chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAY-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Caller stated she has now rheumatoid arthritis and her swelling is high as well as the numbers are very high.; Caller added that she cannot walk and she is always in pain.; Caller said she already have arthritis but she noticed that it got worse after her second shot.; Caller stated she has now rheumatoid arthritis and her swelling is high as well as the numbers are very high.; Caller added that she cannot walk and she is always in pain.; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: Apr2021, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), SWELLING (non-serious), outcome "unknown" and all described as "Caller stated she has now rheumatoid arthritis and her swelling is high as well as the numbers are very high."; GAIT DISTURBANCE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Caller added that she cannot walk and she is always in pain."; ARTHRITIS (non-serious), outcome "unknown", described as "Caller said she already have arthritis but she noticed that it got worse after her second shot.". Clinical course: she already had arthritis but she noticed that it got worse after her second shot. Caller stated she had now rheumatoid arthritis and her swelling was high as well as the numbers were very high. Caller added that she cannot walk and she was always in pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient Mom called stating patient started having chills, aches/pains on the evening of the vaccine.  She further stated patient had severe nightmares through the night.  She reports the patient is taking Tylenol  and is feeling better today.
pt recv vax 31JUL96 & that same evening pt exp temp of 101, body aches, h/a;1AUG96 pt presented to MD & was treated w/APAP;
This case was reported by a physician and described the occurrence of medically attended fever in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included HIB (manufacturer unspecified, unknown route, injection site and batch) given on an unspecified date; rotavirus vaccine (manufacturer unspecified, unknown route, injection site and batch number) given on an unspecified date; pneumococcal vaccines (non-gsk manufacturer, unknown route, injection site and batch number) given on an unspecified date. On an unspecified date, the subject received 3rd dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced medically attended fever. At the time of reporting the outcome of the event was unspecified.
Lump and redness at injection site; Red mark and lump at injection site growing; joint pain everywhere; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Red mark and lump at injection site growing), INJECTION SITE PAIN (Soreness in arm), ARTHRALGIA (joint pain everywhere) and INJECTION SITE ERYTHEMA (Lump and redness at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 030L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and METHOTREXATE for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 22-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness in arm). On 23-Feb-2021, the patient experienced ARTHRALGIA (joint pain everywhere). On 24-Feb-2021, the patient experienced INJECTION SITE MASS (Red mark and lump at injection site growing). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Lump and redness at injection site). At the time of the report, INJECTION SITE MASS (Red mark and lump at injection site growing), INJECTION SITE PAIN (Soreness in arm), ARTHRALGIA (joint pain everywhere) and INJECTION SITE ERYTHEMA (Lump and redness at injection site) had not resolved.            Treatment information includes Dose 1 - ice, Tylenol Dose 2 - Benadryl cream, anti inflammatory gel   This case was linked to MOD-2021-024360 (Patient Link).
On the second morning (Jan-16-2022) after receiving the booster vaccination, I woke up with hives over my entire body, swelling of my ears, and a slightly scratchy throat.
arm soreness; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown. Not Provided          No Concomitant information  provided. No Treatment information  provided
Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 17-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Pt received Adacel about 900 am - woke up that night around 0130am with fever of 102.5F and body/joint aches. These symptoms lasted 48 hrs. She took ibuprofen to help decrease fever. Injection site was also warm to touch and hard - although today (5/7/07) this has resolved but arm is still sore.
Inappropriate dose; Late 2nd dose; adult patient received a pediatric dose; adult patient received a pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 20-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number 9TG49, expiry date 31-DEC-2024) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 12-JAN-2023).   On 30-MAY-2023, the patient received the 3rd dose of Engerix B. On 27-APR-2023, the patient received the 2nd dose of Engerix B pediatric. On 27-APR-2023, not applicable after receiving Engerix B and an unknown time after receiving Engerix B pediatric, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose), underdose (Verbatim: adult patient received a pediatric dose) and adult use of a child product (Verbatim: adult patient received a pediatric dose). On 30-MAY-2023, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate dose). The outcome of the drug dose administration interval too long, underdose, adult use of a child product and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUL-2023 A medical assistant called to inform that an adult patient received a pediatric dose of Engerix-B and dose was administered after recommended interval, which led to lengthening of vaccination schedule, underdose and adult use of a child product  and received the 3rd dose before recommended interval, which led to shortening of vaccination schedule. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Swelling and flushed and hot around left eye and mouth, to lesser degree on right side.  Called doctors office on 4/03/2013 and told no relation to shingles vaccine.  No treatment given.
