chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke up I had a difficult time breathing; big rash I had on my back, my chest; had reaction; my back was itching; there were like at least a 100 small red bumps covering my entire back migrating towards my spinal area; This is a spontaneous report from a contactable consumer or other non hcp. A 28-years-old female patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot Number: FD8448 expiry date was unknown) via an unspecified route of administration at deltoid muscle left on 14Aug2021 as a single for covid-19 immunisation. The patient medical history was not reported. Consumer stated no prior vaccinations. Medical Conditions or Concomitant medications: Consumer stated, "No. She means she do take an antidepressant (Further not clarified hence not captured) but She don't know if it even (incomplete sentence). Can she tell you the name?" (Further not clarified). Probed for side effects experienced: Consumer stated, "Well with her first shot, she had reaction so after 2 days she developed, she woke up she had a difficult time breathing and she back was itching so she reached back there and there were like at least 100 small red bumps covering her entire back migrating towards her spinal area and that lasted in for, that persisted for about 10 days. she went to the doctor to show her and everything and she told her to call you guys but she did not think that she would get any exemptions or anything, so she did not, she just went ahead and got the second vaccine, she went ahead and got the second vaccine and she did not have a rash the second time, for the second time was worse she ended up having this like pretty severe asthma attacks like her spO2 was at 73 percent. She had a very hard time breathing and it took like 15 days for her breathing to return to normal but she am still having to take albuterol and she know that was like from the vaccine itself other than that nothing, but she don't think that was necessarily safe for me to take it being she really had like such a severe reaction and with her breathing being so compromised but she did take like that was the second one so she already took her first and second she am just reporting her what happened and she don't see like she should be taking that again. No laboratory tests. Treatment: Consumer stated, "she took Albuterol. It was her inhaler, a rescue inhaler it was not one that she was like it was her nephew's, so she had to end up getting her own to help with her breathing. Outcome of the events was unknown.    Follow-Up (20Sep2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Current conditions and relevant medical history were not reported. On 04-OCT-2014 the patient was vaccinated with ZOSTAVAX (Subcutaneous injection; dose number, route, batch and lot # and expiration date not reported). Concomitant therapies were not reported. On an unspecified date in October 2014, after receiving the dose of ZOSTAVAX, the patient experienced "a little redness and soreness at the injection site. The patient sought medical attention by contacting the pharmacist. The outcome of the events was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Redness and swelling at injection site, noticed next morning. Patient described tingling and numbness down her arm and up neck. She was taken to local ED just over 24 hours after vaccination due to feeling of chest tightness and some wheezing, also had low grade fever of 100.4-100.6 F. Also, c/o sensitive feeling to eyelids.
First report on 10/6/11. Initially slight discomfort in right arm, then awakened by the pain twice during night. Worse 24 hours later, applied ice and took ibuprofen and Benadryl but not much relief. Reports intermittent shooting pains from shoulder to thumb, limited range of motion, painful to move arm. Has had previous influenza vaccines without any problem. Gradually worse by 48 hrs later. Observed redness 4 inches laterally at injeciton site low on the R deltoid along with some swelling. Attempted range of passive motion but met with complaints. Recommended call own provider for treatment. F/U phone call 10/12/11 she went to NP who prescribed antibiotic for infection and suggested referral to neurologist if continues. She states still having pains but able to go to work. Recommended see another provider for additonal meds to quiet nerve irritation but she declined.
My arm was swollen , Large welt  at the injection site. My hands were itching and swelling  Inside of my mouth was tingling  Hard to breathe  Bad Headache  12/23/2020 Benadryl- IV
> The day of / next day, I had what was expected as "normal" sore arm. The second day was worse, and I also had a lot of muscle pain in my chest/neck the next day. By the third day, I felt fine. > 8 days after vaccine, April 25th, 2021, I woke up with a sore arm again (injection arm); it felt the same as the day I had gotten the shot. > 10 days after vaccine, April 28th, 2021, I woke up and my face felt very puffy/swollen and I had a headache. I thought it was allergies/migraine and took some excedrine migraine but the brain fog got much worse and by lunch I had a fever (101.1). I also had an upset stomach; I was hungry, but everything bothered my stomach immensely. > Today, April 29th, 2021, the brain fog is still there, my arm is only a little sore. My fever is lower (99.3) and I was able to eat better but still with some intestinal discomfort.  I do not know if it is the vaccine, but because I felt find for several days and then my arm started hurting again, I thought it was maybe that my immune system took a while to react, so I thought I should report it. I found very little information online regarding delayed side effects, but I don't think anything else could be the cause, especially because of the sore arm.
