chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Dose administered 5 days after the 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 5 days after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-2023 at 6:40 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Apr-2023 at 6:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 5 days after the 30 day BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered 5 days after the 30 day BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered 5 days after the 30 day BUD).    No concomitant medications were reported.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No reported symptoms. No additional doses, medications, or treatments was given.
Pt has gastroesophageal reflux and seem to have problems that started shortly after hep B vaccine. That was when he started having some observed apnea bit also he had moderate reflux that was discovered. He has had some metabolic studies that have had some mild abnormalities, although recent carnitine studies have all come back okay. He seems to be doing good while on the monitor. He is also on Prilosec 1.25 cc bic. He seem to be developing and growing well otherwise.
This was a vaccine error. The nurse reconstituted yellow fever with sterile water instead of sodium chloride. According to CDC and Sanofi Pasteur there are no side effects. The vaccine is now ineffective. Patient notified and aware.
RING OF BUMPS ON BOTH ELBOWS; PAIN IN ARM AFTER COVID-19 VACCINE; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (RING OF BUMPS ON BOTH ELBOWS), VACCINATION SITE PAIN (PAIN IN ARM AFTER COVID-19 VACCINE) and FATIGUE (FATIGUE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced SKIN DISORDER (RING OF BUMPS ON BOTH ELBOWS), VACCINATION SITE PAIN (PAIN IN ARM AFTER COVID-19 VACCINE) and FATIGUE (FATIGUE). At the time of the report, SKIN DISORDER (RING OF BUMPS ON BOTH ELBOWS), VACCINATION SITE PAIN (PAIN IN ARM AFTER COVID-19 VACCINE) and FATIGUE (FATIGUE) had resolved.            It was unknown if the patient was enrolled in COVID-19 vaccine trials.  No concomitant product reported by reporter. No treatment medication reported by reporter.  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.
Cried, high pitched screeching on & off x 3 hrs, then non stop 3hrs;
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient experienced fainting for 2-3 seconds followed by 10 minutes of nausea/vomiting/flushing. Patient returned to baseline
After 12 hours of getting the shot, I woke myself and my partner up from shaking so bad. I took some Benadryl to call the Nausea but I vomited everything in my stomach up by 1AM. I cannot sleep because of the fever (100.5 F) and I cannot eat anything without being sick
A warm circular tender area about 3in x 2in in dimension on right lateral side of thigh.
Mild swelling in lips; Mild swelling in cheeks; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Mild swelling in lips) and SWELLING FACE (Mild swelling in cheeks) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Lip cosmetic procedure (patient was injected with 1 ml of volume 0.6 volbella in the lip) on 30-Oct-2020 and Dermal filler injection (patient was injected with 1 ml of volume 0.5 per side in the cheek) on 30-Oct-2020.    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 LIP SWELLING (Mild swelling in lips) and SWELLING FACE (Mild swelling in cheeks). At the time of the report, LIP SWELLING (Mild swelling in lips) and SWELLING FACE (Mild swelling in cheeks) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
This case was reported by a physician and described the occurrence of fever in a 38-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Relevant medical history included history of hepatitis b, hepatitis b carrier. On 9 June 2013 the subject received a dose of HAVRIX (1 ml, unknown route, left arm). In June 2013, less than one week after vaccination with HAVRIX, the subject presented to the physician having experienced fever, joint pain, joint swelling, rash, flu like symptoms and walking difficulty. At the time of reporting the events were unknown. The physician reported another case with HAVRIX. See case A1031781A for details on the other case.
[Produc] Pfizer vaccine use for COVID-19 under Emergency Use Authorization (EUA): 53-year-old gentleman with a BMI of 37.9, diabetes mellitus type 2 A1c 8.0 who recently received his second dose of the Pfizer vaccine on Sunday, 9/12/2021 and subsequently developed SIRS-like symptoms with fevers, chills, diaphoresis and overall generalized fatigue
Arm warm to the touch; Feels like the muscle has hardened; A hard, red lump that is 10 cm in diameter out from the injection site; Itchy arm; Swollen arm; Red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE SWELLING (Swollen arm) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A/011T20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm). At the time of the report, VACCINATION SITE WARMTH (Arm warm to the touch), MUSCLE DISCOMFORT (Feels like the muscle has hardened), VACCINATION SITE INDURATION (A hard, red lump that is 10 cm in diameter out from the injection site), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included an ice pack.  Based on the current available information and temporal association between the use of the product and the start dates of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events a causal relationship cannot be excluded.
