chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a patient who on 01-MAY-1998 was vaccinated with a dose of Varivax. Subsequently, on 16-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
vaccine reaction; full body rash; hives; itching; This is a spontaneous report from a contactable other hcp (medical assistant calling on behalf of the nurse practitioner).   A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiry Date: unknown) via an unspecified route of administration on 19Feb2021 (at the age of 35-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No investigation assessment was provided. Two days after the second dose of vaccine, on 21Feb2021, the patient began having a full body rash, hives, itching and vaccine reaction. Therapeutic measures were taken as a result of full body rash, hives, itching and vaccine reaction. The patient was placed on 5 days of steroids which were completed on Saturday (27Feb2021) but he was still having a full body rash and was itchy and uncomfortable, the patient received IV famotidine and dexamethasone. The outcome of the events full body rash, hives and itching was not recovered. The outcome of the event vaccine reaction was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient got flu shot on 9/25/16. She came back to the pharmacy on 10-7-16 and states pain/soreness on shoulder of injection site. Claims she has decreased range of motion.
Breakthrough case admission after 4 vaccines  Moderna 2/13/21 Lot# 007M20A;  Moderna 3/16/21 Lot# 010A21A;  Moderna 10/28/21Lot# 012F212A;  Moderna 5/27/22 Lot# 059M21A
No known symptoms. Patient under 18 years old given a Moderna 0.25mL booster dose in error.
Exactly 12 hours after second dose : Severe chills ,headache ,fever ,stabbing pains in both legs  Shortness of breath Chills lasting 6hours  Fever 12 hours   Fatigue 2 days  Weakness  on going.
Approximately three hours post-vaccine administration, patient's spouse reported "excruciating" pain in both of patient's arms (left arm was Fluzone-HD, right arm was PPSV23), particularly in right arm, with inability to move the arms. Patient was given ibuprofen but it did not help. Patient and spouse were concerned re: history of stroke. They proceeded to urgent care, at which point patient was transported by ambulance to a local hospital. At hospital, it was determined that patient did not suffer a stroke, but was given Dilaudid for pain, which helped significantly. Patient was released home with a prescription for Vicodin. The next morning, patient's spouse reported patient was feeling much better; the left arm had typical, but non-significant soreness, and the right arm was still in pain, but not nearly as much as before.
Rapid increase of severe migraines after vaccine and lasting until brain aneurysm rupture on 04/29/2021. Patient was put on life support at Hospital on 04/29/2021 and had no brain activity . Patient was pulled from life support and died on 05/03/2021
severe back pain; also under her breast and armpit on the same side as the injection; also under her breast and armpit on the same side as the injection; soreness at the injection site; she had tightness at the injection site; This is a spontaneous report from a contactable consumer. This 67-year-old female consumer (patient) reported for herself that. A 67-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: FF8841), via an unspecified route of administration, administered in Arm Left on 10Oct2021 14:00 as DOSE 3 (BOOSTER), single for covid-19 immunization. The patient medical history included hip arthroplasty from an unknown date and unknown if ongoing hip replacement about 12 years ago. Concomitant medications included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported. The patient previously received Historical vaccine bnt162b2 (formulation: Solution for injection, Lot Number: EN6203), via an unspecified route of administration, administered in Arm Left on an 01Mar2021 as DOSE 1, SINGLE, received second dose bnt162b2 (formulation: Solution for injection, Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on an 22Mar2021 as DOSE 2, SINGLE for covid-19 immunization. All she had with the first two shots was sore arm and After receiving the booster dose, the patient felt tight at the injection site started pretty much right away on Sunday, 10Oct2021. She had read about the lymph node problem and thought that was a normal side effect, so she did not call her primary care about that. She was trying to wait this out a day or two to see if it gets better. she had tightness and soreness at the injection site, and also under her breast and armpit on the same side as the injection. The patient started soreness under arm and breast started late Monday,11Oct2021. Today (13Oct2021) the patient had severe back pain. The patient reported that she never had back pain before. The patient reported that she walks every day and was in good shape. She was healthy and had no underlying conditions. She can barely move without pain. She took Ibuprofen 200 mg tablet Lot: P111343, Expiry: Jul2021and it had not done anything. The patient's arm was totally better. The arm pit and breast was getting much better. Her back was horrible. The patient was asking if it was reported before and asked if she get a bad batch. She was very upset and hopes it was not permanent. The clinical outcome of the events was she had tightness and soreness at the injection site, also under her breast and armpit on the same side as the injection was recovering and another event severe back pain was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
Mild soreness in my left arm at the site of injection (deltoid); Moderately-bad headache; A spontaneous report was received from a 51-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mild soreness in his left arm at the site of injection (deltoid) and a moderately bad headache.  Relevant medical history included migraines. No relevant concomitant medications were reported.   On 30 Dec 2020 at 11:30am, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient woke up with mild soreness in his left arm at the site of injection along with a moderately-bad headache. The patient mentioned he is prone to migraines so the headache may be unrelated to the vaccine. Otherwise he "felt normal".  Treatment information was not provided.    Action taken with mRNA-1273 in response to the reported events were not reported.   The outcome of events mild soreness in his left arm at the site of injection (deltoid) and a moderately bad headache were unknown.; Reporter's Comments: A spontaneous report concerns a 51-year-old, male patient, who experienced mild soreness in his left arm at the site of injection (deltoid) and a moderately bad headache. The events occurred the following day after the administration of the first dose of mRNA-1273 ((lot number 011J20A, expiration date unknown). Treatment provided and outcome are unknown. The reported events are temporally associated with administration of mRNA-1273 vaccine  and  consistent with the known safety profile of vaccine , hence a causal association cannot be excluded.
