chrisvoncsefalvay/vaers-outcomes huggingface dataset:
worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain.; Covid-19 Booster; felt like passing out; Pain; flushed; tooth infection; has not helped with hives; trigeminal neuralgia; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 02Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hemifacial spasms" (ongoing); "weight gain" (unspecified if ongoing); "allergies" (unspecified if ongoing); "Recollection is not good with dates" (unspecified if ongoing). Concomitant medication(s) included: XOLAIR; BOTOX; TEGRETOL. Vaccination history included: Covid-19 vaccine (dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 02Nov2021, outcome "unknown", described as "Covid-19 Booster"; LOSS OF CONSCIOUSNESS (medically significant) with onset Nov2021, outcome "unknown", described as "felt like passing out"; ANGIOEDEMA (medically significant) with onset 02Nov2021, outcome "unknown", described as "worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain"; HYPERSENSITIVITY (non-serious), ASTHMA (non-serious), FACIAL SPASM (non-serious), WEIGHT INCREASED (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 02Nov2021, outcome "unknown" and all described as "worsening of angioedema, allergies, asthma, hemifacial spasms and weight gain."; PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Pain"; FLUSHING (non-serious) with onset Nov2021, outcome "unknown", described as "flushed"; TOOTH INFECTION (non-serious) with onset Nov2021, outcome "unknown", described as "tooth infection"; URTICARIA (non-serious) with onset Nov2021, outcome "unknown", described as "has not helped with hives"; TRIGEMINAL NEURALGIA (non-serious) with onset Nov2021, outcome "unknown", described as "trigeminal neuralgia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sepsis symptoms; Increasing fever; unresponsive to medication; Cold hands and feet; Extremely sore body; Hot flashes and chills
930A< by 10AM began screeching/screaming; APAP given per MD-eased up @ 4PM; seen by MD 13JUL94 @ 9AM; parent told had a react to pertussis;
rash, soreness, intense pain (shoulder to elbow); never experienced anything like it with her yearly flu shot,
I felt a little bit cold & achy; Extended period of time between receiving the 1st and 2nd doses of the vaccine; I felt a little bit cold and achy; I was very tired; Shingles; Couldn't sleep; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), INSOMNIA (Couldn't sleep), FEELING COLD (I felt a little bit cold and achy), PAIN (I felt a little bit cold & achy) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 28-Jun-2021, the patient experienced HERPES ZOSTER (Shingles), INSOMNIA (Couldn't sleep) and FATIGUE (I was very tired). On 29-Jun-2021, the patient experienced FEELING COLD (I felt a little bit cold and achy). On an unknown date, the patient experienced PAIN (I felt a little bit cold & achy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Extended period of time between receiving the 1st and 2nd doses of the vaccine). At the time of the report, HERPES ZOSTER (Shingles), INSOMNIA (Couldn't sleep), FEELING COLD (I felt a little bit cold and achy), PAIN (I felt a little bit cold & achy), VACCINATION SITE PAIN (Sore arm at the injection site) and FATIGUE (I was very tired) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Extended period of time between receiving the 1st and 2nd doses of the vaccine) had resolved.            No concomitant medication and treatment medication was reported by the reporter.   This case was linked to MOD-2021-304348.
Palm size area of heat/redness. R upper arm sore-lasted approximately 1 wk (resolving now; no longer tender/sore, but still reddened and swollen). Note-H1N1 contained thimerosal/mercury-multi-dose vial.
Flushing, tachycardia   Exam:   General: Alert, no acute distress   HEENT: airway patent   Cardiovascular: RRR  Respiratory: Normal effort, CTAB   Extremities: Moves all fours equally   Skin: No rash   Neuro:  Oriented x 3        Interval Time: 1145A   Reports she feels better
Information has been received from a nurse and a mother concerning her approximately 12 month old son with a history of unspecified brain condition (cortical irritability), seizure activity, after the therapy with erythromycin and sulfa the patient developed hives (since age one) and after therapy with amoxicillin the patient developed hives and throat swelling at age 4-6 months which was treated with steroids who on 8/5/91, was vaccinated with MMR (second generation), left leg, (lot #84188/0851T). A few days after vaccination, the patient developed a lot of rash over his entire body with a high fever and seizure. Subsequently, the patient was treated in the emergency room and released. The nurse reported that the patient was under the care of a health center at the time of his vaccination. Upon internal review, the seizure was considered to be an other medical event (OMIC). Additional information has been requested.
