chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is one case out of a cumulative total of 214 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 26 September 2013. These 214 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. A case of pertussis disease in a 15 month-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL; dose one lot number C4047AA received on 16 July 2012, dose two lot number C4268AA received on 06 September 2012 and dose three lot number C4232AA received on 07 November 2012 (routes and sites of administration for all doses not reported). The subject developed cough and cold-like symptoms on 11 August 2013, approximately nine months after the last dose. The subject was found to have a paroxysmal cough on 17 August 2013. The subject also experienced posttussive vomiting, apnea and sleep disturbance. Laboratory testing included positive PCR on 18 August 2013. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 18 August 2013 for five days. The subject was not hospitalized. At the time of final contact on 24 September 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 44 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
I was wiped out the day; my arm was swollen and hot for almost a week; arm hot for almost a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tired out in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced tired out (Verbatim: I was wiped out the day), swelling arm (Verbatim: my arm was swollen and hot for almost a week) and extremities hot feeling of (Verbatim: arm hot for almost a week).  The outcome of the tired out was not reported and the outcome of the swelling arm and extremities hot feeling of were resolved (duration 1 week).   It was unknown if the reporter considered the tired out, swelling arm and extremities hot feeling of to be related to RSV vaccine.     It was unknown if the company considered the tired out, swelling arm and extremities hot feeling of to be related to RSV vaccine.   Additional Information: GSK receipt date: 10-SEP-2023 The case was received from the patient interactive digital media. The patient got the RSV vaccine a little over a week ago.  The patient was wiped out the day after and my arm was swollen and hot for almost a week. The follow-up could not be possible as no contact details were available.
Needle loss from syringe while vaccine was being administered. vaccinator reports less than 1/2 of the 0.3 ml dose was administered. Another dose given arm pain in arm where needle was in.
Pt received her second GARDASIL vaccine in June on her left arm. Patient states that her arm is stills swollen and feel very tender. She is sensitive to touch.
Vacinne given left arm  2/2/2021  3 days later Fri. 2/5 I  left  side of my face developed a sore face  began to swell  all way to my mouth.I've had cellulitis  in the past. Began taking Kleflex  saw my general medicine who advised  me   to contact your office
Pt came in to the vaccine clinic to receive her first Bivalent Vaccine. The clinician asked standard questions. Pt stated she has a history of syncope after receiving vaccines in the past, but it has not happened for a long time. Per the clinician, pt was instructed to wait 30 minutes after vaccination to ensure she was ok. Vaccine was administered and approximately 5 minutes later the pt complained of feeling light-headed, with ears ringing, and felt hot as if she might pass out. She was also diaphoretic.  Pt assisted to the floor where she laid down, to avoid pt falling if she did lose consciousness. 911 was called. Pt's breathing was coached to slow down and to take deep breaths by the clinician. Upon EMS and fire department arrival, the pt was feeling better. At no time did the pt lose consciousness. EMS stated that pt's vitals were normal and the pt stated she was feeling better and refused to go with EMS.  Pt called her mother to drive her home at the instruction of the clinician and informed to call 911 if symptoms returned.
Numbness; weak muscles; muscle twitching; Chills; flu-like symptoms without fever; This is a spontaneous report received from a contactable consumer (Patient). A 45-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration at left arm on 28Apr2021 12:00 (at the age of 45-year-old) (Lot Number: EP7534) as single dose for COVID-19 immunisation. Medical history included guillain-barre syndrome (previously had), factor V leiden and HIV and concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY) and apixaban (ELIQUIS). The patient did not receive other vaccine in four weeks. The patient did not test COVID post vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via an unspecified route of administration at left arm on 07Apr2021 12:00 (at the age of 45-year-old) (Lot Number: EN6199) as single dose for COVID-19 immunisation. The patient had neurological symptoms 6 weeks after vaccination. Numbness, weak muscles, muscle twitching, chills and flu-like symptoms without fever on 01May2021. Lasting 4 weeks now. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21May2021. Patient visits the physician office and emergency room for the events and no treatment received for the events. Outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Breakthrough case admission  after three vaccines Pfizer 3/26/21 Lot# ER8727;  Pfizer 4/16/21 Lot# Ew0158;  Pfizer 3/16/22 Lot # FJ9943
Felt dizzy and weak after first dose of the Covid Vaccine; Felt dizzy and weak after first dose of the Covid Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), DIZZINESS (non-serious) all with onset Jul2021, outcome "unknown" and all described as "Felt dizzy and weak after first dose of the Covid Vaccine".  Additional Information: Reaction/event as reported by primary source- Felt dizzy and weak after first dose of the Covid Vaccine. Report not related to a study or programme. Patient is also the reporter. Patient states that she had the first dose and got dizzy and weak. Asks does she have to take the second dose. Verifies that she is calling about the Covid Vaccine; then states it is the Pfizer. States she had her first dose on 06Jul2021 and is supposed to get the second one on Tuesday. Wants to know if she has to get the second one because the first one made her so dizzy and weak. Caller abruptly disconnects at 0910 on 22Jul2021. Outbound call attempted at 0910 on 22Jul2021; call rang a few times and then went to voicemail; ININ: #. Outbound call attempted again at 0911 on 22Jul2021; call rang a few times and then went to voicemail; ININ: #.  Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected.
