chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain at the site of injection; swelling at the site of injection; experiencing extreme heat at the site of injection; vaccine was administered 4 inches below from the upper arm; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 28th April 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, injection site warmth and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site warmth were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The Shingrix vaccine was administered 4 inches below from the upper arm which led to vaccine administration at inappropriate site.  The patient experienced extreme heat, swelling, and pain at the site of injection.  The reporter seemed as she was in hurry and ready to get off the call.  The reporter asked for different department to answer her additional questions, therefore was provided contact information to Medical information for her healthcare professional to consult if there were any additional questions.  The patient refused to provide her full mailing address, date of birth, email address or fax number and stated that if required her healthcare professional would provide her information to Medical information when they call.  The reporter refused to give a consent for safety department to follow up with healthcare professional, therefore, did not ask further questions about healthcare professional's contact information.  The reporter did not know the lot number or expiration date of the vaccine. Also, there was no information on dose or route of administration.  The patient stated that the pharmacists who gave her 1st dose of Shingrix and 2nd dose of Shingrix were different individuals.  The reporter did not consent to follow up and did not give consent to follow up with healthcare professional.
Moderna COVID-19 Vaccine EUA: hospitalized for COVID-19 infection with pnuemonia. Administered antimicrobials, remdesivir and steroids and anticoagulated. Discharged to home medically stable.
This spontaneous report was received from a nurse and refers to a 32 year old female patient. No medical history and current conditions were reported. The patient did not have any drug reactions or allergies. On 21-MAY-2015, the patient was vaccinated with VAQTA 50 IU/ml, 1 ml intramuscularly (lot # and expiration date were not reported). Concomitant therapy included vitamin d. On 22-MAY-2015, the patient had complete metabolic panel test performed and the patient was determined to have an elevated liver enzyme level. The outcome of the event was reported as not recovered. The patient sought medical attention. The relatedness between the event and VAQTA was not reported. Additional information is not expected, because the reporter declined any further contact.
Headache, Myalgia, Arthralgia, NauseaVomiting, Chills, Fatigue, Pain/redness/itching to injection site Narrative:
Chills and fatigue set in 16 hours after vaccine received. Lasted less than 24 hours. Also had bladder pressure that resumed after all other aches went away after that 24 hour period that has lasted for one week. Not sure if related, but this was the only thing that happened during this time that was out of the ordinary, and its onset was same day as vaccine (maybe within just an hour of receiving the vaccine, definitely realized it in the evening that there was bladder pressure/throbbing).
approx 1yr p/vax pt devel 2 vesicles at inject site. addl info recv indicated on 5jan99 pt also devel redness at inject site & sore to touch
2nd dose symptoms: dragging/low energy, chills, upset stomach, onset of sudden constipation, stomach swelling, runny nose, constant taste of a chemical, uncomfortable/not a pain in throat, and sore arm.  About 4:00 PM, I felt pains in my chest and I could not hear.  My ears felt very hot and then became so dizzy I fell to the ground.
patient received dose from a vial punctured more than 20 times; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient received dose from a vial punctured more than 20 times) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, the patient experienced UNDERDOSE (patient received dose from a vial punctured more than 20 times). On 08-Nov-2021, UNDERDOSE (patient received dose from a vial punctured more than 20 times) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Shingles rash; This is a spontaneous report from a contactable other healthcare professional, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 26Apr2021 at 13:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Concomitant medications were not reported. On 01May2021 at 11:00, 5 days post vaccine, the patient had experienced shingles rash. The event had resulted in doctors or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event which included treatment with valacyclovir (MANUFACTURER UNKNOWN). The clinical outcome of the event shingles rash was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
29APR97 10PM fine red rash to for arms, stomach, back, lungs clear, denies SOB, c/o sore throat;throat red & swollen;
This spontaneous report was received from a registered nurse, concerning seven unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX, lot # R007693 with expiration date on 14-MAR-2020 and lot # R009411 with expiration date on 29-MAR-2020, for prophylaxis (dose, route of administration and anatomical location were not reported). The administered doses of the vaccine experienced a temperature excursion of 15 to 46 (14.5) degrees Fahrenheit (°F) for 50 minutes, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is a non-valid report due to lack of patient identifiers. As of 28-JAN-2019, all telephone attempts to obtain follow-up information have been unsuccessful.
