chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received dose of Abrysvo RSV vaccine on 9/7/2023 to the L deltoid. On 9/9/23 pt reports experiencing "arrythmias". On Monday 9/11/23, pt reports going to the local urgent care for further evaluation. An EKG was done. On 9/12/23, she visited her PCP for annual visit and to further evaluate arrythmias. She had a stress angiogram done and reports wearing a holter monitor. She is scheduled for a follow up with PCP on 9/19/23. Patient reports that she has had a history of premature ventricular contractions in the past.
Dose 1 of Moderna was given on 04/22/2021 - client was 17 years old at the time.
Right side of face felt hot and slightly numb. Continued to persist for several hours. Appeared slightly puffy on right side. Muscles on right side of face felt stiff when moving them. Symptoms seemed to resolve but the next morning but returned around 1pm on 12/25. Additionally I noticed slight dropping in my face on the right side of my face.
Developed severe headache 1-2 days after vaccination. Then on day 3 developed left leg weakness, numbness, tingling. Patient admitted to hospital and diagnosed with Right parietal parasagittal IPH.
vaccine 3/7/21.   4/9/21 presented in ER with leg pain.  dx with dvt.  has no prior hx or fam hx of clots.  is not a smoker.  is on hrt.  treating dvt with eliquis.
Patient had his seasonal flu vaccine. Patient awoke around 9 pm, crying.  When I (his mother) picked him up, I could tell he was running a high-grade fever.  I took his temperature with a temporal thermometer and it read 106F.  I looked for ibuprofen, but couldn't find any.  So, I gave him acetaminophen instead, 160mg.  He couldn't stand on his own and couldn't speak.  He sounded very hoarse, hysterically crying. I called his pediatrician, who told me to get ibuprofen for him (which I had located.)  I gave him 125mg Ibuprofen about 10 minutes after the acetaminophen.  The dr. said if his fever had not lowered in 1 hour, take him to the ER.  I took his temperature with a digital thermometer under the arm and it read 105.6F.  This ws after APAP and IBU, at about 30 to 40 minutes into this episode.  I got in a tub of luke warm water with him.  At about 45 minutes, his fever began to come down.  I alternated APAP and IBU all night.  He maintained a low-grade fever until about 24 hours post-vaccine.
This spontaneous report as received from an office manager refers to a 51-year-old female patient with no pertinent medical history and no drug reactions or allergies. On approximately 12-OCT-2017 (reported as two weeks ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided) for shingles prevention. Concomitant therapies included sterile diluent (STERILE DILUENT), multivitamins (unspecified), iron (unspecified) and calcium (unspecified). On approximately 22-OCT-2017 (reported as 10 days after receiving ZOSTAVAX), the patient experienced jaw pain, jaw swelling and swelling of the gums. The patient sought medical attention (reported as "dentist and doctor"). On an unknown date, the patient had a jaw X-ray (results were normal) and "blood work" done (results unknown). An unspecified treatment was given for the events. The outcome of pain in jaw, jaw swelling and swelling of the gums was reported as not recovered. The relatedness between ZOSTAVAX and the events was not provided.
Pt c/o pain to left shoulder the evening after getting the injection. He was unable to lift his arm. Symptoms were worse the following day, which brought him to the urgent care clinic for evaluation.
Red color; Very itchy; Rash in arm; Bump on arm; Heart was beating very fast like Tachycardia; Felt so bad; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart was beating very fast like Tachycardia), FEELING ABNORMAL (Felt so bad), PERIPHERAL SWELLING (Bump on arm), ERYTHEMA (Red color) and PRURITUS (Very itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to antibiotics.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, the patient experienced TACHYCARDIA (Heart was beating very fast like Tachycardia) and FEELING ABNORMAL (Felt so bad). On 14-Jun-2021, the patient experienced PERIPHERAL SWELLING (Bump on arm). On an unknown date, the patient experienced ERYTHEMA (Red color), PRURITUS (Very itchy) and RASH (Rash in arm). At the time of the report, TACHYCARDIA (Heart was beating very fast like Tachycardia), FEELING ABNORMAL (Felt so bad), PERIPHERAL SWELLING (Bump on arm), ERYTHEMA (Red color), PRURITUS (Very itchy) and RASH (Rash in arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jun-2021, Blood pressure measurement: 173/103 (High) BP was 173/103..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.  On 13-Jun-2021, at 5AM the patient got up to go to bathroom and her heart was beating very fast like Tachycardia and called 911. Her BP was 173/103 and she felt so bad but was not transported to hospital. The following day she had rash in arm with big bump, the red color lasted a week and it was very itchy.
