chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 2 to 3 minutes after the vaccine was given the patient's body, head, arms, hands, legs and feet begin to bow and draw. Eyes were rolled back and body felt clammy. Two RNs gently began to lower patient to the floor. Approximately 10 to 15 seconds after lowering patient to the floor she sit straight up and ask what happened. Crash crat had been retrieved and vitals checked, patient's O2 was 99, pulse was 56 and BP was 99/62. Patient was alert, aware of where she was and why. Patient stated she only felt dizzy before the incident and at this time was just shaky. She stated she had not eaten or drank anything all morning prior to the visit and vaccine administration. Patient was given something to drink and was sipping slowly. She stated she felt better. Patient was monitored for approximately 40 minutes. Patient's brother and stepmother was with her. Advised stepmother to take the patient to a doctor for further evaluation for precaution.  Stepmother stated she was informed by family member to take the patient to Hospital ER, she was going to do so. Patient walked out of the building without any assistants or further incident.
This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 22Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had some concern because he/she had some side effects from Pfizer shot and wanted to know if have they all heard about any of these side effects. The patient was having side effects from the Pfizer shot and wanted to talk to somebody about the side effects. Asked if anybody have reported the side effects yet. (Vaccine name not clarified, hence suspect captured as Unspecified Shot and is this a Pfizer product tab left checked-Yes). On Monday, the patient was supposed to get that second shot but couldn't get it because he/she have got cellulitis in the arm from the shot (vaccination site location unspecified). The patient had been having anxiety effects from the shot. The patient stated 'I have been having' (word not clear). The patient had been feeling like he/she was about to die. 'I feel like' (voice not clear)." Patient further stated, "I am having shakes, I am having anxiety. 'I feel like not talking' (not clear). How long people have been reported, do people have reported side effects after two weeks of the shot. My body is having reaction to your shot and I am trying to figure out what should I do?", she stated. The outcome of the events was unknown. Information on the lot/batch number has been requested.
cellulitis @ inj site 3x3cm erythema/induration systemic sx fever, myalgias, sore throat & h/a;sx resolved 48hr p/vax;
broke out in red rash, individual, looking like pus underneath; then break & spread till area all red; no fever; was seen by MD of hosp put on Pred;
Information has been received from a medical assistant referring to 26 unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M010440, expiration date:09-DEC-2018, dose and route were unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed red rash, approximately 3 inches round, on the morning of 3/15/21.  Also had mild headache for 5 days post vaccination.
Within 8 hrs of receiving vaccine, she reports pain and edema radiating from (L) upper arm (inj. site) to neck and jaw (L) and (L) eyelid and (L) lip edema.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received KINRIX for prophylaxis. On 5th September 2018, the patient received KINRIX. On 5th September 2018, unknown after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The 2 month old patient inadvertently received a dose of KINRIX, which led to inappropriate age at vaccine administration.
I had the acute ischemic stroke on 11/25/2022 and treated in the ER. I have been suffering  left side body deficit from the stroke. I have been treated at hospital,
Chest pain, elevated Systolic pressure, tachycardia  Hospitalized, hospital reports dx of NSTEMI
soreness, redness in area of infection, approx 60mm stiff on entire lt side of body, neck down to legs & feet; c/o sharp pain radiating fr lt side of neck to head; lt arm swelling fr humerus to lt hand;
This spontaneous report as received from a pharmacist refers to a 70 years old patient (of an unknown gender) who on 15-OCT-2012 was vaccinated with ZOSTAVAX injection vial, 1 standard dose subcutaneous for shingles prevention. In October 2012 3-5 days later the patient experienced mild rash approximately 5-6 inches surrounding the ZOSTAVAX injection site. It was not specified if the patient sought medical attention. The outcome of mild rash approximately 5-6 inches surrounding at the injection site was reported as recovered on an unspecified date. Additional information is not expected.
