chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a dose of Moderna vaccine on 07/06/2021.  He completed both Pfizer doses (03/15/21 and 04/05/2021). Mistake was found after accessing MIIC on 07/19.  Patient indicated that he did not experience any adverse events and  is advised to  follow up with his doctor and contact us if he  experiences  any adverse events.
Fever, chills, body aches, sore are, swelling in arm, rash at injection site, tachycardia, headache
first noticed yesterday w/swelling & soreness; redness less in rt deltoid 45x80mm irregular borders;
Irregular heartbeat/palpitations lasting 13 hours, fever/chills, headache
3/2/21 - Received 1st dose of Pfizer COVID-19 vaccine 3/3/21 - Rash on legs, itchy and burning in nature. Progressed to upper extremities and increased in severity over the following days.
The day after the vaccine he started to get an headache, brain fog, and dizziness. He also lost his sense of smell and taste. Went to see his doctor stated they increased his Effexor. They tried giving him Atarax but it didn't work also gave him supplements L-theanine 200 ml, Ashwagandha 200ml and Magnesium Glycinate 300ml said it helped a little.
Vaccine was initially stored in refrigerator on 04-Nov-2022 and administered on 07-Dec-2022; No adverse event; adult patient received an expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (adult patient received an expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 04-Nov-2022 and administered on 07-Dec-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (adult patient received an expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date) and NO ADVERSE EVENT (No adverse event). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 04-Nov-2022 and administered on 07-Dec-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (adult patient received an expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 04-Nov-2022 and administered on 07-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (adult patient received an expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in refrigerator on 04-Nov-2022 and administered on 07-Dec-2022).    No concomitant product reported by reporter.  Patient received expired Monovalent first dose Moderna COVID-19 vaccine after 30 day beyond use date. Vaccine was initially stored in refrigerator on 04-Nov-2022. Affected vial was individual vial with vial size of 5.5 ml with red cap. Vial did not undergo any temperature excursion issue.  No treatment medication reported by reporter.
Cervical lymph node enlargement of several nodes on the right (same side as the injection).
Intense Abdominal pain that wrapped around to the sides and back and injection sight pain. Lasted about 32 hours in all Applied heat to abdomen that helped.
Patient started experiencing pain in the left arm that evening after receiving the vaccination in the morning. The next morning on 8/3/18, the patient had a red onsite reaction which hasn't improved since 8/3/18. The rash is warm to the touch. She is also experiencing tingling/burning in the left arm as well.
Undiluted vaccine was given to pediatric patient. Caregiver reported no adverse effects on 7/21/22 at time of vaccination and again no adverse effects on 7/26/22.
It started with difficulties breathing, and severe headache. Woke up at 4:30 AM with nausea, started vomiting with abdominal pain for about 4 hours. Still had bad headache. The next day vomiting stopped, the nausea diminished, but the headache continued until the day after (for about 2 days after the vaccine was administered).
This spontaneous consumer case (initial report 02-JUL-2014) concerns a 72-year-old elderly male patient. On an unspecified date, the patient received flu shot (manufacturer and batch number not provided) and also received Zemaira, weekly infusion at a dose of 5658 mg for alpha one (refer to case 2014042841).  On an unspecified date, the patient experienced flu-like symptoms. The events were not severe enough to go to the doctor. The patient stayed in bed until the symptoms subsided. The patient experienced severe headache, sore throat and breathing had not improved. The patient was sick most of the time. Outcome was reported as improving on flu symptoms, however, headache continued to be severe.  Reporter's comments: it was reported that the patient was sick most of the time so his spouse wouldn't know if it was the treatment or not. It was thought the flu-like symptoms were because he had taken the flu shot.
This spontaneous report was received from a Medical assistant referring to multiple unknown patients of unknown age and gender. Patient's concurrent conditions and medical history were not reported. On an unspecific date the patients were vaccinated with improperly stored VAQTA (lot # M021124, expiry date 02-FEB-2018) concentration, dose and route of administration were not reported. It was reported that the temperature excursion was for 46 minutes at 1.7 degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Injection administered by med assistant (Hib ordered). MA noted "no vaccine" in syringe when gave injection (air likely injected IM), MA gave HIB vaccine after drawing up/mixing HIB vaccine. Mom question air injection IM vs repeat dose of Hib. Reassurance given re air injected IM (and even primarily of IV). I spoke with Dr, reassurance given re side effect of local erythema if Hib given x 2.
Patient experienced change in sense of taste and change in facial sensation within 12 hours of his 6th Anthrax and 3rd Typhoid vaccination.  The symptoms progressed, leading to brain MRI, hospitalization and ultimately the diagnosis of suspected acute disseminated encephalomyelitis.  7/31/09 Hospital records received DOS 7/10/09 to 7/11/09. Assessment: Suspected acute disseminated encephalomyelitis. Patient experienced some decrease in taste on his tongue as well as some loss of sensation over the lower portion of his jaw and face. Decreased sensation in the right upper extremity and the right lower extremity. Imaging revealed a cerebellar lesion. On admission patient presents with decreased sensation in bilateral lower face. Decreased to cold, pinprick, light touch throughout thr right side. Blurry vision.  8/18/09 ICD-9 Codes: 323.9 Encephalitis myelitis and encephalomyelitis unspecified cause.
