chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme shakes; Vertigo; Mentally fuzzy; Sick; Extreme headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Extreme shakes), VERTIGO (Vertigo), FEELING ABNORMAL (Mentally fuzzy), ILLNESS (Sick) and HEADACHE (Extreme headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.   On 10-Feb-2021 at 9:00 AM, 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 10-Feb-2021, the patient experienced TREMOR (Extreme shakes), VERTIGO (Vertigo), FEELING ABNORMAL (Mentally fuzzy), ILLNESS (Sick), HEADACHE (Extreme headache), NAUSEA (Nausea) and PYREXIA (Fever).   The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at a dose of 3 dosage form.   At the time of the report, TREMOR (Extreme shakes), VERTIGO (Vertigo), FEELING ABNORMAL (Mentally fuzzy), ILLNESS (Sick), HEADACHE (Extreme headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 102 (High) Patient had fever of 102 F.   Concomitant product use was not provided by the reporter.
**Due date 5/8/21, Second pregnancy** I had a fever of 101 pretty consistent form 8:30am till mid day Wednesday . I had body aches and  chills, When I got to work my heart rate was 160, I was checked out by my OB, the baby was fine. I was sent home to work, rested for the evening. I woke up Wednesday with Shingles.  I called my Ob and she treated me with  Valtrex for 5 days, then the rash cleared up. I still have some side effects for most went away. The baby has been perfectly fine through the whole thing, she is doing great.
After the 2nd vaccination patient complained of arm soreness that evening- which we expected. Upon waking he had pain in his collar bone, shoulder and under his arm. His arm and underarm area were swollen and his lymph nodes under his arm was also swollen. The pain has been continuous thru-out the weekend and into this week. We have given him some pain medication (over the counter) and it is slowly subsiding. A week after his first vaccination on 8/24/2021 he complained of a swollen lymph node under his right arm where he got the vaccination. His PCP looked at him and had us talk to our oncologist- it was determined it was most likely from the vaccination and a reaction he was having.
Patient had bleeding in to the arm and has a large right shoulder effusion that needed ED visit and now referred to orthopedic to drain.
Could not walk, hospitalized for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Could not walk, hospitalized for 4 days) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Could not walk, hospitalized for 4 days) (seriousness criterion hospitalization). The patient was hospitalized for 4 days due to GAIT INABILITY. At the time of the report, GAIT INABILITY (Could not walk, hospitalized for 4 days) had resolved.            No concomitant medication was reported.  It was reported the patient could not walk after receiving the second vaccine dose.  He was hospitalized 4 days, treated with steroids and got better.  Company Comment  Very limited information regarding this event has been provided at this time. Further information has been requested.  Cross linked with case MOD21-124652; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 2nd February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site swelling, erythema of extremities and incomplete course of vaccination. On an unknown date, the outcome of the injection site swelling and erythema of extremities were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the injection site swelling and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in physician's office. On 2nd February 2018, the patient received 1st dose and was already late for her 2nd dose at the time of reporting, which led to incomplete course of vaccination. After 1st dose of SHINGRIX, the patient had swelling around the injection site and redness that went down her arm almost to her elbow. Both symptoms resolved within 2 to 3 days. The reporter was unable to provide any additional details. The reporter's call was transferred to Medical Information.
received extra dose by error; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 22-year-old male patient who received HBV (Engerix B) (batch number TB3KN, expiry date 3rd December 2023) for prophylaxis.   On 29th July 2022, the patient received the 4th dose of Engerix B. On 29th July 2022, unknown after receiving Engerix B, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The nurse had two adult patients that received Engerix-B extra dose by error. The reporter consented to follow-up via email. This case is for 1 of 2 linked patients, reported by same reporter. Additional supportive information: The patient received an extra dose of Engerix-B, which led to extra dose administered. As there is no information regarding the primary vaccination of Engerix therefore Extra dose administered event coded as it was clearly stated by error dose was administered and for the primary vaccination details follow-up query was raised.; Sender's Comments:  US-GSK-US2022113819:Same reporter
UNSPECIFIED ADVERSE EVENT; 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious. This case, from the same reporter is linked to 20210731837 and 20210732421.
10 minutes after shot, walked away felt dizzy and fell. Called facility and 911 became more unresponsive. Felt sleepy. EMT arrived more responsive but took to hosp.
Patient stated her vision was blurry and she felt "drunk" within 15 minutes of vaccination.  Observed patient for another 15-20 minutes.  Patient asked for paramedics to be called because she never has had any adverse effect from vaccinations previously.  Paramedics tended to patient and took her to the hospital.  She received and Epi-pen and stayed overnight for further observation.  Patient was told she had an allergic reaction to the Moderna vaccination.
