chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arthritis in my hands; Joint pain and joint cramping/The pain and stiffness totally gone; Joint pain and joint cramping/The pain and stiffness totally gone; This spontaneous case was received on 11-Sep-2021 via Med Communications (reference number: SEQW21-02146) from other non-health professional (consumer) and concerned a patient, of an unreported age and gender.   The patient's concurrent conditions included deathly allergy to peanuts and all peanut products. The patient's concomitant medications were not reported. The patient had gotten a flu vaccine each year and did not have any reactions at all.  On an unspecified date in Sep-2017, the patient was vaccinated with Seqirus influenza virus vaccine polyvalent (brand not specified; route of administration, dose, indication and anatomical location: not reported). The batch number was not reported.   On the same day, within a couple of hours after receiving influenza virus vaccine polyvalent, the patient developed severe joint pain and joint cramping. The severity lasted several weeks and then milder pain for the next four months.  On an unspecified date, the patient went to doctor and she tested the patient for several illnesses, but nothing appeared to be the problem.   On an unspecified date in 2018, after about five months, the pain and stiffness were totally gone, but the patient started having arthritis in hands, which the patient did not have before.  The outcome of the event 'arthritis' was not reported.   The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A patient of an unreported age was vaccinated with influenza virus vaccine polyvalent. On the same day, within a couple of hours after receiving influenza virus vaccine polyvalent, the patient developed severe joint pain and joint cramping. The severity lasted several weeks and then milder pain for the next four months. After about five months, the pain and stiffness were totally gone, but the patient started having arthritis in hands, which the patient did not have before. With information available at the moment, causality is assessed as possibly related for all events.; Sender's Comments: A patient of an unreported age was vaccinated with influenza virus vaccine polyvalent. On the same day, within a couple of hours after receiving influenza virus vaccine polyvalent, the patient developed severe joint pain and joint cramping. The severity lasted several weeks and then milder pain for the next four months. After about five months, the pain and stiffness were totally gone, but the patient started having arthritis in hands, which the patient did not have before. With information available at the moment, causality is assessed as possibly related for all events.
swelling in Left axilla (entire length, approximately 3 inches), next to Left Breast (area of lymph nodes); both L axilla and L breast tender and sore; symptoms began within 18-19 hours after vaccination; as of today, day 4, swelling and tenderness is decreasing.  No fever, no redness; no other reactions or symptoms.
Febrile convuls w/in 24 hrs of inject; Also had pnuemonia & bilateral otitis media;
RASH ON ABDOMEN THEN SPREADING TO THE BACK FACE THROAT AND ARMS; NAUSEA; ACHY; FLU; LUMP AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, food allergy, and drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced lump at injection site. On 13-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced achy. On 14-MAR-2021, the subject experienced flu. On 17-MAR-2021, the subject experienced nausea. On 19-MAR-2021, the subject experienced rash on abdomen then spreading to the back face throat and arms. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, and flu on 17-MAR-2021, lump at injection site on 20-MAR-2021, rash on abdomen then spreading to the back face throat and arms on 26-MAR-2021, and headache, and nausea on 18-MAR-2021. This report was non-serious.
This spontaneous report as received from a certified medical assistant refers to a patient of unkonwn age and gender. On 18-SEP-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location, lot# and expiry date were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Herpes Zoster; Information has been received from a lawyer regarding a case in litigation concerning a currently 88-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated for the event. The outcome of the event was not reported.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
This spontaneous report was received from a physician, via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 26-DEC-2014, the patient was vaccinated with an improperly stored dose of (23-valent) PNEUMOVAX 0.5 ml (VIs 10 SDV) (Lot number K007822, expiration date 15-AUG-2015), dose, route and anatomical location were not provided. There was no concomitant medication provided. On unknown dates, the (23-valent) PNEUMOVAX had temperature excursions for 48, 24 and 2220 hours, with the highest recorded temperature of 46.8 F (8.2 Celsius), 47.5 F (8.6 Celsius) and 59.9 F (15.5 Celsius) respectively. The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
body aches; chills; headache; dizziness; goes from being cold and hot; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 20Apr2021 08:00 (Batch/Lot Number: EW0171) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 20Apr2021, body aches, chills, goes from being cold and hot, headache and dizziness. Reporter clarifies that after the first dose of the covid vaccine, patient had all of the same symptoms but he did not pass out. Patient never felt 100 percent after receiving the first dose of the covid vaccine. All of the same symptoms after the first dose began the night patient received the first dose of the covid vaccine, 20 Apr 2021. The outcome of the event goes from being cold and hot was unknown while not recovered for the other events.
