chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt complained of having numb toes when the observation period was over. I asked the patient if she wanted to report to the emergency room and she stated "no, I want to go home and put some plush socks on". Pt was  wearing flip flops at the time of her vaccine appointment. I followed up with the patient twice. the last time was at approximately 245 p.m on 1/18/21 at which time the patient stated that only the tips of her toes on one foot were still numb.
After the second vaccine:Severe total body pain for 4 hours beginning 8 hours after the second vaccine, weakness in the legs so severe that I could not stand, vomiting, nausea, diarrhea , chills, profuse sweating, heartache,  total fatigue.  After the first vaccine: extreme fatigue and two days after the first vaccine swollen glands for a two days. After about a week a felt back to normal after the second vaccine.
This spontaneous report was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 29-JUL-2015, the patient was vaccinated orally with a dose of 2 ml of ROTATEQ 10 unit dose tube, lot # K000487, expiration date 27-SEP-2015. This vaccine was improperly stored exposed to three temperature excursions, one for a sum of 144 hours with a lowest temperature recorded as 31 degrees F; (-0.555555556 degrees C), other for a sum of 24 hours with a lowest temperature recorded as 33 degrees F (0.555555556); and another for a sum of 240 hours with a lowest temperature recorded as 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 11SEP95 & 15MAR97 pt devel chickenpox a very mild case of approx 20 pox;20MAR97 pt recovered;
covid positive; fever; really nauseous; generally exhausted; super weak; lost my sense of taste and smell; lost my sense of taste and smell; a really disgusting wet cough which has become dry; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (super weak), ANOSMIA (lost my sense of taste and smell), AGEUSIA (lost my sense of taste and smell), COUGH (a really disgusting wet cough which has become dry) and COVID-19 (covid positive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced ASTHENIA (super weak), ANOSMIA (lost my sense of taste and smell), AGEUSIA (lost my sense of taste and smell), COUGH (a really disgusting wet cough which has become dry), PYREXIA (fever), NAUSEA (really nauseous) and FATIGUE (generally exhausted). On 29-Jan-2021, the patient experienced COVID-19 (covid positive). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and GUAIFENESIN (MUCINEX) at a dose of 1 dosage form. At the time of the report, ASTHENIA (super weak), ANOSMIA (lost my sense of taste and smell), AGEUSIA (lost my sense of taste and smell), COUGH (a really disgusting wet cough which has become dry), COVID-19 (covid positive), PYREXIA (fever), NAUSEA (really nauseous) and FATIGUE (generally exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Information has been received from a registered nurse concerning many females, who were vaccinated with varicella virus vaccine live. Subsequently, the patients later had varicella. All of the children received the vaccine after one year of age and later. Unspecified medical attention was sought. Additional information has been requested.
Pt recvd 1st dose of Recomb w/no adverse exp; Following 2nd dose 4OCT90 pt devel herpes around the mouth & aching joints; @ time of the report, pts herpes had lessened but continued to be a problem & aching joint had started to subside;
Patient had difficulty breathing after receiving COVID vaccine. She  was given her prescription for Albuterol immediately.
Pain at the injection site; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at the injection site) and fever (Verbatim: Fever). The outcome of the injection site pain and fever were not reported.   It was unknown if the reporter considered the injection site pain and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain and fever to be related to Shingrix.   Linked case(s) involving the same patient:  US2023074573   Additional Information: GSK Receipt Date: 25-MAY-2023 The reporter was the twin sister of the patient. The reporter reported that the patient received Shingrix vaccine and experienced pain at the injection site and experienced fever from the vaccine but unknown after which dose. This case had been linked with US2023074573 by same reporter for same patient.; Sender's Comments:  US-GSK-US2023074573:Same patient, 2nd dose
1AM pt crying, mom went in to pt & picked pt up & felt hot touch & was due for next dose of APAP; mom did not take pt temp @ this time; while chewing APAP baby began sz type episode w/twtiching of all extremities, eyes rolled back;
The pharmacist drew up a dose of the Moderna Pediatric 6yr to 11yr instead of the Moderna Bivalent. No adverse reports.
Vaccine administered 4/23/16. Same day patient started feeling pain and noticed swelling and redness later on that day. Patient noticed it worse on Sunday 4/24/16. Pt. seen on 4/25/16 and cephalexin and BENADRYL was prescribed.
