chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rec'd imm on Tuesday 8/13/02. Noticed increased swollen L arm on Wed 8/14/02 PM. Did not run fever. Mother had adm Advil prophifactically. Does not c/o pain at site and has full ROM of L arm. Saw MD who recommended Advil and ice pads. Swelling now spread to below elbow and high on shoulder. Recommend see PMD. Saw MD 8/15/02. Dx with cellulitis and treated with Keflex.
Swelling in right axillary, supraclavicular area. Some itching at site of injection.
Slight chills started to set in 8 hours after the injection. After an hour long bath, the chills were extreme. I shivered and sweated for 12 hours overnight with a severe headache. I tossed most of the night and had to get up to pee 3 times throughout the night - which is extremely uncommon. By 24 hours after the injection, I still had a strong headache and was mostly able to regulate my body temp. By 36 hours after, I felt tired but no longer had a headache or chills. My injection site is red, raised and very tender.
Information is entered at follow-up provider's request. Information relates to patient vaccinated elsewhere and is based on parent reporting. Provision and date of DTaP admin as reported by parent is consistent with information in state immunization registry.   Patient seen for suture removal today. Mother reported child had #3 DTaP at the ED when these were placed. Time of vaccination is unknown. Mother reports child had erythema and swelling following this dose. On exam today, provider documentation relates "no erythema but had circumferential swelling of left thigh consistent with local reaction. Mother reports that she did put oil on the area yesterday and redness then resolved."
Facial swelling on left side of face; Severe headaches; feeling tired; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 17:30 (Lot number: FC3180) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious) with onset 10Aug2021 06:00, outcome "unknown", described as "Facial swelling on left side of face"; HEADACHE (non-serious) with onset 10Aug2021 06:00, outcome "unknown", described as "Severe headaches"; FATIGUE (non-serious) with onset 10Aug2021 06:00, outcome "unknown", described as "feeling tired"; ILLNESS (non-serious) with onset 10Aug2021 06:00, outcome "unknown", described as "sick".  Additional information: No relevant past drug history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. Since the vaccination, the patient had not been tested for COVID-19. Facial swelling on left side of face. Severe headaches, feeling tired and sick. Not sure if he should get the 2nd dose due to swelling of his face. Device Date: 10Aug2021.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 28-MAY-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot number, dose and route were not reported). No adverse experienced were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The day after receiving the vaccine, the lymph nodes in my left arm (armpit, clavicle, left pectoral, etc) became swollen and painful. This has continued today. This also happened during the first round of vaccination, although much less severe in pain and scope; prior, it was just my armpit that became swollen and painful.
I have had my period non stop since getting vaccinated; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: Ew0170), via an unspecified route in the left arm on 26Apr2021 (age at vaccination: 45-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: Er8733), via an unspecified route in the left arm on 01Apr2021, as a single dose for covid-19 immunization. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 01May2021, patient had her period nonstop since getting vaccinated. Adverse event resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. Therapeutic measures taken as a result of the events included unknown medication. The patient underwent lab tests and procedures which included ultrasound and biopsy, surgery next. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: 911 was called and paramedics assisted the patient, patient seemed ok by the time paramedics came
about an hour after getting the first vaccine, I started to get hives on the opposite arm. Followed by a itchy sensation inside my nose and sinus areas of face swelling.  I took 50mg Benadryl per pharmacy direction. Reported allergy reaction to my physicians office. At about hour three of the first dose of Benadryl, the symptoms returned. I waited for the four hours between to take 50mg more. The second dose did not change the symptoms but they proceeded to get worse to a sinus headache and back neck/upper shoulder pain. My blood pressure was slightly elevated and I was light headed. I then went to my physicians office urgent care hours. It was confirmed that I was having an allergy reaction to the vaccine and a stronger allergy medication was written. I took Hydroxyzine mg. I did not take a second dose because symptoms were gone in the morning when I woke.
Chills, headache, burning sensation in both eyes, body ache, nauseas, lack energy
No additional AE reported; VARIVAX that experienced temperature excursion was administered to one patient; This spontaneous report was received from an other and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 10-FEB-2023, one patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W021743, expiration date: 10-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided) concomitantly with sterile diluent (dose, strength, route of administration, lot#, expiration date were not provided) after a temperature excursion of 6 degrees Fahrenheit up to 14 degrees Fahrenheit (6.8 degrees Fahrenheit) for 10 minutes which occurred on 09-FEB-2023 (product storage error). There was a previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit (47.3 Fahrenheit) for 11 hours 50 minutes. No additional adverse events details or product quality complaints were reported (no adverse event).
