chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm for a couple of days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a mild case of shingles in April (year unspecified)).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR116813   Additional Information: GSK Receipt Date: 06-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient had mild case of shingles, so they recommended after that, the patient got the series of two shingles vaccines. After the first dose patient experienced a sore arm for a couple of days. Additional Supportive Information: Follow-up would not possible as no contact details were available. For tolerance of 2nd dose refer case US2022AMR116813, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR116813:Same reporter.
pt recvd 3rd dose of vax 24AUG92 & devel a sore arm @ the inject site; No further details were provided
Patient given a booster dose too early.  Received pediatric dose on 11/18/2021, a second adult dose on 01/10/2022 and his booster dose on 02/24/2022.  After review of CDC guidance the parent was instructed no further booster is needed at this time.
This spontaneous report as received from a nurse practitioner refers to a 14 year old female patient. The patient had no pertinent medical history and no previous drug reactions or allergies. On 04-AUG-2014, the patient was vaccinated with the first dose of GARDASIL lot # K005083, exp. date: 04-NOV-2016, 0.5 ml, intramuscularly (anatomical location was not reported). On the same day, 04-AUG-2014, the patient was vaccinated VAQTA, lot #K007791, exp. date: 22-AUG-2016, dose, route and anatomical location were not reported. At the time of vaccination the patient was not taking any medications but had recently weaned off of ACCUTANE. On 04-AUG-2014, later that evening, the patient experienced fever, hyperventilation, chills and nausea. The patient sought medical attention, he called to the office. No laboratory tests were performed. The reporter stated that there was no treatment given for the adverse events. The outcome of hyperventilation, chills, nausea and fever was reported as recovered on the same night, on 04-AUG-2014. The relatedness between vaccination with GARDASIL and VAQTA and the adverse events was not reported. Additional information has been requested.
Pt was observed for 30 minutes after vacination secondary to h/o hypothyroidism (autoimmune) pt was discharge and was in her usual state of health she came in the visit anxious about needles and vaccination process and tolarated well, upon leaving the faculty the pt started to feel dizzy and lightheaed and brought back for evaluation in a wheel chair no headaches ,no change in vision,her blood sugar was taken was 89,BP 142/82 HR 82 O2 SAT 98 Pt drank some water which she tolerated well. her legs were elevated she was monitor for 60 minutes vitals were retaken ww]as wnl,pt symptom were total resolved she walked out of the facility without any complications to be transpoted to her home with her family
POSITIVE QUANTIFERON (QFT) GOLD TUBERCULOSIS TEST; This spontaneous report received from a pharmacist concerned a 34 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with bcg vaccine. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced positive quantiferon (qft) gold tuberculosis test. Laboratory data included: Tuberculosis test positive (NR: not provided) Positive. The action taken with covid-19 vaccine  was not applicable. The outcome of positive quantiferon (qft) gold tuberculosis test was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
pt recv vax 31JUL95; egg size lump @ inj site & edema of axillary nodes inj arm on 1AUG95; early am of 2AUG95 pt had episode of sl chest pain & SOB; referred to MD; prescribed ATB & antiflammatory meds; MD states sx not reaction to vax;
A non serious, spontaneous report of flu-like symptoms and Influenza A has been received from a licensed practical nurse concerning three children of unconfirmed age, subsequent to receiving FluMist. This case is subscribed in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 50 months of age for FluMist. The patients' medical history and concomitant medications were not reported. On an unknown date, the patients received FluMist. On an unknown date, within three to seven days subsequent to receiving FluMist, the patients experienced flu-like symptoms manifested as high fever, cough, sore throat and runny nose and also tested positive for Influenza A. The events resolved. Required follow-up attmepts have been performed, requested information unable to be obtained. 18-Feb-2010.
patient stated that after receiving their vaccines and waiting their 15 minutes, they went to work. after being at work for 20 minutes they stated they felt a euphoric high feeling and left to go hone to sleep it off. the next day they felt terrible with normal symptoms (headache, fever, chills) but also said that they were suffering from severe pain at the bottoms of their feet. furthermore, the patient stated they went to the emergency department due to feeling so terrible and it was seen that her blood pressure was 90/60 and that she was given fluids at the hospital and monitored before being released. Although it has been a few weeks since immunization, the patient stated that they still are suffering from pain in their feet.
