chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had burning pain from toes to brain; Body ache; Aching in patient's thigh muscle in her both legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Patient had burning pain from toes to brain), PAIN (Body ache) and PAIN IN EXTREMITY (Aching in patient's thigh muscle in her both legs) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A2109 and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Patient had burning pain from toes to brain) and PAIN (Body ache). In March 2021, the patient experienced PAIN IN EXTREMITY (Aching in patient's thigh muscle in her both legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) at an unspecified dose and frequency. On 11-Mar-2021, PAIN (Patient had burning pain from toes to brain) had resolved. On 12-Mar-2021, PAIN (Body ache) had resolved. At the time of the report, PAIN IN EXTREMITY (Aching in patient's thigh muscle in her both legs) had not resolved.            No concomitant medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-JUL-2021 and contains significant information updated outcome of event pain in legs was changed from unknown to not recovered or resolved.
Pt reports receipt of entire initial anthrax series plus one booster, (Last anthrax vaccine in 2004). Patient noted pain and soreness of joints (knees, ankles, elbows and wrists) after receipt of first anthrax vaccine, After his 3rd anthrax vaccine, the pain lasted about 3 months. Initially pain was mild, but at worst, he describes pain as a constant throbbing with an intense level of 8-9/10 on pain scale. He also says significant others have noted a change in his personality in that he is "not as sharp" as he used to be. In 2007, pt denied ongoing joint pain. Symptoms: Joint pain, multiple joints, Fatigue, Malaise <60 Days, Cognitive deficiency.
This spontaneous prospective pregnancy report has been received from a consumer (patient's mother), for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female patient. The patient's medical history and concurrent conditions were not provided. The reporter indicated that the patient was currently pregnant and was vaccinated with two doses of GARDASIL. Therapy dates, dose, route and lot number were not provided. Concomitant therapies included CERVARIX. The patient's Last Menstrual Period (LMP) and Estimated Delivery Date (EDD) were not known. the pregnancy outcome was pending (patient was still pregnant at time of report). The reporter indicated the patient had not experienced any side effects. There was no indication as to why the patient was administered CERVARIX and GARDASIL concomitantly. No further information was available. Additional information is not expected.
During medication reconciliation, it was found that patient was given a non-valid dose of COVID 19 Pfizer vaccine on 8/19/2021. Patient notified and verbalized understanding that patient would need revaccination after 48 hours.
Was in line to schedule second appointment felt dizzy, caught by another person and did not hit his head. Last meal at 8am (vaccinated at 12:37PM). Denies any chronic medical conditions or taking any medications. BP 102/67 HR68 RR16, released in stable condition.
Guillian Barre syndrome - ascending paresthesias worsening over two weeks. Unable to drive 5 days of IVIG CSF leak from lumbar puncture tx with blood patch
Give it to her due to her being 17 years old; This spontaneous case was reported by an other caregiver and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Give it to her due to her being 17 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Give it to her due to her being 17 years old). On 27-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Give it to her due to her being 17 years old) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was unknown.  This report refers to a case of inappropriate age at vaccine administration  for mRNA-1273, lot # 013A21A  with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of inappropriate age at vaccine administration  for mRNA-1273, lot # 013A21A  with no associated AEs.
Patient did not experience an adverse event. Patient presented to pharmacy, requested a booster dose and filled out an eligibility form stating he was past his 6 month primary series. The technician that talked to the patient missed that patient was approximately a week too early for his booster dose, so the vaccine was administered a week early. Per CDC guidance, I am submitting  a VAERS for the administration error.
Today is 11/7/2016. My Shoulder and arm are still sore. My little finger tingles like it is asleep. The soreness kind of moves up and down from my shoulder to elbow, but hasn't gone away.
