chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received on 02 October 2013 from a health care professional. A 66 year-old female patient with an unknown past medical history had received on 30 September 2013 an intramuscular left deltoid injection of FLUZONE HIGH-DOSE, lot number U4715AA and the next day on 01 October 2013 fainted at home. The patient was taken to the hospital by ambulance. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Prior to shot, pt expressed anxiety about getting shots.  I used calming conversation during prep to calm her.  She received shot in the left deltoid muscle.  The patient continued to act anxious and cradled her head in her hands.  I asked, "Are you ok?"  My colleague offered water.  Shortly thereafter, the pt leaned to the side and fell off her chair, unconscious.  I was unable to catch her, and she fell and slumped against a partition.  I was able to rush over and prevent her from slumping to the concrete floor.  A colleague ran back to call 911. Pt had a pulse and was breathing.  About 30 seconds later the pt became conscious.  She did not want 911 to be called.  She simply wanted to rest in the shot booth with her friend.  We provided materials to lie down on.  Pt walked out with her friend about 20 minutes later.
Patient as well until 3 December 2013 when she received in her left biceps area her first AVA vaccine. States that it immediately 'stung' and subsequently developed a headache mid AM on the following day. She experiences headaches anyway secondary to TMJ and is unsure if this headache was different than those. About 3 days later she developed swelling around the injection site and at day 7 post vaccine she noted a nodular, red area at injection site with a pruritic maculopapular rash. The rash consisted of "raised pinhead bumps in an arc shape at the bottom of injection site near that elbow." She continued to have headache with muscle soreness in the injected arm. She denied similar reactions from other vaccines. The mobility of her left arm was limited -"I could hardly raise my arm"-and impacted her ability to move it in full range of motion. Due to the occurrence of her initial reaction with AVA it was recommended that her next dose be given approximately 35 days after the initial dose and that the 2nd dose be preceded by an antihistamine and ibuprofen. She took all pre-treatment 45 minutes prior to the 2nd dose that she received on 7 Jan '14. Within 24 hours following the receipt of the vaccine she reported moderate generalized myalgias/arthralgias with fatigue. Her injected arm was again very sore with redness and swelling and a pinpoint nodule at the needle entry site. She felt weak and sore and felt progressively worse throughout day 2 post vaccine and experienced an intense headache (10/10) which lasted 2 days. At 48 hours post-vaccine, she also reports chills and temp of 101.7. All symptoms resolved within 60 hours after receiving the vaccine. She received no other vaccination simultaneously.
Chills; mild headache; loss of appetite; muscle pain; severe fatigue; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 07Dec2020 15:00 (lot# EH9899), second dose on 04Jan2021 08:00 (lot# EL1284), both intramuscular in left arm at single dose for covid-19 immunization.  Medical history reported as none. Allergies to medications, food, or other products: No. There were no concomitant medications.  The patient experienced Chills, mild headache, loss of appetite, muscle pain, severe fatigue, all on 04Jan2021 18:00 with outcome of recovering. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: no. Treatment received for the adverse event: paracetamol (TYLENOL).  Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
This spontaneous report was received from a pharmacist concerning to a patient of unknown age and gender. The patient's concurrent conditions, medical history or allergy/drug reactions were not reported. On an unspecified date in 2014, reported as one year ago, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency and lot No. not specified) subcutaneously. Then, on 22-SEP-2015 the patient received a second dose of ZOSTAVAX (lot No. not informed) 0.65 ml, subcutaneously. No adverse effect nor product quality issue were informed. Additional information has been requested.
About 3 weeks after my second Pfizer shot my blood pressure has spiked from a normal of 130/70 (medication controlled) to 150+/80, and has not responded to an increase in my Losartan as directed by my physician.  My hypertension has been very stable for years, the only change is receiving the COVID vaccine.  As recently as March of this year I had my annual physical and my BP was under control.
