chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for Covid; tested positive for Covid; No symptoms at present time; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV1685) via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history included Covid-19 12 weeks before 25Dec2020. The concomitant drug was reported as levothyroxine sodium (SYNTHROID), hydrochlorothiazide and vitamins. The patient got the vaccine (Covid 19 Vaccine) on 22Dec2020 (Tuesday) and then on 25Dec2020 (today) had to be tested at work and was tested positive for Covid. So, she was wondering if that might have something to do with the vaccine or it was not for sure. Patient had already had Covid once and this is the first time she got tested since for 12 weeks. It just happened to be three days after the vaccine. So, the lady she work with told her a study was done and people were shown to test positive like two days after they got the vaccine. So, that's what she wanted to find out. If that could be." She states the test on 25Dec2020 was a routine follow up Covid-19 test. No symptoms at present time. The outcome of the events was unknown.; Sender's Comments: BNT162b2 provides protection against COVID-19 after 7 days from the second dose. This case does not match this condition.
1 year old patient got Kinrix; off label use; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female 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.   On an unknown date, the patient received Kinrix .5 ml and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration and off label use were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-FEB-2023 Reporter's Comment: The vaccine was administered off label to a infant patient. Additional Supportive Information: 1 years old patient received Kinrix vaccine, which led to inappropriate age at vaccine administration and off label use.
patient feels a slight tingling sensation on L hand.   Vitals 97% RA 85 bpm 141/87 Bp 19 cpm   #21 pt stable and sent home
No additional AE reported; Customer calls and reports a temperature excursion. She reports that some of the vaccines were administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 27-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T019423, expiration date 02-DEC-2021 for prophylaxis (dose, anatomical location and route of administration were not reported).  Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 8.3 degrees of Fahrenheit for 9 minutes. There was no previous temperature excursion reported.  No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000620: US-009507513-2108USA000658:
Feel nauseated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Feel nauseated) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Feel nauseated). At the time of the report, NAUSEA (Feel nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
tiredness; patient was so tired; Muscle pain; swelling throat and lymph nodes.; Diarrhea/ having diarrhea for three years but it was now worse; Joint pain; she can't do any of the domestic housekeeping chores she usually did; swelling throat and lymph nodes; has lost 20 pounds since getting the shot; Patient can't do anything, can't even walk; These side effects all were started three weeks after the vaccination (Mar2021); they have been lingering a long time and getting worse; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6200) via an unspecified route of administration, in the left arm, on 24Feb2021 (at the age of 77-year-old) (in the morning), as single dose, for COVID-19 immunization. The patient's medical history diarrhea, crohn's disease, kidney cancer with removal of her kidney two years ago and colonoscopy.  Patient's concomitant medications were not reported. The Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EL9299, expiry date: Unknown) via an unspecified route of administration, in the left arm, on 03Feb2021 (in the morning), as single dose, for COVID-19 immunization. Patient had the vaccination in Feb2021 (both doses). Patient had a lot joint pain, muscle pain, some trouble swallowing. Patient had some dental work done and they thought maybe that was it because her jaw has been sore but the dentist said no, her jaw checked out good, adds this dentist was like oral facial pain. Patient was still experiencing tiredness; patient was so tired she can't do any of the domestic housekeeping chores she usually did, swelling in her throat and lymph nodes. These side effects all were started three weeks after the vaccination (Mar2021); they have been lingering a long time and getting worse. Patient can't do anything, can't even walk, can't do nothing. Patient has also been having diarrhea. Patient has been having diarrhea for three years but it was now worse. Mentioned patient has lost 20 pounds since getting the shot. Mentioned that the doctor who did the colonoscopy, was treating her for diarrhea with a prescription of Kreon and Citron, but she still has diarrhea, but not like she had it before. Patient is having blood work tomorrow (unspecified date) because her doctor thinks this might be serious. No Emergency Room visit. Patient visited physician office, gone to the regular doctor for diarrhea. They have been treating her for diarrhea before the vaccine but now it was worse. The patient underwent lab tests and procedure which included the body weight and result was lost 20 pounds on an unknown date in Mar2021.  The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 30-JUL-2015 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II 0.5ml (rHA (recombinant human albumin), lot #J014876, expiration date 21-NOV-2015, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine were refrigerator (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Swollen left upper arm, below injection site, and pain in left arm and left leg. No fever.
achy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "achy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sinus infection, hearing loss, my tinnitus is 19 times louder than it was
felt an itchiness in her throat 10 minutes after receiving vaccine.  She denies trouble swallowing or shortness of breath. Transported to ED, with  itching sensation in her throat but no sign of airway compromise.  No wheezing or urticaria.  She does have some perioral swelling.  Benadryl, Pepcid, Solu-Medrol given and discharged to home 1/1/2 hours later.
