chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She slept for 24 hours; Hives that started on the stomach, and then went to the top of her hand/ hives are on and off on different parts of the body, they appear and then go away/ They are big, itchy, burning hives; They are big, itchy, burning hives; They are big, itchy, burning hives; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (She slept for 24 hours), URTICARIA (Hives that started on the stomach, and then went to the top of her hand/ hives are on and off on different parts of the body, they appear and then go away/ They are big, itchy, burning hives), PRURITUS (They are big, itchy, burning hives) and BURNING SENSATION (They are big, itchy, burning hives) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (She slept for 24 hours), URTICARIA (Hives that started on the stomach, and then went to the top of her hand/ hives are on and off on different parts of the body, they appear and then go away/ They are big, itchy, burning hives), PRURITUS (They are big, itchy, burning hives) and BURNING SENSATION (They are big, itchy, burning hives). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency and CALAMINE (topical) for Hives, at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (She slept for 24 hours), URTICARIA (Hives that started on the stomach, and then went to the top of her hand/ hives are on and off on different parts of the body, they appear and then go away/ They are big, itchy, burning hives), PRURITUS (They are big, itchy, burning hives) and BURNING SENSATION (They are big, itchy, burning hives) outcome was unknown.            No concomitant drug details were reported.
Patient presented to the pharmacy with localized swelling, pain, redness, and heat at injection site and surrounding areas.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. Information about the patients' pertinent medical history and drug reactions/allergies was not reported. It was reported that since 16-MAY-2016, the patients' were vaccinated with improperly stored doses of VARIVAX, lot # M000760 with expiration date 06-JAN-2018, (dose, frequency and route of administration were not provided). Concomitant medication was not reported. No adverse effects reported. The VARIVAX was exposed to a temperature of 21 F for 63.5 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Additional information has been requested.
Third dose of COVID vaccine, first bivalent. Significant left under arm edema, with tenderness and radiating pain to left breast.
patient was given expired IPOL vaccine/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Medical Information (Reference number- 00567201) and transmitted to Sanofi on 19-Apr-2021.  This case involves a 4-years-old male patient who received expired  0.5 mL fourth dose of IPV (VERO) [IPOL] vaccine (frequency: once, Strength: standard, batch number: R1B25 and expiry date: 13-Mar-2021 via an intramuscular route in right thigh) (expired product administered) on 06-Apr-2021.  The patient's medical history, past medical treatment and family history were not provided.  Concomitant vaccines included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and CHICKENPOX prophylactic vaccination. No other vaccines were received by patient.  Caller wanted to know what to do if 8 patients got expired IPOL vaccine.   It was an actual medication error case due to expired vaccine used (latency: same day)  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Her period was already over a day before vaccination. After vaccination, however, her menstrual period came back/Prolongation of Menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Her period was already over a day before vaccination. After vaccination, however, her menstrual period came back/Prolongation of Menstrual bleeding) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: Pfizer (First dose she had on time menstrual periods but heavy bleeding during menstrual period for 3 months) in March 2021 and Pfizer (Second Dose she had on time menstrual periods but heavy bleeding during menstrual period for 3 months) in April 2021. Past adverse reactions to the above products included Heavy menstrual bleeding with Pfizer and Pfizer.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced MENSTRUAL DISORDER (Her period was already over a day before vaccination. After vaccination, however, her menstrual period came back/Prolongation of Menstrual bleeding). At the time of the report, MENSTRUAL DISORDER (Her period was already over a day before vaccination. After vaccination, however, her menstrual period came back/Prolongation of Menstrual bleeding) outcome was unknown.            No concomitant medications were reported   The patient stated that she had Medium menstrual bleeding after booster.  No treatment information was provided   Reporter did not allow further contact
Began with itching, progressed to wheal/swelling/lump in arm.  Began on day 7/8 after immunization.  Patient sought care at her infectious disease doctor.  As of 1/21/21 symptoms have subsided but not completely gone away.
Arm above elbow swelled and felt hard, joint pain all over body, occured after vaccine and continued to worsen
Pt described his left upper arm and leg being numb the day after flu vaccination and it was resolved the following day.   He did not report the symptoms (until today 10/4/19) or require/request treatment.