C/O feeling hot, dizziness, racing heart.  HR 122 per smart watch.  0900 BP 132/80, HR 96.  At 0920 BP 125/84, HR 72, RR 16, Denies SOB, denies tachycardia.  Pt states still feels weird.  At 0930 pt refused transport to ED.  Called for family member to pick up.  Escorted to car w/o incident.
Patient received Pfizer Pedi dosage (0.2 ml) instead of standard recommended dose (0.3 ml).
Two days after receiving  my third booster jab, I experienced acute vertigo and imbalance issues. After attending two morning, meetings  on 11/8,  I returned home and immediately went to bed ill.  The following morning, I awoke progressively worse and called in sick to my my employer. I remained on sick leave for the following  2.5 weeks.  I experienced severe vertigo / nausea.  Immediately scheduled  appointments with my primary doctor. He said my ears did not appear as normal. Thus, I was referred to an Ear, Nose and Throat specialist; and had hearing and balance testing done. I also had an brain  MRI performed.  Each test was conducted to identify the cause of my sudden and unexplained imbalance issues.
HCP called to report inadvertent administration of expired ROTATEQ to a 2-month-old patient. Product expired on 14OCT2023 and was administered on 08NOV2023. No additional AE/PQC.; HCP called to report inadvertent administration of expired ROTATEQ to a 2-month-old patient. Product expired on 14OCT2023 and was administered on 08NOV2023. No additional AE/PQC.; This spontaneous report was received from a registered medical assistant concerning to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-NOV-2023, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 mL, once, lot #1837127, expiration date: 14-OCT-2023, as prophylaxis (Expired product administered). No additional adverse event (AE) reported.
10 am- Td administered by RN in clinic. 10:35 am RN asked to come to elevator- client sitting on floor, faint, pale and needing to vomit. Person with her stated she eased client to floor when she said she felt faint; said she lost consciousness and made snoring sound briefly. Was able to walk to waiting area around 10:45 am. BP 96/61. Advised to call MD if any other problems.
Thursday 3/25/2021 small red dots began to appear on my abdomen. By Friday 3/26/2021 the red dots has spread to my bad. On Sunday Morning 3/28/2021 the rash had spread to my chest, neck and face. The rash did not itch, it was only uncomfortable. Due tot he severity of the rash spreading I opted to be seen at the Emergency Room located at the below address. I was examined at the ER and was told the rash looks like Pityriasis rosea which is commonly caused by a virial infection. The ER staff was unable to determine if the rash was cause by the COVID-19 vaccine.
hit her like a ton of bricks; horrible for her; This is a spontaneous report from a contactable consumer for doctor's associate.   This is Report 4 of 6.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 for covid-19 immunisation on unknown date. The patient medical history and concomitant medications were not reported.  The patient experienced hit her like a ton of bricks, but it was her second, not her first. It was horrible for her on her second, it was really horrible. Outcome for events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient Passed out a few minutes after he received his vaccine and was walking to observation. was with patient and claims it is not unusual for the patient to pass out from needle fear. Patient was monitored by staff and had no other issues. Patient rested and drank fluids for thirty minutes and left. was fairly certain it was his fear of needles that made him pass out.
Patient was hospitalized within 24 hours after a syncopal episode due to hypotension. She was found to have a UTI due to E.coli and subsequently treated for the infection. It was felt, that the syncope was due to sepsis related to the UTI caused by known chronic constipation rather than the vaccine.
