chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had a rapid test performed which indicated a positive test result; she had a rapid test performed which indicated a positive test result; This is a spontaneous report from a contactable nurse (patient). A female patient of unspecified age received the first dose of BNT162B2, via an unspecified route of administration on 18Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient indicated she received the first dose of the vaccine on the 18th and due to a family member testing positive, she had a SARS-CoV-2 rapid test performed in Dec2020 which indicated a positive test result. Her employment was questioning as to whether this is due to her receipt of vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The reported information is limited. 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.
Family considers patients demise 5/8/2021 a result of vaccination with COVID-19 series given 2/3/2021 and 3/3/2021. He died from respiratory acidosis yet never had breathing problems prior tom vaccine.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. On an unknown dates those patients were vaccinated with PNEUMOVAX 23 (dose, units, route of administration, anatomical location, lot number were not reported) that may had been stored improperly. No adverse effects reported. This is one of several reports from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Felt Weak; Diarrhea; Back ache; Shivers; Fever; Injection site pain; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Felt Weak), DIARRHOEA (Diarrhea), BACK PAIN (Back ache), CHILLS (Shivers) and PYREXIA (Fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (Felt Weak), DIARRHOEA (Diarrhea), BACK PAIN (Back ache), CHILLS (Shivers), PYREXIA (Fever), VACCINATION SITE PAIN (Injection site pain) and VOMITING (Vomiting). On 22-Jan-2021, ASTHENIA (Felt Weak), DIARRHOEA (Diarrhea), BACK PAIN (Back ache), CHILLS (Shivers), PYREXIA (Fever), VACCINATION SITE PAIN (Injection site pain) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient took Aspirin on 21-JAN-2021 for treatment of the symptoms.
Narrative: Patient had fever 5 hours and severe shivering after  receiving their 5th COVID vaccine (Moderna) on 7 December 2022. The patient took over the counter medications.
Extreme fatigue Lightheaded, especially upon standing Migraine (persisted for more than 24 hours) Fever, first taken at 100.8 but went as high as 104.2 (Fluctuated throughout the day, but did not break until more than 24 hours after first fever recorded) Nausea
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female with penicillin allergy and no pertinent medical history who on 21-OCT-2008 was vaccinated IM with the first 0.5ml dose of GARDASIL (lot# not reported). There was no concomitant medication. The patient was administered her third dose of GARDASIL on 20-JUL-2009. On 14-AUG-2009, a urine pregnancy test was performed and the patient was determined to be pregnant. No problems reported. Unspecified medical attention was sought. The patient's last menstrual period was 20-JUN-2009. Expected date of delivery was 27-MAR-2010. Follow up information has been received from a registered nurse concerning a 20 year old female patient with penicillin allergy and a history of preeclampsia in 2007 pregnancy and one full time delivery at 37 weeks gestation who on 21-OCT-2008, 12-FEB-2009 and 20-JUL-2009 was vaccinated IM with the first (lot# 661764/0650X), second (lot# 661952/1129X) and third (662300/0100Y) 0.5ml doses respectively of GARDASIL. An ultrasound was performed for dating on 25-AUG-2009 and it showed pregnancy at 6 weeks and 5 days gestation. A maternal serum Alpha-Fetoprotein Screening was performed on 02-NOV-2009, and the result was within normal limits (WNL). Follow up information from a register nurse indicated that on 09-APR-2010 (39 weeks from LMP), the patient delivered a normal male baby (6 lb 8 oz, 20 in length, head circumference 32 and APGAR score 9 at 1 minute /9 at 5 minutes). On 12-AUG-2009, 18-SEP-2009, and 29-DEC-2009, the patient experienced urinary tract infections and was treated with MACROBID. On 09-FEB-2010, the patient experienced shingles. On 29-DEC-2009 and 12-FEB-2010, the patient experienced pyelonephritis and was treated with BACTRIM. On 20-FEB-2010 the patient was treated with cephalexin for suppression. On an unspecified date, the patient experienced headache. On 23-NOV-2009, an ultrasound was performed and showed echogenic focus left ventricle. On 30-NOV-2009, a level II ultrasound was performed and the result was not provided. During the patient's pregnancy, on 05-OCT-2009, the patient was vaccinated with a dose of influenza virus vaccine. There was no complication during delivery. At the time of the report, the patient's status was unknown. The baby's experience has been captured in WAES# 0909USA01379B1. Additional information is not expected.
