chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received form a physician concerning a 60 year old male with COPD who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The following day the pt had developed a swollen arm and redness from the shoulder to the wrist. He was prescribed abx and the adverse events had started to resolved by the next day. The physician expressed concern about the particular lot of vaccine and inquired if there was "a way to have the vaccine sent in to be looked at". The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional info has been requested. It was also reported that a male pt was vaccinated with a dose f pneumococcal 23v polysaccharide vaccine and developed a fever of 103 to 104 degrees, was lethargic, had breathing problems, chills, swelling of his arms and a 4cm area of erythema.
Pt went to walk in clinic on 10/28/21 for c/o chest discomfort and cough. Sent to local ER for eval. At ER he reported body aches, back pain, cough, n/v, on 10/27/21. On 10/28/21 started with chest pain described as heaviness, worse when laying down. Denied SOB, palpitations, etc. Troponin level elevated to 8 then increased to 10. Cardiology consult to ER and ECHO done. DX: myocarditis secondary to covid vaccine. Transferred to Hospital.
1. Dizziness/Vertigo that lasted for 14 days from date of injection 2. Injection Site bruising and significant pain that lasted for 4 days from date of injection 3. Swelling at injection site  about the size of a very large lemon that started on day 4 after the injection and lasted until day 13 after date of injeciton.The swollen area was bright red and very hot to the touch.
Information has been received from a licensed practical nurse referring to an adolescent patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-SEP-2016, the patient was vaccinated with an expired dose of (wistar ra 27-3) M-M-R II (lot # reported as L024104, expiration date 14-SEP-2016, dose not reported) subcutaneously in the right arm. No adverse effects were reported. Lot number L024104 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Additional information has been requested.
Fever, chills, nausea beginning about 6 hours after the vaccination and continuing for about 36 hours
Swollen Lymphnode and injection site rash w/in first 4 days.  Two weeks following first injection full body measles looking rash.
Caused a flare up of fibromyalgia pain. Has lasted over a week.  Pain is 8-[ out of 10. Headache that lasted over a week
Heart palpitations @1600 lasted till 1920ish Headache @1800 lasted 72 hours  Fever around 0000 lasted for 1-2 hours  Chills and body aches started next morning lasted for 2 days Tinnitus started 2 days after currently still persistent
Symptom onset was 12/04/2022 with a severe cold, cough and SOB. Admitted to hospital 12/05/2022.
Migraine,  extreme fatigue, extreme  bone and joint pain, nausea,  low grade fever, sensitivity to cold
Vaccine was expired on 07-Apr-2022 and administered on 13-Apr-2022/administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 13-Apr-2022/administer expired vaccine to patients, after the manufacture date of expiration.) in an 83-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 13-Apr-2022/administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 13-Apr-2022/administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions  No treatment information was provided.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up was received, additional reporter was added.
Patient c/o chest tightness and difficulty breathing at 1200. She was pale and diaphoretic, pulse 118. Sent to facility. Returned to work adverse reaction not found by facility.
Started crying around 11:30 AM about one hour after vax this AM. Crying unabated until few minutes ago when fell asleep in car. Mom nursed at 11 AM but not since. Dad states cry was pain cry, very hard, loud and insistent, whimpering to catch breath. Agitated. Tylenol given 3:45. Used cold compresses. Pt stopped crying in office. Nursed avidly. Length unconsolable crying 3-3.5 hours.
ADMINISTERED 2.5ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) 2.5 ml,, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced administered 2.5ml of the vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered 2.5ml of the vaccine and off label use was not reported. This report was non-serious. This case, involving the same patient is linked to 20211201168. This case, from the same reporter is linked to 20211220129, 20211220146, 20211220152, 20211202199, 20211202193, 20211202161, 20211201963, 20211201450, 20211201443, 20211201392, 20211201351, 20211201304, 20211201286, 20211201179, 20211201168, 20211200994, 20211201082, 20211200723, 20211200717, 20211200675, 20211165041, 20211202371, 20211202250, 20211202246, 20211202207, 20211202193, 20211201963, 20211201228, 20211201046, 20211200769, 20211200752, 20211200723, 20211165041, 20211219871 and 20211220155.
This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (having blisters that looked like pimples.), PRURITUS (itchy blisters), PUSTULE (blisters filled with puss), PAIN (painful blisters) and FATIGUE (fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 030A21A and 004M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient was healthy.  Concurrent medical conditions included Dry eyes. Concomitant products included CICLOSPORIN (RESTASIS) for Dry eyes, PREDNISONE for an unknown indication.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.      Most recent FOLLOW-UP information incorporated above includes: On 08-Dec-2022: Follow up information included reporter details added, new events added, suspect vaccine and concomitant drug details updated, and event description updated in narrative supplement.
