chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: pt receieved moderna covid vax and shingrix in right arm on same day, pt c/o spreading erythema which is hot to the touch.  Denies itching, swelling.  Advised pt to try cold compress, acetaminophen, and contact healthcare provider if continues to spread.
1stApril: Patient Reports: Arm pain [Onset: 2 Day(s) Acute; Char.: Denies Swelling, Trauma, Arthritis Reports Ache; Location: Reports Left arm; Pattern: Reports Constant, Worse with lifting, Worse with movement; Free text: Patient presents with left arm pain and numbness since yesterday morning. Patient describes the pain as a 7/10 aching pain that is worse with extension of the shoulder and shoots down to the hand with associated numbness and tingling. He denies any weakness or loss of sensation. Patient denies any leg, neck, or facial involvement. No facial droop or impaired speech. No cardiovascular history. Patient denies any known injury to the area or history of similar symptoms but states that he received the 1st dose of thePfizer vaccine in the left arm on Friday. Patient has been using diclofenac at home without relief. He denies any erythema, swelling, itching, or rashes in the area]; Arm numbness [Onset: 1 Day(s); Char.: Reports Ache; Assoc. Sx: Denies Chest Pain, Grip weakness, Neck pain, Speech impairment, Tingling, hands, Chest pressure, Leg weakness, Chest tightness]. Patient Denies: Grip weakness; Neck pain; Speech impairment; Leg weakness; Chest tightness. 5 April: Pain has receded and arm can be moved again.
Child seen at local health facility for earache but relatively well on 11/27/19, and again had earache along with sore throat on 1/25/20,  This time much more ill, spent two days in bed with fever. Home sick for a week.
He tested positive with Covid-19 virus; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. A male patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 11Mar2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient wanted to reschedule his appointment tomorrow for his second dose because he wanted to know if he still had the Covid-19 Virus. The patient said on 11Mar2021, he got his first dose of the Covid-19 vaccine and then 17Mar2021 tested positive with Covid-19 virus. The outcome of the event Covid-19 virus was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Confusion, Headache, Myalgia, Arthralgia, Fatigue, tingling/numbness in lips and fingers, difficulty speaking Narrative:
I felt achy 24 hours after the exam but after 72 hours started feeling worse and developed a fever which progressed to a head cold and further progression to full Upper Respiratory infection, viral in nature. 168 hours later, lost sense of taste and smell and had some GI discomfort.
accidentally received a 3rd dose on 5/27/2023; both doses of Shingrix in 2020 (1st-1/8/2020 and 2nd-8/14/2020); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) (batch number 7532P, expiry date 18-AUG-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th January 2020).   On 27-MAY-2023, the patient received the 3rd dose of Shingrix. On 14-AUG-2020, the patient received the 2nd dose of Shingrix. On 14-AUG-2020, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: both doses of Shingrix in 2020 (1st-1/8/2020 and 2nd-8/14/2020)). On 27-MAY-2023, the patient experienced extra dose administered (Verbatim: accidentally received a 3rd dose on 5/27/2023). The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 31-MAY-2023 The health care professional (HCP) declined to provide patient demographics. She also did not had the lot number for the 2nd dose of Shingrix (which was a late dose).  The vaccine administration facility is the same as primary reporter. The reporter consented to follow up via mail. The patient accidentally received a 3rd dose of Shingrix, which led to extra dose administered. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Headache; Tiredness/Fatigue; Sore throat; weak; This is a spontaneous report from a contactable consumer for his wife.   A 78-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 at SINGLE DOSE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received first  dose of bnt162b2 on unknown date at SINGLE DOSE for covid-19 immunisation. On the morning of 1Apr2021, she had a headache, tiredness, fatigue and a sore throat and he gave her a couple Tylenol and the sore throat went away. She was tired and weak and has a headache. She has no fever. She was fine yesterday. The headache, tiredness and she took a couple Tylenol for the sore throat and that went away and they went shopping and she was a little more tired and weak a little bit so they came home and she is sleeping now. The outcome of Sore throat was recovered, of other events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a child who was vaccinated with 2 doses of VARIVAX (Merck), and developed chickenpox. The chickenpox developed more than a year after the second dose. The patient received unspecified medical attention. On an unknown date, the patient recovered from chickenpox. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), GAIT INABILITY (I could not walk or take 1 step), NASOPHARYNGITIS (I had a cold), RHINORRHOEA (runny nose) and EYE PRURITUS (eyes were itching  like they put needles in my eyes) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, the patient experienced DIZZINESS (dizzy), GAIT INABILITY (I could not walk or take 1 step), FATIGUE (tiredness) and MYALGIA (body ache). On 12-May-2021, the patient experienced NASOPHARYNGITIS (I had a cold), RHINORRHEA (runny nose) and EYE PRURITUS (eyes were itching  like they put needles in my eyes). On 16-May-2021, the patient experienced EYE PAIN (I could not open my eyes because they hurt really bad) and HYPERSENSITIVITY (allergy attack). On 17-May-2021, the patient experienced HEADACHE (headache). The patient was treated with ACETAMINOPHEN on 09-May-2021 for Adverse event following immunisation, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) on 16-May-2021 for Eye pain and Headache, at a dose of 2 dosage form and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-May-2021, DIZZINESS (dizzy), GAIT INABILITY (I could not walk or take 1 step), FATIGUE (tiredness) and MYALGIA (body ache) had resolved. On 17-May-2021, EYE PRURITUS (eyes were itching  like they put needles in my eyes) had resolved. At the time of the report, NASOPHARYNGITIS (I had a cold), RHINORRHEA (runny nose), EYE PAIN (I could not open my eyes because they hurt really bad), HYPERSENSITIVITY (allergy attack) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient reported she does not use any concomitant medications.
