chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever (over 101F); body ache; injection location soreness/pain; Administration date: 10Nov2021; Dose number: 3; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 (Lot number: FF8841) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Seafood" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose brand unknown: False, Previous dose Lot number= EL3247, Previous dose Lot unknown= False, Previous dose Administration date= 10Feb2021, Previous dose Dose number= 2, Previous dose vaccine location= left arm), administration date: 10Feb2021, for COVID-19 Immunization; Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose brand unknown: False, Previous dose Lot number= EL3247, Previous dose Lot unknown= False, Previous dose Administration date= 20Jan2021, Previous dose Dose number= 1, Previous dose vaccine location= left arm), administration date: 20Jan2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Nov2021, outcome "unknown", described as "Administration date: 10Nov2021; Dose number: 3"; PYREXIA (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "Fever (over 101F)"; PAIN (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "body ache"; VACCINATION SITE PAIN (non-serious) with onset 11Nov2021, outcome "recovered" (Nov2021), described as "injection location soreness/pain". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Extreme Fatigue, Fever even after alternating Tylenol 500 and Ibuprofen 200 it was 100.7, Myalgia - muscle pain and joint pain. Chills Redness on injection site. On 05/31 evening, the site became extremely itchy. Fever was gone after 05/31 afternoon. Sore throat after 05/31 afternoon.
systemic itchy rash: Day 1 concentrated in right underarm, took 1-2 benadryl every 4 hours throughout following days.  Day 2 on rash right underarm, right upper and lower arm, lower legs, back, neck. Day 2 Dr advised treating most of the rash with Lidex and the rash in the underarm with  Hydrocortizone. Day 3 rash on right underarm intensified, most of the rest of the body no longer rash, Days 4-6 same as Day 3. Day 7 rash appeared in left underarm though less intense than right underarm.
Itching swelling first few days . Now a 2 inch round red spot remains at the injection site in the upper left arm for11 days .
Shivering, stomach cramps, fever, headache, body ache, chills. Fever was 102F, signs started 3 hours immunization. Patient took Tylenol and went to bed. 7 hours later, awoke with shaking and other signs mentioned above.
Patient and family report memory problems the day after receiving COVID booster. They emphasize concerns specifically for short-term memory loss. A MOCA was performed in the office, in which the patient scored a 20/30. Patient did not present with any other symptom or neurological finding. Follow-up labs were unremarkable.
19FEB DTP/OPV recvd 19FEB92 & sz activity; fever 100.4 ambulance called & taken to hosp; fever 102.7 late PM admitted to hosp; 21FEB released from hosp;
This case was reported by a nurse and described the occurrence of extra dose administered in a 6-year-old male patient who received KINRIX (batch number KJ924, expiry date 22nd October 2015). Concomitant products included KINRIX. On 14th October 2014, the patient received the 2nd dose of KINRIX. On 14th October 2014, an unknown time after receiving KINRIX, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. Additional information: A 6 years old child was immunized with 2 doses of KINRIX as catch-up vaccination in the primary series of DTAP>
Patient got dizzy and felt like she was going to pass out right after receiving vaccine. Also, stated she felt nauseous and had a metallic taste in mouth. Patient remained dizzy until paramedics took her to hospital.
Around 6 pm the same day I received the J&J shot I started to feel chilly and a little nausea. I went for a walk for about 40 mins started to feel worse. I had body aches throughout my back and chest and in both arms, was freezing. Tried to eat dinner but couldn?t, too much pain and increased nausea. Tried to lay down, but began having a fast heartbeat and fast/some difficulty breathing. The pain in my chest was the worst pain I?ve ever felt. Continued feeling horrible with a fever of 100.7, nausea, headache pains throughout chest back and arms, freezing, and my arms and legs felt like they were becoming numb. Could not stand, very dizzy, tried to sleep through it. I threw up around 11 and did so a couple more times after that. Was finally able to sleep and woke up feeling much better. Arm is still sore at the injection point.
within a week of the second shot the patient began to have problems with both legs, such as burning in both legs, continued weakness, and when he walks his feet want to go in one direction and he wants to go in another. It is now July 25, 2021 and his legs are no better.
Felt some pain on the injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 91, unit not provided) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: arm right) on 21Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported patient received the first dose of Pfizer vaccine on 21Jan2021. Patient mentioned that she did not have any bad reaction, but she cooks and cleans for herself and uses her right arm for those and felt some pain on the injection site. Patient wanted to know if she needs to rest for a while. Patient also mentioned that her second dose is due on 11Feb2021 and asked if it is possible to get the shot on the opposite arm. Outcome of the event was unknown.    Information on the lot/batch number has been requested.
