chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has pneumonia; Patient has pneumonia; Allergic reaction to Prevnar 13 / Arm swelling, big time, like a lot; Allergic reaction to Prevnar 13 / Arm swelling, big time, like a lot; This is a spontaneous report received from a contactable reporter (Pharmacist), Program ID: (004756). A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALLERGY TO VACCINE (medically significant), PERIPHERAL SWELLING (medically significant), outcome "unknown" and all described as "Allergic reaction to Prevnar 13 / Arm swelling, big time, like a lot"; PNEUMONIA (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Patient has pneumonia". The event "allergic reaction to prevnar 13 / arm swelling, big time, like a lot" required physician office visit. Clinical course: it was reported that a while before, 8, 9, or maybe 10 years before patient had allergic reaction to Prevnar 13. Arm swelling, big time, like a lot. Had to go back to doctor and got a Diphenhydramine shot. Clarifies a Diphenhydramine shot, like Benadryl allergic reaction shot. Patient had pneumonia, was interested in getting Prevnar 20. The reporter want to know if it was possible for patient to receive Prevnar 20 even though had allergic reaction to Prevnar 13.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many factors. The association between the event lack of effect (pneumonia) with PREVNAR13 can not be fully excluded. There is a reasonable possibility that the events peripheral swelling and allergy to vaccine were related to PREVNAR13 based on known drug safety profile.  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.
Following my vaccination on 2/23-I awoke at 5 am on 2/24/21 fever, body aches, chills, fatigue.  On Sunday 2/28 in the evening, I developed a rash on my right buttock which at first just looked like a simple rash.  As Monday 3/1 and Tuesday 3/2 progressed, the rash became, very painful, hot and it hurt to sit or even have clothing touch it.  I went to the doctor today, 3/3/21 at 3 pm and was diagnosed with Shingles.   I have been prescribed an anti-viral medication to treat the Shingles.
Breakthrough case admission after 4 vaccines Moderna 2/4/21 Lot# 013M20A;  Moderna 3/4/21 Lot# 030A21A;  Moderna 10/20/21 Lot# 076C21A;  Moderna 9/8/22 Lot# AS7143C
Generalized itchy rash on abdomen, legs and arms. Benadryl po.
On 7/23/16 child had hot feeling, redness, swelling and large lump on Left deltoid. No fever noted.  Mother took her to Urgent care and was prescribed an antibiotic twice daily for 10 days, on 7/26 Mother reports swelling, redness, and warm are gone, a small lump remains.
I had a pulmonary embolism about 3-4 months after my second Moderna shot.  Was treated for it at the hospital above.  I have none of the underlying factors for having a pulmonary embolism.  Neither the emergency room folk or my local physician could determine any underlying factor that triggered it.  Did the vaccine lead to it?  I obviously don?t know but that I would share this with you given that pulmonary embolism event occurred a few months after my shots.  Also I have had a 100 percent recovery.  And one other piece: in the 12 hours prior to my embolism event (it was an acute episode), I had significant rashes over my entire body.
pt recv vax 1FEB97 & exp maculopapular rash on abd, upper arm & legs along w/itching;tx w/pred & DPH;
Swollen throat, shortness of breath, heart palpitations, nausea, lightheaded, extreme fatigue, weakness, shivering without fever, ticks around arm & sides, tenderness by rib cage, unable to walk, ache on arm that got the vaccine shot, hands go numb, heaviness in left chest , tender chest,
UNSTABLE ANGINA 2/7/2023 NAUSEA AND VOMITING  ACUTE NON ST ELEVATION MI 2/7/2023 NAUSEA AND VOMITING  UNSTABLE ANGINA 2/7/2023 ACUTE NON ST ELEVATION MI  ACUTE NON ST ELEVATION MI 2/7/2023 ACUTE NON ST ELEVATION MI
pt recv vax 4AUG97 papular red rash erupted 13AUG97;office visit 14AUG97;probably varicella per MD temp;
p/vax pt c/o chills; fatigue; chronic cough (productive); vomiting & blood in stool; pain in groin area;
This spontaneous report was received from a healthcare worker referring that on multiple unspecified dates, multiple unspecified patients were administered improperly stored doses of VARIVAX (Merck), (lot #s L011084, expiry date 01-APR-2017 and L013063, expiry date 17-APR-2017). No adverse effect reported. This is one of two reports from the same reporter source (MARRS linked 1510USA004258). Additional information has been requested.
Information has been received from a physician concerning a 10 year old female who in January 2008 was vaccinated with her first dose of 0.5 ml Gardasil.  The patient developed a localized arm reaction.  The affected area was 8" on her upper deltoid and involved swelling and induration.  The patient was treated with diphenhydramine hydrochloride (BENADRYL) and unspecified anti-inflammatories.  The patient did not experience any systemic reactions.  No other details were available.  Additional information has been requested.
Pfizer vaccine given on 06/15/22, BUD date 06/13/22.  Provider notified.  Upon manager calling manufacturer: pfizer states that vaccine is stable 2 days beyond the 10 week BUD date
Patient went to the ER reporting severe nausea, headache and uncontrollable shaking 2 days after receiving vaccine. According to patient's wife all test that were run at the hospital were normal.
patient c/o nickel sized red round & hard around injection site, placed heat pack over site with good relief.
