chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date 30th August 2022) for prophylaxis.   On 1st September 2022, the patient received Menveo. On 1st September 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 2-Sep-2022 Reporter's Comment: Reporter reported that 11 years old patient received the expired dose of Menveo. The reporter consented to follow up. Additional Supportive Information: Patient received expired dose of Menveo which was already expired on 2nd September 2022 which led to expired vaccine used.
Pt complained of red, blotchy face starting the morning after vaccines received. No hives or rash elsewhere on body. No difficulty breathing. Activity is normal.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 08May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Afib" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Sep2022 at 15:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (08Sep2022) Negative, notes: On Thursday I tested negative; (11Sep2022) Positive, notes: Today 11Sep2022 I woke up feeling as sick as I was before taking the paxlovid. I retested and was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient had completed the course on Tuesday and she was feeling much better. On Thursday she tested negative. Yesterday 10Sep2022, she started to feel sick again. Today 11Sep2022, she woke up feeling as sick as she was before taking the paxlovid. She retested and it was positive. Patient was treated with Paxlovid from 02Sep2022 to 06Sep2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
BEDRIDDEN FOR LAST 3 HOURS; WAVES OF CHILLS; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced bedridden for last 3 hours, waves of chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the waves of chills, fever and bedridden for last 3 hours was not reported. This report was non-serious.
The next day I felt intense lethargy; Soreness of the injection site; Dizzy; Light-headed/ Light headedness; Intense chills; Shaking; Feverish; Nausea; Body aches; This 25- year-old female patient contactable other HCP (reported for herself) received the second dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME)(lot EL3247; expiration not provided), via an unspecified route of administration, on 25Jan2021 at 10:00 AM (at the age of 25-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. Patient is not pregnant. The patient received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME)(lot EL0142; expiration not provided), via an unspecified route of administration, on 04Jan2021 at 11:00 AM (at the age of 25-years-old) as a single dose for COVID-19 immunization. Medical history included: allergies to: Azithromicin, raw fruit (apples, peaches, pears, plums, cherries, apricot). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Jan2021 at 11:00pm, she reported "Within the first 15 min I felt dizzy and light-headed, that subsided after that. Around 12hours later I had intense chills, shaking, feverish, nausea and body aches. This lasted for around 5 hours, no medication was taken to treat. The next day I felt intense lethargy and light-headedness. The day after the lethargy continued with body-aches and continued soreness of the injection site" The clinical outcome of the events dizzy, light-headed, intense chills, shaking, feverish, nausea was recovering; the outcome of the events lethargy, body-aches, continued soreness of the injection site was not recovered.   No follow-up attempts are possible. No further information is expected.
Rash around injection site, treatment of Neosporin 1x, rash resolved after approx 1 week
Information has been received from an unspecified source ("someone who is not part of the clinic") concerning a 15 year old (reported by the source as a 16 year old) female who was vaccinated at the clinic with GARDASIL.  The unspecified source told the Company representative that it was reported on television that the patient experienced "fainting and seizure like movements" after receiving GARDASIL.  The unspecified source recounted the news report stating the patient was supervised in the office after the vaccine was given for about an hour and was released to home.  The patient had "splitting headache" and "fatigue" that persisted for about one week after the fainting incident.  According to the archived television program, the patient was a healthy, athletic 15 year old who in approximately July 2008 was taken to the clinic by her mother for a routine physical.  As part of her exam, she was offered GARDASIL.  When the mother asked about the side effects, she was told only about possible redness and soreness.  Almost immediately after getting the vaccination, something went very wrong.  The patient stood up and couldn't see anything.  She fainted and began having seizure like motions. For several moments, the patient was thrashing on the examining room floor. When she woke up, the patient didn't know where and who she was.  She was very pale.  At first the clinic staff had her sit on the ground, and then eventually had her sit on the table.  The patient then became nauseous.  After more than two hours, the patient was sent home.  Her parents were afraid to let her sleep.  It took five days for the patient to get over the migraine-like headaches and debilitating loss of energy.  The Company representative attempted to contact the clinic for follow up, but was unable to get anyone to verify the incident.  Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Within 12 hours right arm had swollen with redness. 9/14/07-Rt arm Red swollen, tender 25m x 25m soft to touch
Vomiting; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER2613) 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: VOMITING (non-serious) with onset 01Apr2021, outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious) with onset 01Apr2021, outcome "unknown", described as "Diarrhea".  Additional information: Patient age was reported as 81 (no units reported). Second dose was scheduled on 16Apr2021.  No follow-up attempts are possible. No further information is expected.
pt adm due to dizziness & inc phenytoin level; had flu vax about 3 wks prior to admit; could have contributed to increased phenytoin level; no other recent changes in drug therapy;
This AM, hands and feet were red and swollen. Hives were on face and torso; HEENT- unremarkable.
