chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous prospective pregnancy report was received from a consumer and referred to a female pregnant patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported) or GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported). The reporter stated that it was "the number to report human papilloma virus (HPV) and pregnancy". The date of last menstrual period (LMP) and estimated date of delivery (EDD) was unknown. The outcome of exposure during pregnancy and interchange of vaccine products was unknown. The pregnancy outcome was unknown as there was no possibility to contact the reporter. The relatedness between the events and GARDASIL 9 and GARDASIL was not reported.
Rapidly increasing fever over about 30 minutes.; Acute bout of nausea; Dry heaving; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 24Mar2021 at 09:30 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 03Mar2021 at 13:15 (at the age of 45-years-old), as a single dose for COVID-19 immunisation.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021, the patient woke up in the middle of the night at 01:30 (approximately 14 hours after the second dose) with a rapidly increasing fever over about 30 minutes, also experienced acute bout of nausea, followed by dry heaving for about ten minutes which happened again at 08:30. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event.  The clinical outcome of the events fever, nausea, vomiting and dry heaving was resolving at the time of this report.  No follow-up attempts are needed. No further information expected.
Patient came in for a well child visit. Provider suggested a covid vaccine. Patient was eligible for the first primary dose of the Moderna Monovalent 6M-5Y vaccine, but instead was accidently given the Moderna Bivalent 6M-5Y vaccine. Patient had no adverse reaction to the vaccine. Father of patient was notified the following day by provider that the Covid-19 Bivalent vacicne was given to patient. Father stated patient was fine and had no reactions.
Sore big toes on both feet; bruising under toenails; poor circulation on both big toes; This is a spontaneous report from a contactable Other Health Professional. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 03Jan2021 at 09:30am (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. The patient had none medical history. The patients Concomitant medication included buprenorphine hydrochloride (SUBUTEX) taken for an unspecified indication, start and stop date were not reported. The patients past drug included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose1 administered in Arm Left arm on 23Dec2020 at 09:30am(Batch/Lot Number: EK5730) as single dose for covid-19 immunisation. The patient experienced sore big toes on both feet, bruising under toenails and poor circulation on both big toes on 15Jan2021 at 20:00. The outcome of the events was not recovered.
Next day Saturday, blisters started to form on top of the toes; Evening of second shot foot started to itch, itching increase over the week and by the following Friday two toes are unbearable itching; Friday two toes were red; Friday two toes were hot; Friday two toes were swollen; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 at 08:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and kidney donor (donated a kidney). Concomitant medications included norethisterone (NORETHINDRONE), vitamin d (vit d) (MANUFACTURER UNKNOWN), levothyroxine (l-thyroxine) (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN) for unknown indication, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 05Mar2021 at 08:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient received penicillin (MANUFACTURER UNKNOWN) and amoxicillin (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021 at 22:00, in the evening of second shot, the patient foot started to itch, itching increase over the week and by the following Friday two toes were swollen, red, hot and unbearable itching. On 27Mar2021, next day, Saturday, blisters started to form on top of the toes. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with methylprednisolone tablets (MANUFACTURER UNKNOWN) and mupirocin ointment (MANUFACTURER UNKNOWN). The clinical outcome of the events itching, two toes were swollen, red, hot and blisters started to form on top of the toes was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
AM of 2/19/2020 felt very warm and fatigue/malaise, 2/19/20 noted arm where vaccine received warm & red. Also noted, blistered lesion on (L) arm
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 75-year-old female patient 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 that if patient had any relevant medical history, allergy, concomitant diseases and risk factor and was also unknown if patient had any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In October 2022, the patient received fifth 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. It was reported that patient had received 5 COVID-19 shots . No treatment information was provided.
VOMITING; FEET AND LEG PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included aspirin allergy, and concurrent conditions included history of blood clot, and chronic inflammatory demyelinating polyneuropathy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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. Concomitant medications included immunoglobulin human normal for chronic inflammatory demyelinating polyneuropathy. On 28-MAR-2021, the subject experienced vomiting. On 28-MAR-2021, the subject experienced feet and leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting and feet and leg pain was not reported. This report was non-serious.