Nauseous; I am not feeling good; Vomiting; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EL9261), via an unspecified route of administration, on 29Jan2021 at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported.  Patient stated receiving COVID vaccine on Friday (29Jan2021) and have been nauseous and vomiting from an unspecified date and was asking if it was normal. Patient also reported not feeling good from an unspecified date. The outcome of the event was unknown.
pt cried for 4hrs on day of vax & for 6hr on day p/vax
Cold; Aches/pains; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and MYALGIA (Aches/pains) 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 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and MYALGIA (Aches/pains). At the time of the report, NASOPHARYNGITIS (Cold) and MYALGIA (Aches/pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.
Spasms in chest, pain in chest, swelling of joints such as knees, wrists, fingers , feet and the areas I had my surgery (hysterectomy). I also felt body aches, headaches, tired and chills. I also had cramps in my legs and feet throughout the time. I felt sick for 7 days.  I also had gone to clinic and they said I had a urine infection and it wouldn?t go away. A blood vessel also popped in my eye. I have a photo documenting my eye issue.
Felt ill; fatigue that prevented her from getting out of bed; Nausea; vomiting; Red welt below the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema urticarial in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received Shingrix. On 29th June 2019, 1 days after receiving Shingrix, the patient experienced erythema urticarial. On an unknown date, the patient experienced feeling unwell, fatigue, nausea and vomiting. On an unknown date, the outcome of the erythema urticarial, feeling unwell, fatigue, nausea and vomiting were unknown.   It was unknown if the reporter considered the erythema urticarial, feeling unwell, fatigue, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient developed A red welt below the injection site a day after the first dose of Shingrix. The patient went on to feel ill, had nausea, vomiting and fatigue that prevented her from getting out of bed. The reporter consented to follow up. This case is 1 of the 2 linked cases, reported by the same reporter.
torax painful, inexplicable sintoms; right arm pain from intercostal inside of esternon; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    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 CHEST PAIN (torax painful, inexplicable sintoms) and MYALGIA (right arm pain from intercostal inside of esternon) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHEST PAIN (torax painful, inexplicable sintoms) and MYALGIA (right arm pain from intercostal inside of esternon). At the time of the report, CHEST PAIN (torax painful, inexplicable sintoms) and MYALGIA (right arm pain from intercostal inside of esternon) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up accepted on 27-05-21
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick with all three doses), URINARY TRACT INFECTION (A week after dose 2 got UTI), VACCINATION COMPLICATION (second and third dose had an impact on her hormones), VULVOVAGINAL DRYNESS (dry vagina) and PYREXIA (fever not above a 100°F after dose 1) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A, 013M20A and 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced PYREXIA (fever not above a 100°F after dose 1). On an unknown date, the patient experienced ILLNESS (sick with all three doses), URINARY TRACT INFECTION (A week after dose 2 got UTI), VACCINATION COMPLICATION (second and third dose had an impact on her hormones), VULVOVAGINAL DRYNESS (dry vagina) and VOMITING (vomited after dose 2). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and ESTRADIOL for Vaginal dryness, at an unspecified dose and frequency. On 10-Jan-2021, PYREXIA (fever not above a 100°F after dose 1) outcome was unknown. At the time of the report, ILLNESS (sick with all three doses), URINARY TRACT INFECTION (A week after dose 2 got UTI), VACCINATION COMPLICATION (second and third dose had an impact on her hormones), VULVOVAGINAL DRYNESS (dry vagina) and VOMITING (vomited after dose 2) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-335745 (Patient Link).
Individual had a near-syncopal episode  about 6 min post vaccine. She became bradycardic, diaphoretic and reported feeling "closed in."
Started feeling pain in all body parts, unable to walk with weakness to legs, inability to walk. Pelvic pain
Severe Hives all over body that led to a trip to the emergency room on Wed, 12/1/2021.  My ears swelled up to the point they were sticking out so far I looked like a monkey.  I told the ER that I had recently had my Moderna booster, but they did not think that was the reason I was breaking out.  Got an IV of Benadryl and steroids, and they urged me to get an appt with an allergist since we didn't know what had caused my reaction.  By Friday I was still breaking out.  Got an appt to see an allergist on Sat, 12/4/2021.  When I went in to allergist and we went through a list of symptoms.  After going through a laundry list of things that could have caused the out break, I told them about my booster. She immediately felt that was what caused the outbreak.  I have been taking 3-4 Allegra a day for about 2 weeks, and using topical cream as needed.  Some days I am ok, but other days my hives are quite bad.