Headache; This is a spontaneous report from contactable consumer. This 60-year-old male consumer (patient) reported for himself. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine Solution for injection Lot number was not reported) via an unspecified route of administration on 10Feb2021 14:00 as dose number unknown, single (age at vaccination: 60 years) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Feb2021 16:30, the patient experienced headache. It was reported by the patient that he was a senior, living by himself in a senior community, took the shot at 2'oclock and then at 04:30, experienced a headache. Also, he was reading a paper and it says he was not the only one, but people are also complaining about headache, took Tylenol 500 mg as treatment, it became little better and asked what he should take, it goes if I take the Tylenol and queried that does it go or stays and for how many days it stays. The clinical outcome of the event was resolving.  Follow-up attempts are completed. No further information is expected.
Loss of smell and taste, ongoing as of 11/06/2023. 3 visits to 2 different ENTs.  Over the course of the past 2 1/2 years I have taken the following: Olfactory training, Budesonide spray, Azelastine HCL spray, diphenhydramine, Cetirizine, sterimar nasal spray, saline nasal gel, vitamin a nasal drops, saline inhalation, oxytocin nasal spray, zinc, vitamin D3
Redness and swelling in right arm that worsened in the next few days, pain in head and throughout body, especially in right thigh and hip.
lightheaded, near syncope, sweating, HR = 45, BP 80s/50s, pt laid down, BP improved  EKG showed sinus rhythm, symptoms improved with , pt declined juice/rest, ED recommended
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A male patient received BNT162b2 (BNT162B2), in Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: cancer came back over different spots. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Series of primary immunization completed, Manufacturer unknown), for Covid-19 immunization. The following information was reported: RECURRENT CANCER (medically significant) with onset 28Jun2022, outcome "unknown", described as "He said he got his booster and his cancer came back over different spots.". Clinical course: It was reported that the patient was fine prior to vaccination and his cancer is all over after he received his booster shot. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain on left arm; petechiae; pyrexia; nausea; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on left arm), PETECHIAE (petechiae), PYREXIA (pyrexia), NAUSEA (nausea) and VOMITING (vomiting) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain on left arm), PETECHIAE (petechiae), PYREXIA (pyrexia), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (Pain on left arm), PETECHIAE (petechiae), PYREXIA (pyrexia), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
patient said his arm felt warm and hard and today (3/31)  it is swollen.
Information has been received from a registered nurse concerning multiple female patients who were vaccinated IM with a 0.5ml dose of Gardasil.  Subsequently, the patients experienced injection site pain with the prefilled syringes of Gardasil.  Unspecified medical attention was sought.  At the time of this report, the patients' outcomes were unknown.  No product quality complaint was involved.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Patient said she woke up on Sunday the next day with large red rash that was located along her entire upper chest and upper back. The rash did not resolve until that Tuesday. She said that rash did not hurt, and she "does not remember but is pretty sure it was not itchy." The rash did not occur when she got the first dose of Shingrix just 2.5 months prior on 5/4/2019. During her first shot, she said she experienced flu-like symptoms - fever and body aches, but no rash.
Pt states had pain in arm around injection site from the time she received the vaccine. Pt states pain has worsened and is now radiating down to her forearm. Pt states also now having difficulty lifting arm.
Headache, Myalgia, Diarrhea, NauseaVomiting, chills Narrative:  Other Relevant History:
Muscle aches, low grade fever, fatigue lasted about 12 hours.  Slept well overnight and woke up feeling fine and no symptoms since then.
