chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at the top of his index figure; injection site pain; left wrist; left elbow; pain in left arm; radiating pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pain), PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (left wrist), PAIN (radiating pain) and ARTHRALGIA (left elbow) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (injection site pain), PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (left wrist), PAIN (radiating pain) and ARTHRALGIA (left elbow). On an unknown date, the patient experienced PAIN (Pain at the top of his index figure). At the time of the report, VACCINATION SITE PAIN (injection site pain), PAIN IN EXTREMITY (pain in left arm), ARTHRALGIA (left wrist), PAIN (radiating pain) and ARTHRALGIA (left elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.
This spontaneous case, initially received on 24-Feb-2018, was reported by other non-health professional and concerns a female patient of unspecified age. The patient's relevant medical history and relevant concomitant medications were not reported. On 10-Oct-2017, the patient was administered with FLUCELVAX QIV (batch number: 195210, dose, route of administration, anatomical location, expiry date: not reported). On 24-Feb-2018, after 4 months 15 days of vaccination, the patient was diagnosed with "flu strain B" [explicitly coded as vaccination failure]. At the time of this report, the outcome of the event was not reported.
pt recvd 2nd dose of Energix-B vax 13NOV90 & exp visual problems,blurring episodes lasting 30 secs & recurring 2 times / day.
Onset of erythema L thigh day after immunizations. Continued to increase spread of erythema. Mother had given Benadryl et had applied ice to site. Margins today 14 cm X 16 cm.
Information has been received from a nurse concerning a female who on an unknown date was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657449/0597U). Subsequently, the patient experienced "cellulitis" after getting the second dose. The physician was concerned that there might be a problem with the lot number. The patient sought unspecified medical attention. A lot check has been requested. Subsequently, the patient recovered. Follow-up information was received from a licensed practical nurse who reported a female between the age of ?-11 years old developed softball sized bumps on her arm following vaccination. The patient returned to the office. The physicians office has since switched to using another lot of vaccine and have had no other problems. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. No additional information is available.
This spontaneous report was received from a registered nurse refer to an unspecified number of unspecified patients received of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck), (lot number, expiration date, dose, frequency and route of administration not specified). No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. This is one of two reprots received from the same reporter. Additional information has been requested.
Hypotonic, hyporesponsive episode, "event immediate following shot."  pt recovered;
p/vax pt unable to walk; rt knee red, swollen X 2wk; to MD; tx  w/ibuprofen; cont to have difficulties w/knee & eyes; Dx=juvenile rheumatoid arthritis; pt had been walking fine since 10mos old;Annual follow-up states the pt has recovered.
1/22/10 pt received yellow fever vaccination; 1.29/10 Pt began experiencing intermittent "dizzy" feeling; she denies fever. SOB, difficulty breathing; states stomach feels queasy and today 2/1/10 feels dizzy with vague weakness; discussed options and patient will be seen if symptoms worsen or if she has continued concerns; patient plans to get a thermometer to take her temperature as directed.
This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 5-month-old male patient who received HIBERIX (batch number 5FC3Z, expiry date 20th January 2018). Co-suspect products included HIBERIX (batch number 4294M, expiry date 20th January 2018) and HIBERIX (batch number 4B745, expiry date 23rd February 2018). On 9th January 2017, the patient received the 1st dose of HIBERIX. On 21st April 2017, the patient received the 2nd dose of HIBERIX. On 30th June 2017, the patient received the 3rd dose of HIBERIX. On 21st April 2017, not applicable after receiving HIBERIX and HIBERIX, unknown after receiving HIBERIX and not applicable after receiving HIBERIX and HIBERIX, the patient experienced drug dose administration interval too long. On 30th June 2017, the patient experienced drug dose administration internal too long. On an unknown date, the patient experienced injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation. Rechallenge with HIBERIX was positive. Rechallenge with HIBERIX was positive. On an unknown date, the outcome of the injection site hyperpigmentation and injection site hyperpigmentation were recovered/resolved and the outcome of the injection site hyperpigmentation was not recovered/not resolved and the outcome of the drug dose administration internal too long and drug dose administration interval too long were unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. Additional details were reported as follows: The health care provider was called back with additional patient details regarding an adverse event he reported on 13th June 2017. He stated that the patients developed a hyperpigmented dark spot at the site of the injection of HIBERIX that was not resolved. It occurred with all three doses of HIBERIX which the patient received. The patient received 2nd and 3rd dose of HIBERIX later than the recommended schedule, which led to lengthening of vaccination schedule. This case was 1 of 3 cases reported by same reporter.
Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional (reported as office Staff). This case involves a 66 years old male patient who received expired dose of vaccine FLUZONE HIGH DOSE (batch number: UI884AA, expiry date: 24-May-2018) (dose, dose in series, route and site of administration was not reported) which was expired (last season) and had been out of proper storage temperature on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no concomitant vaccines. It was a case of actual medication error due to Expired vaccine used and incorrect product storage. It was not reported that if any adverse reaction was experienced or not. 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 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. List of documents held by sender: none.
Rash on neck 2 hours after 1st shot Rash on chest 5 days after first shot Rash on neck n chest worsen 1 hour after 2nd shot Rash on left eye n left temple 5 days after 2nd shot Rash in left ear n right top forehead 7 days after shot All rashes still present
Covid positive 12/29/22 headache, red burning eyes, head congestion, brain fog, difficulty performing mental and physical tasks, body aches
The night of receiving her second dose she began having full body muscle spasms and aches, horrible headache, confusion(not knowing answers to things she should know), and chills .  As of right now its been about 14 hours of this, some symptoms were expected but the full body spasms and confusion have been scary and we cant find information regarding those symptoms.
Patient received FLULAVAL QUADRIVALENT vaccine the afternoon of 09/07/17; later that evening patient presented with fever of 102; aches and chills.
Left arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 (Lot number: EL3249) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMICTAL; VIT C; MULTI VIT. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EK5731, Location of injection: Arm Left), administration date: 21Dec2020, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jan2021, outcome "not recovered", described as "Left arm pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Pt reported with 3 - 4 cm circular area of erythema, no bruising, neg for cellulitis, neg for infection, c/o of itching and tender to palpation. Pt states she noticed tenderness and swelling 5 days post vaccine for yellow fever.
Hodgkin Lymphoma, Lump on L side of neck Nodular Sclerosis. lymph nodes of head, face neck C81.11 Chemotherapy CT Scan, postiron Emission tomography (PET SCAN) biopsy L side of neck, MUGA Scan IV Port Placed
Sore arm right after receiving vaccine. In the middle of the night, soreness went down arm into the hand.; Dose received: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 21 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 18:00 (Lot number: FH8030) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 06Nov2021; TRI FEMYNOR. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin allergy", notes: Known allergies: Amoxicillin allergy. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Vaccine Administration Time: 05:15 PM, Route of Administration: Intramuscular), administration date: 07Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Vaccine Administration Time: 05:15 PM, Route of Administration: Intramuscular), administration date: 17Mar2021, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021 18:00, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2021 20:00, outcome "recovered" (2021), described as "Sore arm right after receiving vaccine. In the middle of the night, soreness went down arm into the hand.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.  Follow-up attempts completed. No further information expected.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 in Total dose were not reported, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported On an unspecified date, the patient had negative antibodies test (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210860607 and 20210860500.; Sender's Comments: V0: 20210860781-COVID-19 VACCINE AD26.COV2.S- suspected immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Fatigue, sore and pain in the arm, chill, fever like, headaches, light headed, weak, low heart rate measured 44-46 through out the next day. Blood pressure measured 133, 67. Felt like I was loosing it.   2nd day after the shot, rash and itchiness through out my left arm, left side of my mid section and both of my hands.   I didn?t have much reactions after the first two shots except for soreness in my injection arm. If I knew this,?I most likely would not have gotten the booster shot given the seriousness of the side effects.
Redness and swelling to both injection sites high outer legs bilateral.  Benadryl/ ice to areas-better in 24 hours per mom's report.
