chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. Patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored RECOMBIVAX HB (lot number reported as M001578 and expiration date 21-NOV-2018, lot number L045117 and expiration date 06-OCT-2018, dose and route of administration were not reported). Concomitant therapy was not reported. The vaccine was exposed to a temperature of 0.6 Celsius degrees for 12 hours and 28 minutes total cumulative time. There was no previous temperature excursion. It was stated that it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Uncontrollable shaking, fever of 103, headache,  and nausea x 36 hours. Also very sore arm with pain, swelling, and heat to touch.
pt recv vax 24JAN96 & 12hr p/vax & exp an indurated, painful arm (inj site), shakiness all over, & hives on chest; tx hot bath & APAP;sx subsided the morning of 25JAN96 x/for the shakiness;
Narrative: Pt reported "behavioral changes after vaccination. It is unknown if this occurred after the 1st dose, 2nd dose, or both as further information is not available.
Generalized myoclonus occurred on the following dates: 7/17, 8/29, 9/01, 9/02. On July 17th I was admitted to the ER with a high fever, soaked in sweat. While being attended by a nurse I began to experience violent muscle convulsions throughout my entire body. The attending physician administered Lorazepam via IV which stopped the convulsions. I followed up with my primary care physician who didn't recommend any additional treatment. The same symptoms reoccurred on 8/20, 9/01, and 9/02. My physician has been on vacation and I have been unable to contact her for the past week during which time I have had 3 episodes of violent convulsions.
patient received half the adult dose of Hep B. pediatric Hep B was given instead of Hep B adult dose. patient had no adverse reaction noted or described.
hand & arm tingling, perspiring, side tingling, questionable tightness in throat w/i mins of inj;no treatment;stable p/1hr 1wk prior, while riding bike bitten 2-3" above ankle by dog;
I felt lethargic and had a minor headache at 5:00 pm. I took a two hour nap, still had a headache. Headache was alleviated with 800 mg ibuprofen.
Provider had ordered Varicella, as well as a MMR vaccination. Patient was injected with a MMRV vaccination, already containing the Varicella vaccination, as well as a regular Varicella immunization. This was in error, as the incorrect MMR/MMRV was drawn up, resulting in the patient receiving a double dose of Varicella. Due to patient's age, provider stated that the possible side effects are flue like symptoms, and rash.
I received a Moderna booster at a mobile clinic at the fire station. The injection site was at the joint between my shoulder and left arm. Within 3 hours I was experiencing severe pain.  My GP believes the vaccine was given into my biceps tendon.  I need PT and follow up if it does not heal. I do not have use of my left arm and it is very painful.
The day following the Moderna vaccine the patient was seen walking early morning to get coffee, and had no visible trouble when using his walker. His ability to move around without nursing assistance was a requirement when staying at the home due to patients size and heavy weight. At breakfast time, patient asked staff for assistance getting up but staff was unable to help him to avoid injury to themselves. Prior to this day patient has had no known issue walking besides use of walker. Patient has a weekly nurse come in to assist with shower, and at this time the nurse was able to help patient sit up, he then went on to walk approximately 50 feet, with the assistance of his walker, to the bathroom. CONTINUED
Patient arrived 12-1-11 for 6 mos well check with parents. Parents described severe side effect after ROTATEQ at 2 mos & 4 mos - x 4-5 days of severe diarrhea & abd pain, which was worse after 2nd dose. Parents declined dose # 3.
30 minutes after receiving vaccine, client said "I feel funny". I instructed him to remove shirt. No rash present. Client said he felt tightness in his throat I administered Epi 0.3 ml and called EMT's. Client treated and transported.
