chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Constant headache started second after the vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13May2021 16:00 (Lot number: Ew0168) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (lot Number:  Ee0158, administration route: Intramuscular, Administration time: 12:00 PM, vaccination Location: Left arm, Dose : 01), administration date: 22Apr2021, when the patient was 44 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 15May2021, outcome "unknown", described as "Constant headache started second after the vaccine". Therapeutic measures were not taken as a result of headache.  Additional information: Patient did not have covid prior vaccination. Patient did not have covid tested post vaccination. Patient has no medical history. Patient has not taken other vaccine in four weeks. Patient has taken other medications in two weeks.  Follow-up attempts completed. No further information expected.
shots hurt; This 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 an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient: US2022AMR081873   Additional Information: GSK Receipt Date: 20-MAY-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the dose of Shingles vaccine and shot hurt but so worth it to never go through that again. The patient reported that it was one of the most painful thing he/she ever gone through. Additional supportive information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081873:Same reporter
This is a spontaneous report from a Pfizer-sponsored program. A contactable physician (pediatrician and also the prescribing provider) reported that a 18-year-old female patient received TRUMENBA (lot S26962) on 09Aug2017 at 09:58, at 0.5 ml single, in left arm, for meningitis B prevention (immunization). On 09Aug2017 the patient also received the second dose of MENACTRA and HPV vaccine, both at 1 DF single, for immunization. Prior vaccinations given within 4 weeks were none, as per reporter awareness. The patient previously received the first dose of MENACTRA and HPV vaccine, both for immunization, on unspecified dates, without any adverse event. Medical history included just minor things like pharyngitis, colds, wheezing, that kind of stuff. Family history was none, as per reporter awareness. Concomitant medication were none, as per reporter awareness. On 09Aug2017 the patient experienced headache. On 14Aug2017 the patient experienced tingling, pins and needles feeling all over and was feeling hot. The patient had tingling all over, returned in a few days and the tingling had gone away. The patient returned to the office on 16Aug2017, but was not to be seen for the reported events as she returned to have blood work and to make sure she was not coming down with a virus or something else. She also returned to the office to have it documented that she did have reactions to the vaccine. The patient's mother picked up forms from the office and reported that the patient was doing much better. The reporting physician told to patient's mother that the events were transient and would go away. The events did not require an ER visit or a physician visit. On 16Aug2017 CBC test showed nothing abnormal. Other tests done on 16Aug2017 showed low vitamin D, high total cholesterol and high good cholesterol. Most of the labs were fine. The reporter mentioned that the patient's good cholesterol was a little higher than normal, so that could contribute to higher total cholesterol. Headache resolved on 10Aug2017. The other reported events were resolving at the time of report. The reporting physician considered the events as medically significant and was not sure if the patient's reactions were from TRUMENBA or not. The patient received previous doses of MENACTRA and HPV and did not have reactions to those, thus caller was thinking it may be TRUMENBA. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Breakthrough COVID-19 infection; positive COVID-19 test on 10Mar2023; Breakthrough COVID-19 infection; positive COVID-19 test on 10Mar2023; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID; MELATONIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Mar2023, outcome "unknown" and all described as "Breakthrough COVID-19 infection; positive COVID-19 test on 10Mar2023". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Mar2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient has no Known allergies. Facility type vaccine: Workplace clinic. Patient had not received any other vaccine in four weeks. Patient had no covid prior vaccination. If Patient was tested covid positive post vaccination.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the use of suspect product BNT162B2, BNT162B2 OMI BA.4-5 cannot be fully excluded.
I95.9 HYPOTENSION 1/27/2023 PLEURAL EFFUSION
Since her COVID-19 vaccination series, patient's chronic pulmonary health has worsened.   Specifically, she has developed repeated COPD exacerbations many times twice monthly, and multiple episodes of recurrent pneumonia.   Prior to her vaccination, I cannot find any record of COPD exacerbation or pneumonia in our clinic records or our local hospital, Porton of Medical Center, records. Pulmonary function has declined so much, that myself and her pulmonologist were worried she was developing lung cancer, but imaging including PET scan negative for this.
Body aches; Fatigue; got a headache which lasted for 13 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "got a headache which lasted for 13 days"; PAIN (non-serious), outcome "unknown", described as "Body aches"; FATIGUE (non-serious), outcome "recovered", described as "Fatigue". The events "got a headache which lasted for 13 days", "body aches" and "fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Clinical course: The patient had a 13 days reaction. The patient had to get a CT scan on my head because the headache was so severe. It was like patient could not let head up until yet and the headache last for 13 days. The patient got the first shot and had a terrible reaction that the patient needed medical care. It started with body aches, then got a headache which lasted for 13 days. Also was actually fatigue for 10 of those 13 days. The patient went to the doctor.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained after receiving vaccine that he had redness with swelling to the injection site with pain that goes down to almost his hand. He stated he was not able to use the arm and rated the pain a 10/10. He denies any fevers, shortness of breath, wheezing or joint pain. He has not had reactions to vaccines in the past. Rash, urticaria pruritus and decreased ROM.
