chrisvoncsefalvay/vaers-outcomes huggingface dataset:
exposed to excursion and administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 31st March 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022150629   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's comment: Nurse reported that their Bexsero was exposed to 11 degree Celsius for 53 hrs and 1.09 degree Celsius for 150 minutes with no prior excursions and the vaccine was administered administered to the patient. HCP (Health Care Professional) was not aware of patient´s gender when asked. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: The patient received dose of Bexsero vaccine after temperature excursion, which led to Incorrect storage of drug. This was one of the 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022150627:Same reporter US-GSK-US2022150629:FU1 - Deleted US-GSK-US2022150631:Same reporter US-GSK-US2022150632:Same reporter
Patient received an expired vaccine, which expired on 4/25/2021 at 1:25pm. The patient received this vaccine on 4/26/2021. No adverse reaction has been reported
1st Vaccine - I experienced mild numbing from my left cheek up and around my eye. It started just a few hours after my vaccine and it stayed that way for 48 hrs. I would still experience this mild sensation every now and then until I took my 2nd vaccine. My injection site was very sore for 2 days. No other symptoms to report..  2nd Vaccine - I experienced a very sore injection site for 2 days and felt warm to the touch. Later in the evening i had mild achy sensations in my lower back, legs, calves, knees and shoulders. During the night I experienced chills and lots of tossing and turning. In the morning my lower back, shoulders, legs, knees and calves were extremely achy and sore. I was also very exhausted. I took some ibuprofen and drank lots of water and rested. Today, 10 March my lower back and thighs are still a little achy but much better than yesterday.
Within 6 hours of receiving the COVID-19 Pfizer booster shot, I developed a fever reaching 105.2°F. I also developed other severe flu-like symptoms, including extreme body aches (especially in right elbow where I had recent surgery), shivering and chills, loss of appetite, nausea, and severe headache (non-migraine).  At times of high fever,  I could hear my pulse in my ear. I treated the fever with 1000mg acetaminophen every 6 hours for 48 hours. Symptoms began to resolve 54 hours after injection, except for a lingering,  mild headache. The medication was effective in reducing the fever to the range of 102-103°F but fever returned to 104.8-105.2°F exactly 6 hours after taking the acetaminophen. My fever did not "break" until 50 hours after injection.
9am- vaccine injected 911a left hand started tingling, chest pressure noted 912a Benadryl 50 mg PO liquid given and 10 mg zyrtec given PO physician notified, vital signs taken, blood pressure and pulse elevated 945a  symptoms remain, BP137/86 P 73 O2 sat 99 958a-BP 141/88, P-75 O2 sat 99 1015a-BP-135/86 P85 1030a-BP-130/80 P78 symptoms improving, no further tingling in left hand or arm, chest tightness improving, no resp diff. 1115a BP129/78 P 81 feeling well 1140a BP 118/78 P78 slight headache noted, no further tingling or chest tightness, alert and oriented
continued aching and sharp pain and unable to lift or use left arm -As of 7/20 pt had seen MD. MD believes events due to her Fibromyalgia. Advise pt to use heat & Tylenol
Vaccine was administered 11/3/21, but adverse reactions didn't start until 11/6/21. Patient presented on 11/7/21 with a  large (4-5" diameter) red raised circle at the site of injection, which was slightly warm to the touch. She reported on 11/6/21 she began to notice a red rash/swollen neck so she proceeded to the emergency room. She has an epinephrine auto-injector at home but she did not use it. In the ER, they administered IV steroid which calmed the reaction. 11/7 the injection site reaction was still present, but her neck swelling/rash was improved.
Client reported severe allergy to seafood and some medications, but did not list them. Denied allergies to vaccine ingredients. Reports she spoke with her healthcare provider and was told there was no concern about this vaccine. Received vaccine and within a few minutes red blotchy hives spread up her arms, neck and torso.  EMS responded. Client reported this was a common response for her and stated she has had about 8 similar episodes over the last several months. After about 20 minutes the rash continued. No difficulty breathing had occurred, however the client then reported  that occasionally  some tightness in her breathing occurred after about 45 minutes. After initially declining to be transported to the ER, she agreed to be transported to be monitored.  Client declined the use of the stretcher and walked out with EMS to be transported to the ER for observation.
Patient did not have any adverse events from vaccine. Patient was given a Covid vaccine for ages 5-11 years old when she was 12 years old. Given a 2nd Covid  5-11 year dose per recommendations.
Immediate local reaction- red wheal approx 6 inch diameter- sent home with instruction to take Benadryl PO.
"I received the second does of the Pfizer vaccine on Jan 8th with no adverse reaction that day. When I awoke on Saturday the 9th my arm was very sore at injection site but later went away.    I had a dull headache, nausea, I was yawning all day, muscle fatigue, esp my quads, lightheaded enough to lay on the floor a few times during day. These symptoms did not stop me from painting, but I did feel horrible but I pushed through it.    Sunday still nauseous, just feeling not my self..... I awoke on Monday morning and I was 100% fine!"
pt recvd vax; following morning pt devel fever w/ t 102 along w/ a screaming episode that lasted approx 1 hr;
Severe arm pain at and around injection site. Fever and chills throughout day after vaccine (about 18 hours until symptoms calmed). Drowsiness. Headache. Itch at and around injection site,  No treatment.
