chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, batch/lot number: not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, batch/lot number: not reported) via an unspecified route of administration on an unspecified date in beginning of May2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed hives. It was reported that patient had taken aleve. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
sinus cavities expand; This spontaneous case was reported by a consumer and describes the occurrence of SINUS DISORDER (sinus cavities expand) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced SINUS DISORDER (sinus cavities expand) (seriousness criterion medically significant). At the time of the report, SINUS DISORDER (sinus cavities expand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Chest X-ray: negative (Negative) came back negative.         No treatment information was provided.  Based on 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.   This case was linked to MOD-2021-245604 (Patient Link).; Sender's Comments: Based on 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.
box on Infanrix says 6 weeks to 7 years; Pharmaceutical product complaint; Nurse reported that back in June 2023 a 7 year old was administered Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa (Infanrix) for prophylaxis.   In JUN-2023, the patient received Infanrix. In JUN-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Nurse reported that back in June 2023 a 7 year old was administered Infanrix). On an unknown date, the patient experienced product label issue (Verbatim: box on Infanrix says 6 weeks to 7 years) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the inappropriate age at vaccine administration, product label issue and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 Nurse reported that back in June 2023 a 7 year old was administered Infanrix, nurse days that although package insert says booster dose at 4 to 6 years of age, which led to Inappropriate age at vaccine administration.  The box on Infanrix says 6 weeks to 7 years and she went by that.  Patient was doing a catch up on the vaccines and it shows late for Dtap series because. No other details provided. The reporter consented to follow up.
Information has been received from a registered nurse concerning a 6 year old white male with known medical history or allergies who who 17-OCT-2000 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 635981/0447K). There was no illness at the time of vaccination. In February 2006, the patient developed a mild breakthrough case, characterized by a rash with less than 50 lesions. There was no fever. Unspecified medical attention was sought. The rash lasted about two days. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a unk patient who received ROTARIX (batch number A41CB4464, expiry date 30th January 2016) and (batch number A41CB4464, expiry date unknown). On 14th October 2014, the patient received ROTARIX (oral). On an unknown date, the dose was an unknown dose. On 14th October 2014, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. ROTARIX was continued with no change. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional information: 2 of 5 reports. Nurse reported to Account Manager that 5 patients had inadvertently received only the diluent portion of the ROTARIX vaccine. All five patients returned to the physician's office that day to receive the vaccine and diluent product. No AEs were reported. It is thought that one child may have been 2 months old, it is unknown if any had received ROTATEQ previously as the office was changing over vaccine manufacturers.
9PM on 14DEC95 had sx 911 responded 02 stimulation;did not resp on 5mins;MD saw pt in ER;spinal tap RBC NON;WBC NONE;protein 17;glucose 54;WBC 22,400;segs 46;lymph 50;UA 1+ protein;
Large ring around the injection site with some swelling. Itching for the first 24-48 hours on the day symptoms presented (1/18/2021, 7 days after vaccination)
Patient should have received a Dtap vaccine. Tdap vaccine was administered by mistake.  Patient did not experience any adverse reaction.
Information has been received from a registered nurse concerning an adult who in approximately October or November 2010, was vaccinated with a dose of PROQUAD (Merck) (dose, route and lot # not reported) instead of ZOSTAVAX (Merck) because she believed that they looked similar. No adverse effect reported. Additional information has been requested.
The pt immediately experienced a headache. She recovered. The pt reported undergoing a thyroidectomy in 1966 and reported experiencing viral infectious attack on her nervous system in 1984.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Lot number: GJ6739), in left arm and on 04Jun2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 71 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 17Jun2021 as dose 3 (booster), single (Lot number: 20125BA), in left arm and on 23Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing); "Dermatitis herpetiformis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "slightly high cholesterol" (unspecified if ongoing), notes: slightly high; "Overweight" (unspecified if ongoing); "recurring Vertigo" (unspecified if ongoing), notes: recurring; "Known allergies: Several, too many to list" (unspecified if ongoing), notes: Known allergies: Several, too many to list. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Oct2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2023) Positive; (Oct2023) Positive; (15Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 01Oct2023 to 05Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329903 Same patient, different vaccine dose/event;
itchy rash at injection site, warm to touch. Swollen lympth node on right side per pt's descriptions
fever; body aches/aches and pains; headache; allergic reaction; her feet a little, were swollen. Her hands were very swollen/both hands swelled up very much; This is a spontaneous report from a contactable nurse (patient). A 54-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported patient got vaccinated 3 weeks ago, got the first one and patient was very symptomatic; had fever, headache, body aches. Patient had an unusual symptom: both hands swelled up very much and they weren't red and were not itchy. Caller, a directed of nursing in a long-term care facility, who is reporting on the Pfizer COVID vaccine. It is explained she got the first vaccine and afterwar was pretty symptomatic with fever, aches and pains, and a headache. On the 2nd day her hands, and her feet a little, were swollen. Her hands were very swollen. This went away after 2 days but it was reported to the (name). She was told that based on the swelling it was not recommend she get the booster dose, she is assuming it was allergic reaction and not just a reaction. The caller explains that she has been told that this has happened to a few people, even when they had COVID not just with the vaccine. She is wondering if she has to miss the second dose and if we have an recommendations for her. The caller has no information or specifics for these patients. This was just conversations here and there with different people. She notes a coworker's son's hands were swollen after getting COVID. She confirms (coworker's son's) after getting the virus not vaccine. The outcome of event her hands were very swollen/both hands swelled up very much was recovered on an unspecified date. The outcome of other events was unknown.  Information of lot/batch number has been requested.
