chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 30-Nov-2017, reported by a Pharmacist and concerns a 20-year-old female patient. Patient's medical history and concomitant medications were not reported. On 21-Nov-2017, the patient received FLUVIRIN (dose: 0.5ml, route of administration: intramuscular, anatomical location: not reported, batch number: 170104P, expiry date: May-2018). It was reported that, while administering the vaccine the most of it leaked onto the patient's arm. It was reported that, the patient was revaccinated, no leakage with second vaccination occurred. The patient had no adverse effects after administration of the vaccine. The reporter assessed the case as non-serious. Significant case correction received with IRD: 30-Nov-2017: The product expiry date changed from May-2018 to 31-May-2018. The event 'product leak' was changed to 'skin contact'.
This medically confirmed spontaneous report (initial receipt 21-OCT-2014) concerns a male patient. On 14-OCT-2014, the patient received AFLURIA (batch  number T52808) at 0.5 ml via intramuscular route in the right deltoid. On 14-OCT-2014, the patient experienced muscle tightness at the injection site. On 21-OCT-2014, the patient returned to the clinic due to muscle tightness. The reporter did not know what made the tightness better or worse. Outcome was reported as not yet recovered.
about 15-20 minutes after receiving the vaccine started experiencing  a ( mild) shortness of breath, chest tightness/pressure and dizziness and about 10 minutes after these symptoms started i got very cold and started shivering a lot ( had to use 3 blankets to warm myself up) and I wasn't running any fever, these symptoms lasted for about 3 hours or so
Ongoing chest flutter and tightness, spikes in blood pressure, lower extremities numb or disconnected feeling, erectile dysfunction.  Ongoing, no issues as described prior to vaccination.
A consumer report has been received. The report concerns a 5 year old, female consumer, who had been receiving FLUMIST. FLUMIST started on 15-Nov-2012. The patient experienced STOMACH PAINS, LOOSE STOOLS, NAUSEA, VOMITING and TIRED which started on 16-Nov-2012. The outcome of the event of STOMACH PAINS, LOOSE STOOLS, NAUSEA and TIRED is unknown. The report was considered to be non-serious by company physician.
redness, swelling, burning,  little heavyness in arm, but not quite numbness swelling is in all over upper arm (biceps, triceps, deltoid),and underarm
5/27/21 PMH of lap gastric bypass 2018, chronic back pain, DM, HTN presents with severe epigastric pain
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 31-JUL-2015, the patient was vaccinated with an improperly stored dose of (Wistar RA 27-3) M-M-R II 0.5ml (recombinant human albumin (rHA), lot # K018990, expiration date 15-OCT-2016, 0.5 ml, route was unspecified). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 152 hours with the highest recorded temperature of -14 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the highest recorded temperature of -12 Fahrenheit degree. The total cumulative excursion time of the third time was 88 hours with the highest recorded temperature of -13 Fahrenheit degree. The storage criteria for this vaccine was refrigerator (R)/Freezer (F). The type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received Moderna Vaccine on 3/9/21.  Sat for 15 minutes with no reactions.  Left to go to lunch and then returned to different pharmacy location and reported difficulty breathing.
Sore throat, headache, and fever (100.7) for first 3 days. Shifted into chest and lead into coughing 5/9, Feeling better overall so far.
Patient was administered third dose of vaccine by health department staff. contacted health department to administer vaccines to  new patients or those who only received one dose. When health department staff returned to agency to enter vaccines administered in Impact, it was noted that patient already received two doses administered on 1/14/21 and 2/12/21.
