chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After first injection only had sore achy arm for few days About 4 hours after second injection on Friday morning,  I started feeling bad with chills, then fever of 102-103; severe body and joint aches for a duration of roughly 48 hours;  I just went to bed,   By Sunday morning fever & chills had subsided, joint pain better, just very tired.  Was able to return to work on Monday, and didn't need to contact my primary physician.
Patient here with her son on 12/14/2020. Son was over due for vaccines, one of which was PCV13. During administration of the vaccine there was a plunger malfunction and the vaccine did not go through the needle, instead it splashed out of the plunger. Most of the vaccine ended of on the table but a drop did splash into patient's left eye. She immediately went to the restroom and her eye out with water. Prevnar 13 safety data sheet states if exposed in the eyes with vaccine the recommendation is a full 15 minute eye wash with proper solution but she declined this since she already flushed her eye with water. She reported some itchiness in eye but denied pain, blurry vision, or loss of vision. PCP came in to evaluate eye and did not notice any redness or other abnormality. Patent opted to go home with instructions that if she still feel itchiness she can flush at home with water or use lubricating eye drops.
headache; shivering; fever; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 6th August 2019 10:00, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 6th August 2019 22:00, 12 hrs after receiving Shingrix, the patient experienced headache, shivering and fever. On an unknown date, the outcome of the headache, shivering and fever were recovered/resolved.   It was unknown if the reporter considered the headache, shivering and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that he administered Shingrix around 10 AM. The patient visited the pharmacy and told the pharmacist that around 10 PM on the day of vaccination, she experienced headache, shivering and a low grade fever. The symptoms have resolved.
Headache, Myalgia, Fever, fatigue loss appetitie Narrative:
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 28-JUN-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012223: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA012231: US-009507513-1907USA012222: US-009507513-1907USA012221: US-009507513-1907USA012219: US-009507513-1907USA012220:
Both the patient and the Mom were sent to the LPN's station for a Pfizer Booster and Flu vaccine.  In error, the pediatric patient was administered the Adult Pfizer Bivalent booster.  The parent was informed of this error.  Follow up for assessment of any symptoms will be performed by an RN with the parent on 12/24/2022 and 12/25/2022.
Watery eyes; Itching and redness in both eyes; Itching and redness in both eyes; Blurred vision; This is a spontaneous report from a contactable consumer (patient). A 75-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Right, on 18Mar2021 10:00 (at the age of 75-year-old), as dose 2, single, for COVID-19 immunisation in public Health Clinic. Medical history included sulfonamide allergy. There were no concomitant medications. The patient previously took cipro and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 20Mar2021 at 09:00, the patient experienced watery eyes, itching and redness in both eyes and blurred vision. The patient took over the counter eyedrops as a therapeutic measure and by Tuesday (23Mar2021) vision was restored to normal. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the event blurred vision was recovered on 23Mar2021 while that of watery eyes, itching and redness in both eyes was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021332195 Same reporter/ drug /AE, different patient
Upper respiratory symptoms (runny nose, congestion), cough, wheezing, difficulty breathing onset approximately 10-14 days after vaccination.  Went to urgent care multiple times between 5/11/2021 and 5/17/2021 for prolonged issues with breathing and severe rib and back pain related to cough and was given albuterol PFA, pain medication, and cough suppressant PRN. Started antibiotic (Augmentin) 5/17/2021 due to continued wheezing and cough which led to severe diarrhea/GI upset. Augmentin was stopped 5/18/2021 and Z-pack started AM of 5/19/2021. Went to Emergency Room evening of 5/19/2021 due to incessant bouts of diarrhea and GI pain that could not be managed with Imodium. Received fluids, Pepcid, and pain medication at ED and was d/c to continue medications at home. Sought out medical attention via urgent care and PCP multiple times since event (May 2021 to present) as wheezing is ongoing. Currently utilizing albuterol PFA PRN and lansoprazole 15mg daily to manage symptoms.