Staff walked into resident's room around 10:00am and noted resident's left side of his face was flaccid. Nurse was called and upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard to understand. Physician, hospice, and family were notified. Resident had a stroke at 10:06 am on 1/8/2020. He lost all ability to use his left side. Resident passed away on  1/11/2020.
This spontaneous report received from the nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. Between November 2014 until 03-DEC-2014 the unspecified number of patients was vaccinated with unspecified number of doses of improperly stored M-M-R II (doses, indications, route of administration were not reported). The nurse did not know whether any patients experienced any adverse effects. This one of several reports from the same reporter. Additional information has been requested.
Vaccine adm 1838 after approx 2 minutes, pt feel week, pale and dizzy c/o fainting like sensation, pt alert and oriented x3.  Ammonia inhalers given, PCP informed, pt placed in examination table for recovery.  BP 90/58, SPO2 98-99 at room air pulse 66 bpm.  Pt recovered and d/c home in good condition.  12 minutes - total - recovery time.
Tinnitus continuously since onset. Varying loudness. Both ears.  Visited ENT. No treatment recommended at this time. Scheduled for hearing test.
I'm not sure if this is a result of the vaccine or not.  Beginning 4/25/21, I had intense GI issues, NVD, resulting in a trip to Urgent Care on 4/26.  The PA thought it was gastroenteritis and to follow-up if I wasn't feeling well later in the week.  The following Monday, I went to the ER as I wasn't better, had a CT scan which showed my appendix had burst and abscessed.  I had an emergency laproscopic appendectomy on 5/3, released from the hospital 5/4.  On 5/10 I felt a sharp pain in my lower back that I attributed to a pulled muscle.  After several days of difficulty breathing, intense periodic back pain, I went back to the ER on 5/14 and I was diagnosed with a small PE in my right lung after CT scan.
A patient received her first dose (Pfizer COVID-19 Vaccine), in Dec and before Dec, before her 2nd, before the 21 days she was diagnosed with COVID.; A patient received her first dose (Pfizer COVID-19 Vaccine), in Dec and before Dec, before her 2nd, before the 21 days she was diagnosed with COVID.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "A patient received her first dose (Pfizer COVID-19 Vaccine), in Dec and before Dec, before her 2nd, before the 21 days she was diagnosed with COVID.".  Clinical course:Dates for A patient received her first dose (Pfizer COVID-19 Vaccine), in Dec and before Dec, before her 2nd, before the 21 days she was diagnosed with COVID. When confirmed is it with Pfizer COVID-19 Vaccine: Reporter added, Yes, for the 7Apr to 11Apr. Is there a Product Complaint: Yes.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient called our office on 10/23/23 for advice re: vaccine reaction. He had gotten his covid shot elsewhere on Friday, 10/20/23. Starting 10/22/23, he began experiencing swollen lymph nodes in his armpits, especially on the side he get the shot in. Advised that this is an uncommon, but well known side effect of the vaccine, that it is not harmful, but to keep an eye on it. If it becomes uncomfortable, continues to grow larger, or is not going away, advised to give us a call for further eval.
This is a hospice admit with COVID pna. Placed on HFNC but could not wean. Placed on comfort care. Expired.
Information has been received from a health professional concerning a patient in the sixth grade who was vaccinated with a dose of Varivax. On 31-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 07-year-old child of an unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 08-Feb-2018, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 30-May-2018, dose: not reported) that was stored out of recommended temperature for an unknown indication. The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realized that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
local swelling and inferior Pain, (R) Arm.  Site warm to touch.  No shortness of Breath or fever  No Prior Reactions to Vaccines  Steroid injection given in office  Steroids to start next day orally  Apply cold compress on site  ER for worsening symptoms
1st dose Pfizer 5/6/2021 Lot # EW0167  Patient tested positive for Covid on 12/7/2022 and died 12/19/2022
This spontaneous report as received from a 87 years old female patient regarding herself. The patient's pertinent medical history reported as blood pressure. On an unknown date the patient was vaccinated with ZOSTAVAX, (lot, expiration date and dosing regiment were unknown) subcutaneously. Concomitant therapies included LIPITOR and blood thinner (unspecified). On an unknown date the patient experienced outbreak of shingles, rash, soreness, flaky skin, scalp irritation, and a headache. The patient sought medical attention with her physician. The outcome of the events were reported as not recovered. The causality assessment was not provided by the reporter. No product quality complaint was filed. Additional information has been requested.
Patient fainted approximately 5 minutes after receiving vaccination. Fortunately she was still seated and I was still with her due to her history of fainting with vaccines. We provided an ice pack, bottle of water, and a cold washcloth. I remained with patient for approximately 30-40 minutes after episode and ensured that she was feeling better before letting her leave. Store management provided a cart and she was escorted by an associate and her friend (who was driving her) to the parking lot.
