chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Abrupt onset of muscular/nerve twitching in lips, jaw tremors.  Acute symptoms lasted several hours. Now with significant sensory disruption to lips and jaw (tremors) with progression to arms and abdomen.  Saw PCP 3 times in the past 3 weeks, had MRI with contrast. Referred to Neurologist.  Neurologist observed weakened reflexes in left arm, diagnosed with ADEM in response to H1N1 nasal vaccine.   Symptoms currently progressing, not yet resolved.
Date the vial was initially stored in the refrigerator on25 Jan 2022/ Date of administration of vaccine 03 Mar 2022; Four patients received an expired 30-day use by date booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on25 Jan 2022/ Date of administration of vaccine 03 Mar 2022) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2022, the patient received third 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on25 Jan 2022/ Date of administration of vaccine 03 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Four patients received an expired 30-day use by date booster dose) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on25 Jan 2022/ Date of administration of vaccine 03 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided.  The vial was initially stored in the refrigerator on  25 Jan 2022. The vial did not undergo any temperature excursion. It was reported that the patients were not experiencing any symptoms after receiving the vaccine.   No treatment information was provided.   This case was linked to MOD-2022-503153, MOD-2022-503157, MOD-2022-503162 (Patient Link).
At the injection site, I have a very large (softball size) lump that is warm to the touch, swollen, itchy, and very sore.
In 1989, pt recvd 3 injects of Engerix-B uneventfully; On 13JAN92, pt recvd booster dose of vax on 14JAN92, the following evening pt exp nausea & devel diarrhea; 16JAN92 hospitalized x 2 days due to dehydration; tx meds;
Lightheaded immediately after receiving IM injection of Moderna vaccine in L deltoid. Resolved within 5 minutes. No loss of consciousness.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 08-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J004268 and expiry date 12-JUL-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his record didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot # was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
migraine headache; difficulty breathing / I was able to breath in but not out; nose bleeds; acute inflammation in entire body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 10:15 (Lot number: FF2590) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "genetic marker HLA-B27 positive" (unspecified if ongoing); "history of ankloysing spondinitis" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Past drug history included: Mesalamine, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3184, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 22Sep2021, when the patient was 47 years old, for Covid-19 immunization.  The following information was reported: MIGRAINE (hospitalization) with onset 23Oct2021, outcome "recovering", described as "migraine headache"; DYSPNOEA (hospitalization) with onset 23Oct2021, outcome "recovering", described as "difficulty breathing / I was able to breath in but not out"; EPISTAXIS (hospitalization) with onset 23Oct2021, outcome "recovering", described as "nose bleeds"; INFLAMMATION (hospitalization) with onset 23Oct2021, outcome "recovering", described as "acute inflammation in entire body". The patient was hospitalized for migraine, dyspnoea, epistaxis, inflammation (start date: 29Oct2021, discharge date: 03Nov2021, hospitalization duration: 5 day(s)). The events "migraine headache", "difficulty breathing / i was able to breath in but not out", "nose bleeds" and "acute inflammation in entire body" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: hla marker study: (unspecified date) positive; sars-cov-2 test: (30Oct2021) negative, notes: covid test type post vaccination=Blood test, covid test name post vaccination=Hospital did it. Therapeutic measures were taken as a result of migraine, dyspnoea, epistaxis, inflammation which included antibiotics.  Clinical course: Within 1 week after 2nd dose, she had migraine headache, difficulty breathing, nose bleeds. She was able to breath in but not out. Ended up in hospital 29Oct-03Nov with acute inflammation in entire body.  Follow-up attempts are completed. No further information is expected.
received third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacy intern reported that, a patient received the two dose series of Shingrix in the appropriate timeframe, then patient went to pharmacy and stated they were at the pharmacy to receive a 2nd dose. A dose was administered and then it was discovered to be the third dose.  After investigating, the patient received this third dose approximately one year after the second Shingrix dose, which led to extra dose administered. The reporter did not have patient details, exact dates administered, or vaccine lot number/expiration dates. The reporter did not consent to follow up.
day after immunization patient stated felt nausea joint acheness everything then tensed up  and caused shaking and jerkiness all over laste 3-5 minutes also had cold sweats and skin got hot!
Received injection on 9/10/2021. As of 9/14/2021- Injection site still sore and red, feeling painful nodes under same arm. Feeling dizzy.  Stomach ache ongoing. Nausea, Blood pressure higher than routine blood pressure.
