chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with urticaria as a reaction due to histamine release; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (diagnosed with urticaria as a reaction due to histamine release) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had never been diagnosed or tested positive for COVID-19. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccination.  The patient's past medical history included Mosquito bite (had reactions with mosquito bites since patient was 5 years old). Concurrent medical conditions included Shellfish allergy, Herbal allergy (sage), Spice allergy (sumac) and Allergy to chemicals (preservatives).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced URTICARIA (diagnosed with urticaria as a reaction due to histamine release). At the time of the report, URTICARIA (diagnosed with urticaria as a reaction due to histamine release) outcome was unknown.            No concomitant medication information was reported.  2 to 3 days after getting the vaccine, the patient again had the same skin reaction of red dots on her legs after receiving the second dose of the Moderna COVID-19 vaccine. Patient started getting red dots on her legs again and at this time it was itchy too. She again went to her dermatologist and was diagnosed with urticaria as a reaction due to histamine release.  Patient reported that she had a history of reactions like that with mosquito bites since she was 5 years old.  Patient reported that she iced the rash and put aloe vera on that and she had not had any more rashes since her second dose.   This case was linked to MOD-2022-670154, MOD-2022-669963 (Patient Link).
Information has been received from a physician concerning a 16 week old female patient who on 21-MAR-2011 was vaccinated orally with a dose of ROTATEQ (lot number 668951/1136Z). Concomitant therapy included oral vitamin D supplement. On 04-MAY-2011 the patient developed intussusception and was hospitalized but the intussusception resolved on its own without treatment the same day it was discovered on 04-MAY-2011. Diagnostic laboratory test ultrasound was performed, no result provided. A lot check has been initiated. Intussusception was considered to be immediately life-threatening. Additional information has been requested.
Fever; This is a spontaneous report from a Pfizer-sponsored Program. A contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 12Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the consumer stated that, after a few days she got fever, and she was asking if having a fever is a side effect of the covid vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever/gone up to 106.0 Fahrenheit and as high as 107.0 Fahrenheit; Body aches; chills; Diarrhea; upset stomach; This is a spontaneous report from a contactable consumer reported for son. A 26-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) intramuscular in the left deltoid on 15Jan2021 at 0.3 ml single for COVID-19 immunisation. There was no medical history. There were no concomitant medications. The patient had the Pfizer Vaccine last Friday 15Jan2021. Later that evening on 15Jan2021 he got a fever. It has gone up to 106.0 Fahrenheit and as high as 107.0 Fahrenheit. Reporter has given patient Ibuprofen and Tylenol. The fever has gradually come down. He has also been having upset stomach and diarrhea, and body aches and chills, all on 15Jan2021. The fever went down to 104 degrees Fahrenheit and is now 100.3 degrees Fahrenheit. Their provider told reporter to call the Hospital Hotline or go to the Emergency Room. Reporter has also been giving patient Imodium and a probiotic for the upset stomach and diarrhea. The reporter did not believe the temperatures when he took them, so reporter went out and bought a new under the tongue thermometer, and they are all consistent. Event outcome of fever/gone up to 106.0 Fahrenheit and as high as 107.0 Fahrenheit, chills, body aches was recovering, for diarrhea and upset stomach was not recovered.
On April 13, 2022 I tested positive for COVID. I had a stuffy sneezing and runny nose. I had a headache that felt like I had on a headband, no fever, tired, no breathing problems little to no cough. This lasted only a week, the headband headache took about two weeks to finally dissipate and be gone.
This spontaneous report as received from a registered nurse refers to a patient(s) of unknown age and gender. It was unknown if the patient(s) were vaccinated with VAQTA (dose, concentration and lot number not reported) that had gone through a temperature excursion of 31 F. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
6 days after receiving my 2nd dose of the pfizer covid vaccine, I got a bad sunburn on my forehead which became extremely painful. I submitted images of the affected area to a Teladoc dermatologist for diagnosis, and she diagnosed it as a flareup of Herpes-1 or Shingles. I am currently taking Valtrex and the issue has almost completely cleared up now. I am reporting this because I saw an article about herpes flareups being discovered in 6 people who received the covid vaccine.
I did not have an adverse reaction to the vaccine.  I was advised by CDC VSafe staff to report that I contracted Covid on July 27.  I took Paxlovid from July 28 thru Aug 2.  Symptoms went away by Aug 4 but I continue to test positive.  Symptoms came back on Aug 6.  Covid symptoms go worse thru Aug 9, and have mostly resolved by Aug 12.  Still testing covid positive at this time.