He got the vaccine, started to get the headache within 45 minutes, ran some errands and after a couple of hours he felt like something was burning on his buttock, and noticed a really bad red rash on the left side on the left cheek from the crack outward. It was extremely hot to the touch and very sore, kind of throbbing and swollen and progressively got worse. He was just not feeling well, nauseous and dizzy and went to sleep but when he woke up it had spread to the other cheek. It looks like he got burned or scalded red/purple in color. He has no reaction on the arm itself, but only on the buttock and a blistery, blood red, leathery feeling rash/blotch on his entire buttock to both hips on both sides. It is difficult for him to sit. He also had headache, the muscle pain, joint pain, chills, nausea.  He did not vomit but had not eaten anything. He has had a high fever up to 103 until this morning 4/8/21 which is about 99-100.  He woke up soaking wet today. He has not been able to turn his neck, and not able to lift his arm above his waist level since the vaccine, and not able to turn his neck to the left at all. He can turn it 5-10 degrees, but right is okay. He took some Benadryl over the last 2 days for the reaction but it has not. He also has taken aspirin/Aleve for the fever. He was so sock and had no energy and could not sleep but could not keep his eyes open either, was not able to open them. He did write his doctor when the rash was only on one side, which they did not give him any advice as he was not feeling any worse at that time. He was at 101 fever throughout the day and then at night went to 102. He was hoping that the rash would be better, but actually worse as described above. He has not had any appetite, trying to drink fluids but made him nauseous, and he normally drinks water all day long. His normal temp is 97.7. He has been taking showers to try and keep his fevers down and the water hitting the rash feels like somebody is pouring scolding water on it. He did call Moderna on 4/6/21 asking if this was a reaction that anybody has reported, and he is waiting for somebody to call him back.
Bruise and cellulitis at site of vaccination. Redness extended deltoid to elbow
Fever 100.5, chills, malaise, aches, cough, diarrhea
pt recvd vax; drowsiness-keeps falling asleep at desk; onset 30 min after dose; vital signs stable;
itchy throat, next day chills at night woke with fever itchy throat, terrible  r lung pain; lung pain still continues to occur throughout the day.  Hurting when she breaths or exhales, runny nose. Sought treatment Urgent Care
Received a dose of Engerix B instead of Havrix; Patient had already completed the Hep B series; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 62-year-old male patient who received HBV (Engerix B) (batch number 7B2YL, expiry date 25th February 2024) for prophylaxis.   On 2nd August 2022, the patient received the 4th dose of Engerix B. On 2nd August 2022, unknown after receiving Engerix B, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were unknown.    Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's Comments: The nurse reported that the patient was supposed to receive a dose of Havrix but instead was given a dose of Engerix B. The reporter stated that the patient had already completed the Hepatitis B series. The reporter consent to follow up. Additional Supportive Information: The patient received Engerix B instead of Havrix vaccine, which led to wrong vaccine administered. The patient received extra Engerix B dose, which led to extra dose administered.
muscle weakness; pain in her extremities; fever; This spontaneous report was received from a health care business professional referring to a 16 years old female patient. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were unknown.  In 2018 (reported as 2 years ago), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, strength, batch/lot# and expiration date were unknown) for prophylaxis.  In 2018 (reported as 2 years ago) after the first dose, the patient experienced muscle weakness, pain in her extremities, and fever lasting several days. The patient had no prior medical conditions and it was unknown if she sought medical attention for symptoms experienced. It was unknown if any treatment was given to the patient. It was unknown if any lab diagnostic/study was performed. The outcome of the event was unknown. The causality assessment was not provided.
I had patches that are itchy and red on my head. It fared up and did not go away. I went to the doctor about this. They did an allergy test down. I was referred to GI specialist because he thought it was food allergy. I went to the GI and it turns out that it is not a food allergy. They did an endoscopy and coloscopy, normal results. These symptom is still ongoing as of today.
DT given & 2 days later pt came back w/ c/o redness, tenderness & itching @ site; involved area 1 1/2" x 3" according to MD; pt examined by MD that day 30DEC91;
sore underarm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 2, single (Lot number: EL9266) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nightmares" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing), notes: Caller states that because of that the doctor put her on the Clonazepam for anxiety in 2016. Concomitant medication(s) included: CLONAZEPAM taken for anxiety, start date: 2016; AMLODIPINE BESYLATE taken for blood pressure measurement. Vaccination history included: BNT162b2 (First Dose of the Pfizer Covid Vaccine: Received by the caller on 23Jan2021; Lot Number: EL9262; Administered in the caller's left arm.), administration date: 23Jan2021, when the patient was 79-year-old, for COVID-19 immunization, reaction(s): "sore underarm". The following information was reported: AXILLARY PAIN (non-serious) with onset 14Feb2021, outcome "not recovered", described as "sore underarm". Relevant laboratory tests and procedures are available in the appropriate section.