patient had tonic movements in the arms, adminstered an EPI pen due to reports of patient not breathing, but observed patient having labored breathing. Patient refused to go to hospital after EMS arrived. Patient threw up after we elevated legs, and patient described having strange dreams. blood pressure was normal, ems also reported normal vital signs
red, swollen upper arm, fever, headache, myalgia onset 24 hours after vaccine, started improving 96 hourse after vaccine
Throat swelled within 25 minutes of injection. Gagging, coughing, swollen throat. Felt like throat closing down and chocking on fur ball. Returned to nurses station. Checked by nurse, doctor and paramedics called. Gave Benadryl liquid. Paramedics recorded blood pressure 143/110, inserted IV for medications to treat choking. Taken to nearby ER facility and treated with additional Benadryl and Prednisone. Patient held for observation for approximate 2 hours, while vitals monitored and chocking ceased.   Later in the evening, patient experienced gums bleeding. Rinsed with salt water and brushing.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In June 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in July 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
About 10 mins after administration patient complained of feeling sweating, clammy and nausea. No visible hives. Per protocol diphenhydramine liquid was administer. Pt vomited and started to complain of difficulty breathing. 911 was called when pt vomited. Pt laid on floor and an epi pen was administered upon protocol. EMS arrived within 5 mins and took pt to hospital. Physician was contacted per protocol.
Adacel was administered since the excursion with no reported adverse event; Initial information received on 22-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2022SA303430(CLUSTER).  This case involves a 13 years old male patient and it reported a medication error (there was range from 31.7 to 52.4 Fahrenheit (F) for 300 hours due to a refrigerator malfunction and Adacel was administered since the excursion with no reported adverse event),  for the  vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA). It was reported that there was a condition from 05-Apr-2022 to 15-Jul-2022 and the range was from 31.7 to 52.4 Fahrenheit (F) for 300 hours due to a refrigerator malfunction (not human error) On 20-Jul-2022, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE, ( lot: U6923AA ; expiry date: 21-Jan-2023) via intramuscular route in the right deltoid for immunization.  It was reported that Adacel was administered since the excursion with no reported adverse event (poor quality product administered) (onset date: 20-Jul-2022; latency: same day)  Action taken : not applicable.  Outcome: unknown    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Pt said the bruising around the immunizing area (of the size of a golf ball). Staff at Dr was informed.
10 min after receiving vaccine had symptoms - Tachycardic, BP elevated, chest tightness, flushing, mouth felt weird.  Tongue felt strange but doesn't think it was swollen and then developed throat tightness.  Immediately given 50mg PO benadryl and symptoms improved over 20 min.   90% improved at 60 min.
8/27/02  vaccination. Day later 1st notice seizure lasting 3-4 seconds. Parent has completed all vaccination on child. Last vaccination 6/24/02 and still had seizure after vaccination. EEG result focal seizure/developmental delay.
Initial report received from a consumer (the patient) on 18 February 2014: A 70-year-old male patient, with a history of hypertension and concomitant medications were not reported, had received a dose of FLUZONE HD, (batch number and dose number not reported) intramuscularly in left deltoid on 03 December 2013. The patient denied any illness at the time of vaccination and the patient had received a flu shot 3 years ago (details not reported). On 08 December 2013, 5 days after vaccination, the patient developed fever 102, sore throat, cough, stiffness of the left jaw and left neck area. The patient self-treated with ice packs and ASA. The patient was evaluated by his physician and dentist. Results were negative for any ear/sinus and dental problems was referred to TMJ specialist for evaluation. No tests were conducted per reporter. The TMJ specialist prescribed physical therapy which he had 11 sessions. At the time of this report, the outcome was unknown. Documents held by sender: none.
slight rise of temperature after the first dose; This is a spontaneous report from a contactable consumer or other non healthcare professional..A 85-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration on 29Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced slight rise of temperature after the first dose on 2021. The patient underwent lab tests and procedures which included slight rise of body temperature. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
still got the flu; Initial information received on 18-Dec-2022 regarding an unsolicited valid non-serious social media case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age male patient who still got the flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, route: unknown) (lot number and expiry date: not reported) in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event of still got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, not today, husband was vaccinated. It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu).  At time of reporting, the outcome was Unknown for the event still got the flu.