Patient reported feeling dizzy and drunk, felt like he was going to blackout and reported tingling in both arms and lips.
Patient presents clinic for mild swelling and pain with a rash in her left upper arm after getting tetanus shot 4 days ago.      States the swelling has improved slightly over the last couple  days but wanted to make sure she was okay. She denies any      fevers or chills. She reports having tetanus injections in the past without reaction. arm and dry; has  erythematous rash of left upper arm 10x14cm marked with skin marker, no induration, or nodules; normal turgor; some warmth to touch, no lymphatic streaking.
SORE ARM FIRST DAY. 1/9/2021 AT 7 AM HEADACHE, FATIGUE, BODY ACHES, CHILLS, FEVER RESOLVED IN 2 DAYS Narrative:  Other Relevant History:
This case was reported by a consumer via call center representative and described the occurrence of swelling of feet in a 55-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included stem cell transplant. On 14th January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced swelling of feet and ankle swelling. On an unknown date, the outcome of the swelling of feet and ankle swelling were unknown. It was unknown if the reporter considered the swelling of feet and ankle swelling to be related to SHINGRIX. Additional details were reported as follows: This case was reported via online chat. The patient had swelling of the feet and ankles and had just wondered if anyone might had reported this as a side effect. The patient would be happy to know. The patient stated that, she also consulted her oncologist regarding this problem. The reporter consented to follow up.
Persistent fever >101, vomiting, severe headache, severe joint pain, anorexia,  started 12 hours after vaccine and persisting now Day 3 since vaccine. Unable to function for work.  Had Covid illness 3/2020. Antibodies still present on blood work one week prior to vaccine. No hx of vaccine reactions in the past.
Patient's neck swale up both sides after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Patient's neck swale up both sides after receiving 1st dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL], ATORVASTATIN, LISINOPRIL, DIAZEPAM and CARVEDILOL for an unknown indication.    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 SWELLING (Patient's neck swale up both sides after receiving 1st dose). At the time of the report, SWELLING (Patient's neck swale up both sides after receiving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Called and the consumer refused for further follow-up, he is doing fine
Wrong Drug Administered; No adverse event; Minor Bleeding at Injection Site; An 11-month-old male patient mistakenly administered Td Vaccine (Lot #A126A) instead of SYNAGIS® (palvizumab). The administration error occurred on 22APR2021 at the patient's primary health care provider's office and the error was noted on the same day as administration. The total dose administered was 1.4mL (0.7mL IM into each thigh). The source of the report indicated that she made the error because she did not read the label closely, as opposed to label confusion. The source indicated there was minor bleeding at the injection sites but no other immediate reaction.  During the follow up call on 18May2021, the reporter indicated the patient was doing well and did not experience any adverse reactions. At the time of follow-up call patient still had not received SYNAGIS® (the intended drug product) but was expected to receive it soon. The patient's status is considered recovered and no further follow-up is needed.; Sender's Comments: The adverse event reported in this case was assessed as non-serious and not used as labeled.
administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29Dec2022. HCP mentioned the 1st dose of the bivalent was given on 22Sep2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29Dec2022. HCP mentioned the 1st dose of the bivalent was given on 22Sep2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On 29-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29Dec2022. HCP mentioned the 1st dose of the bivalent was given on 22Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29Dec2022. HCP mentioned the 1st dose of the bivalent was given on 22Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29Dec2022. HCP mentioned the 1st dose of the bivalent was given on 22Sep2022).    Patient was inadvertently administered with a 2nd dose of the COVID-19 Vaccine Bivalent on 29-Dec-2022.  HCP mentioned the 1st dose of the bivalent was given on 22-Sep-2022.  HCP mentioned patient did not reported any adverse event after the vaccine was given.  It was unknown if patient experienced any adverse event after previous doses of the vaccine. No concomitant medications were reported. No treatment medications were reported.
