chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4cm x 7cm red, raised, warm, tender area at site of injections of Adacel and Typhoid on 8/3/07. Patient reports sx began 8/4/07 and was seen at facility 8/8/07 with patient report of sx worsening. Treatment: Augmentin 875mg 1 PO BID x 7 days, Ibuprofen 400,g q 8 hours with food, Loratadine 10mg qd x 3-5 days, warm compresses QID. RTO 8/13/07 and call 8/10/07.
Information has been received from a registered nurse concerning a 24 month old male who on 25-JAN-2008 was vaccinated SC with a 0.5ml dose of PROQUAD Merck (lot # 656154/1353F). The RN reported that on 03-SEP-2008 the patient developed less than 50 lesion vesicular rash in trunk and axillary areas. The patient called the office for medical attention. The outcome is unknown. A product quality complaint was not involved. Additional information has been received from a nurse indicating that on 25-JAN-2008 the patient was vaccinated with the first dose of PROQUAD Merck, SQ in the right arm in the a.m. The nurse states that all pertinent information was given via phone. It was reported that the patient recovered. Additional information is not expected.
Symptoms began shortly after receiving vaccine.  Stomach began to hurt, achy feeling.  Following day c/o noticeably sore arm, ? low grade fever, then diarrhea, legs aching, and stomach "churning.
For about 4 months after receiving Anthrax shot, I had a severe upper respiratory infection, severe cough and chest congestion. Antibiotics did not help. Numerous test did not reveal anything significant. Effects eventually went away after 4 months.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "ITP" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; AIRBORNE; CALCIUM; PROBIOTICS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I finished Paxlovid then tested positive 5 days later. My cough and some symptom have returned. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medications in 2 weeks was Vitamin D, Airborne, One a day chewy, calcium and Probiotic. Patient did not have known allergies. Patient received Paxlovid (anti viral) from 06Jul2022 to 11Jul2022 for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feeling weak; throwing up; throwing up, diarrhea; Stomach felt hot; fever of 99.1 degree F; This is a spontaneous report from a contactable consumer received from program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 21Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the vaccine on 21Mar2021, and She called to report the symptoms she experienced on an unspecified date in 2021, after receiving the first dose like feeling weak, throwing up, diarrhea, stomach felt hot, and fever of 99.1 degree F for two days. The patient wanted to know when to receive the second dose. The patient underwent lab tests and procedures which included body temperature 99.1 Fahrenheit on an unspecified date in 2021. There was not any unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Initial unsolicited report received from a non-healthcare professional on 10 Oct 2016. This case involves a 66 year old female patient who was vaccinated with a dose of Fluzone HD (Batch number: UI634AB expiration date: 22 Mar 2017 and a dose of Pneumovax (Manufacture: Merck, Batch number: L047185, expiration date and route not reported) on 04 Oct 2016. Patient had cough and chest congestion illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects and medical conditions included Hyperlipidemia, PAD, and Emphysema. Concomitant medications were not reported. On 05 Oct 2016, 1 day following the vaccination, the patient had cellulitis to arm, arm began with erythema in morning. On 06 Oct 2016 was worse with warmth and pain. No fever noted. Patient required ER/doctor visit. Cellulitis diagnosed only by physical exam. Relevant diagnostic tests, laboratory data were not reported. The patient was treated with doxycycline. The outcome of the events were not reported. Upon internal review the case was considered as serious because of important medical events Cellulitis to arm/with warmth and pain. List of documents held by sender: none. Sender's Comments: Patient had suspected cellulitis following FLUZONE HD vaccine. Time to onset is compatible, but additional information regarding patient medical history, allergic history, aseptic precaution taken for injection, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed as two vaccine is administered.
Had mild to moderate pain in injection site (R upper arm) for approx 4 days after the vaccine, resolved entirely by 1/3. On 1/5, 7 days after receiving vaccine, developed onset within a matter of hours of R upper arm pain, swelling, itching and erythema.
slowly started to walk very slow,like her right leg was not  responding,now she is going like someone that is going into rehab for a stroke, after their first booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GAIT DISTURBANCE (slowly started to walk very slow,like her right leg was not  responding,now she is going like someone that is going into rehab for a stroke, after their first booster) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no allergies to medication, food and other products. The patient had not diagnosed or tested positive for COVID-19.  The patient's past medical history included Hemorrhage brain in 2013. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concomitant products included WARFARIN, ESTRADIOL, MECLIZINE [MECLOZINE], FAMOTIDINE, SODIUM LACTATE (LACTAT), AMITRIPTYLINE, SIMVASTATIN and LORAZEPAM for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (slowly started to walk very slow,like her right leg was not  responding,now she is going like someone that is going into rehab for a stroke, after their first booster). The patient was treated with Rehabilitation therapy for Gait disturbance. At the time of the report, GAIT DISTURBANCE (slowly started to walk very slow,like her right leg was not  responding,now she is going like someone that is going into rehab for a stroke, after their first booster) had not resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received blood thinner as concomitant medication.  The patient had no adverse event and both acute and chronic illnesses at the time of vaccination. It was reported that, the patient had this reaction a couple of week later. The patient had back in 2013 a brain bleed and the hospital cauterized the vain to stop the bleed. The patient was in rehab to control her right leg and was susceptible for covid.