mom states pt had shots aroud 150PM, noticed next 3 days baby slept alot, more than usual only woke up enough to eat called MD on 9JUN94 & explained aobut baby sleeping alot was instructed @ that time to bring pt in;
I have migraines. I also take a high enough dose of Seroquel that it can be dangerous for me to drink alcohol or take other medications with sedative side effects. I have attempted to drink alcohol while taking Seroquel at previous lower dosages, and it results in what I can best describe as having a strong migraine aura while drunk and high. A few hours after my COVID vaccine, I experienced this feeling. It was sustained and lasted the rest of the day. I left work and went home to stay with my mother. She is a retired RN, and monitored me during this event. I was able to sleep this off and returned to normal the next day.
Dizziness when I first received the vaccine. (Immediately) Runny and stuffy nose (Same Day) Really bad soar throat (Same Day) Dehydration (Same Day) Cough (Next Day 4/8/21) Sore left arm/unable to lift it (Same Day) Itchy where the injection was performed (Same Day) Sometimes I feel like it's hard to breathe but it's manageable (Started two days after 4/9/21) I start coughing right away.  I still feel like if I had a cold, still have a cough and soar throat.
Received vaccine on 10-16-15. Developed "cellulitis" (L) injection site extending to lower arm. Treated with KEFLEX PO.
fever, chills, severe headache, achey bones, freezing, foggy brain, nausea  almost 12 hours after shot, last symptom left 4 days after administration
Severe tremors, unable to walk. Taken to hospital, given antibiotics to treat UTI's - Backstrom. Hospitalized for 5 days, few days later same symptoms reoccurred. Second event resulted in 5 day stay again at hospital.
Pt reports dizziness with shaking. Pt reports shaking is baseline, but is worse at present. Pt reports she ate breakfast PTA. Pt assisted to stretcher from chair with x2 staff assist. Transported to med obs #1 with spouse at bedside. Pt placed in trendelenburg position. Given water per her request. Pt assisted to sitting position, but reports headache. Placed back in trendelenburg position with relief of headache. Orthostatic VS obtained. VSS. No s/s of distress noted. Escorted to exit via w/c with staff and spouse. VS at 0840: BP 151/82, HR 105, RR 17, O2 sat 94% on RA. VS at 0845: BP 124/82, HR 99, RR 17, O2 sat 96% on RA. VS at 0850: BP 127/77, HR 89, RR 18, O2 sat 96% on RA. VS lying: BP 126/79, HR 88, RR 17, O2 sat 98% on RA. VS sitting: BP 104/70, HR 104, RR 18, O2 sat 95% on RA. VS standing: BP 137/99, HR 99, RR 18, O2 sat 95% on RA.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (vaccine given 6 days post expiry) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 046C21A) for COVID-19 immunization. No medical history reported. On Dec 21, 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 12, 2021, patient administered expired product (vaccine given 6 days post expiry). On Nov 12, 2021, administered expired product (vaccine given 6 days post expiry) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-395985 (patient link).
Pt vaccinated with DTP developed induration, erythema, small puncta, no pus expressible; sterile/bacterial abscess secondary to immunization?
bad headache throughout the night; fever; chills; sweating; muscle ache; tightness of the chest (some pressure; not pain); and when I stand up, I feel winded; This is a spontaneous report from a female contactable consumer (patient). A 31-year-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Mar2021 as a 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the Pfizer BioNTech COVID-19 Vaccine second dose yesterday morning, 9Mar2021. Patient reported to have a bad headache throughout the night, fever, chills, & sweating. Patient woke up with no more fever but still has headaches, muscle ache, tightness of the chest (some pressure; not pain), and when I stand up, I feel winded on an unspecified date in 2021. The outcome of the events bad headache throughout the night, muscle ache was not recovered; chills, sweating, tightness of the chest (some pressure; not pain) and when I stand up, I feel winded was unknown, fever was recovered on an unspecified date in 2021.  No follow up attempts are possible. Information about lot or batch number cannot be obtained.
Headache, Myalgia, Fever, muscle spasms in leg Narrative:
This is in follow-up to report(s) previously submitted on 2/14/2007. Information has been received from a physician concerning a 16 year old female patient with on pertinent medical history or drug reactions/allergies, who on 10-NOV-2006 was vaccinated intramuscularly with the first dose of Gardasil (0.5 ml) (lot #653937/0637F). There was no concomitant medication. Subsequently, on an unspecified date, the patient experienced severe cramping after her last menstruation which she had never experienced before. Unspecified medical attention was sought. The physician stated that no further doses of Gardasil will be given until further information was received. At the time of this report, the patient was recovering. No further information is expected. This is one of several report(s) received from the same source.