A report has been received from a Pharmacist concerning a 7 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on 15-Oct-2013. The reporter stated that FLUMIST had been inadvertently administered entire dose into one nostril of the patient which started on 15-Oct-2013. The outcome of the event of inadvertently administered entire dose into one nostril is unknown. The report was considered to be non-serious.
arm was punched/arm is sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER2613) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple Sclerosis", start date: Aug2004 (ongoing). The patient took concomitant medications. Vaccination history included: Hepatitis b vaccine, for Immunization, reaction(s): "Multiple Sclerosis"; Hepatitis b vaccine, administration date: Mar2003, when the patient was 40 years old, for Immunization, reaction(s): "neck and back swollen, extreme swelling". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm was punched/arm is sore". Additional Information: Caller states his arm is sore, like his arm was punched, and he felt this with the first Covid vaccine as well. Caller states he had an adverse event to a Hepatitis B vaccine years ago, and that caused Multiple Sclerosis. Multiple Sclerosis took 9 months to diagnose. No Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Patient skipped second dose due to fears from side effects; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient skipped second dose due to fears from side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient skipped second dose due to fears from side effects). On 17-May-2021, INTENTIONAL PRODUCT USE ISSUE (Patient skipped second dose due to fears from side effects) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was provided.  As per client, MI error in DOB capture as 1-JAN-1900
Starting having nausea/vomiting and general lethargy starting the evening after receiving the injection. Treated with mostly bedrest.
5 min post vaccination weird metallic taste in mouth and severe flushing/heat felt, some heart racing, lasted 2 min. 24 hours later developed fever, severe chills,  severe fatigue, heart racing, general malaise. All of these symptoms improved and gone within 24 hours.
pt got the vaccine. he was standing up waiting for the 15 minute period. he fell down on the floor. his dad put a pillow under his head. he still remained conscious. he asked for a glass of water. then he sat down on a chair for about 10 minutes and felt better. according to dad, patient has a history of passing out while getting vaccinations.
Stomach flu was also circulating at the time. Unknown if symptoms were due to vaccine administration or flu. Fever, diarrhea, nausea, vomiting and body aches, chills.
On March 9, 2021, 11 days after receiving the Moderna COVID-19 vaccine, I woke with a left sore arm that felt similar to the sore arm I experienced after receiving the vaccine. As the day progressed I developed a rash beginning near the injection site that eventually spread from my shoulder to just above my elbow.  The rash is not raised, warm to the touch with mild itching. Left arm is slightly swollen.
This spontaneous report was received from a Pharm. D, referring to a 41 year old female patient with no drug reactions/allergies. The patient's medical history and concomitant medications were unknown. On 18-FEB-2017, the patient was vaccinated with a dose of VAQTA (lot # M039055; expiration date 22-JUL-2018) at the pharmacy (Route and anatomical location were not provided). On 18-FEB-2017, 5 minutes after vaccination with VAQTA, the patient complained of paresthesia oral reported as " tongue feeling funny", oropharyngeal pain described as "sore throat" and pharyngeal oedema reported as "felt like throat was swelling". The pharmacist reported that she brought the patient to a physician "down the hall" who injected the patient with BENADRYL(injection) and then epinephrine (injection). Then, the patient was released by the physician. It was unknown if some lab diagnostic studies were performed. The pharmacist reported that she spoke with the patient on 22-FEB-2017 and she was recovering from the events. The pharmacist considered paraesthesia oral, oropharyngeal pain and  pharyngeal oedema as life threatening and medical significant events. There was no product quality complaint involved. The primary reporter did not assess the causality between the events and VAQTA. Additional information has been requested.
Left thigh, at administration site of varicella vaccine, is reddened with swelling, hard and warm to touch. Instructed parent to alternate cold and heat therapy, use TYLENOL or ibuprofen for any discomfort as needed. Re-check in clinic in a couple of days if symptoms persist.
Initial case was retrieved from the scientific literature on 28 September 2010. Verbatim from the report: "Serious adverse events: Three SAEs were identified among HCP, all of whom reported Td/TT > or = 2 years prior to current TDAP vaccination; none were pregnant or aged > or = 65 years. The third patient with an SAE had wheezing immediately following vaccination; the patient was given one dose of epinephrine at the vaccination clinic and transported to the emergency department. She recovered without further treatment or sequelae". This case is linked to 2010-05551 and 2010-05552. Documents held by sender: None.
shortness of breath, fast heartbeat, small hives from neck to hips that lasted for several weeks, headache, dizzy spells.  Most symptoms lasted close to a month and some longer.
