chrisvoncsefalvay/vaers-outcomes huggingface dataset:
minor discomfort at injection site; This is a spontaneous report from a contactable consumer.  A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318), via an unspecified route of administration on the left arm on 28Jan2021 14:00 at single dose for COVID-19 immunisation.  Medical history included hypertension, pre-diabetic, gout, prostate cancer surgery and minor psoriasis.  The patient experienced minor discomfort at injection site on 28Jan2021 20:00. The patient received no treatment. The outcome of the event was recovering.
Patient complained of feeling dizzy, itchy throat  and feeling numb, chest tightness and difficulty breathing.  Patient was given benadryl  12.5mg/5ml (given 30ml) initially but patient complained of difficulty breathing at that time she was given epipen injection 0.3mg.  EMS was called and patient was taken to a local hospital
On Thursday, June 17th, I had a very difficult time remembering the day of the week, and specific tasks that I was working on  that I do daily on a regular basis.  I also had to think additionally for the simple tasks that I perform at work, and noticed that I also had some recall issues with remembering server names and people's names.  I couldn't keep my concentration on a single task.  I am a multitasker by profession.  Loosing my concentration ability, or my inability to focus on my assignments, cause stress-induced panic attacks throughout the day on June 17, and June 18th.  On June 17th in the morning, I noticed that both of my leg muscles immediate behind my knees started to tense up as I stretched my legs, bent my legs to sitting position, and also when I walked the stretch in my calves was painful. Starting June 17th evening, I noticed that getting into bed and out of bed resulted in the stretching in both of my legs starting to prevent me from being able to move freely as I did before June 16th at 12:45pm.   Since June 17th both of my arms when stretched wide are feeling the same tension pain as my leg muscles.  The arms are also tender to touch in the front muscle areas (both arms, FYI), in the crevis, and in my lower arms when I ball my fists.  I am using a topical pain relief ointment -- Pain-a-Trate -- daily on both arms and both legs in the adverse event sites three times a day.  My last treatment was June 21st at 7am.  Additionally, I have been monitoring my blood pressure and am noticing slightly lower numbers (on 6/19/2021, my AM reading was 131/85).  I will continue to monitor my blood pressure daily and will report any increase or decrease to the VAERS.   My anxiety is another event that started to surface on Saturday, June 19th along with the stiffness in my muscles in both legs (back of knee and calf areas) and both arms.  This caused me to have some panic attacks and I informed my children of my symptoms in the event I died or had a stroke or heart attack from the COVID-19 vaccine dose 1 of Pfizer.
temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates; temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No medical history information was reported.  Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 Vaccine on 01-May-2021 and Pfizer COVID-19 Vaccine on 22-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine.    On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that they had temperature excursions involving 4 Moderna COVID-19 vaccines inside the refrigerator on 28-Jan2022 to 30-Jan-2022, 31-Jan-2022 and 04-Feb-2022. The impacted vaccines were administered to the patients.  Storage condition at the time of the excursion was refrigerator. Maximum or minimum temperatures reached and excursion duration were on 28-Jan-2022 temp range: positive 34.7 Fahrenheit (F) to positive 41.2 F; on 30-Jan-2022 temp range: positive 34.7 F to positive 41.2 F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7 F to positive 41.2 F for 12 hours and on 04-Feb-2022 temp range: positive 35.2 F to positive 41.7 F for 12 hours. Date the vials were moved from freezer to refrigerator were not available. As per the reporter the vaccines were thawed on 28-Jan-2022 because they were in the refrigerator.  The patient did not report any adverse events.  No treatment information was provided by the reporter.
Persistent Numbness and swelling on right side of face several hours after injection. General dizziness, malaise, fatigue.  Numbness  in right arm at time of injection and subsequent pain later.  Minor stomach pain.  Mild headache.  Symptoms persisting into the next day.