Improperly stored vaccine administered; This spontaneous report as received from a nurse and refers to a 60-year-old patient. The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.      On 09-OCT-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter lot # S024808, expiration date on 02-JUN-2021 as prophylaxis (strength,  frequency, route of administration, and anatomical location were not reported). The administered dose of vaccine experienced the temperature excursion below 2 degrees Celsius (minus 17 degrees Celsius) for 63 hours and 45 minutes. There was no previous temperature of excursion. Data logger was not involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
C/O Pain, left armpit lump; "node" enlarged red, and painful. "Very large" 1 inch. 3/19 Saw MD, no infection noted. Never had mammogram - sent for one (negative) still painful 3/28 enlargement less. No redness
Information has been received from a physician concerning a 17 month old female, with no allergy of immunosupression and no known varicella exposure, who on 04/10/2001 was vaccinated with varicella vaccine in her left thigh. On 04/25/2001 according to the pt's mother the pt developed papules at injectio nsite. The lesions are concentrated at the injection site; however, the pt has also developed lesions on the rest of her body. He had no other case info to report at this time. Additional info has been requested.
This spontaneous report was received from a medical assistant and refers to two patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On 12-SEP-2016, the patients were vaccinated with improperly stored VARIVAX (doses and route of administrations were not reported) (Lot # L038132, expiry date: 01-OCT-2017). No concomitant therapy was reported. Temperature excursion was 11F for 3 hours. Digital Data logger was involved. There was no previous excursion. No adverse effect was reported. Additional information has been requested.
Mild diarrhea began about 1 hour after receiving shot and lasted about 24 hours. About 24 hours after receiving shot, fatigue, muscle soreness, headache began and lasted for 3 days.  Fatigue persisted for 10 days post-shot.  Approximately 8 days after receiving shot, until present, lost sense of smell.  Sense of smell is still about 90% gone.
Initial information received on 13-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old patient who was vaccinated with expired dose of ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DTAP for Immunisation. On 12-Jul-2018, the patient received a dose 4 Primary dose of suspect HIB (PRP/T) VACCINE lot U1796AA in the left thigh. It was an actual medication error due to expired dose of ACTHIB. The patient outcome is reported as Not Applicable for nurse gave an expired dose of ACTHIB. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: None.
(1) Erythema & induration at site posterior (L) upper arm. (2) (L) axillary lymphadenopathy. (3) Reported malaise/body aches, fever past 2 days.
Immediately after coming home swelling of the injection site then spread to the whole body and leg were there were no injections, took him to urgent care immediately. Fever, headache, vomiting, not interested in toys or food. Not normal for him.
Slight pain at injection site, redness and itching at injection site, moderate headache chills, body aches, chest pain.
pt recvd vax; pt was running T & cranky; gave apap & bath; pt went to sleep; at MN gave more apap & at 1am had convuls lasting 5-10 mins; to er;
8x5 cm induration w/ tenderness to Rt. shoulder. No fever.  Tx'd with Keflex 250mg - tid, IBU 250mg - q6-8hrs, and ice packs - prn.
HAD TROUBLE WITH LONG DRIVES; NOT SLEEPING WELL; FEELING COLD LIKE SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (HAD TROUBLE WITH LONG DRIVES), POOR QUALITY SLEEP (NOT SLEEPING WELL) and NASOPHARYNGITIS (FEELING COLD LIKE SYMPTOMS) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On 10-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (HAD TROUBLE WITH LONG DRIVES), POOR QUALITY SLEEP (NOT SLEEPING WELL) and NASOPHARYNGITIS (FEELING COLD LIKE SYMPTOMS). The patient was treated with MERCAPTOPURINE at an unspecified dose and frequency. In 2021, POOR QUALITY SLEEP (NOT SLEEPING WELL) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (HAD TROUBLE WITH LONG DRIVES) was resolving and NASOPHARYNGITIS (FEELING COLD LIKE SYMPTOMS) outcome was unknown.            No concomitant medication was reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
After receiving shot went to another appt and within 30 mins or so, got headache, vomiting, weak; sent to ER and found to have wheezing. After epi improved and sent home. Feeling better next day.
sounded like an anaphylactic reaction; throat which feels like an elevated restriction; had swelling of the upper lip, like a lot like feeling like its going to burst; swelling of the upper lip, a lot, a little bit in the throat; itching and swelling in other areas; Swelling in other areas; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on 17May2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 as dose 1, single for COVID-19 immunization and had no reaction. On 17May2021, within an hour after second dose, patient's experience sounded like an anaphylactic reaction. Patient had swelling of the upper lip, and had a feeling like its going to burst, a little bit in the throat felt like an elevated restriction, and some itching and swelling in other areas. It has subsided, it took a few days. Even today like right now the patient is feeling some swollen areas and its been a month after the vaccine at the time of report. The outcome of sounded like anaphylactic reaction and swelling in other areas was unknown and rest of the events was recovered on unknown date in 2021.   Additional information on the lot/batch number has been requested
Left Breast Lump found June 2021? Left Breast Cancer diagnosis given on 7/30/21, Mastectomy upcoming August/September 2021
Admitted to hospital on 10/14/17-Acute hypoxic respiratory failure secondary to pneumonia/COPD. Bil sacroilitis, H/O prostate CA discharge summary 10/26/17 list Guillain-Barre Syndrome as one of the discharge diagnosis.
