chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the dose was expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-week-old male patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.   On 12-JUN-2023, the patient received the 2nd dose of Engerix B. On 12-JUN-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: the dose was expired). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Jun-2023 At the time of reporting the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Was well at time of vaccination and became ill1 day post vaccination. Tested positive for COVID-19 on 05/05/2021
Patient experienced syncope less than 5 minutes after receiving the Janssen COVID-19 shot.  We alerted store management and called 911.  He regained consciousness after about 15 seconds or so.   We laid him on the floor and got cold, wet paper towels to hold on his head.  He felts weak but was alert.  EMS arrived and checked his vitals.  His vitals were ok.  He refused to go with EMS when he was asked.  We called his wife and she came and picked him up.
The second day after vaccine was given I awakened with both glands below my ears swollen as though I had the mumps. It lasted 2 days.
Knots on feet; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2022, the patient received the 1st dose of Shingrix (intramuscular). In February 2022, 1 week after receiving Shingrix, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix on left arm. She states that approximately one week after her Shingrix dose, she experienced knots on both of her feet.  The bigger ones were the size of golf balls.  The left foot had cleared completely but the right foot still had some knots. The reporter consented to follow up.
developed localized superficial phlebitis of his lower extremity; This spontaneous case was reported by a physician and describes the occurrence of PHLEBITIS SUPERFICIAL (developed localized superficial phlebitis of his lower extremity) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Phlebitis. Concurrent medical conditions included Diabetes.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHLEBITIS SUPERFICIAL (developed localized superficial phlebitis of his lower extremity). At the time of the report, PHLEBITIS SUPERFICIAL (developed localized superficial phlebitis of his lower extremity) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Pt was fine immediately after shot but around 5 PM was very tired & slept for most of the evening didn't want dinner & went back to sleep. Early next morning Temp 101.4. Motrin given. Around 04:00 & went back to sleep. Woke up with a yell. Parent's found him shaking in the bed for about 4 min. Mom rubbed his back & Pt said he could not feel his legs. Mom massaged his legs & Pt said they felt weak & shaky. He was shaking off & on. He got some Tylenol & went back to sleep. No fever, decreased P.O. intake & taking Pedialyte . Went to school. 2/10 back to normal.
This male subject was enrolled in a prophylactic study. On 16 February 2011, he received the 1st, 2nd dose of Sanofi Pasteur's PENTACEL (IM R thigh), ENGERIX B (IM L thigh), Wyeth's PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 10 May 2011, 83 days after the 1st dose of PENTACEL, 83 days after the 1st dose of ROTARIX, 83 days after the 1st dose of ENGERIX B, 83 days after the 1st dose of PREVNAR 13, this four-month-old subject developed pallor, low hemoglobin. The subject was hospitalised and the event was disabling. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the pallor, low hemoglobin may have been caused by PENTACEL, ROTARIX, ENGERIX B and PREVNAR 13 and that the event was possibly due to rule out viral infection, diamond black fan anemia and transient. Investigator Comments: Subject presented to the clinic on follow up for poor weight gain on 10May2011, it was noticed by the primary investigator that the subjects color was pallor. Hemoglobin was performed and was found to be significantly low at 4.4 g/dl, the subject was sent to the hospital for admission. Upon admission a 1/2 of a unit of packed red blood cells was administered followed by 2 more transfusions over the next day for a total of 3 transfusions. More labs were ran and a hematologist was contacted for consult. Upon review of labs he was unable to make a definitive diagnosis and would like to rule out Diamond blackfan anemia, Transient Erdythroblastopenia or viral illness. Child was discharged on 11May2011 and will follow up with primary investigator in 3 weeks, at that time more labs will be ran with hope to have a final diagnosis. Primary Investigator is unable to rule out possibility to vaccinations.
Within 24 hours of administration, quarter sized redness at site of vaccination - warm and raised. Normal soreness following vaccination.
Patient reports that roughly 2 hours after receiving the vaccine, she developed a sore, swollen arm (near the injection site). Over the next few hours, she became weak, experienced extreme shivering (no fever), muscle aches, and a tingling sensation that spread from her arm, across her chest, down her legs. The patient also reported a severe migraine headache, nausea, and some difficulty breathing. She reported using her asthma inhaler (albuterol), but this proved ineffective. She stated that the breathing difficult was "too bad", but that she still felt short of breath. Today (6 days after the injection), the patient is feeling somewhat better...though the tingling sensation remains.
This spontaneous report was received from a physician regarding a 9 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with PEDVAXHIB (reported as Hib) lot # L051124 with expiration date 14-OCT-2018 (dose, route and frequency were not reported) for prophylaxis when refrigerator was out of range (Incorrect product storage). This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004566: US-009507513-1701USA004717: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726.
