chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm itching really bad after booster dose; arm is a little red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm itching really bad after booster dose) and VACCINATION SITE ERYTHEMA (arm is a little red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (arm itching really bad after booster dose) and VACCINATION SITE ERYTHEMA (arm is a little red). At the time of the report, VACCINATION SITE PRURITUS (arm itching really bad after booster dose) and VACCINATION SITE ERYTHEMA (arm is a little red) outcome was unknown.            No concomitant medications were reported. No treatment information were reported.  Company comment: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the expected events of Vaccination Site Pruritus and Vaccination Site Erythema. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This case concerns a patient of an unknown age and gender with no relevant medical history, who experienced the expected events of Vaccination Site Pruritus and Vaccination Site Erythema. The event occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Information has been received from a registered nurse concerning a 20 year old female patient with allergies to Sulfa, dust and mold who on 29-MAR-2007 was vaccinated IM into the left deltoid (previously reported as gluteus) with a first dose of Gardasil (lot # 656372/0243U). The patient became faint after the injection, but did not lose consciousness. The patient put her head down, used a cool cloth, spirits of ammonia and laid down in the exam table. The patient was give apple juice. The patient's blood pressure was 117/86 with a pulse of 63. On 30-MAR-2007, the patient returned to the office and stated that she had felt woosy and experienced a sensitive stomach the 24 hours following the vaccination. The patient recovered from her experience on 30-MAR-2007. No product quality complaint was involved. Additional information is not expected.
Information has been received from a pharmacist concerning an immunizing pharmacist that developed shingles. A product quality complaint was not reported. Further information was not available. Additional information has been requested.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 15-DEC-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient vaccinated with Pfizer 3 weeks previously. Inadvertently, today 06/06/21 was administered the Janssen vaccine. Patient was placed under observation for 45min. The patient became very upset, upon being advised the second dose received was not the Pfizer but Janssen. She was see by site medical (Fire Rescue) and the parent declined transport to hospital after contacting the Pediatrician.  All vitals signs were within normal limits when patient left the observation area.
Information has been received from a physician concerning a male patient with no medical history or allergies who was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck). It was reported that the patient developed fever after receiving the vaccine. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
Patient states he felt a lump at the injection site the next day which eventually led to a sore arm which still lingers today.  He stated he put ice on the area but the lump and sore arm still persists and is seeing his physician in 1 week for a follow up and exam.
Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4, Pfizer / BioNTech; Dose Number: 5, Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset May2022, outcome "unknown", described as "Dose Number: 4, Pfizer / BioNTech; Dose Number: 5, Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment drug included paxlovid from 13Jan2023 to 18Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2011US009386 is an initial spontaneous report received from a health care professional on 11 Nov 2011. this case refers to a 34-year-old female patient. She was vaccinated with MENVEO vaccine (batch number: M11032) intramuscularly on 08 Nov 2011. On the same day she experienced a rash and slight swelling at the injections site following vaccination. The outcome of the events was not reported.
Was around COVID-19 positive people. Started feeling kind of tired and tested positive for COVID-19. Prescribed PAXLOVID, was better after 5 days.
RPh didn't realize we were supposed to give bivalent boosters. Mistakenly administered the monovalent shot instead. The bivalent shots were not in-stock at the time.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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, batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 15-SEP-2021 (at the time of reporting), the patient underwent finger prick test (Immunoglobulin G (IgG) and Immunoglobulin M (IgM)) and the results showed no antibodies (coded as confirmed immunological vaccine failure). 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: 90000193493.; Sender's Comments: 20210929248-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
febrile sz 42 hrs p/immun; no sequele nl exam; fever controlled APAP, Pediaprofen;
dosage was given from a vial that expired the previous day, patient was monitored with no adverse effects
Patient had a precipitous drop in hemoglobin and absolute neutrophil count after administration of Pfizer COVID-19 vaccination. This was 2nd vaccination and similar phenomenon noted after 1st vaccination.
Cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a patient of an unknown age and gender 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 NEOPLASM MALIGNANT (Cancer) (seriousness criteria death and medically significant). The reported cause of death was Cancer. It is unknown if an autopsy was performed.      It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication details not reported by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that the Moderna Covid-19 caused cancer in 25 patients who were the friends of reporter. The patient will not provide any additional information on these patients. It was also reported that the those patients who died were killed by the Moderna Covid-19 vaccine because Moderna vaccine is poison Cancer rates for jabbed Moderna Cancer patients was up 300% The Doctors are part of the Kabal along with Moderna.  Treatment details was not reported by the reporter.  This case contains information about 4th patient out of 25 patients. Company comment- This is a fatal spontaneous case concerning a patient of unknown gender and age with no medical history reported who experienced the serious (death and medically significant) unexpected event of neoplasm malignant. A dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It is unknown if autopsy was performed. Reporter stated that vaccine caused cancer in 25 patients who are friends of her. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735987 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2023: Follow-up information received included reference section updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735987:4th patient out of 25 patients; Reported Cause(s) of Death: Cancer
p/ pt recv vax approx 7 days later pt devel sx of varicella. 2 days later devel 400-500 chickenpox type, blister-like lesions essentially everywhere. 2nd tests revealed wild type varicella zoster virus. 1st test inadequate.
Right after the vaccine was administered, patient complained about  dizziness, temporary blurred vision & loss of hearing. Patient became pale, hyperventilating and complaining of shortness of breath. Soon after, he passed out for 20 seconds. When he gained consciousness, he felt tingling and numbing on both hands.
AT AROUND 3 AM PATIENT EXPERIENCED FEVER, CHILLS, VOMITING, HEADACHE AND FATIGUE. PATIENT WANTED TO CALL 911 BUT DID NOT ATTEMPT TO. PATIENT TOOK ASPIRIN 325 AS SELF TREATMENT.
Random nerve like pain in left arm and left leg. Leg nerve pain seems to be progressing.
her throat started severely burning/throat irritation; the inside of her cheeks had a patchy red rash that was fire red in color; her uvula became swollen and bright red; face is still swollen; neck is still swollen; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date were unknown), via an unspecified route of administration on 15Apr2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitantly patient was taking Benadryl 50 mg every 4 hours. It was reported that after administration of first dose of vaccination on 15Apr2021 patient had an allergic reaction afterwards. Patient had throat irritation, rash erythematous, enlarged uvula, swelling face, swelling. Patient reported that her throat started severely burning, the inside of her cheeks had a patchy red rash that was fire red in color, and her uvula became swollen and bright red instantly after receiving the vaccine. Reportedly, few hours later her face and neck began to swell as well. It was reported that burning in her throat started to subside on Saturday night, but she still experienced burning here and there, uvula, face, and neck was still swollen. Patient consulted with a physician after the vaccine in which she states they were unable to see much of the swelling. They advised her to take 50 mg of Benadryl every 4 hours for the day. Patient reports that the symptoms ended up getting worse and she has a long allergy list and is unable to try new medications. Patient stated that the vaccine was the only thing new introduced to her body and this was very scary because her symptoms occur and then follow with more intense reactions and is unsure that she will get the second dose due to the reaction she was experiencing. Patient asked if this would be considered an allergic reaction and reason to not receive the second dose. No PQC was present. At the time of reporting, the outcome of the events was unknown.  E-transmitting AE information to agent due to caller stating that she reported her reaction to agent before she was transferred.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
panty line down to my knee cap and my neck so red now; tightness of the throat; over the body rash; the symptoms are back to my legs, arm, in the palm; the symptoms are back to hands; chest pain; tightness of the chest again; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), CHEST DISCOMFORT (tightness of the chest again), ERYTHEMA (panty line down to my knee cap and my neck so red now), THROAT TIGHTNESS (tightness of the throat) and RASH (over the body rash) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and lot#016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced CHEST PAIN (chest pain), CHEST DISCOMFORT (tightness of the chest again), THROAT TIGHTNESS (tightness of the throat), RASH (over the body rash), RASH (the symptoms are back to my legs, arm, in the palm) and RASH (the symptoms are back to hands). On 09-May-2021, the patient experienced ERYTHEMA (panty line down to my knee cap and my neck so red now). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (chest pain), CHEST DISCOMFORT (tightness of the chest again), ERYTHEMA (panty line down to my knee cap and my neck so red now), THROAT TIGHTNESS (tightness of the throat), RASH (over the body rash), RASH (the symptoms are back to my legs, arm, in the palm) and RASH (the symptoms are back to hands) outcome was unknown. Not Provided
