chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax;approx 10 mins p/ vax, turned pale white while sitting on mom's lap & became shock, collapse;became unresponsive for approx 10-15 sec;was crying;recovered completely & left clinic in 30 mins;
Pt presented to the ED on 10/17/2021 with complaints of nasal congestion, sore throat, nausea, vomiting, diarrhea, cough, fever, and SOB. Her symptoms progressively worsened over the past week. Pt was tested for COVID-19, which resulted positive on 10/17/21.
Information has been received from a pharmacist concerning a 65 year old female with hypertension and hypothyroidism and a history of "fever blister" in the past and no known drug allergies/reactions who on 15-JUL-2010 was vaccinated SC with a dose of ZOSTAVAX (Merck) (dose and lot number not reported). Concomitant therapy included SYNTHROID and COREG. It was reported that in the morning of 16-JUL-2010, the patient developed fever blister. No laboratory tests were performed. The patient sought unspecified medical attention by making a phone call. Additional information has been requested.
Within an hour of shot the arm swelled and hurt to move, low grade temp, Then by next day extreme fatigue, continued temp and arm was extremely soar, At 1 am on Friday morning extreme chest pain began, fast heart rate, and stiffness in neck. Was seen at clinic on Friday morning at 11 am and Dr increased MOTRIN dosage for pain etc. By evening Dr had to be called back because condition had worsened and vomiting had started as well, plus no relief from chest pain. At 3 am Saturday morning he was taken to emergency room. He was given an EKG, chest x-ray, and complete blood profile. Still had rapid heart rate. He was given 2 bags Sodium Chloride, Ondansetron for vomiting, and Fentanyl for the severe chest pain. Was monitored for the rest of the morning and discharged with prescription Tramadol for pain, and Ondansetron for vomiting. The rest of the day on Saturday he continued to run a low grade temp but the chest pain was controllable. Still weak and some arm pain.
Received the vaccine outside of temperature range; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the vaccine outside of temperature range) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the vaccine outside of temperature range). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the vaccine outside of temperature range) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  It was reported that 10 people received the vaccine that were outside of the temperature range.  No treatment information was provided.   Reporter did not allow further contact
no known adverse rxn to vax;pt was seen twice in the clinic & was gaining weight & developmentally WNL;visit of 25JAN96 weight 13# 13oz seen for bronchiolitis & OM;5MAR96 seen for OM & Upper resp infect weight 14# 5oz
2 days after second COVID vaccine patient began to have purple spots on his legs and erythematous spots on the rest of his body.  lower extremity rash become bullous purpura with eventually necrotic tissue in the center of the larger lesions that became up to 3 inches in diameter and many 1/2 inch to inch size lesions as well.  swelling of ankles and feet all causing severe pain.    seen over several weeks and had biopsy and placed on Norco for pain control and prednsione for inflammation.
Diarrhea immediately started when I got home. I took Imodium. Stomach pain. Then started the fatigue and muscle pain. Hot flashes followed by chills. Fatigue worse next day with headache. Lungs are wheezy. Dr has me up'd my Prednisone to 10 mg for 5 days. I have been taking Tylenol 4 consistently.
This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with MMR II. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced expired vaccine used. No treatment information was reported. The outcome of expired vaccine used is unknown. Expired vaccine used is not related to MMR II. (Lot # 0496AE) on 10/27/2012 that expired on 10/26/2012. NO adverse effect has been observed or reported. No additional information currently available.
LOST TWO FRIENDS; This spontaneous report received from a consumer via a company representative via social media concerned two patients of unspecified age, sex, race and ethnicity. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total, start therapy date were not reported for prophylactic vaccination. The batch number were not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, both patient died. Reporter stated that "A friend lost two friends due to the vax." On an unspecified date, both patient died due to unknown cause. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220200584.; Sender's Comments: V0 20220200610- COVID-19 VACCINE AD26.COV2.S- Lost two friends. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient expired three days after receiving first dose  of Moderna COVID-19 vaccine.  The death certificate states cause of death is sudden cardiac arrest.
8/26/10 Woke up with rash on entire body spread rapidly to include palms & soles. No mucous membrane involvement.