Has a terrible itchy red rash after getting the second dose; This is a spontaneous report from a Pfizer Sponsored Program via non-contactable consumer or other non hcp (Patient's daughter). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received bnt162b2 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date the patient experienced a terrible itchy red rash after getting the second dose of the covid vaccine and was still experiencing these side effects. Event was non-serious, and the outcome was not recovered.   No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Injection site swelling. From initial information received on 28/Apr/2003 from a health care professional, regarding an adverse event occurring in the USA, it was reported that a 15 month old female patient received her fourth dose of DAPTACEL, lot number C1281AA, given intra-muscularly in the right thigh on 09/Apr/2003. The following morning, her entire upper right thigh was swollen. The patient was seen by a physician and the parent was advised to administer Benadryl 3/4 teaspoon every four hours and either Advil or Motrin 75 milligrams every six to eight hours. Reportedly, the patient recovered from this event. The reporter of this case is the same reporter for cases: 2003-01534 and 2003-01535.
Chills, nausea, loss of appetite, vomitting, fever, headache, rash, fatigue, joint pain, ears ringing, muscle pain and continued until 04/03/2017 and required complete bed rest.
Patient began running a low grade fever the same night as she received the immunizations. The next day, her fever increased throughout the day until it was 102.8 degrees. She was also having difficulty breathing at that point. Her arm was swollen, red, painful and hot to the touch. She went to the ER and was admitted to the hospital where she stayed for 4 days. They gave her fluids until her fever was resolved. She has made a full recovery.
The patient was scheduled to receive her 2nd dose of the series on 1/27/21 and received it on 1/19/21. The patient reports experiencing a headache, chills, fatigue, and a high temperature of 100.1 within 6 hours of receiving the vaccination. The symptoms were intermittent and resolved within 24 hours of receiving the vaccination.
Elevated sedimentation Rate; This spontaneous case was reported by a consumer and describes the occurrence of RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation Rate) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) and LORAZEPAM for an unknown indication.   On 02-Apr-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 22-Apr-2021, the patient experienced RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation Rate). At the time of the report, RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation Rate) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Blood test: unknown (High) Elevated Sedimentation rate.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.
The evening of his second shot, he collapsed.  He said he became light headed, but I believe he may have lost consciousness briefly.  He rand a low fever for 12 hours.  Afterwards, he complained that he had "not felt right" since the second shot.  He died of a heart attack on May 27, roughly one month after his second shot.
pt recv vax 15JUL97 & reported pain immed p/vax;also exp tingling, paresthesias, aching & weakness on arm which persisted throughout the day & noc;
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of DEC2021, JAN2022, and FEB2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients.
respiratory distress   Narrative: Patient is a 77yo gentleman with medical comorbidities of Gold III COPD (FEV1/FVC 0.34 on 6/2017) on baseline 4L O2 NC, R MCA CVA in 1999 with residual L spastic hemiparesis, tobacco use disorder in remission, HTN, HLD, mild cognitive dysfunction, OSA (cpap noncompliant), GERD, Chronic Pain syndrome, and unspecified mood disorder who presented to facility ED with 1 day of generalized malaise, fatigue, and subjective fevers after being discharged 2 days PTA s/p L biceps and brachialis release (2/22/21) and s/p 2nd dose of COVID vaccine 2/25/21.
The patient was given Moderna Covid Vaccine (Lot # ar9236b 0.5 ml) designed for age 6 M-5 year old by mistake.  Patient was informed about this incident, and was suggested to keep track of signs and symptoms, as well as contact information with the vaccinated clinic in case any adverse events happen. Pt. was contacted on Monday, 10/24/2022, and was not reached.
light head; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 52-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Feb2021 10:00 (Batch/Lot number: unknown) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 16Feb2021 10:30, outcome "recovered" (2021), described as "light head". Therapeutic measures were not taken as a result of dizziness.  Additional Information: Thirty minutes after the first shot, the patient felt light head. It was not too bad but a bit concerning. The patient had no allergies to medications, food, or other products. He had a history of unspecified drugs having unusual reactions in his system and had taken psychedelics in his youth but not in 30 years. The reporter classified the event as not serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021338140 Same patient and drug; Different dose and event
Posterior vitreous detachment. After each vaccine left eye first then right.  3 days after vaccine.
exp severe head pain, soreness in arm @ inj site;t105;soreness in lt side, weakness
Got the Rotavirus within ten days of shot cough within 1-2 days lasted 1 week. Fever diarrhea, vomit.