Initial report received from a health care professional, on 27 November 2006.  A 17 year old female patient, with no previous pregnancies, received on 07 August 2006, intra-muscular, 0.5 ml booster of Adacel (lot number C2492BA), while she was 13 weeks pregnant (Last Menstrual Period was on 04 May 2006, Estimated Due Date: 07 February 200)).  The patient did not receive any concomitant vaccines.  The patient had ultrasound on 08 August 2006 and 06 October 2006, the results were normal.  At the time of this report, 27 November 2006, the patient did not experience any adverse reactions.  The patient was taking Prenatal as concomitant medication.  The patient had no known allergies, medical conditions or illnesses.  No information about prior exposures to Adacel was provided.  Follow-up information received on 19 March 2007.  The patient also received Engerix B (GSK, lot number AHBVB194AA) - dose 1, intramuscularly in the right deltoid on 07 August 2006.  She received dose 2 of Engerix B (GSK, lot number AHBVB194AA) intramuscularly (site not reported) on 02 September 2006 and Fluzone (lot number U2189AA) intramuscularly in the left deltoid on 01 November 2006.  Her maternal drug exposure was the following: Prenatal vitamins - 1 daily, po, starting 05 July 2006; Chromagen Forte, for anemia - 1 bid, po, starting 09 August 2006; Rhogam, Rh negative - 1 dose - intramuscularly on 20 November 2006 and Nasonex, for allergies - 2 sprays nasally daily, intranasally beginning 03 January 2007.  She did not experience any adverse event.  Her current pregnant history had "no risks and was a normal pregnancy".  She had serologies performed on 07 August 2006 with normal results.  The patient gave birth vaginally on 31 January 2007, at 39 gestational weeks, to one (1) female, live child (with no congenital anomaly).  The child weighed 7 lbs, 1 oz.  Her Apgar scores were "8" at 1 minute and "9" at 5 minutes.  Follow-up information received on 16 April 2007.  The patient recovered from the anemia.
The patient received 0.2mL of non-diluted Pfizer Bivalent 6mo-4yr Covid vaccine IM.
Severe pain in left hand - injection in left arm. Swelling - numbness - redness in left hand. Symptoms began evening of injection. Two emergency room visits followed.
Patient had local reaction to site; swollen; redness, and rash on face and torso. Benadryl 1.5 teaspoon given PO per physician order. Reaction appeared within 5 minutes after injection.
This case was reported by a nurse via call center representative and described the occurrence of vomiting in a infant female patient who received ROTARIX lyophilized formulation (batch number Y5CZ7, expiry date 26th February 2019). On an unknown date, the patient received ROTARIX lyophilized formulation. On an unknown date, immediately after receiving ROTARIX lyophilized formulation, the patient experienced vomiting and accidental underdose. On an unknown date, the outcome of the vomiting and accidental underdose were unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX lyophilized formulation. Additional details were provided as follows: The age at vaccination was not reported. The patient immediately vomited the administered dose of ROTARIX, which led to accidental underdose.
Patient came down with tummy pain, headache, and vomiting on 11/20/21, early in the morning, 4am.  Just 2 days after receiving the first injection of the Pfizer vaccine. She had Covid (tested positive) in October.  I was told she was good to go for the vaccine (according to the pediatrician's office).  When she had Covid in October, she was only mildly congested, and had tummy and head pain.  Her tummy bug lasted about 3 days.  She seemed to recover after that.
5 month old boy received usual 4 month vaccines at clinic on 4/27/11, spiked temp to 102 that night (axillary) and broke out in generalized maculopapular rash on body on 4/28 - 4/29. Otherwise asymptomatic.
The following day I woke up with almost a Migraine Headache, Fatigue, Blood Pressure and heart rate very high, Fever  103.7 max, , was in bed all day. (same symptoms I had with Covid 19 in November)  The second day I was able to be up and do work, but again that evening my temp was up to 102.6, very feverish.  Third day in the evening, night my temp was at 101.7 max.  Fourth day, no fever, back to normal.
