chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MILD GUILLAIN BARRE SYNDROME; This spontaneous report received from a patient concerned a 53 year old male The patient's weight was 180 pounds, and height was 69 inches. The patient's concurrent conditions included: bees allergy, non smoker, and alcohol use, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug use. The patient had excellent health before this. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) 1 total, dose was not reported, administered on 14-AUG-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  The patient reported on AUG-2021, About a week or ten days after the vaccination, he started experiencing muscle weakness and pain in his arms, and the sensation was more dominant in his left arm. It is not continuous, but he had noticed a significant difference in his grip. It was reported that If patient took a drive for an hour or more, he notice a pressure in legs behind the knee and upper calf. Had been taking fish oil to help. Had gone to PCP, and she thought it was possibly a Mild case of GBS (Mild Guillain Barre Syndrome). Treatment medications (dates unspecified) included: fish oil. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Mild Guillain Barre Syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211121450-COVID-19 VACCINE AD26.COV2.S - Mild Guillain Barre Syndrome. This event is labeled per RSI and is therefore considered potentially related.
Received T-DAP, MENACTRA and HPV #1 at 3pm - became sick with fever 101 degrees lightheadedness, nausea and severe headache at 7pm.
This case was reported by a pharmacist and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ENGERIX B (unknown) and experienced not responding to therapy. Pharmacist reported, he was asked about a subject's immune status; he did not have any specific information about the event, subject, or timelines. The subject is described as a non-responder to ENGERIX B. Additional information from call audit on 24 September 2009: The subject had completed the series. Last dose was given two months prior to reporting. A titer was done and the subject had no hepatitis B protection. Follow-up information was received on 01 December 2009 from a nurse. The subject received ENGERIX B on 21 January 2009, 09 March 2009 and 08 June 2009. On 05 August 2009, hepatitis B surface antibody was non-reactive. The pharmacist reported that the event was unchanged. Series was restarted on 24 September 2009.
Last week she mentioned to me that soon after her flu shot last year she developed shoulder pain. Went through physical therapy and is still doing exercises at home.
I did not have an adverse reaction to the vaccine. On 02/06/2023, I had surgery and went into atrial fibrillation at the end of the surgery. I also developed a cough after the surgery that will not go away. I was referred to a cardiologist and he had me to wear a monitor for a week. I talked to someone from the office yesterday and I was told it is still there but not to worry.
leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain) 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) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain). At the time of the report, PAIN IN EXTREMITY (leg pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Feeling cramps and bloating; Feeling cramps and bloating; Extreme cramping and bloating and some spotting. I dont normally bleed during my period because I have the Mirena IUD; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient had no known allergies to medications, food or other products. The patient previously received  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 08:00, the patient experienced period cycle symptoms which lasted as usual for 3-7 days. The patient started feeling period symptoms again on 08Apr2021 and had been feeling that since long. The patient's period cycle  was usually in the beginning of the month. On 26Apr2021, the patient started spotting again, feeling cramps and bloating. The patient had period symptoms for a full month. Extreme cramping and bloating and some spotting. The patient had Mirena IUD and hence do not normally bleed during period. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events spotting menstrual, cramps and bloating was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
5/26/2020: platelets 133 12/2020: possible covid infection, but no testing done, nucleocapsid antibody testing pending. persistent fatigue following illness. 2/14/21: 1st dose moderna 3/14/21: 2nd dose moderna 5/24/21: plts drop to 26 on difficult lab draw. no clumping noted in lab report. no active bleeding noted by patient. 5/25/21: Repeat plts: 104.  6/8/221: repeat plts: 141
he had a hard time navigating to the bathroom on 2 separate occasions and is unable to walk on his own.  10/19/09 Physician fax received for date of service 10/12/09.  Dx:  Death secondary to Guillain-Barre Syndrome. Assessment:  Intubated due to GBS.  EMG showed denervation distally.  Due to increased neuronal injury and poor prognosis (also coupled with post-Polio syndrome) the family decided to extubate the patient.  12/1/09 ED and Hospital records received. Service dates 9/28/09 to 10/12/09. Assessment: Severe Guillian-Barre Syndrome. Patient developed profound, progressive and generalized weakness over the last 24-36 hours. Numbness toes, feet, fingers. Unable to walk on his own. Peripheral edema. Rhonchi bilateral. Intubated. Subdural hematoma. Hematuria with clots. Gallbladder polyp, Renal cyst. Atrial fibrillation. Sinus Bradycardia. Left ventricular hypertrophy. Nonresponsive to voice / touch. DTR's absent. IVIG Administered.
