chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Jynneos intradermally; Case reference number US-BN-2022-002052 is a spontaneous case report initially received on 24-Aug-2022 from a consumer via Bavarian Nordic and concerns a male patient of unknown age.  The patient's medical history was not provided.  The patient's concomitant medication included Dupixent (dupilumab).  On 20-Aug-2022, reported also as four days ago, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live nonreplicating; batch number: unknown), at a dose 0.5 mL, administered intradermally, for pre-exposure immunization for monkeypox (explicitly coded as 'inappropriate route of vaccination').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 25-Aug-2022 included confirmation of the country of occurrence.  Additional information received from Communications on 25-Aug-2022 included additional information about the vaccine, about the reporter, reference number.  Additional information received from Communications on 01-Sep-2022 included the patient's gender and an additional reference number.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos at a dose 0.5 mL, administered intradermally, for pre-exposure immunization for monkeypox, which is considered as inappropriate route of vaccination. No associated adverse events have been reported with the reported medication error. Incorrect route of product administration is considered as listed per company convention. The patient's medical history was not provided, and concomitant medication included Dupixent. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of Jynneos at a dose 0.5 mL, administered intradermally, for pre-exposure immunization for monkeypox, which is considered as inappropriate route of vaccination. No associated adverse events have been reported with the reported medication error. Incorrect route of product administration is considered as listed per company convention. The patient's medical history was not provided, and concomitant medication included Dupixent. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Woke up in a.m. of the next evening with severe nausea, extremely large pupils to the point of not being able to open eyes, erratic breathing, headache. My husband drove me to Emergency Dept. , administered fluids and watched for several hours.  Began feeling better after approximately six hours in ED.
This is a spontaneous report based on the information received by Pfizer from Sanofi-Aventis Group (1-1510835783). A contactable healthcare professional reported that a 70-year-old male patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 3 hours after receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), it was reported that the patient's arm swelled causing ripped tendons requiring surgery. The patient reported that it took 2 years to recover. The outcome of the events was recovered on an unspecified date. Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, the vaccination with PREVNAR 13 might have played a contributory role in triggering the occurrence of arm swelled causing ripped tendons considering the plausible time association.  However, more information such as medical history and concomitant medications are needed for fully medical assessment.   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 and Investigators, as appropriate.
very sick; nausea; abdominal cramp; low grade fever; headache; feels very tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (very sick), NAUSEA (nausea), ABDOMINAL PAIN (abdominal cramp), PYREXIA (low grade fever) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced ILLNESS (very sick), NAUSEA (nausea), ABDOMINAL PAIN (abdominal cramp), PYREXIA (low grade fever), HEADACHE (headache) and FATIGUE (feels very tired). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Patient is 8 years old and received a Dtap vaccine instead of a Tdap vaccine.
All over swelling both arms, hot and burning sensation. Hive outbreak on face and in throat. Took prednisone, epi pin, and benadryl
11:30 am Patient almost fainted in waiting room after receiving HPV9 and MCV4 vaccine. Patient states he felt nauseous and felt like vomiting. BP 90/60. Patient taken to back room to lie down; wet hand towels placed on his forehead and neck: BP taken again at 11:45 110/70. Mother gave him a candy to suck on. Pt states he feels better now; refused EMS services.
12 Hours after Menactra, pt developed a sensation of tightness over extremities (UE and LE) which developed over 3 days into weakness of B UE and LLE. She was evaluated by neurology who did not believe pt was CXN Gillian Barr. Symptoms revolved over 2 weeks. 01/09/07-records received and reviewed from Dr. for DOS 8/22/06-Impression: 12 hours after receiving meningitis vaccine developed tingling in her left foot and a pressure sensation in her left leg and then tingling in her arms. All of these symptoms have been transient. No evidence of GBS, the paresthesias may reflect a mild reaction to the meningitis vaccination in which these symptoms will probably melt away over the next week
couple hours after getting 2nd dose vaccine, patient called to notify us that she was feeling heavy chest pain on left side.
