chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost 18 hours after the injection, my arm was painful, I began to run a fever above 102 degrees, I was so achey, I had to get help to get off the commode.  It hurt to roll over in bed.  I lost my taste and smell. It lasted approximately 24 hours.  I had Covid in June, 2020 and had all of the exact symptoms, 100 times worse than when I had Covid.  9 days later, I had fever above 102 again, chills, shaking for approximately 6 hours again.  Is this a normal reaction?
vaccine administered to 17 year old; A spontaneous report was received from a nurse concerning a 17-year- old male patient, resulted in the event of inappropriate age of dose of administration.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 012L20A) on 20 Jan 2021, in left arm for the prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient received vaccine who was under the age of 18 years old.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, resulted in the event of inappropriate age of dose of administration, was considered resolved.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 012L20A) with no associated AEs reported.
Beginning around 10:00 a.m. (about 18 hours after injection) my joints became very sore and I had a severe headache.  I was tired and nauseous.  As the day progressed the symptoms became more severe until they peaked around 5:00  that afternoon.  I continued to have body aches and headache for another 8 hours but they lessened as time passed.  My left arm continued to be sore for four days after the injection.
COVID arm; Could not move her arm; Urine infection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) and URINARY TRACT INFECTION (Urine infection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 027B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, 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 experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) and URINARY TRACT INFECTION (Urine infection). At the time of the report, VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) had not resolved and URINARY TRACT INFECTION (Urine infection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient reported taking both doses of vaccine. Patient went for for a urine infection prior to second dose. she had no insurance so did not go to the doctor at the time. The patient still had COVID arm and can't raise hand over head  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-273598 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Client experienced a panic attack after receiving vaccine, EMS assessed vitals and everything was normal, she laid down and was observed, cleared to leave by EMS
Received the 1st dose of the Moderna vaccine on the beginning of March, tested positive for Covid-19 on 10Mar2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Received the 1st dose of the Moderna vaccine on the beginning of March, tested positive for Covid-19 on 10Mar2021) 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 10-Mar-2021, the patient experienced COVID-19 (Received the 1st dose of the Moderna vaccine on the beginning of March, tested positive for Covid-19 on 10Mar2021). At the time of the report, COVID-19 (Received the 1st dose of the Moderna vaccine on the beginning of March, tested positive for Covid-19 on 10Mar2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  No treatment medication included.  The patient tested covid-19 negative on 29th march 2021and is due for 2nd dose on 31st march 2021.
Patient immediately felt I'll.  Over the next few days he fell a few times and was hypotensive and taken to hospital.  He was diagnosed with COVID 19 and placed in ICU. His kidneys and heart were shutting down and on the 15th, 3 days after the shot, he was placed on hospice.  He died the 19th.
Adacel was administered on 11Apr2019 and expired on 05Apr2019; Initial information received on 17-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist by phone.  This case involves 36-years old male patient who was vaccinated with 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U5626AA and expiry date: 05-Apr-2019) in the left arm on 11-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to expired vaccine used.  It was unknown if any adverse event occurred or not following the vaccination.  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 the sender: none.
Patient received vaccination 5:25pm for second dose of Pfizer vaccine. Patient stated that after the 1st  dose she had a fibromyalgia breakout with tingling in the hands, headache. Patient stated that about 15 minutes she had the injection she started to have some the same symptoms, slight tingling in the hands, light sensitivity. Had patient wait until 5:55pm. Patient stated that symptoms weren't really worsening or improving, denied dizziness and shortness of breath/itchiness. Patient stated that she would like to go home and she how she feels because it was starting to feel like a fibromyalgia breakout, advised patient to contact PCP if symptoms worsen or go to emergency room if she experiences severe dizziness or shortness of breath. Will follow-up with patient tomorrow to check on them.
Patient received vaccine on 2/04/21. She said that it became red and swollen but it went down. She called 2/13/21 because the redness, swelling, and pain came back and she has a fever of 101. She was advised to go to urgent care. I advised her to use ibuprofen for the pain/swelling and use an ice pack for 15 minutes on and off.