flu; Initial information was received on 09-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves a patient with an unspecified demography who got flu (influenza), when received INFLUENZA VACCINE [Flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  It was reported that, patient got flu every time she took shot.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
18AUG92 pt recvd 1st dose of vax & 20AUG92 devel numbness on the rt side of face spreadin to arm & leg, h/a & difficulty w/thought & speech processes; no tx was given;
Extreme pain in shoulder immediately following the injection. Limited mobility, dull aching for weeks, inability to lift light objects, inability to use arm to full capacity. I was recommended and administered treatment of Motrin as needed, a steroid injection (in the hip), oral steroids, naproxen prescription (upon follow-up visit when there was no improvement). Referred to orthopedic doctor and they have now ordered an MRI.
Approximately 12 hours after receiving injections patient developed localized reaction 4 inches of redness, swelling, and itching
4 pts recvd 3 doses of Engerix-B- 2 pts JUN92, 2 pts JUL92 had neg titer; non responder;
Information has been received from an office manager related to a female patient in her 60's who was vaccinated with a dose of Zostavax (Oka/Merck) (reported as " vial"/single dose).  Subsequently the patient developed a fever, redness in the injection site that looked like sunburn and swelling on the injection site after receiving Zostavax (Oka/Merck). Lot number was not available.  Subsequently, the patient recovered from fever, redness in the injection site that looked like sunburn and swelling on the injection site.  There was no product quality complaint.  The patient sought unspecified medical attention.  Additional information has been requested. 06/24/2008 This is in follow-up to report(s) previously submitted on 3/26/2008. Additional information has been received from the physician. This 64 year old female was vaccinated in the left arm at 09:00 on 26-MAR-2008 with a first dose of ZOSTAVAX (Oka/Merck). There was no illness at the time of vaccination. At 09:00 on 27-MAR-2008 the patient developed redness, swelling and a rash at the injection site. On 28-MAR-2008 the patient developed a rash around her neck. Medical attention was sought via a doctor visit. On an unspecified date the patient recovered. Additional information is not expected.
Within 3 hrs of vaccine pt felt lethargic, disoriented, difficulty with balance, twitching and shooting pain in feet bilat. Pt also c/o "grasping for words" difficulty articulating as normal. Pt had similar symptoms with 1st vaccine but milder lasting 2 days. Pt tx with BENADRYL 25mg po BID.
have neurologic distress in the right eye, he can see but cannot blink or wink, and all the muscles from his eyebrow, side temple, and cheek portion are in neurological distress; he could maintain his eye open halfway; This is a spontaneous report from a Contactable consumer via medical information team.  A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot: not reported), via unspecified route of administration on unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications not reported. patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot: not reported), via unspecified route of administration on unspecified date as a dose 1, single for COVID-19 immunization. It was reported that patient received both doses of the Pfizer Covid-19 vaccine of the Pfizer Covid-19 vaccine and within 30 days after the second dose started to have neurologic distress in the right eye, he can see but cannot blink or wink, and all the muscles from his eyebrow, side temple, and cheek portion are in neurological distress on an unspecified date. Reporter stated that eventually as it started to wear off, he could maintain his eye open halfway on an unspecified date. Stated that his health care professional (HCP) referred him to a neurologist and had a brain scan, MRI of chest, and pulmonary exam performed and all were normal. Reporter stated that the only way to keep his eye open was his HCP prescribed him tyridostigmine bromide 60 MG TABS twice a day to keep eye open. Reporter queried for if anyone else has reported the same above complaints as her employer with the Pfizer Covid-19 vaccine. Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. Outcome of events was unknown.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Fluzone given 10/09-arm red, swollen, painful (right arm).  Lasted 3 days, stand day after injection (given in right arm)-arm swollen from shoulder to elbow and red.  Had large induration-grapefruit size.
