chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. went to the ER the day after her PREVNAR shot when a rash that she had had for several days spread and worsened and presented as hives. The ER documented a non-specific allergic reaction without a direct link to the PREVNAR shot due to the patient having reported a chronic and persistent fungal infection and a rash of several days. Pt received prednisone and famotidine for treatment. Patient reported to be much better within 2 days, but was seeing her dermatologist for follow-up on the allergic reaction and history of skin disorder.
tired/ exhausted; Headache every day since taking Pfizer Covid19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A 63 year-old female patient received BNT162b2 (BNT162B2), administered in arm right, administration date 22Mar2021 (Lot number: EP7534) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing); "sciatica" (unspecified if ongoing), notes: was getting acupuncture. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing). The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tired/ exhausted"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache every day since taking Pfizer Covid19 vaccine". Additional information: She had sciatica before and was getting acupuncture. Concomitant Products included only Synthroid for her thyroid. She had been taking it for quite a few years because her thyroid was off the charts. She was gaining weight and got checked and her thyroid was off the chart. That was why she was on Synthroid as dose: 150mg early in the morning with no food. She was fine with first dose. She didn't get fever except she was tired and exhausted with both of them. She had had more headaches that she had ever had in her life. Headached every day since taking Pfizer Covid19 vaccine. Both doses were given in top of right arm because that is her stronger side. She was pretty sure that she had both in right arm.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101689528 same reporter/ pateint/ product, different dose and similar event
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 04-MAY-2015 the patient were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (lot# reported as K011979 with expiration date: 21-AUG-2016, lot#K026384 with expiration date: 15-DEC-2016, lot# K021487 with expiration date 30-NOV-2016 respectively; strength, dosage, frequency and route unspecified). No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Injection site pain, Injection site and area surrounding itching, fever, joint pain, left armpit lymph node pain, increased heart rate, muscle pain, fatigue, nausea, chills, headache. Duration of: fever, joint pain, muscle pain, fatigue, nausea, chills from 03:30pm 8/4/2021 to 08:30am 8/6/2021. Duration of increased heart rate from about 04:15am 08/05/2021 to 04:30am 08/05/2021. Duration of: Injection site pain, Injection site and area surrounding itching, headache, left armpit lymph node pain from 03:30pm 08/04/2021 to present day.
This is an instance of breakthrough COVID-19 after which death occurred. They were vaccinated with the Moderna product on 01/16/2021, 02/13/2021, and 11/02/2021. They tested positive for COVID-19 on 08/13/2022. They were admitted to hospital same day. They were found to be experiencing hypoxic respiratory failure. Their condition deteriorated and they were placed on Hospice care. They died on 08/16/2022.
Had Covid in Sep2022; Had Covid in Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6201), on 07Mar2021 as dose 2, single (Lot number: EN6208) and on 05Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "She used to be a heavy smoker" (unspecified if ongoing); "she has a history of COPD" (unspecified if ongoing); "She has a semi-permanent implant" (unspecified if ongoing); "She has a little conditions and allergies" (unspecified if ongoing); "Within 4 weeks her cataract on right eye had gotten worse" (unspecified if ongoing), notes: Within 4 weeks her cataract on right eye had gotten worse. The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (She took the flu shot on 14Dec or 14Nov.), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Sep2022, outcome "unknown" and all described as "Had Covid in Sep2022". The patient underwent the following laboratory tests and procedures: Computerised tomogram: (unspecified date) Unknown results, notes: CT scan on her head; SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with Paxlovid.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 11-NOV-2012 09:33, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Received 2 mo vaccines on 4/3 - 2-3 hours later crying inconsolable x 3 hrs. Mom ? if immune sides red. Seen in office fussy but consolable. Fed well. No redness noted at sites, tyl given.
4 degrees post vaccine notable redness edema and warmth at injection site.  Persistent unhl observation 4/11/03 12 noon. Reported a previous dose of vaccine fall 1999.
a nurse administered TD (Tenivac) that expired on 25-Jan-2020 to a patient on 29-Jan-2020/no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves female patient of unknown age who was administered with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number not reported, expiration date: 25-Jan-2020) via unknown route at an unknown administration site for prophylactic vaccination on 29-Jan-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication.  Information on the batch number is requested.