Severe and extended dizziness for 5 days.; Headache and very tired so sleepy can hardly keep eyes open; Headache and very tired so sleepy can hardly keep eyes open; Headache and very tired so sleepy can hardly keep eyes open; Muscle pain around abdomen; ran fever of 102.5 for 12 hours post injection with rigors; This is a spontaneous report from a contactable nurse (patient). A 65-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200 and expiration date was not reported), via an unspecified route of administration, in left arm on 20Feb2021 at 14:30 as SINGLE DOSE for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269 and expiration date was not reported), via an unspecified route of administration, on 03Feb2021 at 17:00, as SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, has the patient not been tested for COVID-19. The patient was allergic to medications, food, or other products. The patient medical history included autoimmune disease iritis-right eye for which she was hospitalized for 2 days. Concomitant medications were not reported. On 21Feb2021, patient experienced severe and extended dizziness for 5 days. Headache and very tired so sleepy can hardly keep eyes open. Muscle pain around abdomen, generalized, ran fever of 102.5 for 12 hours post injection with rigors. The outcome of all events was reported as not recovered.  No follow-up attempts are possible. No further information was provided.
Pt with syncope within 5 minutes post vaccination- pale, clammy, "shaking." Within a few seconds pt began to have color return to face and become more oriented to self and place. Pt monitored until returned to baseline.
Pt recv vax in 8/98; 7-10 days post vax pt exp truncal proximal limb petechial rash, blanchable
erection; This spontaneous case was reported by a consumer and describes the occurrence of ERECTION INCREASED (erection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ERECTION INCREASED (erection). At the time of the report, ERECTION INCREASED (erection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
I contracted COVID-19 and experienced symptoms of sore throat, cough, chest congestion, shortness of breath and the symptoms began to resolve after 3 to 5 days. I took Mucinex at symptom onset, and was prescribed Paxlovid 5 day regimen. I have a small amount of lingering congestion and cough, but feel much better.
Rash developed 9 days after administration started with macular papular rash at site on right leg then spread-right leg most involved but other areas noted. No vesicles. Follow up 03/01/05: Symptoms still present on 01/28/05, when seen in clinic.
Red, painful, swollen arm at injection site, these were reported by pharmacy on 10/13/17. Any treatment was not revealed to reporter.
Pt stated feeling floated and having feelings of anxiety. Vitals were taken. bp138/59, Pulse 80, RR 22. PT legs were raised on chair. PT monitored by nurses. Pt stated feeling better a few minutes after vitals taken. Vitals retaken and VSS. RR was 18. Pt was monitored for extra 30 minutes post event.
pt recvd vax & next day diffuse urticaria-no angioedema reported;
Pfizer-BioNTech COVID-19 Vaccine EUA Nausea, chills, HA, muscle aches, weakness and some dizziness. The Nausea started around 05:00 Am on 2/3/21 some dry heaving. Other symptoms have been progressively worsening throughout the morning. No Temp.
A ball formed on her shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "A ball formed on her shoulder".   Additional information: Reporter said her sister in law's godmother, the lady that was her godmother was her family, it's her aunt, she had the same thing, she got the Pfizer COVID vaccine one, and a ball formed on her shoulder, in the same spot where the patient had hers, but her Godmother's went down.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, chills, hives.  Fever and chills gone on 7/5/21.  The hives are the reason for going to urgent healthcare on 7/5/21 where they prescribed prednisone and famotidine.
Patient received vaccine while sitting and leaned over stating she felt lightheaded. No fainting occured BP 86/54  P-70. Rapid response team took over and checked vitals.
Narrative:  74yo male patient died at home in home hospice from Cholangiocarcinoma. Pt received 2 covid vaccines on 3/4/2021 & 8/24/2021. Pt's death is not related to covid vaccines.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 11-MAR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II (rHA (recombinant human albumin), lot #L003856, expiration date 05-FEB-2017, strength, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 824 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Vaccine given 10/2/12 approx. 9 AM. Pt. reports arm became swollen and feverish a few hours later. She became achy with fever and chills by late evening. Now reports nausea x 24 hrs. Follow-up in office today 10/4/12 for symptoms.
Large Swollen Red Rash and Ring at Injection Site. Pain, tenderness, Itching. Swollen Lymph Nodes under arm put (Starting 7 days after vaccine, lasting three days so far.) Bad headache (one day)
Development of small fiber neuropathy in stocking-glove distribution.  Symptoms were at their worst after first vaccine with some subsequent improvement and then flared again after 2nd vaccination.  Some subsequent improvement but some persistent symptoms still.
I have been vaccinated and had 3 Pfizer boosters. I recently contracted covid; I have been vaccinated and had 3 Pfizer boosters. I recently contracted covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I have been vaccinated and had 3 Pfizer boosters. I recently contracted covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a registered nurse regarding a 1 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 09-SEP-2016, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous instead of VARIVAX. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Developed palpable purpuric rash, arthritis, gastrointestinal bleeding, needed blood transfusion. Also developed blood clot in left arm needing anticoagulation. Work-up showed crescentic glomerulonephritis and C-ANCA positive vascultiis. Later had pulmonary hemorrhage. Information from Annual Follow-up report states this patient is still on anti-congulation therapy.  Nurse follow up on 08/31/04 states: "loss of consciousness; Dehydration; venious thrombosis; pleural effusion."  Nurse follow up on 09/15/04 states: "loss of consciousness, dehydration, venious thrombosis, pleural effusion."
COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/21/21 (ER8730) Pfizer Dose 2 4/11/21 (EW0153) COVID Positive 12/10/21  12/10/21: This is a 71-year-old male with history of tobacco use and prostate cancer status post radiation in remission who presented with shortness of breath and cough. Patient reports that his symptoms started 3 days ago. He has been having fever, chills, shortness of breath, cough, nausea, vomiting and diarrhea. He is vaccinated against COVID-19 and had 2 shots. He denies chest pain or dizziness. He has history of prostate cancer and underwent radiation therapy in the past and follows at the University of Iowa and was told that he is currently in remission.   In the emergency department, patient was found to be hypoxic and was put on 2 L of O2 via nasal cannula. Labs showed a lactic acid of 2.1, D-dimer of 1.15. Patient had a positive rapid COVID-19 antigen test. CT abdomen and pelvis with IV contrast showed mild small bowel dilatation suggesting enteritis. CT angiography of the chest was negative for pulmonary embolism but it showed bilateral patchy infiltrates and chronic granulomatous disease. Patient received nebulizer treatments and a dose of IV azithromycin, Rocephin and Solu-Medrol.  12/14/21: Albuterol HFA q.6 hours  P.o. azithromycin course  P.o. Decadron course P.o. vitamin-C, vitamin-D and zinc sulfate  Patient requires 1 L of O2 with activity  Hemodynamically stable for discharge  Will discharge home  Follow-up with PCP in 3-5 days  Patient agrees with plan of care
Muscle and joint aches, dizzy, tired, nausea, headache, mild.
This spontaneous report was received from a physician regarding a 10 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with unidentified Merck hpv vaccine, GARDASIL or GARDASIL 9 valid lot# M016193 with expiration date 24-APR-2018 (dosing details and route of administration unknown) for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004566: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004725: US-009507513-1701USA004726.
5 yo with onset of LE and buttock purpura on 8/5/09. Pt has developed subsequent hematuria. Pt hs been diagnosed with HENOCH SCHONLEIN Purpura
SEVERE VESTIBULAR STROKE. Complete occlusion. Patient is now in Rehab trying to regain her ability to swallow properly, see without double vision, and walk again.
Patient presented for dyspnea which appeared to be due to pulmonary edema, likely from valvular disease. She responded well to 1 day of IV diuresis. She stayed inpatient for her chemotherapy. Vaccinated for the COVID vaccine while in the hospital. ED visit within 6 weeks of receiving the vaccine for vomiting and nausea due to cancer treatment.
urticarial rash, itchiness, periorbital puffiness, nasal discharge;
Fever (100 degrees Fahrenheit); Violent chills; she was shaking/Her hands shake terrible; she slept the entire night, which she never does; This is a spontaneous report from a contactable consumer reporting for herself.  A 72-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left deltoid on 16Dec2020 08:05 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient experienced fever on 17Dec2020 with outcome of not recovered, violent chills on 16Dec2020 19:00 with outcome of recovering. The reporter described the events as pretty bad violent chills where she was shaking, and she could not get warm. Her hands shake terrible. She did not realize she had a fever until she slept the entire night through 16Dec2020-17Dec2020 which she never does. She took her temperature after she woke on 17Dec2020 09:50am and her temperature was 100 degrees Fahrenheit which is her ongoing temperature at time of the call.  She asked if there are any recommendations regarding treatment or management of fever following administration of the vaccine; like if it is ok to take Tylenol or something.  Information about lot/batch number has been requested.
pt devel a fever of 104 aux 4-5 hrs p/vax; starting w/persistent crying; THis lasted 4-6 hrs;
Pt into office on 11/18/22  for post exposure rabies due to a cat bit on 11/11/22. Cat bit pt on lt hand/thumb area. Tolerated Rabies vaccine/ rig after injection.  Wound was infiltrated  with Rig and remaining  Rig administered in bilateral thighs.  On 11/21/22 when pt presented to office for Rabies Day 3, Mom stated that patient started with rash Sunday night 11/20/22. Rash on pt's arms, torso, thighs back. C/o itchiness. Mom states patient may have had salad dressing made with anchovies so not 100% sure if it was from rabies ig, vaccine or salad dressing.
About 30 mins after vaccination - light-headed, sl headache, R hand redder than left. Tx'd with ibuprofen. @ 3pm student called mom @ work c/o tingling/swollen lips, 1 eye swelling. @ 430pm mom home - student with increased facial swelling, eyes swelling, throat itchy, "splotches all over" went to ER IV BENADRYL 12/1/09 8 am - eyes still sl swollen, few blotches - 10:30 am appears clear.
Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX (lot# and route not provided) to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2007, a healthcare provider administered the ZOSTAVAX vaccine to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 30-JUN-2014, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.