sx of paralysis, unable to hold head up;loss of coordination;memory loss;sx occurred same day of vax including a cold;nurse was called in-who suggested that MD see pt immed
Swelling and induration with redness from shoulder to below elbow. Hot to touch. Pain and fever of 102 F.
Pt not having an adverse reaction at this time but the fact that the vaccine was Expired it's my understanding from talking with staff from the program help desk to file the VARES report as protocol and as a just in case something were to go wrong with this pt it's documented and acknowledged  that the expiration of the vaccine was noted and both the Provider and the Pt's mother have been informed. The provider advised to re administer in the 4 weeks as it is recommended so the pt can have more chances of being fully immunized, but the Mother declined to have the child receive the  valid vaccine and just move forward with out re administering it.
Malaise, low grade fever, nausea, vomiting, body aches, difficulty voiding, sore thorat, morning stiffness/swelling of knees.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advied vaccine maintained activity necessary to protect against covid 19 on the day the vaccine was administered. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
Broke out in a rash on the left side of her chest going up to the neck and on to her face; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered (at the age of 59-years-old) in Arm Left on 24Feb2021 14:30 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Patient stated that she had not yet had her 2nd dose but was scheduled on 17Mar2021. The patient medical history and concomitant medications were not reported. The patient had the vaccine administered in her left arm and experienced broke out in a rash on the left side of her chest going up to the neck and on to her face on 25Feb2021. It was an itchy rash that took a couple of days to subside and it started the next day after her 1st dose of the Pfizer COVID Vaccine and took a couple of days to go away but was completely gone now. She did not have treatment for the event. None additional vaccines administered on same date of the pfizer suspect. There was none prior vaccinations (within 4 weeks). The outcome of event was recovered on an unspecified date in 2021.   Follow-up attempts are needed. Information on the lot/batch number has been requested.
hallucinations; drowsiness; Insomnia; extremely vivid and realistic dreams; metallic taste in mouth; muscle soreness; joint pain; headache; nausea; This is a spontaneous report from a contactable consumer reporting for self.  A 43-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 01Feb2021 08:15 at single dose for covid-19 immunisation. Medical history included allergies to azithromycin, erythromycin, amoxicillin, penicillin. Concomitant medication included influenza vaccine inact split 4v (FLUZONE), diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (ADACEL), hydrochlorothiazide, lisinopril (LISINOPRIL HCTZ). The patient experienced Insomnia, extremely vivid and realistic dreams, hallucinations 16-20 hours after injection (that night), metallic taste in mouth, muscle soreness, joint pain, headache, nausea, drowsiness for approximately 36 hours on 01Feb2021 11:00. Outcome of events was recovering.
95% Room air, 64 pulse, BP 112/72. Patient noticed to be less talkative. He had an almost syncopal episode. Patient never lost consciousness. Provided water. Patient recovered at vaccination table.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 27-AUG-2015 the patient was vaccinated with an improperly stored dose of VAQTA (dose, frequency and route of administration were not provided), lot # L021361, expiration date 30-MAR-2017. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Arm soreness was present almost immediately following the vaccine but redness and swelling occurred at around the 48-hour.
Expired Dose of Heplisav-B Administered; Initial Report Received on 09-DEC-2022  This is a spontaneous report, received from a Support Specialist at a distributor supply chain regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   Medical history was reported as unknown.  Concomitant medications were not reported.  On an unknown date, a dose of HEPLISAV B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunisation.  The reported stated that a doctor reported that  a patient was administered an expired dose of HEPLISAV B.   No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
experienced a bad headache; had arm pain in the vaccinated arm (left), only when lifting my arm; This is a spontaneous report received from a contactable consumer (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021 13:00, at single dose, for COVID-19 immunization, at workplace clinic. There were no medical history and no allergies to medication, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included vitamin c, colecalciferol (VITAMIN D), vitamin b and ibuprofen (ADVIL). The patient did not receive other vaccines within 4 weeks prior to BNT162B2 vaccine. On 20Jan2021 at 08:00, the patient had a bad headache and had arm pain in the vaccinated arm (left), only when lifting her arm. The headache went away during the evening without treatment. The patient did not take any pain relief medication. No treatment was given for the events. The patient recovered from headache on the evening of 20Jan2021 and recovered from "had arm pain in the vaccinated arm (left), only when lifting my arm" on an unspecified date. The events were assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Patient was in the office for PE on 4/30/18, at around 9:30 am she received both vaccines as noted above in separate deltoid muscles. She developed a fever, Tmax 103.7, headache, chills, myalgias, fatigue at around 5 pm. She was seen in the office on 5/1/18 with persistent fever (103) and mild muscle aches. Influenza test was negative.