A 4 year old white female, with no illness at the time of the vaccination, on 05/07/01 (also reported as 05/09/01) was vaccinated with a 2nd dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, SC in the right thigh. Concomitant therapy that day included the 5th dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia), administration IM in the left thigh, one dose of tuberculin purified protein derivative, and the fourth dose of poliovirus vaccine (IPOL), SC, in the left thigh. It was noted that the child was being vaccinated for kindergarten. Subsequently, on approximately 05/07/01 (also reported 05/10/01), the patient's left leg in which she received alum, potassium (+) diphtheria toxoid () pertussis vaccine (+) tetanus toxoid and poliovirus vaccinations became hot and swollen. On the next day the patient's symptoms worsened. That morning, on 05/08/01, she had redness and swelling of the left thigh, was seen in urgent care, and was diagnosed with cellulitis. The child was treated with cephalexin (Keflex). It was further reported that on 05/10/01, the cellulitis was resolving. Subsequently, on 05/24/01, the patient recovered. It was also reported that the patient had received one dose of varicella virus vaccine live at one year of age, on approximately 06/27/97 and on approximately 05/17/97 developed chicken pox. Upon internal interview the cellulitis was considered to be an other important medical event. From faxed information "F/U: corrected report: tuberculin purified protein derivative (Tubersol 5 TU) has been injected the same day, 5/7/01.
Patient reported the injection site feeling warm and itchy and dizziness after her flu shot. There was no redness or rash visible at the injection site. BP was taken and it was normal. We did have the patient lie down and she was given 10ml of diphenhydramine liquid 25mg/ml.
Mod severe migraine HA with dizziness, somnolence; no fever, no vomiting; TX: NSAID's (Hx of migraines in the past)
pt acting strangely, shaking, breathing strangely, inc heart beats, awake/asleep repeatedly;exam in HR, tremulous, crying cont, inc temp;
This case was reported by a physician via sales rep and described the occurrence of swelling arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling arm, fatigue and erythema of extremities. On an unknown date, the outcome of the swelling arm, fatigue and erythema of extremities were unknown. It was unknown if the reporter considered the swelling arm, fatigue and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced red arm swelling size of a grapefruit. The reporter agreed to be followed up.
pain at injection site / feels like a bee sting; indentation in skin at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 4LH35, expiry date 11th September 2021) for prophylaxis.   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2019, 35 days after receiving Shingrix, the patient experienced injection site pain and injection site indentation. On an unknown date, the outcome of the injection site pain and injection site indentation were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and injection site indentation to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on the right deltoid. Approximately 1 week before the date of reporting, the patient developed pain at the injection site that he stated felt like a bee sting.  The patient also experienced an indentation at the injection site. The caller did not provide any additional information.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 58 years, in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Heart Disease" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: walnuts" (unspecified if ongoing). Concomitant medication(s) included: RABEPRAZOLE SODIUM; LOSARTAN POTASSIUM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and treated with Paxlovid from 20Jan2023 to 24Jan2023.
This spontaneous report as received from a pharmacist refers to a 51 year old female patient. The patient's medical history included coeliac disease and previous history shingles. On 09-JUL-2016 the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU lot # L040442 expiration date 15-JAN-2017, subcutaneous. No other suspect or concomitant therapies were reported. On follow up call placed to the patient on 10-JUL-2016 she stated that she had a quarter sized red area at the injection site. It was unknown if the event began on 09-JUL-2016 or 10-JUL-2016. A second phone call was placed to the patient on 12-JUL-2016, she stated that the red area had grown to 3-4 inches, was hard in the middle, warm to the touch, and itchy. The outcome of the events was reported as not recovered. The causality between the therapy with ZOSTAVAX and the events was unknown. Additional information has been requested.
I have had severe lymph node swelling on the right side where I got the vaccine; 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough; My sputum is greenish/yellow brown with blood flecks; My sputum is greenish/yellow brown with blood flecks; chest tightness; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), intramuscular in the right arm on 11Jan2021 15:45 at single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, polycystic ovarian syndrome (PCOS), endometriosis, chronic allergies, gastritis, and walnut allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), metformin, loratadine (CLARITINE), spironolactone, and calcium carbonate, colecalciferol (VITAMIN D 2000). The patient previously took first dose of bnt162b2 (lot number and expiry date not reported), intramuscular in the right arm on 21Dec2020 15:15 at single dose for COVID-19 immunisation. The patient verbalized, "I don't know if it's related but I figured I should report just in case. I have had severe lymph node swelling on the right side where I got the vaccine. 24hrs post 2nd vaccination I have had a sudden onset of an extremely violent cough. By sudden onset, I mean I had no desire to cough and over about 30 min I developed the severe need to cough. My sputum is greenish/yellow brown with blood flecks. I've never experienced such a violent cough with so much sudden sputum production. I am using an Albuterol inhalor to help chest tightness." Clinical outcome of chest discomfort was unknown while for the other events was not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on a close chronological association, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient got 0.4mL of the Moderna dose; A spontaneous report was received from a nurse concerning an unidentified patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient got 0.4mL of the Moderna dose, instead of the 0.5mL.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient got 0.4mL of the Moderna dose, instead of the 0.5mL. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, patient got 0.4mL of the Moderna dose, instead of the 0.5mL, was considered resolved.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.