8 hrs p/recvd DTP/OPV/HIB pt had red, slightly raised rash on face, neck, abd; not ill a/shot given; rash gone p/3 days; no other sx or reaction;
Patient did not have a reaction. The vaccine was given accidentally instead of Hep A. This action was caught immediately and discussed with the patient and the parent. Neither patient or parent have reported any reactions.
Redness, swelling, tenderness at vaccination site Malaise / Nausea / Weakness Chills / Low Grade Fever
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chickenpox with 7-8 lesions. The pt recovered two days later.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore), PRURITUS (severe itching all over my body focusing on the chest and arms, with no rash) and MYALGIA (cant lift arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore) and MYALGIA (cant lift arm). On an unknown date, the patient experienced PRURITUS (severe itching all over my body focusing on the chest and arms, with no rash). At the time of the report, PAIN IN EXTREMITY (Arm was very sore) and MYALGIA (cant lift arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Per narrative complaint from patient, her arm was very sore the afternoon of injection. Next morning patient wrote that she felt horrible and was running a temperature of 99-101, all limbs were weak and her head was throbbing and her eyes were sensitive. Patient states in complaint that she could do nothing on Saturday except lay under blankets and use the restroom. On day 3 after injection patient writes that her arm had a pinching feeling and the back of her was getting stiff and she still felt bad. She then reported to local ER at Hospital. She reports that it was at that time she noticed the redness and swelling at the injection site and that she could not turn her neck at that time. She had labs drawn at Hospital and was diagnosed by ER physician with Cellulitis of the left shoulder and upper arm. ER report notes that there is a 5cm area of erythema to left mid bicep and only a small amount of swelling and ttp to injection site at left deltoid. Patient was given discharge instructions to use TYLENOL or MOTRIN PRN for fever according to label instructions.  And she was prescribed Doxycycline for 10 days as well as a MEDROL DOSEPAK to be taken as per package instructions. At time of patient filing written complaint with the Immunization Clinic patient reported that her arm was still sore.
ringing in ears; soreness; This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced ringing in ears and pain. On an unknown date, the outcome of the ringing in ears was not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the ringing in ears and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and was experiencing ringing in ears and soreness. The patient refused to provide any additional details. The reporter did not consent to follow up.
Vial was first punctured on 02-Nov-2022 at 06:00 pm and was administered on 03-Nov-2022 at 09:00 am; No Adverse Event; given vaccine from a vial punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 02-Nov-2022 at 06:00 pm and was administered on 03-Nov-2022 at 09:00 am) and NO ADVERSE EVENT (No Adverse Event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2022 at 9:00 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022 at 9:00 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine from a vial punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 02-Nov-2022 at 06:00 pm and was administered on 03-Nov-2022 at 09:00 am) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine from a vial punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 02-Nov-2022 at 06:00 pm and was administered on 03-Nov-2022 at 09:00 am) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (given vaccine from a vial punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Vial was first punctured on 02-Nov-2022 at 06:00 pm and was administered on 03-Nov-2022 at 09:00 am).    Concomitant drugs were not reported. Patient received 1st dose of Moderna on 29-Apr-2021 lot number 004C21A. Patient received 2nd dose on 27-May-2021 lot number 033B21A. Patient received 1st booster dose on 27-Nov-2021 lot number 027H21B. The 2.5 ml vial was initially stored in refrigerator on 31-Oct-2022. The vial was stored in room temperature post puncture and was exposed to room temperature for 13 hours. The vial did not undergo any temperature excursion. Treatment medications were not provided.
