chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PRURITUS (itchiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and PRURITUS (itchiness). At the time of the report, RASH (Rash) and PRURITUS (itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment drugs were reported. No contact information provided. Transfer was not completed, call dropped.
This spontaneous report was received from a nurse concerning a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-SEP-2012 (also reported as at the age of 11 years old), the  patient was vaccinated with the first dose of GARDASIL 9, intramuscularly for prophylaxis (lot # and expiration date were unknown). On 12-JUL-2016, the patient was vaccinated with  the second dose of GARDASIL 9, lot # M005714, expiration date 03-OCT-2017, intramuscularly for prophylaxis (inappropriate schedule of drug administration). On 05-JUN-2018, the patient was vaccinated with the third dose of GARDASIL 9, lot # N025428, expiration date 19-JUN-2020, intramuscularly for prophylaxis (inappropriate schedule of drug administration). No adverse effects reported.
Fully vaccinated with Covid-19 Pfizer EUA  04/08/2021-04/30/2021
was vaccinated with the J&J 5/28/21, 10/28/21 got booster Moderna. Symptoms onset 10/28/21 related to booster  - severe h/a, chills, fatigue, arm pain, not subsides up to 11/4/21.
Local swelling of arm, distended to shoulder, itching and limitation in movement of left arm x48 hours, mildly warm, no fever.60 day follow-up dated 7/10/00 provided no additional data.
19 year old patient received Engerix B adult; 19 year old received Engerix B adult; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number NT9X3, expiry date 9th September 2024) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced accidental overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.      Additional Information: GSK Receipt Date: 30-NOV-2022 Reporter's Comment: The medical assistant reported that a 19 year old patient was inadvertently administered an adult dose of Engerix-B. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up via email. Additional supportive information: The patient was inadvertently administered an adult dose of Engerix-B, which led to overdose and inappropriate age at vaccine administration.
On 05/06/2002, the pt complained of lethargy, diarrhea, malaise. Symptoms persisted and increased in severity. On 05/07/2002, additional symptoms began "anorexia, nausea, mid upper abdomental tenderness radiating to back and right thoracic area. large "lump" appeared on right hand between middle finger. Acephex and Celebrex were prescribed.
not feeling well; Arm hurting; Flu-like symptoms; aching badly; Nausea; Fever of 99.7; SHOULDER AND HIP PAIN; Muscle pains; HEADACHES; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), PAIN IN EXTREMITY (Arm hurting), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (aching badly) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-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 MALAISE (not feeling well), PAIN IN EXTREMITY (Arm hurting), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (aching badly), NAUSEA (Nausea), PYREXIA (Fever of 99.7), ARTHRALGIA (SHOULDER AND HIP PAIN), MYALGIA (Muscle pains) and HEADACHE (HEADACHES). At the time of the report, MALAISE (not feeling well), PAIN IN EXTREMITY (Arm hurting), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (aching badly), NAUSEA (Nausea), PYREXIA (Fever of 99.7), ARTHRALGIA (SHOULDER AND HIP PAIN), MYALGIA (Muscle pains) and HEADACHE (HEADACHES) outcome was unknown.            Concomitant medications were not reported. The patient wanted to confirm if she can take Tylenol for the symptoms or not.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: NNI
10/10 pain in left arm, left side of neck, left shoulder blade, decreased sensation in left arm and hand and unable to move extremity without pain.
extra dose administered with no reported AE; Initial information received on 11-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA113854.  This case involves a 7 years old male patient who was administered an extra dose of HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Jun-2022, the patient received 0.5 ml  of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number: UJ635AAA; Expiry date: 30-NOV-2022) (Strength: Standard; Frequency: utr) via intramuscular route in unknown administration site for immunisation.  On 21-Jun-2022 the patient was administered an extra dose of HIB (PRP/T) VACCINE with no reported adverse event (extra dose administered) (Latency: same day).  It was reported, Nurse has questions on how to proceed. She states the PENTACEL components were all given separately and an extra dose was given by accident. Call transferred. The nurse states that their clinic did not receive the immunization records on a new patient until after extra doses of DAPTACEL, IPOL, and ACTHIB were given in error. Extra dose of ACTHIB given on 21Jun2022. The nurse asks if these are valid doses or should they be reinjected. The HCP asks if the patient will experience any AE's as a result of this  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event extra dose administered with no reported ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report was received from the mother's patient referring to a non-pregnant 15 year old female patient with drug reactions or allergies to TYLENOL. No information was provided regarding the patient's medical history or concomitant medications. On 11-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 route of administration reported as injection for prophylaxis (lot number and expiration date were not reported). On an unspecified date in 2017, the patient had not had her period in three months after being administered the first dose in the GARDASIL 9 series. The pediatrician will not administer the second dose in the series until the patient has her period. The reporter spoke with the patient's pediatrician, who ordered a series of unspecified blood work. The patient was then seen by an unspecified gynecologist who ordered additional unspecified blood work at two different times. The gynecologist had ordered "abdominal and transverse ultrasounds". Furthermore, the patient did not received treatment for the aforementioned event. The outcome of amenorrhoea was unknown. Additionally, the reporter did not provide causality assessment between the event and therapy GARDASIL 9.
