chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose / on September 13th 2018 / second dose on December 13th 2018 / remains / with shingles./ suspected vaccination failure; remains until today with shingles; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included acyclovir.   On 13th December 2018, the patient received the 2nd dose of Shingrix. On 13th September 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was a pharmacist intern.  The age at vaccination was not reported. The reporter stated that the patient remained with shingles till the time of reporting. No lot number or expiration date were provided. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and exact time to onset were unknown. The reporter did not consent to follow up.
After receiving immunizations and walking to office to be checked out he became "light headed" fainted hitting desk. Small abrasion R eye brow + bottom lip.
Pt recvd MMR vax on 18OCT90 & devel an anaphylactic reaction & was treated w/Pred & Epi @ MD's office;
Approximately 1 week after shot was given, my son developed a large hive at the injection site, a measles like rash, a high fever 102.5, refusal to eat, diahrrea, puffy eyes, etc.
Lasted from 7 pm till this report posting.  Most severe from 7pm time 1 pm ( scale of pain 1-10) it was a solid 8 going on nine.
I had the first migraine headache I every had in my life. On the 15th of April (middle of night) I went to ER because it would not respond to any meds at home. They gave me an IV Cocktail of three different medications. That was what I needed. Migraine - happened again 2 weeks later. That happened on May 12 and - I went to ER again  - they gave IV Cocktail  and that did what it needed to. No tests were done the second visit.
Thumbprint size welt on arm about an inch below injection site, similar to that of an allergic reaction to bug bites or allergy shots. Fever of 100 for 18 hours starting about 10 after shot as well as chills. Tylenol taken every 4 hours. Sinuses swelled shut as well and headache behind eyes.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients. The patients medical history and current conditions were not reported. It was reported that an unspecified number of patients have received improperly stored doses of LIQUID PEDVAXHIB (strength, dose and frequency not reported) on 15-OCT-2014. No symptoms reported. Product quality complaint was not reported. The outcome of the event is unknown. Thi sis one of the two reports received from the same reporter and linked to case # 1410USA008573. Additional information has been requested.
The second morning after my second covid vaccination in my left arm, my left arm pit was swollen and very sore.  It was painful and warm to the touch.  It took a good three weeks post vaccination for the swelling to reduce.  The pain and redness went away after 5-7 days.  There is still a small amount of swollen tissue in the armpit. About 5 days post vaccination,  I also had some rash around my armpit and chest area. It did not itch.
pt devel gen maculopapular rash mostly on anterior chest & face;no fever, coryza, cough noted;resolved in 48-72hr completely w/no or mild relief from DPH by mom;
No additional AE; Caller reported AE for inadvertent administration of PEDVAXHIB after TE.; This spontaneous report was received from other and refers to a 22-months-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection,lot # W002453, expiration date:24-JUN-2024, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) which underwent temperature excursion before administration (Product storage error). Temperature excursion was in 65.2 Farenheit (F) for 9 hours 45 minutes and 32.4 Farenheit (F) for 42 hours 45 minutes. No additional adverse event was reported. .
PPV was given on 7/14/05 at hospital just before I was discharged, in R upper arm. My arm was sore that night 7/15/05. When I woke up my arm was red, swollen and hot. I had generalized aches, pain. Slept all AM. When I got up in the PM, called doctor and he ordered a z-pack. It took about 3 days but did fully recover.
Severe migraine 5 days Prolonged headache and severe fatigue 3 weeks Runny nose 2 weeks Rash on chest and neck sometimes severe flare ups to todays date, still happening Increase in occurrence of eczema flare ups on arms and legs
I did not have a reaction to the vaccine. I did not have symptoms prior to testing positive. I had been exposed to COVID-19 at my job and with patients. I woke up on 11/30/2022 with a scratchy throat and so nose like I was getting sick with a sinus infection. I tested two times with a home test on 11/30/2022 and both were positive for COVID-19.
Patient fainted due to carry over fear of the needle.  He stated before the shot that he did not like needles.  After the shot I took him to the waiting area to wait for 15 minutes.  After about 3 minutes, he lost consciousness and fell off of his chair.  After about a minute he came to and slowly got to his knees and came to and was able to sit back down in the chair.
The day the vaccine was given she had dizziness all day an seeing black spots an really bad headache. An no till today she still has the headaches everyday an some dizziness not sleeping well.
Patient reported redness and warm to touch about 24 hours later. Also sore to touch.
Pt had fever cough runny nose for two weeks and redness and swelling at the site of injection that subsided.
PATIENT COMPLAINING OF PAIN IN THE ARM NOT GOING AWAY EVEN WITH MEDICATION 10 DAYS LATER.
arthritis flare-up and swollen knees after 1st dose; arthritis flare-up and swollen knees after 1st dose; This is a spontaneous report from a Pfizer. A Non-contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included arthritis. Concomitant medication(s) included meloxicam (MOBIC); aspirin [acetylsalicylic acid] (ASPIRIN, ACETYLSALICYLIC ACID) and arthritis medications a day before first dose. On an unspecified date, the patient experienced arthritis flare-up and swollen knees after 1st dose. The outcomes of events was unknown.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained. No further information is expected.