Sore arm; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 004M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (Nausea). On 03-Mar-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. Not Provided          Patient used cold pack   and Marijuana infused cream as treatment.   This case was linked to MOD-2021-031230 (Patient Link).
Had pneumovax on 12/29/03, developed pain in that arm hours after shot. Seen in office on 12/31/03 with large area redness, given antibiotics for possible cellulitis. Treated with Dixloxcillin 500mg every 6 hours.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 16-MAR-2021 , the patient was vaccinated with an improperly stored dose of hepatitis rotavirus vaccine, live, oral, pentavalent(ROTATEQ) dose 1 (units not provided), per oral route (strength, dose #, frequency, and anatomical location were unknown) with lot # 1691301 and expiration date 12-DEC-2021 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The Vaccines program did an audit, and they were unaware of the excursions.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003496: US-009507513-2105USA003497: US-009507513-2105USA003498: US-009507513-2105USA003499: US-009507513-2105USA003500: US-009507513-2105USA003501: US-009507513-2105USA003502: US-009507513-2105USA003503: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
A non-serious spontaneous report of FLUMIST went into patient's eye was received from a RN/other health professional concerning a 39-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 11-Nov-2010, the patient received first half dose of FLUMIST, but while administering the second half dose vaccine the nurse slipped and the FLUMIST went into the patient's eye. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 20-Apr-2011: reporter confirmed that the patient did not experience any late occurring adverse events.
Within 5-10 minutes after receiving vaccine, patient began to become very pale.  Her symptoms included dizziness, syncope, stomach ache, foaming at the mouth, vision disturbances.  911 was called and paramedics arrived..  Her vital signs were all normal.  Patient did not wish to go to hospital, and her mother took her home.  Other pertinent information is that patient has a history of seizures and had been off of her seizure medication for 4 weeks.  I believe that I understood her mother to say that her neurologist knew she was getting the vaccine today.  Patient reported no allergies to any other vaccine, medication, or other.
Gave patient 0.25 Influenza vaccine (should have been 0.5 - I called mom and she brought patient back on the same day for additional 0.25 dose.
I received the shot in my upper right arm. This was on Wednesday. By the evening my arm was very swollen and hurt. The next day, Thursday, I was in significant pain and I could not extend my right arm completely. That evening the bicep on the right arm was red, swollen and very warm to the touch. The redness began to move down my arm into my lower arm. My son remarked that it looked like hives. I took some benedryl. I went to the urgent care the next day and they diagnosed the condition as cellulitis. They drew a line around the red area and said to monitor the spread. The redness continued across my whole upper arm and beyond the line. I was in signiicant pain and continued to be unable to extend my arm completely.  I took the antibiotics. My daughter sent me an article where I discovered there are significant side affects and saw the pictures of other patients with this result and suspect that this is an allergic reaction and not cellulitis. I contacted my primary care doctor via email and she also said it was cellulitis. I believe this is not cellulitis. My arm is still painful. I am taking Benedryl.
Patient came in to vaccination clinic for 3rd dose Moderna booster. Patient was given wrong vaccine and received a Pfizer booster instead.
This spontaneous report as received from a licensed practical nurse concerning a 68 year old male patient with no drug reactions or allergies reported. On 21-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose not reported) (Lot number J000444, expiration date 11-APR-2014). The nurse reported that the patient developed a blistering oozing rash and arm swelling after receiving ZOSTAVAX and was hospitalized in an unspecified hospital. The nurse requested a lot check for ZOSTAVAX lot the patient received. The patient sought medical attention. No PQC involved. At the time of report, the patient had not recovered from the events. Additional information has been requested.
A report has been received from a Physician concerning a 49 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced positive for influenza B, body aches and stuffy nose which started on 13-Nov-2012. At the time of reporting, the event of positive for influenza B, body aches and stuffy nose was improving. The report was considered to be non-serious.
Patient developed shakiness in legs while waiting in line due to standing too long. Taken to medical observation at 1036 for vaccine administration and for assessment. BP 124/62 HR 82 RR 16 At 1046 patient had resolution of symptoms She self administered 2 glucose tablets while in observation.