tired; he came home, sat in front of TV, fell asleep, woke up slobbering, then slept for 14 hours; This is a spontaneous report from a contactable consumer or other non health care professional (patient) via Medical Information Team. A 67-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, Expiry date not reported), via an unspecified route of administration in Jun2021 (26Jun2021 or 27Jun2021 at 13:00 or 14:00) as single for covid-19 immunisation. Medical history included hepatitis C, blood pressure measurement from an unknown date and unknown if ongoing. The patient takes unspecified concomitant medication for blood pressure. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date in 2021 (three weeks before the second dose) for covid-19 immunisation. The patient reported that he had heard different things, about it tracking people and altering DNA. All of that information scared him. He has always thought that is immune system was good. He has Hepatitis C, so he went to get medication to treat it, and it was very expensive. He got Medicare. Now he takes medication for his blood pressure. He had a heart stress test done, and he did okay. He went back to the doctor, and they said his Hepatitis C was gone, that is immune system had cleared itself. He thought he would be okay not to get the covid vaccine, because around his area, covid is starting to go away, and is getting better. He seen a guy who had covid, he was over 20 feet away from him. The guy looked really bad and he started thinking maybe he should get the covid vaccine. He got his second dose of the covid vaccine, he came home and felt okay for a good while. He stated that he came home, sat in front of TV, fell asleep, woke up he came home, sat in front of TV, fell asleep, woke up slobbering, then slept for 14 hours. He became really tired, so he laid down and slept for 14 hours. He got up and still feels tired. Thinks he got the dose on 26Jun2021 or 27Jun2021 about 13:00 or 14:00 but is unsure. Feels like he lost a day in there, he's so tired. Wants to know if this is normal or if it's been reported. Doesn't want to go to the hospital if this is something that is expected. The patient underwent lab tests and procedures which included: heart stress test with results, he did okay. The outcome of all events was resolving.  Information about batch/lot number has been requested.
Within 48 hours of administration of PCV13 patient have called with increased swelling, redness bruising at site of injection. Upon clinical evaluation pt dx with cellulitis.
Tested positive for Covid-19; Tested positive for Covid-19; Not feeling very well; This is a spontaneous report received from a contactable consumer or other non hcp and from a Pfizer Sponsored Program. A 52-years-old male patient received bnt162b2, Solution for injection (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 17:45 (Batch/Lot Number: EP7534) as single dose for COVID-19 immunization. Medical history included supraventricular tachycardia from Oct2019 and ongoing. The patient's concomitant medications were not re-ported. The patient was tested positive for covid-19 on 30Mar2021 and not feeling very well in Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on 30Mar2021. He was given a steroid and an albuterol inhaler. Therapeutic measures were taken as a result of, covid-19 and not feeling very well. Patient got his first dose of the COVID Vaccine on 16Mar2021 and a few days later started not feeling very well and it has continued since then. He went to the doctor today and tested positive for COVID 19. His second dose is scheduled for 06Apr2021. He asks if a positive test has any effect on if he should follow through with the second shot or should he reschedule. Physician said he does not have a PCP right now and he went to Urgent Care. Within a couple of days patient did not feel well. It was probably the 17th or 18th. His symptoms are lingering. He tested positive today. He was taking over the counter stuff until today, he got prescribed a steroid for his symptoms. How he feels depends heavily on if he was taking medicine or not. He does not have product information for the over the counter medications taken available. No further details provided. There was not a date on the card, not an expiration date, but there was a date for his second vaccination. His employer gave him a letter that said he was eligible for it. He had avoided getting COVID for a year. Patient received his first COVID vaccine two weeks ago, went to urgent care today and has tested positive for COVID and would like to know if he should still take the second COVID vaccine or wait until his symptoms are gone. Transferred to public service due to having side effects and getting COVID. Due to their being a few callers ahead asked him if he would mind waiting in the waiting que and the next available medical professional from public service will be happy to answer your question. The outcome of the event was not recovered for malaise and unknown for other events.
NauseaVomiting Reports of GI distress. Went to primary provider next day with diagnosis of gastroparesis Narrative:
patient wants to have Menactra, but had Meningicocal vaccine group B; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received vaccine MENINGOCOCCAL VACCINE B instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site on an unknown date.   It was a case of actual medication error due to Wrong vaccine administered.  It was unknown whether the patient had any 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 2001/83/EC and Module VI of the Good Pharmacovigilance 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 error.  Information on the batch number was requested.  Documents held by sender: none.