4th dose administered; 3rd dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose was received on 18th November 2019) and Shingrix (second dose was received on 14th January 2020).   On 15-FEB-2023, the patient received the 4th dose of Shingrix. On 07-DEC-2022, the patient received the 3rd dose of Shingrix. On 07-DEC-2022, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered). On 15-FEB-2023, the patient experienced extra dose administered (Verbatim: 4th dose administered). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 03-APR-2023 The reported stated that the patient received 4 doses of Shingrix doses on 4 separate occasions. They were unable to find further information on this incident.  The reporter asked for the more information on what to do in this situation like what kind of reaction or harm should patient expect in the future. The reporter consented to follow up. This was all the information provided. The patient was administered an 3rd and 4th dose of Shingrix, which led to extra dose administered.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed low grade fever, respiratory symptoms, chickenpox that consisted of 30-50 lesions and characterized by itchiness.  It was noted he the pt was exposed to chickenpox two weeks prior to the onset of this episode.
Vaccination site pain; Heartbeat felt a little bit faster now feels fine; Slight headache; Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heartbeat felt a little bit faster now feels fine), HEADACHE (Slight headache), FATIGUE (Tired) and VACCINATION SITE PAIN (Vaccination site pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Endometrial cancer. Concurrent medical conditions included Plant skin sensitivity (Denies allergies but Paclitaxel caused tachycardia to patient and was told it was plant based.). Concomitant products included VITAMIN D NOS for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced HEART RATE INCREASED (Heartbeat felt a little bit faster now feels fine), HEADACHE (Slight headache) and FATIGUE (Tired). On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, HEART RATE INCREASED (Heartbeat felt a little bit faster now feels fine) was resolving and HEADACHE (Slight headache), FATIGUE (Tired) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment taken by patient is Tylenol.   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.
Severe body aches,headache,severe left arm pain (injection site), chills,fever up to 101.4,insomnia. Symptoms started at 5:00 am (approx 19 hours after vaccination) and lasted approximately 20 hours. Managed symptoms with Motrin and Excedrin alternately. Mild symptoms of generalized fatigue and weakness,headache persisted the following day for one day. Tenderness at injection site persisted for one week after vaccination.
Fever 101-103F; Developed pinpoint red rash all over body.  Nasal congestion.  Supportive treatment given.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L019297, expiry date 18-AUG-2017, lot # L026602, expiry date 19-OCT-2017, lot # L043213, expiry date 28-AUG-2017, lot # L019297, expiry date 19-FEB-2017 (dose, route and site of administration were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 0.2 degrees Celsius for 48 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
This initial spontaneous case was received on 21-Sep-2017 from a pharmacist, concerning a  57-year-old, adult, female patient. The patient's concomitant medication and medical history were not reported. On 21-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: less than 0.5 ml (as reported), route of administration: intramuscular, anatomical location: deltoid, batch number: 195216, expiry date: 30-Apr-2018). It was reported that, the pharmacist administered the vaccine to a patient, when the needle was in the patient arm while pharmacist pushed the plunger, the dose started to leak out from the barrel and leaked down her arm (explicitly coded as under dose) and the issue was with the leaking pre-filled syringe (explicitly coded as syringe leak). The patient had not experienced any adverse reaction after administration of vaccine. As per the PTC (product technical complaint) report, with reference number (1024666), it was reported that, the package condition was good and stored in the original box until use and the needle which used was 25 gauge. The reporter considered the events as non-serious. Follow-up received from the reporter on 27-Sep-2017: The patient's route of administration and anatomical location of the suspect vaccine were updated. Additional event (no adverse reaction) was added and narrative amended accordingly. Follow-up received from the reporter on 13-Oct-2017 and 31-Oct-2017: The event exposure via skin contact was deleted as case correction. Batch number was added in the screen. It was reported that the issue was with the leaking pre-filled syringe. The narrative was amended accordingly. Significant case correction received with IRD 21-Sep-2017: The case 201701660 (deletion case) was identified as duplicate to the case 201701629 (retained case). Hence, all the information from the case 201701660 (deletion case) was merged into the retained case 201701629 and the case 201701660 will be deleted. The PTC (product technical complaint) reported with reference number (1024666) was merged from 201701660 (deleted case) to 201701629 (retained case). The narrative was amended accordingly. Significant follow-up receive on 08-Dec-2017. Based on the investigation performed, it can be concluded that  FLUCELVAX batch 195216 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No definitive root cause was identified in the manufacturing process, or relating to the stopper or syringe components, and  no trends were identified for the batch, or any other batches FLUCELVAX QIV batches from the 2017-2018 FLUCELVAX Commercial season. However, without an inspection of the involved sample, a root cause of user handling could not be ruled out for this PTC. Therefore, no internal root cause could be confirmed and no external/user root cause could be determined.