Moderna COVID -19 Vaccine  Red itchy upper arm side and front in large area from just under injection site down to inside elbow.   Tylenol, Zyrtec, Benedryl, Hydrocortisone cream.    9 days
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      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.    No treatment information was provided.
pt recv vax 12AUG98 & pt c/o pressure in throat & chest w/diff to breath, coughing, (vomited later) MD was called STAT;pt cold & clammy, pulse 60, EPI & DPH;
Patient became dizzy, heart rate became elevated, and blood pressure became elevated. Patient did not improve after 15 minutes. EMS was activated and at scene in 10 minutes. Patient was walked out by EMS.
Patient received the 2nd dose 2 weeks apart instead of 3 weeks apart and tested positive for covid on 1/4/22
Pt recvd 2 doses of Engerix-B & had no reaction following 1st dose; w/in 24 hrs of 2nd dose devel adenitis, nausea, vomiting & diarrhea which lasted for 3-4 days a/resolving w/o treatment;
This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 52-year-old female patient who received ENGERIX B adult (batch number 3FZ74, expiry date 29th August 2014). Previously experienced adverse reactions included drug allergy. On 5th January 2015 09:00, the patient received the 1st dose of ENGERIX B adult (intramuscular) 1 ml. On 5th January 2015 09:00, the dose was 1 ml. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 6th January 2015, 1 days after receiving ENGERIX B adult, the patient experienced nausea. On 8th January 2015, the patient experienced rash. On 6th January 2015, the outcome of the nausea was recovered/resolved. On 12th January 2015, the outcome of the rash was recovering/resolving. The reporter considered the nausea to be probably related to ENGERIX B adult. The reporter considered the rash to be possibly related to ENGERIX adult. Additional information: Patient received first dose of ENGERIX-B and developed nausea one day afterwards and then a rash on both sides of the neck 3 days after the vaccination. The rash was raised and pink and was not itchy. No pustules or scabing. The nausea only lasted on day. The nausea is resolved and the rash is resolving.
PATIENT STATE HER THROAT SEEMS LIKE ITS HARD TO SWALLOW. NO OTHER C/O. ONSET 15 MIN POST VAX. NURSE ADVISED ADDITIONAL 15 MIN WAIT. A/W CLEAR NO DIB AFTER ADDITIONAL WAIT SITUATION IS RESOLVED 144/98 HR 103 RR 18 96% 98.4
uncontrollable shaking/twitching in fingers, hands, and arms when resting. Began when sick from second shot, and continuing to get worse and more frequent.
dizziness; diarrhea; tingling sensation; knee joints electric shock feeling; hives; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, diarrhea, tingling sensation, knee joints electric shock feeling and hives. Patient took anti-allergy medication and tylenol the second night after her first dose. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Rash and hives all over low arms (right and left), back, neck, chest. Injection site is normal with no rash
BLOOD CLOTS; This spontaneous report received from a consumer via social media via a company representative concerned a 10-decade (over 90 years)old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: chemotherapy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter stated that "One of my customers is over 90 years old she is on chemo and was pushed into taking the vaccine now she has blood clots on top of all the other problems she had".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220102495-Covid-19 vaccine ad26.cov2.s-Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient reports itchy rash all over upper torso that started about 6 hours after receiving vaccine. Patient denies swelling, difficulty breathing, or signs/symptoms of anaphylaxis. Patient took an antihistamine (does not remember which one, but not Benadryl), and the condition began to improve, yet not fully resolved as of 4 days after vaccination. Patient was instructed to inform primary care physician of reaction and to sign up for the V-Safe program to report the reaction to the CDC as well.
SWOLLEN RIGHT SIDE OF FACE/LOWER SIDE NOT CLEARED UP TILL NOW; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (SWOLLEN RIGHT SIDE OF FACE/LOWER SIDE NOT CLEARED UP TILL NOW) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced SWELLING FACE (SWOLLEN RIGHT SIDE OF FACE/LOWER SIDE NOT CLEARED UP TILL NOW). At the time of the report, SWELLING FACE (SWOLLEN RIGHT SIDE OF FACE/LOWER SIDE NOT CLEARED UP TILL NOW) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hypertension: (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no relevant concomitant medications was reported. No treatment information was provided
T103 2 days p/vax;pt was very weak in legs;pt had trouble standing on own p/waking from a nap;
clear runny nose; This case was reported by a consumer via interactive digital media and described the occurrence of runny nose in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced runny nose. On an unknown date, the outcome of the runny nose was unknown.   It was unknown if the reporter considered the runny nose to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUN-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient received the dose of Shingrix vaccine and experienced side effects such as runny nose. The patient asked was clear runny nose common side effect. Additional supportive information: The follow-up would not possible as no contact details were available.
