chrisvoncsefalvay/vaers-outcomes huggingface dataset:
contracted Covid 19; contracted Covid 19; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration in arm left in Apr2021 (at the age of 43-year-old) as dose 2, single dose and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration in arm left in Mar2021 (at the age of 43-year-old) as dose 1, single dose for COVID-19 immunisation was in clinic. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. After 4 months being fully vaccinated with the Pfizer/BioNtech vaccine, she contracted COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive treatment in response to the events. The patient underwent lab tests and procedures which included PCR-COVID Test (nasal swab): positive on 03Aug2021. Outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Chills-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: vision was obstructed for a little. took off mask to get some breaths in and felt better. blood pressure was a little low. water given. followed up a few hours later. pt felt fine.
Swollen arm, hot flashes completely stopped for 6 months, extreme fatigue for 4 months that is still lingering to a lesser degree, vit d levels bottomed out, was unable to lift injection site arm above head for 2 days, headaches, muscle aches that continues, strange bruising, fatigue started at 24 hours and hit me like I was hit by a car, All at once at 2:15 the next day.
Fever to 102 x3 days starting on day 14 after vaccines; febrile seizure on day 16 after vaccines
I received the MDRNA Booster Shot, besides arm pain, I also had sever muscle and joint pain AND developed a rash on my torso, front and backside.
Pt received TD immz on 4/14/03, some pain was noted in imm site L arm that pm. On the next day ? around 1pm pt c/o sudden sharp pain on R side of chet, then later that day pt c/o pain when attempting to move his neck, not applied prior to this per pt or family. Child seen at MD 4/16/03 talked to mom of child 4/17/03 states MD says not related to shot, possibly inflammed muscle from a possible hx playing sports ? child states feeling better today 4/17/03.
joints froze up- barely get to the bathroom; couldn't move the knees; muscle pain; fever; fuzzy mind was very hard to concentrate; fuzzy mind was very hard to concentrate; she was acting all weird and feels like not herself/nowhere near her normal self; blood sugar dropped fast; This is a spontaneous report from a contactable consumer. A 73-year-old female patient (consumer) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: unknown), via an unspecified route of administration on 14Apr2021 (vaccinated at the age of 73 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She described this side effect as "so pretty bad" but not that bad for her to end up on the emergency room (ER). She said that it was hard to pinpoint if the vaccine had really caused the side effects because she has a lot of underlying health conditions. Caller mentioned that the side effects she experienced 15 minutes after getting the vaccine- no side effects experienced, 1 1/2-2 1/2 hours after first dose, blood sugar dropped fast, 2-3 days later had joints froze up, barely get to the bathroom, couldn't move the knees, muscle pain, fever, fuzzy mind was very hard to concentrate. Her neighbor was with her and neighbor mentioned that she was acting all weird and feels like not herself. Everything was just so worst and have never gone through anything like this. Right now, she was feeling a lot better but nowhere near her normal self. She has had several side effects, but nothing bad enough to go to the hospital. It has been bad. The patient wanted to know if the second vaccine will do like the first vaccine. She was trying to decide if she should take it. She wants to, but if the side effects are the same, she does not worse. There have been various things she has experienced, and she would not know how to pinpoint what was a reaction to the vaccine. She does not want to report her side effects. She just wanted to get over to Medical Information. Outcome the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist, via company representative, who refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of live ZOSTAVAX (dose, route and lot# not reported). No adverse event reported. Additional information has been requested.
Pt presented to med center 12/21/09. Stated "had H1N1 shot", don't feel good", "have back pain". Also c/o low energy, scratchy throat. Symptoms started 12/18/09. Tx at ER: DECADRON 4mg, IM. Rx: LORTAB 5mg, ULTRAM 50mg, ELAVIL 25mg. ER Dx: Viral Syndrome (T 98.8 degrees F). Chronic low back pain.
NOT a misfill vaccine incident. Pt lied on consent form 8-21-21 & stated NEVER received covid vaccine.  Rph Ran CAIR on 8-21-21 = no covid vaccine on report, so savon gave pt pfizer shot. Pt came in 9-28-21 for 2nd dose, ran CAIR again & it shows pt got moderna at another facility on 3-16-21. Pfizer dose 9-28-21 refused & pt did NOT get vaccine.
pt adm to hosp ICU 9 hrs p/vax fever 104.6-generalized sz;
Fever, fatigue, severe chills, sweating, nausea, headache, body aches.  1 1/2 weeks after experiranced vaginal bleeding for approximately 4 days with cramping. Prior to the first vaccine I had not had a period in over 7 years.
Starting about 16 hours post-injection, left arm was becoming very sore and painful to move.. almost 24 hours post-injection I started getting strong chills. I was shivering and chattering on the walk out to the car (it was 30 degrees outside). When I got home, even though it was New Year's Eve, I put a light jacket on and sat in my cozy chair most of the evening, celebrated New Year's with the family, then I had to put on flannel pajamas in order to be warm enough to sleep. I usually don't have to wear pajamas to bed. And for most of New Year's Day I kept the pajamas on and a light jacket and I was in my chair most of the day trying not to shiver. The shivering finally stopped late on the First, about 54 hours post-injection. And over the weekend the pain in my arm slowly went away, and by now, one week post-injection, I feel no pain in my arm at all.