A serious report of pneumonia has been received from a study investigator concerning post-marketing study for FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for newly indicated population of 2 to 59 months of age for FLUMIST. Medical history included no known allergies, asthma, and a positive purified protein derivate on 04-Dec-2007. Concomitant medication includes amoxicillin and albuterol. On 08-Jan-2008, the subject received FLUMIST. On the same day, the patient also received DTaP and MMR-VAR. Since 04-Dec-2007, the subject had two cases of cough, fever, and abnormal X-ray. She was diagnosed with community accuired pneumonia. Her father had recently been diagnosed with active TB so she was admitted to the hospital on 05-Feb-2008 to rule out active TB. Gastric aspirates x three were obtained for AFB smear and TB cultures. Chest CT scan was obtained to further evaluate the subject's pulmonary process. It showed no hilar LAD but two areas of infiltrated possibly consistent with resolving pneumonia. The county TB clinic indicated the contact case was pan-sensitive Mycobacterium tuberculosis but very high organism load/infectivity. Given the subject's risk and possibly abnormal pulmonary imaging, she was discharged on 07-Feb-2008 on quadruple drug therapy to be continued at least until the gastric aspirate cultures were final. On 08-Feb-2008, all three gastric aspirates were negative and the subject was doing well with no respiratory distress and was able to return to preschool. The pneumonia resolved on 11-Feb-2008. The investigator assessed the causality of the event of pneumonia to FLUMIST to be none and provided the alternative etiology of natural, viral. The severity of the event was moderate. Additional information received on 23-Oct_2008 and incorporated into narrative included concomitant therapy, medical history, and event outcome.
A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a nine-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. On 28-Dec-2011, the patient inadvertently received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 19-Mar-2012: reporter's information and it was reported that the patient did not have any adverse events.
pt is only 12 years old and received the moderna vaccine - which is not recommended for this pt age.   Moderna was contacted - case # MOD22-001168. was told to just monitor pt but should be safe and no further action required by pharmacy,
Chills followed by fever followed by loss of balance and  incontinence.  Pretty intense but relatively short lived. I stayed in bed most of the following day and within 24hours of the onset of symptoms felt pretty normal.  I was disoriented at the lowest point and considered going to the emergency room at 2 am.
Bumpy rash; itchy / rash on her arms and legs; red bumpy rash on her arms and legs; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 22nd September 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, 2 days after receiving Shingrix, the patient experienced itchy rash and red rash. On an unknown date, the patient experienced papular rash. On an unknown date, the outcome of the itchy rash and red rash were not recovered/not resolved and the outcome of the papular rash was unknown.   It was unknown if the reporter considered the itchy rash, red rash and papular rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. A pharmacist reported the patient received the 1st dose of Shingrix and developed an itchy red bumpy rash on her arms and legs that was worse in the morning of 25th September 2020. This event was ongoing. The reporter consented to follow up.
No adverse event; Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient).    No concomitant medications were reported. The patient received Moderna vaccine between 08-Apr-2022 to 15-Dec-2022. No treatment information was provided. NDC was reported as 80777027399.
Patient was diagnosed with first occurrence of atrial fibrillation in June 2017 with no episodes since. he received his first dose of COVID-19 vaccine on 1/30/21. Eleven days later on 2/10/21, he developed atrial fibrillation.
This spontaneous report was received from a consumer refers to her father, an 88 years old male patient without drug reactions/allergies and with concurrent conditions of congestive heart failure, low heart rhythm, pacemaker user and history of blood pressure. The patient's medical history included enlarged prostate. The patient was vaccinated under the skin with a dose of ZOSTAVAX (dose, lot# not reported) in the fall of last year, about in 2011. The patient also received unspecified concomitant medications. It was reported that the patient got a dose of ZOSTAVAX and about 9 months later, in 2012 the patient broke out with shingles. The patient had blisters on one of his legs and up into his buttock region. The pain was described as burning pulsation sensation. The patient went to the doctor and was diagnosed with shingles. The reporter reported it seemed to be a very minor case. It was reported that the patient still had remaining crusted blisters but the patient did not complain about any lingering pain. Unspecified lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Agency recommends using single-use vials of normal saline to dilute to each vial of the Pfizer vaccine.  Staff member incorrectly used 100 ml bottles of normal saline to reconstitute multiple vials of vaccine each day.  Staff member used a new bottle per day, however, and used the correct amount of normal saline to dilute each vial (1.8 ml per vial). We have since corrected this error and also notified local health authorities.  Patient has not reported any adverse events to health clinic where error occurred.
Patient states that the vaccine bandage was full of blood to the point of overflowing.  She stated that there was also a bluish knot at the injection site.
By the end of the evening, experienced pins and needles on forearm. Still experiencing them constantly through today.
Extreme body aches and chills starting on 8/30/21. Swollen injection site accompanied by rash/hives around injection site.
Pt recv vax. Lab eval revealed lack of response. Another pt was reported w/same exp. (WAES98012778).