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 07-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 dose 1, (Lot # reported as 195223 with an expiration date in April 2018), intramuscular, for prophylaxis (dose was not provided). On 07-OCT-2017, 6 hrs after onset of therapy, the patient experienced swelling from injection site on arm down to elbow, soreness, tightness and felt sick. As a result, on 08-OCT-2017, the patient went to an unspecified urgent care unit and was prescribed with diphenhydramine hydrochloride (BENADRYL) and ice to be applied to the affected area. Furthermore, the patient went to visit her physician on 09-OCT-2017. At the time of reporting, the outcome of pain, malaise, injection site swelling and injection site movement impairment was reported as recovered on 10-OCT-2017. The causal relationship between PNEUMOVAX 23 and the reported events was not provided. Lot number 195223 is an invalid lot number for PNEUMOVAX 23.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient was vaccinated with 0.65ml ZOSTAVAX (lot number unknown) subcutaneously on an unspecified date and contracted shingles on an unspecified date in December 2012. The patient only experienced one lesion on the side of his face and severe pain on his face and ear. The patient did not seek medical attention. The outcome of adverse events was recovered. The relatedness for adverse events was unknown for ZOSTAVAX. Additional information is not expected.
migraine, pain from shoulders to head, stomach pain, vomiting. For treatment, patient took Zofran, insomnia
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number P57AA, expiry date 5th July 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.
Pt recvd 2nd dose of vax 1JUL92 & devel serum sickness described as achiness, joint pain, fever, angioedema, SOB, abdo pains; pt was hospitalized overnoc & treated w/DPH;
4 hours after receiving the injection, I suffered sudden onset of violent chills, fever, exhaustion, diminished strength, severe all-over body aches, had difficulty even walking, and suffered an acute asthma attack which was the worst attack I have ever experienced.  I experienced severe shortness of breath and violent coughing.  I took my rescue inhaler and breathed steam from a bowl of boiling water.  The acute breathing distress improved in about a half hour, but the entire night I had consistently shallow breathing.  The next day my breathing returned to normal, but I continued to have the exhaustion, all over body aches and low fever, and basically had to remain in bed the entire day.  The following day, I still felt ill, but symptoms were diminishing.  By the fourth day I had returned to normal.  I scheduled a virtual visit with my physician in order to report what happened and to ask her if I should take the second shot.  She recommended that I take the second shot at the proper time.  She suggested that I take a dose from my rescue inhaler before taking the shot.
Chills 3 Days, Dizziness 3 Days, Nausea  and diarrhea 3 Days.
One week after my shot, my shoulder became red, hot to the touch, itchy and swollen. I have about a 3? diameter rash that is hard to the touch.
General Message: Patient left voicemail regarding his COVID-19 positive status after being fully vaccinated. He had spoke with physician over the weekend who said another physician might be interested in testing him for variants.
Mild rash to upper trunk, around ears, head (Scalp), abdomen. Afebrile, rash lasted 2-3 days and then faded.
Received varivax vaccine 06/21/02. Diagnosed with varicella 5/21/02.
Developed small shingles like outbreak; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included rituximab (Rituxan).   In March 2019, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, less than 9 months after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced small shingles like outbreak on leg and at the time of reporting had small outbreak on back. The patient had rheumatoid arthritis as a current medical condition, because of that, the patient delayed for 2nd dose of Shingrix. The reporter did not consent to follow up.
Similar to my 1st dose vaccine - I suddenly got my menstrual cycle back after 15 years. I have undergone menopause and this was diagnosed by my doctor as a menstrual disorder. I also developed shingles. I apply an homeopathic ointment to help ease my situation.
This is a spontaneous report from a non-contactable consumer. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient got the pneumococcal 13-val conj vac (dipht crm197 protein) injection at his or her doctor's office last Tuesday and had about 10 inches red band around half of his or her arm on an unspecified date. The patient asked was that normal after a week? The outcome was unknown. No follow-up attempts are possible. No further information is expected.
Pain in arm ~6hours after injection, muscle pains, fatigue after 24 hours, for 1 day, still pain and redness after 2 days.