chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the ED and was subsequently admitted on 4/10/21. Patient also presented to the ED on 4/13/21. These visits are within  6 weeks of developing COVID vaccination.
On 6/29/2021, I developed a severe right radial nerve palsy and had no use of my right hand for months. Had to go through neuro/nerve testing and OT. Still have difficulty. Have now developed arthritis in right wrist.
sl soreness p/shot-by evening arm was sore & felt heavy; following morning unable to arm-arm neither red or hot, sl swollen; sx improved w/in 24 hrs; missed one day of work;
9 year old patient was given .025 Moderna booster dose (meant for his father) in error. Patient should have received 0.2 of pediatric Pfizer 5-<12.
incorrect product/dosage is administered, resulting in a lower-than-authorized dose.  NO Adverse event  occured.
friend had a mini stroke after receiving the second dose of his Moderna primary Series.; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (friend had a mini stroke after receiving the second dose of his Moderna primary Series.) in a 65-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (friend had a mini stroke after receiving the second dose of his Moderna primary Series.) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (friend had a mini stroke after receiving the second dose of his Moderna primary Series.) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.  Company comment: This is a regulatory case concerning a 65-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest of Transient ischaemic attack. The event occurred on unknown day after the second dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a regulatory case concerning a 65-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) adverse event of special interest of Transient ischaemic attack. The event occurred on unknown day after the second dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient reports pain in muscle in arm and area that vaccination was administered. Pain has continued for 14 days following vaccination.
The day following my vaccination (4/24/21) I awoke feeling completely nauseous and dizzy. Upon getting out of bed I immediately sat on the floor due to the extreme dizziness and fear of passing out I felt. After a few minutes in this state I vomited. I had a fever which I managed with Tylenol. I felt fatigued and weak the entire day. I ran a fever the entire day, again managing it with Tylenol.  The following day (4/25/2021) my fever was gone and I felt better, however about midday I began experiencing cramps and vaginal bleeding. I was 5.5weeks pregnant with an estimated due date of 12/24/2021. I went to the ER with concerns of a miscarriage. Based on abdominal ultrasound and subsequent HCGquant testing over the next week it was determined I had encountered a miscarriage and lost the baby.
Onset of body aches, chills, nausea, and fatigue at 6:00 pm on the date of vaccination 10/3/17. Symptoms lasted for approximately 5 hours.
Influenza, Sanofi, FLUZONE, 2013-2014, 0.5ml prefilled syringe, Lot UH888AA, in right deltoid. Tdap vaccine, GSK BOOSTRIX, 0.5ml, prefilled syringe, 0.5ml, Lot 4G995, left deltoid. Both vaccines administered near 6:30PM. Within 6 hours of the injections, leg pains and right hip pain began. Pains were in both legs, worse with sitting, laying down or standing still. Walking seemed to make the pains more tolerable. No relief of painful symptoms with cold compresses, warm compresses, warm bath with Epsom salts, massaging. Symptoms were present through 48hours when the pains began to decrease and by 96 hours were gone except pain in the right hip joint remained. Interestingly, the patient experienced the same leg pains and aggravated right hip pain 24-48hrs post-op Feb 2014.
MD DOCTOR NOTE:   "Left arm. Had COVID and Flu Vaccines in that arm 1 week ago. Did feel a bit unwell next day or so, subjective fever. 2-3 days later started developing rash. Left shoulder, upper and lower arm, until wrist (not hand). Skin-Colored papules, many, covering the entire surface. Reviewed dad's photos, worse than current. Does seem to be improving. No longer feeling ill. No more fever. No other rashes."
Red, bumpy, hot, rash at the injection site  Slight dizziness that lasted a week
Felt faint, sleepy, pain in head, blood pressure jumped to 185, tingling and numbness on right-side of face.
Not feeling well, extreme muscle aches. Went to her Dr at 5 pm 10-25. She was sent immediately to the Emergency Room with flu like symptoms test done. Blood pressure extremely high. Was sent home after several hours of observation. By 10-22-11 she was feeling better.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot#, route and site of administration not reported). Subsequently, the patient had an abnormal pap test after vaccination. Unspecified medical attention was sought via office visit. Pap test was performed with ASCUS (atypical squamous cells of undetermined significance) result. At the time of this report, the patient's outcome was not reported. Additional information has been requested.