Numbness in my legs and hands and arms; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0164), via an unspecified route of administration on 17Aug2021 at 10:00 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient stated that patient got second Pfizer vaccine today (17Aug2021) and patient guessed after 20 minutes (10:20) patient got the vaccine, patient had like numbness in the legs and hands and arms and patient just wanted to know if that was normal. The clinical outcome for the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
cankers under her tongue; above her left kneecap it looked like a mushroom hard in the middle water around it; On right leg there was a big red welt the size of her calf.; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A 63-year-old female patient received bnt162b2 (BNT162B2) (at 63 years of age), dose 1 via an unspecified route of administration on 08Mar2021 14:20 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history included allergic reaction now and then to sulphur based medicines. The patient's concomitant medications were not reported. The patient received 1st shot 0220 pm yesterday (08Mar2021), she came home and she was fine, she worked around the house, she took a shower and above her left knee cap it looks like there was another knee cap and it looks like in the shape of a mushroom it was hard in the middle, water around it. On her right leg there was a big red welt that was the size of her cap, she had canker under her tongue. She went to the hospital and the hospital gave her an Epipen. She was curious if she should receive her second shot. Therapeutic measures were taken as a result of the events with Epipen which was given to her as a precaution. The patient was hospitalized due to the events. The outcome of the events was unknown.  Information on the batch/lot number has been requested.
10 days after vaccination, the upper arm area around the injection site became inflamed with a red rash, swelling and itching. She treated it with Neosporin ointment, Aquaphor ointment and covered the area with a large Band Aid. It cleared up within a few days.
Twelve hours post vax, she developed generalized maculo-papular rash all over her body. Swollen extremities and swollen eyes.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: none" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL topical, start date: May2021, stop date: 26Aug2023; OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL], start date: Jan2020, stop date: 28Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: 2 negative tests on days 8 and 10; (2023) Negative, notes: 2 negative tests on days 8 and 10. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received: Paxlovid from 28Aug2023 to 02Sep2023 as treatment of COVID-19 and Patient had no known allergies.  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-202300296511 same patient, different drug/event;
This spontaneous report as received from a registered nurse refers to a 35 year old male patient. On 06-SEP-2013, the patient was vaccinated with PROQUAD, .5 ml, one dose subcutaneous (not number was not provided). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
swollen gland in my neck/swollen from the back, behind my earlobe about 3, 4 inches down; My neck was itching and get swollen; This is a spontaneous report from a contactable consumer (patient) reporting on herself. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 27Mar2021 (at the age of 69-years-old) as SINGLE DOSE for covid-19 immunization. Medical history was not reported. Concomitant medications included alprazolam (XANAX), omeprazole magnesium (PRILOSEC), denosumab (PROLIA) for bone every six months. It was reported that, in Mar2021 the patient had her first shot Saturday and last night in the middle of night it started, her neck was itching and get swollen, swollen gland in the neck. It happen 3 or 4 days after the shot. She also stated "It started right now and it's itching and it's swollen from the back, behind my earlobe about 3, 4 inches down. It really don't hurt but itches perfect. stated that "I don't think its feel good, it is swollen, it's kind of hard". The patient underwent lab tests and procedures which included blood count: normal. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Patient reported difficulty lifting arm where vaccine was administered. Also, soreness, and weak feeling in hand, shoulder and back of neck, and some numbness in her right hand. Symptoms got worse one week later when she got the typhoid vaccine (administered at another facility), but have since gotten better. (still feeling some soreness and weakness in arm).
EXTREME tiredness, couldn't keep eyes open by 7pm. Woke up with a terrible headache and slept the entire next day. Jittery, fast heartbeat, mild confusion/forgetfulness, feeling scattered, anxious and weepy all lasted into the 3rd day following the injection.
9:00 pm.  heart palpitations and pressure in midline.  Heart felt like it was beating out of my chest.  A little light headed.  Took antacids.  Lasted about 60 minutes.  Woke up around midnight with a painful muscle cramp down back of left leg.  lasted about 5 minutes.  woke the next morning and have felt fine since.
dvt        ER  despense blood thiner                 Left arm swelled  to twice  its size from shoulder to tinger tips.