Generalized seizure-reported by mother- pt collapsed-period of unconsciousness for 5-7 minutes- shallow breathing -called ambulance -02 given -pt regained consciousness - to Emergency Dept.
Dose 2 02/05/2021 EM9810 After the first dose of the vaccine, I was very dizzy for two hours. I waited in the Urgent care and someone had to pick me up. Within 15 minutes of getting the vaccine I felt funny in a certain spot of my head. I experienced brain fog and problems with my speech. My speech and gross motor movements were delayed. I got the second dose as scheduled and I had some joint pain and Flu-like symptoms for a few days. I stopped getting periods in February within weeks of the second dose and I have not had one for a year now. I had Hormone testing and they have stated that I am in Menopause now at 42. I started to get rashes on my face about two months after the second dose which came and went. It was a big circle all on the right side of my face. It came and went in the same place. It had never happened before, and it did not happen after I had been exposed to my known allergies. My Allergist had asked if I had Covid-19 but I have never tested Positive. I had kidney stones three months after my second dose and I have not had them before. I had Appendicitis five months after my second dose. Initially I had some weight loss and then a rapid weight gain. I have finally experienced some relief with the brain fog after 11 months. I had still been having the feeling like the words were on the tip of my tongue and I couldn?t get the words out. Currently after a year I still have a little pain in my left temple but my Brain Fog is better. My speech is finally more normal.  I am in Menopause.
Within 45 minutes of receiving vax, the pt developed a reddened face, vomiting, shortness of breath, moaning and incontinence of bladder and bowel. The pt was taken to the ER and treated with IV normal saline and Benadryl.
Patient admits that he did not realize the reaction until the next day with loss of appetite fever, nausea and edema redness and tenderness at site of left deltoid.
Body aches, chills, headache, sore throat, trouble sleeping. Started 7 hours after vaccine
BECAME PALE AND LIGHT HEADED WITHIN 10 MINUTES OF ADMINISTERING VACCINE.  LAID DOWN ON FLOOR WITH COOL COMPRESS TO FOREHEAD.  MOTHER PRESENT.
Could not get out of bed as he lost function of his legs and they would not work; A spontaneous report was received from a consumer, concerning her husband, a 87-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and could not get out of bed as he lost function of his legs and they would not work.  The patients' medical history and concomitant medication details were not reported.  On 07-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route in left arm upper arm for prophylaxis of COVID-19 infection.   On 07-Jan-2021, after the first dose of vaccine, the patient could not get out of his bed as he lost function of his legs and his legs would not work. Hence, he was taken to hospital on 07-Jan-2021 and was discharged on 10-Jan-2021.  The patient's wife reported that the treating physician did not determine the cause of the patient's symptoms.  On 04-Feb-2021, the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) via intramuscular route in left arm upper arm for prophylaxis of COVID-19 infection.  On 04-Feb-2021 following the second dose of the vaccine, he could not get out of bed, legs would not work.  Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of the events Could not get out of bed as he lost function of his legs and they would not work was considered resolved on an unspecified date in 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-030097:Same patient, 2nd dose
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for two patients. This is the first of the two reports. A female patient of an unspecified age, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain at the injection site and the arm hurt for a few days. Clinical outcome of the events was unknown at time of this report. Sender's Comments: Linked Report(s): US-PFIZER INC-2017313839 Same reporter/drug/event, different patient.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Sep2021 (Lot number: FF8835) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; METOPROLOL TARTRATE taken for hypertension; HYDROCHLOROTHIAZIDE taken for hypertension; METFORMIN HCL taken for diabetes mellitus; GLIPIZIDE taken for diabetes mellitus. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Pfizer 1- EL0142), administration date: 12Jan2021, when the patient was 73 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Pfizer 2- EL9265), administration date: 02Feb2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : It was reported that patient had taken all three of shots. Patient took last one today and had mentioned that had finished the series and somebody says, how do you know that Pfizer didn't give you a placebo, well the shot patient got came from a pharmacy, they are the one that gave shot patient had doubt that he would give me a placebo but do Pfizer give placebo when you expecting a vaccine. It was reported that there is a product complaint and report is related to a study or programme. Patient had no complications from any injections and remain committed to telling others of what Pfizer is doing for communities all over the world, during this COVID PANDEMIC. Patient remembered when he was employed as a high school graduate back and in training lined up and received our injections as told to do by the medical community. We got so many injections, given to us by injection guns, one after another that was 55 years ago. It was reported that patient have had zero side effects of major concern with Pfizer and not with standing sore arm ex 3 . 1and 2 Nothing.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M028799 with an expiration date 18-AUG-2017 and lot# M032139 with an expiration date 02-OCT-2017 (doses, route of administration and anatomical locations were not reported). Administered doses of ZOSTAVAX experienced temperature excursion of 32 degrees Fahrenheit for 16 hours, on an unknown date. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. Additional information is not expected as the reporter did not wish to be contacted.
