chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On morning of 31 March 2013 I woke up feeling tired with mild flu like symptoms and some dull pain radiating from left shoulder area. On night of 31 March I slept 15 hours and woke up on 1 April with same symptoms. Night of 2 April I slept 12 more hours and woke up on 2 April with same symptoms but getting worse in severity. Reported to work and started feeling dizziness, SOB, and pain radiating from left shoulder cap area. An ambulance was called and I was transported to Medical Center. BP on ambulance was 166/126 with disorientation, and dizziness. Was kept in ER for about 3 hours and released with normal vitals. ER doctor said he thought I was experiencing an Auto-Immune reaction to vaccines received on 29 Mar 2013. Referred to flight medicine. On 3 April 2013 saw flight medicine at. I told flight doc I still had mild pain radiating from left shoulder and chest area but thought I was getting better and he said it was probably a reaction of some kind to vaccines and I should be OK. Returned on 4 April 2013. Started feeling same symptoms in post mission crew rest and reported the following week to squadron that I should see a doctor again about symptoms. I was referred to another facility and saw my PCM on 12 April. Symptoms at that time were; pain radiating from left side chest, shoulder and breast area (7/10 in severity). EKG was normal blood work showed an acute zoster infection and was put on Gabapentin, Valtrex, Prednisone, Hydrocodone, Amitriptyline, Naproxin, Docusate, and Lidocaine Patches. Condition continues...
PNEUMOVAX 0.5 cc administered SQ L arm and 45-60 minutes later developed temperature 102.7 oral and chills - TYLENOL given and symptoms gone in 3 hours.
Employee received Moderna vaccine on 1/6/2021 and Pfizer vaccine on 2/2/2021.   No complains except of light pain in the arm and some pain behind the neck.
Received PNEUMOVAX 23 vaccination on same day I received the flu vaccination, different arms. Side effects included for 5 + days: sore arm, severe chills,fatigue,instant cramping, nausea diarrhea, bloody stools.
Patient states she fell to the floor and was feeling generally sick and had to call paramedics. Also claims her arms are red and swollen.
You get the shingles shot you get a mild case of shingles been there done that/ Suspected vaccination failure; a mild case of shingles been there done that; my arm was sore for over a year and a half; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain in arm. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Shingles vaccine and got a mild case of shingles been there done that and his/her arm was sore for over a year and a half. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions; positive for Covid-19; positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "positive for Covid-19". The patient underwent the following laboratory tests and procedures: oxygen saturation: 60-80%; sars-cov-2 test: positive. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed. There were 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions. 5 were long term residents and 3 were short term residents. 5 of them passed within a two week period. One of the above patients were sent to the hospital and was pumped with 20L of oxygen but there was no success. 1 of the above patients tested positive for Covid-19 and 4 tested negative for Covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200377557 same reporter/drug, different patient with similar event;US-PFIZER INC-202200377559 same reporter/drug, different patient with similar event;US-PFIZER INC-202200377560 same reporter/drug, different patient with similar event.;US-PFIZER INC-202200377558 same reporter/drug, different patient with similar event.;US-PFIZER INC-202200377563 same reporter/drug, different patient with similar event;US-PFIZER INC-202200377562 same reporter/drug, different patient with similar event;US-PFIZER INC-202200377561 same reporter/drug, different patient with similar event; Reported Cause(s) of Death: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions
Fever, chills, soreness at injection site and muscle aches lasted about 24 hours.
Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist via other company (Merck). This case involves patient (age and gender unknown) who experienced localized injection site reaction with large hard while received vaccine TETANUS TOXOID ADSORBED. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect TETANUS TOXOID ADSORBED produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, more than a year ago, the patient developed a non-serious localized injection site reaction with large hard bump and (vaccination site reaction) with unknown latency following the administration of TETANUS TOXOID ADSORBED. Lab data was not provided. Final diagnosis was localized injection site reaction with large hard bump. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for localized injection site reaction with large hard bump that lasted about a year. List of documents held by sender - none.
Patient reported to medical clinic  24 hours after COVID 19 injection (03/19/2021) with symptoms of visual hallucinations, myalgia, rigors, headache, nausea, vomiting and dehydration.  At the time of arrival to the medical clinic, he had refractory nausea and vomiting after receiving Zofran earlier in the day at another clinical site. Medical treatment consisted of IV Fluid bolus with maintenance fluids, IV Phenergan for the nausea and vomiting, and IV Ketorolac for headache pain. His  symptoms resolved and he started to feel better so a clinical decision was made to discharge him home in the care of a close friend. He declined any other treatment modalities or medications at the time of the discharge.  The patient returned on 03/28/2021 with a right arm DVT proven on U/S. He was then started on anticoagulation therapy after specialist phone consult and will be closely followed.