stiffness in her neck; Red Circle; Itchy; bright red, round splotch from injection site almost down to elbow; splotch area that was dry and itchy; Swollen Lymph Nodes; Sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness in her neck), ERYTHEMA (Red Circle), VACCINATION SITE ERYTHEMA (bright red, round splotch from injection site almost down to elbow), PRURITUS (Itchy) and VACCINATION SITE PRURITUS (splotch area that was dry and itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Palpitations on 30-Dec-2020, Gastroesophageal reflux (reflux started before the vaccine), Throat pain on 25-Jan-2021 and Swallowing difficult on 25-Jan-2021. Concurrent medical conditions included Oral lichen planus (autoimmune disorder Oral lichen planus), Osteoporosis, Fragrance sensitivity (Diesel, smoke and fragrance smell cause an asthma like attack), Dust allergy and Bundle branch block left (bundle branch blockage on her left side) since 18-Nov-2020. Concomitant products included OMEPRAZOLE, ALUMINIUM HYDROXIDE, MAGNESIUM CARBONATE (GAVISCON [ALUMINIUM HYDROXIDE;MAGNESIUM CARBONATE]) and LOSARTAN for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in her neck), ERYTHEMA (Red Circle), VACCINATION SITE ERYTHEMA (bright red, round splotch from injection site almost down to elbow), PRURITUS (Itchy), VACCINATION SITE PRURITUS (splotch area that was dry and itchy), LYMPHADENOPATHY (Swollen Lymph Nodes) and VACCINATION SITE PAIN (Sore). The patient was treated with EUCALYPTUS GLOBULUS OIL, MENTHOL, PROPYLENE GLYCOL (ICE COOL GEL) at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and CORTISONE ongoing since an unknown date for Rash, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness in her neck), ERYTHEMA (Red Circle), VACCINATION SITE ERYTHEMA (bright red, round splotch from injection site almost down to elbow), PRURITUS (Itchy), VACCINATION SITE PRURITUS (splotch area that was dry and itchy), LYMPHADENOPATHY (Swollen Lymph Nodes) and VACCINATION SITE PAIN (Sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Electrocardiogram: inconclusive (Inconclusive) bundle branch blockage on her left side. On 11-Feb-2021, Endoscopy: inconclusive (Inconclusive) had an endoscopy.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was Reported CORTISONE LOTION.   This case was linked to MOD-2021-193777 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: No specific follow-up information recorded. On 07-Jul-2021: Non significant follow up
Expired vaccine used. A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse in the military concerning a 23-year-old male. Neither medical history nor concomitant medications were reported. On 12-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic and patient demographic data was received. Additional information was received on 12-May-2009: Product Complaint Investigation results.
Burned tongue; This is a spontaneous report from a contactable consumer (patient). A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER8730 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 26Mar2021 11:00 AM (Age at vaccination was 28 year) as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was reported as none. Concomitant medication included sertraline (in two weeks). The patient did not have known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since vaccination. The patient did not take any other vaccine in four weeks. On 01Apr2021 at 12:00 pm, the patient experienced burned tongue.Therapeutic measures were not taken. The outcome of event was recovered with sequelae.  No follow-up attempts is possible. No further information is expected.
Dizziness when laying prong and sits up; Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (Dizziness when laying prong and sits up) and DIZZINESS (Lightheaded) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced DIZZINESS POSTURAL (Dizziness when laying prong and sits up) and DIZZINESS (Lightheaded). At the time of the report, DIZZINESS POSTURAL (Dizziness when laying prong and sits up) and DIZZINESS (Lightheaded) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient started off with high fever and a sore arm. On the next day, the fever spiked to 101F. Pt went to see the doctor with a swelling arm. Doctor prescribed antibiotic LEVAQUIN 500mg for her. Since then she felt better and the fever went down.
Mother called us on 2/24/12 to report that patient has emesis x 3 hours -beginning within 1 hour of receiving IPV vaccine. Later in the day he developed low grade fever (100.4); and was 100.8 the following morning. He was completely fine within 24 hours of receiving the vaccine. No diarrhea.
Redness and slight swelling in the arm at the injection site 9 days after first dose.
IPV given 01/05/2004.  At 21:00, father came home and noticed child looked red.  Pt reports redness of checks, arms below elbows and upper chest.  Went to ER.  In ER temperature 100. ER note indicated blanched, erythematous macular rash on cheeks, chest and left forearm.  Thought to be related to IPV.  NO treatment in ER.  Motrin given and Benadryl later that night.
The patient states that the arm she got her pneumonia shot in is extremely red and swollen. She states that the swelling is spreading and moving around and under her arm.
Inconsolable crying/screaming from 7:30 pm on past 10:30 pm.  Parents attempted every conceivable method to calm child, none successful.  Child normally and regularly very calm and quiet.  DTaP vaccine administered about 2 pm same day.  Doctor/nurse only advised Tylenol if fever present.  Temperature of child was 98.1 degrees fahrenheit at 8:30 pm, so did not administer Tylenol.  Called nurse at 10:30 pm, was advised that Tylenol should have been administered to child before vaccine.  Within 10 minutes of giving child Tylenol, child was asleep and quiet.
