PHN that he fainted before. He became light headed, nauseated and fainted for few seconds.
Episodes of vomiting, pain in both legs, headaches, fevers. Seen in the ER x 2. Unsure of previous vaccine history.
very itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS and RASH in a male patient of an unknown age 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 PRURITUS and RASH. At the time of the report, PRURITUS and RASH outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Tested positive for Covid / 3 days later had a return of symptoms and have been positive with symptoms for 5 days now; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jun-2022 and was forwarded to Moderna on 06-Jun-2022.    This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for Covid / 3 days later had a return of symptoms and have been positive with symptoms for 5 days now) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065k21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Unknown historical drug). Concomitant products included SERTRALINE for an unknown indication.   On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid / 3 days later had a return of symptoms and have been positive with symptoms for 5 days now). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid / 3 days later had a return of symptoms and have been positive with symptoms for 5 days now) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Patient had been vaccinated plus received 2 Moderna boosters.  Patient tested positive for Covid, took Paxlovid, then 3 days later had a return of symptoms and had been positive with symptoms for 5 days as of 01-Jun-2022.  Device date was reported as 01-Jun-2022; Sender's Comments: COMPANY COMMENT: This is an spontaneous case concerning an 48-year-old female patient with  medical history of Drug allergy (Unknown historical drug), products included SERTRALINE and  PAXLOVID for COVID-19 treatment from 24-May-2022 to 28-May-2022 who experienced the unexpected event of COVID-19 unknown days after  4th dose of  mRNA-1273 vaccine. On May-2022, SARS-CoV-2 test: positive The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a registered pharmacist concerning a 64 year old male patient who on 06-MAR-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (unspecified). On 08-MAR-2009 the patient experienced rash in multiple spots on her body after getting ZOSTAVAX. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
No adverse effects or other symptoms as a result of administration.; Caller is an office manager who reports vaccine was administered following multiple temperature excursions. Patient had no adverse effects or other symptoms as a result of administration. AE onset date in this case is the date of administration for t; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and drug reactions/ allergies were not reported. The patient's concomitant medication was reported as sterile diluent (DILUENT MRK), which was used to administer the suspect vaccine.  On 18-MAY-2022, the patient was vaccinated with improperly stored (on 11-MAY-2022 the vaccine underwent a temperature excursion of 5.7 Fahrenheit degrees, for 7 minutes) measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, dose 0.5 ml, once, lot number W006583 was found to be valid, expiration date: 23-AUG-2023 (strength, route of administration and vaccination site were not provided) for prophylaxis (product storage error). The patient had no adverse effects or other symptoms as a result of administration.; Sender's Comments:  US-009507513-2207USA007867: US-009507513-2207USA007928: US-009507513-2207USA007832: US-009507513-2207USA007847: US-009507513-2207USA007985: US-009507513-2207USA007826: US-009507513-2207USA008018: US-009507513-2207USA007975: US-009507513-2207USA008097:
Awakened 5/8/03 am with redness of large area to R upper leg into buttock area. Area hot with lump at injection site. saw MD at 1pm 4x7cm area of redness and firm to R outer thigh using Motrin prn for discomfort 5/9/03 follow up call-no increase in size. Motrin helpful.
11 days after getting the shot, I experienced full-body allergic dermatitis. My skin became very itchy and sensitive to touch, especially around the neck and head. After three days with no improvement, I sought care from my doctor through an e-visit. They prescribed five days of Prednisone and recommended an over-the-counter antihistamine, which I have been taking twice a day for the past week. The full-body itching is less severe but my skin is still extremely sensitive.
heart palpitations; chest pain; leg cramps; rash; This spontaneous report as received from a medical assistant refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscularly (dose, lot and expiration date were not reported) for prophylaxis.  On an unknown date, a few day after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced heart palpitations, chest pain, leg cramps and a rash. The medical assistant stated that the patient had seen her primary care physician for medical attention. No treatment was given for the events. There were no laboratory tests performed.  The outcome of the events was reported as recovered/resolved on an unknown date.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Pt received first dose of Hepatitis B vaccine on 09/16/05.  Pt received a second dose on 10/21/2005.  Pt came to health department for third dose today 03/17/06 and stated she started having painful, constant head and neck pain, migraines, numbness and tingling in her right hand, and vision problems a few weeks after dose 1.  She doesn't remember the exact date or time.  She thought it was just some strange "bug" and would just go away, so she had the second dose.  The symptoms are still present and she just had to get eye glasses.  Pt states she is not under any stress and has no other known health problems.  Pt states the only new thing she had done was this shot a few weeks prior to symptoms starting.  Pt did not receive her third dose today because the Hepatitis B package insert did state that delayed hypersensitivity reactions with some of these symptoms has been noted days or weeks after the vaccine.  Pt was referred to her physician to be evaluated.
Member received TDap at approximately 1000 hrs in her left arm on 5 Apr 08 - she reported that her arm is numb (started today 6 Apr 08.)  She also stated she was very tired yesterday and that since receiving the shot she has not felt well.
On 12/20/21, 10 days after the Covid 19 booster, I started to experience hives and severe itching all over my body. The hives and redness vary in location depending on the hour (from the soles of my feet to my scalp). I have been taking OTC antihistamines and topical anti-itch lotions which provide temporary relief. Today is day 4 with no significant improvement.  I saw an allergist today, 12/23/21, who instructed me to continue with antihistamines (Claritin in the morning and Allegra at night) for the next few weeks.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 20-JAN-2015 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX dose: 0.65 ml, subcutaneously (lot # J013133, expiration date: 17-JAN-2015). No adverse effects reported. Additional information is not expected, because there was no consent to contact the reporter.
fine red rash covering body onset 23JAN 830AM; mildly pruritic; no fever;
Headache and nausea at 3:00am on 04jun2021. No treatment given. Drank plenty of water throughout the day. Headache and nausea resolved approximately 8:00pm   04Jun2021.  Left arm soreness at time of injection at injection site.
Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; Redness, swelling, warmth and itch on injection site; This spontaneous case  was received on 22-Oct-2020 from other health professional (nurse) via Med Communications (reference number: SEQW20-04125) and concerned a female child patient of unreported age. At the time of this report the patient was 10-years-old.  The patient's medical history included pollen allergy. The patient's historical vaccines included Flucelvax QIV vaccines in 2018, with the same reaction of redness, swelling, warmth and severe itch on injection site. The patient concomitant medications were not reported.   On an unspecified date in 2019, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.   On an unspecified date in 2019, the patient experienced redness, swelling, warmth, and severe itch on injection site.   The outcome of the events was not reported.  The reporter did not provide causality assessment.  This case is linked with cases 202005407, 202005409 (the same patient) and 202005414, 202005411 (the same reporter).  Company comment: A female child patient of unreported age was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: A female child patient of unreported age was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient experienced vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pruritus. Causal role of the suspect vaccine is assessed as possibly related for all events.
Janssen COVID-19 Vaccine EUA Received on 3/11/21. Symptoms began in the evening. Chills, low grade fever, sever body and head aches, some loosened bowel movements, fatigue. Could not attend work. Continued all through 3/12/21. All had ceased except minor body and head aches along with fatigue by 3/13/21. Fatigue has continued. Significant body aches returned 3/18/21 and are still going today (3/19). Fatigue continues as well.