Severe drowsiness within 20 minutes of vaccine. Continued throughout the event with onset of fever. Mother took child to ER.
Severe Pain in the right shoulder.  Next A.M. could not raise arm.  After 1 month still can not lift arm without pain.  Weight greater than 5 lbs. still has severe pain.  Full range of motion with assistance, pain with any arm movement greater than 15 degrees away from the hip.
Joint pain limited to hands that started approximately 1 week after injection. Started in one finger and progressed to entire hand, then both hands after each vaccination.
right sided face numbness developed on 12/5 at 9am, continued through 12/7 when evaluated by CNP
This spontaneous report as received from a licensed practical nurse refers to a 38 year old female patient. On 04-APR-2014, the patient was vaccinated with a dose of PROQUAD (Merck), subcutaneous (lot # and expiration date were not provided). Other suspect therapies also administered on 04-APR-2014, included VARIVAX (Merck) (route, lot # and expiration date were not provided). On 04-APR-2014, when the patient was 38 years old, she received PROQUAD (Merck) and VARIVAX (Merck) in error. There were no known adverse effects. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
After a week of administering the vaccine, my arm was given a red, itchy and hot area.
Ten hours after receiving Pfizer COVID vaccine Dose 2, client experienced "serious nausea and vomiting" lasting 6 hours. Client reported that felt "fine" the next day and did not seek medical attention or take any medication to treat.
Swollen fingers; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER873-) via an unspecified route of administration in the left arm on 19Apr2021 at 13:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to food, medications or other products. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 13:30  (at the age of 31-year-old) as a single dose for COVID-19 immunisation. 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 20Apr2021 at 12:00 the patient experienced swollen fingers . The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen fingers  was recovered on 20Apr2021.  No follow-up attempts are needed. No further information is expected.
severe case of shingles leading to spinal meningitis; shingles leading to spinal meningitis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER MENINGITIS (severe case of shingles leading to spinal meningitis) and HERPES ZOSTER (shingles leading to spinal meningitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 03-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. In May 2021, the patient experienced HERPES ZOSTER MENINGITIS (severe case of shingles leading to spinal meningitis) (seriousness criteria hospitalization and medically significant) and HERPES ZOSTER (shingles leading to spinal meningitis) (seriousness criterion hospitalization). The patient was hospitalized on sometime in May 2021 due to HERPES ZOSTER and HERPES ZOSTER MENINGITIS. At the time of the report, HERPES ZOSTER MENINGITIS (severe case of shingles leading to spinal meningitis) and HERPES ZOSTER (shingles leading to spinal meningitis) outcome was unknown.            Patient was taking immunosuppressants but stopped since being Hospitalized.  No treatment information was provided.  This case concerns a female patient with no relevant medical history, who experienced the unexpected event of Herpes Zoster Meninigitis and Herpes zoster. The events occurred approximately 2 months after the second dose of Spikevax.  The events were considered related to the product per the reporter's assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a female patient with no relevant medical history, who experienced the unexpected event of Herpes Zoster Meninigitis and Herpes zoster. The events occurred approximately 2 months after the second dose of Spikevax.  The events were considered related to the product per the reporter's assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.
5/5/09 At time of injections noted client flinched mildly. 5/6/09 Contacted client after receiving a phone call from his employer of an adverse reaction.  Client reported pain at time of injections in his right shoulder.  The pain increased during the day until he was experiencing severe pain and unable to move his right arm without pain.  He went to the Er at approximately 20:00-20:30 and received Benedryl and Prednisone along with a Rx for. He described the pain as almost gone and able to use right arm.  Client advised to contact Public Health if the pain did not go away.  No contact from client.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient).  A 6-decade-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's and concomitant medications were not reported. The patient experienced positive covid-19 test with symptoms on an unspecified date after both doses of vaccine. Expressed symptoms not great, felt like a super bad hangover with a bad cold, cough, no smell/taste. No problem breathing or anything. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a patient's mother concerning her daughter, an 18 year old female with a family history of grandfather's hypothyroidism and no known drug reactions or allergies who received the complete 3 series of GARDASIL (Lot numbers not reported) beginning in August 2010 and completed in January 2011. The caller reported her daughter experienced chest pains and shooting neck pains, and was taken to the ER on 11-FEB-2011. The patient stayed in the ER for 5 hours but was not admitted to the hospital. Blood work was done and ultrasound of thyroid was scheduled. The patient was diagnosed with Hashimoto's disease on 14-FEB-2011 by the physician. Patient's mother felt her daughter's diagnosis was related to having received GARDASIL. At the time of the report, the patient had not recovered from the Hashimoto's disease. No further information is available.