Information has been received from a physician concerning a 50 year old female who on approximately 27-MAY-2009, last week, was vaccinated with a dose on PNEUMOVAX 23. On approximately 28-MAY-2009, one day after the PNEUMOVAX 23 was given, the patient had a "very swollen right arm with soreness". The swelling did subside several days after the vaccination. In approximately June 2009, the patient was recovered (date known). Follow-up information was received from a registered nurse concerning this 50 year old female who on 27-MAY-2009 was vaccinated SQ with the first dose of PNEUMOVAX 23 (Lot #: 661527/0112Y) into her left arm. There was no illness at the time of vaccination. On 27-May-2009, hours after vaccination, the patient's left arm had a whitish welt which developed after the injection. The next day, the patient felt sore and swollen under her arm below the injection site. A hard lump was noted at the site. It was noted that it was improving the day after the injection. Subsequently, the patient recovered 1 day later. No further information is available.
pt received number 1 on 9/2/21.  Received #2 on 9/23/21 instead of 9/30/21
Back of neck painful; Right jaw painful; Sense of smell heightened, repulsed at certain smells; Felt achy all over; Head hurt all over; Very very tired/ Suddenly will feel fatigued at times; Developed fever of 102 F; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Back of neck painful), PAIN IN JAW (Right jaw painful), PAROSMIA (Sense of smell heightened, repulsed at certain smells), PYREXIA (Developed fever of 102 F) and MYALGIA (Felt achy all over) in a 72-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.     Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (erythromycin), Drug allergy (sulfa), Drug allergy (Toprol) and Blood pressure high.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (Developed fever of 102 F). On 07-Apr-2021, the patient experienced NECK PAIN (Back of neck painful), PAIN IN JAW (Right jaw painful), PAROSMIA (Sense of smell heightened, repulsed at certain smells), MYALGIA (Felt achy all over), HEADACHE (Head hurt all over) and FATIGUE (Very very tired/ Suddenly will feel fatigued at times). On 06-Apr-2021, PYREXIA (Developed fever of 102 F) had resolved. On 08-Apr-2021, NECK PAIN (Back of neck painful), PAIN IN JAW (Right jaw painful), PAROSMIA (Sense of smell heightened, repulsed at certain smells), MYALGIA (Felt achy all over) and HEADACHE (Head hurt all over) had resolved. At the time of the report, FATIGUE (Very very tired/ Suddenly will feel fatigued at times) outcome was unknown.
Sore/ painful ankles. Have never had this before. Both feel weak and sore.
Awoke at 1:30 am with intense chills, measured temp 102F.  Fever lasted an additional 4 hours , and broke.  At 7am, body temp returned to 98.6F.
Patient was pregnant. LMP 9/28/09 giving EDC 6/30/10. Had H1N1 shot 11/4/09. Came in with brown spotting 12/7/09. Ultrasound showed fetus 6 week size with no cardiac activity. She would have been 6 weeks at time of shot 11/4/09.
Acute inflammatory demyelinating polyneuropathy or Guillain-Barre causing subsequent respiratory failure and aspiration pneumonia Leading to long hospitalization ICU stay intubation for 5 days 5 doses of IVIG and 5 episodes of plasmapheresis
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FEELING ABNORMAL (Feeling of blood rushing into veins), SKIN DISCOMFORT (Skin crawling), MYALGIA (Muscle/joint pains) and ARTHRALGIA (Muscle/joint pains) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included APIXABAN (ELIQUIS), ATORVASTATIN, METHYLPREDNISOLONE, TRAMADOL and METOPROLOL for an unknown indication.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, 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 experienced DIZZINESS (Dizziness), FEELING ABNORMAL (Feeling of blood rushing into veins), SKIN DISCOMFORT (Skin crawling), MYALGIA (Muscle/joint pains), ARTHRALGIA (Muscle/joint pains), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), FEELING ABNORMAL (Feeling of blood rushing into veins), SKIN DISCOMFORT (Skin crawling), MYALGIA (Muscle/joint pains), ARTHRALGIA (Muscle/joint pains), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 136/72 (Inconclusive) 136/72. On an unknown date, Heart rate: 46 (Inconclusive) 46.         No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
I began having chest discomfort on February 4, 2021.  I then developed sinus congestion, sore throat, and coughing by February 9, 2021.
jaundice; Drug exposure in utero; issues with latching; This retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of jaundice in a male patient exposed to DTPa (Reduced antigen) (Boostrix) in utero. The mother received the product for prophylaxis.   On 30th December 2019, the 31-year-old mother received Boostrix. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed to Boostrix at an unknown time during the pregnancy. At 37 weeks gestation, the patient was born via vaginal delivery and weighed 3260 grams (7lbs 3oz) at birth. The patient was diagnosed with jaundice (serious criteria hospitalization) and breast feeding problem (infant). On an unknown date, the patient experienced drug exposure in utero. On an unknown date, the outcome of the jaundice was recovered/resolved and the outcome of the breast feeding problem (infant) and drug exposure in utero were unknown.   It was unknown if the reporter considered the jaundice and breast feeding problem (infant) to be related to Boostrix.     See case US2020172562 for details regarding the mother case.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that the patient's mother received Boostrix vaccine on 30th December 2019 at 33 weeks gestational age, two weeks after receiving the vaccine the patient's mother developed gestational high blood pressure.  The mother first high blood pressure reading was 130/81 and had the other blood pressure readings. At 37 weeks the patient's mother was sent to the hospital for an induction due to continued high blood pressure.  The mother had a normal delivery of a baby boy with a birth weight of 7lbs 3 oz. The patient and mother were in the hospital for three days due to baby being jaundice and having issues with latching. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020172562:same reporter
low grade fever 100, dizziness starting on 26JAN (on & off) lasting for 7 days;
3 days after the vaccine was administered the patient experience severe dryness and cracking around the eye corners and cheeks(no change in face creams or soap).  She went to her physician who prescribed a steroid cream, and the dryness improved, but reappeared 3 weeks later.
