chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; the patient was administered a properly store but expired dose of PROQUAD; This spontaneous report was received from an office manager regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug allergies/reaction were not provided. On 06-NOV-2019, the patient was vaccinated with a properly stored but expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection lot# R011216, expiration date:15-OCT-2019 (dose number, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No adverse effects reported. No product quality complaints (PQC) were involved.
pain under the left arm; swelling under the left arm; pain on their left breast; a knot around the injection site; abnormalities on their left breast; lymph nodes under their left arm were swollen; Patient did not get the second dose still; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site) and BREAST DISCOMFORT (abnormalities on their left breast) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site), BREAST DISCOMFORT (abnormalities on their left breast), LYMPHADENOPATHY (lymph nodes under their left arm were swollen) and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose still). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site), BREAST DISCOMFORT (abnormalities on their left breast) and LYMPHADENOPATHY (lymph nodes under their left arm were swollen) had not resolved and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose still) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2021, Mammogram: abnormal (abnormal) some abnormalities on their left breast. On 04-Oct-2021, Ultrasound scan: abnormal (abnormal) some abnormalities on their left breast.     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 medication reported.
"allergic reaction" "patient complained of respiratory difficulty, PRN respiratory tx administered per RT x 1.  Upon entering room RN noticed audible stridor.  Patient continued to complain of respiratory difficulty after 2 prn tx.  Physician notified and orders received.  Benadryl IV administered d/t same problem with another patient.  Flu vaccine or pneumonia vaccine given earlier, suspected as possible cause"
Monday evening I was feeling very tired. Tuesday morning i started getting a headache which lasted all day and night Tuesday. Wednesday morning still have a headache and feel sickly. I have been taking Tylenol every 4-6 hrs.
Client vaccinated x 2 with Pfizer vaccines for Covid in February 2021.  Symptoms of Covid on 11/6 - chills, cough, myalgia.  Had infusion of monoclonal antibodies administered to him at home on 11/6.
reports that on 1/21 she received 2nd dose of Covid vaccine. Went to work Friday 1/25--started having chills, body aches, HA. On Saturday,- fever and chills, body aches, HA. Reports on Sunday she felt slightly better, but still some s/s. Today 1/25: reports she feels flushed and HA still present.
Pain, Fatigue, Chills, Body Ache I used Advil to ease the pain I doesn?t last long.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/30/21.pfizer Lot#EL0142 2nd dose:01/20/21.pfizerLot#EL3247 Diagnosed covid positive: 02/26/21 Exposure:Unknown Symptoms:Cough, Headache, fatigue
. Client c/o incidence of dizziness, being cold and was provided cover and a heater. 12:00 pm B/P 142/87, 80, 26,  moving her left shoulder around, talking rapidly . At 12:10 pm client became restless, face became flushed, c/o numbness in her face and fingertips with increased respirations. 12:11 pm Dr. was contacted via phone by RN and Benadryl 50 mg IM in RD was administered by RN. 12:13 V/S 136/79,65,24 client was reclined, decreased flushing, slowed resp and decreased SOB. 12:16 pm DON was contacted and notified of incident.12:21 pm Dr. was called by RN.911 was active at that time.02 via facial mask @ 2 liters was applied. No redness or swelling to injection site noted. Client raised to upright position. V/S 141/82, 73, 26.  12:33 EMS arrived on scene. B/P 143/91, 72, 24.EMS was provided history and V/S. Client?s respirations and SOB decreasing, still flushed. Client refused transport. EMS departed at 12:45. Client called friend to come pick her up. She continued to be flushed and shaky. V/S at 1:06 pm were 148/96, 72, 22. Respirations were unlabored, client remained somewhat flushed. Friend is to monitor her. Client was transported to friend?s car via W/C for safety.