Numbness and tingling in bilateral arms. No previous neuropathies.   Chiropractic adjustments on 9/1/21, 9/2/21, 9/3/21, 9/1/21, 9/8/21, 9/9/21, 9/10/21, 9/13/21, 9/15/21, 9/17/21 all yielding no noticeable results.   11/4/21- Cervical Spine X-Rays normal  1/8/22- Neurology Assessment normal
SYNCOPE OCCURRED APPROXIMATELY 1-2 MINUTES FOLLOWING IMMUNIZATION. PATIENT WALKED A FEW FEET AND COLLAPSED. PATIENT APPEARED TO SHAKE BRIEFLY. SHE WAS ASSESSED IMMEDIATELY AND OBSERVED. APPEARED TO BE VASOVAGAL SYNCOPE. PATIENT WAS OBSERVED FOR 20 MINUTES FOLLOWING EPISODE AND NO OTHER SYMPTOMS OCCURRED.
Severe discomfort in left shoulder limiting movement began roughly 6 hours after injection and persisted for 48 before subsiding to minor discomfort. On Jan 28, 10 days after injection, left shoulder pain resurgence occurred, again severely limiting range of motion of the arm. After 20 hours pain is still persistent and severe
optic neuritis; This is a spontaneous report from a contactable physician. A 65-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. Medical history included lost vision in one eye on unspecified date, 20 years ago in the military. Concomitant medications were not reported. After 2 days, on 06Feb2021, the patient developed severe optic neuritis in one eye. Event was assessed as serious, medically significant. The patient is getting a fairly extensive workup. He was getting labs (unspecified) and will get 1 gram a day of Solumedrol for three days followed by oral Prednisone. He was going to get the typical. Outcome of the event was unknown.  Information on Lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
feel Terrible; head cold; Diarrhea; really bad pains in my back and joints; very tired; Nausea; feel fluish; very upset stomach; really bad pains in my back and joints/my back is really really sore, my Lower back; This is a spontaneous report from a contactable Other HCP(patient). A 71-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Right on 02Feb2021 at 13:00 (vaccinated at the age of 71 years) as DOSE 2, SINGLE for COVID-19 immunization. No known allergies. Other medical history included lymphoma, thyroid cancer, Afib. The patient's concomitant medications and past drug(s) were not reported. No prior COVID vaccination. No vaccine received in 4 weeks. Other unspecified medications received in 2 weeks. He was not tested COVID post vaccination. Previously Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in Arm Left on 12Jan2021 at 16:00 (vaccinated at the age of 71 years) as DOSE 1, SINGLE for COVID-19 immunization. After the second shot on 03Feb2021 (next Morning) at 10:00AM, he started to feel fluish. Then he started to have a very upset stomach, diarrhea, really bad pains in his back and joints and by day five(08Feb2021), he felt terrible. He felt like he had a head cold and his back was really really sore, specifically his lower back. Nausea and diarrhea continued and he was very tired. No treatment received. On 07Feb2021, Covid test type post vaccination was nasal swab and Covid test result was negative. The outcome of all events was not recovered.  Information regarding batch and lot number requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 05-MAY-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Information has been received from a physician concerning a 54 year old male patient who on 09-MAR-2011 was vaccinated with a dose of PNEUMOVAX 23 (lot # 669372/1822Z, Exp. 05-AUG-2012). Four hours after vaccination the patient had a fever (100.5 F) along with myalgia and arthralgias. On 10-MAR-2011, the patient was at the emergency room but the physician stated that the patient would not be admitted to the hospital. At the time of the reporting,  the patient had not recovered from fever (100.5 F), myalgias and arthralgias. Additional information has been requested.
broken ankle; not able to work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: ANKLE FRACTURE (medically significant), outcome "unknown", described as "broken ankle"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant), outcome "unknown", described as "not able to work".  Clinical course: The patient got vaccinated and a booster. The patient has been having medical issues, from a broken ankle and not able to work.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to an patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. ON 29-APR-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (dose, route of administration were not provided) lot # K006960, expiration date 19-FEB-2017. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a licensed practical nurse concerning an 81 year old female who was vaccinated with a dose of Pneumococcal 23v polysaccharide vaccine (lot 650331/0749P). On approx 9/27/05 the pt experienced swelling, tenderness, and redness at the injection site. The pt was treated warm compresses and antihistamines. The symptoms resolved. The outcome was reported as recovered. No further information was available. There was no product quality complaint. Additional information has been requested.