Debilitating, relentless full head pain. My head feels like it is in a vice and is being constantly and continuously sqeezed. My entire head hurts to include my face and neck. The pressure reminds me of a headache associated with a CFS leak. It hurts terribly. I have been taking Sudafed sinus, Tylenol, Ibuprofen and saline nasal spray. I am also putting heat pads on my neck, face and head for relief. I am reporting this because I am still in a great deal of discomfort. I typically do an hour of yoga a day, ride my bike for an hour and exercise 4-5 times a week. I eat a healthy plant based diet. I would say I am in the best shape of my life. I have not been able to exercise since the vaccine. I have also been very tired.
DEC97 pt devel 3 lesions which were dx as shingles p/2  siblings were vaccinated w/varicella in early DEC97;
Approximately 8 minutes after patient received vaccine 248 PM she said that she just did not feel good that she was light headed and nauseas. States that when she got to lobby to finish waiting her 15 minutes she went to bathroom to vomit. When nurse got to her in bathroom she was pale, clammy but never loss conciseness. Patient stated that she has done that in past with giving blood but not immunizations. Patient was taken back to exam room and assisted to lie down and given water to drink and given a fan to cool down. BP was taken at 3:00 PM and it was within normal limits at  114/76. Patient  was allowed to cool off and drink water and she also got a piece of candy in case she was having a drop in her blood sugar. After another 15 minutes she stated she felt much better and more like herself and her BP was taken again at 3:15 PM and it was still stable 116/74. Patient  walked out of the clinic in stable condition with her grandmother at her side. No other reactions noted. Patient never had LOC.
Had vaccines on 10/25. Broke at in hives on Tuesday 10/31 treated myself with with cortisone and Benadryl. Had steroid injection at doctors office on 11/3. Nurse said I was second pt in there for hives that day. Will need to go back on 11/6 for another injection because I am still breaking out badly.
This is my first booster shot, and it was in my right arm. My right armpit got very swollen in about 24 hours, with a soft pear-shaped swelling 4x2x1" and a mild burning sensation. This didn't happen during my first two shots.  Other side effects: fatigue, very sore arm at the injection site.  During the first evening after my shot, I also experienced intense nausea and vomiting every other 10-15 min for about 3 hours, very likely because of food poisoning from takeout food.
Fever tmax 102.8 x 1 day. Local reaction to pneumococcal vaccine, local reaction to influenza redness swelling pain to left arm and back.
administrated / batch recall on April 26 2021/ recall date 10FEB2021; administrated / batch recall on April 26 2021/ recall date 10FEB2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 26th April 2021, the patient received Shingrix. On 26th April 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient received Shingrix from  recalled batch, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. This was 1 of 6 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169136:Same reporter. US-GLAXOSMITHKLINE-US2021169129:Same reporter. US-GLAXOSMITHKLINE-US2021169133:Same reporter. US-GLAXOSMITHKLINE-US2021169134:Same reporter US-GLAXOSMITHKLINE-US2021169135:Same reporter
This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 19-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L039659 expiration date: 15-MAR-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
After 4th does Moderna , 2 days late I had migraines headaches for 10 days. Took Tylenol and herb for headaches
Difficulty breathing, then went to emergency room and then started feeling very nauseous. She then vomited a few times, then had dry heaves.
Patient  received Moderna Vaccines initial on 5-7-21 and 6-2-21 . Patient was given booster on 11-19-21 before the complete 6 month interval approved for the booster to be given.
Excessive redness developed on arm (left) of injection site. Also, said sore, itchy.
First 2 days had redness and swelling at injection site.  5 days later left arm pit was in pain. It was extremely painful to move my arm or touch.  I didnt think it was related to the vaccine.  I just thought it was a muscle strain but now i have  lump under my arm pit.  I believe this is lymphadenopathy.
Can you take Advil/Tylenol to reduce any pain from the 1st injection?; This case was reported by a consumer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient asked if he/she can take advil/tylenol to reduce pain from 1st injection.
subacute thyroiditis; neck pain; odynophagia; pyrexia; This is a spontaneous report from a contactable consumer or other non-HCP. A 39-years-old female patient (Pregnant: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (Age of vaccination: Unknown) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE , Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunization The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced subacute thyroiditis, neck pain, odynophagia, pyrexia. Therapeutic measures were taken as a result of subacute thyroiditis, neck pain, odynophagia, pyrexia. The outcome of event was not recovered.