Stomach pains; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EM9809, NDC number was reported as unknown) dose 1 via an unspecified route of administration in left arm on 06Feb2021 16:00 (at the age of 71 years old) as dose 1, single for COVID-19 immunisation. Medical history was none. Concomitant medication was not reported. No other product was given. No investigation assessment was reported. The patient took COVID shot to prevent getting COVID-19. On 09Feb2021 the patient experienced stomach pains. No treatment was given. The patient wanted to know if this was a side effect of the shot and stated that she went to the ER because she thought she was having an intestinal blockage but there was no blockage. The clinical outcome of the event was resolving.   Follow-up attempts are completed. No further information is expected.
RIGHT ARM  2cm Redness, Hot sensation at first, now warm. Itching relieved with Benadryl. Symptoms return without Benadryl 9/4/19  LEFT ARM  STIFFNESS. SORENESS AT FIRST NOW LESS, TINGLING 9/4/19
I began symptoms on 18FEB2023. I had a very gravely voice severe nasal congestion and achy joints and very tired. I tested positive for COVID-19 on 21FEB2023. Symptoms were clear by 07MAR2023.
1.5 INCH X 1.5 INCH RED BLOTCH NOTED TO RT LEG.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates the patients were vaccinated with GARDASIL, (route, lot numbers and expiration dates not reported). The reporter stated that the patients received GARDASIL off schedule. No adverse symptoms reported. Additional information has been requested.
inflammation and redness at the injection site; redness at the injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammation and redness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE INFLAMMATION (inflammation and redness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). On 25-Mar-2021, VACCINATION SITE INFLAMMATION (inflammation and redness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       On 19 -Mar-2021, the inflammation and redness became significant enough that the patient went to the  clinic for medical attention. The patient was prescribed steroids and sent back home. The physician also recommended her not to take the second dose.  No relevant concomitant medications were reported.  Treatment included steroids where prescribed to treat the vaccine site reaction.
PATIENTS MOTHER CALLED-SAID THAT PATIENTS ARM HAD SWOLLEN FROM THE TOP OF SHOULDER DOWN, IT WAS ALSO SLIGHTLY RED AND HOT TO THE TOUCH
Patient received only the liquid portion of the pentacel vaccine, no AE; Initial information was received on 24-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional via phone.  This case involves a four months old male patient who was vaccinated with a second dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ29ABA and expiration date  25-APR-2021) via an unknown route at an unknown administration site for prophylactic vaccination on 08-Sep-2020. However the patient received only the liquid portion of the pentacel vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   The patient's concomitant vaccination included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  It was an actual medication error case due inappropriate reconstitution technique (latency was same day).  The reporter wanted to know if this dose can count as a valid dose.  No adverse event reported to the patient at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had several events of passing out without a memory and then waking up. But I did not have any numbness until the most recent event when I went to see my doctor. I didn't have any major symptoms until after my 4th booster. I had passing out, dizziness, tenderness, lightheaded, some numbness which stopped the following day in my last 3 finger and part of my left arm. But it stopped after 24 hours, and I reached out to my doctor.
Patient started having diarrhea for 1 week after receiving her second COVID vaccine (Pfizer)
Initially vaccinated with J&J in April. Flu-like reactions the next day, no fever, strong headache. Received Moderna as a booster, same symptoms the following day, fatigued and headache. The following night I woke up in my sleep at 3:30am in a cold sweat and chest pains. I went back to sleep and upon awakening the chest pain resolved.
we gave 3 doses of expired Moderna bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (we gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we gave 3 doses of expired Moderna bivalent) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (we gave 3 doses of expired Moderna bivalent).    Concomitant product use was not provided by the reporter. Treatment information was not provided. This case contains information about patient 2nd out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730168 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730168:Master case patient no. 01
Severe abdominal pain/diarrhea, nausea, vomiting, fever after 2nd dose of oral typhoid.
Pt. reported leg weakness "similar to when my blood sugar was low".  Pt. had sugar containing candy on person and was advised to ingest it.  Pt. observed for additional 15 minutes and dismissed in stable condition thereafter.
