chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs; Expired Sterile Diluent was administered on 12/21/2022; Expired Sterile Diluent was administered on 12/21/2022; This spontaneous report has been received from a pharmacist, concerning a 27-year-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies, and historical drugs were not reported.  On 21-DEC-2022, the patient received an expired sterile diluent (MERCK STERILE DILUENT) (lot number T014588 was verified to be valid for sterile diluent [MERCK STERILE DILUENT], expiration date reported and confirmed as 25-NOV-2022) (Expired product administered), and also received varicella virus vaccine live (oka/merck) (VARIVAX) (not expired and stored properly) (doses and routes of administration were not provided) (Product preparation error).  No additional adverse events (AEs) were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA008375:
fever; muscle pain; upset stomach; This case was reported by a consumer via sales rep and described the occurrence of fever in a 55-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th May 2019, the patient received Shingles vaccine. In May 2019, less than a day after receiving Shingles vaccine, the patient experienced fever, muscle pain and upset stomach. On an unknown date, the outcome of the fever, muscle pain and upset stomach were unknown.   It was unknown if the reporter considered the fever, muscle pain and upset stomach to be related to Shingles vaccine.  Additional details were reported as follows: The patient was a service connected veteran. The age at vaccination was not reported. The patient got the shingles shot the day before reporting and woke up in the middle of the night with bad muscle pain and felt like had a fever. The patient expected arm to be painful but the pain in muscles was tough and was asking was it normal. The patient had an upset stomach as well.
Chills; Fever of 101; Nausea; Extreme thrist; heart rate increased to 80bpm; Headache; Injection site soreness; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), VACCINATION SITE PAIN (Injection site soreness), CHILLS (Chills), PYREXIA (Fever of 101) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029KZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Injection site soreness). On 21-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever of 101), NAUSEA (Nausea), THIRST (Extreme thrist) and HEART RATE INCREASED (heart rate increased to 80bpm). At the time of the report, HEADACHE (Headache), VACCINATION SITE PAIN (Injection site soreness), CHILLS (Chills), PYREXIA (Fever of 101), NAUSEA (Nausea), THIRST (Extreme thrist) and HEART RATE INCREASED (heart rate increased to 80bpm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information - Medication to slow her heart rate No treatment information provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TUSSIN CF, start date: Jul2022, stop date: Jul2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Muscle ache and tenderness; Joint pain; I even ran a low fever like a 100.5; Chills; This is a spontaneous report from a contactable consumer reporting for himself. A 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) on 14Jan2021 10:00 at single dose intramuscularly in right arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient started experiencing muscle ache and joint pain around 21:00 or 22:00 on 14Jan2021 and then he ran a low fever like a 100.5, and had chills pretty much all throughout the night. The patient noticed that those are common side effects but he had main concern on his work that he was unsure if he was okay to work on 15Jan2021. The chills and fever were gone on 15Jan2021 but he still had the muscle ache and tenderness. He stated that on 15Jan2021 the muscle ache and joint pain was about the same, it'd gotten a little better compared to what it was throughout the night, mild. The patient took two ibuprofen (ADVIL). The patient was recovering from the muscle ache and joint pain. The events low fever, chills were resolved on 15Jan2021.  Information on the lot/batch number has been requested.
My mother had a seizure on February 15th after recieving the moderna vaccine on February 11th within four days of the vaccine.  Doctors at hospital. Staff cannot answer what caused the seizure though they found a 4mm bleed on her brain; believed unrelated to seizure; on an MRI.  My mother has never had a seizure and noone in my family have had seizures.  I don't know if it's related to the vaccine but felt it should be reported to you.
all joints the next morning after getting the 2nd shot were really hurting, aching feeling, low grade fever most of the day, chills generally felt really bad and couldn't do much.  The next day there was a red rash on my arm near the  injection area, It lasted about 3 days and arm was very sore.