Brain fog; Nonfunctional/debilitated/weakness; Dizziness; Headache; Overwhelming fatigue/ feeling tired; Muscle pain; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), ASTHENIA (Nonfunctional/debilitated/weakness), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Overwhelming fatigue/ feeling tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immune system disorder (lower immune system), Multimorbidity (Several comorbidities), Lung cancer, Lymphoma (non-Hodgkin's) (B -Cell follicular lymphoma stage 2 [NHL) and Visual impairment.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog), ASTHENIA (Nonfunctional/debilitated/weakness), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Overwhelming fatigue/ feeling tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Brain fog), ASTHENIA (Nonfunctional/debilitated/weakness), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Overwhelming fatigue/ feeling tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) Blood pressure normal. On an unknown date, Oxygen saturation: normal (normal) Oxygen normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-253765 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up information contains Current Comorbidities and Preexisting Conditions
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was thrombosis of AV fistula.
pt recv vax & became faint p/vax, then OK;had some bleeding @ site of inj 7MAR97;referred to MD 10MAR97;
Information has been received from a RN concerning a 7 year old white male student with no known drug allergies who on 10/23/1997 was vaccinated with a dose of varicella virus vaccine, live. There was no illness at the time of vaccination. The RN reported that the pt was given the varicella virus vaccine, live at a different practice. The pt mother called and reported that on 05/18/04, the pt had a rash on his trunk, chest, back, and face. The mother reported that the diagnosis of varicella was confirmed on 05/19/2004. There were no laboratory or diagnostic tests performed. The pt recovered with no problems. No furhter information is expected.
08/17/2005 - 6PM temperature 100.1 - Children's Tylenol given 2 hours apart.  Redness and swelling noted with slight tenderness.  08/18/2005 - On examination - no tenderness noted but redness and edema - area warm to touch - area size is from shoulder to above elbow - looks like Cellulitis.  Referred to doctor.
Information has been received from a licensed practical nurse referring to a 66 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 08-SEP-2015 the patient was vaccinated with an expired dose PNEUMOVAX23 lot # K010016 with expiration date 05-AUG-2015 (dose, dose number and route were not reported). Information regarding concomitant medication was not reported. No adverse effect had been reported. Additional information has been requested.
Break through case of Covid 19 with 101 fever, terrible headache, fatigue and nasal congestion. Fever and headache lasted one day, second day fatigue, have been improving daily since then. Contacted doctors office on day of testing Positive July 24 and was prescribed Paxlovid which I started at 10Am on July 24. My last dose will be Thursday at 10PM.
This spontaneous report as received from a pharmacist refers to a 79 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated SC with a 0.65 ml dose of ZOSTAVAX on 21-JUL-2012. No other co-suspects were reported. There was no concomitant medication. The pharmacist reported that on 23-JUL-2012 the patient experienced red swelling a couple of inches around the injection site and the area was hot to the touch after receiving ZOSTAVAX (lot # reported as "0255AE", exp date: 14-MSAR-2013). The patient sought medical attention by contacting the pharmacist. Cold packs were given for treatment. At the time of the report, the patient was recovering. This is third of three AE cases reported by this pharmacist. Lot check requested by the pharmacist. Additional information is not expected.