Information has been received from a physician concerning a 10 weeks old female patient with no pertinent medical history and no drug reactions/allergies who on 12-OCT-2011, was vaccinated with the first dose of ROTATEQ, oral. On 12-OCT-2011, the child also received other unspecified vaccines that should be administered at two months of age. On 16-OCT-2011, four days after receiving ROTATEQ, the patient began crying inconsolably for three straight hours. No treatment was given for the AE. On 15-NOV-2011, the patient's outcome was recovered. No laboratory diagnostic studies were performed. The parents mentioned the AE occurrence during the child's three month check-up visit on 15-NOV-2011. Additional information has been requested.
Rash with lump just under injection site. Has some heat in it, itches. Rash and itching still present today. No lump.
Exposure during pregnancy; Sore at the injection site; Headache; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy), INJECTION SITE PAIN (Sore at the injection site) and HEADACHE (Headache) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-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 an unknown date and the estimated date of delivery was 01-Jun-2021. On 14-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy), INJECTION SITE PAIN (Sore at the injection site) and HEADACHE (Headache). The delivery occurred on an unknown date, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Jan-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) outcome was unknown. At the time of the report, INJECTION SITE PAIN (Sore at the injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 24 Aug  2020 the patient received a positive pregnancy test. The patient estimated due date of 06 Jan 2021. There have been no complications or acute illnesses during this pregnancy. Pregnancy ultrasound taken but results have not been provided.Treatment information included Tylenol and Rhogam shot for being blood group  O negative.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: No specific follow-up information recorded.
Vaccine administered via subcutaneous route; A spontaneous report was received from a healthcare professional concerning a 85-year-old, female patient who received a Moderna's COVID-19 vaccine (mRNA-1273) administered via subcutaneous route.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 05 Feb 2021, patient received their second of two planned doses of mRNA-1273 (Lot number: 013L20A) subcutaneously for prophylaxis of COVID-19 infection.  On 05 Feb 2021, second dose of Moderna COVID-19 vaccine was administered via subcutaneous route to three patients. The patients have not reported any side effects. No treatment information was provided.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The event, vaccine administered via subcutaneous route was considered resolved on 05 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect route of product administered for mRNA-1273 (Lot number: 013L20A) with no associated AEs.
p/vax pt woke w/stomach pain; tried for bowel movement during the morning w/no results; then began vomiting;
activation of shingles, left leg within 4 hours of receiving 1st dose of moderna.  7 days later I was hospitalized with acute kidney failure
Partial dose of vaccine (less than 1/2 dose) was given in error and repeat dose has been rescheduled per CDC Guidelines.  Patient reported to RN no adverse effects and he will return 2-17-2021 for revaccination.
swollen armpit (lymph nodes?); overnight sweats; elevated heartrate; chest pain; burning sensation throughout the day; fatigue; overnight chills; injection-site pain; This is a spontaneous report from a contactable consumer or other non-HCP. A 33-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF8841), via an unspecified route of administration, administered in left arm on 08Oct2021 at 10:20 (at the age of 33-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection, lot number: EL3247) on 14Jan2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection, lot number: EL3247) on 04Feb2021 for COVID-19 immunization. Medical history included cholesterol, hypothyroidism and Hashimoto's Thyroiditis. Concomitant medications included levothyroxine sodium (LEVOXYL), colecalciferol, fish oil (OMEGASAN 3) and Multi-vitamins. On 08Oct2021 10:20 the patient experienced overnight chills and injection-site pain. On 09Oct2021 13:00 the patient experienced fatigue, elevated heartrate, chest pain, burning sensation throughout the day, overnight sweats. On 09Oct2021 19:00 the patient noticed swollen armpit (lymph nodes?). Facility type vaccine mentioned as Workplace clinic. No other vaccine in four weeks has been administered. Other medications in two weeks mentioned as Levoxyl, Omegas, Multi-vitamins, Other medical history: Cholesterol, Hypothyroidism, Hashimoto's Thyroiditis. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19. No known allergies reported for the patient. The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): Negative on 31Mar2021 COVID 19 Antigen/Rapid; heart rate: elevated on 09Oct2021. Therapeutic measures were taken as a result of overnight chills, injection-site pain, fatigue, elevated heartrate, chest pain, burning sensation throughout the day, swollen armpit (lymph nodes), overnight sweats. On 08Oct2021 at around 20:00 took two Tylenol PM tablets. On 09Oct2021 at around 9am took two Tylenol Gelcaps. May plan to visit Primary Care Physician this coming week reporter stated. The outcome of event overnight chills, injection-site pain was recovered on an unspecified date of Oct2021 while outcome of event fatigue recovered on 09Oct2021. The events were reported non-serious. The outcome of event overnight sweats was outcome of recovering while outcome of rest all event was not recovered.  Follow-up attempts are completed. No further information is expected.