No additional AE details available; A 15-year-old female patient received only 1 dose of GARDASIL 9 in 2018. It is unknown why the series wasn't completed however, reporter mentioned the family may have "forgotten about" completing the series.; Information has been received from a medical assistant referring to a 15-year-old female patient. The patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided.  On an unknown date in 2018, the patient received only 1 dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, route, lot#, and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). It is unknown why the series wasn't completed, however, reporter mentioned the family might have "forgotten about" completing the series. The reporter would like to know if HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) series could be restarted. No additional adverse event details available (No adverse event).
Fever up to 102.4 (confirmed in the clinic 3/12/10 @ Physical Exam) and 104 (at home, as per mom) was unremarkable except for fever.
Injection site reaction - arm is still extremely tender 6 weeks post vaccine.  Pain is sharp.
Left arm pain with restricted range of motion. Immediate onset, worsened over 3 days and then improved. Still slightly symptomatic.
Chest pain; A regulatory authority report was received from a healthcare provider concerning a 49 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain.  The patient's medical history included allergies to tetracyclines and Wellbutrin, bipolar disorder, and hypothyroidism. Products known to have been used by the patient, within two weeks prior to the event, included trazodone, lamotrigine, celecoxib, buspirone hydrochloride, levothyroxine, and cariprazine hydrochloride.  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient developed chest pain 5-10 minutes after the first dose. The patient was hospitalized. Lab data included chest X-ray, electrocardiogram and troponin- all normal. No treatment information was provided.  Action taken with the drug in response to the event was not provided.  The outcome of the event, chest pain, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
On 10/7/2014, he received his annual Influenza vaccination with FLUMIST. He denied any problems for the next two days. Approximately 48-72 hours after vaccination (day 2-3) he noticed a 1x2 inch pimply like flat rash under his left chest wall/breast area that itched. He is dark skinned so he was unsure if red or not. He denied any papules, vesicles or oozing from the site, no fever, myalgia, arthralgia, headaches, runny nose or any other systemic symptoms. He reported no trauma, new clothing, detergents, deodorants, lotions, creams, does not shave chest hair or used/exposed to any new foods or environmental exposures. He reported over next few days this itchy rash spread in patches to right side of chest, onto his back under right scapula, and onto right antecubital. He denied this rash spreading to his hands, feet or lower torso below waist or legs. He reported he was self-treating with topical coconut oil. He reported one provider thought he had PFB on his neck. He presented to medical on 10/21/2014 where provider documented skin eruption to his upper chest, back and abdomen as some flesh colored papules with no pustules or vesicles. He was diagnosed with "skin symptoms" and prescribed Triamcinolone and Cetirizine HCL and referred to Allergy clinic. Allergy clinic referred to IHB for further evaluation.
impacted stool; Impacted bowel movement; She actually tore and was bleeding really bad; exhausted; she had arrhythmia episode; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 76-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date: 30Jun2021), via an unspecified route of administration, in Arm Left, on 09Mar2021 at 01:30 PM, as a single dose for COVID-19 immunization, at hospital and administered by a Nurse. Patient's medical history was not reported. Concomitant medications included rosuvastatin calcium, at 10 mg, 3x/day, (three days a week) and then at 5 mg, 4x/day, (5 mg four days a week); levothyroxine (50 ug) for Thyroid disorder and amlodipine besylate (2.5 mg) and had been taking fiber and probiotics. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Lot number; EN5318, expiry date; 31May2021, Received in right arm) for COVID-19 immunization; Had no problem with first COVID-19 Vaccine. No pain at site, nothing. Patient stated that she had arrhythmia episode and that was unusual for me; Since then I have had four more episodes in Mar2021. Patient stated that her second dose of the vaccine at 1:30 pm. The same day at 10 pm, she experienced an impacted stool. She stated that she was on the toilet from 10 pm-12:15. She wanted to know if this is a reported side effect of the vaccine. After receiving second dose, patient stayed 30 minutes and felt fine. At 10 PM felt that need to go to the bathroom, which she thought was odd. More than two hours she tried to pass a BM. It was so impacted she could feel it all around her anus. Was ready to go to the hospital. Didn't know what to do. Waited and waited sitting on the toilet. Was trying to see if she could dig anything out and it was non-productive. At 12:15 AM bowel movement finally left. It was 13 inches long and 3 inches around. She actually tore and was bleeding really bad. She usually drinks a lot of water, but was not able to the day of the second COVID-19 Vaccine. It was stated that total time of bowel movement impaction was two hours and 15minutes (Began 10PM on 09Mar2021 and passed at 12:15AM on 10Mar2021). She was not supposed to push with bowel movement impactions. Patient was told by Doctor, patient could get a heart attack or stroke from pushing impacted bowel movements. Patient was so exhausted and a very bad experience. No further details provided. Had a lot of vaccinations over the time due to living in Honduras for 2 years and traveling in Brazil. No further details provided. Scheduled mammogram fourth months from second dose. Patient did not receive other vaccines within 4 weeks or prior vaccination. She had a colonoscopy 6-8 months before the vaccine and had been taking fiber and probiotics. Outcome of the events impacted stool and Impacted bowel movement was recovered on 10Mar2021; for all other events it was unknown.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a pharmacist refers to an approximately 84 years old male patient. Pertinent medical history was unspecified by the reporter. On 16-OCT-2014 at 14:27, the patient was vaccinated with an expired dose of ZOSTAVAX (Strength, dose unknown, lot # J007858, expiry date 28-SEP-2014) dose 1, intramuscular. Patient was not taking any concomitant medications. No relevant lab tests were performed. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Coughing and wheezing hours later sore throat & cough next day with red/sore eyes.  (self reported - did not seek care).
No treatment required. Pt had severe swelling (as described by pt: from elbow to shoulder) and soreness for 4 days.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with ZOSTER (Oka/Merck).  Within 24 hours of vaccination, the patient experienced varicella like rash.  Subsequently, the patient recovered from varicella like rash.  The patient called the physician.   Additional information has been requested.
p/vax pt exp nausea & vomiting; fever 101-102; mild ataxia
Muscle cramps; Muscle pain; fatigue; dehydration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 (Lot number: ER8733) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism", start date: 2005 (unspecified if ongoing). Concomitant medication(s) included: SHINGRIX, start date: Mar2021.  The following information was reported: MUSCLE SPASMS (non-serious) with onset Apr2021, outcome "unknown", described as "Muscle cramps"; MYALGIA (non-serious) with onset Apr2021, outcome "unknown", described as "Muscle pain"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "fatigue"; DEHYDRATION (non-serious) with onset Apr2021, outcome "unknown", described as "dehydration". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported as first dose was mild, though she did get weird muscle cramps that were a different kind, they were not usual ones like flu, they were more like the kind with dehydration. She says actually she had the muscle cramps both times, even though she was drinking a lot of water, and weird muscle pains and fatigue. Patient had Shingrix vaccination during the four weeks of first dose of the Pfizer COVID-19 vaccine. She says that they had said wait two weeks after she had Shingrix, so she got that 15 days ahead of the first Pfizer COVID-19 vaccine dose. Patient had difficulty remembering when she was diagnosed with hypothyroidism and says something about mental that she does not clarify. Body temperature was 101 Fahrenheit on 24Apr2021, 100.5 Fahrenheit on 26Apr2021 and 100.1 Fahrenheit on 27Apr2021.  No follow-up attempts are possible. No further information is expected.
When processing paperwork, patients insurance rejecting saying won't pay for moderna, that patient got pfizer and they will only pay for pfizer as a second dose. Patient stated he hadn't had any immunizations in last 4 weeks. Pulled up vaccine database and there is not data showing he has gotten anything. Calling patient and only getting voicemail
Continue to have persistent bleeding while on birth control after receiving the booster shot of Moderna (no history of similar breakthrough bleeding while on birth control before), now with menorrhagia after stopping birth control
It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every four hours was prescribed. The symptoms resolved on 11/9/99. No additional information was provided from follow-up correspondence returned on 12/6/99.
