chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received covid a few months after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient received covid a few months after receiving the vaccine) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient received covid a few months after receiving the vaccine). At the time of the report, COVID-19 (Patient received covid a few months after receiving the vaccine) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   The patient had covid a few months after receiving the vaccine. Not sure of when the events started and was not able to locate the card for when she received the vaccine.  Treatment medication not reported.
extreme exhaustion, low grade fever 98.2 to 99.5 (normal is in the 97 degree range), loss of appetite
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's' medical history was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ZOSTAVAX, lot # reported as L046293, expiration date reported as 17-FEB-2017 (dose, route and site of administration were not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 8.8 degrees Fahrenheit for 7 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports from the same reporter.  Additional information has been requested.
Few papulovesicular rashes on ant (R) thigh where VARIVAX and PCV were administered the next day after vaccines were given.
Mo states pt fainted; pt pale & diaphoresing but responsive & answered questions appropriately-NH3 inhalent given & helped to building; 135PM BP 110/40, p 110; 145PM, bp 108/50, p 100; 215PM, BP 92/50;
No event; temperature excursion - vaccine not viable according to manufacturer; This spontaneous report was received from a physician and refers to a 7-week-old male patient.  The patient's medical history and concurrent conditions were not reported. On 08-JUN-2023, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (basic series); pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) (booster series).  On the same day, the patient received the first (also reported as booster series; conflicting information), improperly stored (Product storage error) dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # reported and upon internal validation confirmed as: 1968385, expiration date was reported and confirmed as: 22-MAY-2024, administered orally (exact dose was not provided) for prophylaxis, at private doctor's office/hospital, by the physician. No prescription drug treatment was required. Alarm believed to be due to sensory issues, monitoring temperatures with back up logger. Temperature in range, new data logger currently in use. No adverse effects reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA013096:
Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. The reporter states that the patient had "a tingling sensation in both her arms and hands" right after getting vaccination. Additional information has been requested.
sore throat; rash on side of arm; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RASH (rash on side of arm), PYREXIA (fever) and HEADACHE (headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RASH (rash on side of arm), PYREXIA (fever) and HEADACHE (headache). The patient was treated with IBUPROFEN for Headache, at a dose of UNK dosage form. On 15-Apr-2021, OROPHARYNGEAL PAIN (sore throat), RASH (rash on side of arm), PYREXIA (fever) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       M  Caller stated that he received his first dose on 13Apr2021 and he experienced side effects of headache, sore throat, fever, rash on side of arm. All his symptoms lasted for 2 days and he took Ibuprofen to relieve symptoms. Caller stated he did not want to get the second dose which is scheduled for today. Caller stated he wanted to report the symptoms and so he doesn't get billed for the services. Caller also mentioned that his son had some symptoms but when agent asked about his son, caller stated his son reported and he does not want to report for him. Caller also consented for agent to document contact information but wishes not to be contacted by safety.   This case was linked to MOD-2021-131474 (Patient Link).
continuous crying for 2 /12 hrs to 3 hrs some fever but mom did not have a thermometer to check
extreme nausea; body aches; headache; chills; I did not have antibodies; This is a spontaneous report from a contactable consumer reported for herself.   A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# 3246 on 12Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm in the hospital. Relevant medical history was not reported. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) for birth control. The patient had received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, on 24Dec2020 02:00 PM from Lot number#5730 at single dose for immunization, via intramuscular route at the left arm. The patient is not pregnant. No COVID prior vaccination. On 06Jan2021 the patient done a SARS coronavirus 2-VITALAXIS test (Nasal Swab) with negative result. On 13Jan2021 the patient experienced extreme nausea, body aches, headache, chills. The outcome of the events was reported as recovered on unspecified date in Jan2021. No treatment received. The patient received an antibody test two weeks after second dose and it indicated that she did not have antibodies.
This spontaneous report was received from a practitioner nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, concomitant medication or drug reaction described. On 29-OCT-2013, the patient received a second dose of RECOMBIVAX HB (route, strength, dosage schedule, lot # and expiration date were not reported). Then, on 10-DEC-2013, the patient was vaccinated with a third dose of RECOMBIVAX HB (route, strength, dosage schedule, lot # and expiration date were not reported), on a date so less than the recommended dosage schedule of 8 weeks. At the time of reporting, there was no adverse event reported. Additional information has been requested.
This spontaneous report was received from a medical assistant, referring to a 81 year old female patient. None medical history, concomitant therapy and drug reactions or allergies were reported. On 05-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (strength, dose, frequency and dose number were not reported), lot number N012840, expiration date 20-JAN-2019, for immunisation. The patient called to the physician's office on 06-OCT-2017 and inform that on the same date, the injection site was painful to touch, she was unable to lift arm and lightheadedness; but there was no redness or swelling. The patient was instructed to take MOTRIN or ALEVE, to put ice on the injection site and to contact the physician's office if there was not improvement. It was also reported that the patient made an appointment to see the physician 09-OCT-2017. Lab diagnostics or studies were not performed. The outcome of vaccination site joint movement impairment, injection site pain and dizziness was reported as not resolved. The causality assessment between PNEUMOVAX 23 and the aforementioned events was not provided.