Recent foot surgery that was healing very nicely suddenly flared with pain and seemed to reverse the healing that had taken place.
At 11pm, 10/5/21 I woke up uncomfortable, achy and feeling cold and continued to progress throughout the night. By 5am 10/6/21, I woke up with severe chest and back pain, sweats and chills. When I stood up, I began to feel dizzy and light headed. I took 600mg of Motrin shortly after and symptoms started to subside after about 30-40mins.   The morning of 10/6/21, I started having tingling sensations in my neck, upper to mid back, left tricep, left forearm and left hand. Tingling was intermittent throughout the day, along with Brain Fog. These symptoms lasted a few days and started to subside by Saturday 10/9/21, lingering symptoms only in left leg and foot and Brain Fog.   Symptoms in left leg and foot continued until Monday 10/11/21, nearly 100% gone, still lingering discomfort in left big toe.   Contacted Primary Care Physician on 10/11/21 to discuss these symptoms at 7:17pm. Dr. recommended to keep an eye on symptoms and to contact back if symptoms re-present themselves or worsen.   As of 10/12/21, symptoms seem to be improving, continued feeling of brain fog and left foot/toe discomfort.
Gave vaccine 1055 am IM LD, patient c/o nausea, vomiting at 1115 am took vitals B/P, PO x2, glucose, O2 at 2 liters. At 1122 am patient states was feeling better might have been nervous she said.
Within about six hours, started having violent spasms. Each lasting 45-60 seconds, from neck down. Everything would seize up including jaw. Felt like I was having a seizure but completely conscious. Happened every 2-3 minutes until about 5:00am.  Husband had same reaction the next day after his injection.
On 2-19-15 at 4:25 p.m. pt presented with bilateral arm swelling, redness, and warmth. Hard to touch. Dimensions: (L) arm 10x9 inches (R) arm 5x6 inches. Per provider, tx with ice and Children's ibuprofen and RTC if worsens.
Patient received the 5th dose of the Covid vaccine on this day. It was not in our records that the patient received a 4th dose at her living facility in May of 2022 already; verified this in electronic immunization records and our EHR.
Treatment of COVID-19; Treatment of COVID-19; elasomeran (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Lot number: 049l21a), in left arm 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "elasomeran (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4". Therapeutic measures were taken as a result of drug ineffective, covid-19, interchange of vaccine products.  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.
Night of second injection arm pain, redness. Second day entire arm pain, swelling (size of baseball), redness, Second night arm huge red (size of tomato and color), stomach swelling and extreme stomach pains. Third day stomach pain swelling redness. Took benadryl for two days to help with reaction. By day four symptoms cleared up.
