chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several colleagues got the Covid vaccine and tested positive; Several colleagues got the Covid vaccine and tested positive; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot Number: GN6204 and Expiry date were not reported), via an unspecified route of administration, on 08Apr2021 as dose1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8736; Expiration Date: 31Jul2021), via an unspecified route of administration, on 29Apr2021 as dose2, single for COVID-19 immunization. The patient medical history was not reported.     The patient's concomitant medications were not reported. Stated that she received the first dose on 08Apr2021.and received the second dose on 29Apr2021. She tested positive after the second dose. Stated that she developed Covid on 06Jul2021. Stated that she has to call colleagues when they get Covid. Stated that in the past several days several colleagues got the Covid vaccine and tested positive. Stated that website will not accept Pfizer her Pfizer email. Stated that she reported two yesterday without a problem. Does not have reference numbers from the website from reports yesterday. Stated that the colleagues call in to report this and she follows up. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Jul2021 got the Covid vaccine and tested positive.  QA Review and Rationale: The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot ER8736 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot ER8736, fill lot EP8688, and the bulk formulated drug product lot EP8585. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8736 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8736, fill lot EP8688, and the formulated drug product lot EP8585. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
SEVERE CHEST PAIN emanating from solar plexus area. Head/Neck/Body aches, chills/fever, nausea, loss of appetite,  difficult to breath, sleep and urinate. Dr. told me I have a virus (unknown). COVID-19 Rapid Test- None Detected.  LAB RESULTS - 11 anomalies; P02 Venous-23 low, 02 Saturation-43% low, RBC-3.77 low, Hemoglobin-11.7 low, Hemocrit-39.5% low, MPV-7.3 low, Potassium-3.3 low, CK-293 high, Alkaline Phosphate-29 low, Amylase-108 high, Leukocyte Esterase- Trace. Script for 2 days med for nausea and released after 4hours. Symptoms lasted 8 days.
After 10-15 minutes, patient ready to leave, then he said he feel faint sweat, hand tremor. He sit there for another 10-15 minutes he feel better. BP at that 101, D-60. His wife came to pick up and leave.
On 11/13/2021 later on in the day started getting a pain in my left armpit, felt like whenever I put my left arm down the circulation cut off, there was no lump. The pain lasted for 4 days, and now is gone.
Patient was vaccinated with Pfizer COVID-19 vaccination in error at the age of 15. Patient came to the clinic with both parents. The griage/triage person, table screener and nurse all missed the month and day of his birthdate. The error was discovered in post-dose observation during a casual conversation with nursing staff. Patient was observed for 60 minutes post-dose in abundance of caution, during which time he and his parents were notified of the error. They were instructed to seek medical assistance after discharge in the event of an emergency, and that Patient is not to obtain his second vaccination until is 16th birthday or after. Patient was discharged without any untoward symptoms or problems.
Redness; swelling; severe itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (severe itching) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (severe itching). At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (severe itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.     Treatment details was not provided.  Event outcome was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
Mom reported that symptoms started about  half hour after the vaccinations were given.  She said the thigh areas where the shots were given  had become hard and purplish color.  Child was fussy and had a fever later that night. Symptoms had resolved 18 hours later.
p/vax pt exp excessive swelling; pain; erythema & heat at inj site w/restriction of motion of rt elbow joint;
Fatigue; body aches; low grade fever of 100.3; pain at injection site; This is a spontaneous report from a contactable consumer. A 69-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266), via an unspecified route of administration on 24Feb2021 15:00 as SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included: Paroxysmal Afib and mild COPD. The patient has no allergies. The patient received first dose of bnt162b2 (Lot Number: EN9581) via an unspecified route of administration on 03Feb2021 at 12:45 as SINGLE DOSE in right arm for covid-19 immunization. The patient did not receive any other vaccines in four weeks prior to the COVID vaccine. Concomitant medication(s) included: levothyroxine sodium (SYNTHROID), apixaban (ELIQUIS), metoprolol succinate (TOPROL) and umeclidinium bromide, vilanterol trifenatate (ANORO). The patient was not pregnant at the time of vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19. On 25Feb2021 10:00, the patient experienced fatigue, body aches, low grade fever of 100.3, pain at injection site. The patient underwent lab tests and procedures which included body temperature: 100.3 on 25Feb2021. The patient did not receive treatment for adverse events. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Received H1N1 vaccine 1456 called back at 1530 c/o hives, itching and heated sensation to arms, neck and chest. Advised to seek medical attention. Called back at 1600 when arriving at Hospital c/o racing heart, hard to swallow.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Doses of PNEUMOVAX 23 (dose, frequency, lot# and route were not reported) which were exposed to temperature outside of the recommended range, were administered to unspecified patients on unspecified dates since 09-APR-2015. No adverse experience had been observed or reported. No product quality complaint (PQC) was involved. This is one of several cases reported by the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patient's current conditions and medical history were not provided by the reporter. On an unknown date, the patients were vaccinated with multiple doses of improperly stored M-M-R II (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown). The temperature and time frame to which vaccine was exposed was unknown by the reporter. There was no previous temperature excursion. No adverse events were reported. Digital data logger was involved. It was reported that there were multiple lots involved. There was no product quality complaint (PQC) involved. It was requested to send copies of data logger information as opposed to multiple excursion forms. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003605: US-009507513-1708USA003607: US-009507513-1708USA003604: US-009507513-1708USA003603: US-009507513-1708USA003606.
