chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Legs hurting, couldn't move legs; I am having bad cramping, never have cramping like this usually; Armpit hurting along with cramps that she has not experienced before; Nausea; Vomiting; Chills; 100.08F Fever; Fatigue; Headache/Felt like a weight on my head; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea) and VOMITING (Vomiting) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (100.08F Fever), FATIGUE (Fatigue), HEADACHE (Headache/Felt like a weight on my head), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Legs hurting, couldn't move legs), MUSCLE SPASMS (I am having bad cramping, never have cramping like this usually), AXILLARY PAIN (Armpit hurting along with cramps that she has not experienced before), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (100.08F Fever), FATIGUE (Fatigue), HEADACHE (Headache/Felt like a weight on my head), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Body temperature: 100.08 (High) 100.08F.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.
Pt received ZOSTAVAX sub-q. Later redness at site of inj. Gave pt BENADRYL. Pt. called 7pm said she felt ok (9/24). 9/27, pt called 9:10am said area is red and small bump has formed. Asked pt to call primary care physician if not better by 9/28/12.
Patient felt nauseous, dizzy, and flush. Patient was given a bottle of water and monitored for 30 minutes. After the 30 minutes he said he felt better and was able to leave.
12 yr old got Menactra and Adacel and both these vaccines were not given in deltoid, with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a consumer (Patients grandmother) via Agency on 03-Nov-2020.  This case involved a 12 year old male patient for whom it was reported that, 12 year old got menactra and adacel and both these vaccines were not given in deltoid (Product administered at inappropriate site), with no adverse event, while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination (Product administered at inappropriate site).  Final diagnosis was Not Applicable 12 year old got Menactra and Adacel and both these vaccines were not given in deltoid, with no adverse event.   Relevant laboratory test was not reported.  It was not reported if the patient received a corrective treatment.  There will be no information available on the batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
I'm an NP working in primary care and have received numerous complaints about s/e to the shingrix vaccine, and I don't know if these are getting reported back to the pharmacies giving the vaccine such that they can complete these reports. I have NOT had the vaccine myself. I'm just reporting that I would say at least 1/2 of my patients that have received the vaccine (always from local pharmacies, as we have not had supply in a long time) c/o significant localized pain and swelling from the injection, and full body aches, sometimes with GI sx.
Lymph node has bursted and started bleeding; The second vaccine gave me a lot of joint pain; I broke out with swollen lymph node; swollen lymph node that came up under my arm, the same arm where I had the vaccine; Lymph node has bursted and started bleeding/she was told that her lymph nodes were infected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): -PFIZER INC-202101698202 (Pfizer).  A 47-year-old female patient received bnt162b2 (BNT162B2; Formulation: Solution for Injection), administered in arm left, administration date 03Nov2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunization. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure; "numbness" (unspecified if ongoing); "severe Vitamin D and B12 deficiencies" (unspecified if ongoing); "severe Vitamin D and B12 deficiencies" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension; VITAMIN D 3 taken for vitamin d deficiency. Vaccination history included: Bnt162b2 (First dose), administration date: Oct2021, for Covid-19 immunization.  The following information was reported: HAEMORRHAGE (medically significant) with onset Nov2021, outcome "not recovered", described as "Lymph node has bursted and started bleeding"; ARTHRALGIA (non-serious) with onset Nov2021, outcome "not recovered", described as "The second vaccine gave me a lot of joint pain"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "not recovered", described as "I broke out with swollen lymph node; swollen lymph node that came up under my arm, the same arm where I had the vaccine"; LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "not recovered", described as "Lymph node has bursted and started bleeding/she was told that her lymph nodes were infected". The events "lymph node has bursted and started bleeding", "the second vaccine gave me a lot of joint pain", "I broke out with swollen lymph node; swollen lymph node that came up under my arm, the same arm where I had the vaccine" and "lymph node has bursted and started bleeding/she was told that her lymph nodes were infected" were evaluated at the physician office visit. Therapeutic measures were taken as a result of haemorrhage, arthralgia, lymphadenopathy, lymphadenopathy.  Action taken for bnt162b2 (BNT162B2) was not applicable. Therapeutic measures was taken as a result of haemorrhage and lymphadenopathy and included treatment with Neoskin'.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Follow-up (30Nov2021): This is a spontaneous follow-up report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team.  Updated information: Treatment for events haemorrhage and lymphadenopathy. Event verbatim for event lymphadenopathy (she was told that her lymph nodes were infected).
Vaccination interval betwwen 1st dose and 2nd dose was more than 25-35 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccination interval betwwen 1st dose and 2nd dose was more than 25-35 days) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD (start date can be 5 or 6.) since March 2020. Concomitant products included OMEPRAZOLE (OMEPRAZOLE DARNITSA) for Acid reflux (oesophageal), TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA RESPIMAT) for COPD, SIMVASTATIN (SIMVATATINE) for Cholesterol, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Cold sores.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccination interval betwwen 1st dose and 2nd dose was more than 25-35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccination interval betwwen 1st dose and 2nd dose was more than 25-35 days) outcome was unknown.            Patient was not tested positive for COVID-19.  No treatment information was reported.   This case was linked to MOD-2021-062206 (Patient Link).