Post vax, the pt sought medical attention and a laboratory test revealed that the pt had failed to seroconvert for measles, mumps, and rubella. Follow up provided no additional data.
side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     no medical history was provided.    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, 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 VACCINATION COMPLICATION (side effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown.            concomitant medications were not reported. treatment medications were not reported.
approx 15-20 mins p/vax pt exp breathing difficultes; EMS called 02 administered & pt transported to ER; pt was treated w/02, breathing therapy & meds;
Received immunization on Friday. No appetite Friday night/lethargic. No appetite Saturday AM but good disposition.  By Noon, severe lethargy, no appetite and vomiting.  Repeat Saturday exactly on Sunday with vomiting and addition of fever. Treated with Acetominophen and Ibuprofin.  Reported to doctor on Monday morning.  No major concerns by parent or office/doctor.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 22-NOV-2013, the patient was vaccinated with VARIVAX (dose strength and route was not reported) (lot# H018455 and expiry date: 09-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Nausea; Vomiting; Fever; Headache; Muscular pain; loss of apetite; Urinating discomfort; Pelvic pain after urination; decreased mobility, left arm/cannot even hold the phone with my left arm.; Fibromyalgia; sick she felt for 3 days; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 29th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injected limb mobility decreased, fibromyalgia worsened, malaise, nausea, vomiting, fever, headache, muscle pain, appetite lost, painful urination and pelvic pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the injected limb mobility decreased, nausea, headache, muscle pain, appetite lost, painful urination and pelvic pain were not recovered/not resolved and the outcome of the fibromyalgia worsened was unknown and the outcome of the malaise, vomiting and fever were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased, fibromyalgia worsened, malaise, nausea, vomiting, fever, headache, muscle pain, appetite lost, painful urination and pelvic pain to be related to Shingrix.  Additional details were provided as follows: The patient that received her 1st dose of Shingrix vaccine in her left arm. The patient was suffering from fibromyalgia.   The patient reported that, she did not get the 2nd dose of Shingrix because she had to take the COVID vaccine and because she felt sick for 3 days. The patient had all the symptoms written in the vaccine sheet. The patient reported nausea, vomiting, fever, headache, muscular pain, loss of appetite, urinating discomfort with pelvic pain after urination.  The patient reported decreased mobility of her left arm and she could not even hold the phone with her left arm. She took Tylenol at that time.  The patient reports that she still had the following symptoms of headache, loss of appetite, nausea, muscular pain, decreased mobility of her left arm, that had not resolved. The patient reported her fibromyalgia had gotten worsen. The patient reported she had not taken a vaccine in her left arm since then. Not all information was available, lot and expiration date were unknown.  The patient consent to follow up with health care professional(HCP) and would follow up with HCP phone information. The reporter consented to follow up.
No adverse event but administration error. This female was not 18 years of age and the vaccine is indicated for those 18 and older.
First Day August 31: nausea, chills, headache, weakness, went to sleep for about 5 hours and woke up  sweating and  had to change into dryer PJ's went back to sleep and woke up feeling a little better (no headache, or chills, or nausea) still felt very wobbly and tired until the afternoon of the second day,  September 1
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 60 years old patient (gender not reported) who experienced pain at the injection site and headache, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UI975AC and Exp. Date 30-JUN-2019) via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious pain at the injection site and headache following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Details of lab data not provided. Final diagnosis was headache and pain at the injection site. It was not reported whether the patient received a corrective treatment. The event outcome was not reported. List of documents held by sender: none.
Upset stomach and low grade fever (100 degrees F) -> same Sx on both 1st and 2nd vaccine in series.
This spontaneous report as received from a physician refers to a 26 year old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 20-MAR-2007, the patient started vaccination course with GARDASIL 0.5ml, intramuscular (lot numbers and expiration dates were not reported). The patient had completed GARDASIL vaccination schedule in 2008. On 27-APR-2015, the patient was vaccinated with the fourth dose of GARDASIL, 0.5 ml, intramuscular (lot # and expiration date were not provided). No information on patient's concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
24 hours after injection developed diffuse cellulitis around injection site of pneumococcal. Clarification from vaccine provider.  Reaction was in left arm (Pneumovax and Adacel). MR reveals an 11 yr old who developed fever and  rash on his Left arm at the site of his Pneumovax and Adecel vax.  HPI: Child woke with pain in both arms the night after vax. and c/o fever.  Mom noticed a rectangular rash at the site of vax. on the left arm.  Seen by PMD and treated with Keflex without improvement.  Fever continued to rise and erythema and pain continued and spread.  ER visit 2 days after vax.   PE showed a 4x5 cm area of erythema, warmth, and tenderness to palpation of the left upper arm.  The patient was febrile.  He was admitted for treatment with IV antibiotics.  Pt. was treated with IV Clindamycin and Vancomycin and released to home after 4 days in stable condition to continue po Clindamycin x 7 days. Discharge DX:  Left arm cellulitis.