Headache comes and go through out the day and evening right until sleep. I am not taking any medication because the headache is bearable
COVID VIRUS; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 64 year old female. 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, intramuscular, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for covid-19 vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported. On 2021, the patient experienced abdominal pain. On SEP-2021, the patient experienced covid virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from abdominal pain, and was recovering from covid virus. This report was non-serious.
This spontaneous report as received from a Pharmacist Doctor refers to a patient of unknown age and gender. Concurrent conditions and medical history was not reported. On an unknown date, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 (dose and route not reported) Lot # K004148 with an expiration date of 10-MAY-2015. Concomitant therapy was not reported. No adverse effects reported. No PQC involved. Additional information has been requested.
12/12/2013 - client came in with concern about white discoloration on her (rt) deltoid area, states it started after the flu vaccine was admin. and has grown to current size.
The patient experienced localized swelling, redness, and pain of the right deltoid. Size 4 inch by 3 inch.
Six days, post vax, pt's injection site became red, indurated, warm with spreading to forearm. Also, lymph nodes in neck, treated with antibiotics and symptoms resolved.
12/18/99:Pt reported generalized urticaria,edema of lips & eyes, malaise.12/20/99:Pt tx w/ Prednisone.12/22/99:Dermatology visit; tx w/ Prednisone injection,Doxepin,& Claritin.12/23/99:Pt feeling better.
is presenting today for Nausea (headachem diarrhea, fatigue, pt had 2nd covid vaccine on 01/26)
Moderate to severe dizziness; numbness and tingling in jaw/face; lightheadedness, headache; weakness/fatigue.  Reactions began within 5-10 minutes of injection.  As of 1:45 pm 11/24/09, symptoms still present.
Patient received a COVID-19 vaccine at the COVID vaccination clinic. The vaccines were shipped to location from other location, addressed to 2 clients who were hosting the vaccination clinic. The vaccination were alarming in transport and both Pfizer and organization both told the clients that the vaccines were no longer viable and should not be given to the patients. Due to a lack of and miscommunication, 5 patients received the vaccines.
Received only yellow fever vaccine 7/7/07. Developed 2 inch red swollen painful area at injection site several hours later-also developed significant pain from injection site into Axilla-Pain level 7-8 on 0-10 scale. Unable to use arm due to pain. Also had significant dizziness and headache that started evening of 7/7/07. Advised to take Advil for discomfort-it did help Dizziness did not get better until 7/10/07-Examined in office by MD-7/11/07
To ED for syncopal episode.  Patient was found in  home  was laying on the floor for several hours.  Amitted with septic shock to the ICU.  When she was stable she was transferred to the floor.  She also had the covid infection, without complication. upon discharge patient does not want to go to the rehabilitation.   wanted to go home, also has the episode of delirium in the hospital.  was seen by the psychiatrist.
Received a Covid vaccine 30 minutes prior to arrival to ED. Started having tingling sensation to her face and throat while driving home. No dyspnea. No dysphonia. No dysphagia. No headache. No dizziness. No chest pain. No itching. No rash. Given diphenhydramine HCl 50 mg and famotidine 20 mg.  Arrived 1831 and discharged at 2016.
No adverse event; The patient's first dose of Moderna was on 03-JUL-2022 and second dose on 26-JUL-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose of Moderna was on 03-JUL-2022 and second dose on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose of Moderna was on 03-JUL-2022 and second dose on 26-JUL-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose of Moderna was on 03-JUL-2022 and second dose on 26-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient's first dose of Moderna was on 03-JUL-2022 and second dose on 26-JUL-2022).    No concomitant medication information was provided.  The Moderna vaccine for children under 4 were given too early and they are looking for some guidance. It was their second dose of the primary series that was given too early.  This case contains information for the Child 2 described by the reporter.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-663893 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663893:(child 1) (same reporter)
patchy erythema, sl raised appeared immed upon IM inj rt thigh, SQ lt thigh;1" diameter around site only, no other sx or rxn
Patient developed cellulitis and sepsis leading to hospitalization after COVID vaccine (unsure of manufacturer). Patient reports cellulitis flaring after all vaccines. Still planning on getting the second COVID vaccine with an empiric course of antibiotics planned.
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date the patients were vaccinated with improperly stored doses of, oral, ROTATEQ (dose, strength and lot# unknown). No concomitant medication was reported. No adverse effects reported. It was unknown if the patients had sought medical attention. No product quality issue (PQC) was involved. Action taken and outcome were not reported. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & 2 wks following vax devel a fever which ranged from 99 to 103; pt also exp noc sweats & chills; @ the time of report sx persisted; No further details were provided;