chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My mother died after her 3rd Moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (My mother died after her 3rd Moderna) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.  Company comment: This spontaneous case concerns a unspecified age female gender, with no medical history, who experienced the unexpected fatal serious (medically significant) event of death, which occurred unspecified days after third dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a unspecified age female gender, with no medical history, who experienced the unexpected fatal serious (medically significant) event of death, which occurred unspecified days after third dose of mRNA-1273 vaccine. Death occurred on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
is there any long term affects reported like joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (is there any long term affects reported like joint pain) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (is there any long term affects reported like joint pain). At the time of the report, ARTHRALGIA (is there any long term affects reported like joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and Treatment medication was provided.
localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand dollar; localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand dollar; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA290939 (same reporter).  This case involves a 26 years old female patient who experienced localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand dollar (inflammation) and (vaccination site reaction), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ269AB/UJ255AB, expiry date: 30-Jun-2020 via unknown route in the left deltoid.  On an unknown date, the patient experienced a non-serious localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand dollar (inflammation) and (vaccination site reaction) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Doctor visit and date 15-Oct-2019.   (Other relevant tests included no lab data.)  Final diagnosis was localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand dollar.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for localized reaction on arm at injection site that were red, raised, warm, and about the size of a sand.
pt felt bad Friday 8MAY98 then 9MAY98 c/o dizziness & chest pain, T102;went to ER Saturday PM; CBC revealed dec WBC;CXR & EKG WNL;ER MD thought pt may have had a rxn to varicella vax;inc temp;devel fine red rash 11MAY98;
Localized swelling and pain (golf-ball sized per pt). Sensation of swollen throat and neck and headaches. Given Benadryl and Naprosyn.
8/19/2008 - Patient was given the Small Pox Vaccine. 8/25/2008 - Patient comes in for injection site check and site where bandage was placed is red and inflammed.  8/28/2008 - Patient returns to clinic with multiple lesions covering the inflammed area.
24 hours after vaccine patient developed pain  and swelling at vaccine site that peaked at 24 hours later (9/30/21) and then began to subside;  has myalgias that were short lived but no fever.   On exam, there is still redness, tenderess and alloydynia in a 6 X 5 cm area.  patient is otherwise afebrile and well appearing.
After my second dose, this problem intensified to the point I cannot stand to be within certain smells. Coffee, meat, onions, white wine, soda, and all fried food are just some examples; I am impaired to the point I can't eat some meals with my family.; After my second dose, this problem intensified to the point I cannot stand to be within certain smells. Coffee, meat, onions, white wine, soda, and all fried food are just some examples; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: EN6207) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing), notes: hypertension, depression, autoimmune disease, allergies; "depression" (unspecified if ongoing); "autoimmune disease" (unspecified if ongoing); "allergies" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Covid prior vaccination. Concomitant medication(s) included: OGESTREL-28; VENLAFAXINE; HYDROXYCHLOROQUINE. Vaccination history included: Bnt162b2 (Dose Number: 1, Prev dose brand unknown: False, Prev dose Lot number: EL9266, Pev dose lot number: False, Prev dose vaccine location: Right arm), administration date: 26Feb2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "After my first dose, I started having altered smell and taste.", "After my first dose, I started having altered smell and taste.". The following information was reported: PAROSMIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "After my second dose, this problem intensified to the point I cannot stand to be within certain smells. Coffee, meat, onions, white wine, soda, and all fried food are just some examples"; EATING DISORDER (non-serious) with onset Mar2021, outcome "not recovered", described as "I am impaired to the point I can't eat some meals with my family.". Therapeutic measures were taken as a result of parosmia, eating disorder, condition aggravated.  Additional information: Reported seriousness was non-serious. Patient had no Known allergies. Patient did not received other vaccine in four weeks. The patient received Ae treatment with Prednisone/Atarax. The patient not been tested for COVID-19 since the vaccination. Patient received other medication within 2 weeks of vaccination included los.  Follow-up attempts are completed. No further information is expected.