Vertigo, nausea, vomiting. Vertigo and nausea lasted around 6 hours. Vomiting began half an hour after vertigo set in, and ended after another half hour.
Bell's Palsy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient noticed symptoms of Bell's Palsy on 27 Apr 2021 and diagnosed through emergency room visit on 28 Apr 2021.  Treatment for the event included oral prednisone for 7 days by emergency room provider.  The patient advised to hold off second dose of Moderna COVID19 vaccine.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Localized rash and warmth at injection sight starting 2 weeks after injection to date.
Presented 1 day after shots with large red, nontender induration at site of vaccines. By the following day (2 days after vaccine) the lesions had progressed with red streaking, encrusting of skin, were red, warm and tender. Pt was treated with Augmentin and Benadryl.
Information has been received from a pharmacist referring to a 47 year old male patient with diabetes mellitus. There were no drug reactions/allergies. In the evening on 11-DEC-2016 the patient was vaccinated with PNEUMOVAX 23 lot # M037669 (expiration date 09-MAY-2018), intramuscularly for prophylaxis. Concomitant therapies included LIPITOR and METAGLIP. The patient contacted the pharmacy and reported that on 12-DEC-2016 at 10:00 am, he experienced numb arm and hurting arm when he moved it. No treatment was given for the events. There were no lab diagnostics studies. The outcome was unknown. Additional information has been requested.
Engerix-B given instead of second dose of Twinrix on 08/21/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 39-year-old female patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 21-AUG-2023, the patient received Engerix B. On 21-AUG-2023, an unknown time after receiving Engerix B and an unknown time after receiving TWINRIX, the patient experienced wrong vaccine administered (Verbatim: Engerix-B given instead of second dose of Twinrix on 08/21/2023).The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The reporter was reporting that Engerix-B given instead of second dose of Twinrix, which led to wrong vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up by safety team.
pt received 1st dose of Moderna , experienced adverse reaction,  anaphylaxis, epi pen administration, 911 called emt arrived and took to hospital, pt was awake the entire time
Reaction to a pneumonia vaccine-fever, chills, muscle weakness and pain, hives at site of injection (one week after injection).
Erythema Multiforme.  Five days after vaccinations with DTaP, Prevnar, and Comvax this patient started with red, raised spots on thigh that progressed to the trunk the following day and then to the face the day after that.  Then, the rash continued to be raised and red and became confluent with some tenderness and some areas with central white patches.    The patient had no respiratory distress, no trouble eating or drinking, and no increased drooling.  No swelling in the throat.
Information has been received from a health professional concerning a patient (16 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 27Jul2022 as dose 4 (booster), single (Lot number: FP7137) at the age of 75 years, in right 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: "pernicious anemia" (unspecified if ongoing); "low thyroid" (unspecified if ongoing), notes: low thyroid; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa; "known allergies: fusarium mold" (unspecified if ongoing), notes: known allergies: fusarium mold. The patient's concomitant medications were not reported. Past drug history included: Known allergies: cipro, reaction(s): "Allergy", notes: known allergies: cipro.   The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: I took five full days of Paxlovid after testing positive for COVID; (08Oct2022) negative, notes: A COVID test on 08Oct was negative; Thyroid hormones test: (unspecified date) low, notes: low thyroid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid from 28Sep2022 to 02Oct2022 for covid-19. It was reported that patient took five full days of Paxlovid after testing positive for COVID. Last does was 02Oct. On 08Oct symptoms returned: congestion, feeling tired and achey. A COVID test on 08Oct was negative.
Patient developed nausea, diaphoresis, pallor, hives and itching. She was given Benadryl.
Patient had swollen right leg (thigh). Pt. became fussy and crying several hours after immunizations.  Treatment Tylenol 3 cool pack compresses.
congestion; fever; headache; sore throat; disorientation; sometimes shortness of breath; had her first dose the 7th/ tested positive on the 13th; This is a Spontaneous report from Pfizer sponsored program. A contactable female consumer (patient) reported that a female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunization. The patient's medical history included autoimmune disease and concomitant medications were not reported. On 07Apr2021 she had first dose and scheduled tomorrow with 28Apr2021 for second dose. She tested positive on the 13th of April, tested negative on the 22nd of April and will have another test for Covid-19 by tomorrow. She also had symptoms like congestion, fever, headache, sore throat, disorientation and sometime shortness of breath since 14Apr2021 until now. She is also high-risk person and has autoimmune disease. She is asking if there will be a problem taking the second dose having these symptoms and if she can delay her second dose because her daughter tested positive and will be in quarantine for 10 days. The clinical outcome of the event COVID-19 was recovered, and other events are unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported Information: Amended  and deleted the event "she can delay her second dose because her daughter"/LLT Circumstance or information capable of leading to medication error" and removed "At Risk" classification
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills that was unbelieveable) and PYREXIA (Low grade fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.  No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced CHILLS (Chills that was unbelieveable) and PYREXIA (Low grade fever). On 17-Apr-2021, CHILLS (Chills that was unbelieveable) and PYREXIA (Low grade fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Treatment information provided was that patient tried to take a hot bath but it did not help. Concomitant medications include High Blood Pressure.