Patient returned to pharmacy with more serious local injection site reaction, needing medical attention/antibiotics. I referred to PCP. Patient prescribed antibiotics.
Immediately experienced burning throughout upper arm. Subsided about 5 minutes. Soreness. 30 minutes after experienced hot, swelling, a knot, redness, and soreness. Caller has already notified health care provider.
Severe body aches muscle and joint.  Severe HA, Fever, Chills, hair loss
Fever, rash started the next day. Rash was five maculopapular, erythematous, confluent on trunk/neck, 4-5 papules on the forearm & hands (dorsum).
Pt was given a TRIPEDIA on his (Lt) arm on 9-22-09, patient called on 9/2509 state arm was red, swollen, rash in that area.
Pt was seen for annual physical 5/14/09 & found to be well on exam. No labs needed. ADACEL vaccine done. 3-4 days later some symptoms of vague fatigue and over 1 wk increased urination. Diagnosed with diabetes mellitus on 5/24/09.  7/1709 Hospital records received DOS 5/24/09 to 5/26/09. Assessment: Diabetes Mellitus w/o Complication Type I. Patient transferred from another facility for hyperglycemia and management of new-onset diabetes. Presents with 1 week of increased frequency of urination, polyuria, urinating hourly while awake. Nocturnal enuresis. Increased thirst, polydipsia. Fatigue, decreased energy, increased appetite. Weight loss. Trace pitting pedal edema.  ICD-9 Codes - 250.03, 250.00A
This spontaneous prospective pregnancy report as received from Registered Nurse refers to a 23 year old female patient with no drug reaction. The patient was no medical history. On 27-FEB-2013 the patient was vaccinated with VARIVAX (Merck), 05 ml/once, subcutaneous (Lot# J005869 and unspecified expiration date) and a dose of M-M-R II (Lot # H015833 and expiration date was on 24-AUG-2014). Concomitant medication included prenatal vitamins. The patient was seen in office today on 04-APR-2014, due to "a positive tuberculosis (TB) blood test". During the office visit, the nurse stated the patient "had a positive pregnancy test". The nurse stated the patient was 10 weeks pregnant. The patient became pregnant with LMP of 24-JAN-2014 and EDD of 31-OCT-2014. Initial exposure to VARIVAX (Merck) was at 5 week(s). The pregnancy outcome was outcome pending. The patient did not treat events. The outcome of events was unknown. Additional information has been requested.
first dose of Shingrix in 2019 and a second dose in 2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 529KK, expiry date 30-SEP-2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On 21-APR-2023, the patient received the 2nd dose of Shingrix. On 21-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Shingrix in 2019 and a second dose in 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 17-JUL-2023 A healthcare professional reported that a patient received a first dose of Shingrix in 2019 and a second dose in 2023. They provided limited information about the vaccine, patient and event. They did consent to follow up, leaving a phone number which was documented in the adverse event case. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.
Symptoms started as extreme sensation of cold or hot on the bottoms of my feet, 2 1/2 months later my symptoms changed primairly to cold & began to slowly migrate up my body.  It feels like a shroud or vapor of cold that moves all around my body (feet/legs/low back/Rhomboids/arms/lips), it can be 1 area of my body, multiple areas or all areas, it's ever changing, constant & never goes away.  The intensity varies & averages 5-8 in general (10 being freezing).  I've also experienced strange tastes/sensations in my mouth, 1st I had a constant taste of salt or metalic present with or without food/water intake, that's gone, now I have constant migratory tingling/itchiness on my tongue/back throat/mouth.
My left thigh went numb.  Like I had a few shots of novocaine in it. Its been numb for 2 days now. The nurse who gave me my shot told me I got Johnson and Johnson. Just found out today that I got Moderna apparently. Unless someone messed up.
I have a fever since last night at 10 PM about 101.4. The highest it?s been as 101.8. My bones and body ache very bad and I have severe chills and nausea. My headache is so severe that I?ve had to take migraine medication. I?m still not feeling better at 6 PM on Sunday. Burning up. It feels like I have a flu.