Sores on my arms and hands that spread and won't go away. Dr. says its contact dermatitis. Stuffiness and runny nose Headaches
Patient living with two positive cases became symptomatic on 4-17-21. Patients symptoms consisted on cough, HA, body ache and loss of taste and smell.
Day after vaccination, experienced extreme fatigue and had to leave work early. In the two weeks following the vaccine experienced the following: lightheadedness, heart palpitations, elevated temperature, rash on front and back of torso. Treated the rash with hydrocortisone cream and the fever with Tylenol and bed rest.
Information has been received from a physician concerning an 18 or 19 year old female patient who in approximately Nov 2006, was vaccinated with a dose of HPV vaccine. Concomitant suspect therapy included YAZ, an oral contraceptive, which was started at the same time (dose and duration not reported). Subsequently, the patient developed papillary rash and pruritis on lower extremities after Gardasil injection. Medical attention was sought. It was reported that the rash went away after therapy with YAZ was discontinued. Additional information has been requested.
One day post vaccination, the patient experienced a raised red pimple-like bumps over arms. The reaction progressed to his lower abdomen and upper thighs. There was no itching or fever. It was suggested to him that he treat the adverse event with Benadryl, both the pill and topical cream.
Tired; Muscle ache; Redness marks on the skin near the vaccine area; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021, the patient experienced tired, muscle ache, redness marks on the skin near the vaccine area. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired, muscle ache, redness marks on the skin near the vaccine area was recovered on an unknown date in 2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in an unspecified number of patients who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional information was provided as follows: The age at vaccination was not applicable for this report. The injection site pain lasted a week. The reporter gave consent to follow up. This case linked with case US2019GSK011434, reported by same reporter.
Information has been received from a consumer concerning her 6 month old daughter who on 29-NOV-2010 was vaccinated with a dose of ROTATEQ (Lot #, expire date and route not reported). No adverse effect was reported. Follow up information was received from a physician who reported that the patient with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions, who received the first dose of ROTATEQ (Lot # 665258/0201Z, expire date 12-AUG-2012, route not reported). No laboratory tests were performed. No adverse events were reported. No further information is available.
Felt a cloud smashed on me; Lethargic; Slept for two days; Bright red rash 2-3 inches below the injection site; Felt tired; Headache; Fever; injection site was tender,No grip; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt a cloud smashed on me), LETHARGY (Lethargic), SOMNOLENCE (Slept for two days), RASH ERYTHEMATOUS (Bright red rash 2-3 inches below the injection site) and FATIGUE (Felt tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MONTELUKAST for Allergy, METFORMIN for Diabetes mellitus, LOSARTAN, HYDROCHLOROTHIAZIDE and AMLODIPINE for Hypertension, LEVOTHYROXINE for Hypothyroidism, GABAPENTIN for Pain.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced FEELING ABNORMAL (Felt a cloud smashed on me), LETHARGY (Lethargic), SOMNOLENCE (Slept for two days), RASH ERYTHEMATOUS (Bright red rash 2-3 inches below the injection site), FATIGUE (Felt tired), HEADACHE (Headache), PYREXIA (Fever) and VACCINATION SITE PAIN (injection site was tender,No grip). On 27-Apr-2021, FEELING ABNORMAL (Felt a cloud smashed on me), RASH ERYTHEMATOUS (Bright red rash 2-3 inches below the injection site), HEADACHE (Headache) and VACCINATION SITE PAIN (injection site was tender,No grip) had resolved and LETHARGY (Lethargic), SOMNOLENCE (Slept for two days), FATIGUE (Felt tired) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided.   This case was linked to MOD-2021-094926 (Patient Link).
Pt. recieved vaccine greater than 12 hours after drawn up. Contacted by MD. No adverse event. Pt. declines revaccination.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 56-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided.
PATIENT STATED THAT HER LEFT TRICEPT AND UPPER ARM BECAME RED AND INFLAMMED DOWN TO ELBOW, SHE PUT AN ICE PACK ON IT TO REDUCE SWELLING.  SHE STATED IT FELT ITCHY AND NEEDLE SENSATION EVEN THOUGH IT DID NOT APPEAR INFLAMMED OR RED AT TIME OF VISIT.  ALSO REPORTED THAT HER RIGHT EYELID EXPERIENCED SWELLING BUT WAS NOT PRESENT AT TIME OF CONSULTATION.
a slight swelling under the armpit, it's jelly-like; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (a slight swelling under the armpit, it's jelly-like) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, MELOXICAM and TOPIRAMATE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (a slight swelling under the armpit, it's jelly-like). At the time of the report, PERIPHERAL SWELLING (a slight swelling under the armpit, it's jelly-like) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
I have cold like symptoms. I had nasal congestive, tired, and burning throat. I had a headache as well.  These symptoms have lasted for about 10 days now. I tested positive for Covid-19 on Dec 24th.  They also did the Flu test, negative results.
