chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner regarding a child of unknown age and gender. Information on the concurrent conditions, medical history and drug allergies of the patient were not reported. Illness of the patient/siblings at the time of/prior vaccination were not reported. On an unknown date the patient was vaccinated with ROTATEQ (lot, expiry date, dose number and anatomical location were not specified) orally. Concomitant medication were not reported. On an unknown date (after receiving ROTATEQ), it was reported that the unspecified parents of the unspecified child reported, during a routine follow-up visit that the child had experienced "black stools" for an unspecified length of time. The patient had sought medical attention by going for a routine follow-up visit. Lab diagnostics studies were not performed. No treatment was given for adverse event. Outcome of faeces discolored was unknown at the time of reporting. There was no Product Quality Complaint (PQC) filed. Reporter did not provide the causal relationship for faeces discolored with ROTATEQ. Additional information has been requested.
Myalgias; Left leg sensitivity; Fatigue; This is a spontaneous report from a non-contactable Other Health Professional. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly on 21Dec2020 at single dose for COVID-19 immunization.  Medical history included COVID from an unknown date and unknown if ongoing (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). The patient's concomitant medications were not reported.  Facility where the most recent COVID-19 vaccine was administered: Hospital. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Was treatment received for the adverse event: No. Since the vaccination, has the patient been tested for COVID-19: No. The patient experienced myalgias, left leg sensitivity, fatigue on 21Dec2020 with outcome of recovered in Dec2020. AE resulted in none. Serious: No: Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.  No follow-up attempts are possible. No further information is expected.
Patient was 14 weeks and 3 days along in her pregnancy when she came in for her 2nd dose of Covid Pfizer vaccine. Patient's first pregnancy EDD: 9/16/2023  This vaccination was given in error by CMA on 3/21/2023.
Pt to ED 10/24 for hip injury. Pt tested for COVID prior to discharge, COVID+ 10/31 , no anti-COVID rx needed.  Pt discharged 11/1.
Patient has complained of pain of left shoulder and deltoid. Since injection. Started after injection and has persisted to the point that patient has difficulty sleeping. Orthopedics evaluation, xray and MRI all negative. No functional deficit, normal exam.
CLOTS; This spontaneous report received from a consumer from social media via a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: myocarditis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose 1, 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced clots. Consumer reported that "...2 friends with myocarditis..one had a stroke..one a clot..2 now with kidney issues..." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220750301, 20220750036, 20220750167, 20220752074 and 20220752219.; Sender's Comments: V0: 20220750085 -Covid-19 vaccine ad26.cov2.s -CLOTS. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
SORE ARM; This spontaneous report received from a patient via a company representative 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210744182.
Patient received adult dose Pfizer for first dose, patient should have gotten pediatric dose. Symptoms of nausea, fever, sore arm, tiredness.
Pt recvd 3 doses of Engerix-B, 3rd dose given 17SEP90 & it was determined that pt failed to convert to HBSAB p/3 doses of Engerix-B; 4th dose of Engerix-B given 31DEC90 & pt converted p/4th inject;
I have extremely swollen and very painful lymph glands under my right arm. The swelling is the size of a baseball and the pain extends to my arm and side.; I have no fever and only had some nausea.; This is a spontaneous report from a non-contactable consumer. A 50-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 08Feb2021 08:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Not known allergies. The patient previously received first dose of bnt162b2 on an unspecified date of covid-19 immunisation and had no issues other than a sore arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Feb2021 patient reported that I have extremely swollen and very painful lymph glands under my right arm. The swelling is the size of a baseball and the pain extends to my arm and side. I have no fever and only had some nausea. The patient was not received treatment medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
02/12/2003. Pt came in for annual woman's exam. Pt stated she would like TD booster shot this visit. Pt signed consent. TD booster injection vaccine given. Pt returned to clinic 02/20/2003 with red, puss filled abcess on left arm at injection site. Pt states it has been present since 2/14/03. Pt treated in clinic by incision and drainage o fabcess. Sterile dressing change and Keflex 800mg po qid x 7d in 5 days for follow up.
Rash developed within minutes of vaccine administration. Patient given BENADRYL in office. Mother advised that patient will need to be premedicated in the future.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 8:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 8:25 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 71.29 No concomitant medications were reported. The vial underwent temperature excursion on 17-Feb-2021 with temperature 22 degrees Fahrenheit at 9 am and 20 degrees Fahrenheit at 8 am and the vial was initially moved to the fridge on 11-Feb-2021 and proposed beyond use date was 13-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was reported.
Initial case received from a health care professional on 18 November 2009. It involves a case of overdose, i.e. vaccine administered twice in a 24 hour period. A 64-year-old male patient received an intramuscular injection of DECAVAC (lot not reported) on 05 November 2009, and again on 06 November 2009. On 16 November 2009, eleven days after vaccination, the patient presented to the emergency department with complaints of increasing lower limb weakness. The patient had a leg laceration at the time of vaccination, and had a history of hypertension, hyperlipidemia, gout, and penicillin allergy. Concomitant medications included LISINOPRIL, NORVASC, NIACIN, ALLOPURINOL, GABAPENTIN, aspirin, and PREVACID. He was admitted to the hospital with Guillain-Barre Syndrome vs transverse myelitis. The patient had undergone an MRI and was being followed by neurology; no additional information was available. At the time of the report, the patient had been hospitalized for three days, and the event was ongoing. Documents held by sender: none.
