chrisvoncsefalvay/vaers-outcomes huggingface dataset:
choking sensation in neck; jaw felt like it was getting huge; couldn't stand; couldn't walk; This is a spontaneous report from a contactable consumer (patient) received via the Medical Information Team. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 18Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced choking sensation in neck. It was really bad, her daughter gave her many glasses of water and that seemed to help. Her jaw felt like it was getting huge and she couldn't stand or walk for a few days. Her doctor told her to take paracetamol (TYLENOL) and diphenhydramine (BENADRYL) before and after she gets the vaccine. The patient asked if she should get the second vaccine. It was scheduled on 08Apr2021. The outcome of events choking sensation in neck, jaw felt like it was getting huge, couldn't stand, and couldn't walk was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had single episode of loss of consciousness - episode preceded by nausea and lightheadedness Paramedics came to home, no vitals done, patient not transferred to hospital Patient continues to have lightheadedness  No personal or family history of stroke, diabetes, hypotension, seizures, migraines
This spontaneous report was received from a pharmacist via a healthcare student refers to a approximately 59 year old male patient. Approximately 2 months ago on 15-MAY-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown) (lot #, expiry not reported). On an unknown date in 2013, the patient experienced swollen lymph nodes. The patient also received a cortisone injection(manufacturer unknown). Since the pneumococcal vaccine was unknown to the healthcare student, this adverse experience was reported as Merck's PNEUMOVAX. The healthcare student did not have physician details available at the time of the call. The outcome of swollen lymph nodes was reported as recovered on an unknown date in 2013. Additional information has been requested.
achiness on lt side, redness & swelling;lt shoulder pain w/area of erythema about 4x8cm in lt deltoid area;no regional adenopathy or signs of cellulitis;warm to touch & gen tenderness in the area;oropharyngeal exam negative;
HIGH FEVER, CHILLS, BODY ACHES, FATIGUE, DIARRHEA, VOMITTING, HIGH BLOOD PRESSURE, DEHYDRATION, MINOR COUGH AFTER OTHER SYMPTOMS HAD CLEARED.
Headache, Body & Joint Pain, Fatigue, Tingling/numbness in right hand (ring and pinkie fingers), Muscle twitching in right hand, right eye
The child's mother called 2-12-02 stating child had been seen on 2-8-02 by a doctor and diagnosed with ear infection. Child had awakened during the night screaming and covering his ears. Child has had ear infections in the past. He was at the end of his course of antibiotics on 2-1-02 when immunizations were given. Healthy at that time. Mom states that the doctor didn't think there was any connection to immunization. On another antibiotic at present for the ear infection. Has follow-up doctor appointment scheduled.
achy; headache; warm spot at the injection site; raised spot at the injection site; itchy spot at the injection site; red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm spot at the injection site), PAIN (achy), VACCINATION SITE INDURATION (raised spot at the injection site), VACCINATION SITE PRURITUS (itchy spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm spot at the injection site), VACCINATION SITE INDURATION (raised spot at the injection site), VACCINATION SITE PRURITUS (itchy spot at the injection site) and VACCINATION SITE ERYTHEMA (red spot at the injection site). On an unknown date, the patient experienced PAIN (achy) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm spot at the injection site), PAIN (achy), VACCINATION SITE INDURATION (raised spot at the injection site), VACCINATION SITE PRURITUS (itchy spot at the injection site), VACCINATION SITE ERYTHEMA (red spot at the injection site) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Patient stated that the spot was 2inches in diameter and then grew to 5 inches in diameter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-JUN-2021, contains no newinformation. On 10-Jun-2021: Follow-up information received on 10-JUN-2021, updated contact details(mail address).
Initial information was received from a consumer on 21 Feb 2014. This report represents one of a cluster of two patients reported by the same reporter. The case is linked to serious case 2014SA023341. A 89 year old male patient whose medical history and concomitant medication were not reported received, a dose of FLUZONE HD vaccine (route, site, dose and batch number not reported). It was reported that on an unspecified date patient had experienced muscle and joint aches. Patient had muscle and joint aches for several month. Laboratory investigations and corrective treatment were not reported. At the time of report outcome of event was not recovered. Documents held by sender were none.
swelling face, mouth, lips; swelling of face, tongue; Itching; From my lips and left ear, down my jaw I am numb; face and neck turned red/hand are itching and red; hives all over body; Allergic reaction; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (swelling face, mouth, lips), SWOLLEN TONGUE (swelling of face, tongue), PRURITUS (Itching), HYPOAESTHESIA (From my lips and left ear, down my jaw I am numb) and ERYTHEMA (face and neck turned red/hand are itching and red) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced SWELLING FACE (swelling face, mouth, lips), SWOLLEN TONGUE (swelling of face, tongue), PRURITUS (Itching), HYPOAESTHESIA (From my lips and left ear, down my jaw I am numb), ERYTHEMA (face and neck turned red/hand are itching and red), URTICARIA (hives all over body) and HYPERSENSITIVITY (Allergic reaction). At the time of the report, SWELLING FACE (swelling face, mouth, lips), SWOLLEN TONGUE (swelling of face, tongue), PRURITUS (Itching), HYPOAESTHESIA (From my lips and left ear, down my jaw I am numb), ERYTHEMA (face and neck turned red/hand are itching and red), URTICARIA (hives all over body) and HYPERSENSITIVITY (Allergic reaction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient was given Benadryl after the initial onset of the events. 5 hours after taking Benadryl, the events returned and the patient took another dose of Benadryl.