Just broke down in a rash all over; Area was sores in pain; I started hurting in like next day; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number: EW0180) via an unspecified route of administration, administered in left arm (left shoulder) on 25Jun2021 10:30 in the morning (at the age of 60-years-old)) as dose 2, single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number: EW0177) via an unspecified route of administration, administered in upper left arm on 04Jun2021 10:00 in the morning (at the age of 60-years-old)) as dose 1, single dose for covid-19 immunization and experienced no adverse events. The patient's medical history included diabetes, blood pressure high and cholesterol from an unknown date and unknown if ongoing. Consumer stated that prior to vaccination she had an IV when she had CT scan. They just call it a contrast. When probed if the consumer has received any other vaccine 4 weeks prior to COVID shot, consumer stated as she had another one, and also stated had two injections. Patient confirmed that the 2 injections consumer is mentioning about are Pfizer covid vaccine. The patient's concomitant medications included metformin 850mg (METFORMIN) one, twice a day taken for diabetes, lisinopril (LISINOPRIL) 10 mg, once daily taken for hypertension and atorvastatin (ATORVASTATIN) 10 mg, once a day taken for cholesterol and start and stop date were not reported. On 25Jun2021, the patient experienced just broke down in a rash all over, area was sores in pain and started hurting in like next day. Patient stated that after the vaccine, it was the 25Jun, around 10 to 10:30 in morning, she started hurting in like next day. Patient concerned that everything was fine with the first vaccine but since yesterday (second shot) just had broke down in a rash all over. Consumer stated that she needs to get a cure to get rid of this rash and she still have a rash all over and she doesn't understand what was going on and why she was breaking out in rash. The patient underwent lab tests and procedures which included blood sugar and urine analysis results unknown on unspecified date, computerised tomogram (CT scan) on 21Jun2021 but not yet received results and patient stated will receive it on monday. It was reported investigation assessment as yes and antibody test to platelets factor iv was no. No treatment received for the events. The outcome of the events was not recovered.    Follow-up attempts are completed. No further information is expected.
Patient is pregnant; This 32-year old, female subject was participating in a Program and became pregnant.   The patient's medical history, was not reported. The pregnancy history of the patient included 1 prior pregnancy: no additional pregnancy or infant details provided. No concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 29 Dec 2020. The date the patient had a positive pregnancy test was not reported. The patient is reported to be 5 weeks pregnant. The due date was estimated as 06 Sep 2021.   Action taken with mRNA-1273 in response to the event(s) was not reported.   No additional pregnancy details were provided from the reporter.  Patient gave consent for Safety to Follow-up.; Reporter's Comments: This case concerns a 32-year-old female G2P1 who reported Maternal exposure during pregnancy. The subject took first dose of vaccination while she is 5 weeks pregnant. Estimated Due Date is 06/Sep/2021.
lump on the injection site; injection site warmth; injection site itching; injection site redness; soreness on the injection site; A report was received from a consumer who was a 74 year old, patient who was participating in the mRNA-1273 Emergency Use Program and experienced soreness on the injection site, a lump on the injection site, and itchiness and warmth at the injection site.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 039R2019- patient unsure of number as the vaccination card was illegible) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The patient reported that she received the Moderna Covid-19 vaccine on 29 Dec 2020 and 12-24 hours later had experienced soreness on the injection site, which spontaneously resolved. On 05 Jan 2021, 7 days after the vaccination, she felt a lump on the injection site which was less than 2 inches in size, itchy, and warm to the touch. The patient took her own temperature, 98.9F. On 07 Jan 2021, she stated that there is no more lump felt, but now the site is blotchy, pink in color and irregularly shaped. Treatment for the events included paracetamol and diphenhydramine hydrochloride.   Action taken with mRNA-1273 in response to the events was not reported.   The event, soreness on injection site was considered resolved on 05 Jan 2021. The events lump on the injection site, and itchiness and warmth at the injection site were considered resolved on 08 Jan 2021.; Reporter's Comments: This case concerns a 74-year-old female who had NS events of unexpected injection site warmth, injection site mass and expected injection site pain, injection site erythema, injection site pruritus. Event onset Day 1 after first dose mRNA-1273, with later events on Day 8. Treatment paracetamol and diphenhydramine. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
12/03/2001 Received Havrix Hep A vaccine. On 12/09/2001 developed diarrhea x2, 12/10/2001 Temp 101.8 and mother gave Motrin. Fifteen minutes after Motrin patient had two large hives, tightness of both thumbs and one foot and swelling of lips. Mom took patient to ER where he was given liquid Benadryl & told he had fluid behind ears". Mother reports she is allergic to Motrin.
Pt received 0.3ml of Pfizer vaccine, believe Vial was not reconstituted as was only dose in vial
Hospitalization for anemia/ COVID + with mild hypoxia 2/8/22-2/14/22. Treated with Remdesivir, baricitinib, dexamethasone, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
p/recv vax pt devel stomach ache, severe h/a, fever (104f), sent to ER, pt  arm slightly swollen & red.
Unexpected swelling of the left elbow and subsequent bruising ( I have images but there seems to be no place to upload them for your review) - I have reached out to my primary care provider about this as well.
