chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dime size welts (raised hives); nauseous; itchy arms; A spontaneous report was received from a consumer concerning a 40-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nauseous, itchy arms, dime size welts (raised hives).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events nauseous, itchy arms. On 11 Feb 2021, the patient experienced the event dime size welts (raised hives).  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.  On 10 Feb 2021 the outcome of events, nauseous was resolved. On12 Feb 2021 the outcome of event, dime size welts (raised hives) was resolved. The outcome of event, itchy arms was unknown.
Red raised bump at the injection site; small red dots from injection site spread to arms, also on torso and back
This was my second course of  Shingrix vaccine. Approximately 24 hours after injection felt shivery and achy all over. Feel warm but prefer to be under covers than to shiver.   Injection site hurts but not anything to report about. Very similar to pain from first injection.  I don?t have the vaccine info to add above.
This is a spontaneous report from a contactable consumer. A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot/batch number and expiration date were unknown), via an unspecified route of administration on the left arm on an unspecified date in Dec2020 at a single dose for COVID-19 immunization administered at the hospital. The patient had no medical history. He had no known allergies. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient had no other vaccine in four weeks. The patient had no Covid prior vaccination. He was not tested for Covid post vaccination. The patient's injection arm and entire upper body was sore for roughly 3 days on an unspecified date in Dec2020. The patient did not receive any treatment for the events. The patient recovered from the events on an unspecified date. Information on the lot/batch number has been requested.
Two weeks after 2nd dose, suddenly have ?shoosh? or ?thrum thrum? sound in right ear.  In time with heartbeat.  Not very loud but noticeable when quiet or trying to sleep.   Hope it goes away!
CLIENT WAS 12 YO AT TIME OF VACCINATION AND RECEIVED PEDIATRIC PFIZER FORMULATION OF 0.2ML. PEDIATRIC PFIZER IS APPROVED FOR AGES 5-11YO. CLIENT SHOULD'VE RECEIVED THE PFIZER GRAY-CAP FORMULATION OF 0.3ML.
Red, indurated, 6X 5 cm, warm area around injection site in right thigh
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 11-AUG-2016, the patient was inadvertently vaccinated with a dose of expired VARIVAX (lot # K006134, expiration date 29-APR-2016, dose not reported) subcutaneously for prophylaxis. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010737: US-009507513-1612USA005160: US-009507513-1612USA005161: US-009507513-1612USA005162: US-009507513-1612USA005163: US-009507513-1612USA005164: US-009507513-1612USA005165: US-009507513-1612USA005168: US-009507513-1612USA005167: US-009507513-1612USA005169.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017,  the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot N002720, expiration date 12-MAY-2019 (dose and route were not reported)  for prophylaxis. The vaccine was exposed from 32 Fahrenheit degrees (°F) to 35 Fahrenheit degrees (°F) for 1 hour. There was no temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA006643:
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 25-MAR-2014 at 14:00, the 20 year old female patient was vaccinated with the first dose of GARDASIL (lot # J005661, exp. 26-SEP-2014) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20; Feb 17, 20/20; Mar 20, 26/40. This is one of several reports received from the same source. Additional information is not expected.
Body aches, fever 101.6, headache, tiredness.  Body aches lasted only about 6 hours. Fever was off and on for about a week. Tiredness : I slept for over 24 hours starting about 8 hours after injection and was tired for 10 days.  Dry mouth and loss of taste lasting 3 weeks or  more.  Rash at injection site and under arm started at day 10 and is there but more redness than rash now. It took atleast 10-14 days to feel normal again.
This case was reported by a nurse and described the occurrence of limb swelling in a 19-month old female who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. On 27 May 2003, the patient received Infanrix. Within 24 hours post-immunization on 28 May 2003, the patient experienced a "more than usual reaction" characterized by a "large amount" of swelling extending form shoulder to elbow, redness, and warmth. She also developed a fever of 103 to 104 degrees Fahrenheit. Six days post immunization on 02 Jun 2003, the patient developed a rash all over her body. The patient was seen by the physician. The fever resolved within four days. The other events resolved after an unspecified period of time greater than four days. The nurse considered the limb swelling, injection site redness, and injection site warmth to be related to vaccination with Infanrix. She considered the fever and rash to be possibly related to Infanrix.
Right after shot had extreme pain, couldn't hold phone, arm was swollen and sore, joints and hips were sore, stomach ache, 102 fever, coughing, lymph nodes swollen up under her arm, very tired and weak.
MODERNA COVID VACCINE #3 GIVEN 11/2/21, LOT #071F21A; pt had a positive COVID test on 2/17/22 at Medical Center; dc'd to Hospice where he passed away; pt terminally ill due to COPD;
Patient administered vaccine beyond the published expiration date. Per Moderna, re-vaccination  not required. The vaccine determined to still maintain the activity necessary to protect against COVID-19.
