chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Angioimmunoblastic T-cell lymphoma; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (Angioimmunoblastic T-cell lymphoma) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (Angioimmunoblastic T-cell lymphoma) (seriousness criterion medically significant). At the time of the report, ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (Angioimmunoblastic T-cell lymphoma) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication were reported.  Patient was diagnosed with an angioimmunoblastic T cell lymphoma six months after having received the moderna vaccine. The patient had a poor prognosis at the time of diagnosis. No treatment medication were reported.  Company Comment: This spontaneous case concerns a male patient (age not specified) with no medical history reported, who experienced the unexpected, serious (medically significant) event of Angioimmunoblastic T-cell lymphoma about six months after receiving a dose of mRNA-1273 Bivalent. 222 (Original/Omicron BA.4/5). Vaccination. The patient had a poor prognosis at the time of diagnosis. No further information on clinical course, investigations and treatment received was available in the report. The outcome of the event reported as unknown. The benefit-risk relationship of mRNA-1273 Bivalent. 222 (Original/Omicron BA.4/5). Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient (age not specified) with no medical history reported, who experienced the unexpected, serious (medically significant) event of Angioimmunoblastic T-cell lymphoma about six months after receiving a dose of mRNA-1273 Bivalent. 222 (Original/Omicron BA.4/5). Vaccination. The patient had a poor prognosis at the time of diagnosis. No further information on clinical course, investigations and treatment received was available in the report. The outcome of the event reported as unknown. The benefit-risk relationship of mRNA-1273 Bivalent. 222 (Original/Omicron BA.4/5). Vaccine is not affected by this report.
20JUL98 h/a, knees ached;21JUL98 h/a, aching all over;went to ER early 22JUL;22JUL98 some relief from percodan;23JUL98 improved still some aches;28JUL98 much improved;
Administered to the interior thigh subcutaneously; Administered to the interior thigh subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 3-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 997A5, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2022, the patient received Fluarix Quadrivalent 2022-2023 season (subcutaneous) and Fluarix Tetra Pre-Filled Syringe Device. On 15th December 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The adverse event contains all reported information. The reporter consented to follow-up. The case was linked with case US2022188027, reported by same reporter for different patient. Additional supportive information: The patient was administered a Fluarix vaccination to the interior thigh via inappropriate route, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site.; Sender's Comments:  US-GSK-US2022188027:Same reporter
31 Aug 2021 pfizer covid #1, 9/16/21 new dural sinus thrombosis with associated cognitive deficits, dysphagia, weakness, and impairing mobility and self-care, no h/o covid, poss IBD?  CT head: Unchanged hyperdense thrombus involving the internal cerebral veins, vein of Galen, straight sinus, left transverse sinus and left sigmoid sinus, as well as cortical/tentorial veins along the left tentorium. Additional hyperdense, nonocclusive thrombus within the right transverse sinus is unchanged. Retrospectively stable hyperdense thrombus within the upper left jugular vein (series 303, image 8). Increasing conspicuity of symmetric hypodensity within the bilateral thalami, which corresponds to diffusion restriction seen on comparison MRI.  1.  Findings consistent with extensive deep cerebral vein and dural sinus thrombosis 2. Symmetric hypodensity of the bilateral thalami, corresponding to diffusion restriction seen on comparison MRI, consistent with evolving cerebral venous infarcts.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, every 1 total, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the patient experienced confirmed immunological vaccine failure. On 28-APR-2021 the patient given test SARS-CoV-2 IgG antibody test and SARS-CoV-2 IgM antibody test. The results were found to be negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000178015; Sender's Comments: V0:210458243-covid-19 vaccine ad26.cov2.s- confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Pt was given Adacel vaccination in left deltoid. Pt develop localized blisters, inflammation, redness, pain and swelling at site of reaction. Pt said events occurred the evening after the injection was given. Followed pt over the next couple days. Told pt to take Tylenol and Benadryl. Also to continue using cold packs to help with swelling. Informed patient's PCP. PCP agreed with treatment plan and told her to come in if symptoms got worse. Documented allergy to Adacel.
This is a spontaneous report from a husband referring to his 51 year old wife who at the end of 4/99, the pt received her 1st left arm dose of Lymerix. Two weeks later, she experienced right arm, elbow and wrist pain; her joints ached; she had chills and then felt hot; she could not lift up a coffee cup, and she was nauseous. These symptoms are getting worse. An ER or doctor visit was required. She was treated with Vicodan, which she found to be ineffective. Lymerix was discontinued. The most recent information, received on 9/3/99, reports the condition of the pt is ongoing.