lymph node swelling started at 8hrs after injection; arm swelling and pain began >48hrs after injection and gradually worsening; mild redness to the area as well
Heart attack like symptoms, fainting, sweating, nausea, confusion, dizziness, trouble breathing
Pt recv vax on 2/8/99; on same day pt exp dizziness, facial blisters; tx=Benadryl IV
STIFFNESS IN BACK OF NECK OR STIFFNESS OF SHOULDER; PAIN IN NECK; WOKE ME UP; SHOULDERS PAIN; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, diabetic, non smoker, non alcohol user, and arthritis, and other pre-existing medical conditions included the patient had no known allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204N21A, expiry: UNKNOWN) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for arthritis, metformin for diabetic, and lisinopril for high blood pressure. On 26-JUN-2021, the subject experienced stiffness in back of neck or stiffness of shoulder. On 26-JUN-2021, the subject experienced pain in neck. On 26-JUN-2021, the subject experienced woke me up. On 26-JUN-2021, the subject experienced shoulders pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiffness in back of neck or stiffness of shoulder, pain in neck, woke me up, and shoulders pain on 26-JUN-2021. This report was non-serious.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with unspecified improperly stored LIQUID PEDVAXHIB. Reported lot number/expiration dates included valid L012837/11-MAR-2018, L006545/16-NOV-2017 and non-valid one J011272/21-APR-2016. The vaccines were exposed to 9.7 degrees centigrade for a cumulative time frame of 4 hours and 41 minutes. There was no excursion. This report was for data logger. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
- After 1st shot L lip Lower Tingled for 12 (I am SP Trigeminal  L surgery.) 12:05 shot got huge cold sore L inner lower lip - After 2nd shot L lower lip tingled x 24 and 18:05 shot got huge cold sore L inner lip - 10/1/21 developed severe shingles Rt. Back and Rt. lower abdomen. I had Shingles shots x2 about 6 yrs. ago severe pain and itch and rash. PCP started me on Valtrex.  Med x 7 days.
Narrative:  A 71yo male with PMH of Tobacco use, Cocaine dependence, Alcohol Dependence, Chronic Hepatitis, Seizure Disorder, Cirrhosis of Liver, Herpes Zoster, Benign Essential HTN, solitary Pulmonary Nodules, Primary Malignant Neoplasm of Liver ( Metastatic Cholangiocarcinoma ) and Immediate Transfusion Reaction. He received Pfizer Covid-19 vaccine per Policy and Protocol without complication, on March 18, 2021 No record of second vaccine dose No ADE reported An oncology patient with metastatic Cholangiocarcinoma and on palliative care System showed he passed away on April 11, 2021.
was suffering from insomnia; feels slightly elevated / possibly her heart rate; This case was reported by a consumer via call center representative and described the occurrence of insomnia in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypothyroidism.   On 27th May 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced insomnia and feeling abnormal. On an unknown date, the outcome of the insomnia and feeling abnormal were not recovered/not resolved.   The reporter considered the insomnia and feeling abnormal to be related to Shingrix.  Additional details provided were as follows: The patient had hypothyroidism and takes thyroid medicine. The patient was suffering from insomnia and stated that she felt slightly elevated like possibly her heart rate and states it felt as if she took 2 doses of her thyroid medicine.  The patient did not know the lot number or expiration date.  The reporter consented to follow-up.
