chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Palpitations; Facial flushing; Mild shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), FLUSHING (Facial flushing) and DYSPNOEA (Mild shortness of breath) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PALPITATIONS (Palpitations), FLUSHING (Facial flushing) and DYSPNOEA (Mild shortness of breath). In January 2021, PALPITATIONS (Palpitations), FLUSHING (Facial flushing) and DYSPNOEA (Mild shortness of breath) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitants and Treatment medication were reported.
Flu shoot given in left deltoid. complained of pain in rt arm that  evening, then pain spread to both legs and buttocks. She is still havign some pain in back of lower legs, today 02/04/2005"does not wish to see her doctor but does want this reported.
No adverse event; Patient received a vaccine that under went a temperature excursion; Patient received a vaccine that under went a temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion). On 16-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that under went a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that under went a temperature excursion).    Concomitant medication list was not provided.. Patients weight was given as 16.3. Patient was administered vaccine on 16-Aug-2022, site was LQ. It was reported that Moderna COVID-19 vaccine experienced one temperature excursion. Some vaccine was stored in the freezer and other vials in the refrigerator. 38 patients received Moderna COVID-19 vaccine that under went one of two temperature excursions either in the freezer or refrigerator depending on where the vaccine was stored at the time of the temperature excursion.The excursions were picked up by state review of the temperature data logger 2 weeks later after the excursion. Storage condition at the time of the excursion was refrigerated storage. Date vial was moved from freezer to refrigerator was 08-Aug-2022. Maximum or minimum temperatures reached, as applicable was positive 14 degrees Celsius. Excursion duration was 3 hours and 5 minutes. They were administered and discarded. Proposed desired Use by date was 18-Aug-2022. Number of vials/ per doses impacted was 1 vial. The excursion occurred on 07-Aug-2022. The vials were not punctured until they were used for a patient and then discarded. No side effects were experienced by the patient. Treatment information was not provided.
Dizzy, woozy, confusion, muscles burning, joints burning on left side of body, headaches, eyes burning, extreme fatigue, malaise,  sudden food allergies, constant fatigue, congestion,
New shingles vaccine, shot #1: Flu like symptoms: aches, chills, swollen lymph node under left arm.
Information has been received from a registered nurse concerning a 35 year old white female with sulfonamide allergy who on 03-MAY-2007, at 1:15 pm, was vaccinated intramuscularly into the left deltoid with a first dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot 656680/0010u). There was no illness at the time of vaccination.  On 03-MAY-2007, at 2:15 pm, one hour post vaccination, the patient reported experiencing a rapid heart beat, which lasted about one half hour. The patient did not report this at the time she was experiencing it. No treatment was sought or given. Subsequently, the patient recovered from the rapid heart beat. There was no product quality complaint. Additional information has been requested.
I had cold symptoms on Tuesday 11/01/22 that seem to get worse at night. I have a runny nose, head pain, cough, congestion in my chest. In the mornings my chest is really congested, my sleep is really poor, no fever, I feel fatigued, no aches or pains. I tested on 11/04/22 with a home COVID-19 test that came back negative.  I called the nurses hotline for my insurance on 11/05/2022, and she suggested that I treat myself for a cold. It has helped.  The day all of this started I was knocked down by a young teenager before all of this had started. The scraps on my elbow have still not healed from this incident. This was very stressful as there were a lot of people trying to be helpful.
Hurt a little on the first day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24-APR-2023, the patient received the 1st dose of Shingles vaccine. On 24-APR-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurt a little on the first day). The patient was treated with paracetamol (Tylenol). The outcome of the pain was resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2023 This case was reported by a patient via interactive digital media. Likewise. The patient was very happy.  The patient also got the vaccine on Monday It hurt a little on the first day, then patient get relieved with Tylenol and the next dose was going to be in June 2023. The follow-up could not be possible as no contact details were available.
Patient said that she was told by the doctor to come and get a Tetanus Shot, so we obliged. Then when she asked for a shot record, we realized she had the immunization 28 days prior.
Bilateral hand and wrist numbness, weakness and tingling. First onset lasted about 2 hours, has been returning intermittently for shorter episodes or longer but lessened symptoms
Swelling, redness, bruising at injection site 4 hours after. Fever and body aches
This case was reported by a pharmacist via claims management company and described the occurrence of adverse event(s) in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 28 October 2013 the subject received a dose of FLULAVAL (unknown details). On an unspecified date in 2013, within months of vaccination with FLULAVAL, the subject experienced adverse event(s). At the time of reporting the outcome of the event(s) was unspecified.
Client returned to the office to have TB test read & notified RN that site of varicella vaccination from 2 days prior was "red and itchy".  Client stated that this reaction started on 4/8/08 in the afternoon.  She received the vaccination on 4/7/08. She reported no prior history of chickenpox disease or vaccination and was required to recieve the vaccine by her school (nursing degree).  Site was noted to be red, raised, warm to the touch and client reported 'itchy'.  Client denied signs or symptoms of anaphylaxis but was encouraged to go to the ER for evaluation.  Client returned to the office after going to the ER where she reported being told that this was a possible injection reaction and that she should return to the ER if she developed trouble breathing.  The Health District RN instructed the client to contact her physician for an opinion as to whether to receive the second dose of varicella and for an exemption notice for her school of nursing, should the doctor forbid her to receive the second dose.