Pt states his blood pressure has been uncontrolled since receiving 1st Covid vaccine.  Pt states he has been on 3 different blood pressure medications since vaccines received and BP still not controlled.  Pt instructed by PCP -, NP to call HD and report condition.
Patient with a history of neurocognitive disorder brought in by paramedics from home with concern for increased agitation, restlessness, confusion, hallucinations. Temporal relationship to 2nd dose of Moderna vaccine approx 24 hrs prior to onset.
Shakiness; Acute headache; nausea; Vomiting; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Nov2021 13:00 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pernicious anaemia" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 09Apr2021, when the patient was 57 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 19Mar2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Nov2021 13:00, outcome "unknown", described as "Booster"; TREMOR (non-serious) with onset 29Nov2021 09:00, outcome "recovering", described as "Shakiness"; HEADACHE (non-serious) with onset 29Nov2021 09:00, outcome "recovering", described as "Acute headache"; NAUSEA (non-serious) with onset 29Nov2021 09:00, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 29Nov2021 09:00, outcome "recovering", described as "Vomiting". Therapeutic measures were not taken as a result of tremor, headache, nausea, vomiting.  Additional Information: No other vaccine in four weeks administered. Adverse event:  Acute headache nausea vomiting shakiness beginning about 30 hours post vaccination and lingering 4 more days at present. Patient did not have Covid prior to vaccination and not test performed. No Known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Meraglia paraesthica; tingling and a numbness in my right thigh. It feels similar to your foot "falling asleep". It happens while standing or lying down.; tingling and a numbness in my right thigh. It feels similar to your foot "falling asleep". It happens while standing or lying down.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 18:00 (Lot number: Ew0179) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT D; VITAMIN C; IRON. The following information was reported: MERALGIA PARAESTHETICA (non-serious) with onset 04Jun2021 12:00, outcome "not recovered", described as "Meraglia paraesthica"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 04Jun2021 12:00, outcome "not recovered" and all described as "tingling and a numbness in my right thigh. It feels similar to your foot "falling asleep". It happens while standing or lying down.". Therapeutic measures were not taken as a result of meralgia paraesthetica, paraesthesia, hypoaesthesia.  Additional Information: Seriousness criteria reported as no. List of any other medications the patient received within 2 weeks of vaccination: Multi vitamin, vitamin d, vitamin c, iron supplement. The patient did not receive any vaccines within four weeks prior to the vaccination. Meraglia paraesthica, tingling and a numbness in right thigh. It feels similar to your foot falling asleep. It happens while standing or lying down. It has begun to subside over the past 2 weeks but not gone completely. Prior to vaccination patient was not diagnosed with covid-19. since the vaccination the patient had not been tested for COVID-19. No known allergies. Other medical history: N/A  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of 6 month old patient of unknown gender. It was reported that on an unspecified dates the patients were vaccinated with the first, second, third and fourth doses of LIQUID PEDVAXHIB (dose, route and lot number not reported), respectively at the 2 months, 4 months, 6 months of age and the fourth dose at an unspecified age. No adverse events were reported. This is one of two reports received from the same source (linked MARRS#: 1312USA003666). Additional information has been requested.
Severe burning, tingling, chest and back pain, intense pressure started on 04/14/21. Visited the family doctor on 04/15/21 and visited ER on 4/16/21 to rule out a heart attack. Shingles rash appeared on 4/18/21 and pain persistent and unrelenting. Extreme pain, only prescribed Advil or any OTC  from HCP.
Body ache. Fever. Chills. Diarrhea.  Headache.
I have been having chest pain that persists through to my upper back. Pain is new not something I have felt before and feels like it is located between my collar bone and breast. I have been unable to get into my pcp or an urgent care.
pt recvd vax & indicated that the numbness was progressing (spreading) up to calf & that had no sensation to needle pricks in foot; 3PAR93 pt was seen by MD & had blood specimens drawn for a series of tests;
Pt recvd MMR vax on 18DEC91 & 6JAN92 pt devel OM & on 13JAN92 devel parotid gland swelling on lt side of face; pt did not have a fever but exp some fussiness;
Myalgia; Arthralgia; Fatigue; Fever; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Arthralgia), MYALGIA (Myalgia) and FATIGUE (Fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included Lyme disease and COVID-19. Concomitant products included HCTZ, CLONIDINE, ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID), MONTELUKAST SODIUM (MONOCAST [MONTELUKAST SODIUM]) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue). On 08-Jan-2021, the patient experienced ARTHRALGIA (Arthralgia). On 09-Jan-2021, the patient experienced MYALGIA (Myalgia). On 08-Jan-2021, PYREXIA (Fever) had resolved. On 09-Jan-2021, HEADACHE (Headache), ARTHRALGIA (Arthralgia) and MYALGIA (Myalgia) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.