A few days after receiving the first dose of the Pfizer COVID-19 vaccine, I developed a constant sense of smelling smoke.
At 0230 on 1/15/21, woke up with fever, headache, chills, body aches that were extremely debilitating. Could hardly get out of bed. Fever with chills continued until 1/16 at 2200. Body aches with joint stiffness continued until 1/17/21.
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 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had Paxlovid Treatment from 06Aug2023 to 11Aug2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300277805 same patient, different event/ drug;
improperly stored doses of PNEUMOVAX 23 were administered; No adverse effect; This non-valid spontaneous report was received from a nurse and refers to an unspecified group of unspecified patients. Their medical history, concurrent conditions and concomitant drugs were not reported.  On unknown dates, the patients were vaccinated with improperly stored doses of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly, lot# R021045, expiration date 14-APR-2020 (exact doses were not reported) for prophylaxis. The vaccines were stored in a temperature below 36 Fahrenheit degrees (F) (average 34.2F) for 65.5 hours. No previous temperature excursion occurred. Digital data logger was involved. No adverse effects reported.  This case is non-valid due to lack of patients' identifiers provided.  Follow up information has been received on 28-AUG-2019. As of that day, all telephone attempts to obtain additional information have been unsuccessful.
"Approximately 1/3/08 she received her 3rd Gardasil injection in the left deltoid shoulder area.  She said it felt a little more uncomfortable than usual, felt just ill inside, like the fluid going into her arm.  Since that time, she has had progressive pain extending down the entire arm with some tingling generalized in the arm and hands.  Pain in a broad area.  She denies any skin changes over the site, no constitutional symptoms during the last symptoms.  She denies any generalized reaction to prior injections or to any immunizations in the past that she can recall.  She has pain with resistant abduction and external rotation.  No treatment at this time."
I had pain in my right arm a couple hours after receiving the shot. The next day, there was itching in my arm. I contacted the doctor office. I was advised by the nurse to purchase a lotion that is prescribed to cancer patients. The lotion provided some relief. I experienced a lot of this itching for about a week.
Initially, my arm started throbbing in the afternoon of the first day.  Then I developed chills and started in the evening about 12 hours after my shot.  I went to bed.  When I woke up in the morning, I felt nauseous.  I got out of bed at about 8am to take 2 tylenol and shower hoping that I'd feel better.  While in the shower, I suddenly felt like I couldn't breathe and needed air.  The moments after that are bit hazy, but I can tell you somehow I found myself crashed into the window on the opposite wall of my bathroom.  Then I somehow made it out of my bathroom and somehow fell head first onto my carpeted floor of my bedroom.  I think I must have passed out for a minute.  Someone in my house heard me fall and came to help me back into bed and then I fell asleep in bed for the next 5 hours.  I woke feeling better, but not well.  I didn't feel considerably better until the next day.  My right arm still has not regained its strength completely.