INCONSOLABLE CRYING/SCREAMING FOR 5 HRS AFTER DTAP.
8APR99 later afternoon hive type rash on chest, back & arms;no itching;no other sx;given DPH 4:30 & 10PM;hives subsided;has environmental allergies & takes allergy inj;dad will discuss episode w/allergist & determine if r/t vax;
Pt received Varicella vaccine Friday 07Sept07. He developed localized redness, induration later that evening, which worsened and expanded over the next 2 days. Tx'd with Benadryl PO only.
Pt recvd 1st dose of vax w/o adverse exp; recvd 2nd dose of Engerix B vax in AUG90 & 2 to 3 months p/vax, pt devel elevated liver enzymes, fever, fatigue, & h/a lasted approx 1 month, pt was hospitalized;
She had abdominal pain and was diagnosed with an ovarian cyst; She had abdominal pain and was diagnosed with an ovarian cyst; This is a spontaneous report from a contactable registered nurse (patient's mother). A 14-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported, Expiration date: Unknown), via an unspecified route, administered in Left arm on 18May2021 as a 1st dose, single dose for COVID-19 immunization. The patient's medical history was not reported. No concomitant medications were reported for the patient. The initial information was not related to any study or programme.On 30May2021, the patient had experienced abdominal pain and was diagnosed with an ovarian cyst. The reporter had called to her doctor. There was no survey provided due to Physician waited for reporter. The reporter stated that, the doctor does not think it was related to the Pfizer vaccine and recommends that she get the second dose. The reporter explained that there were no reports of Ovarian cysts in Pfizer date or CDC information obtained and was referred to HCP. Offered to email this document for review. The reporter stated that her daughter had not been seen by the doctor provided at this time and stated they were out of town, so she was seen at an Emergency room. The reporter stated that, her daughter's pain was better, but she was assuming the cyst was still there. The reporter stated that her daughter's lab work was also a little off, stated her Lymphocyte count was low, was 15.6 and should have been 28-48. The reporter stated that patient's Chloride was 1.09 and her Anion was 4, so a little low. Exact levels were unknown. No investigational assessment was provided for Ovarian cyst. Product Details: NDC, Lot and Expiration unknown at the time of report. The reporter does not have the patient's vaccine record card on hand at the time of the report. The reporter wanted to know if this could be related to the vaccine. The reporter wanted to know if she should delay second dose because of ovarian cyst and then how long do we have to repeat. The outcome of the event ovarian cyst was not recovered and the outcome of another event was recovering.  Follow-up (02Jun2021): This is a follow-up spontaneous report from a contactable nurse: Added report details, event onset date, lab data and reporter comments. Narrative was updated accordingly.  Information on the lot/batch number have been requested.
Mom called on 07-03-2007 to say had started running a fever et some scattered rash the day prior; had fever again this morning; 101 degrees
Numbness in left arm that spread to neck and upper back. Pt also had a cold feeling in left arm. Phone call to PCP who felt it was a nerve issue and did not recommend treatment.
Back pain; Neck pain; Shoulder Pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder Pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 009C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 14-Dec-2020. Concurrent medical conditions included Drug allergy (aspirin). Concomitant products included VITAMIN B12 NOS and VITAMIN D3 for Blood test, FISH OIL for an unknown indication.   On 17-Apr-2021 at 6:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 13-May-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 13-May-2021, the patient experienced BACK PAIN (Back pain), NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder Pain). On 16-May-2021, BACK PAIN (Back pain), NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder Pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2020, SARS-CoV-2 test: positive Positive.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No treatment reported.    This case was linked to MOD-2021-080111 (Patient Link).