Patient came 05/17/2021 to the Pharmacy and reported the arm at vaccination site was swollen , hot, red and itchy. She said a nurse told her to visit an MD to be evaluated. She said she used the cold compresses and just had a little improvement but the area of redness was growing. She came to the Pharmacy to have the event reported
patient that received 3 Shingrix Vaccine doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2018) and Shingrix (received 2nd dose on 2018 ).   On 01-SEP-2023, the patient received the 3rd dose of Shingrix (intramuscular). On 01-SEP-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient that received 3 Shingrix Vaccine doses).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-SEP-2023 Recommended dose was 2 Shingrix vaccines per Package insert content. The patient received 3rd dose of Shingrix, which led extra dose administration. The reporter consented to follow up.
No additional AE reported; An expired PROQUAD was administered to a patient; This spontaneous report as received from a physician referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 10-SEP-2020 the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live  (rHA) (PROQUAD) 0.5 milliliter, once, lot # S006832, expiration date 02-SEP-2020 (route of administration was not provided) for prophylaxis. There were no prior temperature excursions. No additional adverse event reported.
A 71 year old female reported that she received an injection of Pnu-Imune 23 in 11/99. Subsequently, she developed a slight fever and an injection site reaction characterized by a 3.5" area of redness, burning and pain. The pt stated that the redness lasted for 3 months. She also stated that she still has a "mark" at the site of vaccine administration.
Tiredness; Headache; Muscle pain; Chills; Feeling unwell; Nausea; Vomiting; Diarrhea; Severe radiating stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ENG199) via an unspecified route of administration in the arm left on 05Mar2021 at 16:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, shellfish allergy and bee sting hypersensitivity (bee venom). It was reported that the patient was in good health and was working on lifestyle changes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included minerals nos (MINERALS), ademetionine (SAME) and Multivitamins (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication and unknown if ongoing. The patient previously received formaldehyde (MANUFACTURER UNKNOWN), ethanol (MANUFACTURER UNKNOWN) and xylitol (MANUFACTURER UNKNOWN) on an unknown date and experienced allergy. On 06Mar2021 at 01:00, the patient experienced tiredness, headache, muscle pain, chills. On the same day at the same time the patient also experienced feeling unwell, nausea, vomiting, diarrhoea lasting 36 hours then on/off 24 days, severe radiating stomach pain on 27 day. The events resulted in doctor or other healthcare professional office/clinic visits. The events resulted in the emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included the treatment with unspecified medications. On an unknown date in 2021, the patient underwent a blood test and ultrasound abdomen (reported as ultrasound R quad abdomen) and both the results were not reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, tiredness, headache and muscle pain was recovered on 07Mar2021, after the duration of 36 hours. The clinical outcome of the event chills was recovered on 07Mar2021, after the duration of 24 hours while that of the events, feeling unwell, nausea, vomiting, diarrhoea lasting 36 hours then on/off 24 days, severe radiating stomach pain on 27 day were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
A MA reported that a 14 month old female received a 5th dose of Prevnar on 8/20/01. On 8/20/01, she also received DTAP, Poliomyelitis and haemophilus B conjugate vaccines. On 8/23/01, the child developed an abscess at the injection site. The location of the injection site was not specified. She was treated with cefaclor for 10 days. No additional information was available as of the date of this report. This is 1 of 2 pts from this facility who experienced this event, post vax, of 2 different lots of Prevnar.