Injury of left hand with steel staples and contaminated gloves, inflammation was next day on the wound; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Injury of left hand with steel staples and contaminated gloves, inflammation was next day on the wound) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced LIMB INJURY (Injury of left hand with steel staples and contaminated gloves, inflammation was next day on the wound). The patient was treated with CEPHALEXIN [CEFALEXIN] for Inflammation of wound, at a dose of 1 dosage form and LEVOFLOXACIN for Inflammation of wound, at a dose of 1 dosage form. At the time of the report, LIMB INJURY (Injury of left hand with steel staples and contaminated gloves, inflammation was next day on the wound) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment included T-dap vaccine Concomitant product information, if any, was not provided by the reporter.
Patient's Moderna Booster given at a 4 month interval instead of 5 month interval
Patient was to receive the Pfizer Bivalent and received the Monovalent instead. Patient is doing well, had no adverse events, no symptoms and did not need any medical attention.
Case number PHEH2013US014822 is an initial spontaneous report received from a physician on 10 Jul 2013, with a follow-up received on 30 Jul 2013: This report refers to an 11-year-old male patient. His medical history included cutis marmorata diagnosed in new born and had complete resolution. He was previously vaccinated with MENVEO (batch number: unknown) on an unspecified date and was well tolerated. He was further vaccinated with MENVEO (batch number: M12097, expiry date: 20 Aug 2014) at a dose of 0.5 ml intramuscularly in to right arm on 08 Jul 2013 (at 2.00 pm). On the same day after vaccination, he experienced pain and lack of mobility in the arm. On 09 Jul 2013, he had swelling and could not raise the right arm. Patient went to a comp on 09 Jul 2013 but the physician did not know what he did there. His mother placed ice on the arm. He consulted his physician on 10 Jul 2013. Seriousness and causality of the events were not reported. Following an internal review of the data received on 10 Jul 2013, it was observed that verbatim swelling of the arm was erroneously coded to swelling. Therefore, it was correctly captured as extensive swelling of vaccinated limb, in the case. Follow-up was received on 30 Jul 2013: Patient demographics, medical history, previous vaccination information, vaccination dose and site were updated.
VACCINE EXPOSURE VIA BREAST MILK; This spontaneous report received from a parent concerned an infant of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. Concomitant medications included ascorbic acid/biotin/minerals nos/nicotinic acid/retinol/tocopherol/vitamin b nos/vitamin d nos for drug used for unknown indication. On 02-SEP-2021, the patient experienced vaccine exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine exposure via breast milk was not reported. This report was non-serious.
still coughing; flu; Initial information received on 03-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves a patient of unknown age and gender who experienced still coughing and flu after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in Oct-2022, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, the patient was still coughing (cough) (latency: unknown) following the administration of influenza vaccine.  On 19-Oct-2022, the patient developed flu (influenza) (latency: unknown) following the administration of influenza vaccine.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event still coughing and was Unknown for the event flu.
Nauseous; Puke a little; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) and VOMITING (Puke a little) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced NAUSEA (Nauseous) and VOMITING (Puke a little). At the time of the report, NAUSEA (Nauseous) and VOMITING (Puke a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   Reporter did not allow further contact
No additional AE reported; HCP reported PROQUAD was administered after a temperature excursion to a patient.; This spontaneous report has been received from a registered nurse regarding a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/ allergies were not reported.  On 02-AUG-2022, measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD), subcutaneous injection (lot number: W007748, expiration date 04-SEP-2023; strength, dose, and route of administration were not reported) was administered to the patient once after a temperature excursion of -8.1 Celsius degree for 1 hour and 58 minutes (product storage error). There was no pervious temperature excursion. There was no additional adverse event (AE) reported, and no further information was provided.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA002433: US-009507513-2208USA002443: US-009507513-2208USA002737: US-009507513-2208USA003187:
pt recv vax 13SEP96 & 25SEP96 pt devel erythema multiforme & upper resp infect;pt was hosp;pt recovered from sx & was discharged;
MULTIPLE BILATERAL PULMONARY EMBOLI NONOCCLUSIVE RIGHT POPLITEAL DVT OCCLUSIVE RIGHT POSTERIOR TIBIAL VEIN AND RIGHT SMALL SAPHENEOUS VEIN THROMBOSIS  PATIENT BEGAN TO DEVELOP LEFT FLANK PAIN FOUR DAYS FOLLOWING VACCINATION FOLLOWED BY SEVERE SHORTNESS OF BREATH WITHIN THE FOLLOWING DAYS