chrisvoncsefalvay/vaers-outcomes huggingface dataset:
i have had intense itching at vaccine as well as bumps; i have had intense itching at vaccine as well as bumps; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 14Mar2021 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included montelukast (MANUFACTURER UNKNOWN) for unspecified indication from an unknown date and unknown if ongoing. On 21Mar2021, for 8 weeks (as reported at the time of reporting), the patient experienced intense itching at vaccine as well as bumps. Nothing could stop it. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event intense itching at vaccine as well as bump was not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on unknown date in 2021 (at the age of 60-year-old), as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Pain had injection site reaction. Thought redness looked like streaks and had his orthopedic doctor look at it while have a pre-surgery appointment. MD sent in rx for KEFLEX 500mg.
Patient was to receive PFIZER manufacturer for second dose of vaccine series but received MODERNA in error.  Followed up with patient the next day and on 3/17 - patient reported symptoms (ache, some fatigue) after second dose that resolved within 3-4 days.  She was advised to report this event to her private MD, which she did.
Dizziness, Headache, Myalgia & Arthralgia Narrative: dose 2- day 1-2- joint pain/ha/fatigue/tiredness/muscle pain/dizzy/loss of appetite
Episode of syncope approximately 14 hours after receiving the vaccination. Recovered within several minutes without adverse consequences.
Injection site it's filling up and another spot that's hard; Underneath the injection site it's itching, 3 inches long; Arm is still swelled; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection site it's filling up and another spot that's hard), VACCINATION SITE PRURITUS (Underneath the injection site it's itching, 3 inches long) and INJECTION SITE SWELLING (Arm is still swelled) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included VALPROATE SEMISODIUM (DIVALPROEX), LAMOTRIGINE, ATORVASTATIN, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), LEVOTHYROXINE, PANTOPRAZOLE and TRAZODONE for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Injection site it's filling up and another spot that's hard), VACCINATION SITE PRURITUS (Underneath the injection site it's itching, 3 inches long) and INJECTION SITE SWELLING (Arm is still swelled). At the time of the report, VACCINATION SITE INDURATION (Injection site it's filling up and another spot that's hard), VACCINATION SITE PRURITUS (Underneath the injection site it's itching, 3 inches long) and INJECTION SITE SWELLING (Arm is still swelled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: TCR report
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 43-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 19-APR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009085, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.
Redness of injection site; swelling; head and joint aches; diarrhea; muscle ache in upper arm of where injection occurred; slight numbness of fingers on injection arm.
rt leg redness & swelling-swelling size of fifty cent-no fever; This react was not as severe as previous reaction; ? reaction to adhesive on band-aid-band aids removed p/5 mins;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 11:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 11:37 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 21.27  Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM temperature was 34  total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On  03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported   This case was linked to MOD-2022-566976 (Patient Link).
Swelling and redness to injection site after 2 days. Induration/hive of 10 cm x 6 cm around site of injection.
diagnosed with pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (diagnosed with pneumonia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced PNEUMONIA (diagnosed with pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (diagnosed with pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported. No treatment information was provided.  Company Comment: Based on the 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. No further information is expected at this time.; Sender's Comments: Based on the 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. No further information is expected at this time.
Mild swelling, itching, and redness near injection site. 1 week and 24 hours post first dose. No other symptoms experienced with normal temperature, no aches or pain, and no tenderness to palpation.
On 1-3-07 pneumovax and influenza vaccine administered. On 1-4-07 patient started with fever and headache. Soreness and reddness in arm began 1-6-07. Reddness and swelling extended from left shoulder to elbow.  Patient seen on 1-8-07 by Dr. Patient diagnosed with pneumovax reaction with secondary cellulitis. Keflex 500 tid given. Seen by Dr. on 1-12-07 - patient has decreased redness and cellulitis. Patient under care of Dr.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a adult patient who received FLUARIX QUADRIVALENT (batch number 5T943, expiry date 30th June 2019) for prophylaxis. On an unknown date, the patient received FLUARIX QUADIRVALENT (intramuscular) .5 ml. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were not reported. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional information was reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported that they had been giving FLUARIX QUADRIVALENT at work for years. However, this year they had been seeing a lot of local reaction which was not normal. This case was reported for other staff members. In 2018, the patients were vaccinated with a dose of FLUARIX QUADRIVALENT. The patients had seen similar reaction of redness and raised area at the injection site. They had all received the same lot number of the vaccine. This case was linked with case US2018176517 and US2018176518 reported by the same reporter.