Soreness of his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of his arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0131921a) for COVID-19 vaccination.     Concomitant products included LORATADINE (DESOLIN), ATORVASTATIN and PROBIOTICS NOS for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness of his arm). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 2 tylenol. At the time of the report, PAIN IN EXTREMITY (Soreness of his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Jan 2019 I completed the shots shingrix and today went to doctor and have shingles; Shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.  In January 2019, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In January 2019, the patient received dose of Shingrix and experienced Shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for shingles were not provided
got the shot and got shingles; got the shot and got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-Jul-2022 Reporter's Comments: The patient's wife reported the case via interactive digital media. The reporter stated that her husband got the shot and still got shingles. She stated that it was really bad. Additional Supportive Information:  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Woke up with very bad headache and was screaming and crying for 5 min, mom gave him Tylenol and his headache started improving and he was back to normal in about an hour. He continued to do fine until later that evening when at 6:30 pm while getting out of the shower he started having severe headache again suddenly and started screaming again, mom tried giving him Tylenol which helped a little but he continued to have the headache and vomited 6 times so he was brought to the ER where BP was 146/82 on arrival and went up to 196/124. CT scan head was negative and lumbar puncture showed normal CSF except for elevated glucose. Diagnosed with hypertensive urgency, work-up was suggestive of catecholamine mediated hypertension. Imaging studies, that included MRI of abdomen/pelvis and head as wall as an MIBG scan were negative. Repeat urine and plasma studies for catecholamines and metanephrines were negative. Needed 2 anti-hypertensive medications with good effect and discharged home after 20 days in the hospital. Guanfacine, started 1 month prior to this episode was continued. Over the next 2 months, we were able to stop his antihypertensive medications. In the past 4 months, without anti-hypertensive medications, he has not had recurrence of headaches or hypertension.
Initial report was received on 19 November 2013 from a consumer from an unverified internet source, who is also the patient's parent. A female patient age two at the time of the event had received the HIB vaccine (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later, developed "hib meningitis, a rare case of vaccination failure". According to the mother, the patient was able to mount a much faster and more effective response as a result of the fact that she had been vaccinated. The patient is now 14 years old and is "bright, beautiful and healthy". The patient outcome is recovered on an unreported date. No further information was available at the time of the report. Documents held by sender: none.
Patient was administered incorrect dosage of Pfizer COVID vaccine. 12 year 3 month received 10 mcg dose instead of 30 mcg dose. No adverse event to vaccine administration occurred while patient was in the office.
Later that night patient had symptoms of abdominal pain, nausea, rhinorrhea and fevers. Patient described dry heaving as well. Patient states that similar symptoms occurred after the first shot but less severe.
ADMINISTERED 2ND PFIZER BIVALENT BOOSTER. PATIENT ALREADY RECEIVED THE BIVALENT BOOSTER ON 09/20/2022.  PATIENT STATED HER PROVIDER RECOMMENDED ANOTHER BIVALENT BOOSTER BEFORE GOING ON HER TRIP.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years (gender unknown) old patient who experienced jaw stiffness and jaw pain, while received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On 18-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ042AA, expiry date 19-Sep-2018 via intramuscular route in unknown administration site. On 19-Oct-2018, the patient developed a non-serious jaw stiffness (joint stiffness) on the same side as the injection, 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 19-Oct-2018, the patient developed a non-serious jaw pain (pain in jaw) on the same side as the injection, 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was jaw pain and jaw stiffness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for jaw stiffness and as Unknown for jaw pain. List of documents held by sender- none.
severe muscle ache in neck and between shoulders  lasted 3 days mild headache about a week
Patient approached pharmacist and stated that later the same night after the shot she felt soreness in her arm and knew that was related to the vaccine. However the soreness still hasn?t gone away and she states  that her range of motion in the left arm arm is limited. She still hasn?t regained full range of motion and can only lift her arm to her shoulder.