BAD REACTION; BODY HURTS; FEVER; MASSIVE HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, weight and pre-existing medical conditions were not reported. No concomitant medications were reported.  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers.   On an unspecified date, the patient experienced bad reaction (dose number in series 1). Non-company (manufacturer unspecified) suspect vaccine (booster dose) included: covid-19 vaccine (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 23-OCT-2021 for prophylactic vaccination.   On 23-OCT-2021, the patient experienced fever on and off since vaccination. On OCT-2021, the patient experienced massive headache. On 27-OCT-2021, the patient experienced body hurts (all  3 events dose number series 2). The patient had no injection site tenderness at all. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad reaction, fever, massive headache and body hurts was not reported. This report was non-serious.
Paleness, irritiabilty, profound anemia requiring ICU admission and transfusion. Now diagnosed as severe combined immunodeficiency with parvovirus b19 and rotavirus infections.
MENACTRA vaccine as well as GARDASIL vaccine given 6/10/2008. Pt described waking the next AM with c/o facial (cheek) swelling and pain in face and jaw - face felt stiff. Treated with Medrol Dose Pak. Symptoms resolved by 6/12/2008.
-Freezing cold hands and feet, tingling / prickling in hands and feet as if "asleep" -Tingling more pronounced in right hand, less pronounced in feet -Tingling moved slowly up to forearms / feet and upper thighs (not knees or lower thighs) -3 hour "nap" under many blankets - gradually warmed up a bit but tingling remained and I stayed in bed almost all day -approx. 7:30 p.m. I took 2 Benedryl  and tingling subsided 20 min. later -Next morning: Slight tingling  remained in R hand - took 1 Benedryl and Alleve, still lethargic and stayed in bed -Tingling subsided throughout the remainder of the week until March 31 - cold and tingling returned in R hand only throughout the morning -April 2:  Cold and tingling returned a April 3, cold and tingling R hand returned early morning (approx. 2:00am) and lasted through the early afternoon. Also slight headache - Tylenol -April 5: Cold and tingling R hand and headache returned early morning (2:00am) - Tylenol and lasted through early afternoon -Note: some slight tingling has occurred throughout the time between March 26 and present (April 7) Discussed with Dr. at scheduled appointment on April 2.  He advised me to fill out this form.
Patient was 16 at time of administration, rather than 18yrs as approved. No adverse effects noted.
After being vaccinated, the patient walked to the cashier with his father to check out.  As they were waiting, the patient fainted.  The father caught him before he hit the floor.
got the stupid shot / got shingles/ suspected vaccination failure; very bad nerve pain; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got Shingles shot and got the shingle lasted 3 months and still had very bad nerve pain. The patient stated he/she the Shingles shot did not keep from getting shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Around 6:30 pm Patient noticed he was having dizziness which lasted about 15 minutes along with perfused sweating, O2 was normal. Patient went into Afib; had resting heart rate 76.
slight sore left arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (slight sore left arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (The patient received the Pfizer covid-19 vaccine for her Primary Series). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine. Concurrent medical conditions included Myelodysplastic syndrome, Myasthenia gravis and Macular degeneration. Concomitant products included PYRIDOSTIGMINE and LOSARTAN for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (slight sore left arm). At the time of the report, PAIN IN EXTREMITY (slight sore left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   This case was linked to MOD-2022-662522 (Patient Link).
headache; body aches; fever; fatigue; nausea and chills; nausea and chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Dec2021 14:00 (Lot number: FF8841, Expiration Date: 31Mar2022) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "headache"; PAIN (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "body aches"; PYREXIA (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 21Dec2021 02:15, outcome "unknown", described as "fatigue"; NAUSEA (non-serious), CHILLS (non-serious) all with onset 21Dec2021 02:15, outcome "unknown" and all described as "nausea and chills". Additional information: Event took place after use of product. No follow-up attempts are possible. No further information is expected.