chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs) received from contactable pharmacists reported for a 47-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at 0.3 ml, single for covid-19 immunisation. There were no medical history and concomitant medications. The patient received the first dose of the vaccine and then few days later in Jan2021, tested positive for COVID. The patient was scheduled for the second dose this weekend, on Saturday. They wanted to know what the patient should do and if he should get the second dose. Outcome of the events was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Flu Like symptoms , felt like throat was closing, metalic and salty taste. lips tingly.
I woke up on the 16th with a migraine headache in the back of my head just on one side. It felt like someone was hitting in the head with a hammer. Then over a few hours I started having issues focusing one what I was doing. That night I had a low-grade fever 99.6. Then I was exhausted and then the cough started that same night. I couldn't sleep throughout the night of the 16 or 17. I went to the doctor, and he told me to isolate and treat the symptoms. I was tested for COV-19 in the office, and it was in fact positive.  I had no appetite and couldn't get out of the bed. I was having difficulty's walking down the stairs felt dizzy lightheaded.  I just sat and laid down for two days because I was so tired and confused. I started taking Advil for the migraine, and Delsym Cough Syrup to help with the cough. It actually did help but it didn't go away completely. By day 3 I still felt bad but not as bad. I was able to work some on day five from home but not back to my original self. I felt bad for about a week and the cough lasted for a week and a few days and I also had a runny nose.
3/28/21 Upset stomach, low grade temp of 100. Symptoms resolved by3/30/21
Intern gave patient her covid shot around 12:30 and moved her to a chair. In about 2 mins, pharmacy team was notified of pt drooping out her chair, jilting and siezing. Pt awoke and was unaware of what happened but stated her chest felt heavy and her vision was very blurry and worsening. Team checked her  BP (77/50), gave her water and neck support to stabilize her, called 911 and was transported to hospital.
After 12 hours of receiving the vaccination, my legs felt heavy.   The bottom of my right foot felt numb after standing for a little time. The feeling of heaviness continued, but I was able to walk and completed my daily activities. My right arm felt painful similar to receiving a tetanus shot, I took some Tylenol and drank some coffee and felt better. However, the feeling of heaviness in my legs continued. On Sunday, my left leg continued to swell and I noticed that the area under my knee cap and above the upper part of the rim of my socks was visible swollen, red, and painful.  I took some Motrin and the swelling improved. Later, I noticed I am having musculoskeletal pain and general body aches that improve with Mortin but returns. I am able to continue with my ADLs
Lupus; Obstruction breathing; Lips were swollen; Hives on face/ huge welts all over body; Fever; A spontaneous report  was received from a consumer concerning a 20-year-old, adult female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lupus/systemic lupus erythematosus, fever/pyrexia, hives on face/huge welts all over body/urticaria, lips were swollen/lip swelling and obstruction breathing/obstructive airways disorder.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On  an unspecified date in Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: Unknown) for prophylaxis of COVID-19 infection. On an unspecified date in Feb 2021, Patient received the second of two planned doses of mRNA-1273 (Batch number: Unknown) for prophylaxis of COVID-19 infection.   On an unspecified date in Feb 2021, within 24 hours after receiving the second dose, patient experienced fever, hives on face/huge welts all over body, lips were swollen and obstruction breathing. The patient went to the ER and was given unspecified steriods and Diphenhydramine and the patient went to the ER (emergency room) on 19 Mar 2021 because she had another reaction and the doctor confirmed her that the vaccine triggered lupus. The event lupus was considered as medically significant.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The  outcome of the events, lupus, fever, hives on face/huge welts all over body, lips were swollen and obstruction breathing was unknown at the time of this report.; 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.
03/05/18 approximately 2 PM, SHINGRIX was reconstituted with Sterile Water (LOT M004656 expiration 8/13/18 from Merck) and administered to patient instead of the Adjuvant. GlaxoSmithKline was contacted and said they had no studies to provide with sterile diluent. I then contacted the CDC where they stated that the vaccine was ineffective and to re-vaccinate patient (sent e-mail as documentation). I then contacted patient to have her aware of the situation and she was understanding and had no reaction. 03/06/18 Dr. was contacted and made aware of the situation and said to re-vaccinate patient. Our District manager and Health Supervisor are also aware of what had happened.
EXtreme Dizziness since Monday morning at 6:30am it is now 9:00pm Tuesday evening
Pt stated that she experience pain in the left arm Sat eve and by Sun eve she had redness 8" in length down arm (from deltoid) and 4" wide, very warm to touch and had limited mobility. Placed on Amoxicillin and Prednisone on Mon. am.  According to nurse who administered vaccines, the pt insisted that both vaccines be given in same arm.  However, pt denies being offered the vaccines in both arms.
Headache and muscle aches, fever, abdominal pain, diarrhea, vomiting, sore throat, chills, weakness, dizziness, more than 1 wk. Positive H1N1-TAMIFLU 75mg, azithromycin 250 mg.