Event: Blood clot in right eye causing loss of vision Treatment:  I have been told by 3 doctors that there is no treatment Outcome:  Loss of vision in right eye
Itching throughout body inside & out. Throat tightening, coughing, tiredness. Eppi pin, allergy meds, steroids asthma pump. Hasn't stopped.
PATIENT WAS ADMINISTERED HIBERIX (BOOSTER VACCINE) THIS VACCINE IS INTENDED FOR PATIENTS 15 MONTHS THRU 4 YEARS OF AGE ONLY.  PATIENT IS 4 MONTHS OLD.  THERE IS NO EVIDENCE OR REPORTS FROM PARENTS OF ADVERSE REACTION.
This spontaneous report was received from a registered nurse via company representative and refers to a 12 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications. On an unknown date, reported as "in the recent past", the patient was inadvertently vaccinated with unspecified doses of VARIVAX concomitantly with PROQUAD for prophylaxis, reported as "well baby vaccination", (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported for any of the vaccines) (overdose). On an unknown date, the patient develop a fever up to 103 (units not provided) (pyrexia). It was reported that the patient did not seek for medical attention and that no treatment was provided for the event. The patient's fever come down on an unknown date. The reporter did not assess the causal relationship between therapy with VARIVAX or PROQUAD and the patient's fever. Additionally, it was stated that this incident was reported to VAERS (number not provided).
Stomach going crazy; burning feeling; Bloating feeling; Typical sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach going crazy), BURNING SENSATION (burning feeling), ABDOMINAL DISTENSION (Bloating feeling) and MYALGIA (Typical sore arm) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Anxiety and GERD.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach going crazy), BURNING SENSATION (burning feeling), ABDOMINAL DISTENSION (Bloating feeling) and MYALGIA (Typical sore arm). At the time of the report, ABDOMINAL DISCOMFORT (Stomach going crazy), BURNING SENSATION (burning feeling), ABDOMINAL DISTENSION (Bloating feeling) and MYALGIA (Typical sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
injection site (arm) soreness; This is a spontaneous report from a contactable consumer. This consumer reported a 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on arm single dose for COVID-19 immunization on 20Jan2021 at 39-year-old. Medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had injection site (arm) soreness on 20Jan2021 and was reported as non-serious. No treatment received. Since the vaccination, the patient had not been tested for COVID-19. Action taken for BNT162B2 was not applicable. Outcome of the event was resolving.   Information on the lot/batch number has been requested.
8 hrs after receiving vaccine pt exp severe total body shaking, skin developed bluish tint. 911 called by spouse. Rx'd in ER for 12 hrs, loss of bowel function, in and out of lucidity. 20 hrs later pt was back to normal.
Fever and diaphoresis 2/12/21, followed by neck pain starting 2/13/21. Hospital admission with sepsis with right-sided cervical lymphadenitis without abscess 2/17/21. Treated with Unasyn.
Starting one month after vaccine developed large hard axillary node, excised 8/29/03, fatty nodes then arm node also about 5cm hard, excised 10/7/03 nodular fibrosis. Pt workup revealed hypogamma-globulinemia subclass 1.
On March 15th my arm begin to be sore I did not feel sick. I woke up the next morning at 8:00 a.m. sick. Headache, stomachache (not nausea), skin hurt all over, couldn't stand cold water on it, slight fever, exhaustion, little appetite,  stayed in bed until 5 pm except for bathroom visits and ate a little cereal. 5 pm decided to take acetaminophen. Sat up, began to feel human around 8pm. Went to sleep 9pm, woke up 8am 90% better, still a bit of stomach ache. But felt well enough to go to grocery store. On and off stomach ache when I got tired for the next few days, also sore arm still but both all better by Saturday March 20th.
Second Dose: sick for 5 days with the same symptoms as when he had full blown Covid; This is a spontaneous report from a contactable consumer (patient's spouse). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was diagnosed with Covid 19 on an unknown date. The patient was not related to a study program. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unknown date (after second of vaccine), the patient was sick for 5 days with the same symptoms as when he had full blown Covid. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021665145 same reporter/ product, different patient.
Right upper forearm  likely the flexor carpi ulnaris muscle involuntary near constant twitching.  Started 20 hours post injection.  And persistent even at night.
Pain radiating from injection site up AND down arm - down arm to fingers, up arm to shoulder/back. Down arm is resolving after steroid dose pack (now finished, started 12/15/22), but she is still "just as uncomfortable as before."
Rapid heartbeat, fluttering heartbeat that awakens me often at night; insomnia
Rash - began on neck; spread to trunk; examined in office 2/13/14 (date of onset is approximate per parent).
Rash and hives localized to chest (sternum) only.  Headached.  Lower Back Pain.
Initial R flank pain then painful rash to same area.  Received Valacyclovir and Vicodin from a "physician friend" did not report for treatment with our clinic until 12/23/2009. At That time was told to continue Antiviral and given RX for Norco 10/325.