Imediately after injection of 1st dose Red swollen itchy injection site area. Waited the 5 to 7 days but am currently on Day 10 and injection site still red approximately  tennis  ball size swollen very hot to the touch and itchy. also on and off nausea with lightheadedness.
Pt had erythema of head, chest, arms and swelling of lips within 10min of receiving vaccine. He was given 20mg BENDRYL p.o. and EPI-PEN JR 0.15 ml sub Q. Pt never had wheezing. Erythema and swelling significantly decreased 45min later and he was sent home.
I had my first dose of Covid 19 Pfizer vaccine on the 5th of April, 2021 at 1pm. I had sore arm and was fatigued which was expected. However, the day I had my vaccine was also the day my menstrual cycle started and just to assure myself I informed the pharmacist and asked if that was okay and they said it shouldn?t be a concern.   I was doing fine until toward the end of day 3. I was expecting my period to stop as it always does on 3rd day  but I started bleeding heavier that day there after. It didn?t worry me much until I started discharging huge blood clots  as big as an apple 2 times every after 30 mins from that moment.   I rushed to the ER later that night(still bleeding heavily with blood clots every now and then) but I was not admitted since my vitals and the blood counts were normal at that moment.   I went back home  and hoped the bleeding would stop but again with on pain or fever what so ever I kept bleeding all day. This is my 5th day of bleeding. Then on Sunday morning, I still kept bleeding heavy and I was too weak that I went back to the ER again.   This time , (day 6) I got admitted because I have had lost a lot of blood and I needed blood transfusion. My HB dropped from 11.3 to 6.7 and it went further down to 5 something. I got 3 units of blood transfusion in the ER. They did ultrasound, CT scans(with and without contrast) and still couldn?t figure out the cause of the bleeding. My uterus showed no problems but my body was not even responding to Tranexamic acid to stop the bleeding. So the doctor proceeded with an angiogram and did an emergency uterine artery Embolization to stop the blood supply to the uterus. The bleeding stopped there after and I started regaining my vitals.  However, the cause of the bleeding still remains unknown.
pt recv vax; post vax on same day pt began to have 2-3 days of crabby behavior, temp of approx 100 degrees, & complaints of abdominal pain. pt had a 6 cm area which was hard & hot @ inject site
When patient came for the second dose of SHINGRIX, he showed me a photo he had taken of his arm with a red rash in the inner part of his left arm where you would have given the ZOSTAVAX vaccine subcutaneously. Patient did state that the vaccine was given there. I explained that it should have been given in the deltoid area. The area has cleared up since then. His main concern is that the vaccine would be as effective since it wasn't given correctly. I told him I would contact the manufacturer and follow up with him on it.
Patient she her arm was sore and achy and she thought she had a fever the last night.
Severe chest pain then within about 15 minutes, throat closing breathing restriction---Given shot Epipen Pen on sight transferred to ER.
chest pains during breathing (harshness of this has subsided), severe joint pain, chest pains what feels like behind my heart, and it comes and goes
DIZZINESS; CONFUSION; CHILLS; FEVER, HIGH TEMPERATURE; BODY ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 01-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced dizziness. On 02-NOV-2021, the patient experienced confusion. On 02-NOV-2021, the patient experienced chills. On 02-NOV-2021, the patient experienced fever, high temperature. Laboratory data included: Body temperature (NR: not provided) High (Fever). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, high temperature, body aches, dizziness, confusion, and chills. This report was non-serious.
at the injection site it is as big as a goose egg, it was swollen; at the injection site it is as big as a goose egg, it was swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91 year-old female patient received bnt162b2 (BNT162B2), administration date 13May2021 (Batch/Lot number: unknown) at the age of 91 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), when the patient was 91 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 13May2021, outcome "unknown" and all described as "at the injection site it is as big as a goose egg, it was swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: The caller said he was with his mom who was 91 and got her second COVID shot half an hour ago. He said they waited 15 minutes like they were supposed to and everything was fine. He said she had an appointment at the chiropractor and she was wearing a jacket. They took the jacket off and at the injection site it is as big as a goose egg, it was swollen. He said it was not swollen when they waited the 15 minutes and she was otherwise okay. He confirmed he was talking about the Pfizer COVID-19 vaccine. He said it was not bruised, not red. He was concerned about what to do right now. She was not experiencing any other symptoms other than the injection site. He wanted to figure out what to do, she did not have any other symptoms. He said he figured we would have answers or to be able to tell him if this was unusual.  (Privacy) Communication: Call handler experienced a major power outage during the call. Call back 1 of 1 at 3:30pm: # successful. The caller is referred to his mother's primary care provider or clinic for medical advice. The caller was provided the reference number, contact number, #, option 3, and hours of operation of Monday through Friday 8AM to 8PM for COVID vaccine calls prior to attempted warm transfer to Medical Information. The caller declines to be given the weekend hours for COVID vaccine calls. Due to high call volume caller was placed in the hold queue to continue holding for an agent.