This spontaneous report as received from a registered nurse refers to a 1 year old patient. On 12-FEB-2013 the patient was vaccinated with PROQUAD dose 1 (lot # not reported) subcutaneously along with VARIVAX (Merck) dose 1 (lot # not reported0 subcutaneously. No adverse effect reported. Additional information has been requested.
Patient reported to have received Pneumovax -23 vaccine on 3/16/2023, administered to right upper extremity. Patient developed pain to right upper extremity along with weakness which spread to the lower legs. Patient was unable to walk, where as, prior to vaccination she was able to walk with a walker. Weakness is described as bilateral but predominantly to right side/Right lower extremity. No fever, no rash reported. Patient diagnosed with autoimmune brachial plexopathy.
Patient was given bivalent dose from bottle that had been punctured almost 24 hours prior. max should have been 12 hours.
Information has been received from a pharmacist via Pfizer (Manufacturer Report # 2016546308) referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route were unknown) for prophylaxis. On an unknown date (reported as about 3 to 5 days later), the patient experienced heaviness in the chest and difficulty breathing. The outcome of the events was unknown. The causality assessment was not provided. Additional information has been requested.
crabby, crank & then started screaming 20OCT lump in rt leg started;23OCT97 size of quarter w/redness greatest @ the edges;
extreme fever 103.5, severe HA, extreme lethargy and malaise, upset stomach.
Patient went unconscious and had involuntary movement of arms and legs lasting about 5 to 10 seconds after we administered her the shot.
Sever hearing loss and tinnitus.  Day after shot clogged ear and fullness, noise. Went to ent hearing test showed severe hearing loss was put on round of steroids.
soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced soreness at injection site on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
INCONSOLIBLE CRYING FOR 2 HRS. AFTER ADMINISTRATION OF VACCINE. TREATMENT TYLENOL 60MG SUPP. AND BENADRYL ELIX, 1/4 TSP. POREACTION SUBSIDED.
Pt developed bell's palsy 4 days following the 1st dose of the vaccine. She went to ER and was diagnosed with Bell's palsy.
The 10 year old patient, received the Pfizer BioNTech Vaccine; this vaccine is not authorized for use in individuals less than 16 years of age.
pt recvd vax 8APR93 & fatigue & weakness worsened; also exp nausea, diarrhea & joint discomfort on 27APR93; the following day exp chills & fever; pt recovered;
Low grade fever, muscle aches, site erythema and tenderness, increase resp mucus. Pos - vax adverse reaction, pos mild URI and premenstrual condition.
Monkey pox vaccine give intradermally; wheal formed 10%; I was told by charge nurse to do and incident report. Patient was not in any distress or discomfort for duration of time at facility. He waited an additional 15 mins post vaccination for monitoring. Patient left facility without any distress or discomfort. Notified patient to proceed to ER for any pain or discomfort. Patient verbalized understanding and teaching.
One week later she woke up with an itchy, sore & red arm.  Took Benadryl and the itchiness went away by the next day. The red area is now fading.
chills, sweats, fatigue & very unpleasant convulsive diarrhea.
Patient did not receive Moderna Bivalent booster. Received regular Moderna booster instead.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 51 year-old female patient received bnt162b2 (BNT162B2) (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: SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "Sjogren's Syndrome"; PARAESTHESIA (non-serious), outcome "recovered", described as "Pins and needles sensation to the left side of her face, in her fingertips, and in her toes that lasted for 3 weeks"; LE CELLS PRESENT (non-serious), outcome "unknown", described as "Tested positive for Lupus (they are still in the process of diagnosing her for it) and Sjogren's Syndrome". The patient underwent the following laboratory tests and procedures: LE cells: positive; antibody test: positive. Since having the vaccine she tested positive for Lupus (they are still in the process of diagnosing her for it) and Sjogren's Syndrome. She states the antibodies for Sjogren's were very low but they were positive. She also states her physician also said that a positive Lupus test doesn't mean she definitely has Lupus. She states she saw a list of conditions on the news that someone reported that were very rare. She is not certain if her symptoms have been caused by the vaccine. Her Neurologist told her about Trigeminal Neuralgia and said she does not have Bell's Palsy. She feels the vaccine triggered all of this. She said the symptoms after the vaccine are different that what is going on now.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Case number PHEH2014US012586 is an initial spontaneous report from the nurse received on 18 Jun 2014. This report refers to a female patient of unknown age. She was vaccinated with MENVEO, (batch number: A13012) 0.5 ml intramuscularly into right deltoid on 18 Jun 2014 at 14:30. On the same day, after vaccination she developed cellulitis at site 5 cm diameter. On 20 Jun 2014 KEFLEX 500 BID was used as treatment drug for seven days. The final outcome of the event was recovered. The seriousness and causality of the events were not reported.