Severe fatigue, HA and body aches day of administration.  Ongoing fatigue and sharp joint pain and aches.
Patient received MMRV plus MMR plus Varicella Plus TDAP all in one day
This spontaneous report was received from a physician via company representative, concerning a 6 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date (reported as "several months ago"), the patient was inadvertently administered GARDASIL 9 for prophylaxis, by mistake (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse events were reported for the patient and no product quality complaints were involved.
FEELING UNWELL; SEVERE ADVERSE REACTIONS; SICK; This spontaneous report received from a  a company representative concerned multiple patients (40 patient) of unspecified gender and age.The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced feeling unwell. On MAR-2021, the subject experienced severe adverse reactions. On MAR-2021, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe adverse reactions, feeling unwell and sick was not reported. This report was non-serious.
Tingling and numb sensation beginning at left hand fingertips and emulating upwards to the shot area in the first fifteen minutes.  Sensation turned to stinging sensation which continued up through through the shoulder and into the base of the neck and remained until sleep.  Heating pad was used to reduce sting.   Numbness and tingling continued for the next three days alternating between just fingers and fingers and arm.  Stinging was reduced and there is now continued numbness and tingling in the left hand fingers, in particular when fingers are being used for typing or other activity.   Sensation continues to date of report.
(As reported by mother). Day 3 post vaccine, developed hives "all over" after working out after school. Possibly feverish. Took ADVIL and BENADRYL with easing. Day 8 hives returned. Took BENADRYL again and they eased. Mother reporting this is concerning and she is a nurse.
Patient received a Pfizer COVID -19 vaccine prior to this event.  Patient presented to our public vaccine clinic today and was administered Moderna COVID-19 vaccine.  Patient had no adverse reactions, wrong vaccine administered.
Specialist indicated SIRVA; inflamed (the area); pain went from shoulder to wrist; shoulder pain; shot went straight into my shoulder; stuck needle in twice; This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Specialist indicated SIRVA), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot went straight into my shoulder), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (stuck needle in twice), VACCINATION SITE INFLAMMATION (inflamed (the area)) and PAIN (pain went from shoulder to wrist) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot went straight into my shoulder) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (stuck needle in twice). On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Specialist indicated SIRVA), VACCINATION SITE INFLAMMATION (inflamed (the area)), PAIN (pain went from shoulder to wrist) and ARTHRALGIA (shoulder pain). On 04-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (shot went straight into my shoulder) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (stuck needle in twice) had resolved. At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Specialist indicated SIRVA), VACCINATION SITE INFLAMMATION (inflamed (the area)) and PAIN (pain went from shoulder to wrist) outcome was unknown and ARTHRALGIA (shoulder pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood pressure measurement: 179/101 (High) A VERY SCARY 179 / 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   The vaccination was delivered into the rotator cuff and the patient said that the shot was given in the acromioclavicular area.   The treatment information included anti-inflammatories (for pain), and physical therapy.     Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Demographics updated On 08-Apr-2021: Follow up received on 8 April 2021 and  updated batch number for the first dose, lab data.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273, lot # unknown with associated AEs of Shoulder injury related to vaccine administration, arthralgia, vaccination site inflammation and radiating pain  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Blood clots in the Liver and Kidney also Pulmonary Embolism. went to ER was admitted and spent 6 days there. was put on Heparin as well as antibiotics. currently on Warfarin to maintain proper blood INR numbers.
pt recvd vax; thursday early pm, general itching; dph given; still itching 6dec94; did not see MD;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) 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; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "high BP" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 15Jun2023 to 19Jun2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Appendicitis / colic pain to her right midsection; This is a spontaneous report from a contactable Other-HCP (Nurse Practitioner).   A female patient of an unspecified age received bnt162b2 (BNT162B2) at single dose on 20Dec2020 for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  In Dec2020 3 days after vaccination she experienced colic pain to her right midsection. She was diagnosed with appendicitis. The outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: The event appendicitis is most likely an intercurrent medical condition and is assessed as unrelated to BNT162B2.