chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Brain fog; This case was received via Regulatory Authority (Reference number: US-irms-MOD21-123715 ) on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog). At the time of the report, FEELING ABNORMAL (Brain fog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by reporter
swollen, tender, hot to the touch lymph node under left arm.  Painful moving arm, pushing things, lifting things.
On Saturday afternoon around 2pm had fever 102.0, body aches, felt arm and had "bruise", Right breast sore. By 7 PM felt weak.  On Sunday-Lymph node is swollen and breast. Went to the ER on Monday and given Motrin 800mg only.  On Tuesday-warm, hard lump on Right breast and swollen, seen by RN on Wednesday.
Syncopal episode post vaccine with report of "jaw pressure" , chest heaviness and throat irritation. Treated with Benadryl 25 mg PO and transported via EMS to emergency department.
Information has been received from a physician concerning a 28 year old female pt who on 03/14/2000 was vaccinated with one dose of varicella virus vaccine live. It was noted that the pt received the vaccine on the 14th day of her cycle, which is also the day she was determined to have become pregnant. LMP 02/29/2000; EDD 12/05/2000. Follow-up info reported that the pt had 2 previous pregnancies. The number of live births was not reported. It was noted that no birth defects or miscarriages had occurred in previous pregnancies. The pt did not have any local or systemic reaction to the varicella virus vaccine live. On 07/26/2000 a routine ultrasound was done which showed normal IUP. Maternal serum alpha-fetoprotein on 07/05/2000 was normal. Parvovirus on 11/10/2000 was negative (the pt was tested due to exposure). It was reported that the pt had a positive PPD test and that a chest x-ray was negative. On 05/08/2000, the pt was started on therapy with Macrobid 1 tablet po bid for the treatment of UTI. No other complications occurred during the pregnancy. On 11/14/2000, 37 weeks from the LMP, the pt gave birth to a healthy baby weighing 5lb. 13oz. There were no congential anomalies, complications or other abnormalities. Follow-up info indicated that the baby was positive for thalassemia minor and on 03/16/2001 a hemangioma was noted on the left foot over the 4th and 5th digits. No further info is available. This report is part of the pregnancy registry.
Shortly after receiving the vaccine (04/05/2021), I became very tired, but otherwise had no adverse reactions. I went to bed around 9 pm, and at around 3 am the next morning (04/06/2021), I woke up with severe chills, body aches, a pressure headache, and some mild nausea (I believe caused by the headache) that lasted through until early afternoon. Taking ibuprofen seemed to help the body and headaches, but it seemed like it was difficult to regulate my body temperature. I couldn't tell if I was too hot or too cold, and trying to remedy one or the other made me either too cold or too hot, respectively. All effects completely cleared up by 04/07/2021.
Information has been received from a registered nurse concerning a 40 month old boy without medical history and no allergy who on 23-JAN-2007 was vaccinated with VARIVAX (Merck) (Lot# 653971/0796F). There was no concomitant medication. On 20-SEP-2008 the patient experienced chickenpox, and developed 50-60 lesions all over his body. The patient was seen by the physician. There were no lab and diagnostics tests. At the time of reporting, the patient was recovering from the chickenpox. This is one of two cases reported. No further information is available.
Rash; Aching joints; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash) and ARTHRALGIA (Aching joints) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and ARTHRALGIA (Aching joints). At the time of the report, RASH (Rash) and ARTHRALGIA (Aching joints) was resolving.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered RASH (Rash) to be possibly related. No further causality assessment was provided for ARTHRALGIA (Aching joints).    No concomitant drug reported. No treatment information was provided by the reporter.  The causality for Humira injection for event Rash and for Aching joint was not related with action taken as unknown.
Severe diarrhea event followed by sweating, degradation of vision and fainting. Occurred at approximately 2 a.m. Slept on bathroom floor for indeterminate length of time. Woke up dripping sweat on the floor.
This spontaneous report was received from a healthcare worker during a phone call, concerning a coworker of the reporter, a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, when the patient was a child (unknown age) was vaccinated with (Merck) VARIVAX (Lot No. expiration date, dose, route and anatomical location were not reported). In approximately 2010, reported as "five years ago" the patient was exposed to a patient with active varicella. Despite being vaccinated with (Merck) VARIVAX, the patient developed varicella after this exposure (vaccination failure). The outcome of varicella and vaccination failure was unknown. The relatedness of (Merck) VARIVAX with the varicella and vaccination failure was not reported. This is one of three reports received from the same source. Additional information has been requested.