About 5-10 min after injection, I started to feel a little bit shaky and I felt my heart rate  had increased a lot. I just did not feel myself, out of sorts. Paramedics checked my heart rate, pulse ox and BP. O2 was normal - I did not have any respiratory symptoms.  My heart rate was quite elevated and blood pressure as well. They had me come to the ambulance to monitor me for a bit longer.  Around the injection site I had a large ring of hives, it was red and quite warm. I was red and warm also on my neck and somewhat on the top of my back. They hooked me up to EKG, took my blood pressure, pulse ox and heart rate again,  BP and heart rate were still high, O2 sats were normal,  but I was feeling better. We waited 15 minutes approximately and they checked my vitals again and my blood pressure has down, as well as my heart rate. So they felt it was OK to discharge me with instructions to take an antihistamine when I got home,  and to call emergency services if I needed further help.  My symptoms all subsided completely and I was fine at home.
covid vaccine breakthrough case  no complications of COVID.  admitted for pre-term labor pregnancy, not COVID  35.2 weeks gestation
Patient received  the wrong dosage based on age. 0.2 ml was administered instead of the 0.3 ml needed as the patient was 13 years of age.
Still weak; Felt strange for an hour; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (Still weak) and FEELING ABNORMAL (Felt strange for an hour) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 011A21A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Eczema and Lupus erythematosus (Skin lupus). Concomitant products included DUPILUMAB (DUPIXENT) for Eczema, HYDROXYCHLOROQUINE for Lupus erythematosus, METFORMIN and EMPAGLIFLOZIN (JARDIANCE) for Type 2 diabetes mellitus, ALLOPURINOL and ATORVASTATIN for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021 at 12:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced ASTHENIA (Still weak) and FEELING ABNORMAL (Felt strange for an hour). On 01-Nov-2021, FEELING ABNORMAL (Felt strange for an hour) had resolved. At the time of the report, ASTHENIA (Still weak) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Company Comment: This case concerns a 75  AGE year-old male patient with a history of systemic lupus erythematosus and type 2 diabetes mellitus who experienced the unexpected non-serious events of asthenia and feeling abnormal. The event occurred approximately  1 day after the third dose of Moderna COVID-19 Vaccine. The medical history of systemic lupus erythematosus and type 2 diabetes mellitus remain confounders for asthenia and feeling abnormal. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-374977 (Patient Link).; Sender's Comments: This case concerns a 75  AGE year-old male patient with a history of systemic lupus erythematosus and type 2 diabetes mellitus who experienced the unexpected non-serious events of asthenia and feeling abnormal. The event occurred approximately  1 day after the third dose of Moderna COVID-19 Vaccine. The medical history of systemic lupus erythematosus and type 2 diabetes mellitus remain confounders for asthenia and feeling abnormal. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
left shoulder pain x6 weeks following administration of flu shot. tenderness to palpation at area of injection without erythema, swelling, visible skin changes.
Sore on both arms, painful to hold anything and to reach to get anything. Lung pain. Headache. No smell. Tired.
Moderate continual joint pain in bilateral knees, fibula bones, L hip, bilateral hands, finger joints out of the normal
gastric issues; Thyroid problem after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of THYROID DISORDER (Thyroid problem after vaccination) and GASTRIC DISORDER (gastric issues) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced THYROID DISORDER (Thyroid problem after vaccination). On an unknown date, the patient experienced GASTRIC DISORDER (gastric issues). At the time of the report, THYROID DISORDER (Thyroid problem after vaccination) and GASTRIC DISORDER (gastric issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was on antibiotics for prosthesis for about 5 days now for 14 days treatment.  No treatment information was provided by the reporter.
feeling very sick; major fatigue; fever; ache in all major joints; sore throat; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th August 2019, the patient received the 1st dose of Shingrix. On 12th August 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell, fatigue, fever, joint pain and sore throat. On an unknown date, the outcome of the feeling unwell, fatigue, fever, joint pain and sore throat were unknown.   It was unknown if the reporter considered the feeling unwell, fatigue, fever, joint pain and sore throat to be related to Shingrix.  Additional details were received as follows: After receiving 1st dose patient was feeling very sick, major fatigue, fever, ache in all major joints and sore throat. The patient experienced events after receiving 1st dose and asked whether the 2nd dose would be worse or not. The patient asked not to share information. The patient was asked to refer health care provider as primary resource for patient care. The patient was trying to figure out if there was any data indicating that if the first dose was not tolerated well would the second dose be worse. The patient would need to schedule 4 to 5 days of bed.