Gerd Barrett's Esophagus; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from Regulatory Authority (Mfr. Control No.: 21K-163-4105453-00).   A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 18Mar2021 and dose 2 on 23Apr2021, both via intramuscular (Batch/Lot number was not reported) as single dose for COVID-19 vaccination at the age of 57-year-old; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (batch/lot number was not reported) to an unspecified date, at unspecified dose for psoriatic arthritis. In Feb2021, the patient experienced COVID. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient's concomitant medications were not reported.  On an unknown date in 2021, the patient experienced Gerd Barrett's Esophagus. The action taken in response to the event for adalimumab was unknown. Outcome of event was not recovered.  Causality for adalimumab: The reporter's causality for the event of Gerd Barrett's Esophagus with adalimumab was no reasonable possibility. The reporter's causality for the event of Covid with adalimumab was a reasonable possibility.  Causality for bnt162b2: The reporter's causality for the event of Gerd Barrett's Esophagus with bnt162b2 was possible.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the limited information provided the causal association between the event Gerd Barrett's esophagus with the usage of the vaccine BNT162B2 cannot be completely ruled out. The case will be reassessed once detailed information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Patient presented to ancillary facility on 8/22/2021 with shortness of breath and weakness. He was found to be COVID-19 positive. He was treated with Remdesivir and dexamethasone. He was transferred to a higher acuity facility due to an a non-responsive event. He was discharged home on 8/27/2021.
Hospitalized (11.30.21);  COVID-19 positive (11.30.21); fully vaccinated  Admission Date: 11/30/2021 Discharge Date: 12/1/21 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute appendicitis [K35.80] Acute appendicitis with localized peritonitis, without perforation or abscess, unspecified whether gangrene present [K35.30] HOSPITAL COURSE: Patient is a 51 year old female who presented to the emergency room at hospital on 11/30/21 with concerns of 2 days of periumbilical abdominal pain that eventually moved over to her right lower quadrant. Upon arrival to the a CT scan revealed imaging findings suspicious for acute appendicitis. General surgery was asked to evaluate for a potential appendectomy. After evaluation by the general surgery team, it was decided to take patient to the operating room (OR) for laparoscopic appendectomy for her acute appendicitis after discussing the procedure including risks, benefits & alternatives. In the operating room, the appendix was found to be perforated & was subsequently removed without any complications & she was sent to the post-anesthesia care unit (PACU) in stable condition.  Postoperatively patient was slow to progress and had significant abdominal pain as well as tachycardia and diet intolerance.  On the evening of 12/2 we obtained a CT scan of the abdomen pelvis which showed a few fluid collections concerning for early abscess.  IR was consulted and on 12/05 they were able to aspirate only a few mL of fluid.  After this, the patient reportedly had much improved abdominal pain, was able to tolerate a full meal, was able to ambulate and void independently.  She was discharged home on 12/06 with a course of oral antibiotics and the appropriate follow-up and discharge instructions provided.
About 20 minutes after administration of my 2nd dose of Pfizer COVID vaccine, I very abruptly got a sensation that my throat was closing up, broke out in a sweat,  started to feel very disoriented, and had a hard time speaking or completing a thought.  I was still in the waiting area and was able to find a nurse.  The medical staff took me into a room for observation, and checked my vital signs regularly.  At first check, my pulse was over 200bpm.  The nurse gave me a Benadryl, which I couldn't swallow at first.  I couldn't even swallow a tiny bit of water.  After maybe 15 minutes, I was able to swallow the Benadryl.  I stayed at the hospital for a couple hours being observed.  My symptoms started to resolve about 30 minutes after taking the Benadryl, and later that evening, I actually felt better than I did after I'd taken my first COVID vaccine dose.
Swelling in the arm; This is a spontaneous report from a contactable nurse (patient) and a contactable consumer (patient's son). A 42-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as pneumonia vaccination), via an unspecified route of administration in 2012 at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient stated she experienced swelling in the arm from a pneumonia vaccination, back in 2012, she had no lot number or expiry date of this vaccine. The outcome of the event was unknown.  Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.   No Follow-up attempts are needed, Information about lot/batch number cannot be obtained and no further information is expected.
This spontaneous report was received from a Licensed Practical Nurse referring multiple unspecified patients of unknown age and genders whom on unknown dates, received unspecified doses of improperly stored GARDAISL 9 (Lot #, doses, route and sites of administration not reported). This is one of 8 report from the same source. No additional information provided. Additional information has been requested.
her cycle has been stretching over a period of up to Two months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 28Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for Covid-19 Immunization. The following information was reported: OLIGOMENORRHOEA (non-serious), outcome "unknown", described as "her cycle has been stretching over a period of up to Two months". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer). This case involves unknown age and gender patient who experienced allergy to tetanus vaccines and toxoid, while he/she received vaccine TETANUS TOXOID. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect TETANUS TOXOID produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus vaccines and toxoid (allergy to vaccine) <with unknown latency following the administration of TETANUS TOXOID. Other relevant tests included No lab data. Final diagnosis was allergy to tetanus vaccines and toxoid. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus vaccines and toxoid. List of documents held by sender: none.