This spontaneous report was received from a physician via a company representative, who referred to herself, a female of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the physician was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) for prevention of shingles. On unknown date, the physician experienced a slight headache for 3 days, was disoriented, very tired, her arm swelled up from the injection site down to the elbow and was red and very painful after receiving ZOSTAVAX . The physician recovered on an unknown date. No product quality complaint was involved. The relatedness between the events and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001001:
Fever, apnea, vomiting, diarrhea, feeding problems, grunting, high-pitched crying, possible seizures, lethargy with onset at 24 to 48 hours, possibly sooner. 10 days later, symptoms worsening gradually. At 10:00 on 11/24/1997, pt in respiratory arrest, resuscitated, life support with CT Scan revealing ICH, DAT, hypoxia, ischemia, pneumonia, meningeal inflection, others. Life support terminated 11/29/1997.
The next morning after I received the vaccine I had multiple kanker sores on my tongue. Around 6 of them. Seven days later they are no better or worse.  I am not sure if it related to the vaccine or not but I have rarely ever had a kanker sore and in the past, if I did it would only be one and would be gone in a few days. This was my second vaccine of the series of the Pfizer-BioNTech COVID-19 Vaccine EUA. My first one was on 12/28/2020. I did not have any sores after the first vaccine.
After vaccine, could not sleep for 2 nights, less than an hour a night, normally take 1 melatonin a night, but took 2 and it did not. Told to take Benadryl by cardiologist, which helped sleep. Extreme stomach cramps, nausea, joint pain, sprained ankle flared up again, fatigue. Went to work, but had to leave early because of symptoms.
3/10/15 screaming uncontrollably for 3 hours, fussy, low grade fever, maculopapular rash on trunk and face.
Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i; Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i; Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i; Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i; Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Jun2021 (Lot number: EW0217) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: quinolones" (unspecified if ongoing); "Known allergies:tetracyclines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), MYALGIA (non-serious), ARTHRALGIA (non-serious), FATIGUE (non-serious), VACCINATION SITE REACTION (non-serious) all with onset 06Jun2021 15:00, outcome "recovered" (2021) and all described as "Approximately 4 hours post vaccination:-suborbital headache (moderate)-muscle and joint pain (lower back and both shoulders)-Fatique-Mild injection site Rxn-Symptoms resolved within 24 hours of i". Therapeutic measures were not taken as a result of headache, myalgia, arthralgia, fatigue, vaccination site reaction.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive treatment for the events. AE resulted in: None of the above. Other medical history: N/A. Symptoms resolved within 24 hours of injection. Other medications in two weeks was none reported.  Follow-up attempts are completed. No further information is expected.
have them again/suspected vaccination failure; have them again; pain is excruciating; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 71-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (when was in 40's, got the shot). Previously administered products included Shingels vaccine.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 24-APR-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient got the two shots. In early 60's. Now patient was 71 and had shingles again. The pain was excruciating. Would not bother with any more shots. The patient would not wish the shingles on his/her worst enemy. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Patient developed headache, malaise, subjective fevers and chills, dizziness about 8 hours after receiving one dose of PREVNAR 13.
Family had a bilingual staff member spoke with mom. Mom called HD on 1.23.23 & stated that daughter received vaccines listed above on 1.18.23 at HD & following day daughter had developed a rash on left upper arm that was distributed to part of body. Mom stated there were also some small lesions on the body. Per mom no additional symptoms were noted & no one in the home had any similar symptoms. Per mom started benadryl for 3 days in which "lesions" improved.  After stopping Benadryl, the "lesions" reappeared although smaller. Mom states rash is now resolving.   Patient has received previous vaccinations including 1st dose of MMR and previous doses of polio and DTaP without any type of reaction in past.  This was patient's first time receiving Kinrix.  Patient is without insurance and was not evaluated by doctor. Previously referred to social work on 1.18.23 & several low cost clinics in area were provided to mom for follow-up on day of call.
10:15 AM After vaccination completed pt presented dizziness and nauseas. No loss of consciousness.O2 by nasal canula at 2 lts / min and legs were elevated. Also pineapple juice and cookies given after mom told us no breakfast taken at home. After that, patient completely recovered, vital signs taken  blood preasure 121/68, Pulse 60  and oxygen saturation 99% . Patient referred no nausea or dizziness. Patient active, oriented and stable. After she completed  a whole breakfast given by mother, she was taken for a pediatrician evaluation with Dr. He evaluated pt with normal findings.
Within 24 hours, anterior left thigh swelled and became erythematous. Large patch is well-demarcated and 22 x 25 cm.
This report describes a 49 y.o. male who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. There was no relevant medical history, concurrent condition, or concurrent medication. The subject received three injections of Engerix-B on a 0, 1, and 6 month schedule. The 3rd injections was administered on 4/11/02 (log #NG528A2; expiry 9/18/03). 1 week prior to this injection, on 4/4/02, Hep B surface antibody titer was positive. However Hep B surface antibody titer measured in July 02 was "negative"; he was a "low responder" with a titer value of <0.1 (reference range, 0.0 - 2.0). Comment: The reporter indicated that the subject received Engerix-B from lot ENG5282A2; however, this is not a valid Engerix-B lot number.