Spoke to pt 11-22-10 6:29 P she said her arm was swollen & very painful. She went to the ER on Sat & will follow-up w/primary care MD tomorrow. She said her arm feels fine now.
- Moderna vaccine Sunday 1/3/21 - Vaccine site remained sore from 1/3/21 through Wednesday (1/6/21) before starting to improve.  - On Sunday 1/10/21,area again became painful, warm to touch, firm, and itchy - Woke up this morning (1/12/21) and noticed the redness that was just around the injection site had migrated down, mid-arm and has continued to moved downward today.  - Describes sensation as similar to after spider bite - The area feels itchy when clothing touches the area some burning/itch.
Yesterday evening could not sleep at all last night.  Patient could not sleep and could not eat.  Today it continues.   Patient feels worse than after vaccine.  Patient has received Flu shot every year with no problem.
Patient received dose of Pfizer COVID 19 vaccine in clinic on 4/9/21.  At the time the medical student was removing the needle from the patient's arm, the needle separated from the syringe and a couple residual drops ran down the patient's arm.  The medical student and preceptor reported that >50% of the dose was administered.
Acute arthritis most joints, myalgia so, exhaustion, major welling of bursae both knees and hip, face rash, eyes red and swollen, typican but worse autoimmune SLE flare X 1 month. Joints all markedly enlarged. Lost mobilityo
Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14-day old male patient who was vaccinated with a dose of 0.5 ml PENTACEL (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate age at vaccine administration. It was unknown whether the patient had any adverse event. 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. List of documents held by sender: none.
Patient and I, her mother, were playing.  She asked me to build her a boat with blocks.  I asked her to get the instructions off of the couch and she looked confused and made no response to the request.  I repeated the request and she looked off to the right (the couch was on her left).  I then realized that something was wrong.  I moved to her and asked her to look at me, she didn't respond.  She continued to look off to the right.  I stood up to get my husband in the other room and she began to have a series of dry heaves.  After she stopped heaving, I again asked her to look at me.  She still did not respond.  She was still staring off to the right and her jaw was opening/closing in a continuous biting movement.  I picked her up and took her to my husband.  He sat down with her and about 30-45 seconds later she snapped out of her altered state. She was able to tell us her name and where she was.  She immediately tried to go to sleep and was next to impossible to wake when we arrived at the ER.  She had no recollection of the event. From onset to completion I estimate that the episode of altered mental state lasted 2-3 minutes. At the ER she was given an MRI that was negative for abnormal findings.  We were given a referral to a Pediatric Neurologist for the following week.  The Neurologist performed a sleep-deprived EEG that was reported as abnormal for two occurrences of a brief burst activity with 1 or 2 spike wave discharges in bilateral synchronous distribution, followed by a high-voltage slow wave of 1 second during hyperventilation and in the sleep state.  Prior to this incident, and since, to this date, patient has not had any episodes of an altered mental state.  The Pediatric Neurologist believes that she experienced a complex-partial seizure.  No ongoing treatment is implemented at this time.
17MAY98 devel 20 pox on face & 5 pox on body-fluid filled lasted 1wk;31MAY98 devel swelling (mumps like) on both sides of jaw w/fever;very irritable;will see MD 315PM this afternoon;pt seen by MD 11JUN98 dx tonsillitis;
Fever, sweats, chills, headache, burning eyes, loss of taste were expected side effects.  Was admitted to the ICU on 3/27/2021 with heart failure.  Felt fine before the shot.
I had vaccine in August, first week of November I got COVID, after having a COVID-19 home test on Nov 3rd, I was positive. At the end of Nov, I had a loud sound in my ear, my balance was bad, and went to the doctor on Nov 30th, and mentioned this to the doctor and he referred me to have a hearing test and when I got the results it was a dramatic decrease on my left ear, the inner ear. I always had problem in my ear, but this time was disruptive. I will have an MRI of the brain on Feb 15th and, on the 28th of February I will have follow up with my doctor.
Fever chills heart pain  irregular heartbeat  ongoing lethargy  Increase in heart medications  needed as abnormal lack of wellness continued through June.
received the product frozen when it was delivered to the clinic, and put it into the freezer; This non-serious case was reported by a nurse via sales rep and described the occurrence of intercepted product storage error in a patient who received MMR (Priorix) (batch number GXZ79, expiry date 2024) for prophylaxis.   On an unknown date, the patient did not receive Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced intercepted product storage error (Verbatim: received the product frozen when it was delivered to the clinic, and put it into the freezer). The outcome of the intercepted product storage error was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 10-Aug-2023 The nurse reported that Priorix was not used on any patients in this case report.  The reporter received the product frozen when it was delivered to the clinic, and put into the freezer, where it had remained the past 2 weeks. The reporter had marked the vaccine 'do not use after they spoke on the day of reporting, and placed it into the refrigerator, while planning a follow up tomorrow, who would also send a medical information letter, she requested on storage outside of temperature values and would discuss this situation directly.  The reporter would following up with the logistics department at this base tomorrow (already emailed and left VM this afternoon) to ensure another communication on storage of this vaccine. The 20 doses of Priorix had storage temperature excursion, which led to intercepted product storage error.