Patient did not have any reacting at the time of vaccine administration. We have tried contacting to follow up on any reactions but parents have not answered our calls.
The patient received an expired dose (12/31/2021). No adverse events reported at this time.
I have been light headed and lethargic for 2 weeks now. Started with headaches and exhaustion. Still tired and unstable. Hard to concentrate and keep my balance.
maladministraton after expiration; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a male patient who received Men B NVS (Bexsero) (batch number abxa87az, expiry date 31st January 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 2nd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The reporter reported a maladministraton of bexsero after expiration date to the patient, which led to expired vaccine used. The reporter consented to follow up.
muscle aches, malaise, unexpected vaginal bleeding, joint pain,  congestion, general feeling of being run down and unwell
This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site muscle pain and injection site muscle reaction. On an unknown date, the outcome of the injection site muscle pain and injection site muscle reaction were not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain and injection site muscle reaction to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX vaccine on an unknown deltoid. The patient was due for 2nd dose of SHINGRIX vaccine but at the time of reporting had intermittent muscle pain and weakness at the site of 1st dose of SHINGRIX vaccine. The reporter consented to follow up. The healthcare professional did not have immediate access to lot number or expiry date.
Had MMR given along with Prevnar and flu vaccine (NOS on 10/15/2005). Office visit: 11/1/05 C/O runny nose 1 weep rash 3>2 days, fever on 2 week
at the point of the injection site, my arm hurt, itches, swollen,  and red.  Today is Saturday, March 4 and the redness has grown.
pain; swelling; chills; rash; itchy; This spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant and treatment information not provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I had fever, cough, tired, I went to the doctor and gave me medicine for 5 days but after the 12 day I tested Positive again. On July 18 I had the first home test, and it was positive, on July 22 another test was negative and on July 28 the test was positive. I had stuffy nose and cough.
Getting ready for bed 10 to 10pm chills,unable to get warm - woke middle of the night - everything ached.  1230 pm 10/8/08 less achy with 3 Ibuprofen, no chills.  Feeling better today, slowly improving.
Headache started 4/11/2021 approx 10:30 - ice packs to top of head, over eyes and back of neck, ended 4/11/2021 approx 1600; Nausea started 4/11/2021 approx 10:30 ended 4/11/2021 1600; Malaise started 4/11/2021 approx 10:30 ended 4/11/2021 ended 1600 sips of water throughout day and nibbled on saltines; photosensitivity (lights brighter than usual) started 4/11/2021 approx 10:30 ending 4/11/2021 1630; Bilateral eye pain started 4/11/2021 10:30 ending 4/11/2021 16:30 pain scale 7 (0 no pain, 10 extreme pain); Hot flashes started 4/11/2021 0800 ending 4/20/2021 0800
upon receiving the vaccine the patients arm immediately turned green and formed small blisters underneath the skin at the injection site. Patient denied previous adverse reactions to any previous vaccines however reported feeling not well after a vaccine for typhoid years ago, patient could not state exact time. 1125 patient bp 211/114, pulse 100, respirations 20 temp 97.8 oxygenation 98%. Patient reported anxiety. Po benadryl offered but patient refused. Patient reassessed bp 172/118. Pulse 69, resp 18, temp 97.8, spot 96%,  patient was offered water and taught deep breathing and relaxation techniques. 1210 pm patient stated he was "feeling much better".  Site reduced to a small bruise. Pt educated on locL reactions and scheduled for second appt. Consulted with medical director before booking second appointment.  Final VS 158/112, pulse 70, resp 18, temp 97.2, oxygenation 98%.
Skin red, hot, and swollen down along arm. Was itchy but has resolved. Fatigue
Large red area on administration arm with swelling and warmness which started about 2 days after administration; this is the 2nd consecutive year that she has reacted to high dose.
Excessive drowsiness starting about 11 hours after dose and lasting for approximately 6 hours Chills starting 14 hours after dose and lasting approximately 6 hours
Patient hospitalized with COVID-19 pneumonia on 11/8/2021 despite being fully vaccinated.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 62 years 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), 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 included: "PreDiabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 23Feb2023 to 27Feb2023 for COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.
p/vax pt devel fever of 100.5, chills, groin pain & severe pain to lower abd to lt testicle;pt exp hematuria;pt devel orchitis, prostatitis, epididymitis;poss d/t vax;
Redness and swelling to left arm with 2 1/2x2cm induration and 7x8cm erythema, warm and tender to touch. 4/14/14 vaccine site clear