chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in calf muscle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in calf muscle) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ALPRAZOLAM (XANAX) and FAMOTIDINE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in calf muscle). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and GABAPENTIN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in calf muscle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       for mRNA-1273 (Moderna COVID-19 Vaccine) (intramuscular), the reporter did not provide any causality assessment.    Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: Follow up received on 03 MAY 2021: Updated reporter's address. On 15-Jul-2021: TCR form received on 15 JUL 2021: No new information was provided.
Swollen Lymph Nodes; Arm Soreness; Slight Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph Nodes), PAIN IN EXTREMITY (Arm Soreness) and FATIGUE (Slight Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history reported by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AZILSARTAN KAMEDOXOMIL (EDARBI) and CHLORTHALIDONE for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph Nodes), PAIN IN EXTREMITY (Arm Soreness) and FATIGUE (Slight Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 15-Feb-2021, LYMPHADENOPATHY (Swollen Lymph Nodes) and PAIN IN EXTREMITY (Arm Soreness) had resolved. At the time of the report, FATIGUE (Slight Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-053474 (Patient Link).
A report has been received from a Physician concerning a 5 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 12-Nov-2012. The patient experienced fever of 102.6 degrees F, crabby and eyes hurt which started on 12-Nov-2012. The outcome of the event of fever of 102.6 degrees F, crabby and eyes hurt is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by AstraZeneca/MedImmune on 03-Dec-2012 from physician: Patient details updated.
Pt became unconscious a few minutes after receiving the vaccine then regained consciousness right after he fell off the chair. He did n Pt appeared to become pale for a little bit.
The patient was given the COVID-19 Bivalent Booster without receiving the primary series. The patient was given 1st influenza Fluzone on 10/06/22 and a 2nd influenza Fluzone on 01/19/2023.
Moderate Soreness. Presented 8 hours after vaccination. Contact caused  awakening from sleep during the night. Soreness/Tenderness persisted x 24 hours
Itching, throat tightness. Pt was evaluated by Provider, VS monitored, benadryl 25mg PO X1 dose. Pt full recover within 30min and monitored for another 30 min, discharged to home with husband who is a PA-C.
Developed intermittent sinus tachycardia along with intermittent shortness of breath. Prior to the second vaccine I had never experienced this; I am more than 90 days post the second Pfizer vaccine, and continue to experience these symptoms, which impact my daily life.
arm is very painful; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2019, the patient received the 2nd dose of Shingrix. On 19th November 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was received as follows: The patient had 2nd shot of Shingrix this morning and the patient's arm was very painful. The patient could barely use the arm due to pain was 10. The patient asked whether heat would be helpful.      Lab Comments: On an unknown date lab test was performed.
Moderna was past it's 30 day shelf life from being transferred from the freezer to the refrigerator and given to this patient. The manufacturer was contacted and given the scenario. The manufacturer stated that vaccine would be considered invalid and would need to be repeated. Patient has been informed and did not report any physical reaction.
Kidney problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Kidney problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Oct-2021, the patient experienced RENAL DISORDER (Kidney problems). At the time of the report, RENAL DISORDER (Kidney problems) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided. Reporter reports that the patient had to go to the hospital Reporter reports that she was just running a farm stand she happened to stop
59 year old patient was accidentally given FLUZONE HIGH DOSE, even though it's indicated for 65+ with no reported adverse event; Initial information received on 28-Sep-2021 regarding an unsolicited valid non-serious inbound case received from a other health professional (Inquiry Number: 00788802 and CompanyNumber: US-SANOFI-00788802) and transmitted to Sanofi on 28-Sep-2021.  This case involved a 59 years old male patient who experienced ''59 year old patient was accidentally given fluzone high dose, even though it's indicated for 65+ with no reported adverse event'' (product administered to patient of inappropriate age) while he received QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of 0.7 ml of suspect QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] produced by Sanofi Pasteur Inc. [lot number- UJ731AA and expiration date 30-Jun-2022], via Intramuscular route at right arm as an administration site for prophylactic vaccination.  It was an actual case of medication error due to inappropriate age at vaccine administration (latency same day).  At time of reporting, the outcome was unknown for the event product administered to patient of inappropriate age.  It was unknown if the patient experienced any additional symptoms/events.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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 had contributed to or is to be held liable for the occurrence of this medication error.