On October 21, I had an adverse reaction to the Pfizer.  It was a booster shot.  I had two shots of Moderna in January and February.  On October 22, I went to the  Urgent Care Center where I was diagnosed with an allergic reaction.  Was given Prednisone and over the counter Benadryl.    About 6 hours after the shot, I found it difficult to breath and had a running nose and eyes.
muscle and joint pain; muscle and joint pain; headache; injection site pain; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 27Sep2023 at 10:30 as dose 1, single (Lot number: HF9275) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 27Sep2023 at 18:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 27Sep2023 at 18:00, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 27Sep2023 at 18:00, outcome "recovering", described as "injection site pain"; MYALGIA (non-serious), ARTHRALGIA (non-serious) all with onset 27Sep2023 at 18:00, outcome "recovering" and all described as "muscle and joint pain". Therapeutic measures were taken as a result of myalgia, arthralgia, headache, vaccination site pain, pyrexia.  Additional Information: Patient had no known allergies. Patient took treatment with Tylenol.  No follow-up attempts are possible. No further information is expected.
Since the time of receiving the vaccine I have had the following: Almost three days of extreme pain in my arm. I was not able to sleep the first two nights, because I was in so much pain.  Shortly after, I had symptoms resembling that of the flu to include body aches, chills, headache, nausea and vomiting.  I have had a headache everyday since receiving the shot. I have been nauseous since receiving the shot.
10-15 min. : Difficulty swallowing, Increased pulse (195), Headache  2-4 hrs. Itchy legs, arms, palms, eyes, feet, armpits, headache, sore arm  2/11: Mild itchiness (entire body) and sore arm
This spontaneous report was received from a licensed practical nurse, referring to a 12 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates, the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 11-AUG-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the right arm (reported as RD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
left side breast/rib pain; left leg pain; itching all over; irregular menstrual cycle; left arm pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (left side breast/rib pain), PAIN IN EXTREMITY (left leg pain), PRURITUS (itching all over), MENSTRUATION IRREGULAR (irregular menstrual cycle) and VACCINATION SITE PAIN (left arm pain at the site of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced BREAST PAIN (left side breast/rib pain), PAIN IN EXTREMITY (left leg pain), PRURITUS (itching all over), MENSTRUATION IRREGULAR (irregular menstrual cycle) and VACCINATION SITE PAIN (left arm pain at the site of the injection). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form as required; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form as required and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form as required. At the time of the report, BREAST PAIN (left side breast/rib pain), PAIN IN EXTREMITY (left leg pain) and VACCINATION SITE PAIN (left arm pain at the site of the injection) was resolving and PRURITUS (itching all over) and MENSTRUATION IRREGULAR (irregular menstrual cycle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was noted by the patient that the itching (pruritus) still persists but other symptoms have improved in the past few weeks.  The patient also noted that her menstrual cycles were regular prior to the vaccine and now continue to be irregular since receiving the vaccination.  The patient also stated that she was planning to discuss her events with her HCP.  Further clinical course is unknown/not reported at this time.
noc of vax pt exp shooting pain in arm x 2-3 days;painful movement of arm x 1wk;18JUl-19JUL pt had fever 102 et h/a et nausea;
Information has been received from a health professional concerning an 11 year old female who was vaccinated intramuscularly on an unspecified date with her first dose of GARDASIL (lot# not reported). Concomitant therapy included DTAP-IPV and MENACTRA. Subsequently the patient experienced syncope after receiving GARDASIL. She sought unspecified medical attention and her outcome was not reported. No further information is available.
the next morning my son had broken blood vessels on his face and mouth area. and has had a swollen bloody lip since but woke up with it and didn't remeber hitting it
Information has been received from a physician concerning a female in her 60's with pertinent medical history and drug reactions/allergies reported as unspecified who on 28-OCT-2006 was vaccinated with Pneumovax for the protection of chronic obstructive pulmonary disease (COPD). Concomitant medication was reported as unspecified. On 29-OCT-2006, the patient experienced pruritis. On an unspecified date, the patient sought medical attention. At the time of the report, the patient was recovering from the pruritis. Follow up information indicated that the patient had a sore and red arm that resolved without specific treatment. No further information was available. Additional information is not expected.