Client developed red, swollen and hot skin, approx. 4x4" left upper arm at site of injection. Client had DTaP on 8/23/04.
At approx 8 p.m. on Feb. 4, 2019, I started seeing a partial "halo" of lights in the peripheral vision of my left eye. It appeared only on the left side of my peripheral vision of my left eye. It was similar to the after-affects of having a camera flash go off in your face. It was very difficult to see and lasted for about 2 hours, then began to dissipate. It was fully resolved within a few hours. There was no pain associated with this.
severe ache, chills, fever low grade fever 4 days; back sore to touch;
Hep B injection given, approx 30 min later pt c/o dizziness, sore jaw and lower teeth. Nausea approx 3 hrs later c/o slight SOB after walking 100 yards, also c/o pain at injection site L deltoid and down entire L arm. Labs done. Phenengan 25mg given.
24hr p/vax pt went home ill from work w/nausea, diarrhea, abd pain & fever 6APR98;8APR98 still home from work-somewhat better;will not cont capsules;taken home p/office visit;
Mild headache; slightly stronger waves of nausea; feeling unwell; slight difficulty breathing with weakness & dizziness; slight difficulty breathing with weaknes; slight difficulty breathing with weakness & dizziness; This is as spontaneous report received from a contactable consumer (patient). A 69-year-old non-pregnant female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318, Expiration date: Not provided) via intramuscular route on10Feb2021 at 11:45 in the left arm as a single dose for COVID-19 immunization. Patient's medical history included invasive breast cancer, high grade dysplasia (HGD) - pre cancer, high BP, enlarged heart, high cholesterol, IBS-D, below range white blood cell count. Known allergies of food and medicine included, most medical allergies involved stopping my breathing, severe muscle weakness, allergies, food: Gluten, cauliflower, highsensitivity to grains so limit these, limit corn or eliminate foods - The patient use the Low FODMAP Food Chart as a guide. Allergic to drugs included: Auralgen, Certain Anesthesias, Catapres patch with metal backing, Celexa, Cipro, Clindicimycin, Codeine, Crestor, Cymbalta, Fentanyl, Lexipro, Lipitor,Lyrica, Morphine (very high sensitivity), Sulfa, Tramadol, Vicodin, Simvastatin, Ketamine, and others. Concomitant medications included amlodipine, aspirin, carvedilol, Catapres-TTS patch, clobetasol, desamethasone, estrace, fluticasone, gabapentin, hydralazine, hydrochlorothiazide, losartan, meloxicam, metaxalone, protopic, triamcinolone cream, Zetia Supplements: CoQ10, Womens 50+ Vitamins, Bausch & Lomb Areds Lutein, Vitamin C, Turmeric, Glucosomine/Chondroitin. The patient had not taken any other vaccine in four weeks. The patient had no COVID-19 prior and since vaccination. On 10Feb2021 at 12:15, the patent had mild headache, slightly stronger waves of nausea, feeling unwell, slight difficulty breathing with weakness and dizziness. Events were not treated. Outcome of events were not resolved.
PT LEFT ARM SWOLLEN AND WARM TO TOUCH.  APPRX THE SIZE OF AN ORANGE.  PT DENIES INCREASED PAIN.  NO FEVER.  PT FEELS FINE OTHERWISE.
IZ given 1-25-11 came to clinic 1-28-11 with swollen left deltoid with vesicles. Warm tender to touch.
Site: Pain at Injection Site-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
Swelling of the left side of her face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of the left side of her face) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025AQ1A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced SWELLING FACE (Swelling of the left side of her face). On 26-Feb-2021, SWELLING FACE (Swelling of the left side of her face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Next day post vax, the pt developed an injection site reaction characterized by redness and swelling. The pt recovered.
I may have had the Covid-19 early in 2020 but did not get tested then. I had been short of breath and had problems swallowing and many health problems since early in 2020.  around the time vaccination. I was having trouble after the first shot with Nodules on my throat. They thought they were Fungal as a result of my Asthma medication. I was having trouble swallowing and I was hoarse. As the weeks went on my voice got worse. My lung test showed nodules in my  lungs.  I had a test in October and my lungs were clear. I got the second dose. Lot Number EP7534 Pulmonology
sick; fever; sore throat; mucous and coughing; This is a spontaneous report received from a non- contactable consumer (patient).   A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced sick, fever, sore throat, mucous and coughing all on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 17 year old female who was vaccinated with varicella virus vaccine live (Oka/Merck) (657718/0778U). Concomitant therapy included human papillomavirus vaccine (MSD). Subsequently, the patient developed a rash after receiving her second dose of varicella. Additional information has been requested.