3 days after getting got achy, lasted about 3 days, 1 day later got burning sensation to left hip that lasted 24 hours, 3/27/19 noted rash on back that spread quickly to left lateral chest/anterior chest in 12 hours.
no previous history of covid and was fully vaccinated being very sick due to the delta variant; no previous history of covid and was fully vaccinated being very sick due to the delta variant; This is a spontaneous report from a contactable consumer from a Pfizer, reporting same event under the same suspect product for eight patients. This is one of eight reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the delta variant. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042702 same reporter/SD/AE, different patient
Worsen cough than normal. Constant wheezing flu like symptoms  hard time breathing  laryngitis. Several  rounds of antibiotics and steroid. Cough meds mucinex and tesslon pearls  duo neb treatments
Lower abdomen cramping, nauseous, throwing up, chills, diarrhea, mucus bloody stools, bleeding rectally. Went to Hospital 3/29/2021. Given morphine. Stomach symptoms took a few days to go away. Still sample came back negative for Salmonella, Shigella, Aeromonas, Plesiomonas, isolated, No Campylobacter isolatea.
I am experience severe Diziness and Vertigo like symptoms. I am unable to lay down and can only keep my head on a straight axis without feeling dizzy and unbalanced. I am feeling in a daized state much of the time like I was hit with a punch.
Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 067F21A, 015M20A and 007M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient's weight was unknown. It was reported that the patient received Moderna Covid-19 vaccine that underwent a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The nurse had used the online Temperature excursion tool and was comfortable that her patient dose was valid and that the affected vaccine was viable for future doses. Side effects after any of the doses were unknown. No treatment information was provided.
PATIENT PRESENTED TO THE PHARMACY ON 08/06/2016 WITH A RASH AT THE INJECTION SITE. PATIENT ADVISED TO FOLLOW UP WITH PHYSICIAN AND APPLY ICE, SHE HAD NO OTHER PROBLEMS.
This spontaneous report as received from a consumer refers to herself a 65 years old female patient with tetracycline allergy(give her a headache) and penicillin allergy. The patient's medical history included headache and a prior episode of shingles(in January 2010). The patient was vaccinated with ZOSTAVAX (Lot#, dose/frequency, dose number and route were unspecified) on 29-JUL-2012. No other co-suspects were reported. No concomitant medications were used. It was reported that, while on ZOSTAVAX, the patient experienced a headache, flu like symptom and was sleepy. She also was experiencing a weird, numblike sensation in the right ankle and right foot and a deep pain in the L5 region of her spine on 30-JUL-2012. The patient had sought medical attention via calling the doctor and she was prescribed VALACYCLOVIR HCL as treatment given for the AE. At the time of reporting the outcome was reported as not recovered/not resolved. Additional information has been requested.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. On 29-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 9 (dose and lot# not reported). On 30-JUL-2015 the patient was vaccinated with the second dose and on 12-OCT-2015 the third dose of GARDASIL 9 (doses and lot# not reported). No adverse effects reported. Additional information is not expected, due to no permission to contact with physician.
Resident is admitted to care center on 4/16/21 with COVID-19 (+) test result on 4/14/21 from Hospital. The resident was placed in Transmission-Based Precaution upon admission at care center and completed 4/30/21. She received the FIRST dose of COVID-19 Vaccine (Pfizer) on 5/12/21 at care center.  Resident was discharged to home on 5/19/21 and prior to discharge, the resident was tested with COVID-19 PCR and came out to be still positive - test result came back the day after the resident was already discharged. Family made aware and safety guidelines and instructions/procedures were given.
Localized swelling and erythema at site. Keflex oral antibiotic for 1 week.
Received MMRV#1, Hep A#1, and PCV13#4 vaccines in right leg. Had bloodwork drawn for CBC and lead and then noted to have urticarial lesions all over body.
10mins into his observation Client reported  feeling itchiness on collarbone  and numbness on his right side arm where he had received his vaccine. Client then proceeded to taking his own allergy med that he carries in his bag. Claritin 1 tab 10-15mg. Vitals signs at 3:15pm BP 109/60 HR 60 Respirations 18. He states he is allergic to sulfa, cucumber, avocado, banana which causes him to have an anaphylaxis response. Pt stated he hadn't had anything to eat and a granola bar was provided for him, as well as water. Vital signs BP 130/70 HR 70 RR 18, 3:27pm BP 125/75 HR 71 RR 18.  After third set of vitals were taken client reported feeling much better. 3:34pm BP 130/70 HR 70 RR 18 02 97%. Client reported itchiness had gone away. Client was in no respiratory distress and denied having any closing of throat. Client was informed to follow up with his Primary care provider, and emergency precautions were given. He left site in no apparent distress.
Arms sore; wrist tingling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arms sore"; PARAESTHESIA (non-serious), outcome "unknown", described as "wrist tingling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (18Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.