Child had pain to Righ Thigh and redness Had temp of 100 following day.
Extreme watering of eyes; blood shot eyes, inflamed eyes, headache, itching.
Net like rash, itching, 12 days after vaccination.  TYLENOL, antihistamine as needed.
About four days after the Shingrix injection, I developed neuropathy.  I have nerve pain in the areas where I rest my weight.  These include my feet, buttocks, back, and back of my head.  I also have had pain in both of my ankles, the left one especially.  This has been going on all the time since the injection.  It varies in intensity, but has not subsided.
This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 54-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, intramuscularly). On an unknown date, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, injection site swelling and intramuscular formulation administered by other route. The patient was treated with ibuprofen and non-drug therapy (Cold Compress). On an unknown date, the outcome of the injection site erythema, injection site pain, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: This case was reported by Office Manager. The reporter indicated that, they had a patient who received the 2nd dose of SHINGRIX subcutaneously, which led to incorrect route of vaccine administration. The patient's injection site was very swollen, red, and was very painful. The patient used cold compresses on the injection site. The field representative was unable to provide additional information.
Patient had presyncopal episode after vaccination, patient stated he felt dizzy, eyes blacked out  Patient seen by medical team and vitals were stable  Patient has history of syncopal episodes Patient stated symptoms improved and refused medical transport and signed AMA form Friend will be driving patient home
This spontaneous report was received from a licensed practical nurse, referring to a multiple unspecified patients of unknown age and gender. The patients' current condition and medical history were not provided. On an unknown dates, the patients were vaccinated with PROQUAD dose and route of administration were not reported (lot # M006107, date of expiration 01-AUG-2017). The PROQUAD was reconstituted with properly stored sterile diluent (manufacturer unknown). No adverse effects were reported. PROQUAD was stored between 15 Fahrenheit degrees (F) and 46 F for 2 hours and 12 minutes. There was previous temperature excursion temperatures between 15 F and 46 F for 1 hour and 12 minutes. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA011404.
Confusion & Headache Narrative:  Woke up the day after with a really bad headache, took Excedrin which did not help much, severe fatigue and lethargy. States she also had a bit of confusion, got lost in her yard yesterday, could not find her door. Has a history of lupus. Headache is lingering, also has a history of migraines.
the adverse event its a error on administration. Patient comes to the clinic for his 3rd dose (1rst booster) but patient was injected with the monovalent moderna vaccine instead of the bivalent moderna vaccine, the administered vaccine doesn't present any previous temperature excursion or any related problems.
Local itching, redness observed ice to site, BENADRYL 4 tsps. 125 mg, per tsp.
Employee received the Pfizer vaccine dose #1 on 09/01 at vaccine event. The injection was in the right upper arm in deltoid. Started have symptoms the next day on  09/02 after vaccine: body aches, fever (unknown max temp), and chills,. Has been off of work since 09/03 and 09/07. she has been taking Aspirin and ibuprofen around the clock every 6 hours. has been helping a little still doesn't feel well.   Was told to give a follow up call about Symptoms, if they worsen, and advise to go to PCP and  follow up
Sharp stomach pains within 2 hours of shot.  Hands then became tingly and had"pins and needles", throat then had same feeling. Then had feverish feeling then nausea and itching all over. Then took Benadryl. Then "sick" feeling, then wheezing, then chest pain, then went to emergency room.  Felt sick ,could not function. 2/17/09-records received for DOS 1/14/09-presented to ED with C/O difficulty breathing and wheezing, abdominal cramping . Allergic reaction to Gardasil Impression: anaphylaxis.