Injection site reaction. Pain. Hot to touch. Redness. Horseshoe shape rash continuing down arm, below injection site. Slight itch. Resolved in ~2 weeks. No doctor visit required.
felt weak; hot sweats; could not get warm; lethargic; only wanted to sleep; tired; chills; low grade temperature; joint pain in their arms; headache; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (could not get warm), LETHARGY (lethargic), SOMNOLENCE (only wanted to sleep), HOT FLUSH (hot sweats) and ASTHENIA (felt weak) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING COLD (could not get warm), LETHARGY (lethargic), SOMNOLENCE (only wanted to sleep), FATIGUE (tired), CHILLS (chills), PYREXIA (low grade temperature), ARTHRALGIA (joint pain in their arms) and HEADACHE (headache). On 17-Feb-2021, the patient experienced HOT FLUSH (hot sweats). On 18-Feb-2021, the patient experienced ASTHENIA (felt weak). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 16-Feb-2021 for Headache, at a dose of UNK dosage form. On 15-Feb-2021, ARTHRALGIA (joint pain in their arms) had resolved. On 16-Feb-2021, HEADACHE (headache) had resolved. On 17-Feb-2021, LETHARGY (lethargic), SOMNOLENCE (only wanted to sleep) and FATIGUE (tired) had resolved. On 18-Feb-2021, HOT FLUSH (hot sweats) had resolved. At the time of the report, FEELING COLD (could not get warm), ASTHENIA (felt weak), CHILLS (chills) and PYREXIA (low grade temperature) outcome was unknown.            No concomitant medications were reported.
Nausea; severe vomiting; Fatigue; headache; This is a spontaneous report from a contactable Other HCP (patient)  A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE2), intramuscular, administered in arm right on 05Mar2021 15:15 (Batch/Lot Number: EN6207) (at the age of 45) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were none. No other vaccine was received in four weeks. Patient was not pregnant. The patient experienced nausea on 05Mar2021 21:00, severe vomiting on 05Mar2021 21:00, fatigue on 05Mar2021 21:00, headache on 05Mar2021 21:00. No Covid prior or post vaccination. The events were not treated. The events outcome was recovering.    No follow-up attempts are possible. No further information is expected
After receiving my vaccine, a few days later, I felt like I couldn't breathe. My sinus tissues flared up. I went to the Health ER, but they told me that I was having an anxiety attack. That was not correct. So I walked out of the ER and went to my doctors office across the highway. He gave me a prednisone shot and I felt better the next day.
NO ADVERSE EVENT REPORTED. PATIENT WAS 17 YEARS OLD AT TIME OF 1ST VACCINE. PATIENT RECEIVED DOSE AS PART OF A LARGE, MULTI-LANGUAGE VACCINE CLINIC. AFTER THE VACCINE WAS ADMINISTERED AND PATIENT LEFT, HER REPORTED AGE WAS NOTED AND THE QUESTION AROSE OF CORRECTNESS OF THE REPORT.  ATTEMPTS WERE MADE TO CONTACT THE PATIENT TO CONFIRM HER DOB WITHOUT RESOLUTION. A NOTE WAS LEFT WITH HER CONSENT FORM FOR HER SCHEDULED SECOND DOSE.
Numbness and tightness from forearm to hand. When closing fingers to make a fist fingers feel tight.
Day after vaccination she had right arm pain radiating from upper arm down to wrist from 1 injection site. No redness or swelling. She visited he doctor for regular appointment that week. When doctor touched spot patient said it was painful. I then had no contact with patient until this past Sunday November 18th. She never came in the store to show us her painful spot, but on Nov 18th felt she would let me know the pain was bothering her, but she has not had any treatment done.
Case previously recorded as MA2009-5448. Case received on 24 NOV 2009 via MedCom from a consumer the following information: A 5-year-old male patient was vaccinated i.m. with FLUVIRIN H1N1, batch no. 102125P1, on 20 NOV 2009. The patient experienced on 22 NOV 2009 a runny nose and on 23 NOV 2009 in the morning fever. At the time of report, the patient did not yet recover. MedCom no: NA09-008739.
mild chills; soreness near the injection site; temperature of 100.3; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (mild chills), VACCINATION SITE PAIN (soreness near the injection site) and PYREXIA (temperature of 100.3) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (arthritis pain). Concomitant products included NAPROXEN SODIUM (ALEVE) for Arthritis, METFORMIN and ATORVASTATIN CALCIUM (ATORVASTIN) for an unknown indication.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (mild chills), VACCINATION SITE PAIN (soreness near the injection site) and PYREXIA (temperature of 100.3). At the time of the report, CHILLS (mild chills), VACCINATION SITE PAIN (soreness near the injection site) and PYREXIA (temperature of 100.3) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       CONCOMITANT MEDICATION INCLUDE WATER PILL,METFORMIN,ATORVASTIN
Office assistant gave DTaP rather than Tdap to 11 year old patient during her annual physical. This was during a well child visit to pediatrician. MOD is float for several offices.