This case was reported by a consumer and described the occurrence of incorrect storage of drug in a patient who received FLUARIX QUADRIVALENT (batch number XJ497, expiry date 30th June 2015). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information: The reporter informed that approximately 300 patients were vaccinated with FLUARIX QIV that had been exposed to room temperature for about 96 hours. This time at RT is beyond the stability data that we have.
Daughter called and said she had just been to doctor complaining of pain in shoulder. Doctor stated that he thought it was arthritis. Daughter called and stated that she thought it was due to shot and that pain started soon after shot but did not go to doctor until May 2019.
Very fatigued, went to bed around 7:30 pm on day of shot; woke at about 2 AM - felt awful, flu like.  Headache, body aches, etc. Such fatigue like never felt before.  Just walking the short distance to the bathroom exhausted me.  Woke up and feeling awful all day.  Just want people to know so they won't schedule this shot during the work week.   My arm is also very very sore at injection site.
COVID infection after full vaccination. Vaccination in April, infection in July; COVID infection after full vaccination. Vaccination in April, infection in July; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single; dose 1 via an unspecified route of administration on an unspecified date in Apr2021 as dose 1, single, both doses for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced COVID infection after full vaccination. Vaccination in April, infection in July on an unspecified date in Jul2021. Event took place after use of product. The patient underwent lab tests and procedures which included COVID infection was positive on an unspecified date in Jul2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.
20yoF with history of functional movement disorder (followed by Dr. (Name) and previously seen by Dr. (Name), movement specialist in our department) now presenting with worsening of baseline myoclonus in the setting of receiving the COVID vaccine earlier on 4/5. On exam, she is alert, in NAD with myoclonic jerks, RUE > LUE, perhaps more prominent than usual for her. She is distractible when engaging in parts of exam, such as while holding her mask or before I enter the room. She did not have any dystonia on exam; she has normal tone. Her neurologic exam is otherwise normal with full strength and symmetric reflexes. Most likely this represents a worsening of existing functional movement disorder i/s/o stressor of receiving the vaccine. Given relative distractibility, absence of dystonia, and lack of response to 50mg of Benadryl, this does not look consistent with a dystonic reaction.
Exposed, below freezing, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The pharmacy resident reported that Flulaval which was exposed to temperature below freezing (24.4 Fahrenheit) was administered to 5 employees. The vaccine administration facility was the same as primary reporter. The reporter did not had any other details but agreed to follow-up via email only. The reporter consented to follow-up. This is one of five linked cases reported by same reporter for different patients. Additional supportive information: The patient received Flulaval after temperature excursions, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR152067:Same reporter US-GSK-US2022151428:Same reporter US-GSK-US2022AMR152066:Same reporter US-GSK-US2022AMR152068:Same reporter US-GSK-US2022AMR152066:Same reporter
Case number PHEH2015US026966, is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 27-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 05 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there were no problems since the temperature excursion. No adverse reaction was experienced by the patient following the medication error. Follow up information received via nurse on 26 Jan 2016: Reporter's comments updated.
Headache, NauseaVomiting, mental fog, fatigue , congestion Narrative:  reports she has history of Epstien Barr Virus, reports she will contact her provider for further evaluation
Does not feel like himself; Chills; A spontaneous report was received from a 50-year-old, male, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills and does not feel like himself.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, a few hours later prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 30 Dec 2020, a few hours after receiving the vaccine, the patient had chills. On 31 Dec 2020, the patient felt fine.  On 01 Jan 2021, he had chills again.  On 02 Jan 2021, the patient stated he does not feel like himself and the chills comes and goes.  Treatment for the events included acetaminophen and ibuprofen.  Action taken with mRNA-1273 in response to the events was not reported.   The events, chills and does not feel like himself, were not resolved at the time of this report.; Reporter'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.
pt recv vax 22SEP97 & on 22SEP97 pt devel a fever;23SEP97 pt devel a recent rash & questionable blisters;
No adverse event; patient received Moderna COVID-19 Vaccine, Monovalent, lot number 015B22A, as a booster dose on 27Jan2023 instead of Moderna COVID Vaccine, Bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received Moderna COVID-19 Vaccine, Monovalent, lot number 015B22A, as a booster dose on 27Jan2023 instead of Moderna COVID Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (patient received Moderna COVID-19 Vaccine, Monovalent, lot number 015B22A, as a booster dose on 27Jan2023 instead of Moderna COVID Vaccine, Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received Moderna COVID-19 Vaccine, Monovalent, lot number 015B22A, as a booster dose on 27Jan2023 instead of Moderna COVID Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
A nurse reported that a female in her 30s did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  Concurrent conditions included obesity and tobacco use.  The subject was "otherwise healthy".  Concurrent medications were not reported.  The subject received injections of Engerix-B on 06/05/2002 (Lot # ENG5285C6).  On 03/06/2003, a hepatitis B surface antibody titer was less than 3mIU.  The reporting nurse stated that the lack of response to the Engerix-B immunization series could have been associated with the subject's obesity and tobacco use.  On 03/17/2003, the subject received a fourth injection of Engerix-B.