When I got the vaccine I could feel it sting. A couple days after that my arm was still sore as the time passed on the pain got worse. Now if I try to lift my arm to take off clothes it really hurts. I tried pain patches, medicine, no relief at all.
Information has been received from a nurse, via a company representative referring to 2 adolescent female patients of unknown age. Patients' medical history, concurrent conditions or concomitant therapies were not reported. On an unspecified date, the patients were vaccinated with GARDASIL (dose, lot number, expiration date and administration route were not provided). On an unknown date, the patients experienced syncope, also it was reported that the patients "did not eat prior to receiving the vaccine". The outcome of syncope was reported as recovered/resolved. The causal relationship between therapy with GARDASIL and the syncope was reported as unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Generalized rash & hives.  Symptoms where reported on patient's follow up visit on 3/17/08.
Jaw pain, stabbing pain in back, extreme fatigue for over three weeks which required hospitalization. Drs. thought it was his heart but was released from the hospital. Same thing occurred when patient got the second series on 7/19/18 which prompted the patient to believe it was the vaccine and report to the pharmacy.
Vaccine morning of 10/31/06 was achy and stiff neck next day, stiff neck continued and was severe 11-04 and 11/05. Stated better yesterday evening.
About 3 days after vaccination, underarm was swollen and sore, then spread to shoulder, and forearm with burning forearm, tingling hand and now I cannot raise my arm due to pain and I have lost most grip strength on the left side.
IRRITABLE BOWEL SYNDROME; DIFFICULTY SLEEPING; HEADACHES; This spontaneous report received from a patient concerned a 60-year-old white and not Hispanic or Latino male. The patient's weight was 280 pounds, and height was 71 inches. The patient's past medical history included upper/lower GI (gastrointestinal) done take some bowels removed, and concurrent conditions included lactose intolerance, alcohol user (2 Drinks per week), and smoker (1 pack per 2 week). Patient had no known allergies. He had no any drug abuse or illicit drug usage. On an unspecified date colonoscopy was done and result was unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: UNKNOWN) dose was not reported,1 total administered on 17-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patient experienced IBS (irritable bowel syndrome)/stomach pain/constipation/nausea. On same day patient experienced difficulty sleeping and headaches. On an unspecified date, he was admitted to hospital emergency room for several days. His physician was aware of his situation and patient was advised to take Miralax and fiber and was also prescribed morphine during hospital visit.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty sleeping, IBS (irritable bowel syndrome), headaches. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20210629530.; Sender's Comments: V0: 20210629309-covid-19 vaccine ad26.cov2.s-irritable bowel syndrome. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Golf-ball sized knot, localized heat, swelling.  No fever, no limited joint movement, no infection.
Information has been received from medical assistant concerning a 13 year old female patient who on 11-MAR-2008 was vaccinated IM with a 0.5 ml first dose of GARDASIL (lot# 655604/0052X). Concomitant therapy included MENACTRA. On 11-MAR-2008, after receiving the dose the patient was waiting on the table when 30 seconds later she landed backward on the table in which her eyes rolled back, she stiffened and jerked for 3 seconds. Patient stayed extra 15 minutes then went home. The patient was recovered. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with first dose of GARDASIL (dosing details were not reported) and then received a dose of GARDASIL 9 as second dose in the series. No adverse effects were reported. No concomitant medications were reported. There was no product complaint involved. Additional information is not expected, as the reporter did not wish further contact.
2 months of left shoulder pain and stiffness. Treatment so far has been OTC pain medication but will be referring to an ortho specialist
Office mistakenly gave flublok to a 3 year old patient, no AE; Initial information received on 01-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case involves a 3 years old patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number, route and site of administration were not reported) on an unknown date.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was reported that 3 years old patient received mistakenly flublok.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  Information on the batch number was requested.  List of documents held by sender: none.
Information has been received from a consumer for the pregnancy registry for GARDASIL, concerning her 18 year old daughter who in February 2008, was vaccinated with the first dose of GARDASIL 0.5 ml for HPV prophylaxis. Concomitant therapy included nadolol. On an unspecified date, the physician was unaware the patient was pregnant and vaccinated her with the second dose of GARDASIL. The consumer reported that on approximately 23-JUN-2008, her daughter had a miscarriage after getting the second dose of GARDASIL; and had to stay in the hospital for 5 to 6 days. The patient was 4 and a half months pregnant. On an unspecified date, a blood work and ultrasound were done (results not provided). Her LMP was 15-FEB-2008 and EDD was 21-NOV-2008. The patient sought medical attention. Additional information has been requested.