(R) upper arm (entirely) swollen, not red, (+) tender sensitivity to touch, (+) fever.
after 10 minutes of vaccine given while patient was waiting in the waiting room , patient stated that he was not feeling well and I noticed him that he is diaphoresis and pale. His vitals signs was within normal limit BP-100/60,  O2 sat -98, hr -81 and resp rate was16. I  elevated his  both feet/legs and given cold water and sucker- his wife was presents at the time of incident. After 10 minutes patient felt better and he stated that he did not eat anything sine morning and was scared of vaccination. he felt better and his wife drove him home. advised him to go to  ER if noticed any shortness of breath or not feeling well.. he said he is okay.
dizziness, itchy lips and fingers x15 minutes (30 minutes post immunization)
Unknown **unable to interview case or POA, case was admitted to ICU 12/04/2022.**
Initial and follow-up information has been received from a health professional and a physician concerning a 25 year old white female graphic designer with acne who on 24-MAY-2007 received the first dose of the Gardasil (lot # 657737/0522U), 0.5 ml, intramuscularly in the left deltoid. Concomitant therapy include minocycline. On 11-JUN-2007, the patient developed a mild pink rash on her chest, per patient and dermatologist. The patient sought unspecified medical attention. It was reported that the patient recovered "soon after". The physician reported that the rash may or may not be related to the vaccine injection. Additional information is not expected.
FEVER; HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 74 year old female. The patient's weight was 159 pounds, and height was not reported. The patient's concurrent conditions included prediabetes, high cholesterol, overweight, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or drug illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 11-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and muscle ache. This report was non-serious.
1 of 2 children vaxed the same day 6FEB95 from same lot# exp an adverse event; w/in 24hrs pt exp t101, vomiting x 2, & swelling of lt arm (inj site) from shoulder to elbow, erythematous, mottled, warm & tender;pt recovered;
she does have some injection site pain; chills; fever; aches; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (received 1st dose in August 2020, refer case US2020220536). Concomitant products included INFLUENZA VACCINE (FLUBLOK).   On 4th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, chills, fever and general body pain. On an unknown date, the outcome of the injection site pain, chills, fever and general body pain were unknown.   It was unknown if the reporter considered the injection site pain, chills, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in her left arm and had some injection site pain. The patient had some aches, chills and fever.  The reporter wanted to stay anonymous. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220536:same patient
11 y.o. male with history of obesity, asthma, mild developmental delay, nocturia, and esotropia, presented to CHOP on 1/17/22 with 1 week history of nonbloody diarrhea, vomiting, abdominal pain,  headache, orthopnea, dizziness, malaise and lethargy. Two day fever of 38c. In ED the patient was hypotensive to 70s/30s and admitted to PICU. ECHO revealed left  ventricular dysfunction, moderate to severe tricuspid valve regurgitation. Received IVIG & pulse solumedrol, then transitioned to oral Prednisone wean for 10 days on discharge. Additionally treated with epinephrine, milrinone, aspirin, and enoxaparin. ECHO before discharge showed improved cardiac function.
Child developed mild fever 101 degrees two days after vaccination. She was treated at home with childrens Tylenol. Four to five days later her fever increased to 104-105 degrees with mild discoloration of extremities, mottled, purple. Blood drawn WBC's normal. Child sent home. Fever persisted. Saw private physician. Another blood draw revealed streptococcus.
Arm swelled with severe pain 4-6 hours after injection size of silver dollar. Then swelling spread with redness and pain to rear bicep to elbow. Ice did not reduce swelling. Low grade fever and tired no reaction to any other immunizations.
Increased fatigue and SOB 1 week after receiving vaccine, Acute MI 4 weeks after vaccine administration
Information has been received from a pharmacist concerning a 65 year old female who on 28 Feb 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck).  On 08, Mar 2007 (also reported as shortly after vaccination) the patient developed what appeared to be a chickenpox rash on her hip on the same side as vaccination. The patient was also experiencing a headache and described herself as "not feeling well". Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a pharmacist concerning a 65 year old female who on 28-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 08-MAR-2007 (also reported as shortly after vaccination) the patient developed a chickenpox rash on her hip on the same side as vaccination. The patient was also experiencing a headache and described herself as "not feeling well". Unspecified medical attention was sought. The patient was told to take TYLENOL for the pain. The patient recovered sometime the following week "after the vaccination". There was no product quality complaint involved. No further information is available.
Information has been received from the wife concerning her husband (age not reported) who on 20-AUG-2007 (also reported as 16-AUG-2007) was vaccinated with a dose of ZOSTAVAX. On approximately 22-AUG-2007, the patient experienced headaches, dizziness and fatigue. The patient began to feel better after a few days. The patient's wife also experienced adverse events after receiving ZOSTAVAX. (WAES# 0808USA04947). No further information is available.
Pain at injection site with area of erythema; tingling in left fingers 1-3.