Information has been received from a physician concerning a 22 year old female who "four months ago" in approximately February 2009, was vaccinated with the first dose of GARDASIL and two months after the first dose, "two months ago" in approximately, April 2008, the patient was vaccinated with the second dose of GARDASIL. The physicist stated that he gave the first dose of GARDASIL and twelve hours later the patient's boyfriend called the doctor and stated that the patient fainted and then could not walk. The doctor sent the patient to the emergency room. A full workup was done. The patient was fine. There was no problems. The patient was not on birth control pills and she was not pregnant. The patient is fine now. Additional information has been requested.
Patient received the Pfizer COVID vaccine dose #1 on 1/14/2021 and within 5 minutes of administration the patient developed itching and a flushed feeling, tingling lips, racing heart rate, and headache.  Patient reports these symptoms lasted several hours and then resolved.
Patient received flu vaccine at 11:40.  Started having itching and hives on arms approximately 25 minutes later.  Returned to flu clinic approximately  12:15, was given 25 mg Benadryl PO (following hospital policy PC914).  Pt has taken 2 puffs of Albuterol inhaler prior to coming back to Flu Clinic.  Keeping for observation. Reached out to department manager to make aware of situation. At 12:32 patient stated her throat feels like its getting tight, another 25 mg Benadryl given at 12:33, patient took another two puffs of albuterol inhaler.  12:40 VS: BP 131/84, HR 77, RR 16, Temp 97.1, O2 sat 98%, breathing unlabored.  12:54 patient states breathing feeling better.   12:10 VS: BP 118/73, HR 78, RR 16, Temp 97.0, O2 sat 97%.   1315: Patient states she feel "a lot better"      13:20: Reached back out to department manager, updated on medication given.  Staff member is headed back to department.   Instructed patient if symptoms re-occur to go to the Emergency room.
After I left the facility, driving home I notice that my back was starting to hurt, so I turned on the heat on my back . When I got home, I had difficulty getting out of my car.  I  sat in a chair and within the next few minutes I was not able to stand. My husband had to come help me get up and stand, there was pain across my lower back like pin needles and up part of my spine. I took Motrin and it helped it subside somewhat not much.  The second day it continued but later started to ease a little but I was not able to walk upright.  Third day, 3/24,  it is starting to ease up and I am able to walk upright, there is still discomfort.   I have contacted my physician to report the issue.
Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 14-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2015, strength, dosage and frequency unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter.  Additional information has been requested. This is one of several reports received from the same reporter. Additional information has been requested.
GBS by report approx 10 days or 12 days p/flu vax given 14OCT93;
Administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that dose administered after 30 day Use By Date or after manufacturer date of expiry. 173 doses were administered. On unknown date the vial was stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received contain non significant information include reporter details updated.
Pt recv vax on 2/3/99; on same day pt exp rashes; tx=Benadryl IM
Covid bivalent vaccine is no longer authorized to be given after 09/12/2023, pt was given vaccine on 09/13/2023
anorexia for several days;fever Saturday 19DEC98 102 ax;irritable since 19DEC98;
Generalized hives, arm pain and swelling, inability to rais arm, redness beyond site. Treated with Ranitidine 150mg, Diphenhydramine, heat to site.
1 mm lump left thigh, noticed a few weeks after vaccines, which led to a doctors visit.
At the site of administration there was fluid oozing from the site. Patient also had some fluid under the skin and it was bubbling up. She also said the site was itchy.
About 10-14 days after receiving 2nd dose of HPV vaccine patient complained of double vision, numbness in hands & feet, tremors, abdominal pain, heaviness in arms, fatigue.  She was seen by doctor Dx-sixth nerve palsy, abnormal MRI, admitted to hospital. 7/14/08-PCP note seen in office 6/2/08-for C/O double vision, 15 days prior seen by ophthamologist.  8/6/08-records received for DOS 6/10-6/13/08-DC DX: ADEM. Presented with diplopia a few weeks prior to admission, seen by optometrist and diagnosed with 6th nerve palsy.  Two weeks prior to admission presented with paresthesias involving all extremities. Diplopia somewhat improved.
Patient fully vaccinated (J&J) but not boosted admitted to the hospital with COVID-19 and associated hypoxia.
Patient's asthma worsened after vaccination - increased cough and dyspnea.  CT chest in June showed multifocal pulmonary opacities.  Bronchoscopy with lingula collapse and 44% eosinophils consistent with chronic eosinophilic pneumonia, now on prednisone.
Pfizer Covid-19 vaccine booster dose administered around 90 minutes beyond syringe expiration time of 11:30am (i.e., after 6 hours from mixing vaccine).
Patient with a past medical history of zero palsy, Lennox-Gastaut syndrome with severe seizure disorder, recurrent aspiration pneumonias now admitted with acute hypoxic respiratory failure following severe episode of epileptic seizures. Out of allergy concerns PO antibiotics were limited to cephalosporins and elected to use Cefdinir (3rd gen) to minimize cross reactivity. Patient continued to improve and only change to his medication is the addition of a course of Omnicef. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
After the administration, I was monitored for 15 minutes and I was fine. I left the hospital, start driving, and suddenly felt that my right arm was heavy, numb, with a tingling sensation. I stopped the car and called the nurse and I was told that it will go away, and I can take a tylenol/motrin. It improved over the next hour and I felt it resolved a few days later but then it returned on 1/18 but not to the same extent, and I also felt intermittent tingling and numbing in my right foot. I also experienced intermittent episodes of fast heartbeats and missing heartbeats since the vaccine almost daily. I was fatigued and extremely thirsty for 3 days but that resolved completely.