First shot - slightly tight feeling in my throat about an hour after shot, low grade fever second day Second shot - tight feeling in throat about an hour after shot for about 4 hours, and light headedness; fever later in day, fell asleep early slept 10 hours; second day ok in morning then fever getting higher all day but now better (6:30 pm so 33 hours after shot), extreme itchiness today day 2, like fleas  - took Benadryl at noon and need more now; stomach ache and diarrhea.
right sided bells palsy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).  A 61-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EW0167), via an unspecified route of administration, administered in left arm on 13Aug2021 (at the age of 60-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included hypertension and type 2 diabetes mellitus. No known allergies. Concomitant medications included semaglutide (RYBELSUS) and blood pressure medications (unspecified). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 19Jul2021 as dose 1, single for COVID-19 immunization. Patient not had Covid prior vaccination. Patient was not tested Covid post vaccination. On 01Sep2021 at 15:00, the patient experienced right sided bells palsy. The events resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated with prednisone as a result of event. The outcome of the event was not resolved.  Follow-up attempts have been completed and no further information is expected.
breastfeeding and got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding and got the vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding and got the vaccine). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding and got the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  No treatment information was provided.
I broke out in a really bad rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (I broke out in a really bad rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (I broke out in a really bad rash). At the time of the report, RASH (I broke out in a really bad rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Post vax, the pt experienced a swollen, red arm, fever, and warm to touch. The pt sought unspecified medical attention.
Horrible Tinnitus in my ears affecting my quality of life, my focus at work, my sleep, stress level and motivation in my life.  It started 1-2 days after the 3rd Pfizer vaccine. I went to the Emergency Room for this, have lost time at work, have had to see an Audiologist, an Otolaryngologist and now am getting an MRI.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with dose 2 of GARDASIL (Lot number, dose and route not reported) in January 2012. In February 2012, a month later, the patient received dose 3 of GARDASIL (Lot number, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient received the third dose outside of the recommended dosing schedule. No adverse reaction reported. Additional information has been requested.
received a dose of Menveo that had been reconstituted with sterile water; received a dose of Menveo that had been reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 31-JUL-2023, the patient received Menveo. On 31-JUL-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: received a dose of Menveo that had been reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: received a dose of Menveo that had been reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date:4-Aug-2023 A registered nurse wished to know how to proceed. The partial information about the vaccine, event and patient given as the record seemed to had been erased. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received accidentally received a dose of Menveo that had been reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Injection site reaction: red, hot, inflamed, itchy, painful over 2 days getting worse, advised to contact doctor.
2nd dose Pfizer vaccine administered patient was in Observation Area and c/o of sweating and dizziness. Patient fainted for about 2 seconds. Patient arousable and VS were within normal ranges, blood sugar was 68 when being cared for by EMS. Pt states she has had this history of reaction before to vaccines. She had not eaten or drank anything since around 8pm the night before. Patient given water and a food and stated she felt better. Patient remined in Obs area for an additional 40 minutes with EMT, RN and Physician oversight.
Patient received shot on 10/20/11 & came to pharmacy on 10/22/11 showing a swelling of 3 inches wide around the injection site. Stating it started on 10/21/11 - advised patient to use cold compress - ice.
hospitalized with dyspnea, coughing, chest pain, dizziness, weakness, lightheaded
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # L000456, expiration date 06-JAN-2017, dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Patient presented for second moderna 6m-5y bivalent. Received blue cap moderna bivalent the first time. Accidentally received 6m-5y pink cap booster dose for second dose today.
I exp fluctuating temp 97.3 jump up to 99.5 it will go down 15-20 without taking any medication. I was exp lower joint pain and really bad headache. My temp now feels leveled out.
Patient reported redness and swelling at the injection site, hives,itching all over chest, arm and face.