This spontaneous report was received from a physician and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of an improperly stored VARIVAX injection, lot # N030571 with expiration date on 31-OCT-2019 (dose and route of administration were not reported). The dose of the vaccine experience temperature excursion of 7.5 degrees Fahrenheit for 30 minutes. Previous temperature excursions of 8.8 degrees Fahrenheit for 1 hour and 14.7 degrees Fahrenheit for 1 hour and 45 minutes were reported. It was not reported if digital data logger was involved in the recording of the excursions. No adverse symptoms were reported.
Cold Sore; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2019, the patient received the 1st dose of Shingrix. On 30th October 2019, 3 days after receiving Shingrix, the patient experienced cold sores. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. Past Sunday, before reporting date, the patient received 1st dose of Shingrix and on Wednesday, she developed cold sores. The reporter did not wish to provide any additional details.
PATIENT MOVED FROM VACCINATION SEAT BACK TO WAITING ROOM. WHILE IN WAITING ROOM AFTER ONE TO TWO MINUTES, PATIENT ATTEMPTED TO GET UP OUT OF SEAT AND THEN FAINTED. HE WAS ABLE TO GET BACK INTO HIS SEAT AFTER THE INITIAL EVENT. HE CONTINUED TO FEEL NAUSEATED AND WAS SHAKY AND SWEATY. HE DID FEEL BETTER AS TIME PASSED AND WAS ABLE TO SPEAK IN LONG SENTENCES. PATIENT WAS ASKED TO REMAIN FOR AN ADDITIONAL 15 MINUTES BUT PATIENT REFUSED AND WAS DRIVEN HOME BY HIS WIFE.
Technician was administering vaccination and as the syringe was in patient's arm, syringe malfunctioned and half of the dose shot back into the technician's eyes. Patient was given a half dose afterwards to equal a full vaccination dose. Patient did not have any adverse reaction and was understanding of malfunction.
FOUR DAYS AFTER SECOND VACCINE PATIENT WENT TO EMERGENCY ROOM FOR CHEST PAIN.  PATIENT CONTINUES TO HAVE CHEST PAIN, SHORTNESS OF BREATH, FATIGUE, PALPITATIONS, ABDOMINAL PAIN, SEVERE PRURITIS AND NEWLY DIAGNOSED A-FIB.
15 min after vaccine, pt started complaining of chest pain and shortness of breath. EMS called and transferred to local hospital
3rd dose of Pfizer vaccine given.  Swelling under the right armpit.  Not consistent with lymphadenopathy specifically.  Temporally associated with the vaccine booster in the ipsilateral arm.  Started about 2 days afterward. Given some knowledge of subsequent abnormal mammograms after Covid vaccines, question whether this is some inflammatory response from the vaccine versus something different.  Does not have other alarm features of malignancy.  Will obtain CBC, also note that he is on Eliquis, so would make sense to get CBC from that perspective 2.  Patient will email me his vaccine card so we can fill out the vaers.
Increased temp, seizures, air vac to med center. Given Diastek 5 mg suppositories for seizures.
Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 004E21A, 031B21A and 002B21A) for COVID-19 vaccination.     Patient had no allergic reaction.  Previously administered products included for Flu vaccination: Flu vaccine on 28-Oct-2022. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Diabetes, Hypertension, Blood cholesterol increased (Elevated), Thyroid disorder (Thyroid problem) and Cancer in remission. Concomitant products included ANASTROZOLE for Cancer in remission, METFORMIN, LEVOTHYROXINE, BENAZEPRIL and ATORVASTATIN for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2022, the patient experienced COVID-19 (Covid). At the time of the report, COVID-19 (Covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2022, SARS-CoV-2 test: Positive.         Patient reported that patient had 12th day of COVID-19 and patient still had congestion in the head,rough throat and cough occasionally but not very often. Patient thought that actual Covid symptoms were gone. The adverse event did not cause patient to seek medical care . She had all medical conditions prior to getting the vaccine and they have been stable. The patient did not experienced a similar event in the past.  Treatment information was not provided.