I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 9/28/2021 ATHEROSCLEROSIS OF AORTA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/15/2021 ATHEROSCLEROSIS OF AORTA I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 9/28/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/15/2021 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Left thigh swollen, induration at mid thigh encompasses both DTaP and HIB sites-erythema through vastus lateral muscles. Sore with touch but good range of motion. Swelling and soreness lasted several days with night wakefulness less than 48 hours.
I had stroke on March 8th - I was teaching from home and I got super dizzy; I could see in front of me or focus. I felt like something was wrong and I called someone. She came over and said my face was drooping on one side. I didn't know what day it was. She called the ambulance. Medical Center ER - went there in the ambulance. Confirmed a stroke at the  hospital.  I had TPA; I didn't have any residual damage. They put me on a statin  - Lipitor and a baby aspirin to take at home.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: patient was given second shot and about 3 to 5 minutes later he passed out for less than a second and then reported dizziness and nausea. re was drinking some water and then passed out for less than a second a second time
BEGAN HAVING RASH>HIVES WHICH PROGRESSED OVER NEXT 4 HOURS EVEN AFTER BENADRYL.  NO RESPIRATORY DEISTRESS.  TREATED AT ER WITH PREDISONE AND DEPO MED PACK.
The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022; No adverse event; On 25Nov2022 HCP administered Moderna Monovalent to patient 2 days after 30 Day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to patient 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to patient 2 days after 30 Day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to patient 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to patient 2 days after 30 Day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022).    No concomitant medication details was reported. It was reported that individual vails was used and vial size was 5.5ml. The vial was initially stored in the refrigerator on 24-Oct-2022. The vial did not undergo any temperature excursions. No treatment medication details was reported.   This case was linked to MODERNATX, INC.-MOD-2022-679103 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-679103:same reporter (crosslink MOD22-029943)
pt recv vax 14SEP95 & 20SEP95 pt devel bumpy rashes on arms, face, neck, & chest;25SEP95 devel small white, tiny vesicles on face;sx described as a fine rash on face, upper arms, & chest;
Came home from having the vaccine arm pain, around midnight started getting fever which was 103.5 at that time, now it is 104.1 after taking Tylenol 500 mg every 4 hours, last dose at 2:00 PM.
Between 4:30 PM and 5:15PM, I consumed several alcohol drinks for New Years Eve and became immediately intoxicated. The amount of alcohol consumed has never intoxicated me. My husband drove me home and after arriving home, became dizzy and collapsed on bathroom floor. Bruised hip and top of hand is only injuries. I have never had this happen to me before and feel it was possibly due to the recent vaccination for Shingles that caused this immediate intoxication. The paperwork provided at the time of vaccination did not say you could not consume alcohol within the few hours after receiving it but obviously it had an adverser effect on me.
