chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt identified as needing 30 min observation due to previous severe allergies. Pt reports she is feeling anxious: about the vaccines, long lines, and wait. RN spoke with her she stated that she experienced an allergic reaction to codeine in the past when she was in the hospital. Pt alert, oriented and calm. 3:20 pt reported she thought her throat was feeling itchy. RN called for assistance to observation room EMS called. Pt agreed to receive benadryl IM and 6L O2; and administered benadryl into left deltoid.    EMS/FF arrived, pt declined transport. BP 168/104 taken 138/97, went home with daughter in law.
Diffuse erythema to L upper arm non-tender, not well demarcated, local reaction-no treatment.
12 cm x 12 cm area of erythema/induration at injection site (left thigh extending to buttocks).
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The patient experienced no adverse events.   This case was linked to MOD-2021-395985 (Patient Link).
ALREADY REFRIGERATED IN SOLUTION FORM THEN IT GOT RE-FROZEN; VACCINE GOT RE-FROZEN AND UPON THAWING IT WAS ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 09-JUN-2021, the subject experienced already refrigerated in solution form then it got re-frozen. On 09-JUN-2021, the subject experienced vaccine got re-frozen and upon thawing it was administered. The action taken with covid-19 vaccine was not applicable. The outcome of the already refrigerated in solution form then it got re-frozen and vaccine got re-frozen and upon thawing it was administered was not reported. This report was non-serious.
Patient had an emesis almost immediately after immunizations. He then became clammy, complained of itchiness all over and then unresponsive. Ambulance called. Epi-pen Jr, adm on 15:22 PM. 6/8/06 Received medical records from PCP & from ER which reveal patient was in good health on day of vax but was thin & on Benadryl nightly.  Immediately after vax, developed n/v, extensive pruritic rash, SOB, palpitations, swelling of eyes & angioedema.  Taken to ER & admitted overnight for dx: allergic reaction secondary to MMR.  Treated with epi, steroids & zyrtec.  Responded well & was released for f/u with PCP/ss
headache; muscle aches; nausea; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 25th February 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 26th February 2020, the patient experienced headache, muscle pain and nausea. On an unknown date, the outcome of the injection site pain, headache and muscle pain were recovering/resolving and the outcome of the nausea was unknown.   It was unknown if the reporter considered the injection site pain, headache, muscle pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient wanted to remain anonymous and did not want to provided demographic information. The patient received dose of shingrix in the right arm and 1 day after receiving vaccination experienced headache, muscle pain and nausea. The patient planned to follow-up with his healthcare provider on an unknown date. Did not consent to follow-up.
strep infection; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age, received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient reported that she was scheduled to receive her second dose of Pfizer-BioNTech Covid19 vaccine today/tomorrow. She has recently been diagnosed with a strep infection, and was being treated with "amox/clav 875mg twice a day" and wanted to see if there was an interaction between the antibiotic and the vaccine. On an unknown date, she underwent a COVID test which came back as negative. She wanted to know what would happen if she was unable to receive her second dose, tomorrow?. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
14cm x 16.5cm erythematous, indurated oval on left arm at injection site, fever 103 for 3 days, pounding headache lasting six days.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 IMMUNIZATION, reaction(s): "sore arm"; Bnt162b2 (Dose 2, single), for COVID-19 IMMUNIZATION, reaction(s): "sore arm"; Bnt162b2 (Dose 3, single), for COVID-19 IMMUNIZATION, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine EUA: during telehealth encounter nine days after vaccination patient reports a lump under the collarbone. The provider documented arm redness and a diagnosis of cellulitis and prescribed antibiotics.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N000683 with expiry date: 06-JAN-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Nauseous; Headache; Normal sore arm after shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Normal sore arm after shot), NAUSEA (Nauseous) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Normal sore arm after shot). On 14-Mar-2021, the patient experienced NAUSEA (Nauseous) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Normal sore arm after shot), NAUSEA (Nauseous) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe fatigue, slowed speech. Memory loss or distortion. Severe pain of the sight. Headaches.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administration after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 045J21A, 047B21A and 045A21A) for COVID-19 prophylaxis. The patient's past medical history included COVID-19. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2022 at 10:55 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jun-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administration after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administration after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. The patient had no known allergy. It was unknown if patient had acute illness at the time of vaccination as well as unknown for chronic health conditions. There was no adverse reaction reported with the vaccine. It was reported that vaccine was thawed at the time of excursion. Vaccine was thawed at the time of excursion. Vaccines remained in travel cooler, had a temperature excursion on 6-Jun-2022. At 11:18 am vaccines where placed in refrigerator. 3 booster doses of the vial where given to patients prior to reporting excursion. No visible changes to vial was noted. A total of 1 vial was affected. It was reported that, On 06 Jun 2022 noticed that the datalogger from the travel cooler was out of range. It took approximately 6 mins for the temperature to be regulated. The datalogger failed to alert of the excursion of approximately 36 minutes. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2022: Reporter, Patient details and medical history added, suspect details updated.