The COVID-19 vaccine administered through vaccine administrator, HCF, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
she had one and her arm hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 60-year-old female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "she had one and her arm hurt". Additional information: The caller is the mother of the patient. The caller was asked for the age of the patient at the time the pain began and asks when were the first shots, and states this occurred either for the first or 2nd year of the pandemic and that was when the pain in her arm began and it was in 2020 or 2021. She does not know when the patient's dose of the Pfizer covid vaccine was but she had one and her arm hurt for a while but that went away and then she got the 2nd one and had the pain in her arm and the migraine headache and it would not go away.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300354214 same patient, different vaccine dose number/event;
Flushing of skin; Full body burning; Tingling; Hives (no itch); This is a spontaneous report from a contactable consumer, the patient. A 24-years-old-non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8733) via unspecified route of administration in the left arm on 17Apr2021 at 10:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. The patient medical history included depression and anxiety. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and magnesium aspartate (MANUFACTURER UNKNOWN)all for unknown indications, from an unknown dates. The patient had no known allergies to medications, food or other products was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02May2021 at 11:15, after receiving medications and supplements for several months i.e. approximately 15 minutes later experienced flushing of skin, full body burning, tingling, hives (no itch), appearance similar to sunburn. Resolved on its own 15 minutes later. No breathing problems or nausea. Asked to report these symptoms by local nurse. No therapeutic measures were taken as a result of reported events. The clinical outcome of flushing of skin, full body burning, tingling, hives (no itch), appearance similar to sunburn was recovered on 02May2021 at 11:30 i.e. after the duration of 15 mins.    No follow-up attempts are needed. No further information is expected
Febrile seizure about 10 hours after vaccines. He was crying uncomfortably after a nap 3 hours after the office visit. He did eat and went back to sleep. During his sleep 5 hours later, his mom heard him cry out and checked hom and he was having a seizure. 911 was called. He was taken to the local hospital. The seizure was short lived, and when checked the next day, he was normal.
Patient discovered redness and swelling at vaccine site/(L) arm/deltoid. Moderate in size surrounding site, irregular shape, 8 1/2 cm L x 7 cm W. Patient noticed approximately 21 hours after injection ("woke up next AM with itching).
This is a 74 year female with a PMH of rheumatoid arthritis ( immunocompromised), Non ischemic cardiomyopathy, LBBB, s/p Biv ICD implantation, HTN, dyslipidemia breast and uterine cancer the pt presented to the hospital with complaints weakness nausea and vomiting. The patient was at a wedding 12/18 it was after them that she began to feel sick. She took a COVID-19 test on the 20 second which was positive. The patient has been in contact with her rheumatologist who is been decreasing her meds to improve her immune status. However the patient has continued weakness in began to have dry heaves came into the hospital for further evaluation and treatment.  Patient had the Pfizer COVID Booster shot (dose #3) in September. Here in the ER she was assessed to be hypoxic 84% started on 4 L nasal cannula now saturating 95%. The patient is comfortable on nasal cannula. Respirations even and unlabored. Her labs are significant for elevated markers including D-dimer 515 and leukocytosis 14.3. Tropes was not assessed given the patient's cardiac will trend trops. CT of the chest was negative for pulmonary embolism, but noted ground-glass opacities bilaterally.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 04Apr2021 as dose 2, single (Lot number: ER8737) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3 (booster), single (Lot number: 012H21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: indication, treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected. Anti viral details [{product=COVID 19 Treatment, brand=Paxlovid, treatment start date=19Jul2022, indication=Treatment of COVID-19, administrator route=Oral. Covid vaccine details [{vaccine brand=Other, vaccine brand other=Moderna, vaccine brand unknown=False, vaccine administration date=03Dec2021, vaccine lot number=012H21A, vaccine lot unknown=False, vaccine dose number=3, vaccine dose number unknown=False, vaccine location=Left arm}, {vaccine brand=Pfizer / BioNTech, vaccine brand unknown=False, vaccine administration date=04Apr2021, vaccine lot number=ER8737, vaccine lot unknown=False, vaccine dose number=2, vaccine dose number unknown=False, vaccine location=Left arm}, {vaccine brand=Pfizer / BioNTech, vaccine brand unknown=False, vaccine administration date=11Mar2021, vaccine lot number=EN6208, vaccine lot unknown=False, vaccine dose number=1, vaccine dose number unknown=False, vaccine location=Left arm}] Adverse event: A bad taste in mouth. Adverse event start date: 19Jul2022. AE resulted in: [None of the above]. If patient recovered: Not recovered. If treatment AE: No. Known allergies: no. Other medical history: none.