Patient received 1st dose of Moderna.  The patient immediately began c/o tongue and lip tingling and swelling.  No difficulty breathing or speaking.   HR: 80, RR: 17, O2: 94% Patient declined Benadryl dose
swelling on the right arm where he got injection Migraine like pain and headache and got lump for a little while and then lum got bigger
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.   This case was linked to MOD-2021-395985 (Patient Link).
At 7:30PM, I was laying on a massage table at an appointment. I noticed my left foot started itching. I tried moving it, but it wouldn?t stop. I started feeling twitching and muscle spasms in my thigh and foot. That continued for about 30-45 minutes. It simmered down, but it started getting painful in the big toe area of my foot. When I got home, I had to take off my shoe due to the pain in my foot. I took off my sock to apply magnesium gel. I noticed my foot felt hot in the side of my foot. The magnesium gel helped with the throbbing. I also propped my foot up while I ate. After I went to bed, I woke up with an awful pain in my foot at about 04:00AM. I applied more magnesium gel and kept it propped up for the rest of the night. When I got up the next morning, it was hard to walk on my left foot. I applied more magnesium gel. I couldn't put a shoe on because my foot was swollen and very hot. When I kept my foot propped up, it hurt but I didn't need to take pain medication. On Saturday, I had an appointment with my acupuncturist and my therapeutic massage therapist. I showed her my foot. She said because of the timing of the symptoms, she thought it was due to the vaccine. She noticed my arm, thigh, and calves were swollen and tight as well. The massage therapist said I was knotted up and tight, so she worked on those areas to loosen everything up again. When they were done, I could put weight on my foot and could walk normally. It lessened the pain as well. The swelling has gone down a bit. I can bend my toes and bare weight on my foot. It's still painful, but it's not as painful as it was before the massage.
This spontaneous report was received from a Nurse Practitioner concerning 2 patients of unknown age. On an unknown date, two unspecified patients were vaccinated with VARIVAX  (lot number and other details unspecified), that were stored improperly again. No concomitant therapy was reported. However, no adverse effects were reported. No product quality complaint was filed. The action taken was assessed as not applicable. The outcome of event was not reported. The causality was assessed as not related to the therapy with VARIVAX. This is one of two reports received from the same reporter. Additional information has been requested.
Three tremors within a minute that were approximately one second each.  The next day five tremors through out the day.  By 12/11/2009 there were at least 15 tremors through out the day.  Although tremors increased in frequency, they did not increase in intensity.  The tremors were visible in the face and I could feel on the back, while I was holding the baby.  Today I have also noticed (12/12/2009) the tremors are also in his legs.  It appears to be the whole body.  There has been no fever associated with these tremors.  Went to the pediatricians office on 12/11/2009, pediatrician was not able to observe a tremor during the visit and said everything appeared to be normal.  There was no treatment.  Tremors are continuing today.  Also observed a diaper with diarrhea this morning.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-MAY-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Approximately 1 to 2 months after my vaccine I started having arthritis type sharp pain in both shoulders that increased over time. The pain has now increased to become a 8 out of 10 pain that radiates down my arms.
Petechial rash, onset 5 days after MMR with worsening over the next 7 days. Still present 20 days after immunization.
I am experiencing severe head and ear pressure. Came on two days after my vaccine and has not gone away.  Went to doctor and they said my ears were both inflamed and the right ear had fluid behind it. So I have been put on ear drops and Allegra D. (Said maybe allergies for the head pain). Took ibuprofen as well 600 mg 3 times a day for 4 days with no relief.  I am on Day 4 of the ear drops with not much relief for my head pressure. Ears have slightly improved but the head pressure is still intense.  At this point I am 13 days out since my vaccine.   Also have arm pain in both limbs. Near the biceps pain comes and goes. This has been since day 1 of vaccine.  I believe all this is related to the J and J vaccine.
Cellulitis. Tx-Cephalexin 10ml BID x 10 days, ZYRTEC, BENADRYL.
About 5 hours after receiving vaccine my chest started tightening like I was coming down with bronchitis.  Developed a dry cough which I still have.  No fever, took a rapid Covid-19 test which was negative.  Chest tightness is slowly going away but cough is continuing.
pt says his neck was itching and had swelling and bumps on his neck.  His body was itching and it would swell and turned red everywhere he would scratch.  he took an antihistamine with helped.  He woke up next day and all symptoms were gone with the exception on swelling and redness in the neck which he has a spot the size of a golf ball.  Pt is still taking the antihistamine.  Pt will contact PCP if symptoms do not subside.
Starting itching then became painful and swollen-pt went to ER got prednisone-swelling has gone down now 7/22/17.
Shortly after injection pt notice red area with a lump at injection site and swelling down to elbow. The next morning she was nauseated, went for a drink of water in her kitchen and passed out. This was witnessed by her husband, an MD. Woke up in a few minutes. No problems since.