(L) upper arm swollen, sore, warm from shoulder to elbow - began 8 hrs after vax - using ice and will start Ibuprofen and call MD no fever, no h/a, no rash, not itchy. Also used BENADRYL.
Patient reports that about 1.5 hours after Tdap injection on 3/6/20 she had the following symptoms: dizziness, racing heart and weakness which lasted about 10 minutes. Reports she had not experienced theses symptoms again but wanted it noted in her chart for future reference.
Lips swelled and went numb. Hands swelled and went numb. Rash/redness covering upper body. Hives on arms. Nasal passages clogged
Man received shot and got up to shop and about 2 to 3 minutes later he said he felt real shaky and then fell to the floor. He did not appear to lose consciousness but he was sweating, appeared incoherent and did not appear to be familiar with surroundings. A shopper reported he hit his head on the floor during the fall. As he became more responsive ~ 5 minutes he was sat in a chair at the spot and was given ice to apply to his head. He appeared alert in about 15-20 minutes and left. He said the injection did not hurt and at the time of the injection he did not feel differently. He said he gets shots for his back weekly and has no problems.
About an hour after the injection, I had muscle twitch around left eye. I asked the coworker if they could see it and they could. The twitch in that muscle stopped that evening. Both of my eyelids occasionally twitch for the past few days
Bilateral upper leg itching followed by fasciculations and tremors of R arm followed by facial paresthesias, followed by tightening of throat with change in swallowing sensation and swelling of lips and pharynx, followed by a facial rash/erythema.  Resolved 4 hours after and required multiple doses of diphenhydramine and other antihistamine. This was reported and consulted with an Emergency Room physician.
Killed; Initial information was received on 03-Dec-2020 regarding an unsolicited valid serious social media case from a consumer/non-health care professional.  This case involves a male patient (age unspecified) who was killed (death), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was killed (death) (unknown latency) following the administration of INFLUENZA VACCINE.  This event was assessed as medically significant.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment before death.  It is unknown if an autopsy was done. The cause of death was not specified.  Information on batch number was requested for this case.; Sender's Comments: This poorly documented case from social media involves a male patient who died (NOS) after receiving INFLUENZA VACCINE produced by unknown manufacturer. The time to onset is unknown.  Additional information regarding medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: killed
Case number PHEH2014US025345, is an initial spontaneous report received from a pharmacist on 15 DEC 2014 and follow up report received from health care professional on 27 FEB 2015. This report refers to a 37 years old female pregnant patient. Her medical history was not reported. Concomitant medications included prenatal vitamins. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 141401) intramuscularly in error instead of the corporate approved flu vaccine for expectant mothers on 13 DEC 2014. No adverse events reported after the maladministration. Upon follow up it was reported that on an unknown date the patient delivered a normal baby. No further information was reported. Follow up report received from health care professional on 27 FEB 2015: Pregnancy outcome was update and new event (normal newborn) was coded.
5 min post administration, numb/tingling hands, feet followed by shivering, increased HR lasted about 40 minutes.  Myoclonic jerking began as other symptoms waned.  Myoclonus lasted 2 hours after other sxs resolved.  After 2+ hours of monitoring, and with myoclonic jerking continuing without improvement, patient advised to seek medical attention.  Was taken to Emergency Department
chest pains; alot of stomach pain; missed 2nd dose; pain below sternum; pain in left arm; pain in left thigh; tiredness; headaches; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains), ABDOMINAL PAIN UPPER (alot of stomach pain), PRODUCT DOSE OMISSION ISSUE (missed 2nd dose), CHEST PAIN (pain below sternum) and PAIN IN EXTREMITY (pain in left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pains), ABDOMINAL PAIN UPPER (alot of stomach pain), PRODUCT DOSE OMISSION ISSUE (missed 2nd dose), CHEST PAIN (pain below sternum), PAIN IN EXTREMITY (pain in left arm), PAIN IN EXTREMITY (pain in left thigh), FATIGUE (tiredness), HEADACHE (headaches), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, CHEST PAIN (chest pains), ABDOMINAL PAIN UPPER (alot of stomach pain), PRODUCT DOSE OMISSION ISSUE (missed 2nd dose), CHEST PAIN (pain below sternum), PAIN IN EXTREMITY (pain in left arm), PAIN IN EXTREMITY (pain in left thigh), FATIGUE (tiredness), HEADACHE (headaches), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were reported  No treatment medications were reported; Reporter's Comments: Caller and Husband both reporting adverse events during phone call through speakerphone or passing phone back and forth. Husband got the 1st dose of the vaccine on 12May2021 (Lot # 016C21A, expiration date not available) in left arm. Exact onset date and duration of AEs not provided. Consumer experienced chest pains, pain below sternum, a lot of stomach pain, headaches, vomiting, nausea, pain in left thigh, tiredness, and pain in left arm. Consumer states some of the adverse events are ongoing but getting better. Consumer gave safety consent to follow up via phone.