Fever of 102, headache, dizziness, hives. Treatment: Patient took OTC Tylenol and benadryl.  Awaiting patient to be seen by provider.  Symptoms started around 6pm on 10/5/22 and still present at 10am 10/6/22.
She stated that after getting the Pfizer Covid 19 vaccine her vaginal or genital herpes  has been diminished.; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 14:00 (Lot number: EN6205) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Coronary artery disease" (ongoing); "Diabetes" (unspecified if ongoing), notes: on medicines about 3-years-ago; "vaginal or genital herpes" (unspecified if ongoing), notes: since she was 19, 50 years she had it; "heart attack", start date: 1997 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Batch/lot number: EL9267, Anatomical Location: left arm), administration date: 23Feb2021, when the patient was 68 years old, for COVID-19 Immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "She stated that after getting the Pfizer Covid 19 vaccine her vaginal or genital herpes  has been diminished."; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm".  Additional Information: She stated that after getting the Pfizer Covid 19 vaccine her vaginal or genital herpes has been diminished. Stated that she has frequent outbreak (10 days out of a total month) and to go 3 months on over 50 yr's without having any is wonderful.    Follow-up attempts are completed. No further information is expected.
Time of injection there was a slight increase in heart rate and body temperature. Days later, both taste and smell were altered. Everything smelled of a sweet, yet rancid odor. Taste of certain items was unfamiliar. After three weeks, smell altered to any non-protein items (fruits, vegetables, grains, juices) smell normal while proteins (meats and nuts) still have a sweet and rancid odor and has continued since. Coffee is probably the most rancid smelling followed by anything pork,  then beef, chicken, seafood and turkey. Stool also smells distorted and rancid of a similar nature to proteins.
Within seconds of receiving the vaccine shot in my arm, I felt a feeling of a nerve sensation shooting across my lower face. My lower face, both sides, turned numb. I also instantly got a headache, not severe, the pain was about a 4 on a scale of 1 to 10 with 10 being the worst. After waiting 15 minutes, I asked to talk to a medical person and was directed to an EMT. I explained my facial numbness and he knew nothing about it and just said to see a doctor if it moved to any other part of my body.  Over the following days, my jaw, lips and gums have been feeling a numb tingling feeling, exactly as if I have had Novocain at the dentist and it is wearing off. After one week, the symptoms  were continuing and I was worried, so I called the advice nurse. After explaining my symptoms to her she advised me to immediately have someone drive me to the nearest emergency room. I went to the ER where I was seen by the dr. He did some research and said there have been a couple of other reports of people having these symptoms. He thought they would go away and wasn?t  concerned. It has been 11 days now and my jaw, gums and lips still feel numb and tingly. The feeling comes and goes.
This spontaneous report as received from a nurse refers to a 1 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 15-SEP-2017, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N008823, expiry date: 26-MAY-2018) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA007014: US-009507513-1709USA000054.
Within 12 hours I developed a headache, chills/shivers, and a 99.8 degree fever.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 24 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-SEP-2021, the patient underwent rapid test for Covid-19 and it was tested positive (Suspected clinical vaccination failure and Suspected covid-19 infection). At the time of this report the patient felt very ill and closed to be hospitalized. On 08-SEP-2021, the patient reported that he was feeling much better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192895.; Sender's Comments: V0:20210918333-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
A couple minutes after getting the vaccine the patient complained she was not feeling well. We tried giving her some orange juice to see if that would make her feel better. She started to pass out dropping the orange juice and temporarily became unresponsive. She also had a few minor convulsions. 911 was called and we called a department 50 bringing in the other pharmacist and senior team members to watch over the patient while I had 911 on the line. Patient eventually regained partial consciousness and awareness answering questions. She was able to breath throughout the episode. The EMTs eventually came and got her on a cart administering oxygen and continuing to check her awareness. She was transported out of the pharmacy.
This spontaneous report as received from a company representative who was the patient's mother refers to a 2 year old male patient. The patient did not have any pertinent medical history or drug reactions/allergies and was not taking any concomitant medications. On 03-MAY-2016 the patient was vaccinated with VARIVAX injection (dose, frequency, lot # and expiry date were not reported) for prophylaxis. On approximately 27-FEB-2018 (reported as about 2 weeks ago), the patient had bumps on the back of his left arm. On 13-MAR-2018, the bumps were diagnosed as chicken pox. It was also reported that they have crusted over. It was reported that no lab diagnostic studies were performed. It was reported that the patient sought medical attention and visited an physician. On unknown dates the patient received unspecified treatment for the events. The action taken with the therapy with VARIVAX was unknown. The outcome of varicella was reported as recovering/resolving. The relationship between events and VARIVAX was not provided. No product quality complaint was involved. It was also reported that the patient attended a day care where another child had chicken pox on an unspecified date prior to the patient having bumps.