No adverse affects reported.; unspecified 17 year old patient received adult dose of VAQTA instead of pediatric dose.; unspecified 17 year old patient received adult dose of VAQTA instead of pediatric dose.; Information has been received from a pharmacist referring to a 17 year old unknown gender patient. Information about concomitant medication, pertinent medical history and drug reactions/allergies of patient were not provided.  On 24-APR-2019, the patient was vaccinated with adult dose of hepatitis a vaccine, inactivated(VAQTA) 50/1.0 U/ml instead of pediatric dose intramuscularly (dose, frequency, lot# and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age and incorrect dose administered). No adverse affects reported.
1/10/21 broke out with red rash and hives on neck and chest. Went away after 4 hours
6-7 pm began a fever that lasted until the next morning. Did have a few moments of severe chills.  Minimal nausea and dizziness.  Sore joints, and entire skull hurt. Inner ears also hurt. Slept or 12 hours Headache was also present most of the day before the fever set in.  My period started the day before and usually I have heavy days first. I had a light day after my injection and today it's extremely heavy. So it messed with the flow.
Within 1-2 hours of receiving vaccination by body got feverish: hot all over and I suffered an excruciating past infection. The shot was a large dose like a 4 on the syringe instead of a small one. I'm not sure what was really given to me, but I had a bad reaction. Reminds me of other bad injections. Don't know this was offered to anyone on medication.
Rash began to form on left arm just below the injection site. It is also beginning to spread to other parts of my body. It is mildly itchy and some parts have small bumps.
After the administration of vaccine (while sitting in car) was told to pull up and wait for the allotted time frame. While waiting, within 2-3 minutes afterwards, I began to ?feel? a sensation coming up the back of my neck and going into my head. After that happened, I began to feel tingling on the left side of my face and lips. The firefighter came to check on me and said that he noticed hives and welts on my face and neck. He told me to pull aside to be monitored longer and asked for me to step out of car to get fresh air. He then asked for me to be checked out by the EMS workers. They sat me down and took my blood pressure and pulse. They had asked me if I could breath, which I could . They did notice the hives and welts as well. Upon sitting there for about 20-30 minutes, I began to feel better and they said the hives/welts were subsiding along with the tingling.
2-3 loose to watery stools per day); nausea; abdominal cramping; incontinence; Lymphocytic colitis; This is a literature report.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. A 69 years woman with a history of GERD, hyperlipidemia, paroxysmal SVT, and hypertension. The patient's concomitant medications were not reported. The patient was presented for evaluation of severe abdominal pain, nausea, and diarrhea. She reported no significant GI issues prior to her second Pfizer COVID vaccination on 2/17/21. Within 24-hrs of vaccination, she reported onset of diarrhea (2-3 loose to watery stools per day). Symptoms intensified over the next several days to 3-5 watery stools per day with incontinence, abdominal cramping, and nausea. After consultation with her primary care provider, GI PCR and COVID testing were negative. Ondansetron and loperamide were started with minimal benefit. Two months later, a GI consultation was obtained due to persistent symptoms. Work up demonstrated no anemia with normal CRP, celiac serologies, and GI PCR. Colonoscopy on day 98 post-onset revealed patchy erythema in the descending colon and rectosigmoid. Histologic evaluation of mucosal biopsies revealed lymphocytic colitis characterized by numerous lymphocytes infiltrating the epithelium and abundant plasma cells in the lamina propria. A previous colonoscopy performed in 2012 was unremarkable. At her most recent follow-up on day 113 post-onset, the patient reported gradual improvement of abdominal symptoms and diarrhea.  No follow-up attempts were possible. No further information was expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events Colitis microscopic and suspect drug BNT162B2 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
Dark red rash that grew over the first three days to cover most of the upper arm that was injected(Left arm). Left arm in extreme pain, with burning and itching sensations. Arm was tender to touch and any movement of my body. Pain/throbbing in all joints and limbs, especially legs which include feet, ankles, knees, and hips. Headache for over three days. Extreme dizziness, standing, walking, or lying still. Nausea most of the first two days with little to no appetite. My hands were weak for the first two days, may have been slightly swollen. Extreme exhaustion and weakness for over three days. Fluctuating between chills/shivering and all over sweating.
Woke with extreme cold, had to close all windows, add clothing and blankets to go back to sleep. Woke with fever and chills, headache and body ache. Slept all day under blankets. No appetite or thirst. Stayed like this for 24 hours, passed in about 36 hours.
PATIENT IMMEDIATELY FELT PAIN IN HER ARM AND BACK FOLLOWED BY NAUSEA AND VOMITING AND LIGHTHEADEDNESS.
hurt to move, muscles were sore through-out body; hurt to swollow; lasted for about 3 days;
From initial information received on 15Dec03 from a health care professional regarding and adverse event occurring, it was reported that a four year old female pt received a dose of Fluzone SV 2003-2004 USP, lot number U1127AA, administered IM in the right side of an unspecified site on 12Dec03. Within 24 hours the pt developed a fever of 103 Degrees F and flu-like symptoms, which resolved after being treated with Motrin. The pt recovered from these events. The reporter of this case is the same reporter of case 2003 03398.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 24-JUL-2017 the patient was vaccinated with an incorrect storage PNEUMOVAX 23 lot # M042324, expiration date on 10-JUN-2018; lot # N001007 expiration date on 09-SEP-2018; and lot # reported as M044564, expiration date on 22-OCT-2018,  for prophylaxis. On an unknown date the patient experienced no adverse event. Sender's Comments: US-009507513-1708USA002800: Original Case: 1708USA002800.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 09/07/2021. PATIENT FULLY VACCINATED ON 06/09/2021.