After her COVID vaccine she had a sore spot distal to the injection site near her elbow. She continues to have some discomfort in her left arm. COVID booster was 3/9/22. She feels like her strength is normal but when she carries something she has significant pain in her left elbow. She denies any trauma to the elbow. Left elbow is not swollen or tender to touch. No joint effusion. No erythema. Full range of motion present in the left elbow without discomfort. Muscle strength is 5 out of 5 and equal in bilateral upper extremities. Extremities: No clubbing or cyanosis. No peripheral edema.
Chronic urticaria that developed about 2 wks after the vaccinations, have continued.
mom states pt had fever of 101.3 @ 7PM;By 9AM on 23AUG96, fever was 105.1;pt was taken to ER;
About 24-36 hours after vaccination, the patient began to experience fatigue and malaise, along with chills. By the next day, she experienced low grade fever, scratchy throat, myalgia, arthralgia of hips and lower back, and tinnitus. All of these symptoms began to diminish after about 5-6 days, and most have now fully resolved at day 10 post vaccination, when she presented to our Clinic.
high pitched crying for 6 hrs; local reaction erythema @ site of inject & lump
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 29-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 708 hours (sum of hours in excursion). The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a 12 year old male patient. His medical history and concurrent conditions were unknown. On unknown dates, the patient was vaccinated with GARDASIL 9 (first and second doses) (route, lot number and expiration date unknown) for prophylaxis. On 04-FEB-2016, the patient was vaccinated with GARDASIL 9 (lot # L020015, dose 3, in arm) (route and expiration date unknown) for prophylaxis. Concomitant therapies included methylphenidate hydrochloride (CONCERTA). On 14-FEB-2016, the patient's throat felt like closing (disability) and then he passed out (disability). On the same day, the patient experienced severe headaches (disability), muscle pain (disability), joint pain (disability). The patient now had seizures (disability), was constantly tired with fatigue (disability). On some days, the patient could not get out of bed (disability) and could not play sports he was involved in or even go to school (disability). On an unknown date, the patient required emergency visit for the events. On an unknown date, the patient was hospitalized for the events. The outcome of activities of daily living impaired, throat tightness, seizure, myalgia, mobility decreased, loss of consciousness, headache, fatigue and arthralgia was reported as not recovered/not resolved. The causality of the events was unknown. Additional information is not expected, as the case is from agency and we are unable to do follow up.
a little soreness in the arm; nauseated/cannot throw up anything, he was just continually nauseated; his stomach hurt; headache; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unspecified route of administration, on 10Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The wife stated that the patient received the Covid vaccine on 10Jan2021 with a little soreness in the arm on 10Jan2021 when he first received the shot. However, in a couple days in Jan2021, he got nauseated and his stomach hurt, but cannot throw up anything, he was just continually nauseated. He also had a headache for a while on Jan2021 but that's gone now. The patient's wife asked if there was something to help the patient with the nausea after receiving the vaccine and also asked if the patient should receive the second dose if he was experiencing nausea. The outcome of the event headache was recovered on Jan2021; nausea was not recovered; while the outcome of the other remaining events was unknown.  Information about the lot/batch number has been requested.
flare up of her acid reflux / reflux was really bad; flare up of her acid reflux / reflux was really bad / had silent reflux for several years but it has been well controlled in the last 6 months; Exhausted; Body aches; nausea; bloating; This case was reported by a consumer and described the occurrence of esophageal acid reflux in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included silent reflux.   On 28th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th November 2020, 1 days after receiving Shingrix, the patient experienced esophageal acid reflux, condition aggravated, exhaustion, general body pain, nausea and bloating. On an unknown date, the outcome of the esophageal acid reflux was not recovered/not resolved and the outcome of the condition aggravated, exhaustion, general body pain, nausea and bloating were unknown.   The reporter considered the esophageal acid reflux, condition aggravated, exhaustion, general body pain, nausea and bloating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Patient has had silent reflux for several years but it has been well controlled in the last 6 months. Patient reported that she received the 2nd dose of Shingrix vaccine on Saturday 28th November 2020 and on sunday 29th November 2020 experienced flare up of her acid reflux in night and stated the reflux was really bad also patient was exhausted and had body aches with nausea and bloating. The reporter did not consent to follow up.