p/pt learned was pregnant, called kaiser rep who checked & called back saying it should not be a problem;
Developed Shingles 4 days after vaccination, treated with VALACYCLOVIR HCL 1 GRAM TABLET, PREDNISOLONE AC 1% EYE DROP drops,suspension ,  CIPROFLOXACIN 0.3% EYE DROP DROPS, still have pain and numbness 3 moths later
sharp pain from upper deltoid to armpit and pain on skin - 26 Feb 2021; chills - 26 Feb 2021; "tremendous" headache lasted all day and night - 26 Feb 2021; fever 101F - 26 Feb 2021/fever 100F - 26 Feb 2021 at 10:00pm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sharp pain from upper deltoid to armpit and pain on skin - 26 Feb 2021), CHILLS (chills - 26 Feb 2021), HEADACHE ("tremendous" headache lasted all day and night - 26 Feb 2021) and PYREXIA (fever 101F - 26 Feb 2021/fever 100F - 26 Feb 2021 at 10:00pm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history was not reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (sharp pain from upper deltoid to armpit and pain on skin - 26 Feb 2021), CHILLS (chills - 26 Feb 2021), HEADACHE ("tremendous" headache lasted all day and night - 26 Feb 2021) and PYREXIA (fever 101F - 26 Feb 2021/fever 100F - 26 Feb 2021 at 10:00pm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (sharp pain from upper deltoid to armpit and pain on skin - 26 Feb 2021), CHILLS (chills - 26 Feb 2021), HEADACHE ("tremendous" headache lasted all day and night - 26 Feb 2021) and PYREXIA (fever 101F - 26 Feb 2021/fever 100F - 26 Feb 2021 at 10:00pm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 100f (Inconclusive) 100F. On 26-Feb-2021, Body temperature: 101f (Inconclusive) 101F.         No Concomitant medications were provided
SIDE EFFECT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect was not reported. This report was non-serious. This case, from the same reporter is linked to 20211052831 and 20211052814.
Tinnitus began 3 weeks after my second dose. Although the tinnitus is minimized today,  it was quite bad in my left ear for 3 months. I still have it to this day but not as bad. When I first got the side effect it was intolerable.
Information has been received from a physician concerning a 37 (also reported as 38) year old female graduate school student with a history of an "upset stomach" and some muscle aches (also reported as no significant past medical history including no history of neurologic disease or immune compromise) who on 19-DEC-2006 was vaccinated in the arm with a dose of MMR (lot # 654543/0699F) after laboratory studies performed showed positive measles and mumps titers but negative rubella titer. There was no concomitant medication. There was no illness at the time of vaccination. On 21-DEC-2006 (also reported as 4 days after vaccination), the patient developed numbness in her right leg (from the thigh through the foot) on the contralateral side to which the vaccine was administered. The patient also reported tingling in the right leg including the anterolateral thigh which increased with standing or lying down. Subsequently the patient developed nausea (which increased between the time of onset and 12-JAN-2007) and diarrhea (1 large explosive bowel movement). It was also reported that the patient had intermittent buzzing in the right ear, frontal headaches for 24 hours/day (also reported as 24 hours), and some muscle aches in the shoulders and thighs. The patient also "felt sick" with dizziness and was "febrile" although the health care provider was not sure if her temperature was taken (the only temperature reported was 98.3). The patient had no back pain, sciatica or rash. ON 12-JAN-2007 a complete blood count, complete metabolic panel and thyroid stimulation hormone level were normal. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient had no known adverse events following prior vaccination. No additional information provided. Additional information has been requested.