Patient's left arm is swollen and red from the shoulder to the elbow. Patient stated that he felt pain when he got home and saw that his arm was starting to get red. He came to the pharmacy the following day and he said it is a little better but still a little red and swollen. I told the pain to take Benadryl for the rash and Ibuprofen for the swelling and pain
cont soreness in the lt deltoid since inject; small lump noted by palpation @ inject site;
This case was reported by a consumer via call center representative and described the occurrence of gastroenteritis norovirus in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dehydration (might have been slightly dehydrated). On 8th December 2018 19:00, the patient received the 1st dose of SHINGRIX. On 8th December 2018, 45 min after receiving SHINGRIX, the patient experienced gastroenteritis norovirus (serious criteria GSK medically significant), vomiting, diarrhea, weakness and injection site pain. On 11th December 2018, the outcome of the gastroenteritis norovirus, vomiting, diarrhea, weakness and injection site pain were recovered/resolved. The reporter considered the gastroenteritis norovirus, vomiting and diarrhea to be unrelated to SHINGRIX. It was unknown if the reporter considered the weakness and injection site pain to be related to SHINGRIX. Additional details were received as follows: This case was reported via online chat. The patient asked if their dose could be compromised. The patient stated that they were a nutritionist and declined to provide additional information during the chat. The patient stated that she might have been slightly dehydrated as she had just came from the gym but was feeling good She was drinking water prior to getting the injection. Around 7 pm, the patient received SHINGRIX. The patient became sick with norovirus 45 minutes after a dose of SHINGRIX. The patient stated that 45 minutes after vaccination, she became sick with norovirus and the patient was asking if the 1st dose was compromised. When asked to the patient if her Norovirus was confirmed, she said it was not confirmed but she knew several other friends in her community who she had contact with and they all had the same symptoms of throwing up and having diarrhea. She said this lasted for 5 hours then she was able to start drinking water but she was very weak. The patient did not think SHINGRIX caused her GI symptoms. On 11th December 2018, she felt perfect. Her symptoms were resolved. About 48 hours after receiving SHINGRIX, the arm where the injection was given was sore. In December 2018, injection site sore resolved. Follow up information was received from consumer on 12th December 2018: After 45 minutes later, the patient was thrown up with the norovirus and was sick for the next five hours. The patient was frightened that could have ruined the shot and that might not be fully effective. The outcome of the sick were unknown. It was unknown if the reporter considered the sick to be related to SHINGRIX. Lab Comments: On an unknown date, the patients became sick with norovirus.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 12 year old male patient. On 01-FEB-2017, the patient was vaccinated with GARDASIL 9 (lot # M024261), (route: intramuscular) in the right arm. On 02-FEB-2017 (with in 24 hours of vaccine administration), the patient experienced headache, vomiting, pyrexia, pain, neck pain and nausea. The patient seen in clinic on 02-FEB-2017 and symptoms had improved at the time of the visit. It was also reported that, patient's exam was reassuring. The patient scheduled for follow up on 03-FEB-2017 for re-evaluation. The causality of the events was unknown. Additional information is not expected because no further information could be obtained from the regulatory authority.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium
Seen 1/20/12 with 24 hours of mom noting "red, warm area (R) thigh where vaccine given". Better today but still sl erythematous (4.5 " x 3.5"). Had 1 dose of AMOXIL for suspected strep pharyngitis - later confirmed by throat culture. Antibiotic changed 1/30/12 to KEFLEX to cover cellulitis.
The individual vaccinated reported to his clinic to treat symptoms. He reported aches, general malaise, and a fever of 102.9F that presented the following day after immunizations, lasting through Thursday until treatment was provided.
Booster vaccine was given 10 days after the beyond use date of 11/20/2021 Patient notified, no adverse reactions and patient has chosen to re-vaccinate in 2 months
Swelling and soreness at site of injection, headache, extreme shivering No medical treatment sought By next morning headache was milder and shivering had stopped sometime during the night, injection site was sore for about 3 days
After Pneumovax given 9/18/15, she developed chills and sweats, did not check temperature, noted fatigue.  Injection site painful, and patient had difficulty lifting her arm.  9/19/15, injection site had redness and swelling at injection site which had increased in size from 9/18/15.  Arm, non specific began to swell, and redness continued to increase on 9/20/15.  Patient went to local Urgent Care Center where she was provided with an IM injection of steroids with Toradol for swelling and pain relief.
COVID 19 Treatment.; COVID 19 Treatment.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 12:00 as dose 4 (booster), single (Lot number: GH9694) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment.". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details: Product: COVID 19 Treatment Brand: Paxlovid. Report about COVID treatment.   No follow-up attempts are possible. No further information is expected.