one of the clinics gave an underage girl the first Moderna dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the clinics gave an underage girl the first Moderna dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the clinics gave an underage girl the first Moderna dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the clinics gave an underage girl the first Moderna dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported
had symptoms like something caught in her throat; throwing up; diarrhea; severe allergic reaction; Feels like she has a cold; Runny Nose; A lot of Saliva and Mucous Coming up; A lot of Saliva and Mucous Coming up; Thinks she was panicking; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 12:50 (Batch/Lot Number: EP7533) as single dose for Covid-19 immunisation. Medical history included ongoing issues with stomach she has had for a long time, ongoing bad migraines she has had since she was about 14 years old, ongoing panic attacks she has had since 16 years old, ongoing anxiety she has had since 16 years old, ongoing acid reflux, she has had since she was almost 18 years old. The patient stated that they said she should get the vaccine because she has some medical stuff like issues with her stomach, bad migraines, panic attacks, anxiety, and acid reflux. There were no concomitant medications. There were no additional vaccines administered on same date of the suspect drug. On 07Apr2021, the patient got the Pfizer vaccine had symptoms like something caught in her throat and throwing up and diarrhea 1h after the vaccine. She panicked because she thought it was a severe allergic reaction. It's getting better and asking if its normal. She mentioned when discussing her panic attacks that she thought she was panicking when she got the vaccine but did not have a full panic attack. It was also reported that she got the Covid vaccine on 07Apr2021 at 1250, about an hour after she started throwing up.  She said she has a lot of saliva and mucous coming up and stated it feels like she has a cold. She said she has a runny nose and is spitting up mucous and also she had some diarrhea. She wanted to know if these symptoms are normal. The patient stated that her mom drove her to and from her vaccine and when she got home, she laid down and continues to do so. Symptoms began an hour after vaccine given on that day, difficulty verifying outcomes. Stated she has stopped vomiting for now. She did not say she has recovered from any mentioned symptoms. There were no relevant tests done. The outcome of the event of severe allergic reaction was recovering and other events was unknown.
Patient was in pharmacy several days after vaccination and informed us of her symptoms after being vaccinated. 1. chills for 24 hrs 2. headache the next day
The day after the shot I got an itching sensation in groin area and it looks like I developed psoriasis.
post herpetic neuralgia; pain in the dermatome; This case was reported by a physician via call center representative and described the occurrence of post herpetic neuralgia in a male patient who received Herpes zoster (Shingrix) (batch number GH455, expiry date 29th January 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th December 2019).   On 24th February 2020, the patient received the 2nd dose of Shingrix. On 24th February 2020, less than a day after receiving Shingrix, the patient experienced post herpetic neuralgia and nerve pain. On an unknown date, the outcome of the post herpetic neuralgia and nerve pain were not recovered/not resolved.   It was unknown if the reporter considered the post herpetic neuralgia and nerve pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced post herpetic neuralgia and pain in the dermatome after receiving the second dose of Shingrix. The reporter consented to follow up.
About 5 hours after I received my shot, I noticed a strange taste in my mouth...The next morning even after eating breakfast, brushing my teeth, within a few hours the taste returned...
pt devel cellulitis 2 days p/vax along w/redness, swelling & tenderness @ the site of inject; pt was seen by MD & was treated w/ATB:
Pt developed fever, vomiting and rash X 4 days and a rash appearing today. Pt has moderate injection of the oropharynx and scattered eruption on the cheeks and scattered rash with small blisters over the body, face and ears. Dx: chickenpox. Treat with Calamine lotion and Tylenol.
Red area on right arm, approximately 1.5-2" after receiving flu shot. Area warm to touch.
very sore arm for 3 days, a bit dizzy  2 hrs after shot, lasted about 5 mins, foggy brain for a few days
This spontaneous report was received fro a licensed practical nurse via a company representative concerning herself, a female patient of unknown age who has latex allergy. No concomitant conditions or medical history were reported. On 03-NOV-2015, when the nurse opened the vial of VAQTA to administer the vaccine to the patient, she started coughing and her throat started to close up. The nurse reported that she was still coughing and clearing her throat several hour later. No Product Quality Complaint (PQC) was involved. The outcome of throat tightness and cough was reported as not recovered. Additional information has been requested.
Felt extreme dizziness that would come and go throughout the day. Dizziness subsided considerably after 2 weeks, then returned back. Around June 9th, dizziness was profound while driving, vision went dark as in a downward motion from left to right, 2 times, about 10 seconds apart. Never lost consciousness.
Hospitalization: 10/12/2022 - 10/18/2022 Presentation to the ED: DIALYSIS PORT CLOGGED. NEEDING HEMODIALYSIS.  COVID + date: 10/13/22. Treatment: No indication for COVID therapy.  Discharge to: SNF.
Vaccine administered after excursion from prescribed storage conditions. Vaccine moved from ultra low freezer to freezer on 10/30/2021. Vaccine moved from freezer to refrigerator sometime between 11/23/21-11/26/21. Vaccine mixed and administered on 12/3/21. No adverse events noted. Manufacturer was contacted and does not have stability data to support this excursion from prescribed storage conditions.
cough, shortness of breath, chest pain, nausea/vomiting, diarrhea, difficulty breathing.  patient received mechanical ventilation intubation
received doses that were impacted by the voluntary recall; received doses that were impacted by the voluntary recall; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix from recalled batch, which led to recalled drug administered and drug dispensing error. No further details provided on the call. The specialist neglected to note potential event during call, and thus limited details were obtained and specialist neglected to ask whether safety had permission to follow up. This case was linked with case US2021AMR213387 and US2021212537 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR213387:same reporter US-GLAXOSMITHKLINE-US2021212537:same reporter
Vaccine administered at 4:30 pm on Jan 16, 2021:  Ate dinner at 6:00 pm and began experiencing the following symptoms: nausea with vomiting,  extreme tightness in chest area, front and back,  elevated blood pressure and heart rate.    Went to ER , was treated for nausea and pain.  Discharged at 1:40 am Jan 17, 2021.                                                                                                                                                                         ***Doctor would not confirm that symptoms were result of vaccination, but I wanted to report.