Severe shoulder pain; pain so bad that can not sleep,; hurts to use arm or raise it.; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW01710), via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EP7533), via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. 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 vaccination. On 01Apr2021, the patient experienced severe shoulder pain and pain so bad that cannot sleep and hurt to use arm or raise it. It's reported that the patient had severe shoulder pain that had not went away, pain so bad that he cannot sleep, and it hurt to use arm or raise it. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe shoulder pain and pain so bad that cannot sleep and hurt to use arm or raise it was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EH16208), on 02Apr2021 as dose 2, single (Lot number: ER8732) and on 21Dec2021 as dose 3 (booster), single (Lot number: FJ8757) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: Other medical history: HTN; "GERD" (unspecified if ongoing), notes: Other medical history: GERD; "Known allergies: Pesticides" (unspecified if ongoing), notes: Known allergies: Pesticides; "Known allergies: nuts" (unspecified if ongoing), notes: Known allergies:  nuts. Concomitant medication(s) included: AMLODIPINE BESILATE, start date: 01May2000; BENAZEPRIL, start date: 01May2000; OMEPRAZOLE, start date: 01Jan2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Negative, notes: Tested Negative for Covid 15Jul2022; (19Jul2022) Positive, notes: Tested Positive for Covid 19Jul2022; (23Jul2022) Positive, notes: Still testing positive 23Jul2022; (09Jul2022) Positive, notes: Tested Positive with a home test for the first time on 09Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient took other medication in 2 weeks. Patient took Paxlovid for COVID 19 Treatment, drug started on 09Jul2022 stopped on 14Jul2022.
This spontaneous report as received from a master of science in nursing (MSN) refers to a patient of unknown age and gender who on 20-MAR-2013 was vaccinated with (merck) VARIVAX 5 ml, subcutaneous (route and application site unspecified) (lot # H012506 exp date 25-JUN-2013). The reporter stated that the patient was vaccinated with an improperly (merck) VARIVAX dose. No adverse effect was reported. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown gender, age range reported as 10 (units not reported). On 04-NOV-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX lot number K005180, expiration date 10-APR-2016 (dose, dose number, route and frequency were not reported) which was improperly stored. No adverse effects were reported. The patient did not seek medical attention. No product quality complaint (PQC) involved. The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
next morning were not able to get out of bed and fell bpm  84/56 pulse 121 oxygen 92  next day it was 96/71. Still having problems walking. Blood Pressure is fluctuating, nausea, weakness. could not hold onto objects.  Pt is having extreme reaction to Vax and is not able to perform daily duties.
Information has been received from a licensed practical nurse concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who on 12-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. On 09-JAN-2008 the patient was vaccinated intramuscularly in the left upper arm with a 0.5 ml second dose of Gardasil (659055/1522U). Concomitant therapy included ORTHO TRI-CYCLEN LO. On 09-JAN-2008 the patient developed pain to the arm right after receiving the injection. The pain radiates down the left arm and has gotten worse since the injection. The patient called and was seen by her family physician, who told her that the injection was given improperly into the tendon or ligament causing a puncture wound. The patient last saw the reporting physician on 14-JAN-2008. At that time there was no bruising noted at the site. The patient was not able to lift her left arm. The patient has been using TYLENOL,  CELECOXIB, and heat as prescribed by her family physician. The patient's outcome was reported as not recovered. The patient's mother is requesting an MRI of the left arm, it has not been ordered at this time. There was no product quality complaint involved. Follow up information was received from the licensed practical nurse indicating that she would consider the patient to have temporary incapacity of her arm and therefore felt that the events were disabling. Additional information has been requested.
May 13 the SHINGRIX vaccine was given.  June 1 shingles developed on the right torso from chest to spine along the the underarm line.
Case number PHEH2044US003861, is a spontaneous initial report received from a pharmacist on 21 FEB 2014, with a follow up received on 21 MAR 2014. This report refers to a 15 year old female patient. Past medical history and concomitant medication were not reported. His vaccination history included administration of seasonal influenza vaccine (manufacturer unknown, batch number: not reported) which was well tolerated. She was vaccinated with FLUCELVAX (batch number: 010031A) and expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly into the left arm on 06 JAN 2014 at 17:00 PM. No adverse event was reported following this administration error (inappropriate age at vaccine administration).    Follow up received from pharmacist on 21 MAR 2014: Updated vaccination history, vaccination time and site of vaccination of FLUCELVAX.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 MAR 2014: The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as 'drug use in unapproved population".
Pt reports that he waited for about 20 minutes after being vaccinated. During that time he felt a little hot and drank some water, but says he otherwise felt fine. He states that he stopped for gas after leaving the clinic and has no memories after that until he was being pulled from his car by a paramedic. He states that he was told he had a seizure and crashed his car. After the motor vehicle accident he says he was transported to the hospital, where they told him he had had a seizure, did some tests, and then released him. Pt states his heart rate and glucose were both elevated when he was at the hospital, but that his CT scan was normal. He states he was feeling fine we he got gas, and says he feels fine now (5/10/21: three weeks and two days later). He saw his primary care provider last week (5/5/21) and was referred to Neurology. He had an MRI done, which he reports was normal, and an EEG, which he says he is still waiting on results from. Pt reports no history of seizure prior to 4/17/21.