Pt received a Pfizer 5-11 bivalent covid vaccine undiluted........
about 3 minutes after injection I got a flushed feeling.  It lasted a couple of minutes.   It came back one  more time in about 15 minutes. Again brief a couple minutes.  It did not advance. EMS and Doctor checked me for 40 minutes.  Only slightly elevated pulse.  It was elevated before I left home. It was 100 at home.  Got to about 106 doing this episode.  Went down to 97 before I left.  All other vs-WNL..  LS clear the whole time. O2sat.- 96 up to 100 before I left  I really want to get the second shot when I am due.  My personal doctor can not give me any answers. I never got out of my car.  Did not get any extra care just monitored.  Only sore arm later.
Emphysema; COPD; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EMPHYSEMA (non-serious), outcome "unknown"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "unknown", described as "COPD".  Additional information: The patient had all COVID vaccination and has emphysema and COPD.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
tachycardia lasted 10-15 mins; This is a spontaneous report from a contactable physician. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), dose 1st, parenteral on 15Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient first dose of the Pfizer covid vaccine on the 15Jan2021, right after the injection, patient experienced tachycardia lasted 10-15 mins, Patient informed the doctor about this on 19Jan2021. No other symptoms of anaphylactic reaction. The reporter enquired if any isolated tachycardia event with covid vaccine and if it was safe to give second covid shot. The outcome of the event was unknown.
Slight pain in my left shoulder after injection; was told it was normal and was going to subside after a week or so. As time passed, about a month to two months, pain grew and my shoulder got stiff with limited range of motion. Could hear cracks when moved and very painful to move in certain places. Gets worse when sleeping and especially when waking up. Told my doctor about it after three months and he didn't think anything of it and brushed it off. I didn't get it checked out again because I was managing it with ibuprofen and joint vitamins. As of today (06/11/2015), it's a lot better but not healed all the way. Still take vitamins and ibuprofen for the pain when it's discomforting.
Achy; head stuffy; cough; tired; sweaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Nov2023 as dose 1, single (Lot number: Unknown) at the age of 70 years, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 09Nov2023 (Batch/Lot number: unknown), in left arm for immunisation; tetanus vaccine (TETANUS VACCINE), on 09Nov2023 (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; ZOLOFT; ALLEGRA [FEXOFENADINE HYDROCHLORIDE]; CLARITIN [LORATADINE]. The following information was reported: PAIN (non-serious) with onset 12Nov2023 at 07:00, outcome "recovering", described as "Achy"; COUGH (non-serious) with onset 12Nov2023 at 07:00, outcome "recovering"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset 12Nov2023 at 07:00, outcome "recovering", described as "head stuffy"; HYPERHIDROSIS (non-serious) with onset 12Nov2023 at 07:00, outcome "recovering", described as "sweaty"; FATIGUE (non-serious) with onset 12Nov2023 at 07:00, outcome "recovering", described as "tired". Therapeutic measures were not taken as a result of pain, upper respiratory tract congestion, cough, fatigue, hyperhidrosis.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient has been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Client reports that she had some swelling at injection site following the vaccine, but went away.  Then around 8 days later she woke up with a very sore arm - swelling, redness, and warm to the touch from her shoulder down to elbow.
The night of the shot I started to get chills, body aches, and a low grade fever. This continued to the next day, and stopped by the 2nd day. On the second day I started to develop a rash on my arm that is itchy and painful. The rash has continued to get bigger, and now is welting. Because of the rash it is painful to move my arm, and the rash is hot to the tuch.
shipment was delayed by 2 days with no adverse event; shipment was delayed by 2 days with no adverse event; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case is linked to 2019SA320289 (same reporter).  This case involves a female patient of unknown age who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6719NA, Expiration date: unknown), via unknown route in the left deltoid, on an unknown date.  Relevant medical history and concomitant medication were unknown.  It was an actual medication error due to the incorrect product storage (Product storage error). It was reported that shipment was delayed by 2 days (Product supply issue).  No adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Pruritic body rash starting approx 24 hours after the second dose of the COVID Moderna vaccine. Rash started in chest/upper torso and progressed to bilateral arms, back, upper buttocks, and thighs. Rash feels like a sunburn in that it makes the subject feel warm. Rash is blanchable and fully pinpoint-macular, no papules or plaques.   At approx. 36 hours post-vaccine, the rash had spread down both arms and up the neck, sparing the face. The rash gets intensely pruritic when scratched or itched. There is no pain, shortness of breath, altered mental status, or other compromise of the subject's health or well-being.