Red, swollen arm 2 days post vaccine. Went to urgent care and was put on an antibiotic. Was told she was being treated for cellulitis.
pt noted extremely high blood sugars, dizziness, confusion within a certain time after her second dose. She was admitted to the hospital for the same.
Some numbness in arm; Tingly in arm; Pain on side; Sweat a lot for about 40 hours; Heart rate was 135; Oxygen was down to 91; Joint pain; Chills so bad; Fatigue; Strong headache; Muscle pain; Fever 101.6; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours) and HEART RATE INCREASED (Heart rate was 135) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included METFORMIN for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours), HEART RATE INCREASED (Heart rate was 135), OXYGEN SATURATION (Oxygen was down to 91), ARTHRALGIA (Joint pain), CHILLS (Chills so bad), FATIGUE (Fatigue), HEADACHE (Strong headache), MYALGIA (Muscle pain) and PYREXIA (Fever 101.6). At the time of the report, HYPOAESTHESIA (Some numbness in arm), PARAESTHESIA (Tingly in arm), PAIN (Pain on side), HYPERHIDROSIS (Sweat a lot for about 40 hours), HEART RATE INCREASED (Heart rate was 135), OXYGEN SATURATION (Oxygen was down to 91), ARTHRALGIA (Joint pain), CHILLS (Chills so bad), FATIGUE (Fatigue), HEADACHE (Strong headache), MYALGIA (Muscle pain) and PYREXIA (Fever 101.6) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include metformin, blood pressure medications, cholesterol medications.  Treatment for the event included ibuprofen (Advil)
gout attack  within 2 weeks, and I haven't had an issue in over 10 years., was starting to get better, but then 2nd shot threw into high gear. couldn't walk the pain was so bad
This case is a part of 2 cluster cases and is linked to AER# 2013-07490 (same reporter, similar event after DAPTACEL (batch number: C4452AA), IPOL (batch number: J1028) and MMR vaccine (Merck Product, Batch number: H013040). Initial report received from a healthcare professional on 28 June 2013. A 04-year-old male patient, whose medical history and concomitant medications were not reported; had received fifth intramuscular dose of DAPTACEL (batch number - C4452AA) in right deltoid, fourth dose of IPOL (batch number - J1028, route of vaccination was not reported) in left deltoid and MMR vaccine (Merck Product, batch number - H013040, route of vaccination was not reported) in left deltoid, all on 26 June 2013. On 28 June 2013, two days after vaccination, the patient experienced red hot swelling at injection site. Patient was to be evaluated and treated by physician on 28 June 2013. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the events was unknown. Documents held by sender: none.
pt recvd vax & devel sore throat; pt complaining of stomach pain & headache,n,v; had also dry rash under left eye;
INFLAMATION-BRIGHT RED, SWELLING, SORENESS--AT INJECTION SITE 5 INCHES BY 6 INCHES AT 72 HOURS POST INJECTION.
Pt recvd vax & had a sz; awakened w/o problems & it stopped; recalls that approx 10 mins episode was breathing irregularly;
fever, crying since pt had shots; seen in ER that noc w/fever 102 R; given APAP & pedialyte & temp down to 101 R a/leaving ER;
constant nerve pain now, destructive to my life; anxiety; This ongoing issue has been very destructive to my life; Never had issues until got shots, shingle outbreaks/ suspected vaccination failure; constant shingle outbreaks, breaking point for overall health/6+ times is now a breaking point for me; This case was reported by a consumer and described the occurrence of vaccination failure in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood cholesterol increased, hypothyroidism and osteoarthritis. Concomitant products included rosuvastatin, levothyroxine (Levothyroxin) and meloxicam.   On 22nd September 2021, the patient received Shingrix. On 29th November 2021, 68 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced post herpetic neuralgia, anxiety and quality of life decreased. The patient was treated with clonazepam and valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure, anxiety and quality of life decreased were unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, anxiety and quality of life decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 04-FEB-2023 Reporter's comments: The patient self-reported this case. The patient never had any issues until she got Shingrix shots.  If she would had knew that, she was going to have the shingles just about every month then she would had not gotten the shots for preventing shingles, following the physician orders.  This ongoing issue had been very destructive to her life with the constant nerve pain now, along with never knowing when it would arise again. Six plus times was now a breaking point for her with the anxiety and overall health (constant shingle outbreaks). The symptoms were treated. The reporter gave permission to contact. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Adverse event (AE) outcome captured conservatively and clarification was raised to confirm the same.
Overwhelming body aches and muscle pain, migraine, fever, nausea. Awoke exactly 12 hours after administration with symptoms. Symptoms made it difficult to move or open eyes due to light sensitivity and pain. Eventually took ibuprofen which helped alleviate headache. Symptoms abated after 24 hours
Pt devel measles on 6MAY91 following exposure to daughter who recvd vax;