received daptacel past the expiration date and received 2 doses of the expired vaccine caller is looking for re-vaccination information with no reported adverse event; Initial information received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to cases 2023SA214127, 2023SA213495, 2023SA213561, 2023SA214713, 2023SA213445 and 2023SA214480.  This case involves a 6 years old male patient who had received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] past the expiration date and received 2 doses of the expired vaccine caller is looking for re-vaccination information with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact 3V (vero) (IPOL) for prophylactic vaccination (Immunisation).  On 05-Jan-2023 and 04-Mar-2023, the patient received 0.5 mL dose 3 and 4 respectively of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (batch number: C5829AA; Expiry date: 03-Jan-2023) via intramuscular route in unknown administration site for Immunization, past the expiration date (2 doses of the expired vaccine) with no reported adverse event (expired product administered) (same day latency). Caller is looking for re-vaccination information.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event received daptacel past the expiration date and received 2 doses of the expired vaccine caller is looking for re-vaccination information with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous report from a contactable consumer. A consumer (patient) of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, NDC number, UPC number and expiry date were reported as unknown) via an unspecified route of administration on 18Jun2021 at approximately 13:00 in afternoon as dose number unknown, single for COVID-19 immunization. Medical history included high blood pressure which was diagnosed a year ago and the patient had nausea, vomiting and all same symptoms which occurred after vaccination. The patient concomitant medications were not reported. On 19Jun2021 the patient was not feeling too good and on 20Jun2021 it was even worse as the patient experienced vomiting all day and it seemed to become worse. It was not subsiding as the patient thought it would. The patient asked was this a typical side effect of blood pressure and checked blood pressure which was normal. The patient was wondering if whole nausea thing was picked up since morning and had gotten worse during the day. The patient also experienced some soreness and stuff on an unspecified date in Jun2021. The patient underwent lab tests and procedures which included blood pressure measurement as normal. The outcome of all the events was not resolved. Follow-up attempts are possible. Information about lot/batch number has been requested.
Three weeks after received the second dose, patient developed a "severe burning" rash on her left cheek.  She went to urgent care and was diagnosed with Shingles and was treated with Acyclovir.  Treatment did not help and she returned to her PCP who agreed it was Shingles and treated the condition with steroids with little to no effect.  The rash spread to her right side and was treated with more steroids -- seven rounds in total. Rash continue to spread down to her neck and chest and has only gotten worse since.  She has seen dermatology for the rash.  She has been prescribed Lyrica and gabapentin for the pain, however she cannot take it due to side effects.  She will be referred to Neurology for suspected neurological pain brought about by the vaccine.  It should noted she received the first dose of the Moderna vaccine on 03/03/21 and later was diagnosed with COVID-19 on 03/28/2021.
I received my first Pfizer COVID shot on 8/4/21. About 24 hours after getting the vaccine my lips went numb and tingly. My entire mouth, tongue, and fingertips followed soon after. On the evening of 8/5, I went to an ER and they stated it was from the vaccine and symptoms should subside. Tingling and numbness lasted in my lips and finger tips the longest. As of today, symptoms are mostly gone.  On 8/27, I received my second dose. This dose did not seem to impact the numbness or tingling.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported. There was an excursion from their freezer on 01-Oct-2021
pt recvd 3 doses of Engerix-B & had a lack of therapeutic response;
Vaccinated with DAPTACEL RT 11/8/11, well tolerated at the time the patient has had 2 previous DAPTACEL vaccination. These are the only immunizations he has received. Seen today by Dr. vaccine reaction (local).
Fever ranging from 100-102 from 11:30 PM to 9AM. Treated with Tylenol but only went down to around 99. Chills and aches with fever.  Headache accompanied fever. Tylenol didn't help headache. Nausea around 10 am 5/14, vomiting around 11AM. Fever and headache persisted on and off throughout 5/14. Slight arm soreness that began 7PM 5/13.  Morning of 5/15, all symptoms seem to be gone.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (dose number: 1, All 3 injections were administered in the right arm at each visit), administration date: Mar2021, when the patient was 51 years old, for COVID-19 Immunization, reaction(s): "About 1 week after dose #1 I experienced pain in the right shoulder joint and surrounding muscle"; Bnt162b2 (Prev dose dose number: 1, All 3 injections were administered in the right arm at each visit), administration date: Mar2021, when the patient was 51 years old, for COVID-19 Immunization, reaction(s): "About 1 week after dose #1 I experienced pain in the right shoulder joint and surrounding muscle". The following information was reported: MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "A few days after dose #2 I experienced increased pain in the right shoulder joint and surrounding muscle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, arthralgia. Additional information: All 3 injections were administered in the right arm at each visit. About 1 week after dose #1 I experienced pain in the right shoulder joint and surrounding muscle. A few days after dose #2 I experienced increased pain in the right shoulder joint and surrounding muscle. The symptoms reduced slightly but after dose #3 I again experienced increased pain in the right shoulder joint and surrounding muscle. These symptoms still continue. There is also pain when raising the arm overhead, lifting items overhead and performing any activity requiring rotation of the right shoulder. The left (did not have any injections) remains without any similar symptoms. AE treatment: applied heating pad & used analgesics. The patient was not priorly vaccinated for covid. The patient was not covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The vaccine was given on 4-23-2021 at about 11:30 AM at the Pharmacy. I came home and worked on my computer for about an hour. By 2 PM that day, I had the typical reactions expected of constant chills, fatigue, and soreness at the injection site of my left arm. I took a nap and covered up under many blankets. I drank lots of fluids to help. By 10 PM, I already felt lots of severe body aches and stiffness. Before midnight I started having chest pain. The chest pain continued all night making it difficult to sleep. I woke up completely around 7 AM on 4-24-2021 still feeling all body aches with difficulty moving, continued intensifying chest pain with palpitations, and now also felt nausea. I only ate a piece of fruit. I went with my family to our kid?s soccer games, but I was completely fatigued. I came home and took a nap, but felt chilled, the chest pain continuing, and soreness. When I woke up things were feeling even worse with the chest pain. They started to feel like a real heaviness on my chest, almost as if someone was sitting on me. I also felt a huge tightness the length of my sternum. I had palpitations. I started also having shortness of breath and could not walk up and down my stairs (which is never otherwise a problem).  I was very hot and sweating through my clothese. My sister took me to the ER because the pain became intolerable. I went to the Clinic, Hospital ER for the chest pain (lot so heaviness and tightness in the sternum) and shortness of breath. My blood pressure was really high in the 140s/90s. I was in a lot of pain. I had a temperature. They did an EKG immediately that showed PVCs and a slight pause. Then, I had an XRay of the chest and lots of bloodwork. They did give me fluids and pain medication. The bloodwork had elevated d-dimer and low potassium levels, so they did a CAT scan with contrast to rule out a clot. It showed no clot, but had very enlarged lymph nodes on the left. They believed all of this response and chest pain was due to my 2nd dose of Moderna's COVID 19 vaccine. I am still not completely recovered. I am feeling ill and chest pain with tightness, but at home now. I go back to my cardiologist for a repeat EKG and repeat bloodwork this week.
Injection site (right deltoid) warm to the touch; Injection site (right deltoid) swelling, itching; Injection site (right deltoid) swelling; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Injection site (right deltoid) warm to the touch), VACCINATION SITE PRURITUS (Injection site (right deltoid) swelling, itching) and VACCINATION SITE SWELLING (Injection site (right deltoid) swelling) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site (right deltoid) warm to the touch), VACCINATION SITE PRURITUS (Injection site (right deltoid) swelling, itching) and VACCINATION SITE SWELLING (Injection site (right deltoid) swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site (right deltoid) warm to the touch), VACCINATION SITE PRURITUS (Injection site (right deltoid) swelling, itching) and VACCINATION SITE SWELLING (Injection site (right deltoid) swelling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was a registered nurse who was calling on behalf of their patient who received their second dose of vaccination and had an adverse reaction. On 05-Apr-2021, the patient reached out to one of the registered nurses at the clinic and reported that they had injection site swelling, itching and it was warm to the touch.   Reportedly, the reaction started approximately 5 hours post receiving the second dose. The patient also reported that they experienced the same reaction with the first dose as well.   The patient was taking Benadryl at home.  No Concomitant product use was reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-070850 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up was received on 21-May-2021 and does not contain any new or significant information.
he feels fine but not 100 percent well; 4 days later he tested positive for COVID-19.; This is a spontaneous report received from Pfizer sponsored program. A contactable male consumer(Patient himself) of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown, Expiry date: unknown), via an unspecified route of administration on 22Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Apr2021, After 4 days later the first dose received patient tested positive for COVID-19. Patient underwent lab test and procedure which included COVID-19 test and results positive for COVID-19. on 26Mar2021. Patient was in quarantine and came out on 05Apr2021, patient felt fine but not 100 percent well on unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe arm pain disrupts sleep restricted arm movement can not raise arm up pain feels like in nerve or muscle from shoulder to elbow alleviated temporarily with massage, Advil, over the counter pain relievers, and has gone on for 4 months now and is experienced on a daily basis.  I can not move my arm. No free movement to dance, raise arms, exercise with weights.
Sore arm, bad night with leg muscles drawing and body aches,  stiff joints.  All continued for 36 hours.
Rash and itching of legs and back, began approximately 4.5 hrs after injection; took a Benadryl, still mild itching
shingles; other zoster-related conditions; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 17-AUG-2021. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On or about 02-SEP-2014, the patient was inoculated with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for long-term prevention of shingles and zoster related conditions. Alternatively, on the same date, the patient's healthcare provider at the office relied on the warning label affixed to the Zoster Vaccine Live (ZOSTAVAX) vaccine and believed that it was effective in prevention shingles on a long-term or permanent basis, and that it did not carry any significant risks of adverse effects. Subsequent, the patient was treated by a physician for shingles and sought further treatment with other physician for other-zoster related conditions. Then, on an unknown date, the patient was hospitalized due to the event. As a direct and proximate result of Zoster Vaccine Live (ZOSTAVAX) vaccine, patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries including but not limited to cost for hospitalization, physician care, monitoring, treatment, medications, and supplies, diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. At the reporting time, the outcome of the events was not provided. The reporters considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).