blurred vision, double vision, headaches, dizzy, poor vision, hand and foot twitch
Drooping of left side of face; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head/throbbing pain in left side of head; Facial swelling; neck and arm swelling; neck and arm swelling; Fast heart rate; Numbness in face, neck, and left arm; swollen lymph nodes in chest, under arm, left arm, neck, back, and head; This is a spontaneous report from a contactable other health care professional (consumer, patient). A 33-year-old non-pregnant female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 27May2021 09:15 (at the age of 33 years old) (Batch/Lot Number: EW0182) as single dose for covid-19 immunization. Medical history included known allergies: ondansetron hydrochloride (ZOFRAN) and dairy. There were no concomitant medications in two weeks. The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in right arm on 06May2021 11:30 AM (at the age of 33 years old) (Batch/Lot Number: EW0176) as single dose for covid-19 immunization. No other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. On 28May2021 07:00 AM, the patient experienced severe muscle pain in left arm, neck, and head. Facial swelling, neck and arm swelling. Fast heart rate. Numbness in face, neck, and left arm, swollen lymph nodes in chest, under arm, left arm, neck, back, and head. Drooping of left side of face and throbbing pain in left side of head. All for 11 days. No treatment for events. The outcome of events was not recovered.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  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.
had a bad reaction and got really sick after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 74 years 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: ILLNESS (non-serious), outcome "unknown", described as "had a bad reaction and got really sick after the first dose".  Additional information: The reporter stated they had some patients reporting some symptoms after the vaccine. She stated they had three female patients, all in their 70s, reporting long term fatigue beyond 4-5 days. And another female patient who was 74 years old who had a bad reaction and got really sick after the first dose. She asked if they recommend patients receive their second dose of the vaccine if they have had this type of reaction. She stated all of the patients were older and immunocompromised and she does not think these were adverse reactions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
she is  still sick; nose still stuff; nose starting running and started sneezing; chills; fever; fatigue,tired; headache; throat started hurting /  sore throat; arm sore,; and the one that aren't supper common, like  running nose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she is  still sick), NASAL CONGESTION (nose still stuff), OROPHARYNGEAL PAIN (throat started hurting /  sore throat), PAIN IN EXTREMITY (arm sore,) and RHINORRHOEA (and the one that aren't supper common, like  running nose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (throat started hurting /  sore throat), PAIN IN EXTREMITY (arm sore,), RHINORRHOEA (and the one that aren't supper common, like  running nose), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue,tired) and HEADACHE (headache). On 25-Nov-2021, the patient experienced ILLNESS (she is  still sick), NASAL CONGESTION (nose still stuff) and SNEEZING (nose starting running and started sneezing). In 2021, NASAL CONGESTION (nose still stuff) and OROPHARYNGEAL PAIN (throat started hurting /  sore throat) outcome was unknown, SNEEZING (nose starting running and started sneezing) had resolved. On 25-Nov-2021, PAIN IN EXTREMITY (arm sore,), RHINORRHOEA (and the one that aren't supper common, like  running nose), CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue,tired) and HEADACHE (headache) had resolved. At the time of the report, ILLNESS (she is  still sick) had not resolved.            Treatment details was not reported by the reporter.   This case was linked to MOD-2021-397570, MOD-2021-397552 (Patient Link).
Sleeping Alot; Cough; Chills; Headache Hurting Constantly; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping Alot), COUGH (Cough), CHILLS (Chills), HEADACHE (Headache Hurting Constantly) and PYREXIA (Fever) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-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 31-Mar-2021, the patient experienced HYPERSOMNIA (Sleeping Alot), COUGH (Cough), CHILLS (Chills), HEADACHE (Headache Hurting Constantly) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) on 31-Mar-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPERSOMNIA (Sleeping Alot), COUGH (Cough), CHILLS (Chills), HEADACHE (Headache Hurting Constantly) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported
Guillain-Barre nerve synd;acute idiopathic polyneuritis;had weakness, put on respirator;legs & arms paralyzed;pt hosp 15NOV97;
Nose bleeding; This is a spontaneous report from a contactable consumer (parent). A 17-year-old male patient (son) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 27May2021 as dose 1, single and second dose (Batch/Lot number was not reported) via an unspecified route of administration on 17Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that his son who was 17 years old, he was a minor received the 1st dose of Pfizer Covid19 vaccine on 27May2021 and had nose bleeding few days after the injection for 15 minutes. On his 2nd dose on 17Jun2021 he experience another nose bleeding after few days it lasted for about 15 minutes. He had his shot on Thursday and now he had a nose bleed again today, that was his second shot. She wants to know if this was one of the side effects of the vaccine and what they should do about it. He was wondering if have had this on many occasions or if we should seek medical attention. He want to know if that was a standard reaction that you contain or if we need to seek medical attention. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Increased joint pain in Back, Fingers toes and knees. Regular Headaches and Migraines continuing still to date (11/23/2021) Stomach (IBS) more frequent even with dietary changes.  After 1st shot - Out of work for three days With increased pain along with flu like symptoms. After 2nd shot with even more increased pain in joints and head along with flu like symptoms. Layed up for a week missing 3 more days of work.