I contracted COVID-19 on 06/30/2022 with symptoms of fever of 102, brain fog, headache, cough, congestion, runny nose, lethargy, disoriented, and difficulty standing. I was prescribed PAXLOVID on 06/30/2022 and after taking one dose I became very nauseas and was advised to stop taking it. I took MUCINEX, NASACORT, and a saline rinse while I was ill. I was ill for 3 to 4 days before my symptoms began to improve. I am feeling much better today as of 07/08/2022 with lingering symptoms of congestion and slight fatigue.
Patient had no adverse effects or symptoms; medical assistant who reports six expired doses of VAQTA were administered; This spontaneous report has been received from a medical assistant referring a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On 17-JUN-2022, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliter once, lot number T031201, expiration date: 14-JUN-2022, as prophylaxis (strength, vaccination scheme, anatomical location of administration and route of administration were not provided) (expired product administered). It was stated that the patient had no adverse effects or symptoms from this dose. It was also mentioned that hepatitis a vaccine, inactivated (VAQTA) did not have any prior temperature excursions.  This is one of several reports received from the same reporter.
Head ache every day starting the day after, 3-day later, rash in throat (cold sores or something similar on roof of mouth), rash under right arm and rash on lower left-back.
Employee developed ovoid mass approximately 7 cms in height an 3 cm in width across mid right clavicle. Received FLUZONE on 12 Nov 2008 at 3:10 P.M. here at work. She noted the swelling the evening of 12 Nov 2008 after throwing a baseball. Was seen by me on 14 Nov 2008 and worked up by the personal physician at
Pt has had stiffness and pain in all of his joints since receiving the 1st Hep-B injection. Has not seen MD. Encouraged him to see MD. He also had numbness then a few days later, he had sniffles. 2nd injection not given.
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 32 years old female patient who had unable to move her arm, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Oct-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT626NA and expiry date: 20-Jun-2019) via intramuscular route in the left arm. On an unknown date, following the vaccination the patient had mobility decreased. (Other relevant tests included no lab data.) Final diagnosis was unable to move her arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for unable to move her arm. List of documents held by sender: none.
From initial information received on 29/May/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 31 year old female patient received TDS ADS adult, lot number U)833AA, administered intra-muscularly in the left deltoid on 23/May/2003. The next day, the patient developed a fever, which lasted for four days (temperature ranging from 100 to 101 degrees Fahrenheit), chest tightness and a swollen, red area at the injection site. Treatment included Ibuprofen 400 mg every six hours. Reportedly, the patient recovered from this experience. The reporter of this case is the same reporter for case 2003-01031, 2003-01545, 2003-01546 and 2003-01554.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, patients were vaccinated with a doses of improperly stored VARIVAX (Merck) (route, dose and frequency were not reported) lot # L015048 expiration date 29-APR-2017, lot # L013395 expiration date 16-APR-2017 and lot # L020002 expiration date 02-JUN-2017. No adverse effects have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose route and frequency unknown. On 15-NOV-2011 the patient was vaccinated with second dose of VARIVAX lot # 669601/0138AA which was improperly stored. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
New onset nephrotic syndrome. Symptoms of lower extremity edema started approx 7-10 days after vaccine. Followed by new onset hypertension, proteinuria and hypoalbuminemia, noted about 14 days after vaccine. Required renal biopsy (completed 11/22/22), which demonstrated active focal segmental glomerulosclerosis (FSGS).
Fevers greater than 101 even with Tylenol around the clock; heaviness in my head; chills; weakness and really tired; congestion (nasal - these symptoms continued for three days. Urgent care - Day two post vaccination.
Received Pneumovax on 11/6/07. That evening her arm was red, swollen and sore. Wednesday(11/7/07) the swelling was above and below her elbow. Sh was using cold compresses and Ibuprofen after seeing her MD. On 11/8/07 the arm was not as red or swollen. On 11/9/07 arm was back to normal.
Rash RAT erythema 2 x 3 cm with small vesicles - 1 erythematous ?? in groin. No Tx needed.
Patient experienced eye cornea flares ups; This spontaneous case was reported by a consumer and describes the occurrence of CORNEAL DISORDER (Patient experienced eye cornea flares ups) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. In 2021, the patient experienced CORNEAL DISORDER (Patient experienced eye cornea flares ups). The patient was treated with PREDNISONE for Corneal disorder, at an unspecified dose and frequency and VALACICLOVIR HYDROCHLORIDE (VALTREX) for Corneal disorder, at an unspecified dose and frequency. At the time of the report, CORNEAL DISORDER (Patient experienced eye cornea flares ups) outcome was unknown.            No concomitant medications were reported. The patient reported that after Moderna second covid vaccine dose she got eye cornea flare ups. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.