Throat swelled 20 minutes after injection. I could still breathe, but it was swollen. This lasted for a few hours. I did not need or seek medical attention.
pt recv vax;3 days later devel pinpoint red,pruritic lesions on elbow,knees and thighs;
No adverse event; patient was administered improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 27-SEP-2019, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot number S007770 with expiration date on 24-JUL-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion below 36 degrees Fahrenheit (F) / 2 degrees Celsius (C) for 10 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.
fully vaccinated (moderna, patient misplaced vaccination card); symptom onset 7/30/21
hurting all over like she had flu, slowly aching; sick; really bad, had really high fever/temperature was really high; hurting all over like she had flu, slowly aching; Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (hurting all over like she had flu, slowly aching), ILLNESS (sick), ARTHRALGIA (Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point), PYREXIA (really bad, had really high fever/temperature was really high) and MYALGIA (hurting all over like she had flu, slowly aching) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 013M20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included LEVOTHYROXINE and CLOTRIMAZOLE (LOTRIL [CLOTRIMAZOLE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (hurting all over like she had flu, slowly aching), ILLNESS (sick), ARTHRALGIA (Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point), PYREXIA (really bad, had really high fever/temperature was really high) and MYALGIA (hurting all over like she had flu, slowly aching). The patient was treated with TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) ongoing since an unknown date at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (hurting all over like she had flu, slowly aching), ILLNESS (sick), PYREXIA (really bad, had really high fever/temperature was really high) and MYALGIA (hurting all over like she had flu, slowly aching) outcome was unknown and ARTHRALGIA (Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point) had resolved.            Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-138214 (1st dose) (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received and contact information was updated. On 20-Jul-2021: Follow up received  and updated date of second vaccine administrated, lot/batch number, new events and event outcome.
Information has been received from a nurse practitioner concerning a 26 year old female patient with allergy to sulfa and asthma and a history of "brachial plexus" who on 09-OCT-2008 was vaccinated with the first 0.5 ml IM dose of GARDASIL (lot #660557/0072X). It was given in the left gluteal region. On 20-FEB-2009 the patient was vaccinated with the second 0.5 ml IM dose of GARDASIL (lot # 661764/0650X). Concomitant therapy included hormonal contraceptives (unspecified), montelukast sodium, ZYRTEC, albuterol, VERAMYST and ADVAIR. On 20-FEB-2009 the patient experienced passed out while she was still in the office. No lab diagnostics studies were performed. On 20-FEB-2009, the patient regained consciousness and recovered. The patient sought medical attention in the office. Additional information has been requested.
Presented to the ED with profound weakness including inability to ambulate (at baseline goes on moderate distance walks daily without assistive devices). Patient admitted to hospital on observation due to inability for him or his family to take care of himself due to the profound weakness.
pruritic, erythematous rash involving neck, chest, arms;pt reports developing the rash one day p/vax;reported to MD 3 days later;
Left thigh warm; Sharp stabbing pain in the top of her left thigh/painful; Headache; Nausea; Intense aches all over her body; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Left thigh warm), PAIN IN EXTREMITY (Sharp stabbing pain in the top of her left thigh/painful), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Intense aches all over her body) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Intense aches all over her body) and PYREXIA (Fever). On 26-Jul-2021, the patient experienced FEELING HOT (Left thigh warm) and PAIN IN EXTREMITY (Sharp stabbing pain in the top of her left thigh/painful). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of UNK dosage form. On 29-Mar-2021, HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Intense aches all over her body) and PYREXIA (Fever) had resolved. At the time of the report, FEELING HOT (Left thigh warm) and PAIN IN EXTREMITY (Sharp stabbing pain in the top of her left thigh/painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-269014 (Patient Link).
Nausea; general weakness; headache; pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 02:15 (Lot number: ER8733) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "animal dander dust" (unspecified if ongoing); "Tree" (unspecified if ongoing); "Allergy to nuts" (unspecified if ongoing), notes: Allergy to almond; "grasspollen" (unspecified if ongoing). Concomitant medication(s) included: FERRUM-SR; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 & FOLIC ACID; ALPRAZOLAM. The following information was reported: NAUSEA (non-serious) with onset 27Mar2021 02:30, outcome "not recovered", described as "Nausea"; ASTHENIA (non-serious) with onset 27Mar2021 02:30, outcome "not recovered", described as "general weakness"; HEADACHE (non-serious) with onset 27Mar2021 02:30, outcome "not recovered", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 27Mar2021 02:30, outcome "not recovered", described as "pain in arm". Therapeutic measures were not taken as a result of nausea, asthenia, headache, pain in extremity.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination.  No follow-up attempts are possible. No further information is expected.
Viral exanthem-measles like rash on face spreading to trunk. Measles exanthem, no fever or other symptoms.
Chest pressure, weak and febrile generally overall. All began the morning after the vaccination. Headache began morning of 3rd day post vax.