1/4/2022 I stated with cold like symptoms a couple days later on 1/7/22 my left eye was very itchy and bothering me on that sunday  1/9/22 my eye felt like it was changing vision and collapsing on Monday we went to the ER because my left side of my face was droopy and i couldn't talk , eat, or drink well.
developed rash on the injection site and stayed for 3 days  taken Benadryl 25mg capsule not gone
Swollen Lymph Nodes; Pain; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 17Aug2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received amoxicillin (AMOXICILLINE) on an unknown date for an unknown indication and experienced drug allergy. On 17Aug2021, the patient experienced swollen lymph nodes and pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen lymph nodes and pain were resolved on an unknown date in 2021.
Intense swelling, redness, rash, heat itching starting at injection site and extending down the arm about 7?. The affected area expended over the next few days to be about 7?x10?, wrapping around the arm. About the 3rd day the hand on the affected arm started to become numb. As the swelling and redness reduced, the numbness was replaced by pain in the hand and the forearm. Antihistamines and topical treatments did not improve the symptoms.
Swollen left Clavicular Lymph node still has not gone away since day 1 . Size of a bean.
I had a rash developed on my torso and I had severe itching from head to toe that showed up Saturday the 19th. I saw the doctor on Monday the 21st and he prescribed that I take an OTC allergy medication. At this point the itching is gone but the rash is still here, it is not attractive but it does not bother me at all.
Pain in arm which got worse over the next week and I was unable to lift a coffee cup with my left arm. After a month the pain gravitated to my shoulder and my neck and is 24/7 pain, excruciating pain. I have been unable to do many of my normal activities and chores.
No adverse reactions happened . I explained to the patient the administration method was incorrect . shingrix should have been given IM not SQ . I advised patient dose is still valid and printed out information per CDC website
After I received my first dose Moderna vaccine, I was concerned about having a virus because I was not feeling well. I had pain in chest, sore throat, ear aches and felt very tired.
Circumstance or information capable of leading to medication error; Patient may or may not have latex allergy and possibly received Havrix, Boostrix, FluLaval or Fluarix in 2015 and 2016; This case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included latex allergy (had possible latex allergy).   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced circumstance or information capable of leading to medication error and documented hypersensitivity to administered product. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and documented hypersensitivity to administered product were 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:  US2022AMR051879, US2022AMR051880  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient may or may not have had latex allergy and received Havrix in 2015 and 2016, which led to documented hypersensitivity to administered product and circumstance or information capable of leading to medication error. The reporter declined to provide any adverse event details. The reporter gave permission for follow up. The case was linked with case US2022AMR051879 and US2022AMR051880 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR051879:Same reporter. US-GLAXOSMITHKLINE-US2022AMR051880:Same reporter.
Three doses of Moderna vaccine were given to case under 18 years old. Other two vaccines:  Moderna  025B21A  Administration date : 04/08/2021  Moderna  009C21A  Administration date :5/11/2021
Anthrax vaccination #4.  Right arm-swelling, redness, hot, itchy, diameter 10cm vaccination was given 11/16/2003 during UTA.
rash was diagnosed by her husband's doctor as pityriasis rosea; itching on his back; rash and itching on his back; This case was reported by a consumer via call center representative and described the occurrence of pityriasis rosea in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number T7S73, expiry date 30th June 2021) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, 2 weeks after receiving Shingrix, the patient experienced pityriasis rosea, pruritus and rash. On an unknown date, the outcome of the pityriasis rosea, pruritus and rash were not recovered/not resolved.   It was unknown if the reporter considered the pityriasis rosea, pruritus and rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The patient received Shingrix and about 2 weeks later developed a rash and itching on his back and these had not resolved.  The reporter reported the rash was diagnosed by doctor as pityriasis rosea and was in the shape of a Christmas tree.  The reported stated the rash was fading and doctor said it could take months to resolve completely. The reporter consented to follow up.