Massive headache. Body aches. 102 fever. Hurt to walk. Touching skin pain. Very tired..  slept 18 hours.  4/2/21 . 4/3/21 still had previous symptoms but not as severe.  Note: had covid in October 2020. Hospitalized 4 days only. Still feel certain effects of that.
About one month after receiving my last dose of the Moderna vaccine, I developed a rash on my neck/chest. I went to an Urgent Care facility and was diagnosed with Herpes Zooster, (shingles). I saw Dr. one week after for a second diagnosis and was advised to report my shingles to the CDC in case there is some connection. Dr. gave me a bottle of antibiotics and I am on the mend.
One week post vaccine's pt developed a high fever between 103 -104.3 for 3 days. Fever resolved by noon, Sunday 2/25. Visited doctor and ER (per doctor's request) for fever. No vomiting or diarrhea, pt treated with tylenol and motrin.
Case number PHEH2014US014407 is an initial spontaneous report received from a pharmacist on 16 Jul 2014 with a follow up report received from the pharmacist on 02 Sep 2014. This report refers to a 45 year old female patient. Her medical history and concomitant medication were not reported. Her vaccination history included vaccination with MENVEO (batch number: not reported) in the past which was well tolerated on unknown date. On 15 Jul 2014 at 04:00 pm, she was vaccinated with the liquid component (MenCWY) of MENVEO (batch number: 12104) without being reconstituted with the powder component (Men A) via intramuscular route. Following this error, she was revaccinated with a complete dose of MENVEO (batch number: not reported) on 17 Jul 2014. No adverse event was reported following this administration error (inappropriate preparation of medication).
Facial welts coming and going all day. One hive appeared on injection site which was a long lasting hard, purple lump for the last two weeks. Benadryl given.
Fever 101.9  Achy body soreness at injection site and soreness under same arm
This spontaneous report was received from a nurse and refers to a two unspecified patients of unknown age and gender. The patients' pertinent medical histories, concomitant medications and drug reactions or allergies were not reported. On 07-JUN-2017, the patients were administered improperly stored doses (reported as "two") of PROQUAD (albumin status: recombinant human albumin, rHA) injection (lot # M023932 with expiration date at 09-NOV-2017 and lot # M039447 with expiration date at 20-MAR-2018; for prophylaxis; doses, routes of administration and anatomical locations were not reported), reconstituted with sterile diluent (STERILE DILUENT) (lot # K013708 with expiration date at 13-JUN-2017; strength and dose were not reported). On an unknown dates, the administered doses of vaccine were exposed to a temperature from -14 degrees Celsius (C) to -10 degrees Celsius (C) for 7 hours and 54 minutes and from -9 degrees Celsius (C) to 8 degrees Celsius (C) for 1 hour. There was no previous temperature excursion. Data logger was used to track the temperature. No adverse reactions were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site; Rash around and under the injection site; Rash is slightly itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site), VACCINATION SITE RASH (Rash around and under the injection site) and RASH PRURITIC (Rash is slightly itchy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 VACCINATION SITE MASS (On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site), VACCINATION SITE RASH (Rash around and under the injection site) and RASH PRURITIC (Rash is slightly itchy). At the time of the report, VACCINATION SITE MASS (On 8th day after receiving the vaccination, patient noticed a pecan size lump under the injection site), VACCINATION SITE RASH (Rash around and under the injection site) and RASH PRURITIC (Rash is slightly itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient agreed to follow-up with safety
About  30 seconds after administering  patient's booster shot, she started complaining of  a squeezing feeling in her chest and then started calling it chest pain.  Called 911 and patient's husband came into immunization room. 911 Operator wanted pt to take an 325mg Aspirin while ambulance in root. Pt did not report arm pain, no sweats, or other symptoms of heart attack. BP by paramedics was 142/94.  Pt was taken to hospital across the street to be checked out. Follow up call to husband at 8pm, he reported that EKG in ambulance appeared to be normal per paramedics. Pt and husband got tired of waiting in hospital ER and checked her out after wasn't seen 'quick enough' and was 'feeling better' and chest pain went away. Said they'll follow up with her MD next morning.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Medium, Additional Details: After getting the shot in the 15 minutes of monitoring patient started to feel dizzy. Nurses from the minuteclinic monitored vitals and initial vitals were blood pressure 80/50 heart rate 48. After 5 minutes the vitals rose to blood pressure 92/60 and heart rate 72. Patient and parents said they were fine and no issues and were comfortable leaving.