Right around your second vaccine starting having right sided headaches, blurry  vision in left eye,  extreme fatigue,  constant pain in left side of head, short term memory issues
Before the main adverse event started, I started getting heart palpitations after the first day of my first dose of Moderna.  On August 22, 2021 at 9:45PM my heart started racing, over 160BPM, my heart felt like it was very irregular, and like it was going to explode in my chest. I called 911 and went into Emergency at 10:30 PM After that event, the palpitations never stopped.  I went for my second Moderna dose 4 days later on Aug 26th 2021. Since then, I have had non-stop PVCs, PACs, Abberancy runs and chest tightness/pain every day. I am now on a Beta Blocker for my heart, which helps the amount of palpitations I get a day. I still get them , but this significantly reduces them. I still however get on again, off again chest pain and tightness.   I have been for several EKGs and one Echocardiogram, showing my heart was structurally well, and that this is an elecrtical issue happening to my heart.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-JAN-2017, the patient was vaccinated with improperly stored dose of M-M-R II recombinant human albumin (RHA) lot # M002418 with an expiration date 12-JAN-2018 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of M-M-R II experienced the temperature excursion of -14.4 degrees Celsius for 54 minutes. There was no previous temperature excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742: Original Case : 1705USA009742.
shingles; death; This spontaneous report was received from a lawyer concerning a case in litigation and refers to a 80 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.       On or about 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported)  for long-term prevention of shingles and zoster-related conditions.         On an unknown date (reported as "subsequent to vaccination"), the patient experienced shingles and was treated with unspecified medications. On 07-JUN-2016, the patient died. The caused of death and if an autopsy was performed were not reported.  The outcome of shingles was unknown.  The reporter considered death and herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
2/2/07 R upper arm swollen 2 1/2 inches mildly raised with tiny small papules. TX: none
She first felt dizzy and light headed about 15-20 mins after shot. An hour later she used the bathroom on herself and was disoriented. The ambulance was called, her oxygen levels were low and she was taken to the hospital. She has seizures at the hospital and she has been sedated ever since.
Narrative:  57yo male with PAST MEDICAL HISTORY: 1 hyperlipidemia 2 djd 3 tobacco abuse -- quit in 6/2014 or so/used e cigarette to quit 4 s/p left knee surgery 2000/2002 -- s/p gsw per patient report 5 ptsd sees mhc 6 pvd -- h/o vasospasm at hands has seen hand surg for injections/stellate ganglion block 7 osa/on cpap 8 left lower ext dvt 2/2019/started on dabigatran (3-6 mo of therapy), recurrent dvt left lower ext 10/19 back on doac therapy 9 essential tremor/has seen neuro, taking carbi/levodopa 10 ddd cspine Had received covid vaccines on 3/29/21 & 4/30/21. Pt died on 12/4/2021. Last note on 11/8/21 in database. No info on cause of death or issues leading up to death in database. Unable to assess if vaccines were related to this death, but likely not given length of time from vaccine administration.
Visual disturbance; This case was reported by a physician and described the occurrence of visual disturbance in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2020, less than 2 weeks after receiving Shingrix, the patient experienced visual disturbance. On an unknown date, the outcome of the visual disturbance was unknown.   The reporter considered the visual disturbance to be unlikely related to Shingrix.  Additional information was provided as follows: The patient had a reaction to Shingrix as visual disturbances. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020GSK061777:Same patient
Redness and swelling around the injection site started on 11/29/2022 . Mother of patient reported that patient did not have a fever and the redness and swelling started to became larger on the left leg starting on 11/30/2022. Area was warm to the touch. Patient evaluated by provider and patient prescribed 10 day course of antibiotic.  Patient mother told to return to clinic if symptoms do not improve within 5-7 days after starting the antibiotic.
Seizure. 07/02/2007 MR received from PCP. WCC with normal exam on 4/26/2007.  F/U OV following hospitalization for seizure on 5/8/07 & 6/11/07. No further episodes since then. Assessment: Seizure. Vaccine info updated in VAERS.
No adverse event; Received  0.25ml  instead of 0.5ml for bivalent booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) 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 vaccination.     No Medical History information was reported.    On 15-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose) 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 UNDERDOSE (Received  0.25ml  instead of 0.5ml for bivalent booster dose).    The age of patient was more than 18 years.  No concomitant medications were reported.  The patient had 2 primary and 2 monovalent booster of Moderna COVID-19 Vaccine.  No treatment medications were reported.  This case contains information for the 6th of 7 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-648798, US-MODERNATX, INC.-MOD-2022-648812 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648798:same reporter US-MODERNATX, INC.-MOD-2022-648812:same reporter
Around 7 hours after the vaccine, internal pain started in the arm where the injection was made. After 24 hours had passed, the pain was stronger than any pain I have felt before. 6 days later, it is still interfering with daily activities as well as with sleep quality. No redness or swelling is visible, and pain is more pronounced when I make movements where I have to push my hand out. Only things that have helped are NSAIDs (I specifically used CELEBREX as I get adverse reactions with other NSAIDs, but while things improved over several days, my grabbing a tree leaf in my backyard and throwing it away (the movement made in throwing something quickly) brought me back to the pain I had 24 hours after the injection. I believe the pain/internal inflammation will dissipate on its own, but wanted to report this for statistical purposes. The Tdap vaccine I had 10 years ago did not cause me any discomfort beyond 36 hours after injection. Only thing I recall being different in my medical situation is I was on fexofenadine instead of ZYRTEC, and the age difference.