chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COUGH; FEET HURT; MUSCLE ACHE; FATIGUE; SHORTNESS OF BREATH; FELT DIZZINESS; CHEST HURT; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included panic attack, and quitted smoking, and concurrent conditions included anxiety, and cough.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 to Left Arm for prophylactic vaccination. Concomitant medications included clonazepam for panic attack, and anxiety. On 10-JUN-2021, the subject experienced shortness of breath. On 10-JUN-2021, the subject experienced felt dizziness. On 10-JUN-2021, the subject experienced chest hurt. On 10-JUN-2021, the subject experienced feet hurt. On 10-JUN-2021, the subject experienced muscle ache. On 10-JUN-2021, the subject experienced fatigue. On an unspecified date, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, felt dizziness, chest hurt, feet hurt, muscle ache, and fatigue on 10-JUN-2021, and the outcome of cough was not reported. This report was non-serious.
muscle aches; pain; fatigue; severe headache; lethargy; swollen and painful lymph node in left armpit the size of a golf ball; swollen and painful lymph node in left armpit the size of a golf ball; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 at 10:15 (at the age of 45 year) as dose 2, single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included Hashimoto's syndrome. The patient had no known allergies. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Concomitant medication(s) included thyroid (ARMOUR THYROID), acetylsalicylic acid (BABY ASPIRIN) and Vitamins. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8727), dose 1 via an unspecified route of administration in Left arm on 26Mar2021 at 16:00 (at the age of 45 year) for COVID-19 immunisation. On 16Apr2021 at 19:00 within 10 hours patient experienced muscle aches, pain, fatigue. On an unspecified date in Apr2021, in 24 hours severe headache, muscle pain, and lethargy. In 36 hours, swollen and painful lymph node in left armpit the size of a golf ball. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was not recovered  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 20-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 108 hours with the lowest recorded temperature of -3 Fahrenheit degree. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
severe OCD; This case was reported by a consumer via call center representative and described the occurrence of obsessive-compulsive disorder in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   The patient's past medical history included seizure. Previously administered products included TD vaccine (had TD vaccine ). Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced obsessive-compulsive disorder. On an unknown date, the outcome of the obsessive-compulsive disorder was unknown.   It was unknown if the reporter considered the obsessive-compulsive disorder to be related to Tdap Vaccine.  Additional details were provided as follows: The case was reported by the mother of the patient. The age at vaccination was not reported. The reporter reported her daughter had benign seizures as a baby resulting in postponing pertussis vaccine.  The reporter reported her daughter never had a pertussis vaccine and has not had a seizure since being a baby.  The patient only had TD vaccine although a physician suggested she did not receive vaccines due to her daughter potentially having a compromised immune system.  The patient had a TDaP vaccine thought to be Boostrix, but mother was uncertain and developed severe OCD. The reporter declined to provide daughter's PII due to her privacy reasons. Limited information available.
After getting 2nd covid vaccine by Pfizer, she had sore arm and sore body. She received the vaccine on 12/6/21 2pm and came back to pharmacy on 1/15/22 11:30am with saying she still have her arm sore and body sore pain, and she kept claiming that is allergic reaction. I told her allergic reaction usually happens with symptoms of difficulty in breathing and hives or so but she kept insisting she suffers from allergic reaction. She said she always had problems with all the previous flushots and also with  with this 2nd covid vaccine, so she wanted me to report. I told her not to touch the sore area and keep circulating blood and body but she said that's not helping and causing more pain.
Bad reactions from the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reactions from the first vaccine) in a female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reactions from the first vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, VACCINATION COMPLICATION (Bad reactions from the first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-059502 (Patient Link).
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 drink) on 11-Sep-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 27-Sep-2020 to an unknown date and FISH OIL (OMEGA 3 [FISH OIL]) from 27-Sep-2020 to an unknown date for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 22-May-2021. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 02-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Sep-2020, Pregnancy test: positive (Positive) positive. On 27-Jan-2021, Ultrasound abdomen: normal (normal) no anomalies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment Medication was provided.