Client reports on 6/9/21 that 3 days after first dose she experienced seeing black dots, blurred vision, neck pain that radiated to her head , dizziness and tongue swelling that lasted 2 hours. Client reports she never had shortness of breath. No history of chronic conditions, no medications taken . Client did not follow up with pcp.   Client reports going to the emergency room and that everything was fine except her blood sugar was low.
Soreness at injection site; Body aches; Tired; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 10:30 AM (at the age of 43-years-old), as a single dose for COVID-19 immunization. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not receiving any concomitant medications. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient did not receive any vaccine within 4 weeks prior to the COVID-19 vaccine. On 16Mar2021, the patient had soreness at injection site, felt tired and had body aches. The patient did not receive any treatment for the adverse events. The clinical outcome of soreness at injection site, tired and body aches was recovering. Information about lot/batch number cannot be obtained. No further information is expected.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection (was treated with steroids and antibiotics.) in 2017, Leishmaniasis (infection spread to her kidneys, intestines, lungs.), Fungal infection (After 7 doses the patient had a hyperinfection : fungus), Mole of skin (After 7 doses the patient had a hyperinfection : mole), Candida infection (After 7 doses the patient had a hyperinfection : Candida ), Hair loss (lost all the hair), Skin loss (lost the skin in nose, skin looked like decaying), Skin disorder (Wholes in the skin, whole in the forehead), Kidney infection (Six months ago, the infection spread to her kidneys, intestines, lungs, treated with infusion), Gastrointestinal infection (Six months ago, the infection spread to her kidneys, intestines, lungs,treated with infusion) and Lung infection (Six months ago, the infection spread to her kidneys, intestines, lungs, treated with infusion).    On 10-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 (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.  After the first dose, the patient's hair started to grow in forehead and the forehead started to close.   This case was linked to MOD-2021-325750 (Patient Link).
inadvertently administered an expired ACT-HIB dose to a patient earlier today with no reported adverse event; Initial information was received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 8 months old female patient who received inadvertently administered an expired hib (prp/t) vaccine [ACT-HIB] dose to a patient earlier today with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (Pentacel) for Prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, hepatitis b vaccine RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix) for Prophylactic vaccination; influenza vaccine INACT SPLIT 4V (Fluzone QUADRIVALENT) for Prophylactic vaccination; and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 27-Oct-2023, the patient received a dose of 0.5 ml of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot UJ801AA, Expiry date : 05-Oct-2023, Frequency : once, strength was unknown) via unknown route in unknown administration site for Immunization and inadvertently administered an expired act-hib dose to a patient earlier today with no reported adverse event (expired product administered) (latency : same day).  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered an expired act-hib dose to a patient earlier today with no reported 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 the 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.
Normal symptoms at first: sore arm and lethargy immediately after the shot Went to bed and woke up at 2 am with severe nausea and vomited. First bout lasted about an hour. Experienced what felt like a large lump at the back of my throat and intense heartburn, for about 20 minutes. Vomited a second time for about 30 minutes. Again had a lump in my throat, chills and burning sensation in my chest which continued throughout the night. Woke up in the morning with aching back due to heaving, headache, weakness and lingering heartburn sensation & lump in throat . Drank fluids and ate sparingly throughout the day...only remaining symptom currently is headache, feeling slightly weak, bit of heartburnand slight lump in throat
This spontaneous report was received from a nurse referring to a multiple unknown number of patients of unknown age and gender. No medical history, allergies nor concomitant therapies were provided for these patients. On an unknown date, the patients were vaccinated with a dose of VARIVAX (strength, dose, route, lot #, and the expiration date were not reported) for prophylaxis. On multiple unspecified dates, the patients were vaccinated with an improperly stored VARIVAX and reconstituted with the properly stored sterile diluent (manufacturer unknown). The vaccine was exposed to a -14 to -10 degrees Celsius for an hour. There was no previous excursion and there was a data logger. No adverse effects were reported. This is one of multiple reports from the same source. Sender's Comments: US-009507513-1707USA000976.