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 14-AUG-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19 infection; COVID-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 29 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 17May2022, outcome "unknown", COVID-19 (medically significant) with onset 17May2022, outcome "not recovered" and all described as "COVID-19 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) Positive; (22May2022) Negative, notes: Testing negative each day during this time frame; (23May2022) Negative, notes: Testing negative each day during this time frame; (24May2022) Negative, notes: Testing negative each day during this time frame; (25May2022) Negative, notes: Testing negative each day during this time frame; (26May2022) Negative, notes: Testing negative each day during this time frame; (27May2022) Negative, notes: Testing negative each day during this time frame; (28May2022) Positive, notes: Day 12 - Day 14 - Started testing positive again; (29May2022) Positive, notes: Day 12 - Day 14 - Started testing positive again; (30May2022) Positive, notes: Day 12 - Day 14 - Started testing positive again. Therapeutic measures were taken as a result of covid-19. Patient did not received other medication in 2 weeks. Patient received anti-viral treatment from 18May2022 to 23May2022 for COVID-19. Patient had no known allergies. Patient experienced a rebound infection. Timeline: Day 1: Tuesday 17May2022 - Onset of symptoms - tested positive, Day 2: Wednesday 18May2022- Started Paxlovid, Day 5: Saturday 21May2022- Symptoms went away 23May2022- Finished complete dose of Paxlovid. Day 6 - Day 11: Sunday 22May2022- Friday 27May2022- Testing negative each day during this time frame. Day 12 - Day 14 - Started testing positive again on the rapid antigen tests and symptoms came back as well.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by an other health professional via call center representative and described the occurrence of shoulder pain in an unspecified number of patients who received BEXSERO (batch number ABX6C1AA, expiry date 31st August 2019) for prophylaxis. On an unknown date, the patients received BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patients experienced shoulder pain, injection site pain, joint range of motion decreased and radiating pain. On an unknown date, the outcome of the shoulder pain, injection site pain, joint range of motion decreased and radiating pain were unknown. It was unknown if the reporter considered the shoulder pain, injection site pain, joint range of motion decreased and radiating pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not applicable for this report. The medical assistant reported that the patients experienced shoulder and injection site pain, limited range of motion and pain radiating into the neck after receiving BEXSERO. The reporter could not provide patient demographics or lot number and expiration dates. This case has been linked with case US2019051642, reported by the same reporter.
Pt was sitting on mom lap p/feeding, suddenly jerked both arms & started screaming; pt then noted to be staring w/eyes turned upward, not responsive; lasted about 10 mins; no rigidity or limpness, no siezure movements noted, no cyanosis;
Swollen Glands, fever, rash, joint pain and fatigue, lasted 2-3 days. Took Advil.
General discomfort; aches, swimmy feeling. Red, swollen, itchy welt around injection site that all started a week or so after the injection? Most noticably has been the welt - uncomfortable to try and sleep. Itchy and achey. Applied cool lotion to try and sooth it, taken Ibuprofen and even tried gently holding a cool (unopened) can of soda to it when I had nothing else. Ongoings as of now (5/7/21) Been staying home a resting - wanted to do my part and fill this out.
BITTER TASTE; MUSCLE ACHE; MUSCLE TIGHTNESS; DIARRHEA; This spontaneous report received from a patient via Pfizer Inc. concerned a 60 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, and other pre-existing medical conditions included: patient was not pregnant at the time of reporting. The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment (vaccine). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered at left arm on 19-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at the time of vaccination was 60 years. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s.  The patient additionally received non-company suspect covid-19 vaccine tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 2) (form of admin, route of admin not reported, and batch number: unknown and expiry: unknown) dose was not reported, administered on 12-JUN-2022 for prophylactic vaccination and end date of therapy was 16-JUN-2022. Duration was 4 days. Age at the time of vaccination was 60 years.  On 15-JUN-2022, third day of vaccination, the patient experienced muscle tightness, and diarrhea (Dose number in series 2). On 16-JUN-2022, fourth day of vaccination, the patient experienced muscle ache (Dose number in series 2). On 17-JUN-2022, fifth day of vaccination, the patient experienced bitter taste (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient recovered from muscle tightness, bitter taste, diarrhea, and muscle ache. This report was non-serious.