Pt recvd vax & exp swelling @ site of inject approx 1 cm in diameter & 0.5 cm raised w/surrounding erythema; 15 mins later the swelling was 2.5 cm w/6cm surrounding erythema; skin was dry & warm to touch compared to lt deltoid; exp pain
had gotten GBS; This is a spontaneous report from a contactable consumer. This female consumer reported similar events for five patients. This is 3rd of five reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had gotten GBS (guillain-barre syndrome) on an unspecified date with outcome of unknown.  In reporter city of 30,000 people, 4 people have gotten GBS. One person was still in a wheelchair.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019264899 Same reporter/products/events, different patients
Pt recv vax on unknown date; post vax pt exp increased blood pressure, flu-like sx, headache, dizziness, fever &malaise; tx=Tylenol.
pemphigus vulgaris; This literature-non-study case was reported in a literature article and describes the occurrence of PEMPHIGUS (pemphigus vulgaris) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:(Redacted)     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, the patient experienced PEMPHIGUS (pemphigus vulgaris) (seriousness criterion medically significant). At the time of the report, PEMPHIGUS (pemphigus vulgaris) outcome was unknown. Not Related      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PEMPHIGUS (pemphigus vulgaris) to be related.    Company comment: This is a literature case concerning a 60 year-old, male patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, according, event of Pemphigus. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Very limited information regarding clinical course of event was provided. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a literature case concerning a 60 year-old, male patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, according, event of Pemphigus. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Very limited information regarding clinical course of event was provided. The rechallenge was not applicable, as the event was reported exclusively after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt with sudden fatigue, tiredness, scratchy throat and shortness of breath with in 2 hr of taking vaccine and lasting 3 weeks with only slow improvement
Tinnitus; vertigo; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE8732) via an unspecified route of administration in the left arm on 25Mar2021 at 13:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced tinnitus and vertigo. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 14Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the events tinnitus and vertigo were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Approximately 5 minutes after the administration of the vaccine, my technician called me over to inform her that the patient was not feeling well. The patient was extremely pale from head to toe, and began sweating profusely. He was conscious (never lost consciousness) and was answering my questions; however, his eyes were closing. I moved him to the administration room and laid him on the clinic bed. I immediately called 911 and informed them of the situation. My intern was standing next to him the entire time and made sure he did not lose consciousness. I asked him if he was having a hard time swallowing or if he had any shortness of breathe, but he kept saying that he was OK. He had his eyes closed for a while, and was pale and sweating for a while. The ambulance arrived approximately 10 minutes later and conducted some tests. He seemed to be a little better, however the paramedics advised him that he should go to the ER next door. The patient refused to go to the ER and continued laying on the bed. After 15 more minutes, he was able to sit down on the chair. He continued to sit on the chair for an additional 30 minutes until he felt better. At that point, his color had come back and his sweating had decreased. Patient stated that he felt completely fine before leaving.
Myalgia fatigue/ redness/ swelling Narrative:  Other Relevant History:
Ringing/humming in the right ear; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 10Apr2021 at 16:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified multivitamin from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 13Apr2021, the patient experienced ringing/humming in the right ear that developed 3 days post the vaccine. It has not improved with time. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing/humming in the right ear was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 01May2021 at 13:00 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
4in dia. rash below injection site w pain appeared 12 days after injection.  Has not gone away yet.
Received shot in right arm, started with intense ear ache in right ear, started having chills, spasms, ear ache worsened, used heating pad on ear, had chills all night, woke up with sweating.
Nausea that came on and continued, loss of appetite, vision problems,  balance problems most significant in early morning 4 am but nausea was the presenting symptom then developed into neuro logic-type symptoms involving coordination, vision and inability to eat due to constant nausea.
Increased fatigue. Warm, swollen, hard lump at left arm that itches and is getting bigger still nearly 48 hours later.
Pt presents for evaluation of area of erythema, swelling, warmth and puritis R upper arm at site of Shingrix vaccine which given 5/10.   Initially area firm. Approximately 48 hours after shot, developed small area of redness which then progressively grew to include almost the entire upper arm.   Describes intense itching.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. PMH significant for hairy cell leukemia, thrombocytopenia, cardiac pacemaker, anemia, ckd stage 2, t2dm, advanced age. Pt was hospitalized at a outside entity hospital in late April due to a fall, and found to have a HGB level of 6, admitted for a transfusion. Was planned to be placed in a ALF. Deceased 5/4 with no cause of death documented.
Patient reported having a hand sized red area that was tender to the touch. Also it felt hard in the center. She reported this 3 days after vaccination.