After 24 hours I am unable to smell or taste and do not have any other symptoms except pre-existing sinus infection that I had day prior to second injection
Information has been received from a registered nurse concerning a 6 year old female who was vaccinated on 07/19/2000 with a dose of varicella virus vaccine live (Oka/Merck).  The patient was seen on 02/26/2004 with over 50 pox over his entire body.  No fever and no itching was noted.  The child was noted to have chickenpox breakthrough.  Unspecified medical attention was sought.  There was no product quality complaint.  The reporter indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed chickenpox breakthrough/shingles.  No further information is expected.
PATIENT RECIEVED MENACTRA. IMMEDIATELY FELT DIZZY AND LOOKED PALE. BP 100/42. PATIENT WAS HUNGRY AND GIVEN A GRANOLA BAR AND APPLE JUICE. STATED SHE FELT BETTER AFTER EATING. PATIENT SEEN BY NURSE PRACTIONER AND BP WAS 84/42 WHEN SHE SAT BACK UP. REPEAT AND FINAL BP WAS 100/50 AND SEEN AGAIN BY PRACTIONER. ALL VITALS OK AND PATIENT WAS SENT HOME IN CARE OF MOTHER.
around 15 minutes post-imz, pt reports dizziness and difficulty breathing due to palpitations. sat pt on the floor and gave her cold compress. had epipen readily available but determined difficulty breathing was due to increased HR/anxiety.  second rph came into clinic, took pts temp (WNL), blood sugar (was 122) and BP which was 157/103, HR 83. BP concerned pt so she stayed longer, called pts husband so she wouldn't be driving home. we rechecked 15 minutes later and BP check was 168/109, HR 89. pts breathing was rapid and shallow but no facial swelling or other signs of anaphylaxis. pt did not want us to call  EMS at this time. another 25 minutes later, BP recheck was 147/104 HR 82. Determined husband would take her to urgent care. Upon helping her get up and out to the car, pt became closer to passing out, she fell limp and started gasping for air. At this time I called EMS and paramedics arrived on scene to assess her further and took her to the ER, Follow up with pt about 2 hours later, she was still in the ER with her BP being monitored
Immediately swelling at injection site. The next day swelling was still present just bigger and more red. The third day, it was even bigger. Almost hard and bruised. Followed by a rash a few days later. Rash that's started on neck, the spread to face, shoulders, stomach, back, groin and legs. Still has a bruise at injection site.
This spontaneous report was received from a medical assistant referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates since 21-JUL-2017,  these patients were administered improperly stored VAQTA (lot# N012324 with expiration date 05-APR-2018, lot# N005274 with expiration date 03-APR-2018, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 47 to 77 Fahrenheit (F) for 43 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004623: US-009507513-1709USA004621: US-009507513-1709USA004622: US-009507513-1708USA007735: US-009507513-1709USA004620.
Red, hard and warm local reaction, 3 1/2 inches in diameter, Left, Tylenol, Ice. Child looks/act fine
Pt received covid vaccine and booster and is now hospitalized. Per H&P: Chief Complaint; SOA x 2 days, yellow phlegm, productive cough, vaccinated and boosted
2.5 degree fever for 2 nights and 1 day following shot. Dizziness, chills, and heavy fatigue.
Completed oral typhoid vaccine 2 days prior.  Presented with fine red rash under arms, trunk, lasted 2 days.  No other symptoms.  Treated with Zyrtec, and over the counter hydrocortisone.
on Day 8 post vaccination,  who presents to ED complaining of worsening shortness of breath for the past 4 days associated with cough and fever. Tested positive for COVID 8/29/21.  Pneumonia, ARF, Septic Shock, AKF, Received CRRT from effects of Baricitinib, . Coded resulting in Death 9/25/21.