Information has been received from a pharmacist via a field representative referring to a female patient (unspecified age). On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (dose, dose #, lot # , route and application site were not reported). On an unknown date in October ("in the last week") the patient came into the pharmacy to report that she developed "a rash that was raised and red" at the injection site following administration of ZOSTAVAX. It was unknown if the patient received any treatment. The outcome of the event was unknown. The causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
About 24 hours after the vaccination, I started feeling tired and achy. A few hours later my throat became sore and I developed red splotches all over my face and neck.  The splotches were gone when I awoke the next day but I was sick for about 1 week with fatigue, muscles aches, sore throat, chills. On the 7th day, I awoke with a terrible headaches and had to stay in bed most of the day. On the 8th day, I finally felt better but there was redness on my arm where I received my shot.
The day of the event, two hours after vaccine applied, started feeling extremely drowsy and needed to leave work. Slept most of the night, woke for two hours and went back to sleep until morning time. Following morning started experiencing shortness of breath and tightness in my chest. It made it difficult to breathe. This occurred after I simply walked 10 feet away on a flat surface. Going up and down stairs took my breathe away. The following morning I was able to breathe normally until about midday. Then, shortness of breathe occurred again. Same issue occurred every day following and stayed in constant communication with my PCP. On Monday night, he suggested I go to the ER after describing my symptoms and feeling as if I was trying to breathe under water.
Scarlet fever; Hands were covered with plaques and had not improved much; This spontaneous case was reported by a consumer and describes the occurrence of SCARLET FEVER (Scarlet fever) and SKIN PLAQUE (Hands were covered with plaques and had not improved much) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    No Medical History information was reported.   In 2020, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCARLET FEVER (Scarlet fever) and SKIN PLAQUE (Hands were covered with plaques and had not improved much). In 2021, SCARLET FEVER (Scarlet fever) had resolved. At the time of the report, SKIN PLAQUE (Hands were covered with plaques and had not improved much) had not resolved.            No concomitant medication information was reported.  On unknown dates, the patient experienced hands were covered with plaques and had not improved much on skyrizi and scarlet fever. On 06 Apr 2021,the patient had scarlet fever.  No treatment medication was reported.  In 2021, the scarlet fever was resolved. On an unknown date, Scarlet fever was resolved.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  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.   This case was linked to MOD-2021-117685 (Patient Link).
G40.309 EPILEPSY, GENERALIZED IDIOPATHIC 4/21/2023 SEIZURE, UNSPECIFIED G40.909 EPILEPSY IN PREGNANCY, UNSPECIFIED TRIMESTER 3/27/2023 SEIZURE, UNSPECIFIED G40.309 EPILEPSY, GENERALIZED IDIOPATHIC 4/21/2023 ACUTE CHOLECYSTITIS G40.909 EPILEPSY IN PREGNANCY, UNSPECIFIED TRIMESTER 3/27/2023 ACUTE CHOLECYSTITIS
flu; Initial information received on 03-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu after receiving 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 developed flu (influenza) after receiving an unknown dose of suspect Influenza vaccine produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site with unknown form, strength, frequency, expiry date for influenza.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  Outcome: Unknown.
Fever (102.9); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever (102.9)) 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 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Fever (102.9)). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever (102.9)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Pyrexia: 100.3 f (High) high.         Concomitant medication not provided. . Action taken with mRNA-1273 in response to the event was not applicable.
developed severe skin eruptions causing extreme itchiness which was later diagnosed as Lichen Planus.
- Woke up the next morning (8/21) with tingling, pins and needles, and skin irritation sensations throughout entire body (hands, arms, legs, feet, back, head) - Tingling, pins and needles, and skin irritation/itchiness continued to persist throughout the next day - On 8/23, the sensations developed into more tingling, skin irritation, pins and needles, neuropathy (burning, shock sensations, stabbing pain, hot/cold sensation), nerve pain, joint pain, and muscle pain throughout entire body (both hands, both arms, both legs, back, neck, both feet, head). - Patient also developed tension headaches and head pressure - Patient also developed brain fog, light-headedness and vertigo - These symptoms have progressed and advanced throughout the past three months and are continuing to progress as time goes on. - Symptoms are on a constant 24/7 basis with no breaks or time in-between
Patient's arm got very red and warm to the touch within the first 24 hours. She had no physical symptoms at that time. Within the next 24 hours (total time of 48 hours) she began running a low grade fever and feeling achy. She went to an urgent care clinic to get checked out and they prescribed her a course of antibiotics (cephalexin) in case there was some sort of infection. I spoke to the patient at 72 hours and she reported that her fever was gone and she was feeling much better. Her left arm where she received the vaccine was still red, but no longer warm to the touch.