Patient began developing a rash, itching, and redness within a week of getting the Moderna vaccine on 2/17/21.  Patient reported this on 10/11/21 and couldn't remember the exact date it started, but had a picture on his phone of the rash that was taken on 2/24/2021.  Symptoms were mild and tolerable initially and cleared up in a few days, but then returned, prompting the patient to see his PCP and schedule an appointment with a dermatologist. Symptoms were primarily on his forearm.   After receiving the second dose of Moderna on 3/17/21 the symptoms returned but were much worse and widespread over the body. He had itchy skin welts, edema, and rash, and at one point his hand swelled so much that he could barely bend his fingers.  After multiple visits with the dermatologist the patient has been on regular prednisone since april of 2021, daily high doses of benadryl and zyrtec, daily dosing of singulair, and has recently started Xolair injections to help control symptoms.
Narrative:  Patient, moderna x 3, +covid while in ER of hematuria, weak, history of bladder cancer, flank pain. Given remdesivir, asymptomatic, room air. d/c home.
During and immediately following injection, patient felt pain that she did not experience with initial 2 vaccines. Since then, has had redness and swelling and a hard tender nodule at the site of injection. Also has potential bruising at the site and pain and itching to light touch. Has tried no medications or home remedies for these symptoms.
History of Present Illness:   Patient is a 80 y.o. male who presents with chest pain.  Patient reported that he 1st had the chest pain approximately 2 weeks ago when he woke from sleep.  At that time patient pain lasted about 5 minutes or so and resolved when he got out of bed.  He did well for the rest of the day up until yesterday.  Patient reported that yesterday morning he woke up with the pain at the lasted about 30 minutes or so.  Patient also had associated burping felt that it is likely GI in nature.  The pain was located mainly in the left side of the chest without any radiation.  No diaphoresis.  No shortness of breath or palpitation.  No radiation for the pain.  Since yesterday morning he had another 3 episodes of pain the last after dinner tonight.  Patient reported that this pain was located more on the left side of the chest, likely lasted about 10 minutes or so.  There was no exertional component to the pain.  No known history of heart disease.  Due to rather recurrent nature of the pain patient was brought to the hospital by his son who is a cardiologist to be evaluated.  No fever or chills.  No cough . Patient reported that he got vaccination for COVID 2 days ago-of a concern that this may be a side effect of the vaccine.  No dizziness lightheadedness. Patient with history of GI bleed in the past at that time patient was on NSAIDs.  Patient with burping associated with the pain
Adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced ADVERSE REACTION (Adverse reaction). At the time of the report, ADVERSE REACTION (Adverse reaction) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
pain; itching; swelling at injection site; headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 30Jan2021 17:45 as dose 1, single for COVID-19 immunization (at the age of 68-year-old, non-pregnant). Medical history included diabetes mellitus, high cholesterol and no known allergies. Concomitant medication(s) (in two weeks) included metformin. Patient did not receive any other vaccine in four weeks. Patient had no covid prior vaccination and was not covid tested post vaccination. The patient experienced pain, itching, swelling at injection site and headache on 31Jan2021. Patient did not receive treatment for the events. The outcome of the events was recovered.  Information on Lot/Batch number has been requested  Follow-up attempts completed. No further information expected.
flared up drastically psoriasis after their 1st, 2nd, & booster doses; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (flared up drastically psoriasis after their 1st, 2nd, & booster doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PSORIASIS (flared up drastically psoriasis after their 1st, 2nd, & booster doses). At the time of the report, PSORIASIS (flared up drastically psoriasis after their 1st, 2nd, & booster doses) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-432405, MOD-2021-432424 (Patient Link).
achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced MYALGIA (achy). At the time of the report, MYALGIA (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications not provided. Treatment information was not provided.
was given a dose of Kinrix as well as Infanrix in the same visit; was given a dose of Kinrix as well as Infanrix in the same visit.; This case was reported by a nurse via sales rep and described the occurrence of overdose in a 5-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the overdose and inappropriate schedule of vaccine administered 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 details were reported as follows: The case was reported by the patient. The patient was given both a single dose of Kinrix as well as Infanrix in the same visit, which led to overdose and inappropriate schedule of vaccine administered. Consent to follow up granted.
Received 0.25ml of Bivalent booster instead of 0.5 ml; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml of Bivalent booster instead of 0.5 ml).    Concomitant medications were not reported.  None of the patients are pregnant.  No treatment information was provided by the reporter.  This case is reported for 12th  patient out of 20 patients.