Immediate burning sensation in arm and lightheadedness, lasting 10 minutes. Felt weak for another 1/2 hour. Red  blotch on arm lasted 5 days, went away but came back a couple days later. This time was very itchy, swollen and hot. Size was about 3 inches down my arm from the injection site.. Lasted about 4 days.  Two weeks from shot, arm once again was itchy, with red dots near injection shot and down the arm.
Initial unsolicited report received from consumer via social media (on 16-Sep-2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. (same site, same vaccine). This case involves a patient (age and gender: not reported) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient got flu. Lab data and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none.
Pt got flu shot then about 10 min, pt said she has a headache, her body heated up (she feel hot) stated by technician. RPh gave pt 1 BENADRYL (pharmacy brand). Pt came back 1/2 later & said she feels fine later & went home fine.
Vaccinated on April 18th April 25th Runny Nose, Cough April 27th Irritable, did not want to wear jeans, cried more than usual. Cluster of Seizures, temp was at 99.8 which is high for him.  Last seizure was a tonic clonic and lasted for less than 3 minutes.  April 29th Rash on back of legs appeared.
48 hr. Flu like symptoms - fever 101.7, chills, severe body aches, headache and cramping.
Tinnitus/ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 01Apr2021 at 17:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. 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 did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 17:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021, the patient started having tinnitus/ringing in the ears after receiving the second dose. It had not subsided since then and it was increased quite a bit on occasion. The patient was planning to discuss this with the primary care physician (PCP) this week (at the time of the report). Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event tinnitus/ringing in ears was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
past the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (past the expiration date) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (past the expiration date). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.
This is a 6 month old male who presents for evaluation after an episode for which he was seen at ER yesterday. He was staying with his Aunt who describes him to be well and happy yesterday morning. He was sitting on the floor playing with toys when he suddenly vomited and became limp and unresponsive. She stated that he lost all tone and his eyes rolled back to the back of his head. He was still breathing during the episode. She stated that the event lasted for approximately 5 minutes. She called 911. When the paramedics arrived 10 minutes later, he was still unresponsive but slowly regained consciousness. He appeared somnolent in the squad and during triage at the ER. Dr. evaluated him about 1 hour after the event at which time he appeared alert, active and playful. His vitals were stable. His laboratory evaluation was within normal limits with the exception of an elevated WBC and platelet count. He was discharged him. He received his 6 month vaccines 6 days prior to this event which included Pediarix, HIB, Prevnar and Rotateq. The parents had reported to me that a similar event occurred 3 days after his 4 month vaccines. This event took place at night while he was sleeping. The dad found him lying in his crib. He was asleep, but had vomited a large amount. The parents were never made aware of this by crying or restless sleep. The emesis was cold by the time they found him. They have expressed concern today regarding possible seizures. There is not family history of a seizure disorder. There is no family history of adverse reaction to vaccine, although the timing of each episode has alerted to this possibility. The parents state that he appears back to himself today.
Tingling in vaccination arm. Pt. was discharged home at 10:57 a.m
red patch on her arm; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on 23Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history included she did have reactions to a lot of medications, not like flu shots, but she does reaction to some medications, allergy medicines in particular. Stated did not react to pneumonia vaccine and verbalizes it did not itch. Concomitant medication was not reported. The patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration as dose 1, single for COVID-19 immunisation. Caller stated that she got her second Pfizer shot on Tuesday (23Feb2021). Caller stated that she was a person that had to wait 30 minutes after getting a new medicine, and so far everything was so good. But today (26feb2021), caller discovered a red patch on her arm, the arm she received the injection in, but not right at the injection site, it was a couple inches or so below that. Caller stated that it was about a half dollar, a silver dollar size, and it was not bright red but it was noticeable. Caller was wondering if this was a known side effect of the product. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Very nauseous all night long. Ate a breakfast bar in the morning, threw it up, had dry heaves for a while, then seemed to be OK. About and Hour or so later got up to go to the restroom and just remember walking thru the door. Next thing I knew I was on the floor bleeding,  passed out approx. 24 hrs after receiving shot.  No way to know how long I was out, received head cut.