Rash started 1/20/2021 at 9 p.m.  Took 2 Benadryl and 1 Zyrtec.  1/21/2021 skin irritated but no hives and left arm and armpit very sore took Benadryl at night for itchy skin and 1 Advil for pain at night.  1/22/2021 felt better except left arm very sore so took 1 Advil two times in afternoon and evening.  1/23/2021 Felt perfectly fine until 9 p.m. when hives covered torso back and front.  Began Pepcid, Benadryl and Zyrtec.  1/24/2021 Hives not as red but still present and itchy.  Continued Pepcid (1 every 12 hours), Benadryl (1 every 6 hours) and Zyrtec (1 per day).  1/24/2021  Hives improved not as red but irritated and itchy.  Place towels with Domboro solution on affected area to help with rash and itching.  Spoke to doctor.  Advised to continue medicine as used yesterday and to call at 5 p.m. if not improved.
tinnitus in her right ear/fluttering type of noise like popcorn popping in the microwave; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (tinnitus in her right ear/fluttering type of noise like popcorn popping in the microwave) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced TINNITUS (tinnitus in her right ear/fluttering type of noise like popcorn popping in the microwave). The patient was treated with PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; FLUOXETINE HYDROCHLORIDE (PROZAC) at an unspecified dose and frequency and Surgery (cut a tendon theysuspected was making that noise in ear) for Tinnitus. At the time of the report, TINNITUS (tinnitus in her right ear/fluttering type of noise like popcorn popping in the microwave) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  She had a surgery last week. She had a post surgical visit with her surgeon (contact 3) and is scheduled to receive a booster dose of the vaccine.
Pt & Foster Mother walked into Center. Pt received immunizations 05/04/09. Pt now c/o of dizziness, headache & chest discomfort. Follow-up phone call later in day-Foster Mother reports pt. is feeling better.
Face swollen. Right and left hands and lower arms had hot rashes. Took benidryl  for rash for three days. Six days later, I could not lift my left arm.  Took Aleve for 14 days at Drs. orders.
The injection was given very high in my left arm at a downward angle. Several hours later I had severe pain extending from my left shoulder to my elbow. It continued for 3 weeks during which I iced it and took ADVIL. I went to the doctor at that point and now I am having cryotherapy. I am still having pain in the arm at this time.
sore injection site; fatigue; flashing irregular light; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 16Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore injection site, fatigue and flashing irregular light. Patient reported just received my first dose of your covid vaccine on the 16Feb. Patient had typical side effects of sore injection site and fatigue the day after. The unusual affect was what appeared to be flashing irregular light in the lateral aspect of patient's right eye. This symptom was new to patient. Track if others have had similar experiences. It subsided on the 2nd day after the vaccine. The patient underwent lab tests and procedures which included blood pressure measurement was 136/64. The outcome of event was unknown and for event flashing irregular light was recovered.  Information on the Lot/Batch number has been requested.
headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
The patient developed high fever to over 103F on the day of vaccine.  2 days later, he developed a red rash on the right side of his forehead, and in the next 4 days, swelling of right side of his face, right cheek, right  temple, mandible, right ear, with difficulty of chewing, and some decrease in hearing in the right ear.  The patient never had dermal fillers.  I saw the patient today and put the patient on Prednisone and Keflex empirically, and referred him to dermatologist and plastic surgeon for 2nd opinion.
Abdominal pain, felt like pt had flu, nausea, then on 01/12/2014 pt had hives on forehead and ALL over the rest of the body.
Body Aches started on right side of body. Back/shoulder ache increased to entire body.  Skin sensitivity hurt to have anything touch skin Chills all over body  Cold sweat  Fever of 101 that would not break for 3 days  Extreme fatigue right after injection starting at 1:15pm flu Like symptoms exactly 12 hours after lasting for 4 days. Medicine would not touch this. I took Tylenol and acetaminophen. It did not work. I finally was able to fall asleep  7 hours after initial adverse reaction.   My menstrual cycle also started 7 days early which has never happened and period was lighter than it?s ever been. My period also was affected by the initial injection and has been shorter and heavier than it previously was. Making me believe that more research needs to be done with Covid and women?s fertility.   I did not go to the doctor bc the doctor administering my injection said that I should expect flu like symptoms 13 hours after dosage. I just did not know it would be 4 days of recovery.
I was surprised about the handling of the vaccine and wanted to report the way it was handled in case this has an effect on the potential efficacy for people who came in that day. I checked the CDC guidelines which seemed to not have been followed.  Instead of preparing the syringes right before the vaccination and administering them then, the vaccine was given with prepared syringes which were prefilled and some earlier time. I witnessed at least 10 prefilled syringes and one vial sitting mixed loosely in a household plastic basket next to a station. The syringes from that basket were used to vaccinate people one after another.    Furthermore, they were stored in said basket in direct sun on a warm window sill for the entire time I was able to observe this (~15 minutes). At one point the technician who used the syringes from the basket was told by another staffer to not prefill and let sit around that many syringes but did not act on it.   Given the CDC sheet says to immediately administer the vaccine after extracting it from the vial into the syringe  (https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/prep-and-admin-summary.pdf) and here more than 10 syringes were filled and kept in a basket from which they were then used in a place where temperature may have been rising enough to exceed 77, I wasn't sure if that is acceptable in terms of timing and storing of the vaccines in sunlight on a warm window sill so I wanted to report what happened just in case this is acceptable or not and people receiving doses at this CVS are taken care of if needed.