Awoke with mild headache and neck ache, but at first thought I slept wrong.  Headache grew thru am, however.  By 12:30 pm, it was quite uncomfortable after trying to just ice and nap, which I couldn't sleep due to increasing headache.  So, at 12:30, when the pain was from my neck, up the occiput to behind my right eye, I took Motrin 600mg for good relief.  When the Motrin wore off last evening, I felt fine and mentioned that to my mom who is here visiting.  This morning only the slightest of headache that I will not take Motrin for, however I may ice.
Administered MMR at 9:00am in the Employee Health Office.  No adverse reaction noted upon discharge.  Call from volunteer at 10:30 am stating her throat felt "tingly" and her tongue felt "heavy".  Instructed to call 911 for assistance. According to volunteer, rescue arrived (not sure of time) and they administered Benadryl.  She states she felt better after that dose.
Condition unspecified - Information has been received from a physician concerning six patients who on 21 Sep 2000 were vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 533814/0990k.  subsequently, the patients experienced non severe, unspecified adverse events.  Unspecified medial attention was sought.  Another patient was reported with fever and congestion following vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation weas# 00100661.  In follow up the physician reported she no longer had the records of these patients and could not recall the patients names or the reactions in detail.  She stated, I was just reporting an increase frequency of issues with one lot of vaccine last year and do not have more details.  In follow up the records of testing prior to release of this lot have been check by biological quality assurance and found to be satisfactory.  The lot complies with the standards of the center for biologics evaluation and research and was released.  No further information is available.
GUILLAIN-BARRE DISEASE; This spontaneous report received from a consumer from social media via company representative concerned a 34 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced guillain-barre disease, and paralyzed from the waist down for a year. It was reported as, "I have a 34 yr healthy old friend. He got J & J shot. Within 2 days got Guillain-Barre disease and paralyzed from waste down for a year. Finally now walking again. These shots are experimental". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from guillain-barre disease. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220224976- covid-19 vaccine ad26.cov2.s-guillain-barre disease.This event(s) is labeled per regulatory authority and is therefore considered potentially related.
Developed pain in right side upper back when breathing, sore throat. Contacted 24 hr. RN Line and was told these are just side effects and should go away within 2-3 days. Was also told to contact the 24 hr RN Line for my PCP, and was told the same. When attempting to lay down in bed, the pain was pretty extreme I would say at times. Add to the fact that I'm on a BiPap Machine, so breathing was painful for easily 5-10 minutes before that calmed down enough for me to try to get to sleep.
paralized from his toes all the way up to his waist; Could not move a muscle; can't feel  pain/can't feel temperature; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis legs in a 16-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced paralysis legs (serious criteria GSK medically significant), paralysis voluntary muscle (serious criteria GSK medically significant) and loss of sensation. On an unknown date, the outcome of the paralysis legs, paralysis voluntary muscle and loss of sensation were not recovered/not resolved.   It was unknown if the reporter considered the paralysis legs, paralysis voluntary muscle and loss of sensation to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient had a sever reaction to the vaccine. He was paralized from his toes all the way up to his waist. The patient could not move a muscle.  The reporter states it was a miracle from God that he didn't die.  At 16 years of age, the patient had to relearn how to move his toes, one at a time and then to walk and run again. The patient still could not feel temperature or pain from waist down.
Pt walked in complained of body ache, feverish at the night after vaccination of PREVNAR 13. Temperature 101.5 degrees F. Improved since 7/9/15, but still complained of right UE swelling and redness on 7/14/2015 visit.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. No relevant medical history or concurrent conditions were reported. On an unknown date, the patient received only a partial dose for the third shot (dose and route not reported) in his HPV vaccine series because the syringe was leaking during administration (underdose, product quality issue). The nurse who administered the shot was able to give the patient "a little less than half" of the full dose amount due to the leakage. The reporter did not specify whether the leaking dose was Gardasil or Gardasil 9. However, the lot number was provided as L025737 with expiration date as 28-JUL-2017, which was valid for GARDASIL 9. No adverse effects were reported. Additional information has been requested.