I had the first dose before I found out I was pregnant. I continued with the pregnancy and I went for the first ultrasound. I had to start coming in weekly. The following week I should have been at 7 weeks but the baby was only 6 weeks 5 days and had a heartbeat by then. The next week the baby did not grow and did not have a heartbeat. The following Monday they prescribed a medication for forced my body to eject the fetus. I had an allergic reaction to that medication. I continued bleeding for 11 days which was supposed to be 3 days. At that time it was all clear. We do not know if I would be able to conceive again. I had a shot of RhoGAM because I have an RH factor. Pregnancy- one birth one miscarriage, my daughter is 2 years old with no complications. Estimated date was 01/21/2022. I did not know I was pregnant until a week after getting the vaccine and the nurse advised me not to take the second dose.
Two patients / completed / series / younger than / preferred age; Inappropriate age at vaccine administration; Series was repeated / received / four doses; Extra dose administered; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 2nd dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 3rd dose of Bexsero, Bexsero Pre-Filled Syringe Device, the 4th dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device and not applicable after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, inappropriate age at vaccine administration, extra dose administered and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration, extra dose administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The physician stated that, the patients who completed the series at a different practice were younger than the centers for disease control and prevention preferred age range of 16 to 18, which led to inappropriate age at vaccine administered. And the series was repeated to ensure maximum protection during peak risk ages, which led to extra dose administered. The patients received a total of four doses.  The reporter consented to follow up. The physician did not have additional patient details at the time of reporting, but she does provide permission for safety to follow up via email if additional details were needed. This is 1 of the 2 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR172252:Same reporter. Pt 2 of 2.
Five minutes after I received my first dose on 04/17/2022 about 5 minutes after, I started having chest pain. It continued for a week. I do not remember if I saw a doctor or not. I probably did but they told me to take OTC pain medicine and rest. That is all I remember really. I had pain on my left arm around the injection site but was told that was normal. I still get some chest pains but not as much as I had and they're different feeling. I have asked my PCP and they think it is chest wall related. I have been having some chest pain recently and breathing issues because of my Asthma. Pfizer did have me wait 30 minutes after my vaccination instead of 15 because of my reaction to a previous vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old patient who received SHINGRIX (batch number YS53Y, expiry date 30th January 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of chills (refer case US2018115079, for 1st dose). On 13th June 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills was unknown. The reporter considered the chills to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, however, it could be 65 or 66 years. The patient was a hospital employee. The patient did not have any previous vaccination with ZOSTAVAX. Concomitant medications, vaccination facility, and other specific details were unknown, as no further information was provided during the call. The reporter gave consent to be contacted for follow up information. This case was one of the 9 cases reported by the same reporter. The reporter stated over the phone that about half of the eight patients had experienced flu-like symptoms, one of which was another doctor who could not go to a work related event the next day because of the symptoms. It was unknown which of the eight patients was the concerned doctor.
Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms; 38 patient's symptoms improved after Moderna vaccine; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third 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 OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms), THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine) 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 assessments were provided for OFF LABEL USE (Administered Moderna Covid-19 Bivalent doses to treat long-haul COVID symptoms) and THERAPEUTIC RESPONSE UNEXPECTED (38 patient's symptoms improved after Moderna vaccine).    Concomitant medications were not reported.  Reporter stated she had been administering the 65+ bivalent dose to her patients who have symptoms of "long-haul COVID" (non-indicated use of vaccine) and had seen 88-90% success rate in resolving the symptoms of long-haul COVID. Patients treated for skin lesions, brain related problem, systolic blood pressure was 220, tachycardia greater than 150, and body aches which was improved. No adverse reaction reported. Treatment medications were not reported.  This case contains information for patient 24 out of 42.   This case was linked to US-MODERNATX, INC.-MOD-2023-735199 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735199:Patient 24 out of 42
a little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little soreness at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE PAIN (a little soreness at the injection site). In August 2021, VACCINATION SITE PAIN (a little soreness at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 012 (abnormal) antibody reactive result of 012.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.   It was reported that the patient had just a little soreness at the injection site, started immediately and went away after a week.