This spontaneous report was received from a Licensed Vocational Nurse (LVN) referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date the patients were vaccinated with doses of improperly stored PROQAUD (Merck) (lot # L011080, expiry date: 01-OCT-2016, dose, route and frequency unspecified). Other suspect and concomitant therapies were not reported. No adverse effects reported. No product quality complaint (PQC) reported. This is one of several reports from the same source. Additional information has been requested.
red area, 5 cm, on lt deltoid area. Non-itching. No discomfort noted by pt.Referred to MD to determine etiology/TX if needed.MD seen 4Jun91;determine to be a vax rxn.
Slight fever, chills, body aches, and very sore arm  (Second dose) that happened the next day after vaccine was given
Client called 2/16/11 inquiring about possibility Hep B vaccine caused his "transverse myelitis" he experienced in fall. He admits began in Sept. loss of balance, progressed to loss of bowel and bladder control. Paraplegic hospitalized 10/13/10. Home 12-16-10. Remains in physical therapy. Continues to need self cath, bowel assistance, admits walking is "coming back, using walker.
Case number PHEH2012US023534 is an initial spontaneous report received from a health care professional on 28 Nov 2012, and with a follow up received on 19 Dec 2012. This report refers to an 18-years-old female patient. On 01 Oct 2012 she was vaccinated intramuscularly with 0.5 ml MENVEO (batch number: A11082, expiry date: May 2014) which had multiple temperature excursions above 46 F. The vaccine was stored at 55 F for 1.5 hours, 52 F for 3 hours on 27 Jul 2012 and 08 Sep 2012. It also experienced two temperature excursions; 49 F for 1 hour and 50 F for 2 hours and 09 Sep 2012. No adverse event was reported. No further information was provided. Non significant follow up received on 19 Dec 2012. No new medical information was provided.
Patient was discharged from appointment and collapsed in lobby. After further review patient was not told to wait I exam room for 15 minutes.
Information has been received from a consumer her 6 month old daughter who on 03-OCT-2008 was vaccinated with ROTATEQ. Concomitant vaccinations on the same day included Pneumococcal vaccinel (manufacturer unknown), Influenza vaccine (manufacturer unknown), Hib (manufacturer unknown) and DTaP (manufacturer unknown). It was noted that within 24 hours of vaccination the patient experienced fever, irritability and loss of appetite. There was no medical attention sought. The patient was treated with TYLENOL. It was reported that the patient's symptoms lasted about 24-36 hours post vaccination. At the time of the report, the patient "seemed fine". There was no product quality complaint involved. Additional information has been requested.
Vaccine administered around 11:00 am 4/15/2004 at Primary Care doctor's office, patient presented to the Emergency Department at 15:00 with a large, itchy welt on the left arm (at the site of vaccination) and a complaint of a "funny feeling" in the throat.
Initial unsolicited pregnancy report received from a Nurse on 29-May-2018. This case involves a 15-year-old female patient, who was vaccinated with 0.5ml once injection of MENACTRA (Batch number: U5765AC; expiry date and dose in series were not reported) in her right arm on 23-May-2018 while she was pregnant. Pregnancy information including estimated delivery date and patient was in her third trimester during vaccine exposure. Last menstrual period  Oct-2017, patient was 35-37 weeks pregnant. Patient's medical history and concomitant medications were not reported. It was also reported that patient was having knee surgery. No adverse event symptoms were reported. Pregnancy outcome was not reported. List of documents held by sender: none.
Moderna vaccine was administered outside of Facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------- I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 3/6/2022 PRESSURE ULCER OF BUTTOCK, UNSPECIFIED SIDE AND STAGE
This spontaneous report as received from a 79 year old male patient regarding himself with penicillin allergy. Medical history was not reported. On 06-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 injection, in the arm, lot number; K006681, expiry date- 21-OCT-2015, (dose, route and frequency was not reported). Concomitant medications were not reported. On 06-OCT-2014, patient experienced pain at injection site and throughout his entire arm. Patient also had fever on 06-OCT-2014. No lab diagnostics studies performed. The patient gave himself ADVIL (also reported treatment given as none) for pain relief and also explained that by 07-OCT-2014 his fever was gone and by 13-OCT-2014 his arm pain had completely recovered. Causality assessment was not reported. Patient did not seek medical attention. Product quality complaint was not reported.