Mobility decreased; rib pain; drug induced asthma; coughing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MOBILITY DECREASED (Mobility decreased), MUSCULOSKELETAL CHEST PAIN (rib pain), ASTHMA (drug induced asthma) and COUGH (coughing) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 008B212A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Asthma, Rheumatoid arthritis and Blood pressure high. Concomitant products included LOSARTAN for Blood pressure management, VITAMIN D NOS, CALCIUM, ASCORBIC ACID (VITAMIN C ACID) and IRON for Supplementation therapy.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 07-Mar-2021, the patient experienced MOBILITY DECREASED (Mobility decreased) (seriousness criterion medically significant), MUSCULOSKELETAL CHEST PAIN (rib pain) (seriousness criterion medically significant), ASTHMA (drug induced asthma) (seriousness criterion medically significant) and COUGH (coughing) (seriousness criterion medically significant). At the time of the report, MOBILITY DECREASED (Mobility decreased), MUSCULOSKELETAL CHEST PAIN (rib pain), ASTHMA (drug induced asthma) and COUGH (coughing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, Electrocardiogram: normal (normal) No complications. On 07-Mar-2021, SARS-CoV-2 test: negative for covid 19 infection (Negative) Negative for Covid 19 Infection.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 07 Mar 2021, the patient presented to the emergency room and was unspecified antibiotics and medications for asthma, cough, and pain.  Treatment medication included naproxen, albuterol, tessalon perle, codeine, guaifenesin, buspar, magnesium sulphate and prednisone.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Day 1 - fatigue and headache. Day 2 - SEVERE muscle and joint pain, muscle stiffness, migraine, nausea, dizziness.  Day 3 - SEVERE muscle and joint pain, muscle stiffness, migraine, nausea, dizziness, fever, sweating, chills.  Day 4 - Moderate muscle and joint pain, muscle stiffness, nausea, migraine, dizziness, sweating, chills. Day 5 Minimal muscle and joint pain, muscle stiffness, nausea, migraine, dizziness.  Day 5 I went to the urgent care because of continued nausea, migraine, and dizziness was preventing me from going to work for 3 days.  Before going to the urgent care,I tried taking ibuprofen, naproxen, and acetaminophin and nothing helped the pain.  My normal prescription migraine medication didn't help the migraine.
Patient had extreme vomiting, nausea, fever, fainting, redness, heat and swelling locally at the injection site.  Symptoms were described as extreme and lasted approximately 48 hours.
Chills, fatigue, hallucinations, shortness of breath, chest pain, and body aches
SWELLING OF ARM REDNESS/RED STRIPE ON ARM PAIN AT INJECTION SITE
This is a spontaneous report from a contactable pharmacist.  A 90-year-old female patient of an unspecified race received  PREVNAR 13 on 21Nov2016 at single dose for immunisation.   The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient previously took PENUMOVAX 23 for immunisation when she was 82 years old.   The patient was unable to move her feet/lower extremities since an unspecified date in Nov2016 with unknown outcome and could not feel her feet, lower legs on 22Nov2016 with outcome of recovering. The patient had never complained of her feet before. The reporter said it was difficult to differentiate between generalized pain and if the symptoms were paresthesia.
Supraclavicular lymph nodes inflammation (right side) It started 1 week after the shot and last a week more.
pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fractured ribs (3 cracked ribs on the left side). Concomitant products included LIDOCAINE for an unknown indication.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in the arm). At the time of the report, VACCINATION SITE PAIN (pain in the arm) outcome was unknown. Not Provided
Patient experienced erythema induration at injection site approximately 7cm in circumference, with induration/warmth/tenderness/anesthesia in area next day following injection. Improving after 48 hs. BENADRYL 5 mg.
Client is 13 years old and received a Pfizer Pediatric dose for COVID vaccine.  Client's father made aware of dose received.  Medical consult with county doctor, recommends not repeating dose based on client's weight and height.  Client's father made aware of dose and medical doctor's recommendation.
6-7 days of red rash on back, fever, drop in 02 saturation, headache, fatigue, body soreness, chills
9:00am - extreme headache 9:15am - high blood pressure 168/92, low heart rate 62 10am - extreme headache, dizzy, blurred vision, high blood pressure  2pm - fever 102.1  9pm- blood pressure normal 112/82
Administered ZOSTAVAX/shingles vaccine and realized after the fact that patient is on immunosuppressants. Patient had checked off "no" for having been on any. No side effects occurred as far as we know 8/19/16.