Shortness of breath; racing heartbeat; feeling over heated; elevated blood sugar; This is a spontaneous report from a contactable other health care professional (patient). A 52-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9267), via an intramuscular route of administration, administered in arm right on 11Feb2021 13:30 (age at vaccination 52-years) as single doe for COVID-19 immunization. Medical history included a reaction to epinephrine, even a tiny amount results, causing feeling overheated, racing heart back, slight difficulty breathing, and elevated blood sugar. Concomitant medication included lispro insulin vial taken for an unspecified indication, start and stop date were not reported. The patient was not had COVID prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccine within four weeks. On 11Feb2021 01:30, the patient experienced shortness of breath, racing heartbeat, feeling over heated, elevated blood sugar and it was lasted about 30-45 minutes. The treatment was received for the adverse events and reported that needed to take additional insulin. The patient underwent lab tests and procedures which included blood test: elevated, heart rate: racing on an unspecified date. The vaccination facility type was reported as hospital. The clinical outcome of the events was reported as recovered on an unspecified date in 2021.
4th full dose of 0.5 mL given to patient; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (4th full dose of 0.5 mL given to patient) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient is actively receiving cancer treatment.) and Immunocompromised. Concomitant products included TRAMETINIB DIMETHYL SULFOXIDE (MEKINIST) for Cancer (NOS).   On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 01-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (4th full dose of 0.5 mL given to patient). On 01-Feb-2022, ACCIDENTAL OVERDOSE (4th full dose of 0.5 mL given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.
Symptoms: Light headedness, heart racing (however HR remained under 100 bmp per wrist monitor), facial tingling.   Treatment:  Drank small bottle of water that was provided from staff and remained in facility a little longer.   Outcomes: symptoms improved  Additional info: drank 16 oz of water once I got to my vehicle and facial tingling came back, along with slight headache and fatigue within the first hour. Drank more water, slept 2 hours and all symptoms resolved.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 31-DEC-2014, the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiry date 09-APR-2016 (dose and route of administratoin unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a consumer concerning her currently 24 year old daughter who in approximately 2007 was vaccinated with series of GARDASIL (lot#, route and site of administration not reported). It was reported that the patient had been diagnosed with cervical dysplasia. The patient had not had multiple sex partners and had had yearly Pap smears. The consumer was wondering if cervical dysplasia was related to GARDASIL. At the time of this report, the patient's outcome was unknown. No further information is available.
This case was reported by a nurse via sales rep and described the occurrence of tremor in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received in September 2018, see case US2019GSK002329). On 14th December 2018, the patient received the 2nd dose of SHINGRIX. In December 2018, less than a month after receiving SHINGRIX, the patient experienced tremor, shivering, malaise and nocturnal awakening. The patient was treated with ibuprofen and TYLENOL. On an unknown date, the outcome of the tremor, shivering and nocturnal awakening were unknown and the outcome of the malaise was recovered/resolved. It was unknown if the reporter considered the tremor, shivering, malaise and nocturnal awakening to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient was over 50 years old. The patient with the dose of SHINGRIX, awoke in the night, shaking or shivering, continued malaise that lasted about 24 hours. The patient took ibuprofen or TYLENOL and started feeling better within about 24 hours. The reporter agreed to be followed up from GlaxoSmithKline.