This spontaneous case, was initially received from other health professional on 10-Oct-2017, concerning a 31-year-old, adult, patient of an unspecified gender. The patient's medical history and concomitant medications were not reported. On 05-Oct-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration: intramuscular and anatomical location: deltoid). On the same day, 1 hour after vaccination, the patient experienced red, and hot at injection site. On 08-Oct-2017, the patient had recovered from the events (reported as few days). The reporter assessed the events as non-serious. Non-significant case correction received with 10-Oct-2017: Batch number (195128) was captured in the case form and narrative was amended accordingly.
"Incoming TC from patient's mother, reporting possible COVID-19 side effects / adverse reaction:   Mother called to report side effects from daughter's Pfizer vaccine. Patient denies emergency symptoms at time of call. Only reporting side effects from last week.    5/16 1st dose Pfizer @ pharmacy. Reports minor dizziness and body rash. Called PCP, states to take Zyrtec for 3 days. Symptoms gone after 1 day. Advised to take Zyrtec night before and morning of 2nd dose.    Patient received 2nd dose at EVC 6/08 Pfizer. 10mins after injection pt reported dizziness and was observed for 30 mins at testing site. Pt was taken later to urgent care by her mother, was also seen by PCP. Pt later developed body rash limited to face, bilateral arms, neck and stomach area. Denies any other symptoms. Urgent care advised to take Zyrtec, symptoms gone after 3 days.    Pfizer 1st dose 5/16 Lot# 0177 at pharmacy Pfizer 2nd dose 6/8 Lot# ER8735
Incorrect dose of 0.5mL was administered instead of 0.3mL. No symptoms of adverse reactions reported to date.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (Lot number and expiration date were unspecified by the reporter). On an unknown date, five days after receiving the ZOSTAVAX, the patient experienced flu like symptoms. The patient also stated that he visited an unspecified physician who prescribed TYLENOL on an unspecified date. The outcome of flu like symptoms was reported as fully recovered. Additional information has been requested.
This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 14:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included previous migraine headaches in past (no migraine for 4 years), penicillin allergy and garlic allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified chinese herbs (MANUFACTURER UNKNOWN) prescribed by licensed acupuntu within two weeks of vaccination. On 29Apr2021 at 14:00, the patient experienced left arm pain around injection site for 13 days and continues, instantly felt tired after injection, fatigue increased and continued for 48 hours, headache for 7 days. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm pain around injection site for 13 days was resolving. The clinical outcome of the events instantly felt tired after injection/ fatigue increased and continued for 48 hours was resolved on an unknown date inMay2021 and the clinical outcome of the event headache for 7 days was resolved on 05May2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is in regard to case #01911690 Interaction #01911683. Patient was given a second dose of Pneumovax 23 two weeks after receiving the first dose. On March 25th the patient came in to the clinic for a routine appointment and received his pneumovax 23 vaccination that day. The nurse told the patient that the doctor did not want him to receive both pneumovax and shingrix in the same day and ask that he come back for the other vaccine in two weeks. The Nurse did not chart giving a vaccine that day and when the patient came in on 04/19/2021 to receive the shingrix vaccine, he received another dose of pneumovax instead. Patient states that he immediately felt dizzy and just wanted to get home to lay down. Patient reports feeling better the next day.
Fever 102F, Severe Back Pain, Fatigue, Nausea, Dehydration. The back pain dropped me and I was unable to move without a walker and pain medication. After 5 days, I was finally able to move around and the pain started to subside. This was after I had gone in to see my primary care.
Patient was 12 years old when she received her first Pfizer Covid vaccine. Received appropriate dose for 1st vaccine. At appointment for 2nd vaccine, mistakenly received Pediatric 5-11 formulation of Pfizer Covid vaccine. Parent was notified, no need to repeat vaccination.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was received Paxlovid treatment. treatment start date=04Jan2023, treatment stop date=08Jan2023. Patient had no Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.