Began with Palpitations.  A week later progressed into chest heaviness and shortness of breath.
Deep, aching pain in upper right arm and shoulder developed on 10/30/2006. I took Naproxen and TRAMADOL.  I reported this to PCP through fax and telephone message.  I saw PA name reported on 11/4/2006.  She prescribed Ibuprofen and Lido Derm Patches and ordered blood work.  These medications did not help.  PA name reported prescribed MEDROL Pak after blood work results and ordered referral to neurologist.  MEDROL Pak gave me TY-relief only, after 6 days of use pain became acute, I am now using 2nd Dose Pak and seeing neurologist on 12/07. I am unable to lift anything with this arm.  I feel severe pain when I move this arm or while I am in bed.  12/14/06 Received medical records from provider which reveal patient seen 10/28/06 with dyspnea & + TB skin test, gastritis, DJD, carpal tunnel & high cholesterol.  Records included Lot numbers missing from report.  Next seen on 11/4/06 with pain on palpation over right shoulder, no swelling or redness noted but ROM & grip strength of right arm/hand was decreased.  Referred to neuro & given steroids to start after labs done. 1/16/07 Received records from neurologist which reveal patient seen 12/7/06 for pain of right shoulder & arm subsequent to tetanus vax 10/28/06.  Neuro exam was WNL with some mild difficulty raising arm above head.  It was felt that the problem was frozen shoulder or adhesive capsulitis due to the pain rather than any true muscle or nerve involvement.  She was referred for intensive PT to be continued for 4-6 weeks then was to return for further evaluation.
vasovagal syncope for less than 30 seconds after seeing drop of blood on arm after vaccine administration. Aroused easily.  Drank juice, was released to Mom in 30 minutes, feeling well, ambulating normally.
patient presented with consent to get Pfizer Covid shot. after admin nurse informed staff that the patient got the Pfizer vaccine 4 days ago. no adverse reactions reported at this time.
Please see Temporary Vaers E-Report 308709.  The severe Itchy burny skin rash that continued 21 days after the first shot became more severe after the second shot with a large area forming and growing across the whole lower back.  It had dimensions of about 12 inches across and 8 inches high that became solid red.  A spotted rash formed on the sides of the breasts and upper back.  Topical steroids were used.  To not interfere with the immunization , the dermatologist waited 21 days before prescribing  a programmed decreasing regiment of Prednesone tablets. The rash subsided 6 weeks after the second vaccination.
pt recv vax 10JUL97 & 5AUG97 pt devel a vesicular rash;pt did not have a fever;reporter felt that the vesicular rash was r/t therapy w/varicella vax;
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient got the 1st dose of SHINGRIX it was very painful and his arm was sore afterwards. The patient got the 2nd dose on the day of reporting and he did not feel anything at all. The patient was concerned that the pharmacist missed the muscle, though the pharmacist says it was administered correctly. The pharmacist pinched his arm, so he thinks the needle did not get deep enough to reach the muscle. The patient thought it felt more like when he got allergy shots than when he got the 1st dose of SHINGRIX. The reporter did not give consent to follow up.
RED WARM AREA AROUND THE INJECTION SITE GIVEN IN THE RIGHT ARM. SEEN DR 09/06/2008 MOM WAS TOLD TO WATCH SITE AND APPLY COOL COMPRESS,GIVE IBUPROFEN AND APPLY TOPICORT BID.
Presented to ER 2 days post vaccine with itching, red and swollen thigh.  No pain with palpation or walking.  Most likely localized reaction to vaccine, but placed on antibiotics proactively.  Spoke with parent on 9/27/2019 and redness and swelling resolving.
w/in 1wk of vax pt began exp sx;for 3 consecutive weeks p/vax pt exp sudden onset of dizziness that came & went;pt uncomfortable feeling in midsection coupled w/hot flashes during flight;SOB & exertion;
pt recv vax in 1991 & exp a severe local delayed rxn @ the inj site;pt recovered;
No issue with injection .  Found out on 07/13/2021 that pt recieved Pfizer vaccine in March.   Originally query in database system that store uses didn't populate this for pt
Hives all over joint areas of the body; Stomach ache; Itching; This is a spontaneous report from a contactable consumer, the patient. A 40-Year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration on 21Mar2021 at 12:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. The patient was allergic to doxycycline. Concomitant medications included LIALDA for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced hives all over joint areas of the body with mild itching and stomach ache after the meals on 21Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatments were taken for any events. The therapeutic measures taken for the events was unknown. The clinical outcome of the events hives, itching and stomach aches were not resolved at the time of this report.   No follow-up attempts are needed. No further information was expected.