Patient received expired vaccine. Expired 3/26, received 3/30. No adverse events. Patient opted to not received revaccination.
Fever. Muscle aches. Some, though minimal, swelling of tongue and throat. Severe Chills. Fever. Some difficulty breathing at first.
Back pain, neck pain, injection site pain, fever of 102.5 degrees, headache, fatigue, swollen and painful axillary lymph node. On the 6th I took Tylenol 1000 mg at 9:00 PM. On the 7th I took  Tylenol 1000 mg at 8:15 AM.  I had a fever only on the 6th. Now , no more fever but painful lymph node , body aches, headache, and right side neck pain.
h/a, achy, soreness in thrat w/tingling;sore arm w/red area about quarter size;
round of 2 inches in the site of injection and dots around it; covid arm; hives that spreaded; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (covid arm), URTICARIA (hives that spreaded) and INJECTION SITE REACTION (round of 2 inches in the site of injection and dots around it) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced DERMATITIS ALLERGIC (covid arm) and URTICARIA (hives that spreaded). On 30-Jan-2021, the patient experienced INJECTION SITE REACTION (round of 2 inches in the site of injection and dots around it). At the time of the report, DERMATITIS ALLERGIC (covid arm), URTICARIA (hives that spreaded) and INJECTION SITE REACTION (round of 2 inches in the site of injection and dots around it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Urine analysis: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Tdap given. Child was scared of vaccine. Vaccine procedure explained before. About 5-10 minutes after vaccine was given, he was walking out of the room and had a vasovagal attack. Fall and hit his head. Recovered quickly. Waited in the office till he was fine - then left.
PT here for Johnson and Johnson vaccine, received at 0910. Immediately after vaccination, PT c/o feeling ?shaky?, nauseated, and lightheaded, described a ?hot flash? sensation. PT presented with very slight diaphoresis, but no pallor. PT declined offer to lay down on cot, reported that the lightheadedness and nausea had passed after a minute. PT also reported that she had not eaten yet today and had a history of similar reactions to injections in the past. PT reported that she had been nervous before injection. 2 boxes of juice provided and consumed. Education provided ensure PO intake before future injections. At 1919, PT reported that she still felt ?a little shaky?, but was no longer lightheaded or nauseous. PT appeared calm and affable, responding appropriately. PT educated on vasovagal reactions, when to seek further medical care/symptoms to watch out for, verbalized understanding. PT denies history of allergies, medical history beyond gallbladder removal. VS at 0925: BP sitting was 122/78, HR 89, SPO2 100% RA, RR 18. At 0930 PT stated ?I feel fine.? When asked. VS at 0932: BP sitting 124/70, HR 85, SPO2 100% RA, RR 17. At 0933, PT was able to stand without assistance and walked with a steady gait, denying dizziness. PT exited facility at 0934 with the person who had accompanied her, who will also drive her home today.
Upon administering second dose on left deltoid, patient became non responsive unable to hold her head with tremors. Called local R.N stat. for further assessment. Checked vital signs at 11:46a.m  the following was observed: O2 sat 100% , pulse 88, BP unable register at the time.  At 11:47a.m Epi 0.3mg was given IM right thigh. by doctor orders.  At 11:48am 911 was called. And O2 15L given via mask was initiated. And patient continued to struggle breathing and following simple commands. At 11:49a.m BP 217/81, HR 78, O2 sat 100% via mask; 11:52a.m O2 15L 100% via mask; 11:53a.m redness all over chest area and bilateral extremities; 11:55a.m paramedics arrived, BP 117/93, P85, O2 100% via mask; 11:59a.m Blood sugar 130; 12:01p.m  Vital Signs, BP 179/83, P71, O2 98% Room air; 12:04 pm Patient was taken, location undetermined  by  paramedics.
Pt has a rash at injection site. It is warm to touch, itchy (as per pt) and about 2" x 3". Pt advised to take Diphenhydramine and to see a physician if condition worsens. Pt took Benadryl; "still looks the same" 8:39 PM 2/25/14.
HTN approx 30 min post injection 195-220 systolic. C/o HA, dizziness. Tx to ED for further management where pt received clonidine.
Sore arm, getting worse; Persistent headache; Dizzy feeling/Lightheaded feeling; Slight nausea; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 01Mar2021 at 13:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, obsessive-compulsive disorder (OCD), pervasive developmental disorder-not otherwise specified (PDD-NOS), anxiety, depression, concussions and known allergies to oral steroids. 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. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), sennoside a+b (SENNOSIDES), fexofenadine (MANUFACTURER UNKNOWN) and diphenhydramine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. On 02Mar2021 at 12:00, the patient experienced sore arm, getting worse, persistent headache, dizzy feeling, lightheaded feeling and slight nausea. The clinical outcome of the events sore arm, getting worse, persistent headache, dizzy feeling, lightheaded feeling and slight nausea were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.