July 13 I started experiencing headaches and tingling/burning in the head/scalp.  On July 18th I went to Urgent Care and Shingles in the ear was diagnosed.  Could not get antiviral that day so went back to Urgent Care on July 19 and Doctor on July 20 to get antiviral.  Since Shingles were in the ear, I developed Vestibular Neuritis and went on Gabapentin.  The neuritis lasted 6 weeks and I could not work during this time. I have had a few instances where the headache has returned as if the neuritis was beginning again.  I keep a bottle of gabapentin with me if it occurs again then I take the gaba for a couple of days til it goes away. And two steroid injections and two times taking steroids orally for a couple weeks.
Child developed intense redness and swelling at site. Was placed on KEFLEX for potential cellulitis.
Severe joint pain, shaking, lethargic for 2 days; shaking stopped after day 1 (NDC: 59267-1025-03).
Fever, headache, joint pain and stiffness, soreness in right arm at injection site, mild red rash at injection site, fatigue.
Dose 3 10/22/2021,  048F21A,  COVID Positive, began to feel unwell on 04/03/2022 mild headache and a drip in my throat and did feel right exhausted to a 3 hour night.  Positive on  04/05/2022, and negative on 04/12/2022. Still receiving spurts of tiredness.
As described to me by her son: 04-01-2021 received vaccine , no issues, waited the 15 min and said she felt fine.  Left with no issues.  had been to see her MD that morning for routine visit and everything was fine.   04-02-2021: No issues  - felt fine.  Went shopping and out to eat.  Was a bit tired that evening.  Son left her home at 6pm and all was good. 04-03-2021: son text her in the morning and no answer.  Thought she might be in the shower and text again and no answer.  He called her and no answer, so he went over and found her non-responsive laying on her back on her bed with the same clothes she left her with the prior evening.  sheriff's office pronounced her dead on 04-03-2021 with what appeared to have been a  heart attack.
Systemic: Orange Palms-Severe, Additional Details: Pt reported discoloration of hands. her palms has turned orange since the day after vaccine adminstration.
Case number PHHY2011US68816 is an initial spontaneous report received from health care professional on 27 Jul 2011. This case refers to 10 years old male patient. He was vaccinated with MENVEO (batch number: X10031) 0.5ml intramuscularly on 25 Jul 2011. But, he was given only Men CYW-135 liquid conjugate component without reconstituting it with Men A lyophilized powder component. No adverse reaction had occurred following this drug administration error.
EUA Pfizer-BioNTech vaccine reaction About 101 min after receiving vaccine, patient complained of chest pain rated 7/10.
1. arm pain developed over a few hours and increased with time thru the 2nd day then decreased till it subsided. 2. Fatigue began on 2nd day as the arm pain was subsiding, needed daily nap for 4-5 days. 3. on the day after the fatigue subsided had chest pains, severe enough that I took nitroglycerin, which had no effect. After 12 hours of chest pain went to the Emergency Room. After testing and 2 doses of aspirin and nearly 18 hours in the ED chest pain subsided and I was released.
Presented to ED on 6/21 w/ left knee pain.  Doppler demonstrated DVT in left gastrocnemius veins.  Discharged from ED on apixaban and to f/u with PCP.
Headache, Myalgia, NauseaVomiting,  Left arm swollen and hot 2/17 worsening into lymph notes axilla, Fatigue, Earache.  Narrative:    Other Relevant History:
Systemic: Patient stated she felt burning and tingling sensation all over her body-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
On the evening of 10-9-09, child "started having a fever".  100 degree A.  Had developed cough, runny nose & congestion.  Dad says child had a febrile seizure, went to ER & dx with croup - given DECADRON shot.
fever; very bad headache; she slept for three days; If my levels are very high. Antibodies.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 12Feb2021 (Batch/Lot number: unknown) as dose1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; HEADACHE (non-serious), outcome "unknown", described as "very bad headache"; SOMNOLENCE (non-serious), outcome "unknown", described as "she slept for three days"; ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "If my levels are very high. Antibodies.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information- Patient had protein test antibody test. After she got the test run over 6000. Another test done, her number was greater than 20. >20 test result. She mentioned error. She retested month later but everything was still about high end.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a physician concerning a 20 year old male patient who was vaccinated with the first and second dose of MMR II respectively on 15-JAN-1991 and on 02-SEP-1993.  On 09-NOV-2009 the patient developed afebrile mumps.  The patient was diagnosed on 11-NOV-2009.  The patient's fever count was 9 and his Parotitis was bilateral; count 8.  On 11-NOV-2009 the patient's serum immunoglobulin M (IgM) was negative, serum immunoglobulin G (IgG) was 6.14 and serum amylase was 443.  The outcome of the patient was not reported.  Follow-up information has been received concerning the patient who on 11-DEC-2009 (previously reported as 11-NOV-2009) was diagnosed.  The patient's Parotitis was on the left side (previously reported as bilateral).  The first blood work was refused (previously reported as has performed).  This is one of several reports from the same source.  Additional information has been requested.