Her A1C was 7.2 from Jul or Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 12Feb2021 (Lot number: EN6201) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: she has been a diabetic for about 20 years. It isn't great or well controlled.; "asthma" (unspecified if ongoing). Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE] taken for asthma. Past drug history included: Factin, reaction(s): "Allergy: Factin", notes: She is not sure if there would be something in there, but with those reactions she had a physical form and a big break out. That was 10 to 15 years ago.; Boniva, reaction(s): "muscle aches", notes: Caller states she had a reaction to the Boniva over 20 years ago; Boniva for she couldn't even walk without holding on to stuff throughout the house; Boniva for she had a fine rash on both arms. Vaccination history included: Bnt162b2 (Dose 1, lot: EL9261, Right Arm), administration date: 22Jan2021, when the patient was 69 years old, for Covid-19 Immunization. The following information was reported: GLYCOSYLATED HAEMOGLOBIN ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Her A1C was 7.2 from Jul or Aug2021". Relevant laboratory tests and procedures included Glycosylated haemoglobin (2021): 7.2.  Additional information: Patient said that about her height she has shrunk an inch. Caller clarified that she shrunk prior to the vaccines. She has been shrinking for years due to age. Caller clarified that she was on Flonase and she was changed to something different, like Nasonex. Caller states she is not sure of the first letter but provides EN6201. It is handwritten on the card. Vaccination facility type was pharmacy.  No prior vaccinations (within 4 weeks) were done. No adverse event prior to vaccination. She is allergic to Factin and Boniva. She is not sure if there would be something in there, but with those reactions she had a physical form and a big break out. That was 10 to 15 years ago.   No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 35 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa drugs" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 12Sep2023 from 16Sep2023.
Administered 10/8/03 in left arm By 10/9/03, extremely sore arm; unable to lift arm at all. Severe headache developed by evening; temp of 100.1 at 11 pm that evening. Large welt and rash on left arm where shot administered. On 10/10/03, temp of 100.2 at 6 am; other symptoms (sore arm, headache, welt, rash) continued. On 10/11/03, temp back to normal; arm still sore but able to lift somewhat; welt and rash still visible. Welt and rash on arm still visible until 10/16/03. Arm sore, but pain diminishing. Had influenza shot same day; no symptoms.
On the evening of 9/16/16, patient presented with itchy, red, raised/welted areas about the size of a 50 cent piece on the upper right portion of his trunk and right arm. He also went to the doctor who diagnosed him with shingles.
Fatigue,  headaches,  shoulderache, leg cramp, mouth ulcer, rash, hair loss, fever.  They've been on and off my body for a month. I feel them afternoon. But, it's not serious so that I can't take medications.
TOOTH EXTRACTION; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 17-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 09-MAR-2022, the patient experienced tooth extraction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of tooth extraction was not reported. This report was non-serious.
At 5:30 PM employee states his arm hurt really bad, he has a bad headache, and feels hot than cold off and on. Employee was visibly in pain. Ice pack applied to left arm and employee took Ibuprofen for headache. Employees symptoms started to improve at 6:30 PM.
Pt had redness, swelling (approximately 25mm) and warmth to left thigh
Began having widespread muscle fasciculations on 4/5/21. These continue presently. Areas of fasciculations: feet, calves, thighs, ribs, pecs, neck, hands, arms, jaw, buttocks, knees. Other symptoms similar to Benign Fasciculations Syndrome (BSF) also present: fatigue, exercise intolerance, stiffness, soreness.
Information has been received from a nurse practitioner concerning an unknown number of patients (age and gender not reported) who was vaccinated with Gardasil (lot # unknown). The nurse reported that at two separate clinics the patients were complaining about receiving Gardasil in the deltoid so the office began to administer the injection in the hip. No adverse event was involved. Follow-up information was received from a nurse via telephone. The nurse reported that her office had given approximately 100 injections in the hip. The nurse did not have an exact amount. The nurse also reported that patients complain about burning at the injection site. This report is from one of two reports. Additional information has been requested.
sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-404656 (Patient Link).
I got body sharp pain after vaccinated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (I got body sharp pain after vaccinated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (I got body sharp pain after vaccinated). At the time of the report, MYALGIA (I got body sharp pain after vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
I need a root canal, I have pain; a little bit of sour stomach; This is a spontaneous report from a non-contactable Other Health Professional for herself.  A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose number 1, via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. Patient asked can she now take amoxicillin a week after getting first dose? Patient received the first dose on 23Dec2020. Patient though she needs a root canal, she had pain. Patient had a little bit of sour stomach after receiving the COVID 19 vaccine. Patient heard some people got more of a dose than they should have and wound up in the hospital. Action taken in response to the events for BNT162B2 was not applicable. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
7 days after shot arm upper arm became swollen, red splotch, and very itchy
Client vaccinated with 2 doses of Pfizer vaccine (one in beginning of May 2021 and one at end of May 2021) for Covid.  Symptoms started 11/15/2021 - fever, headache, myalgia, fatigue.  Tested positive for Covid with PVR on 11/16.  Reported as case of breakthrough Covid illness in previously vaccinated person