Tinnitus- A constant high pitched sound in both ears. I have never had it before and there is no explanation for it. I have not been exposed to any loud noises.
pain; herpes zoster; her arm hurt where the shot was administered; Chills; pain; red dot/rashes; flu-like symptoms; upset stomach; feeling tired; This case was reported by a consumer via call center representative and described the occurrence of herpes zoster in a 88-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   The patient's past medical history included shingles (has a history of previous shingles). Previously administered products included Valacyclovir.   On 17th August 2019, the patient received the 1st dose of Shingrix .5 ml. In October 2019, less than 2 months after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced red rash. On an unknown date, the patient experienced herpes zoster, injection site pain, pain in arm, influenza-like symptoms, abdominal discomfort, fatigue, chills and pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the herpes zoster, injection site pain and pain were unknown and the outcome of the red rash, pain in arm, influenza-like symptoms, abdominal discomfort, fatigue and chills were recovered/resolved.   It was unknown if the reporter considered the herpes zoster, injection site pain, red rash, pain in arm, influenza-like symptoms, abdominal discomfort, fatigue, chills and pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in her left arm deltoid and had red dot rashes which was herpes zoster along the back of her right hip and the middle of her lower back more towards the right side.The patient was instructed to take valacyclovir when these spots reappear. The patient did experience left arm pain and flulike symptoms which resolved in a few days.  The patient had red dots rash along the back of her right hip which extends to the middle of her lower back. The patient took valacyclovir and the red dots resolved immediately. The reporter consented to follow up. The patient advised that she had flu like symptoms like the chills, upset stomach and feeling tired. The symptoms lasted for three days. The patient also advised that her arm hurt where the shot was administered.  No further information was provided.
About 3 days after the 2nd dose, I started feeling swelling in my upper gums, and by the 4th day it was so painful that I took Tylenol and I was taking it every 6 hours and I was taking the max I could take. Probably 3 days after I started taking that it went down. Then I had a dentist appointment 2 weeks after and he noted it and I had a bridge in my mouth. It lasted about 3-4 days and my dentist said if I had to get another shot to take Tylenol right after. My gums were swollen over the top of my bridge in mouth and I couldn't eat or anything.
Patient reported dry skin on arms, hand, and face. Patient said it looked like shingles but only had some pain. He reported blurry vision that continued for 2 days. Patient went to the Dr. and was treated with prednisone and his symptoms cleared up after a couple weeks.
Approximately one hour after the shot, my face began feeling strange.  My nose was red and warm as well as my cheeks.  Then my lower lip began to swell.  I would consider these symptoms somewhere between mild to moderate.  The symptoms began around 4:30 in the afternoon and subsided as the evening progressed.  The next morning (today), my face feels basically normal again.  My only symptoms now are a sore arm and a slight headache.  I have experienced allergic reactions before but never from a vaccine.
Today noticed site of injection intramuscular left arm was sore, so inspected more and saw it hard swollen at site, hot to touch, bright pink in color and the tattoo in that area the black lines of the tattoo are raised, the skin and underlying tissue feels odd - kind of tiny lumpy or "textured", not normal.  I just noticed it tonight but don't know how long it has been this way, didn't notice until my shirt seemed to irritate it so I noticed. Treatment: none at this time. Odd so far after the injection. I have not seen my doctor since the reaction is very local to the site and no other symptoms.
Chills, nausea @11:00 PM (10/24); body aches,  shakes @ midnight (10/25); fever 99-100.1 , continued chills, nausea, shakes @ 10 AM (10/25)
pt recv vax; localized swelling & redness lt leg; no pain; approx grapefruit size;
Fever.  Temp increased from 95.7f to 100.7f.   Fever broke after 15 hours.
This spontaneous report was received from a physician concerning a 22 year old female not pregnant patient with none pertinent medical history, concurrent conditions, drug reactions or allergies. On 03-AUG-2015, the patient was vaccinated with the first dose of GARDASIL or GARDASIL 9, intramuscular in her left deltoid area, (dose, lot number and expiration date were not reported). There was no concomitant medication reported. The reporter physician was uncertain whether the patient received a dose of GARDASIL or GARDASIL 9. On the same date in the evening, the patient developed a "low-grade" fever and fatigue. Furthermore on 08-AUG-2015, the patient developed a "pronounced" lymphadenopathy in her "axillary area, supraclavicular and infraclavicular areas and posterial cervical area"; it was unspecified on which side of the patient's body the lymphadenopathy developed. The patient sought medical attention by visited the physician and no treatment was given. No hospitalization or life threatening were reported. The physician further described the patient's lymphadenopathy as being painful and limiting her neck movement and stated he therefore considered the lymphadenopathy to be significant disability to the patient. At the time of the report, the outcome of the fever, fatigue, lymphadenopathy in her axillary area, supraclavicular and infraclavicular areas and posterial cervical area was reported as not recovered. The reporter considered the lymphadenopathy to be significant disability due to painful and limiting the patient's movement. The relatedness between the events and therapy with GARDASIL or GARDASIL 9 was not reported. Additional information has been requested.