-pt describes pain started soon after injection and never sub-sided. mentioned pain level increased and leveled to today at drive-thru pt mentioned range of motion is limited to where she cannot raise arm more than shoulder level and pain is a dull intense pain. Pain shoots from back left shoulder blade and generates pain down arm thru to tingling finger-tips
got bacteria pneumonia last month and was in hospital for 5 days; got bacteria pneumonia last month and was in hospital for 5 days; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer Sponsored Program. An 81-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at the age of 74 (unit not provided), via an unspecified route of administration on an unspecified date in 2015 at single dose for preventing pneumonia, pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), via an unspecified route of administration on an unspecified date in 2016 at unspecified dose for preventing pneumonia. Medical history included A fib (atrial fibrillation) (diagnosed a year and a half ago, not on any medication), had heart issues in the past, and went to a heart doctor every year to have tests to make sure nothing else was going on, diagnosed allergies, compromised immune status, respiratory illness, chromosomal abnormalities, endocrine abnormalities (including diabetes). There were no concomitant medications. The patient got bacteria pneumonia last month and was in hospital for 5 days (as reported) on Sep2019 with outcome of recovering.  The patient got sick in Sep2019 and went on 07Sep2019 to the hospital where he stayed until 11Sep2019 (also reported as 07Sep2019 to 11Oct2019). The patient took flu shots and got other shots and went to doctors for all tests and got 6 months checkups. The patient started having a high fever and oxygen levels was going down. The patient went to the doctor and when the doctor saw the chest x-ray results for pneumonia he sent them and they went on to the hospital to have him treated. It had taken a toll on her husband and had taken a while for him to recover. He had a few issues with it and had been gradually getting better. He was given several antibiotics that he took for treatment, and breathing treatments as well. Several tests were made by a lung doctor to rule out and make sure that it was just pneumonia. Those tests came back fine. All of a sudden the patient's weight was going up again, though he lost about 12 pounds in the hospital. The patient's weight was gradually gaining it back. The patient spent 5 days at hospital. The times they received each vaccine was the only time they had received them since they thought they only had to do them one time each. The patient underwent lab tests and procedures which included chest X-ray: pneumonia on Sep2019.
Severe all over body rash, including arms, back, legs, and face. Took benadryl for two weeks, did not subside. Received triamcinolone acetonide injection and medrol pak perscription on 3/22/21. Symptoms have subsided but there is hyperpigmentation on skin where rashes were.
Received the tetanus/diptheria booster on 4/4/05. On 4/5 I experienced pain and that evening developed a fever, chills, and nausea. By the next day my arm was very painful and I couldn't use it. The next day the fever broke but I still had quite a bit of pain in my arm, the site was a swollen red lump. Today is the 8th and I'm still experiencing some pain in the area. I did not take any pain medication but was only told by 3 different providers to only expect some 'mild' pain at the site. I'm concerned about the longterm effects on my health and my liver.
Information has been received from a physician, for the Pregnancy registry for Gardasil, concerning a 26 year old female with pertinent medical history and drug reactions/allergies unspecified who on an unspecified date was vaccinated with first dose of Gardasil (lot # not reported) injection. On an unspecified date, the patient was vaccinated with second dose of Gardasil (lot # not reported) injection. Concomitant therapy was unspecified. Approximately two weeks after receiving the second dose of vaccine, the patient learned that she was pregnant. The patient sought medical attention, she reported the pregnancy to the physician's office. The date of last menstrual period was not reported. The third dose of Gardasil will not be given to the patient during her pregnancy. The patient has not had any adverse experiences to date. Additional information was received from the physician who reported that the patient had a miscarriage. No further information was available at the time of reporting. Upon internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with 0.5 ml dose of improperly stored GARDASIL 9 injection, intramuscularly (lot # L037554, expiration date: 25-DEC-2017). No adverse effects were reported. It was stated that vaccination with GARDASIL 9 was not discontinued. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient called the pharmacy and stated that she had progressive entire-arm swelling that required medical attention and a steroid shot from Dr office. That is all the info we were given, she didn't call back with further info after we left a message.
Mom called and patient had had a seizure lasting about 10 seconds. Mom stated fussy then seized no fever, known hx of seizure disorder, abnormal EEG, sees doctor at hospital. Doc says to have vaccine no tx'ment.
pain in the left arm; A spontaneous report was received from a consumer concerning a 19-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain (pain in the left arm).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced pain in the left arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was unknown.
HAD THE SHOT BUT I STILL GET SHINGLES/ Suspected vaccination failure; SHINGLES, STRESS CAN BRING IT ON; IT'S STILL PAINFUL; BEEN UNDER SOO MUCH STRESS; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant), shingles, pain and stress. The patient was treated with analgesic, nos (Pain Pill (Nos)). On an unknown date, the outcome of the vaccination failure, shingles, pain and stress were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and stress to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shot but still get shingles.  The patient stated he/she had another outbreak over week ago of reporting date.  The patient stated he/she did not get the full-blown outbreak, never less it was still painful, stress could bring it. The patient stated he/she has been under so much stress. A pain pill helps reduce the pain, if they did like other times in a week, they should get better. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Covid Testing 17Jan2022 result: Pos; Covid Testing 17Jan2022 result: Pos; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 21Apr2021 as dose 2, single (Lot number: EWO169), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: EWV183) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "CSF Leak out left nostril", start date: 2017, stop date: 07Jul2020, notes: Surgery to patch hole, medication for headaches and pressure; "Headaches" (unspecified if ongoing), notes: Headaches; "anxiety/depression" (unspecified if ongoing), notes: anxiety/depression. The patient's family history included: "high blood pressure" (unspecified if ongoing), notes: high blood pressure (mom+dad); "obesity" (unspecified if ongoing), notes: (Mon and dad); "Diabetes" (unspecified if ongoing), notes: Grand parents. Concomitant medication(s) included: ACETAZOLAMIDE oral taken for headache, start date: Jul2020 (ongoing); LAMOTRIGINE oral taken for depression, start date: Apr2021 (ongoing); AMLODIPINE oral taken for hypertension, start date: Jul2020. The following information was reported: VACCINATION FAILURE (medically significant) with onset 17Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 17Jan2022, outcome "unknown" and all described as "Covid Testing 17Jan2022 result: Pos". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Jan2022) Positive.