Redness, mild swelling around site where Inject-Safe? Barrier Bandages was applied, itchiness in the site where bandage had been and beyond it, moderate fatigue, mild lightheadedness
soreness or muscle pain; I just feel like, I guess it is like chest pain; or pumping in the chest; I am having some kind of discomfort but I don't know is this pain or what; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "soreness or muscle pain"; CHEST PAIN (non-serious), outcome "unknown", described as "I just feel like, I guess it is like chest pain"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "or pumping in the chest"; DISCOMFORT (non-serious), outcome "unknown", described as "I am having some kind of discomfort but I don't know is this pain or what".  Additional information: Consumer stated, I was calling about side effects of the Pfizer vaccine, second booster (Clarified as Pfizer Covid-19 booster vaccine). I was trying to get information. I am asking concerning the, I am trying to see what should be expected, not common. When probed for the side-effects: Consumer stated, I just feel like, I guess it is like chest pain or pumping in the chest. I don't know if it is like soreness or muscle pain or what, I don't know. When paraphrased the concern, Consumer stated, "No, I am asking ma'am. I am having some kind of discomfort but I don't know is this pain or what this is. Is it supposed to be muscle pain or what? I am asking a question." Consumer was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information is the right department to answer the question. Consumer was provided with the number of Pfizer Medical Information as # and was requested to select option 3, timings as 8 AM to 9 PM Monday to Friday as per EST. Further probing could not be done as the consumer hung up the call abruptly. Thus, product details (LOT, NDC, UPC and expiration date) were unknown. Hence limited information was available over the call. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approx 6 min after getting shot I felt a jab like a nerve tingle go up my left neck to the left side of my scalp where it felt odd (timgle) and i reported to Emt on site so i stayed an extra 15 and left. Approx 3hr later I felt left face cheek numbness that radiated to the left side of my scalp where i first felt the tingle. This sensation was not present the next day 1/9
Contracted COVID19; Contracted COVID19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 02Apr2021 at 13:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 15Nov2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 27Apr2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "DM T2" (unspecified if ongoing); "Major Depressive Disorder" (unspecified if ongoing). The patient had no known allergy. Facility type vaccine was Workplace clinic. Patient did not receive any other vaccine in four weeks. Concomitant medication(s) included: LEXAPRO; GABAPENTIN; SEGLUROMET. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jul2022, outcome "recovering" and all described as "Contracted COVID19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient was put on steroids and nerve meds  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient returned 3 days after shot with a rash on her bicep and patient claimed that is where vaccine was administered
11/01/22 presents to ED for "shortness of breath". PMHx of "severe COVID-19 s/p tracheostomy, heroin use, CVA, HTN, HLD".
temperature excursion, some administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Engerix B, Boostrix, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Engerix B, Boostrix, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was 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: 21-Oct-2022 Reporter's comment: The nursing director reported that temperature excursion for some GSK vaccines.  Over a month, from September to October 2022, Pediarix, Infanrix, Kinrix, Engerix-B, Boostrix and Bexsero vaccines was exposed to a lowest temperature of minus 3 degree C and some of these vaccines had been administered. The patient had received some of these vaccines.  The reporter consented to follow up by email. Additional supportive information: The patients had received the Pediarix, Infanrix, Kinrix, Engerix-B, Boostrix and Bexsero vaccines which were exposed to a lowest temperature, which led to incorrect storage of drug. This case was considered conservatively for multiple patients as number of patient involved was not clear.
Pt developed mild erythema and localized edema. Also with some pain at site of Varicella inj. Began with 3 min of giving the vaccine. After 30 min did not progress beyond. Treated with ice to the site.
6x6cm erythema left deltoid. Small, swollen and painful node noted left axilla. Onset: 7/23/04: increased swelling 7/24; 7/25 advised to consult PMD.