extremely itchy rash all over her body from the neck down to her  feet; feels heat internally; received her second Shingrix vaccine on 2-20-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 2020 in unknown arm).   On 20-FEB-2023, the patient received the 2nd dose of Shingrix (unknown arm). On 20-FEB-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: received her second Shingrix vaccine on 2-20-2023). On an unknown date, the patient experienced itchy rash (Verbatim: extremely itchy rash all over her body from the neck down to her  feet) and feeling hot (Verbatim: feels heat internally). The outcome of the itchy rash was not resolved and the outcome of the feeling hot was not reported and the outcome of the inappropriate schedule of vaccine administered was unknown.   It was unknown if the reporter considered the itchy rash and feeling hot to be related to Shingrix.     It was unknown if the company considered the itchy rash and feeling hot to be related to Shingrix.   Additional Information: GSK receipt date 21 Jul 2023:  The reporter was niece of the patient. The patient was 82 years at the time of reporting.  The reporter stated her great aunt received her first Shingrix vaccine in April 2020, unknown arm.  Her great aunt received her second Shingrix vaccine and about 1 week after receiving the second Shingrix vaccine her great aunt developed an extremely itchy rash all over her body from the neck down to her feet. To date, the reporter stated that the rash seems to be getting worse with no relief from the itching. The patient had been to her doctor, a dermatologist, a rheumatologist and an allergist and no one knows what the rash was. The patient feels heat internally.  The reporter gave permission to contact both her primary doctor and her Dermatologist.  It was reported that rash was continue until 24 Jul 2023.  The patient received 2nd dose late than recommendation which led to drug dose interval too long.
210 pm 10/4: Decreased fever, chills, pain injection site. Fri AM 10/5: arm swollen red, painful injection site to wrist; unable to lift above head and could not wear wristwatch. Sat 10/6: Fever and chills gone, swelling decreasing, pruritus starts. Takes antihistamines. Tues 10/9: All sx gone, arm better.
This spontaneous report as received from a pharmacist refers to a 55 year old male patient with penicillin allergy, preexisting neck pain and Diabetes Type II. On 21-MAY-2017 the patient was vaccinated with PNEUMOVAX 23, intramuscular (lot# and expiration date not reported) for prophylaxis. On 28-MAY-2017 (reported a week later) after receiving PNEUMOVAX 23, the patient experienced tingling and weakness in the fingers of both extremities and has been unable to swim and visit the gym. The patient did visit his physician and no treatment had been given. The outcome of tingling and weakness in the fingers of both extremities was reported as not recovered. Tingling and weakness in the fingers of both extremities was considered disabling. Additional information has been requested.
Pt received both Fluzone and PPV23 the same day in the same arm.  The next day, patient ached all over, then 2 days after the shots had a temp of 100.3 and had redness and swelling of the mid upper arm.
Pt had febrile seizure day after receiving DTaP, IPV, MMR.
Extreme dehydration caused incapacitating leg cramps at calf, thigh, hamstring.  Has now occured four times.  May be interaction with h wine? Alcohol? Had wine with dinner 3 of the 4 times.  Have never experienced before. No dizziness or nausea.  Severe cramping happens in sleep or at night.
This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 05-JUN-2017, the patients were vaccinated with improperly stored doses of M-M-R II "rHA" (dose, frequency and route were not reported) lot # M045394 with expiration date of 14-NOV-2018 and lot # M040624 with expiration date of 03-OCT-2018, that were reconstituted with diluent MRK (injection; lot # and expiration date were not reported), for prophylaxis. The temperature of the M-M-R II was between 9°C and 25°C for a time frame of 2 hours and 2 minutes. No previous temperature excursion occurred and data logger was involved. No adverse effects were reported. This is one of four reports received from the same source.  Additional information has been requested. Sender's Comments: US-009507513-1706USA004409: US-009507513-1706USA006313: US-009507513-1706USA006314.