(L) arm was sore to lay on the day vacc. was given (8-19-11). On Sunday, 8-21-11, arm became red, warm to the touch at injection site. Soreness is improved Mon. 8-22-11, but redness is still present.
Sudden onset of Ataxia and episode of Nystagmus with irritability.  Nystagmus = horizontal + multivertical, lasting a few seconds.  Patient stopped cruising and starting falling on face when crawling.  Patient seemed more wobbly when standing supporting himself with his hands.  Irritability resolved after 10 approximately 10 days and Ataxia seems to be improving after 3 weeks.  Nystagmus is the same or worse 3 weeks later.
I contacted COVID-19 in January. I tested at home and was positive. I was maybe tired; I did have a low grade temperature. I felt like it was a sinus thing. My temp stayed at 99.8. I sat tight and stayed inside. I started taking TYLENOL. It felt like I had a minor headache. I called my doctor and took PAXLOVID. It was a mild case in my opinion. It was like the same symptoms of the flu. I wasn't hungry and food didn't taste good. A little diarrhea and back pain, but that was all.
she had a fever; runny nose; This is a spontaneous report from a contactable consumer (patient's parent) from a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. 3 weeks after the first dose, the patient had a fever and runny nose. The reporter would like to know if the patient can take the second dose of the Pfizer COVID vaccine. The outcome of the events was unknown.  information on the lot/batch number has been requested.
Guillione barre syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving Flu vaccine and Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillione barre syndrome) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not reported.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine and Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome to be related to Flu vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 03-Mar-2023 This case was reported by a patient via interactive digital media. The reporter reported that the patient (friend) received the Flu and both shingles vaccine shot and ended up in ICU with guillione barre syndrome. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR038431 and US2023AMR038429 reported by same reporter. This case was found as duplicate of case US2023AMR038432. All the information from the case US2023AMR038432 was merged into this case. The case US2023AMR038432 was deleted and this case stand as case of record for this patient.; Sender's Comments:  US-GSK-US2023AMR038431:Same patient US-GSK-US2023AMR038429:Same reporter
received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA433A, expiry date 31st October 2021) for prophylaxis.   On 15th December 2021, the patient received Menveo. On 15th December 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that patient received an expired dose of Menveo during December, which led to expired vaccine used. The reporter consented to follow up. The was 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021261529:Same reporter US-GLAXOSMITHKLINE-US2021261533:Same reporter US-GLAXOSMITHKLINE-US2021261523:Same reporter US-GLAXOSMITHKLINE-US2021261528:Same reporter US-GLAXOSMITHKLINE-US2021261527:Same reporter
Fever, chills for a few hours. Achy, headache, and fatigue for 15 hours after symptom onset.
Tingleling in extremities, abdominal pain, fever,  chills, body aches, chest pressure, diarrhea,
Four days after the first dose, experience weakness on her left side and sought care at the emergency room.  After receiving her second dose today, she began to experience on the left side and altered mental state.  She left with EMS and was transported to the hospital.
Scratchy throat within minutes. Left thigh pain and spasms, left arm pain. The next morning I can't lift my arm above shoulder, thigh pain not as bad, diarrhea at 9:30 am.
Within five mins of receiving the shot, my insides felt like they were burning up.; I felt a bit lightheaded.; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: En 6206), via an unknown route on 06Mar2021 at 15:00 (at the age of 34-years) as 1ST dose, single dose in the left arm for covid-19 immunisation. The patient medical history included asthma, hypothyroidism, anemia, polycystic ovarian, gastric bypass, obesity. The patient had known allergies had reactions to ct contrast dye before. However, this is a different reaction and had throat closing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Synthroid for an unknown indication from an unknown date and unknown if ongoing. On 06Mar2021 at 15:00, the patient experienced felt liked they was burning up and felt a bit lightheaded. However, it mostly subsided within the first 10 minutes. Patient received intermittent recurrences but they were fleeting. It was unknown that patient received treatment for events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Developed Shingles( left upper leg).; Also terrible joint pain. Had to get steroid shot for pain.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 25Mar2021 at 08:15 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included immune system issues (not specified), psoriasis, arthritis and penicillin allergy. Concomitant medications were not reported. 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 27Mar2021 at 02:00, the patient developed shingles (left upper leg), also terrible joint pain. The patient had to get steroid shot for pain. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with steroid shot for joint pain, and medication (not specified) for shingles. The clinical outcome of the event shingles (left upper leg) and terrible joint pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.