Suspected Vaccination failure; sore shoulder; blister; shingles blister; 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.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis, PNEUMOCOCCAL PNEUMONIA VACCINE for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine, Influenza vaccine Quadrivalent unspecified season, PNEUMOCOCCAL PNEUMONIA VACCINE and PNEUMOCOCCAL PNEUMONIA VACCINE. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, shoulder soreness and blister. On an unknown date, the outcome of the vaccination failure and shoulder soreness were unknown and the outcome of the shingles and blister were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, shoulder soreness and blister to be related to Shingles vaccine. It was unknown if the reporter considered the shingles, shoulder soreness and blister to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were received as follows: The age at vaccination was not reported. The patient received flu vaccine, shingles vaccine, both kinds of pneumonia vaccine, and had sore shoulder. Also one shingles blister which lasted 2 days and went away. This case was considered as suspected vaccination failure as completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.  It was unknown if the reporter considered the shingles, shoulder soreness and blister to be related to Pneumococcal vaccine.
no adverse event; received a dose of expired Zostavax; This spontaneous report was received from a medical assistant and refers to a 69-year-old male patient. No information regarding the patient's medical history, concomitant medications and previous drug reactions or allergies was reported. His concurrent conditions included leg swelling.   On 20-DEC-2020, the patient was vaccinated with an expired dose of zoster vaccine live (ZOSTAVAX) for prophylaxis (lot # N035033 was verified to be valid, expiration date reported as 02-MAR-2019, but upon internal validation established as 07-MAR-2020) (strength, dose, frequency and route of administration were not provided). The patient did not experience any additional adverse reactions. It was reported that the reason the patient was initially seen in the urgent care was a leg swelling and he was directed to an Emergency Room to rule out a deep vein thrombosis (DVT), but it was before he received zoster vaccine live (ZOSTAVAX).
A patient received improperly stored vaccine; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history and concomitant medications.  On 29-APR-2019, the patient was vaccinated with 1 dose of improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R021078, expiration date 12-JUN-2021 (strength, frequency and route of administration was not provided) for prophylaxis.        The doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)(LIQUID PEDVAXHIB) were exposed to a temperature excursion of 52.5 ° Fahrenheit(°F) during a time frame of 4 hours and 40 minutes which was detected by the data logger. There was no previous temperature excursion.
PATIENT HAS A 2 INCH CIRCULAR RED, FIRM LUMP ON THE FRONT OF HER ARM SEVERAL INCHES AWAY FROM THE INJECTION SITE. IT IS RED AND WARM TO THE TOUCH. IT DOES NOT ITCH.
Received Shingrix instead of HPV vaccine; 26-year-old received Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 26-year-old female patient who received Herpes zoster (Shingrix) (batch number D734X, expiry date 28-MAY-2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Received Shingrix instead of HPV vaccine) and inappropriate age at vaccine administration (Verbatim: 26-year-old received Shingrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 12-APR-2023 The reporter consented to follow up. A 26 year old patient by accident received a Shingrix vaccine when the intention was to administer an HPV vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Muscular aches, exhaustion for several days. In the past I?ve had occasional vertigo and that has gotten severe since the vaccine shot. Also have been suffering tinnitus since the shot, which I thought was just the sound of my lamps or air filter but it?s worse at night wearing ear plugs. Both conditions have been increasing since the vaccine and it dawned on me this evening that it could be vaccine-related.
This spontaneous report was received from a registered nurse referring to a patient of currently 4 years age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) with lot # L006390, expiry date 25-AUG-2016, (dose, route of administration and anatomical location not reported). The doses of PROQUAD (Merck) underwent temperature excursion: 14.7f for 2 hours and 15 minutes. There were o previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports from the same reporter. Additional information has been requested.
On May 21,2021 I Started To Come Down With Flu Like  Symptoms Which Was Expected , Which Symptoms Ended Approximately On May 29,2021. On May 28,2021 I Felt A Sharp Pain In The Back Right Side Of My Head Which Also Made Me Feel A Slight Nausea. I Started To Have Headaches , Sharp Pain, Head Pressure In All Parts Of My Head . Head Pain Still Can Be Felt Today.
Patient received Hep A and Tdap vaccinations.  Approximately 1 minute later patient complained of nausea and she was pale.  Patient lost consciousness and appeared to stop breathing for just a brief time (approx 30 seconds).  Our nurse assist and code teams were called to the immunization room, and EMS was notified.  O2 was given, IV 0.9 NS started, blood sugar checked.  EMS arrived on scene and took patient to hospital.
Breakthrough case admission after 3 vaccines  Pfizer 1/27/21 Lot# El9264;  Pfizer 2/17/21 Lot#6200;  Pfizer 8/27/21 Lot# FA8448;
runny nose; sore throat; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Jan2021 15:00 (Lot Number: EL0142) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing , food allergy from an unknown date and unknown if ongoing.  Concomitant medication included dapagliflozin propanediol monohydrate (FARXIGA), fenofibrate and dulaglutide (TRULICITY) taken for an unspecified indication, start and stop date were not reported. The patient experienced runny nose, sore throat and headache on 02Feb2021. The outcome of the events was not resolved.   Follow-up attempts are completed. No further information is expected.
18 hrs post vax pt exp pulmonary edema; not known whether vax had some triggering effect;
RECEIVED BOTH PFIZER COVID VACCINES ON 01/29/21 & 02/19/21. WENT TO clinic ON 02/28/21 REPORT HEADACHE AND SINUS PRESSURE. DIAGNOSED WITH SINUS HEADACHE .