5 patient received Menactra vaccine which was store at minus 8 degrees Celsius for 7 hours and 24 minutes/ No AE; Initial information was received on 17-Aug-2021 regarding an unsolicited valid non-serious case received from another health professional via consumer (under Medical Information Inquiry Number:00727996).  This case is linked to case 2021SA275306 (Same reporter).  This case involves five patients with an unknown age and gender who were administered dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] that had stored at minus eight degrees Celsius for seven hours and 24 minutes (product storage error).  The patients medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   On an unknown date, the patients received dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution lot number: U6921AB, U7087AA and expiry date:17-Apr-2022, 05-Oct-2022 via an unknown route in unknown administration site for prophylactic vaccination respectively.  It was case of an actual medication error due to product storage error temperature too low (latency: same day).  It was reported "Nurse calling back to ask specifically about MENACTRA and IPOL that was administered yesterday after temperature. Is re-vaccination needed and if so, when should it be given. Caller states they do not think they had a real temperature excursion but had a faulty data logger because none of the other vaccines were frozen. States he provided minus eight degrees Celsius for seven hours and 24 minutes. Caller states 1 patient had received the IPOL. Caller thinks he had 5 patients between the two lots for the Menactra but is looking through his computer now to gather all the information. Product used."  At the time of reporting, 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 the 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.
Severe arm pain, low-grade fever, headache, some nausea, dizziness, severe body aches Lasted about 12 hours
Arm developed large red, swollen area covering the entire upper area of arm above the shoulder Skin was hot to touch (Infrared Thermometer showed 100.5 °C in the area) Experienced chills and joint pain in legs and arms as well as headache over the two days following vaccination  Took Advil and iced the area of the arm
Swollen lymph nodes under armpits, sore neck, break out on chest and back.
felt like fainting; could not stand up; diaphoretic; sat on bathroom floor and could not get up; felt crushing feeling in head; overwhelming feeling of nausea; felt exhausted; discomfort in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in arm), PRESYNCOPE (felt like fainting), DYSSTASIA (could not stand up), HYPERHIDROSIS (diaphoretic) and MOBILITY DECREASED (sat on bathroom floor and could not get up) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, 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 09-Apr-2021, the patient experienced LIMB DISCOMFORT (discomfort in arm). On 10-Apr-2021, the patient experienced PRESYNCOPE (felt like fainting), DYSSTASIA (could not stand up), HYPERHIDROSIS (diaphoretic), MOBILITY DECREASED (sat on bathroom floor and could not get up), HEADACHE (felt crushing feeling in head), NAUSEA (overwhelming feeling of nausea) and FATIGUE (felt exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Apr-2021, PRESYNCOPE (felt like fainting), DYSSTASIA (could not stand up), HYPERHIDROSIS (diaphoretic), MOBILITY DECREASED (sat on bathroom floor and could not get up), HEADACHE (felt crushing feeling in head), NAUSEA (overwhelming feeling of nausea) and FATIGUE (felt exhausted) had resolved. At the time of the report, LIMB DISCOMFORT (discomfort in arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Nonsignificant FU added
Patient received a vaccine on 1/15/2022 with a BUD of 1/9/2022. No adverse reactions. Patient  offered revaccination per guidelines.
Patient stated her arm was red and swollen from injection site down to elbow.  Hot feeling on the arm.
Headache developed 9 days after vaccination.  Nausea, vomiting and fever developed on day 12 post-vaccination.  Patient was also somnolent but responsive on day 12.  Lumbar puncture performed and triple anti-biotics started to cover various causes.  Vital signs stable and patients symptoms are unchanged at the time of this report.
The evening of the vaccine got a headache and started getting muscle pain. By the next day I had fatigue, headache ,muscle pain, joint pain, chills and nausea. Lasted until the evening of January 26. 2021
pt recv vax; in am, pt devel a T of 102, fatigue, stomach cramps & n; recovered 26may94;
Patient endorsing both lightheadness and also room spinning sensation, two separate types of dizziness.  Right BPPV diagnosed based on dix hallpike manuever. Also diagnosed with orthostatic hypotension. Unable to go home, will be sent to rehab from the hospital.
11-31-08, PC learns client's older sister states client began vomiting about 5 AM, today. No increase temp reported. Referred to PMD. DC to home about 2pm. Client feeling better. Did not see doctor.
Information has been received from a licensed practical nurse concerning a 3 year old male, the son of an employee at her clinic, who at the age of 1 was vaccinated with a single first dose of varicella virus vaccine live (Oka/Merck). Within 24 hours of vaccination, the patient developed chickenpox. The child went to the pediatrician's office. No lab studies were performed. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
large welt puffy; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (large welt puffy) and TENDERNESS (tenderness) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SWELLING (large welt puffy) and TENDERNESS (tenderness). At the time of the report, SWELLING (large welt puffy) and TENDERNESS (tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs were not reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Additional information received
Rash (urticaria) within 24 hrs of Hep A #1, PREVNAR 13, Varicella.