Information has been received from an office staff person concerning a patient who on an unspecified date came to the office for a ZOSTAVAX (Merck) injection and was inadvertently vaccinated with a 0.5 ml dose of VARIVAX (Merck) instead (route and lot # not reported). No adverse event reported. Additional information has been requested.
I could feel my chest tighting as i was receiving the rejection. They took my blood pressure and it was 225/114 and they kept checking it every 8 minutes for about 45 minutes. It wouldn't come down for a few hours. It finally started to go down and she sent me home with a blood pressure and informed me to keep check on it and if it started to rise again to go to a clinic.
Felt lightheaded 8 min after vaccine with vision dark around edges lasting few min. Slight shaky. Aox4. Reports had not eaten yet. Given water & snack. Vitals 100/64  66hr 99% RA 15 resp. 1800 dizziness/shaky improved systolic pressure 84; 1807  request of Ems, APRN evaluating patient.   After evaluation Aprn held ems at 1811. Vitals 77/48 100% RA 69hr 16 resp.  Pt seat layer back & encouraged to drink water. 1813  BP 82/49 98%ra 68hr Aprn talking with patient pt states "feels stronger" last ate at 2pm eating cookies at this time retake of Vitals 116/79 98%ra 71hr 16 resp aprn makes pt aware that needs to be seen if sx return. 1851 pt still here due to car trouble. Pt alerts obs nurse of shakiness. EmS called at this time. Vitals  97.4  124/77 100%ra resp15.  Given snack. Alert oriented x 4. 1856 ems arrived to evaluate patient unit 48. Vitals reported by ems 140/75  1904 pt refused hospital transport. Ems left pt; 1908 pt alerted she was feeling lightheaded Ems still on site returned. Transported pt to hospital
usually has very bad pain in shoulders because she has no cartilage/she had a whole month and a half with no pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 22Jan2021 (Lot number: EN6200) at the age of 83 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Heart trouble" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "A-Fib" (unspecified if ongoing); "Severe glaucoma" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "usually has very bad pain in shoulders because she has no cartilage/she had a whole month and a half with no pain".  Additional information: The patient wanted to talk about her experience with the vaccine. The patient stated that it was awesome, she had no side effect, no pain, and everything went perfect. She was thankful for the COVID vaccine. The patient informed that she had no pain or anything and usually has a very bad pain in shoulders because she has no cartilage. The patient informed that she had no pain in her shoulders from the time between her first to second COVID vaccine and wanted to know if Pfizer can develop a medication for arthritis. The kids of the patient told her that she can move her arms (excruciating to lift her arms because of no cartilage). The patient was thankful because she had a whole month and a half with no pain. The patient wanted tot to get another COVID vaccine just to help her arthritis and for the relief of her shoulder.  No follow-up attempts are possible. No further information is expected.
Chest pain 3 days after 1st dose Saturday 29  At 9pm  for several minutes then Sunday 31 at 9:35 am last for several hours,  Visit =local hospital emergency room
Patient had experienced heart palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: PALPITATIONS (non-serious), outcome "unknown", described as "Patient had experienced heart palpitations".  Additional information: After being vaccinated, patient had experienced heart palpitations and other issues.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
experience large amounts of abdominal gas; bloating; This non-serious case was reported by a consumer and described the occurrence of gas in a 84-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis, TOZINAMERAN (COMIRNATY) for prophylaxis and COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   Concomitant products included levothyroxine (Levothyroxin), rosuvastatin and losartan potassium.   In SEP-2023, the patient received RSV vaccine and Flu vaccine. On 01-OCT-2023, the patient received COMIRNATY. In SEP-2023, the patient received COVID-19 BOOSTER. On 01-OCT-2023, less than a day after receiving RSV vaccine and Flu vaccine, the patient experienced gas (Verbatim: experience large amounts of abdominal gas). In OCT-2023, the patient experienced bloating (Verbatim: bloating).  The outcome of the gas was not resolved and the outcome of the bloating was not reported.   It was unknown if the reporter considered the gas and bloating to be related to RSV vaccine and Flu vaccine.     It was unknown if the company considered the gas and bloating to be related to RSV vaccine and Flu vaccine.   Additional Information: GSK Receipt date: 07-OCT-2023 The patient was self-reported. The patient got the RSV Vaccine on the same day she got the Flu vaccine and Covid-19 booster and about 6 days later she began to experience large amounts of abdominal gas and bloating. It was unknown if the reporter considered the gas and bloating to be related to comirnaty and covid-19 booster vaccine. The reporter had permission to contact.
4-5 hrs p/vax pt began to scream 30-40 mins; mom could not calm him; about 530PM pt had sz-turned blue, went limp; taken to ER had EEG, spinal tap, blood cult; only tx was for temp;