Chills for 23 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills for 23 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced CHILLS (Chills for 23 days). At the time of the report, CHILLS (Chills for 23 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Fatigue, chills, anxiety, morning sweats, no appetite, hives, below normal temperature.
First noticed red marks after band-aids where taken off.  The following day baby had small raised red dots on legs and arms.  Over the course of the next three days the dots became much worse, and large blotches appeared as well. She had these marks over her whole body except on her back.  Mainly on her arms and legs, though.
nausea  after the first dose; upset stomach after the first dose; After the second feeling worse nausea; After the second now upset stomach and feel bowels are loose; A spontaneous report was received from a consumer concerning a 70-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea and an upset stomach after the first dose, after the second, now, they are feeling worse nausea, upset stomach and feel their bowels are.  The patient's medical history was not provided. Concomitant medications reported were blood pressure medication, others, they did not remember at the time for drug use for unknown indication.  On 12 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection. On 9 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) nausea and an upset stomach after the first dose, After the second, now, they are feeling worse nausea, upset stomach and feel their bowels are.  Treatment details included Mylanta.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), nausea and an upset stomach after the first dose, after the second, now, they are feeling worse nausea, upset stomach and feel their bowels are was unknown.
Patient specifies that she received the vaccine on 03/21/2017, pain on the left arm in the afternoon and on Wednesday it was red and warm to touch. It looks warm to touch and a little red.
Chills, nausea, sore throat. Vomited around 9 PM.
This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the first of two reports.  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient experienced acute stroke on an unspecified date. The patient was still hospitalized in ICU. The outcome of the event was unknown.; Sender's Comments: Limited information can not support a complete medical assessment. A causal association between administration of BNT162B2 and the onset of acute stroke cannot be excluded, considering the temporal association. Case will be re-assessed upon the additional information provided. 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.,Linked Report(s) : US-PFIZER INC-2021415134 same reporter and drug, similar events, different patients
Patient received vaccination. Sit for a couple of minutes. He stood for a while he passed out and hit floor with mouth. Mom took him to dentist. Had a fractured tooth and one loose tooth from fall.
PATIENT STATED THAT SHE GOT OLD VERSION OF SHINGRIX VACCINE AND WANT THE NEWER VERSION OF SHINGRIX AND GOT THE SHOT
Information has been received from a nurse practitioner concerning a female patient who on an unknown date, was vaccinated with GARDASIL. After receiving the vaccine, the patient experienced seizure. The patient was in the physician's office when the adverse event occurred. An electroencephalography (EEG) was performed (results were not provided). Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.   10/10/08 Reviewed vax records & office note of 8/4/08 when patient seen for recheck of axillary cyst & states EEG abnormal.  No other records available. 10/14/08 Reviewed neuro medical records of 9/9/08. FINAL DX: complex partial seizure disorder w/secondary generalization Records reveal patient experienced seizure symptoms since 7/2007 each lasting appro 5-10 min.  Starts w/eye deviation, progressed to LOC & tonic-clonic activity followed by confusion.  Tx w/antiseizure meds.
couldn't really sleep on it's side; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (couldn't really sleep on it's side) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Small fiber neuropathy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SLEEP DISORDER (couldn't really sleep on it's side). At the time of the report, SLEEP DISORDER (couldn't really sleep on it's side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.   This case was linked to MOD-2021-360203 (Patient Link).
ringing in the ear(tinnitus); sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in the ear(tinnitus)) and PAIN IN EXTREMITY (sore arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hearing loss and Penicillin allergy.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in the ear(tinnitus)) and PAIN IN EXTREMITY (sore arm). At the time of the report, TINNITUS (ringing in the ear(tinnitus)) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
Almost immediately after the former 5th grade shot, I had a complex partial seizure involving extreme dizziness, the world turning upside down, and at the end projectile vomiting in the hallway. The treatment was go home and rest, my mother didn't know it was a seizure. Since that time I've had flop-on-the-ground seizures and have been on anticonvulsant medication for several years. 4/20/06 Medical records received from neurologist which reveal initial EEG done 3/4/05 was WNL(ordered by patient's psychiatrist).  Reported s/s & repeat EEG of 6/05 revealed subtle slowing in right temporal region w/no specific epileptiform activity.  MRI was WNL.  Dx: mesial temporal sclerosis.