1740 client vaccinated with Moderna, per vaccinator, client anxious about vaccination after visit with allergy doctor who "said I should get Moderna." Approx 5 minutes after vaccination, Safety Officer notified by Observation staff that client felt numbness and shortness of breath. Client observed  taken to lay supine in special observation. Complained of Shortness of breath, cough (not present before vaccination), numbness in hands, feet, lips, and head with slight headache +pain in upper left abdominal region. Denies chest pain or trouble breathing. No wheezing noted on auscultation, heart sounds normal. Hx high cholesterol, 2 heart attacks in 2017 and 2020. Allowed to lay down until feeling better. Client states "I'm feeling a bit better" and verbalized feeling safe to leave ~1830. Ambulated off facility independently. Client made aware to call 911 if symptoms worsen and to follow up with PCP.  Vitals: 1755: BP 122/75, HR 57 -- 1815: BP 121/82. HR 57.
Patient had headaches, weakness, brain fog, dizziness, malaise and hypertensive.
This is a spontaneous report from a contactable nurse. This nurse reported similar events for 4 patients with the same lot number of PREVNAR 13 given on the same date. This is the 2nd of 4 reports. Only 2 cases are serious. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot # L62074, Expiry Date Nov2016) intramuscular at 0.5 ml, single in the deltoid on an unspecified date. PREVNAR 13 was the only vaccine given. The patient medical history was not reported. The reporter did not know of any illness at time of vaccination. The patient's concomitant medications were not reported. The reporter did not believe the patient was given any other vaccines within four weeks of this vaccination. On an unspecified date, in the last couple of weeks, clarified as within the month of reporting, the patient experienced cellulitis and redness after the vaccine was given. The patient called the office and returned for an office visit to see the doctor for the occurred events. It was unknown with what the cellulitis the patient may have been treated. The outcome of the events was unknown. Based on the information currently available, the known adverse event profile of the suspect product and the pathophysiology of the events, redness and cellulitis, the Company cannot completely exclude that the suspect drug PREVNAR 13 contributed to the development of the reported events.
Case number PHEH2015US003129 is an initial spontaneous report from a nurse received on 10 Feb 2015. This report refers to a 17 year old patient of an unknown gender. The patient was vaccinated with MENVEO (batch number: M14071, expiry date: Nov 2015) at a dose of 0.5 ml intramuscularly on 26 Jan 2015. It was reported that the vaccine which was given to the patient was frozen with excursion at 0.4 Celsius for 1 hour and 16 minutes on 14 Jan 2015 and at 0.8 Celsius for 36 minutes on 24 Jan 2015. No adverse event reported following this medication error (incorrect storage of drug).
A patient was inadvertently administered Fluzone Quadrivalent rather that the Fluzone High-Dose Quadrivalent, no AE; Initial information was received on 21-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 69 year old female patient who was inadvertently administered 0.5ml INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number not reported, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 21-Aug-2020 rather that INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any concomitant medications.  It was a case of an actual medication error due to wrong product administered (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on lot number.
Abdominal and back pain started in late April or early May 2010. Developed bilateral leg paresthesia, weakness on 5 May 10 and was hospitalised 7-8 May 2010. Neurology eval of 10 and 12 May 2010 indicated GUILLAIN BARRE is likely. Hospitalised for lower extremity weakness and for back and abdominal pain 7-8 May 10; vaccine given during this hospitalisation, outpatient evaluation on May.
Lost her appetite; Back pain very intense and unpleasant; Pain in upper body; Pain in neck area; Pain in thighs; Could not get out of bed; Mental fog; Chills; Intense fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain very intense and unpleasant), PAIN (Pain in upper body), NECK PAIN (Pain in neck area), PAIN IN EXTREMITY (Pain in thighs) and GAIT INABILITY (Could not get out of bed) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant Medical history Reported.  Concomitant products included ROSUVASTATIN, FLUTICASONE PROPIONATE (FLOVENT) and ESTRADIOL for an unknown indication.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (Pain in upper body), NECK PAIN (Pain in neck area), PAIN IN EXTREMITY (Pain in thighs), GAIT INABILITY (Could not get out of bed), FEELING ABNORMAL (Mental fog), CHILLS (Chills) and FATIGUE (Intense fatigue). On 10-Mar-2021, the patient experienced BACK PAIN (Back pain very intense and unpleasant). On an unknown date, the patient experienced DECREASED APPETITE (Lost her appetite). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form; ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at a dose of 1 dosage form and Physical therapy (Massage her arm and compressors) for Pain. At the time of the report, BACK PAIN (Back pain very intense and unpleasant), PAIN (Pain in upper body), NECK PAIN (Pain in neck area), PAIN IN EXTREMITY (Pain in thighs), GAIT INABILITY (Could not get out of bed), FEELING ABNORMAL (Mental fog), DECREASED APPETITE (Lost her appetite), CHILLS (Chills) and FATIGUE (Intense fatigue) had not resolved.            concomitant medication include promethium and other supplements. Treatment medication include applied compressor.