Patient fell after receiving vaccine  Fall caused bruise on face. EMS called and he was evaluated and refused treatment.
simply felt overall unwell; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16May2021 as dose 1, single (Lot number: EW0183) at the age of 45 years, in left arm for covid-19 immunisation. The patient relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin and albuterol. Concomitant medication(s) included: L-LYSINE [LYSINE]. Past drug history included: Albuterol, reaction(s): "Known allergies: albuterol", notes: Known allergies: Penicillin and albuterol. The following information was reported: MALAISE (non-serious) with onset 2021, outcome "not recovered", described as "simply felt overall unwell". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical Information: With the second dose, she had extreme fatigue for 6 months and a 28-day headache at the base of my skull. After the booster (3rd dose) she suffered from ongoing extreme fatigue, a deep itch/pain at the injection sight, and cysts in my left breasts. She had herpes that was under control for years. Less than 48 hrs after the booster she suffered an outbreak and has continued to have outbreaks (that have now spread to other parts of her body) every 10-14 days. All of the symptoms have remained ongoing even though it's been over 6 months. She had simply felt overall unwell since receiving these vaccines. She was normally a very healthy, energetic, and active woman. She did not covid prior to vaccination. She was covid tested post-vaccination. Patient received vaccine Facility from Pharmacy or Drug Store.
one week after the vaccination the injection site became red, hot and tender to touch, and mild soreness
hives all over face; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives all over face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives all over face). At the time of the report, URTICARIA (hives all over face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .   Reporter did not allow further contact
My daughter received her 2nd dose on 12/27/2021. On 12/18/2022 she had a stomach pain and later diagnosed with strep throat. On 12/20/2022 I took her to the doctor's office they tested her for strep throat which was positive and they prescribed her with amoxicillin for 10 days. As of today 12/28/2022 she is feeling better.
No adverse events. Vaccine was given to a 17 year, 7 month old patient. Vaccine is only approved for 18 years old and above.
7AUG93 devel confluent faint pink rash over sites of all 3 immun; this spread to dark pink raised plaques; 3-5mm covering mostly trunk but also face/extremities neck; sl itchy, low grade temp 99-101, fussy;
Patient reported signs and symptoms of swelling, redness, tenderness and painful of the arm in which the vaccine was injected.
This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (the left side of her face went numb for an hour or so, she could not feel her cheek), NECK PAIN (pain shot up into her neck), PAIN IN EXTREMITY (a bit of a sore arm, by afternoon really started to hurt) and HEADACHE (a bit of a headache (mainly on the left side)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (a bit of a sore arm, by afternoon really started to hurt). On 09-Jan-2021, the patient experienced HYPOAESTHESIA (the left side of her face went numb for an hour or so, she could not feel her cheek), NECK PAIN (pain shot up into her neck) and HEADACHE (a bit of a headache (mainly on the left side)). The patient was treated with IBUPROFEN on 09-Jan-2021 for Headache, at an unspecified dose and frequency. On 09-Jan-2021, HYPOAESTHESIA (the left side of her face went numb for an hour or so, she could not feel her cheek), PAIN IN EXTREMITY (a bit of a sore arm, by afternoon really started to hurt) and HEADACHE (a bit of a headache (mainly on the left side)) had resolved. At the time of the report, NECK PAIN (pain shot up into her neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.
Tingling on right side of face, "zapping" sensation, no drooping, no awkward smile, no abnormality with eye Narrative:
36 hours after vaccine given, employee noted large raised, reddened and hot area around injection site. Employee notes that the site was also itchy. Extended in size to 5" x 5", when she presented back to Employee Health 54 hours after injection. States she had no reaction to 1st dose, one month earlier.
his lips swelled up almost three times the normal; he had welts all over; 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 parent.  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date 07Feb2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: LIP SWELLING (non-serious) with onset 07Feb2022, outcome "not recovered", described as "his lips swelled up almost three times the normal"; URTICARIA (non-serious) with onset 07Feb2022, outcome "unknown", described as "he had welts all over". The events "his lips swelled up almost three times the normal" and "he had welts all over" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of lip swelling, urticaria. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Patient received the second dose yesterday of the vaccine. Reporter wanted to advise that 2 hours after the vaccine his lips swelled up almost three times the normal size and he had welts all over. This did not happen with the first vaccine. We took him to urgent care and they gave him a steroid. Today he is still swollen in those areas. Can you advise what are components of the vaccine? We need to get in contact with his pediatrician with the information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (15Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
experiencing neurological adverse events after receiving the booster dose; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "experiencing neurological adverse events after receiving the booster dose".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Headache, dizzy, feverish feeling, nausea, fatigue, insomnia, worsened tinnitis