The person administering the vaccine to me did not draw up the vaccine into the syringe before giving me the shot. They then drew the vaccine into a new syringe and gave me the shot. I was then given a flu shot in the same arm. It is very sore. I am not sure if it it due to the empty shot or not but wanted to report it as I could not find much information on the effects of a shot of ?air?.
shortness of breath; This is a spontaneous report from a contactable Consumer(patient).A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration in right arm on 26Feb2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. on 26Feb2021, after receiving vaccine dose in the evening patient experience shortness of breath and then again the next day and it has been off and on since then. It was reported that She spoke with her MD who told her to get the second dose but she wants to know but she wants to know what Pfizer's guidance would be. She states she might not take the second dose of the vaccine. The second dose of vaccination was scheduled for next Tues (11 days after first dose). The outcome of the event was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The injection site was warm, swollen and itchy. The swelling had gone down after 24 hours. Pt was instructed to take Benadryl for itching. Allergic reaction to Flu vaccine only.
I have arm pain. My brother who lives in (city withheld) experience the same pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "I have arm pain. My brother who lives in (city withheld) experience the same pain".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200721571 different patient, same drug and event.
After ZOSTAVAX vaccination, patient felt dizzy, became unresponsive, was breathing on her own, we lowered her to the floor, raised her legs and she regained consciousness, felt better and afterwards. EMTs came took her vitals, vitals good. She declined further treatment.
Within a few days of getting the vaccine, I had a herpes outbreak which was much worse compared to my first outbreak. The one I got after the vaccine, I thought I was dying and it was way more painful and awful. I can't remember how many times outbreaks have happened since the vaccine, but maybe I've had about 5, with two back to back a few months ago. Valtrex has been handling it but it's been depressing to know that my body has been handling this well and now it's so much worse now. It's bad how much my immune system has changed. Recently, I had a mild cold, then a sinus infection, then the flu, then bronchitis, and pneumonia. I did go to the ER on 11/25/2022 for the pneumonia. I'm just concerned with how little my immune system can handle compared to prior to the vaccine.  With my menstrual cycle, my periods were super regular and after the vaccine, I didn't get it for 9 months. I even took pregnancy tests and they were all negative. When my period did finally return, it was pretty bad. The second period I had was really awful to where I woke up sweating and I was in extreme pain. My whole abdomen was convulsing. It was so bad that I lost my vision and hearing for 15 minutes and laid on the floor and threw up. I've never had anything like that happen in my life. Since then, my periods have gotten back on track but those first two periods were astounding. I also did have shingles for the first time in March 2022. I initially thought it was a bug bite or something but it was only a feeling in my leg and it was odd. It looked like I had a really weird rash localized to one leg. I finally went to the doctor and he said it was unusual for shingles to last that long because it had lasted for a month. I felt low grade sickness and my leg always felt unusual. I always felt tired and it was a weird feeling to describe. My doctors basically said that it was weird for it to be here for that long, but taking Valtrex resolved it and confirmed that it was shingles. I've also had a huge increase in migraine auras. Auras would appear very rarely, but now my vision in general is much more sensitive to light and I can't see anything. Auras tend to appear more frequently now. I haven't gotten any headaches with the auras but not being able to see has been inconvenient.
fever of 102.6, referral to ER; diarrhea, referral to ER; This case was reported by a other health professional via sales rep and described the occurrence of fever in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 2N2AB, expiry date 10th February 2023) for prophylaxis.   On 28th October 2021 10:45, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever and diarrhea. On an unknown date, the outcome of the fever and diarrhea were unknown.   It was unknown if the reporter considered the fever and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient experienced fever of 102.6 and diarrhea that required treatment and referral to emergency room. The reporter consented to follow up.
pt recv vax & 15min post vax c/o tingling pain @ the inj site, & nausea;became light-headed & felt as if would pass out when stoop up;eventually vomited;because was hypoventilating;seen in ER tx w/IV solu-Medrol;
Mild COVID Disease on 21JUN2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Mild COVID Disease on 21JUN2022) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2022, the patient experienced COVID-19 (Mild COVID Disease on 21JUN2022). At the time of the report, COVID-19 (Mild COVID Disease on 21JUN2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. It was reported that the patient PCP refused to see them because they had symptoms. Patient went to the urgent care.  No treatment medications were reported.  Company comment: This spontaneous case concerns an 86 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19 , about 9 months and 21 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series of doses with the same vaccine in accordance with the recommended schedule. She received the third dose about 6 months and 15 days after the second dose. The patient's COVID-19 PCR test was positive. No further information on risk factors, co morbidities, clinical course, treatment details and outcome of the event was available in the report. The COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an 86 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19 , about 9 months and 21 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series of doses with the same vaccine in accordance with the recommended schedule. She received the third dose about 6 months and 15 days after the second dose. The patient's COVID-19 PCR test was positive. No further information on risk factors, co morbidities, clinical course, treatment details and outcome of the event was available in the report. The COVID 19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a pharmacist referring to a 71 year old female patient, with unknown medical history, concurrent conditions and drug reactions/allergies. On 30-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous, for prophylaxis (the dose, frequency, lot number and expiration date were not reported). On 01-DEC-2016, the patient developed "a large lump" at the injection site following the administration of ZOSTAVAX. It was also reported that the patient stated she was having heart palpitations and her throat feels tight after vaccination. It was reported that none lab diagnostics studies performed, none intervention to prevent serious criteria, there was none significant disability or incapacity, no hospitalization and no life threatening. The patient sough medical attention contacting the pharmacist. No treatment was given for the adverse events. The outcome of injection site mass, throat tightness and palpitations was reported as not resolved. The relationship between injection site mass, throat tightness and palpitations and ZOSTAVAX was not reported. There was no Product Quality Complain (PQC). Additional information has been requested.