4 mm area of induration on L upper arm patient reports soreness and aching with movement some discomfort without movement.
swelling to left underarm lymph node; pain at site; left arm "ache" with decrease in strength; This is a spontaneous report from a contactable other hcp. A 53-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: El3249, expiration date: not reported) via an unspecified route of administration, administered in Arm Left on 27Jan2021(at the age of 53 years) as single dose for COVID-19 immunization. Medical history included hypothyroidism , migraine and rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included thyroid taken for an unspecified indication, start and stop date were not reported. The patient also took BCP in two weeks. The patient previously took cipro and experienced drug hypersensitivity, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Ek9231, expiration date: not reported) via intramuscular route of administration, administered in Arm Left at 09:15 on 06Jan2021 as single dose for COVID-19 immunization and experienced malaise. The patient experienced swelling to left underarm lymph node, pain at site and left arm "ache" with decrease in strength on 28Jan2021. The outcome of events was recovering.
This legal claim was reported by a consumer via a pharmacist and described the occurrence of adverse reaction in a male subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). On 19 May 2014, at an unspecified time after vaccination with BOOSTRIX, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
MI Symptoms, heart racing/ pounding  , chest pain, shortness of breath , lightheadedness. I?m currently being worked up in the hospital and they recommend that I complete this form.
Got Pfizer vaccine on 3/10/21 and 3/31/21. Symptom onset on 7/15 with cough, runny nose and nasal congestion. Tested positive for Covid-19 on 7/21/21.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. From 24-AUG-2015, improperly stored (Oka/Merck) VARIVAX (lot# L007224 and expiry date: 03-MAR-2017 was adminsitered to multiple different unspecified patients on unspecified date. No adverse effects were reported. Additional information has been requested.
Several hrs after vaccination pt developed erythema and around injection site which continued to progress over next 36 hours TX with Rest, elevation, cool compress.
He got his vaccine, there was no problem initially.  About twice a day or three times a day he would have a terrible pain in all of his joints and burning in his feet, hands, arms.  The burning pain that he gets with his other conditions is where he cannot put on shoes or socks it is so painful, and does not matter if he goes from shoes to socks his feel like they are on fire.  All of his arms, shoulders, and is a severe outbreak of his conditions that are just constant and cannot get out of pain whatever he does.  It would last for 2-4 hours at a time.  He could not sleep at night.  His wife did everything she could to try and help with the situation by adding blankets on or taking them off, cool wet towels, plastic under his feet, different pillows, it was just a nightmare, solid pain.  If he would take a nap or sleep for a while it would go away, and then it would come back after an hour with severe pain.  He is afraid to go to water aerobics class as walking just makes it to happen again.  Just walking up and down the stairs to get the medications for me was not a good experience.    He is taking Flomax, Tamsulosin, Robaxin 500 mg split 4 pieces for this and his other symptoms.  He tried aspirin on Friday or Saturday night as he had a terrible headache and took under 500 mg of aspirin, and that and a cup of coffee made it go away.  Then Saturday was when the bad physical symptoms started.  He did not call his doctor or UC as it is a waste of time for him.  He cannot sit as that causes him pain, and standing causing him pain, and has low back issues, and cannot sit due to that pain.    He is not able to get comfortable and had to get up as his arm was hurting, cannot move his arms.  He does not know if it's a cross reaction to his condition and the vaccine.
A COVID dose #1 vaccine was ordered however the vaccine given to the MD to administer was a COVID bivalent booster.
HYPOXIA 2/28/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
severe h/a started evening of 12OCT p/recvng flu shot; went to hosp; CT Scan; lasted about 24 hrs;
Right after vaccination Patient fainted for 2 seconds by sitting on the chair.  Cold packs and water  provided, legs elevated. Vital signs obtained. Patient states that she is athletic and her Vital sings are lot at base line.  In the begining  her pulse and blood pressure were low but improved in 10 minutes.