This case was reported by a physician and described the occurrence of body pain in a 57-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Concurrent medical conditions included penicillin allergy. Concurrent vaccination included pneumococcal vaccine (non-gsk); Merck; unknown; unknown given on 23 January 2012. Concurrent medications included METFORMIN and Lisinopril. On 23 January 2012 the subject received 1st dose of INFANRIX (.5 ml, unknown route, right arm) and experienced inappropriate age at vaccine administration. The subject was older than the indicated age for INFANRIX. On 23 January 2012, less than one day after vaccination with INFANRIX, the subject experienced body pain, fever and headache. It was not clear if PNEUMOVAX was co-suspect or not. At the time of reporting the body pain, fever and headache were unresolved. Follow up information received from the physician on 22 February 2012. The physician reported that the events resolved on 31 January 2012. The physician considered the events unrelated to the INFANRIX vaccination. The physician noted that the events could have been due to erroneous administration described as the "nurse chose wrong vaccine". It was also noted in the suspect drug section that the subject was "given the wrong dose of vaccine" (no dose in label for subject for this age). The physician selected that no action was taken with INFANRIX, that the INFANRIX was not reintroduced and that the INFANRIX immunization series was discontinued. The physician noted that the subject had not received INFANRIX before.
24hr start of erythema-itching & pain 48hr shows 7cm round, raised, erythematous lesion around 2 punch sites;
Patient reported after 1st vaccine experiencing some itching.  Patient also reported an increase in his BS after vaccine 1.  Provider prescribed Atarax to patient for this, patient had previously been prescribed this as he has had a similar reaction to other vaccines and medication changes.  Patient was seen by provider for high BS, patients insurance stopped paying for his insulin and they were transitioning him to Trulicity.  Patient came to vaccine clinic on 4/13/2021.   Patient was given 2nd dose of vaccine and monitored for appropriate period of time post vaccination.  Patients family reports that patient had been feeling SOB for the past several weeks and more fatigue than usual.  4/14/2021, patient triggered an alert thru the monitoring system, nurse reached out to patient to discuss and schedule appointment for further DM education and appt with provider.  Nurse had difficult time reaching patient, but patient did call back same day and scheduled appt on 4/23/21.  Family reports they went to bed on 4/14/2021, brother went upstairs for bed checked on patient and he was unresponsive.  911 called, paramedics and fire department responded, but CPR was unsuccessful.  Patient pronounced dea 4/15/2021 @ 12:26am.
Missed Period, Feeling warm, diarrhea, abdominal pain, tired all the time, sore throat, headaches. Took stool sample which came back normal, Motrin and rest.
sinus type headache; tired; This spontaneous case was reported by a patient and describes the occurrence of SINUS HEADACHE (sinus type headache) and FATIGUE (tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUS HEADACHE (sinus type headache) and FATIGUE (tired). At the time of the report, SINUS HEADACHE (sinus type headache) and FATIGUE (tired) outcome was unknown.      No concomitant medications provided No treatment medications provided   Reporter did not allow further contact
3 days after vaccination woke up with bumpy rash on face, lips, hands, legs and trunk, no itching, decreased appetite because lips hurt, fever x2 days. TX with Tylenol. 1-31/06 still has rash has DR appt today.
Starting 6 hours after vaccination and persisting thru present (appx 36 hours later): - extreme fatigue, -fever of 104.0°F (even with taking Excedrin 2 tablets/ 4 hours -injection site pain -chills, body aches
Got flu shot on Tuesday 11/3/15. Area around the injection site is warm, sore, and itches. Instructed to take Tylenol and use warm compress.
Chest pain; This is a spontaneous report from a contactable consumer reported for a patient. A 15-years-old male patient received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 09Jul2021 (age at vaccination was unknown) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chest pain. The reporter stated, the patient got the vaccine 24 hours ago and he just mentioned he has little side effect, pain the chest pain and asked what he could do. The reporter was informed about Pfizer drug safety. The reporter was informed about the Pfizer Medical Information Department. The outcome of the event was unknown.