At 8:55am individual reported a tingling sensation down the right side of face radiating down to upper deltoid/arm area.  Individual described the sensation as a feeling of pins & needles.  At 9:10 individual reported the symptom was gone.  At 9:12am Blood Pressure 120/76, Pulse 90 and Respirations 20.  Blood Pressure and Pulse taken using an automatic machine using the left arm.
fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: It was reported that Caller received second dose of the Pfizer BioNTech Covid 19 vaccine on 26Feb2021.  After her first vaccine she just experienced a headache and was fatigued for a few days.  After her second dose, she had headaches and a sore arm, her lymph nodes in her arms swelled up, had a fever for a couple of days and couldn't really concentrate.  In Feb2019 she was in a car accident and had a traumatic brain injury/concussion.  The synapses around her brain were injured causing numbness.  After getting the second vaccine, she said it felt like her car accident all over again with the numbness.  This side effect lasted about a month. Five to six weeks after the second dose, she got bloodwork done for the cardiologist and he called her and asked what she had been doing, that all of her enzymes were all elevated, liver, pancreas, everything.  She hadn't done anything differently in that time period other than get the vaccine.  Her husband had all three shots and had virtually no side effects other than fatigue. She is calling to see if these side effects were caused by the vaccine. What is the probability that a rise in enzymes would happen again. Should she get the third dose of the vaccine. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further  information is expected.
Changes in GI tract. Frequent nausea, vomiting, changes in bowel habits (constantly constipated or having diarrhea).  Usually sick for 3-4 days at a time, every few weeks. Starts with nausea, then vomiting, and diarrhea. In between these episodes, I am usually constipated.  Events started roughly 6 hours after receiving the vaccine. Prior to this, no GI issues.
Patient developed a rash on his right leg (the same leg that he received the Varicella vaccine in) that continued to spread to other areas of the right leg. Rash was not painful or itchy. Patient was started on Acyclovir.  Over the next few days the rash continued on right leg. The wound was cultured and tested for Varicella Zoster PCR which came back positive.
Full body hives starting 10 days after booster shot. Hives still present 10 days later. Hives come and go throughout course of day but are present daily on different parts of body. Not resolved by Zyrtec, Benadryl, Allegra, or hydrocortisone/triamcinolone ointment.
Rash and mild hive in injection area with onset 8 days after injection, duration 5 days
Shingles on face; This is a spontaneous report from a non-contactable consumer or other non hcp(patient).  A 25-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced shingles on face on an unspecified date. No, covid prior vaccination, No, covid tested post vaccination. Outcome of the event was unknown.   Device timestamp: 28/Apr/2021  No follow-up attempts are possible; information about lot/batch number cannot be obtained
The adverse event occur the day after receiving the 1st dose of the Pfizer covid-19 vaccine.  I received the 1st dose on Sunday March 28,2021 and start feeling pain on my right leg in the calf area. The area was hot and swollen and in pain, these symptoms started Monday March 29. 2021.
Parsonage-Turner syndrome; This is a literature report for the following literature source(s): Case Connect, 2021; Vol:11(4), pgs:e2100577.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEURALGIC AMYOTROPHY (medically significant), 5 days after the suspect product(s) administration, outcome "recovering", described as "Parsonage-Turner syndrome". Therapeutic measures were taken as a result of neuralgic amyotrophy.; Sender's Comments: Based on temporal association, the causal association between the administration of BNT162B2 vaccine and the event Parsonage-turner syndrome cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Flu like, headache, muscle ache, joint ache, surface of skin sore, chills, shivering, hard to concentrate, tiredness, pain at site area of injection. These symptoms are similar to shot 1 but more severe so I am reporting them.