Multiple Open Wounds with Red Rings, White crusty scabs from date of shot to the present.
I had the vaccine that month 3 weeks earlier, and had a 24 hour fever and 48 hour cough. Heart palpitations followed after the vaccine.   The main issue of me reporting this is that I had leg pain when I had the 2nd vaccine shot including the above fever, cough, and heart palpitations. I didn't report this to a doctor because I took aspirin for a week and it went away. Plus i'm a man so I am stubborn as hell. But seeing the need to report if symptoms arise from what I saw in a article, I thought I should do so.
This spontaneous report as received from a pharmacist refers to a 26 year old female patient with no drug reactions or allergies. On 12-AUG-2014 the patient was vaccinated with PNEUMOVAX23 lot # K005797, 0.5 ml, intramuscular. On 12-AUG-2014, patient experienced immediate flushing of her face and arms after administration of PNEUMOVAX23. Patient sought medical attention in pharmacy. None lab diagnostics studies were performed. At the time of the report the outcome of the event was recovered., reported as the symptoms resolved quickly without requiring medical treatment. Additional information has been requested.
A few hours after the flu shot vaccination I experienced sharp shooting pains up & down the vaccinated arm which encompassed the entire arm into the base of the hand. The pain migrated to left side of my chest but that pain was less severe. I called Doc-on-call and took some pain killers and antioxidants. The pain subsided over the next few days but arm was sore for at least a week afterward. My father mentioned he had a similar experience after his flu shot.
Patient called regarding possible reaction to Janseen COVID vaccine on Friday.  Patient stated between 2:00 pm and 2:30 pm on Friday he started experiencing  joint pain in his left wrist that felt like he "sprained" his wrist.  Patient denies any injury.  Patient also noted some slight swelling in this area.  Patient took Aleve and stated the symptoms went away mid-morning on Saturday.  He denies any other symptoms.
7-10 minutes after vaccine patient becae flushed, diaphoretic , nauseated and started vomiting. Mildly hypotensive BP 101/60. Symptoms resolved after 30 min with IM dose Benadryl and promethazine. BP on discharge 122/70
5 days after vaccination, patient unable to bear weight on either leg. No pain, swelling, bruising or injury. Admitted to the hospital to rule out Guillan Barre Syndrome. Cerebrospinal fluid evaluation and MRI normal. .CPK elevated in 400s. Symptoms resolved within 48 hours with rapid decline in CPK. Working diagnosis of myositis.
pt recv vax 28AUG95 & 17JAN97 pt devel a significant case of chickenpox that consisted of 100 lesions & a fever;pt recovered from sx on approx 23JAN97;
Vesicular rash in dermatomal distribution on thigh appears to be varicella zoster- culture sent. Seen on 4-26-04. Treatment with Acyclovir.
On last Thursday 7/11/22 I came inside from working out in yard. I thought I had just seasonal allergies flaring up. My wife suggested I take an at home test, which was immediately positive. I called my doctor immediately to see if I qualified for any sort of special treatment. I was connected to nurse helpline. My symptoms were significantly worse the next day. I was prescribed PAXLOVID. I started that Friday. I took 3 doses and stopped due to the steroid inhaler I am taking. I was told it could affect my heart. I then had the monoclonal antibody infusion. Symptoms were fatigue, congestion, extreme headache, cough. After first two doses of PAXLOVID I did start to feel significantly better. I am significantly better today and sleeping well.
pt recv vax;devel pain,redness,swelling in lt arm around inj site;arm swollen,red down to upper arm;back pain,spasms in upper lt side of back;not resolved w/apap & cold compresses;to MD;on motrin & warm soaks to arm;also rash 6 days p/vax;
Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Headache-Medium, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient called to report that she had pain on her arm and back of her neck.She says that she experienced the same symptoms last years when she got the flu vaccine at pharmacy.3 years ago, she experience severe flu like symptoms. Patient is reporting her symptoms so she can get a document from us that proves that she is allergic to the flu shot so she can submit it to the school. I refered the patient to her PCP.
Pt recvd vax & 3-4 hrs p/inject exp urticaria w/itching; seen by MD Atarax was prescribed but not taken; sx resolved on its own w/in 1 day;
Ordered to received Dtap #4. Was given Pediarix, Polio and Hep B vaccinations were up to date. Required no medical treatment.