Any problems until a week later i got arm got red and hot and now it has spread and gotten quite large.
Dizziness, weakness, pounding heartbeat, more-than-usual pain in left arm, pain in neck, nausea, and  chills and fever for several hours. All symptoms ceased in a few hours except fever which decreased but remained for three days.
Pain at the injection site when arm moves on certain position.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 11:00 (Lot number: FH8027) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: EL 3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FL 3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, for COVID-19 immunization.  The following information was reported IMMUNISATION (non-serious) with onset 29Nov2021 11:00, outcome unknown; VACCINATION SITE PAIN (non-serious) with onset 29Nov2021 19:00, outcome unknown. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: It was reported that the event started around After the 8 hours. Around 7pm that same day. The patient had no prior vaccinations within 4 weeks prior to the vaccination and had no other medications the patient received within 2 weeks of vaccination. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Every time got sick; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involves a patient of an unknown demographic who got sick every time (Illness) after receiving INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route in unknown administration site.   On an unknown date, (unknown latency) it was reported that every time got the flu shot would be down sick as all get out for a week with the flu. The last 4 years had not got the shot had not got the flu.   No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Client began to have neck and back pain.  Headache and chills developed overnight. Her primary doctor was called in am of 05/07/2015, with instruction to go to the ER where she was treated and released.  Spouse was instructed to call Public Health and county so that a VAERS report can be made.
2 hours after receiving Menincoccal mening vaccine patient experienced pain in the left axilla. A few hours later a few bumps noted. The next day bumps were pustules. A Z-pak was given, avoid deodorant, use antibacterial soap
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients medical history was not reported. On an unknown date, the patients were vaccinated with RECOMBIVAX HB (therapy type, dose, route, lot# and expiration date were not reported), exposed to 50.5 F for 77 hours and 44 minutes. Concomitant medication was not reported. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
started getting repaired herpes breakouts on lips for the first time since college, and constant shingles attacks on hips, sacrum. these persist even now.
Patient was admitted in hospital on Oct. 14, 2008.  He is still in the hospital.  The patient is a 23 year old male.  C/O seen over weekend for headache and fever, low grade SIQ then felt better, rashes 2 days ago, did not tell.  Today scattered more at face, body, scalp and arms plus sore throat and low grade fever today.  No abdomen pain, appetite down and cold and cough 3 days, no breathing problems.  ROS unchanged.  Problem list reviewed and medication list reviewed.  No generalized pain, energy level not specified, not feeling tired or poorly, and no lethargy.  Chills.  Watery nasal discharge.  No hoarseness.  Sore throat.  Skin lesion(s): No head symptoms.  No neck symptoms.  No cardiovascular symptoms.  No pulmonary symptoms.  Appetite not decreased.  No genitourinary symptoms.  No hematologic symptoms.  No musculoskeletal symptoms.  No dizziness, no confusion or disorientation, no focal disturbances, no motor disturbances, and good coordination.  No psychological symptoms.  11/03/2008 MR received for DOS 10/14-21/2008 with D/C Dx:  Varicella. Pt initially presented to clinic with c/o fatigue, H/A and feeling poorly-myalgias and arthragias and fever. PE (+) for tenderness to palpation of bilateral parotids, decreased neck suppleness. Assessment H/A.  Returned 10/14/08 with rash all over-erythmatous, papular lesions, slighly pruritic. Mild throat erythema. Assessment: R/O Varicella. URI. Referred for admission. Presented to ER with Varicella rash and 3 week hx of cough. Placed on Respiratory isolation and tx with Acyclovir with improvement.
Site: Swelling at Injection Site-Mild, Systemic: Joint Pain-Mild, Additional Details: Patient decscribes injection site as warm to touch and has some pain with shoulder movement. No shortness of breath or difficulty breathing.
Beginning on 10/25, my heart rate became high at rest.  Normally it is around low 70s at rest, but it was over 100 from just sitting.  On 10/26 I was unable to breathe in the morning, and went to the ER where they checked me for a heart attack.  I did not have one, and they referred me to my cardiologist.  Ever since then, I am unable to run as I normally do without my heart rate increasing for the rest of the day (I normally run at least ~30 miles per week with no issues as well as weight train).  I am barely able to walk as much as I used to (I used to walk ~3 miles per day).  I have shortness of breath and chest tightness even walking up and down my stairs.  Nothing like this has ever happened to me before.
Initial report received on 14 January 2009 from a health professional. A female patient, whose medical history and concomitant medications were not reported, received a 0.1 ml intradermal injection of FLUZONE (lot number not reported) in the forearm on 12 January 2009. Two days later, on 14 January 2009, the patient had a 7 cm superficial, circular, red, swollen and painful area at the site. According to the reporter, it looked like cellulitis. corrective treatment was not reported. The patient's outcome was unknown.