Hives/erythema confluent around (R) thigh shot site = MMR and lower shot shite in (L) thigh = varicella. No swelling around the HepA site. Child also with urticaria on (R) side of face. No breathing issues. Resolved 3D.
Pt developed  Henoch-Schonlein purpura 11/04/2002 1st diagnosed, was seen at night care 11/2/02 with bilat (sic) elbow swelling and pain X 1 day.
No pain initially. Woke up at ~0330 with a lot of pain and chills. Temperature taken and no fever recorded. By 0430 head felt like I wasn't there. Very cloudy and tired. Incontrollable chills came back around 1000, still no fever. Getting a headache now at ~1100. Chest pain in left armpit region. Blood pressure very high. Highest so far, 169-112, 111 pulse. Still feel very "spacy". Best I can describe is that it feels similar to when I had shingles and was given Neurontin. Feel totally out of my head. Arm is very sore.
About a week after the vaccine I was asleep and woke up abruptly around 2am. I had cramps in my stomach and my heart was pounding intensely.  I started sweating and when I got up I thought I would faint. My heart physically hurt and I?ve never experienced that type of pounding in my chest before. After about 20 minutes my heart calmed down and it felt like my heartbeat had disappeared. I didn?t want to overreact but I?ve never experienced anything like that so I went to the emergency the next morning. The only difference in my routine had been getting the vaccine the previous week but the doctors told me it couldn?t possibly be the vaccine. I feel that as a young woman my issues were not properly listened to. Luckily my primary care doctor is a young woman and when I discussed the incident with her she said it could absolutely be a vaccine side effect as the vaccine has not been tested as much as other medications. Seeing that more people are having this reaction I wanted to add my experience.
Patient received 2nd booster dose 3 days after 30-day use by date, administer  the second Booster vaccine after the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received 2nd booster dose 3 days after 30-day use by date, administer  the second Booster vaccine after the 30 day use by date) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 939909, 008C21A and 003b21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received 2nd booster dose 3 days after 30-day use by date, administer  the second Booster vaccine after the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received 2nd booster dose 3 days after 30-day use by date, administer  the second Booster vaccine after the 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. The vial was initially stored in the refrigerator on 24Jun2022. It was unknown that the patient had any allergies to medications, food and other products. No other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine. No treatment information were provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Added patient DOB , Batch / Lot numbers and Narrative  updated.
Patient came back into the pharmacy on 12-1-2017 at 2:30 pm to show me her arm. The right arm was swollen, red and hurts. She had been using ice. I recommended continuing with ice and gave her BENADRYL to use also. She is to call me again for a follow up.
fever; headache; chills; muscle pain; little bit of swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency.
Exact date vaccines failed to seroconvert; Both VARIVAX and MMR titers showed "negative" titer results/titers draw; Second dose of MMR was administered 11/8/2002; This spontaneous report was received from a pharmacist  referring to a 21-year-old male patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 31-AUG-1999, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, route of administration, lot number and expiration date were not reported). Other suspect vaccines included the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (strength, route of administration, lot number and expiration date were not reported). Other suspect therapies included sterile diluent for prophylaxis (dose, route of administration, lot number and expiration date were not reported), on the same date.  On an unknown date in 2020, the patient had titers draw for varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and both showed "negative" titer results (antibody test negative). Exact date vaccines failed to seroconvert (vaccination failure)  was unknown by reporter. Furthermore, pharmacist reports that first dose of both live vaccines varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) were administered on 31-AUG-1999, rather than one month before or after administration of other live viral vaccines as per PI. Second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was administered on 8-NOV-2002). The patient did not have any symptoms. It was reported that no laboratory was performed, but it was stated that unspecified studies for the negative titers were performed. The patient sought unspecified medical attention. No treatment was given for the adverse events.  At the time of reporting, the outcome of antibody test negative an vaccination failure was unknown.    The causal relationship between varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) and antibody test negative and vaccination failure was unknown.