MODERNA COVID-19 VACCINE EUA Vomiting, fatigue, full body aches.
5/2/08 - ate a lot of pizza before coming to the clinic at about 1 pm = received IPV # & DTaP #5 MMR #2, varicella #2, PPD -> went home.  At around 4-5 pm, noted to have some redness on the face -> check his torso -> there were a bit of hives and welts all over -> he was shaking a little bit, respiration problem - not known? -> ambulance called -> seen at ER, given Benadryl shot & steroid -> almost resolved after several hrs.
Covid-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid-19) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Melanoma and Anxiety. Concurrent medical conditions included Migraine with aura, Premature ventricular contractions (PVCs), Penicillin allergy and Drug allergy (Neosporin).    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  On 23-May-2022 patient experienced Horrible taste and rebound COVID. At the time of the report, Horrible taste and COVID-19 was resolving.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Company comment- This spontaneous case concerns a 36-year-old female patient with no relevant medical history reported, who experienced the unexpected AESI COVID-19. A dose of mRNA-1273 vaccine, given as a third dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event. Patient was treated with Paxlovid for 5 days, it was reported patient had a horrible taste and rebound COVID. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 36-year-old female patient with no relevant medical history reported, who experienced the unexpected AESI COVID-19. A dose of mRNA-1273 vaccine, given as a third dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event. Patient was treated with Paxlovid for 5 days, it was reported patient had a horrible taste and rebound COVID. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Left shoulder, neck and arm pain constant deep pain. Tried and failed physical therapy. Currently seeing chiropractor. Taking Ibuprofen and Tylenol for pain. Have tried pain patches, Norco 5/325mg, voltaren gel, flexeril.
Patient is a 81 y.o. male with a diagnosis of GBS secondary to reaction to COVID-19 vaccine (SIADH likely secondary to vaccine as well). Pt presents with LE weakness and decreased sensation from GBS s/p IVIG. Pt currently is completing ADLs at the hospital bed level and transfers squat pivot with MIN A at this time. Pt appears alert and motivated to participate in therapy and presents with good rehab potential.
PATIENT WAS SITTING AFTER ADMINISTRATION. SUDDENLTY LOST CONSCIOUSNESS. FEW SECONDS LATER SHE WAS DISORIENTED, SWEATY WITH LOW BLOOD PRESSURE. SHE STATED HER VISION WAS AFFECTED AS WELL DRINKING WATER AND EATING LITTLE CHOCOLATE PRODUCED VOMITTING AND PATIENT FELT BETTER.
Fatigue - extreme to moderate.  Virus like feeling - continues and this is 1 week after the shot.  I just went to get a COVID test to rule that out.  Fatigue continues - not resolved.
Redness and swelling of entire upper left arm, some itchiness, redness (rash) on upper left chest. Patient took benadryl. Improving slowly.
Edema and itching at site of injection, one day after administration. Ordered to take OTC Benadryl and APAP for discomfort and RTC for f/u with MD but pt never showed for f/u appointment.
Periorbital swelling, right sided (same side vaccine was given on).  Left eye unaffected.
received booster.  started having sorness in left arm. could not lift arm for 2 days .
pt recv vax 18JUL96 & 13MAY97 pt devel a rash;
Pt came in to receive her second Monovalent Pfizer Covid vaccine. Shortly after getting vaccinated, pt started to complain of dizziness. PT was attended to by the clinician and 911 was contacted however, the pt refused 911. AMA form signed by the patient. Pt stayed at the facility until she states her dizziness was getting better
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 9:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 9:55 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.83. Concomitant products were not provided. Vials underwent temperature excursion with temperature 34 at 09 AM and 10 AM, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 06 vials were sent to clinic. Vaccine was 27-Jan-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.   Reporter did not allow further contact
24 hours after 2nd vaccine, usual injection discomfort, low back ache, felt not well, minor, resolved quickly. 3 weeks after 2nd vaccine, onset of new bilateral lower extremity 3+ pitting edema.  No previous episodes. Very active, healthy exercising/running life style. some relief with self administered HCTZ and leg elevation. Very unusual, not expected, no obvious explanation.  Waxed and waned. No fever, SOB. No risk factors for DVT.  Painful due to new acute stretching of skin around ankle up to mid calf. consulted ab PMD 4/11/21, suspecting side effect of amlodipine or lisinopril, however, I've taking these meds for years.  This is very unusual. Lab. tests are ordered.  My concern is clot.