Patient started not feeling well. Thought it was from flu shot. Had heart attack later in evening.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 16 and 64. The lowest recorded temperatures were of 33 and 34 respectively. the vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd vax; pt devel nausea & vomiting w/ right upper quadrant tenderness for 3 days; pt taken to hosp W/ viral syndrome & dehydration; pt exp elevated liver function tests; pt dx w/ viral syndrome w/ hepatitis, leukopenia & dehydration;
9/14/21 Pt received 1st dose of Moderna vaccine at 10:45 AM . After 15 mins of observation, patient  started to have Rt arm soreness and nausea. Then patient developed Rt arm numbness  and chest pressure.  Patient had some crackers and orange juice . Observed patient until 11:55 AM with no symptoms  improvement , then RN  transported patient to ER for further evaluation.
1 of 4 pts vaxed from the same lot# during month MAY95 who exp fever & inj site rxn w/in 24-48hrs following vax;recovered
At approximately 1409 allergic reaction began.  The patient was immediately assessed and vital signs were taken. The patient developed redness, warmth, and swelling at the site of the immunization injection. The patient then progressively developed a persistent cough, auditory and auscultated wheeze , shortness of breath, and swelling around the mouth. The patient also reported an itchy throat. The patient was given 25mg of IM Benadryl at 1425 and an additional 25mg at 1440. at 1445 a 0.3mg of Epinephrine via an EpiPen was administered and then the patient was immediately transported to the Emergency Department for further evaluation and treatment. At 1510 arrived at ED and at 1741 discharged.
Gradually spreading red rash below vaccine site.  Intense itching, light swelling, warm to touch.  Aches down the arm.  Started day 6 after vaccine and currently on day 8.  In addition, on day 4 significant flare of tendonitis in achilles of right leg.  No prior history of tendonitis in that area, no trigger or injury.   Woke up unable to walk on it, resolved itself 12 hours later.
Patient was inadvertently given second Pfizer covid vaccine 20 days after first dose instead of manufacturer recommended 21 days separation
Case number PHEH2015US019681 is a combined initial and follow-up spontaneous report from a nurse received on 01 Oct 2015 and on 02 Oct 2015. This report refers to a 21 years old female patient. Past medical history and concomitant medications were not reported. Nurse reported that the patient was vaccinated with expired FLUVIRIN (batch number: 1413801, expiry date: Jun 2015) 0.5 ml intramuscular on 30 Sep 2015. No adverse event was reported. No further information was provided.
Achy, tender, swelling, redness (around arm down to elbow), chills, malaise.
Myopericarditis; This is a spontaneous report from a contactable consumer. An adolescent patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 2 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number, unknown) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. On an unspecified date, patient experienced myopericarditis after the 2nd COVID 19 dose. Event took place after use of product. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected. Sender's Comments: Limited information precludes a comprehensive causality assessment however with known safety profile of the drug the causal role of BNT162B2 vaccine cannot be excluded for the reported event of myocarditis.  The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
Little itching; Headache; Knee pain/Elbow pain; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Little itching), HEADACHE (Headache) and ARTHRALGIA (Knee pain/Elbow pain) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM for an unknown indication.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (Little itching), HEADACHE (Headache) and ARTHRALGIA (Knee pain/Elbow pain). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PRURITUS (Little itching), HEADACHE (Headache) and ARTHRALGIA (Knee pain/Elbow pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-167283 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up accepted on 27-05-21
Itching; Hives; Patient declined Benedryl ; took Claritin with some relief
While at home watching TV, I began to have pains in my shoulders. The pain started to move towards the center of my chest. Pain then started in my left shoulder and moved down my arm to my elbow and then in my wrist. I tried to rub the pain in my chest but it was a deep, not in the upper muscle area.   Fearing signs of a heart attack, I went to NYU Langone Long Island hospital. They performed an EKG, chest x-ray and took blood samples. I stayed for 8 hours. All results came back negative for a heart attack. I followed-up with my primary care physician and he recommend to hold off on the second Covid shot and to see a cardiologist. I have a stress test and follow-up later this month. Since the first Covid shot, the area of the shot in my left arm has been sore on a regular basis.
pt recv vax 16MAY97 & lab eval revealed lack of seroconversion (IgG 0.72);
Pt came into the office on 2/28/17 and received a PNEUMOVAX vaccine in the Right deltoid. The area was pink and hot on Patient's (R) arm below the injection site this was reported on 3/2/17.
Asthma, itching in the body especially in the hands and feet, I turned very red, pain in the joints, head and arm. My head felt hot.