left wrist and hand pain, swollen left eye, generalized hives swollen left wrist and hand
Breakthrough COVID-19 case with symptom onset 8/5/2021: Sore Throat, Shortness of breath/difficulty breathing. Hospitalized on 8/3/2021 for unknown duration
This case was reported by a consumer via call center representative and described the occurrence of seizure in a 67-year-old female patient who received SHINGRIX. The patient's past medical history included chickenpox (had chicken pox at young age). Previously administered products included ZOSTAVAX with an associated reaction of pyrexia (received in winter 2 years ago and experienced low grade fever rash, chicken pox Dx by clinic, itching, front and back and soreness). Concurrent medical conditions included asthma and blood pressure. Concomitant products included LAMICTAL, ASMANEX, CLARITINE, clonazepam, FOCALIN, trazodone and ZOLOFT. On 23rd May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced sickness. On 23rd May 2018, the patient experienced seizure (serious criteria GSK medically significant), fever, muscle tension, muscle twitching, sleeplessness, sweating, upset stomach, injection site pain and injection site swelling. On 24th May 2018, the patient experienced general body pain and weakness. In May 2018, the outcome of the seizure, fever, muscle tension, muscle twitching, sleeplessness and sweating were recovered/resolved. On an unknown date, the outcome of the upset stomach, injection site pain, injection site swelling and sickness were unknown and the outcome of the general body pain and weakness were not recovered/not resolved. The reporter considered the seizure, fever, muscle tension, muscle twitching, sleeplessness, sweating, upset stomach, general body pain, weakness, injection site pain, injection site swelling and sickness to be related to SHINGRIX. Additional details were provided as follows: The patient stated it took her a while to agree to the product, because about 2 years ago she had ZOSTAVAX and experienced a rash that was identified as chicken pox or possibly a mild case of shingles. She stated it was itchy, looked like chicken pox and was on her front and back. The patient stated that she also had a case documented for chicken pox when she was younger. A few hours later receiving SHINGRIX, the patient was in bed with a high fever, her body would tense, twitch, freeze and release. She thought she could be possibly be having a seizure and she had difficulty sleeping, sweats during the night and upset stomach. The patient stated that she had very mild injection site soreness and swelling compared to the other issues she was experiencing. On 24th May 2018 in morning, 1 day after receiving SHINGRIX the patient was weak and her body was achy. In May 2018, less than a week after receiving SHINGRIX, the patient was sick. This case has been linked with case US2018093523, reported by the same reporter.
No adverse event. This was an administration error. Mother brought in child for vaccine. She listed DOB having the patient listed at 13 years old. After adult vaccine (12+ years/Purple Cap) vaccine was administered, mom realized the DOB was incorrect on the COVID card. She had accidentally given us the DOB of her other child. When we updated the DOB in the pharmacy system, we then realized the child was 8 years old and should have received the Pediatric COVID vaccination. The child is not experiencing any side effects from the adult vaccination per a phone call with the mother today at 10am.
Patient has fever and lots of swelling in the Left arm, from shoulder to the wrist and a rash.
On Monday, Nov. 29, 2021 I received my booster shot in my left arm. Tuesday, Nov. 30th mid af-afternoon I had a sore arm, body aches and chills for a few hours. Wednesday, Dec. 1st I felt good with the exception of having a stomach ache in the evening. Around 1am on Dec, 2nd I woke up with pain in my left shoulder, left ribs and shortness of breath. I was taken to  Hospital where they did a series of tests and found a small blood clot in my left lung. Prior to my booster shot I had surgery (abdominal hysterectomy) on Friday, Nov. 12th. They believe the clot was caused from that.   I asked them if this was vaccine related and they stated they do not believe so but asked me several times which vaccine I took. I asked them if they do not think this is vaccine related, why do they keep asking me what vaccine I took. They said there is a vaccine that has a history of blood clotting but would not tell me which one....Also I did ask my OBYGN if it was safe for me to get my booster shot on Tuesday, Nov. 23 and she replied it was safe encouraged me to get it ASAP.
In the months following the shot I felt my arthritis worsened. This may have been due to aging and the natural progression of my condition. I am a very healthy individual with a family history of auto-immune disorders. I have Psoriasis amd Psoriatic and  probably other arthritis which does not seriuously effect my quality of life.
The patient came into the Pharmacy to inquire about getting herself an influenza vaccine and her son a J/J vaccine. They decided to obtain the services of the pharmacy and receive their specific vaccines. I, as the pharmacist, drew up the J/J vaccine and attached a needle to the influenza pre-filled syringe. I also obtained all necessary supplies and brought them into the vaccination room. I ushered in Pt and her son and had the mother sit down to receive her vaccine first. After walking through my standard processes of informing the patients and verifying all vaccines, I mistakenly acquired the wrong vaccine and administered it to the mother.  The mother was to receive the influenza vaccine, but instead she received the J/J vaccine. She informed me that she had received the J/J vaccine at least 6 months ago meaning that she has now received a 2nd J/J dose. She opted out of receiving the influenza vaccine, which I also concurred. She remained around the pharmacy and in the store for at least 15 minutes and showed no type of reaction. She received no interventions from myself except informationally. I reported the event in our Costco system. Costco is taking steps to modify factors that may have contributed to this event. At this time, Pt, nor anyone else, has reported any adverse reaction(s). This reporting is to document that an accident in administration has occurred and whether an adverse event is to arise there is a record of reporting. At this time, there has been no adverse reaction reported to me.