The pain got worse by Tuesday with increased backache; stomach pain; stomach gurgling; the worse case of acid indigestion you have ever had in your life; Joint aches; Arm was a little sore; Felt very cold; Backache/Her back pain feels like she had whiplash; Intestinal pain; Headache/woken up in the night with headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore), NASOPHARYNGITIS (Felt very cold), BACK PAIN (Backache/Her back pain feels like she had whiplash), CONDITION AGGRAVATED (The pain got worse by Tuesday with increased backache) and GASTROINTESTINAL PAIN (Intestinal pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 029L20A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced NASOPHARYNGITIS (Felt very cold) and HEADACHE (Headache/woken up in the night with headache). December 2021, the patient experienced BACK PAIN (Backache/Her back pain feels like she had whiplash) and GASTROINTESTINAL PAIN (Intestinal pain). On 27-Dec-2021, the patient experienced PAIN IN EXTREMITY (Arm was a little sore). On 28-Dec-2021, the patient experienced CONDITION AGGRAVATED (The pain got worse by Tuesday with increased backache), ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISCOMFORT (stomach gurgling), DYSPEPSIA (the worse case of acid indigestion you have ever had in your life) and ARTHRALGIA (Joint aches). The patient was treated with FAMOTIDINE (PEPCID AC) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at a dose of Tylenol 500. At the time of the report, PAIN IN EXTREMITY (Arm was a little sore), NASOPHARYNGITIS (Felt very cold), BACK PAIN (Backache/Her back pain feels like she had whiplash), CONDITION AGGRAVATED (The pain got worse by Tuesday with increased backache), GASTROINTESTINAL PAIN (Intestinal pain), ABDOMINAL PAIN UPPER (stomach pain), ABDOMINAL DISCOMFORT (stomach gurgling), DYSPEPSIA (the worse case of acid indigestion you have ever had in your life), HEADACHE (Headache/woken up in the night with headache) and ARTHRALGIA (Joint aches) outcome was unknown.            Concomitant medication list was not provided. It was reported that her arm was a little sore and she exercised her arm. The patient also reported that she did not have any prior stomach issues. She drank a lot of water, drank herbal tea, and had eaten a half piece of toast.   This case was linked to MOD-2021-433634, MOD-2021-433404 (Patient Link).
This spontaneous report was received from a physician concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was inadvertently vaccinated with a dose of VARIVAX as prophylaxis (Strength, dose, route, lot # and expiration date were not reported) and a dose of sterile diluent(manufacturer unknown) (Strength, dose, indication, route, lot # and expiration date were not reported) instead of a dose of ZOSTAVAX. The physician stated that it was not in his office practice site. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1705USA000380:
no adverse event; an expired dose of ROTATEQ was administered to a patient; the vaccine was also potentially part of a temperature excursion; This spontaneous report was received from the other health professional referring to a male patient of unknown age. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided.  On an unknown date, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally for prophylaxis (strength, vaccination scheme frequency, dose, lot number and expiration date were not reported).  On 21-JUL-2022, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1742080, expiration date: 14-JUL-2022, administered orally for prophylaxis (strength, vaccination scheme frequency and dose were not reported) (expired product administered) after a temperature excursion (temperature: 67 Fahrenheit (F); time frame: 4 hours and 15 minutes, date of excursion: 06-MAR-2022) (product storage error). No additional adverse event was reported (no adverse event).
No adverse effect; Improper storage conditions during shipping; This spontaneous report was received from a nurse refers to a 67 year old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported.  On 16-SEP-2019, the product was received and stored appropriately in the refrigerator. On 17-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection of lot # S012246 with expiry date 10-FEB-2021 (strength, dose, frequency, route of administration, date unspecified) for prophylaxis, which was deemed by the wholesaler to have been shipped outside of appropriate shipping temperature conditions (product storage error). The office was notified on 18-SEP-2019 about the improper temperature conditions during shipping. No adverse effects reported (no adverse event). There was no previous temperature excursion reported. Digital data logger was not involved. The outcome of the event was unknown.  This is one of two reports received from the same reporter.
Baby came in with fever, new ear infection, a couple of dots on body but also a 5cm cluster of red macules surrounding Prevnar injection site.
Patient is 16 years old and received Moderna vaccine.  Parent received EUA and consented.  No adverse reaction to vaccine.