2 days post vaccination patient states she developed a warm, red, itchy rash at the injection site.  Left deltoid appears to be red, warm to touch, no vesicles  or open areas noted. Secondary lesions due to itch. Pt states she took benadryl PO and did not help. Advised patient to monitor area,  keep clean and dry, cool rag to help decrease it. Pt instructed to call her PCP if issues continues
Patient got first dose on 18Jan2021 and still has not gotten the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got first dose on 18Jan2021 and still has not gotten the second dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got first dose on 18Jan2021 and still has not gotten the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got first dose on 18Jan2021 and still has not gotten the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # 041L20A, with no associated AEs.
A report has been received from a Health Professional concerning a patient of unknown gender. No relevant history or concomitant medication was provided. The patient had been receiving unknown FLUMIST quadrivalent (intranasal), 0.2 millilitres, unknown starting on 16-Sep-2015. It was reported that a consumer in the doctor's office may or may not have been injected with the FLUMIST quadrivalent vaccine which started on 16-Sep-2015. The outcome of the event of a consumer in the doctor's office may or may not have been injected with the FLUMIST quadrivalent vaccine was unknown. The report was considered to be non-serious by company physician.
2 1/2 year old very severely developmental delayed with mental Retardation also mom states language regression noted after vaccine. Now improved
Information has been received from a registered nurse concerning an elementary school aged child who was vaccinated with a dose of varicella virus vaccine live. On approximately 23-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved.   No further information was available. Additional information has been requested.
The patient was administered with an expired ACT-HIB vaccine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health-care professional via consumer/non-health care professional via Medical Information (Reference number- 00740290) and transmitted to Sanofi on 25-Aug-2021.  This case is linked to case 2021SA284105 (same reporter).  This case involves a 1-year-old male patient who was administered an expired HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] [Expired product administered].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for prophylactic vaccination.  On 24-Aug-2021, the patient received a 0.5 ml fourth dose of suspect HIB (PRP/T) VACCINE (lot UJ351AA; expiry: 09-Aug-2021) via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  It was reported, "Caller states that two patients that were seen on 24AUG2021 received ACT-HIB vaccinations that expired on 09AUG2021. Caller asked how to proceed in this situation."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
RASH, PRURITUS Severe itching/rash on entire body began two days after vaccination.  Seen by doctor. Prescribed methylPREDNISolone 4 MG tablet.  Rash resolved after medication was finished. Doctor advised against any further COVID vaccinations.
COUGH ON AND OFF; This spontaneous report received from a patient concerned a female 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 was not reported, administered on 14-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cough on and off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough on and off. This report was non-serious.
now cannot run; terrible knee pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the COVID-19 Vaccine and after the first shot, experienced terrible knee pain on unspecified date. The patient was an avid runner and now cannot run on unspecified date. The case was reported as non-serious. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
multiple outbreaks of herpes zoster; postherpetic neuralgia; scarring; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, and scarring. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of multiple outbreaks of herpes zoster, postherpetic neuralgia and scarring was considered as not recovered and causal relationship was assessed as related.  These events multiple outbreaks of herpes zoster, postherpetic neuralgia and scarring were considered as disability by the lawyer.
Left arm pain starting that evening.  Radiating from the injection site all the way down arm and also to the left shoulder.  Very painful to move arm or raise shoulder.  Anti-inflammatories, rest and ice/heat.  Just started treating this.  Outcome yet to be determined.
I began to have severe headache that would not go away even with Tylenol I proceeded to take my blood pressure with a blood pressure cuff and noticed my blood pressure was elevated. 140/95. I am a healthy adult and I do not suffer from high blood pressure.  After I received the Maderma booster shot I continued to have ongoing high blood pressure spikes and severe headaches dizziness and blurred vision for the next three days. I would like to add that my menstrual cycle also changed. 48 hours after I received the  Moderma shot I got my period. My menstrual was not due till November 29th.
When to bathroom. Had blood in urine and was dark brown too  drank 3 12oz bottles of water and cleared up  but still yellow. I have abdominal Paine and headache  and tired