Within 5 minutes of receiving vaccine, Pt.t started to feel shaky and nauseous, became tachycardic, however patient stated she rushed to get here and was not sure if that was the reason. Pulse at this time was 100.   She felt she was going to pass out. I got water for the patient and also gave her peppermint candy, after about 10 minutes she didn't feel she was getting worse but she didn't feel much better. She did not want RRT called. I gave 25mg of Benadryl.  Within 5-10 minutes after the Benadryl she started to notice symptoms improving. After 20 minutes patient is standing and no longer feels she is going to pass out.  Patient called her husband to pick her up.
Patient came through drive thru flu POD, requested vaccination. When entering vaccine into patient record the following day, it was noted patient had two records which showed she had received HD flu vaccination August 26, 2023 from another facility. No adverse reaction known. Unable to reach by phone, left message. Records merged.
I experienced loss of voice after my COVID-19 vaccine, I also felt like a truck hit me I was unable to get out of bed.
insomnia - woken up in the middle of the night with elevated heart rate; elevated heart rate; Rash on my back; This is a spontaneous report from a contactable consumer or other non hcp.   A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in Arm Right at Public Health Clinic/Veterans Administration facility on 26Feb2021 (at 02:00 PM) as a single dose for covid-19 immunization (at the age of 56-years-old). The patient medical history was not reported. The patient's concomitant medications were not reported. Patient historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el9265), dose 1 via an unspecified route of administration, administered in Arm Right (at 04:00 PM) on 05Feb2021 as a single dose for covid-19 immunization (at the age of 56-years-old). Patient was not diagnosed with COVID-19 prior to the COVID vaccine. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient visited to Doctor or other healthcare professional office/clinic visit. Patient had taken treatment of topical cream for reported events. On 27Feb2021 (at 02:00 PM), the patient experienced insomnia - woken up in the middle of the night with elevated heart rate, elevated heart rate, rash on my back. The patient underwent lab tests and procedures which included sars-cov-2 test (SCREENING PANEL (WH) NASOPHARYNX SP LB, 230471, Nasal Swab): negative on 05Mar2021. The outcome of the events was not recovered.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Headache, Myalgia, NauseaVomiting, Low back pain, Hot flashes, Chills, Diaphoretic Narrative:  Received 2nd dose on 1/20/21 - 6 hours later noted hot flashes and a headache. On 1/21/21 noted emesis, increased myalgias, headache, low back pain, chills/shivering and diaphoresis. Missed work x 2 days. Most symptoms resolved by 1/23/21, though headache lasted until 1/24/21. No known prior COVID infection.  Other Relevant History:
A non-serious, spontaneous report of administered expired product was received from a nurse concerning a four-year-old female, subsequent to FLUMIST. The patient received FLUMIST on 17-Feb-2009 which expired on 15-Feb-2009. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 31-Mar-2009 and incorporated into the narrative: added product complaint investigation results.
Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 13-AUG-2014 at a health care facility, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 04-MAY-2015, the patient was treated by a health care facility emergency room for an ongoing painful rash that was diagnosed as shingles with post-herpetic neuralgia.  Although shingles and post-herpetic neuralgia are incurable conditions, the patient has been prescribed valacyclovir (VALTREX) and pregabalin (LYRICA) for management of his symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA009733:
With the first shot, I experienced chills for a day and a half.  Absolutely could not get warm.    With the second shot, I experienced chills; was clammy at the same time as the chills; very fatigued and could not stay awake; my muscles, joints and my whole body ached; headache; sinus infection (for which I am currently on an antibiotic); nausea; loss of appetite (lost 5 pounds); loss of taste and smell for 2-3 days.  Too weak to make it to the bathroom by myself.  I felt like I was in a delirium but my husband said that I was not incoherent.  Appetite is still not normal.  Mouth was so dry that I was not able to feel any moisture at all which I feel led to my sinus infection.