PT REPORTED NUMBNES AND TINGLIN IN HER LEFT HAN. IMMEDIATELY AFTER VACCINATION. SHE RECEIVED VACINE IN HER l ARM. SHE PROCEEDED TO STRETCH HER HAND AND APPLY COLD  TO THE AREA AND REPORTED IMPROVEMENT IN SYMPTOMS. PT WAS INSTRUCTED AND THAT SHE COULD LEAVE THE SITE ONCE THE SYMPTOMS IMPROVES AND RESOLVED
This spontaneous report as received from a healthcare worker refers to an unspecified group of the patients (demographics unknown). Information about patients' medical histories was not provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose, frequency, route of administration and indication were not specified) (lot # H020901, expiration date: 05-JUL-2015) which were exposed to temperatures outside of the recommended range. Concomitant medication was not reported. No adverse effect has been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
SLEEP DISTURBED; SORE THROAT; EXHAUSTION; A spontaneous report has been received from a consumer via the regulatory authority in concerning a 14 year old male patient.    No medical history was reported. Concomitant medication included omeprazole for ill-defined disorder.     On 04-Oct-2021, the patient started receiving a treatment with Fluenz (influenza vaccine live reassort 3v), via nasal route, for ill-defined disorder. No malfunction has been reported for Fluenz.    On 04-Oct-2021, the patient experienced sleep disturbed (preferred term: Sleep disorder), sore throat (preferred term: Oropharyngeal pain) and exhaustion (preferred term: Fatigue).     It was unknown if any action was taken with Fluenz).   At the time of reporting, the event of sleep disturbed and exhaustion was ongoing. At the time of reporting, the event of sore throat was improving.     The events were considered serious (important medical event) by the reporter.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUENZ  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect; Sender's Comments: Sleep disorder and oropharyngeal pain are not listed in the core company data sheet for Q/LAIV. Due to lack of information regarding therapy dates, medical history, details of the concomitant medications, clinical course of the events, underlying conditions (sleep disorder, infections), therapeutic measures taken with respect to the adverse events, laboratory results, radiological findings (complete blood panel, infections panel) and social history, the evaluation, did not find evidence to suggest a reasonable possibility of a causal relationship between the events and suspect drug.
BlurredVision, Headache, Sedation, Myalgia & Arthralgia Narrative:  Other Relevant History:
This spontaneous report as received from a father refers to his one year old son. The patient's medical history included hypothyroidism. No drug allergies reported. On 28-MAY-2014 the patient was supposed to be vaccinated with one dose of PROQUAD (lot#, dose, route and frequency were unknown) and one dose (lot#, dose, route and frequency were unknown) for routine vaccine. The nurse accidentally gave 2 injections of PROQUAD at the same time and never gave the PROQUAD. No adverse event was reported. There was no treatment given for the event. The patient sought medical attention by seeing a doctor. The outcome of the event was reported as "recovering". The father also reported that "My son uses SYNTHROID 44 MG and next the day uses 37.5 MG (every other day/manufacturer unknown)". Additional information has been requested.
Right deltoid area warm to touch, some redness some swelling and patient states very itchy and can't move arm up and down with bad pain.
Patient received a second dose of Flu HD at the pharmacy after receiving a dose at her physician?s office. Patient has dementia and had forgotten she had received it. The patient requested her vaccine at the pharmacy while her daughter was shopping and then the pharmacy staff was told from the patient?s daughter when she came back to get her that she had received it already at the physician?s office.
muscle pain, under armpit pain, headache, site redness, swollen site, leg and lower back ached
No known adverse eilects; a patient received an expired dose of PNEUMOVAX; Information has been received from a pharmacy student, referring to a patient of unknown age and gender. The patient's historical and concurrent conditions were unknown. Concomitant medication was not provided.  On 22-OCT-2019, the patient was vaccine with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# R000692, expiration date 09-SEP-2019, strength and dose were unknown) vaccine for prophylaxis, which was expired (expired vaccine used). No known adverse effects were reported.