Body was aching, and injection site was sore for 5 days. He said he couldn't lift his arm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive rapid tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was treated with Paxlovid from 23Nov2022 to 28Nov2022 for Covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She has not been able to lift her arm up at all since she got the vaccine.  She has been to the doctor and is now scheduled to see an orthopedic surgery regarding this.  She says that she has had flu shots here in the past and been fine and it has always been very gentle.  She says that when the pharmacist was giving the vaccine, he just "jabbed" it in and when he did they both heard something crunch.  She doesn't know if she had an allergic reaction or if it was the way it was administered.  She is going to let us know what the doctor says.
Approximately 2 weeks post vax, the pt developed severe flu infection, intestinal and heart problems. The pt was hospitalized 3 times, been to ER, and seen 14 different doctors. The pt is still having intense pain and is unable to work. Upon review of this case on 07/07/00, it was determined that the COSTART coding of pain needed to be added to this report. Follow-up 05/03/02. During internal auditing of all files, it was deemed necessary to amend the report by coding additional A5x.
This spontaneous report was received from a registered nurse regarding to unspecified number of patients. Patient demographics, concurrent conditions,  medical history and drug allergies were not reported. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD lot # L033698, expiry date 28-FEB-2017 (dose number, dose and units were not specified). Concomitant medications were not reported. No adverse symptoms were reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
within 2 days developed R sided cervical adenopathy and retropharyngeal cellulitis/phlegmon., fevers.  hospitalized 11/15-21 with such.  improved and sent home on oral antimicrobials and 3 days decadron.  then developed over following  2 weeks what appears to be reactive arthritis of UE and then LEs.  Hip US show small effusions, L knee small effusion, R knee trace effusion.  On naprosyn BID for reactive arthritis, improving currently.
Headache Dizziness Muscle pain (not injection site) Mild shortness of breath
Vaccine administered to pt at 2:12pm on 5/11/21.  Pt was recommended to wait in waiting area for 15 minutes post injection.  After approximately 5 minutes, he stood up and walked near the counter reporting he was feeling dizzy.  As the pharmacist was recommending him to sit down rather than stand and was attempting to assist him to his chair, he fainted.  RPh and technician reached to hold him and help break his fall.  The pt fell to the ground mainly falling on his buttocks and then to his back.  After approx. 20-30 seconds, the pt awoke and sat up on his own.  He then stated he was feeling better and drank some water. About 3-5 minutes later, he was able to get back to his chair where he sat coherent for another 30-40 minutes.  After being assessed by paramedic/fire chief, it was recommended he go to the hospital to be further assessed.  He left walking away with paramedics.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. No pertinent medical history was reported. On 08-AUG-2014, the patient was vaccinated with VARIVAX (Merck) (lot # K002920 and expiration date was 26-FEB-2016) dose 0.5 ml, subcutaneous injection. Concomitant medications was not reported. The physician reported that temperature excursions beginning 11-AUG-2014, with worst case exposure of -3.9C for 110 hours affecting VARIVAX (Merck) with lot # K002920 and expiration date 26-FEB-2016. Excursion supported for use within 3 months. No adverse effects reported. Patient did not sought medical attention. No Product Quality Complaint (PQC) was involved. This is one of the several reports from the same source. Additional information has been requested.
This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS, DECREASED APPETITE, PRURITUS, THROAT TIGHTNESS, and CHROMATURIA in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Depression. Concomitant products included LIPITOR for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DIZZINESS, DECREASED APPETITE, PRURITUS, THROAT TIGHTNESS, CHROMATURIA, HEADACHE, and FATIGUE. The patient was treated with BENADRYL at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PREDNISONE at a dose of 20 mg. At the time of the report, DIZZINESS, DECREASED APPETITE, PRURITUS, THROAT TIGHTNESS, CHROMATURIA, HEADACHE, and FATIGUE outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included unspecified depression pills for depression.   This case was linked to US-MODERNATX, INC.-MOD-2021-054781. Sender's Comments:  US-MODERNATX, INC MOD-2021-054781: Same reporter; Primary reporter case.
08/16/2001 at 2:30 am, pt had temp 101 with "jerking" seizure activity. CHA prescribed Tylenol/Motrin. Case reported on RMT later that morning. Infabt was fine that morning about 9:30 am. Was sent to pediatrician on 08/17/2001. Older sibling with seizure disorder. Infant had a febrile seizure last month with pneumonia.
Dizziness. Nausea. Diarrhea, high fever, cold sweat and rash.
Patient was given Monovalent Covid vaccine that was BUD on 10/24/22. The manufacturer expiration date was 11/30/22