3AM 1/13 WOKE UP WITH FEVER 12PM 1/13 VOMIT. ALL DAY FEVER, MUSCLE PAIN TOOK TYLENOL 1 GRAM @ 4AM 1/13 12PM 1/13, 10PM 1/13
I received the influenza vaccine on a day when I was feeling very well. One month before getting the influenza vaccine, I received the 2023-2024 Pfizer COVID-19 vaccine and experienced a serve flare of my rheumatoid arthritis. This included severe diarrhea requiring a visit with my physician, followed by 17 days of severe, unremitting low back pain that left me bedridden. I have not had such a flare in more than 2 years, so this was highly unusual. The back pain and diarrhea resolved after approximately 4 weeks, and I was feeling well again. Approximately 6 weeks after receiving the COVID-19 vaccine on October 1, 2023, I received the Fluad Quad influenza vaccine on November 11, 2023. I felt well when I received the vaccine. I have had annual flu shots for the past 30 years, and have never had any difficulties with it beyond mild expected side effects. Twenty-four hours after receiving the Fluad Quad influenza vaccine, I again experienced severe low back pain, thought not quite as severe as what I had experienced after the October 1, 2023 COVID-19 vaccine. It is now 5 days after receiving the Fluad Quad vaccine, and I am still experiencing significant low back pain, which is constant and unremitting.  It has slightly improved over the past 2 days, but remains unresolved. It feels the same as any other arthritis flare, severe back pain, flu-like symptoms of fatigue, stiffness, and generalized discomfort. It remains unresolved as of today, November 16, 2023, which is 5 days after onset, and 6 days after receiving the Fluad Quad vaccine. Both vaccines have clearly triggered an exacerbation of my rheumatoid arthritis.
ERROR: Age- UNAUTHORIZED AGE GROUP (11 years old, Pfizer EUA approved only for children 12 years and older. Parent signed consent form with incorrect DOB indicating age greater than 12yo). Event discovered and forwarded for VAERS reporting. Signs and symptoms: None known Diagnosis and treatment: None known Outcome: No adverse reaction reported
Moderna 2/8/21, 3/11/21, 11/9/21. Positive on 1/25/23
Severe soreness that limited movement for 4 days, swelling and redness extending down to forearm, hot to the touch.
Death Narrative: Death was not determined to be related to COVID vaccination. COVID vaccination (dose 1) occurred on 1/27/21 with no noted side effects. Death occurred on 2/14/21.
bad headache; runny nose; arm turned red from his shoulder to his elbow; arm feel hot; fever; has not been able to sleep; This spontaneous report was received from an consumer and refers to a 17-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUN-2023 at 9:30, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, right arm, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 28-JUN-2023 (also reported as shortly after receiving the vaccine), the patient had a bad headache and runny nose, his arm turned red from his shoulder to his elbow, his arm feel hot where it was red and he had a fever. The patient did also was not able to sleep since receiving the vaccine. The patient contacted a healthcare professional (HCP) and was advised to take Advil and put ice on his arm. At the time of the report, the patient did not recovered from the events.  The causal relationship between all adverse events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Low platelet count on my blood-test taken the next day as part of a routine physical. This has never been a problem for me before.
Started feeling bad mid=morning of the day following the shot, then around noon chills, fever, sweats set in. My temperature was about 101 measured with an oral thermometer.  The fever subsided by that evening but I was left feeling very drained physically and mentally for the next two to three days.  Have been feeling generally tired and listless ever since, going on three weeks now. On Saturday a friend told me about people claiming magnets will stick to their arm around the injection site. I didn't think that was possible but I tried it with some small neodymium magnets and sure enough, they will stick and stay put on my arm in the area where I got the shot. This is a real phenomena that you need to be looking into and coming up with an explanation.