flushing; red face and neck; bleeding at injection site; arm sore; face on fire; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flushing), ERYTHEMA (red face and neck), VACCINATION SITE HAEMORRHAGE (bleeding at injection site), PAIN IN EXTREMITY (arm sore) and BURNING SENSATION (face on fire) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FLUSHING (flushing), ERYTHEMA (red face and neck), VACCINATION SITE HAEMORRHAGE (bleeding at injection site), PAIN IN EXTREMITY (arm sore) and BURNING SENSATION (face on fire). At the time of the report, FLUSHING (flushing), ERYTHEMA (red face and neck), VACCINATION SITE HAEMORRHAGE (bleeding at injection site), PAIN IN EXTREMITY (arm sore) and BURNING SENSATION (face on fire) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was reported.
pt presented at 1300 for 2nd covid vaccine.  at 1310 pt stated her throat was dry.  pt was given water, and then stated it felt better.  pt was advised to continue sitting in car for an additional 15 mins.  pt was agreeable.  at 1345 pt stated her eyes were itchy and slight headache.  writer was accompanied.  prescribed pt 25 mg of Benadryl.  pt was agreeable.  pt advised to wait 15 mins.  at 1415 pt V/S were stable ( temp 97.4, 02 100%, H/R 61, B/P 108/63).  at 1418 pt reported still itchy eyes and now her head was itching.  pt was given a 2nd dose of 25 mg Benadryl.  Pt spouse came to drive pt home.  pt was advised to wait another 15 minutes to be re-assessed.  pt agreeable.  at 1430 pt was assessed and stated she felt fine.  pt educated to concerning s/s.  pt understanding and agreeable.
Swollen lymph nodes and a hard knot close to breast; Swollen lymph nodes and a hard knot close to breast; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (Swollen lymph nodes and a hard knot close to breast) and LYMPHADENOPATHY (Swollen lymph nodes and a hard knot close to breast) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to morphine).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced BREAST MASS (Swollen lymph nodes and a hard knot close to breast) and LYMPHADENOPATHY (Swollen lymph nodes and a hard knot close to breast). At the time of the report, BREAST MASS (Swollen lymph nodes and a hard knot close to breast) and LYMPHADENOPATHY (Swollen lymph nodes and a hard knot close to breast) had not resolved. Not Provided      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.   No concomitant medications were reported.  No treatment medications were reported.
Pain, swelling around injection site, redness and fever 100.3.  Given Motrin 400-600mg as needed.  Keflex 500mg twice a day for 7 days and Benadryl 25mg.
first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021; first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021; This is a spontaneous report from a non-contactable Other HCP. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient received the first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021. She mentioned that her "last recorded symptoms" were on 06Jan2021 and has been "symptom less" for 8 days, now. She specified that her second dose was due today but she didn't receive it at her workplace, as planned (due to isolation measures). She asked what was the allowed window to receive the second dose of the vaccine? She also asked what were the criteria to receive the second dose, after testing positive. She then asked if she would need to repeat the vaccination series.  Patient also mentioned testing positive to COVID on 13Jan2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given. However, a causal relationship between event "first dose of the COVID-19 vaccine on 23Dec2020, and testing positive to COVID on 01Jan2021" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded.
Itching-Benadryl 25mg IVP.  Follow up: Generalized itching.  Patient since had itching post dialysis; center has recently changed suppliers of sulution fused in dialysis.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 01-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017) (Incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
103.5 temp, headache, fatigue.  The temp broke after 24 hours and can back the next day.