Fever; Vomiting; Been Sick All Day; Felt like Garbage All Day; Been Sick All Day; Felt like Garbage All Day; This is a spontaneous report received from a contactable consumer (mother) Parent reported behalf of her daughter. A 12-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0180) via an unspecified route of administration at left arm on 09Jun2021 14:00 (at the age of 12-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Other Products and patient history reported as No. Prior Vaccinations (within 4 weeks), AE(s) following prior vaccinations, Patient's Medical History was not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0168) via an unspecified route of administration at left arm on 18May2021 (at the age of 12-year-old) as dose 1, single for COVID-19 immunisation. It was reported that caller states she was calling about her daughter. Caller states her daughter got her second Covid shot yesterday 09Jun2021 at 2:00p.m and she woke up today around 4:00 p.m to 5:00p.m. with a fever and vomiting and she just vomited again. Caller states she has been sick all day. Caller states this was ongoing, her daughter has felt like garbage all day. The patient experienced fever, vomiting, been sick all day; felt like garbage all day on 10Jun2021. Patient did not visit physician office and emergency room for the events. Patient received treatment for the events Tylenol about an hour or two after her shot. Outcome of events was recovering.   Follow-up attempts are completed. No further information is expected.
On Saturday, 1/9/2021, a rash started around injection site, did not hurt only itched, size tripled over next two days, continues to be hot to touch, red and itch.
Symptoms began with tightening of my throat and difficulty swallowing. Then my chest tightened up and I had difficulty breathing, and was wheezing. It was mild to moderate, so I didn't call the doctor, but around 3:00 pm, I almost completely lost my hearing. It was very scary. Everyone and everything sounded like the volume had been turned WAY down. I couldn't even hear my own voice. By around 8:00pm, my hearing returned to almost normal. My eyes were severely bloodshot for 2 days. Within 24 hours, my chest finally felt relaxed and I wasn't wheezing anymore.
Sore arm; Burning sensation; Muscle stiffness; Infection; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot number: ER8727), via unspecified route of administration in the right arm on 20Mar2021 at 15:15 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history included erathema nodosum and allergy. Concomitant medication included birth control (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown date. The patient has not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient has not tested for COVID-19. On 21Mar2021 at 00:00, the patient had experienced sore arm, muscle stiffness, burning sensation and infection. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of sore arm, muscle stiffness, burning sensation and infection was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
day of & day p/vax had sl swelling & tenderness @ site of DTAP;over night devel redness, swelling & itching @ site;mom brought pt to clinic;pt had 12cm by 9.5cm red, raised, hot, swollen, tender & itchy area on lt thigh @ site;T98.4;
No additional AE's were reported.; missed his second dose and still has not received it; This spontaneous report was received from a pharmacist and referred to a 31-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 26-JUL-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date and route of administration were not provided). The patient missed his second dose in September 2022 (reported as would be 2 months from 26-JUL-2022)a nd still had not received it (product dose omission issue). No additional adverse events (AEs) were reported.
muscle aches; fatigue; headache; shivering; fever; unspecified gastrointestinal symptoms; difficult to dress and do daily activities; can't move arm; injection site Grade 3 pain; pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st May 2022 18:16, the patient received the 2nd dose of Shingrix. On 31st May 2022, less than a day after receiving Shingrix, the patient experienced pain and injection site pain. On 1st June 2022, the patient experienced activities of daily living impaired. In June 2022, the patient experienced movement disorder. On an unknown date, the patient experienced myalgia, fatigue, headache, shivering, fever and gastrointestinal disorder. The patient was treated with ibuprofen and non-drug therapy (Heat Therapy). On an unknown date, the outcome of the pain, movement disorder, injection site pain, activities of daily living impaired, myalgia, fatigue, headache, shivering, fever and gastrointestinal disorder were not recovered/not resolved.   It was unknown if the reporter considered the pain, movement disorder, injection site pain, activities of daily living impaired, myalgia, fatigue, headache, shivering, fever and gastrointestinal disorder to be related to Shingrix.     Additional Information: GSK receipt date: 1-June-2022 Reporter's comment: This case was reported by a consumer via call center representative.  The patient received 2nd dose of Shingles shot at 6:16 pm. Around 9:30 pain got much worse. At 12:30am, the patient could hardly lift my arm.  The injection site Grade 3 pain continued. It was difficult to dress herself and do other daily activities this morning. On an unknown date, less than a week after vaccination, the patient experienced muscle aches, fatique, headache, shivering, fever and unspecified gastrointestinal symptoms.  The reporter consented to follow-up with physician but she had a new doctor she had not seen yet. No contact information provided. The patient might follow up with pharmacy where she received vaccination. She did not know the batch number or expiration date. The patient asked if it was normal. The Ibuprofen didn't help. Heat was not really either. Additional Supportive Information: note: Anatomical location of pain was not reported hence injection site pain and pain was coded as separate event.