I experienced deep muscle aches; right side neck muscle very sore and stiff, difficult to move neck; general malaise and fatigue.
6 month old received BEXSERO; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old female patient who received Men B NVS (Bexsero) (batch number abxb35aa, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th May 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 5th May 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comment:  Three month old patient received one dose of Bexsero. Additional Supportive Information: Three month old patient was administered a dose of Bexsero, which led to inappropriate age at vaccine administration and wrong vaccine administered. Discrepancy- The age of the patent was reported as 6 months but as per date of birth it was considered as 3 months.
Body aches, headache, chills, dizzy, fatigue, sweating, runny nose, cough.  I experienced dizziness (20:30) roughly 5-6 hours after my vaccination (14:50-15:00 12/29/2020). I went to bed and woke up around 04:00 with chills, body aches, slight headache, sweating and very fatigued.  The fatigue did not feel like it was from normal sleep or just being generally tired.  I felt as if physically getting out of bed would be impossible or extremely difficult. I got up and went to the restroom to brush my teeth and noticed my eyes were incredibly blood shot and I had trouble fully opening up my eyes.
Hands; arms and feet fall asleep; developed tingling in hands, lower legs and feet; developed fasciculations in lower legs and rest of body; developed tinnitus in left ear; left eye twich; hands and feet have redness and feel like burning. Diagnosed with peripheral nerve hyperexcitability and benign fasciculation syndrome.
This is a spontaneous report from a contactable nurse via a representative. A 70 year old female patient received PRENVAR13 at 0.5 ml single, on an unknown date. Medical history included allergic reaction. Concomitant medications were not reported. On unspecified date the patient experienced localized rash. The reporting nurse asked if the suspect product contains thimerosal. The representative informed her that it does not contain thimerosal. Event outcome was not provided at time of report.
I had two seizures one on Thursday night and one on Friday night. It is very unusual for me to have two episodes back to back like that without there being a trigger. I did not experience any of my normal triggers for it. I was taking my medicine on time and going to sleep at a decent hour (those are my biggest triggers) I will send in another report if I have one again tonight. (mine are only at night) I will be going to see my doctor on Monday since they are not open on the weekend. There is not really any treatment to prevent this. Please do some research on the effects
MATERNAL EXPOSURE DURING PREGNANCY; FEELING UNWELL; SORE ARM; HEADACHE; This solicited pregnancy report received from a patient concerned a 37 year old female. The patient was enrolled in a non-company sponsored study C-VIPER: COVID 19 Vaccines number: C00366). The patient's weight was 79.36 kilograms, and height was not reported. The patient's past medical history included multigravida, miscarriage, intracytoplasmic sperm injection, and in vitro fertilization. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for covid-19 immunisation. Concomitant medications included acetylsalicylic acid, ascorbic acid/betacarotene/calcium sulfate/colecalciferol/cyanocobalamin/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/retinol acetate/riboflavin/thiamine mononitrate/tocopheryl acetate/zinc oxide, docosahexaenoic acid, and progesterone.  On 05-MAY-2021, the patient experienced maternal exposure during pregnancy. On 05-MAY-2021, the patient experienced feeling unwell. On 05-MAY-2021, the patient experienced sore arm. On 05-MAY-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling unwell, headache, sore arm and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and feeling unwell, sore arm, and headache was related.  This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
no additional AEs/no further information provided; expired vaccine fo ROTATEQ was administered to a patient; This spontaneous report has received from a nurse referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 06-MAY-2021, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 mL orally for prophylaxis (lot# 1676324, expiration date was reported and validated as 21-APR-2021; formulation and strength were not reported) (expired product administered). The administered Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) had not undergone any temperature excursions. The administration of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was supported by the post expiry memo. No additional adverse event or further information was provided.
Patient reported pain and bleeding upon vaccination. She had shoulder pain and pain upon shoulder movement. She was unable to lay on that arm while sleeping until 5 days post vaccine. She reported redness and itching at injection site
Sudden onset of severe neck pain and severe headache as well as upper body aches making it almost impossible to get out of bed. Almost unable to even hold head up. Fever up to 102.6 taking a while to get it down with ibuprofen. Got Toradol 60mg for pain and headache. Unable to do anything at all and neck and head pain continued and kept from doing daily activities
Chills, headache, fatigue, lack of appetite and fever.  High fever to 103.6 for first three days; fever of 102 for 2 days, fever of 100 for 2 days.  Thereafter low-grade fever 100 or less for 4 days.
Fever 101.4, fatigue, sharp stomach pains, took Tylenol through 10/10/2013 AM; drank liquids but no solid food for 24 hours-loss of appetite.
Pt stated that they go an infection at the site of injection. The vaccines were given on 11/15/13 and patient call the pharmacy to say her doctor gave her a 10 day treatment of antibiotics on 11/18/13.
systemic body rash on arms, legs, back, trunk started 8PM night of vaccine administration, unresponsive to zyrtec, hydrocortisone cream - went to urgent care and received a medrol dose pak which resolved the rash