Sudden onset of intense fatigue, after having only mild arm soreness at injection site, followed by fever (max. 102 degrees) and chills with headache. Took acetametaphine for fever and headache, bed-rest for several hours. Some improvement after approximately 5 hours. Back to "normal" by next day, although still mildly fatigued.
Extreme left at injection site; by 5:00 PM, could not lift my arm; getting out of my jeans/bra/jersey took me almost 30 min. due to inability to move L arm. Pain came and went but by 11PM. it seemed worse; woke up 3x w/Muscle cramps in my left leg; slept about 3hrs. +/-.
Horrible nerve pain - one minute fine and than unable to walk - felt like a groin pull but after a massage I realized it was nerve pain from my legs up to my rib cage that was the first one Today 4/10 I was fine I swam and walked and than around 6:30 pm I had difficulty walking this time it was like a groin pull but in both legs , it doesn't seem to be radiating at this time
30 minutes after injection, hives developed at injection site. Developed flushing and hives across chest, throat closing, wheezing. Pt is being worked up for possible carcinoma due to ongoing, repeated espiodes of the anaphylactic reaction.\ Medical records state urticaria, dyspnea. msv
10 days post vax the pt experienced nausea and vomiting with low grade fever. the following day the pt developed five non-vesicular lesions on her arm with low grade fever and nausea. It was noted that the lesions did not become vesicular.
a rash on my abdomen and it's really itchy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: ER8727) as dose 2, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot Number: unknown) as dose 1, single for Covid-19 immunisation. The patient received the second Pfizer COVID-19 vaccine on Wednesday and have gradually gotten a rash on the abdomen in Mar2021 and it's really itchy and it is about the size of the thumb. The patient was wondering if it was related or what the patient should do. The outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
after / first dose / took 24 hours / rapid heartbeat and called paramedics; This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included premature ventricular contractions (has metoprolol for PVC.) and heartbeats increased (has metoprolol for slight rapid heartbeat.).   On an unknown date, the patient received the 1st dose of Shingrix (intraparietal). On an unknown date, 24 hrs after receiving Shingrix, the patient experienced heartbeats increased. On an unknown date, the outcome of the heartbeats increased was unknown.   It was unknown if the reporter considered the heartbeats increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient herself. After receiving 1st dose of Shingrix, the patient experienced rapid heartbeat and called paramedics. The reporter did not consent to follow-up. This case has been linked with US2020190519, reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020190519:same patient
Office would draw up all COVID booster vaccines at the beginning of the day and discard vial. They kept a sticky note with bivalent  NDC, lot and expiration date and used that data to enter into the medical record. At some point the realized that on some days they had pulled and administered monovalent instead of the bivalent booster as intended. Office is unable to say with certainty who received monovalent or bivalent.
Left side of face became numb, almost like a Bell's Palsy, or like having a novocaine shot at the dentist's office.  I was however able to close my eyes properly, wiggle eyebrows, blink, mouth was not drooped.
Patient received an expired dose of PEDIARIX; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 10th August 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Health care professional reported that the patient received Pediarix which was expired on 14th June 2021, which led to expired vaccine used. No further events were reported at the time of the call. The reporter stated that in case he needed follow-up would call back.
The shot was given deeply in the left arm in the middle of the deltoid muscle. At the time of the injection, the shot felt deep and painful. I said, "ouch, that hurt." Following the vaccine, my left arm muscle has been sore for an extended period of time. I am unable to raise my arm, put on my coat, wear my purse, lift my child, etc. without sore pain in my left arm. This has been going on since the date of the vaccine on March 28th.