Upon going to bed, I experienced severe chills and shaking for 5 hours.  Also severe headache, jaw, body and neck pain.  Lymphnodes were swollen.  Body aches; fever and nausea and fatigue.  This lasted until 8 pm the next day (4/22).  I am still experiences chills, fever, nausea, fatigue and general malaise as of 4/23/2021
Within hours upper arm became red and swollen. Progressed to involve lower arm extending to just at the wrist. Sore to touch. She went to urgent care 5/1/18, placed on antibiotics. I saw her 5/2/18, no change in therapy. Patient phoned 5/3/18- improving.
@10:30am-onset of headache, body aches, mild fever. Lasted all day. 9:30pm began to have scratchy throat, mild body aches and mild headache.  Next morning- 08/11/2012- Woke up at 7:00am with swelled tongue, throat and uvula. Throat felt covered with mucus/film.  Throat felt sore, voice sounded like throat was swelled. Body aches were more severe with feeling of fever.  Called advice nurse and instructed to take 50mg Benadryl..Swelling went away after taking it. 12:30 feeling a little better. Injection site still sore and still not feeling well, but no swelling in throat.
I have never had anything like this. I was having gastric discomfort, I was extremely dizzy, I could not even stand up. The dizziness lasted for 2 days after I got out of the Hospital. I was so dizzy I had fallen down, it was very alarming, I could not get up. I had to roll over to get up. It lasted for 2 days.
This case was reported by a physician and described the occurrence of dizziness in a 32-year-old female subject who was vaccinated with Engerix B for prophylaxis.  Concurrent medication included an unknown diet medication (Diet Pill).  On 27 February 2007 at 11:15 the subject received 3rd dose of Engerix B, intramuscularly, in the left deltoid.  About 85 minutes after vaccination with the 3rd dose of Engerix B, the subject experienced dizziness.  At the time of reporting the event was resolved.  Follow-up information was received on 10 April 2007 via a physician, who reported that the subject received her 1st dose of Engerix B on 08 March 2006, and her 2nd dose of Engerix B on 05 April 2006.  In addition, the physician stated that the dizziness lasted for approximately 30 minutes and may not have been related to the Engerix B injection.  After receiving fluids (unspecified) and rest, the symptoms improved.  The subject has no history of alcohol or tobacco use.  The physician indicated that the subject's medical history and/or concurrent illness of dehydration may have been associated with the event.
a big red patch the size of a hand around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE RASH (around the injection site). At the time of the report, VACCINATION SITE RASH (around the injection site) outcome was unknown. Not Provided      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.   This case was linked to US-MODERNATX, INC MOD-2021-089236 (E2B Linked Report). This case was linked to MOD-2021-089409 (Patient Link). Sender's Comments:  US-MODERNATX, INC MOD-2021-089236:
This spontaneous report as received from a health care professional refers to an unspecified number of patients who were vaccinated on unknown dates with unspecified doses of RECOMBIVAX HB that were improperly stored. No adverse effects reported. No further information provided. Additional information has been requested.
sick; 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.  A 55 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient woke up the next morning and said her arm really hurt. She went to the bathroom and then fainted, fell to the ground, and hit her head. She had a very, very high fever. I treated the fever with Tylenol. I noted she was menstruating.
Tested positive for covid 19; Tested positive for covid 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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) all with onset 15Aug2022, outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective and COVID-19 and included treatment with PAXLOVID. The patient stated he was feeling well and experiencing very mild symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse symptoms reported; The patient was vaccinated with expired M-M-R II; This spontaneous report as received from a other health professional referred to a patient of unknown age.    On 16-APR-2019 the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N010495 for prophylaxis.       On 16-APR-2019, 1 day after onset of therapy the patient experienced expired product administered.  The outcome of expired product administered and no adverse event was unknown.
Case number PHEH2012US013227 is an initial spontaneous report received from a nurse on 27 Jun 2012: This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: not reported) on an unspecified date in Jul 2011. It was reported that nurse vaccinated her again with MENVEO (batch number: M10062) intramuscularly on to unspecified site on 27 Jun 2012 without realizing that she had been vaccinated in Jul 2011. No adverse event was reported.
Noticed redness (3" x 2") area and soreness in Lt deltoid this A.M. Swelling and redness better than at 7:00 AM. Advised TYL. Q 4 hrs. prn for soreness and BENADRYL 25mg x 1 dose. Area very warm to touch. Advised see MD if no better tomorrow.
It was reported that a 22 year old female pt received a Menomune vaccination on 03/28/2001 at 11:40am. Reportedly at 1:42pm that same day the pt felt tightness in chest area, up towards her neck. Elevated her feet (sitting) and gave her juice. Took her vitals (okay). Symptoms subsided-pt thinks she was nervous. The pt reportedly recovered from this experience.
Large dark red raised welt approximately 4 inches wide and 3 inches high above injection site.  Itching.  Very firm to the touch. Color and swelling diminished after a few days but still able to see redness 3 weeks later.
rash consistent w/varicella buttocks, thorax, scrotum, extremities, papules/vesicles w/some scabbed;negative fever;no treatment;