Fetal renal anomaly, bilateral MCDK resulting in pregnancy termination at 21 weeks. Delivery date was estimated on July 15
pt recvd vax & exp local react for 3 days followed by development of leukopenia & acute respiratory distress; pt was hospitalized; lab tests showed WBC Count 1.7 & CXr showed lt lung infiltrate & poss pneumonia;
This spontaneous report as received from a licensed practical nurse refers to a 33 year old female patient. No pertinent medical history or drug reactions/allergies were provided. On 25-FEB-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # J014401; expiry date 26-NOV-2014), 0.5 ml, subcutaneously in the arm (dose number not provided). No co-suspect or concomitant therapies were reported. After receiving PNEUMOVAX 23, approximately on 25-FEB-2014, the patient developed swelling and redness on her arm, at the injection site. The reporter did not know if the patient had received PNEUMOVAX 23 in the past. At the time of the report, the outcome of the events was unknown. It was reported that the patient may had been using an unspecified cream to treat the injection site symptoms. The patient sought medical attention by calling the office. The reporter requested a lot check. This is case is linked to case MARRS # 1403USA001361 (same reporter link). Additional information has been requested.
COLD SWEATS; SEVERE BODY ACHES; SORE ARM (LIKE PUNCH IN THE ARM); FEELING NAUSEA; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, and expiry: 27-APR-2022) dose was not reported, administered on 08-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-DEC-2021, the patient experienced cold sweats. On 08-DEC-2021, the patient experienced severe body aches. On 08-DEC-2021, the patient experienced sore arm (like punch in the arm). On 08-DEC-2021, the patient experienced feeling nausea. On 08-DEC-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) More than 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling nausea, cold sweats, sore arm (like punch in the arm), fever and severe body aches was not reported. This report was non-serious.
26JUL91 devel flu like sx w/joint soreness & chills; 28JUL91 arm @ site became red, hot & sore; 30JUL91 systemic sx gone but arm site still sore;
The short was not properly administered which led to me not receiving a full dose. The nurse gave me the shot but some of it ran down my arm. I was told it happens often and they overfill the needed so I should have received enough. I contacted the agency and they advised that I should have been given another shot in my other arm but I was told there was no need
The patient was given an expired moderna.  Moderna was expired approximately 7 hours and 15 minutes before administration. no adverse effect yet
10MAR developed swelling, soreness rt upper arm inject site; 12MAR developed fever >101; 18MAR temp down to 98.9 personal MD dx = cellulitis vs allergic reaction;
feet are jittery/hard to walk up stairs/difficulty in putting her feet still; swollen lower legs; Painful lower legs/ pain in her calves thatsometimes shift to her ankles; Red lower legs; Tender lower legs; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (feet are jittery/hard to walk up stairs/difficulty in putting her feet still), PERIPHERAL SWELLING (swollen lower legs), PAIN IN EXTREMITY (Painful lower legs/ pain in her calves thatsometimes shift to her ankles), ERYTHEMA (Red lower legs) and TENDERNESS (Tender lower legs) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen lower legs), PAIN IN EXTREMITY (Painful lower legs/ pain in her calves thatsometimes shift to her ankles), ERYTHEMA (Red lower legs) and TENDERNESS (Tender lower legs). On an unknown date, the patient experienced PARAESTHESIA (feet are jittery/hard to walk up stairs/difficulty in putting her feet still). At the time of the report, PARAESTHESIA (feet are jittery/hard to walk up stairs/difficulty in putting her feet still), PERIPHERAL SWELLING (swollen lower legs), PAIN IN EXTREMITY (Painful lower legs/ pain in her calves thatsometimes shift to her ankles), ERYTHEMA (Red lower legs) and TENDERNESS (Tender lower legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    On 02 Feb 2021, the patient experienced red, tender, swollen painful lower legs. The patient reported that she had very sore, red legs that are swollen, difficulty in putting up her feet still, feet are jittery and has some pain in her calves that sometimes shifts to her ankles. The patient also reported that it is still kind of sore and hard to walk upstairs and her left leg is affected more than her right leg.
Nose bleed 7 hours after vaccine on 10/18/22 and again today about 31.5 hours after vaccine. I have had a nosebleed after every vaccination tonight being the hardest to get stopped.
Pt complains of his left leg from the knee down as feeling numb.  He only has this numbness when he is lying down at night when he is in bed.  Patient said since his first COVID vaccine he has had this issue.  It has happened every time since he got his first COVID vaccine.  The numbness typically lasts for  a few weeks.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 09-NOV-2013 the patient was vaccinated with M-M-R II injection (dose, lot and expiry date unknown). The M-M-R II doses were exposed to 52 Fahrenheit since 07-NOV-2013. No adverse effect was reported. This is 1 of 2 reports from same reporter. Additional information has been requested.