Rash chest neck to waist; Pain at injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash chest neck to waist) and VACCINATION SITE PAIN (Pain at injection site left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site left arm). On 02-May-2021, the patient experienced RASH (Rash chest neck to waist). The patient was treated with PREDNISONE at an unspecified dose and frequency. On 15-Apr-2021, VACCINATION SITE PAIN (Pain at injection site left arm) had resolved. At the time of the report, RASH (Rash chest neck to waist) outcome was unknown.        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 relevant concomitant medications reported.
Vaccine taken during 6 weeks of pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine taken during 6 weeks of pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use on 13-Oct-2020. Concurrent medical conditions included Hypothyroidism and Graves' disease (Treated with l-131 @15 y/o, takes levothyroxine 112 mcg 9 pills a week) since May 2003. Concomitant products included LEVOTHYROXINE for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, VITAMIN D NOS for an unknown indication.   On 04-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 25-Oct-2020 and the estimated date of delivery was 27-Aug-2021. On 04-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine taken during 6 weeks of pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, 6 weeks pregnant. On 03-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine taken during 6 weeks of pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Dec-2020, Blood test: Inconclusive. On 12-Dec-2020, Pregnancy test: Positive. On 28-Dec-2020, Ultrasound foetal: ultrasound for viability, size outside dating range. On 11-Jan-2021, Ultrasound foetal: Ultrasound for viability, GS and YS visualized 3.6mm, embryo visualized 12.1 mm, FHR 166 bpm. On 19-Feb-2021, Blood test: results not provided. On 19-Feb-2021, Ultrasound foetal: Sex determined: Boy NIPT low risk for T21, T18, T13 and turner. Nasal bone present, 154bpm, NT 2.1mm, CRL 71.8, Z36.82.     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 treatment information provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.      Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Initial pregnancy report filled and submitted. Updated the medical history, pregnancy details, con meds and prior history.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Right thigh with 20cm erythematous plaque. Skin warm to touch with some tenderness. No drainage. Treated with Keflex 250mg/5ml po qid x10days; erythema had spread the next day, patient was referred to emergency department
Awoke feeling exhausted, nauseas and dizzy. Exhaustion worsened and felt exertion breathing in and out. Legs felt week and had slight hoarseness that evening. 04/05/12: leg muscle pain getting worse. Coughing, still feeling dizzy and nauseas. 04/06/12 completely exhausted. Muscles aching in legs worse. Coughing and dizzy. 04/07/12 muscle aches and pain throughout body and legs. Coughing and still feeling exertion breathing in and out.  04/08/12 pain in legs gone. Coughing easing up. Slightly exhausted slight exertion when I breathe in and out. Nausea is gone.
I went blind to my left eye for about an hour. slurred speech, numbness and tingling to the left side of body, and then heaviness and weakness to the left side of my body.  The next day 08/22/2021 I was driving home and all of a sudden I had double vision. My bowels also became  inflamed  and swollen down to my anus. It was so swollen and painful that I could not dedicate or even wipe my anus. During that time I was nauseous, poor appetite, feeling of malaise, with abdominal pain 9 out of 10 on the pain scale; this pain continued until 09/10/2021. Last from 08/22/2021 until about 09/03/2021 I had periodic times where I loss feeling in my left leg and it would go out or become flaccid, this would only last 10 minutes or so. The only lingering symptom that I currently have is joint pain and foggy brain.I never had covid.
Information has been received from a pharmacist concerning a 65 year old female with hypothyroidism, penicillin allergy, tremors, gastrooesophageal reflux disease and hyperlipidaemia who on 03-OCT-2007 was vaccinated with a dose of PNEUMOVAX 23. Concomitant therapy included NEXIUM, ELAVIL, XOPENEX, LEVAQUIN, SYNTHROID and simvastatin (MSD). On approximately 04-OCT-2007 the patient had extreme pain in the arm at the injection site. The injection site was tender and red. The patient had a 3 inch by 1 inch area that was red. The patient was unable to move her arm. The patient was given TYLENOL. That laboratory data revealed that the patient's eosinophils were elevated. The patient spoke with the pharmacist. At the time of the report the patient had not recovered. This is one of several reports received from the same source. Additional information has been requested.
Parent reported child had 102 fever and general aches beginning 12 hours after vaccines. Fever lasted about 24 hours.