Feels tired; Arm is very sore like someone gave her a punch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore like someone gave her a punch) and FATIGUE (Feels tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PAIN IN EXTREMITY (Arm is very sore like someone gave her a punch). On an unknown date, the patient experienced FATIGUE (Feels tired). At the time of the report, PAIN IN EXTREMITY (Arm is very sore like someone gave her a punch) and FATIGUE (Feels tired) had not resolved.            The patient took the 2nd shot on 04-May-2021 and reported that their arm was very sore, like someone gave them a punch. The patient also reported that they felt tired.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-076227 (Patient Link).
COVID-19 booster use for COVID-19 under Emergency Use Authorization (EUA): Patient stated that a low dose of flu shot was given at the same time as COVID-19 booster (manufacturer not reported). Patient stated that she wasn't feeling well for two week following injections, but not symptoms of fever. Symptoms decreased after first week.
HEADACHE; FEVER; SWEATING; BODY ACHE ( FINGERS, HIPS, FEET, ARMS ); CHILLS; FEELINGS OF WEAKNESS; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced sweating. On 08-APR-2021, the subject experienced body ache ( fingers, hips, feet, arms ). On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced feelings of weakness. On 08-APR-2021, the subject experienced fever. On 08-APR-2021 11:00, treatment medications included: paracetamol. On 09-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body ache ( fingers, hips, feet, arms ), fever, chills, feelings of weakness, headache, and sweating. This report was non-serious.
Information has been received from a RN concerning a 12 month old male who was vaccinated in approx 2003 with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Subsequently, the pt had a seizure after he was given the vaccine. Unspecified medical attention was sought. The pt's outcome was unk. No product quality complaint was involved. Upon internal review, seizure was considered an other important medical event (OMIC). Additional information is not expected.
Initial report received from a parent in the USA on 10/03/05. A female patient (age not reported) reportedly developed bacterial meningitis 13 days after she received an injection of Menactra vaccine on 8/3/05 (lot number, route and site of administration not reported). The patient is home from the hospital. The parent stated that their daughter is still pretty sick and it had been 6 weeks since she was diagnosed with BM. The parent felt that her daughter should be making progress with her recovery, but she does not feel she is doing so. Follow up information received on 10/6/05. The patient is an 18 year old female who developed malaise, 3 hours after she received an injection of Menactra, lot number U1741AB (route and site of administration not reported) on 8/3/05. On 8/16/05, she developed headache and leg weakness. She went to the hospital where a spinal tap was taken and found to be positive for meningitis (no strain identified). She was treated with antibiotics and discharged on 8/26/05. On 8/28/05, she developed post-meningitis headache and continuing leg weakness. She was readmitted to hospital where she was given a spinal patch with DHE and steroids. She was discharged on 8/30/05. On 9/3/05, she was readmitted to another hospital for continued weakness and discharged on 9/7/05. She went to the same hospital on 10/6/05 complaining of continued leg weakness. The patient also had a CT head - within normal limits and MRI with contrast, but no dates were provided. As per the parent, the patient has not recovered.
Maybe a minute after shot began feeling very light headed and hearing became muffled. This did not last too long and I was able to drive home. The next day I began to get chills without a fever and had arm numbness and some pain to move the arm at all. By the afternoon evening, I spiked a fever of 102. It came down to 100.6 and stayed until early morning. I took Tylenol to help when it wouldn?t break.
Started with a head ache and sore arm last night.  Today she has a strong headache, her arm hurts, is achy, and is having intolerable hip pain.  Is taking ibuprofen for comfort.
COVID-19 first dose on 2-18-2021 Second dose on 3-18-2021 Symptoms of allergic reaction were identified by primary care physician on 10/11/2021. Symptoms consisted of swollen lips, split lips (skin split/cracked) and had been intermittent beginning sometime in September. Frequency seemed random and cause could not be identified. Patient had been experiencing the swollen lips without knowing the cause.  When physician (PA-C at Clinic) identified it as allergic reaction, patient made appointment with an allergy specialist, Dr.
Inject site warm, red & edematous; stated joint pain, bruising on lt amr, itching on head, neck & arms; t98; Decadron, ice applied on inj site; DPH given;