chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his feet started getting scars/arm has scars/back of his neck looks like rainworm but it's not rainworm.; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (his feet started getting scars/arm has scars/back of his neck looks like rainworm but it's not rainworm.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer in 2002. Concurrent medical conditions included Diabetes (Patient has been diabetic for 4 years).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCAR (his feet started getting scars/arm has scars/back of his neck looks like rainworm but it's not rainworm.). The patient was treated with TRIAMCINOLONE ACETONIDE for Adverse event, at an unspecified dose and frequency and PRAMOXINE HCL for Adverse event, at an unspecified dose and frequency. At the time of the report, SCAR (his feet started getting scars/arm has scars/back of his neck looks like rainworm but it's not rainworm.) had not resolved.    No relevant concomitant medications were reported.   Reporter did not allow further contact
This case was reported by a pharmacist to sales representative and described the occurrence of spinal pain in adult female pt who received Engerix B. On an unspecified date, the pt received a dose of Engerix B (dose number not specified). At an unspecified time following the administration of Engerix B, on an unspecified date, the pt experienced spinal pain, back pain and a headache. The outcome of events is unknown.
The patient was initially given 0.25ml of the Bivalent dose. The patients was contacted and returned to the pharmacy. The 0.25ml additional 0.25ml was delivered on the same day.
Erythema, swelling  involving  left shoulder extending to mid upper arm. No restriction of movement.  Subsided in three days.
2-27 Child got 6 vaccines (3 to each thigh). Several hrs later, c/o pain, fever, unable to stand, unable to bend right knee. Child was seen in ER 2-28-12 1AM - MOTRIN given. Was seen in office again 2-28-12 2pm - worsening pain was to be admitted, but no beds avail. Seen in ER again 5pm. X-rays normal. Labs done. Given MOTRIN & TYLENOL & discharged at 8pm.
I had repeated spontaneous weakness and lightheaded. I felt like I had the flu, but I did not. My blood sugar levels were fine also. Normal things that make me tired were wiping me out. The last time I went to the doctor, my blood work came back Anemic. They are looking at my blood count more closely now.
Cough; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and NAUSEA (Nausea) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough) and NAUSEA (Nausea). At the time of the report, COUGH (Cough) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Fatigue, arm sorness, headache, body ache, chills, low grade fever, nauseous
This patient received his first Moderna vaccine today, 6/18, however, it was discovered after administration of the vaccine that she is under the age of 18. The patient was observed for a total of 15 minutes post-vaccination and there were no reactions, complaints, or complications. For Item 20 - I entered unknown as there was no adverse drug reaction prior to her departure from the vaccine event at Safer Foundation.
I have had both my shots and the booster; I tested positive for covid today; I tested positive for covid today; I had a stuffy nose; sore throat; a slight cough; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: IMMUNISATION (medically significant), described as "I have had both my shots and the booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "I tested positive for covid today"; NASAL CONGESTION (non-serious), outcome "unknown", described as "I had a stuffy nose"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; COUGH (non-serious), outcome "unknown", described as "a slight cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
X 2, 6 x 6 cm sized, erythematous, tender lesions to left upper arm after receiving Hep A, meningococcal & influenza vacin. to site 2 days ago. No hx of diff breathing, no swelling to throat/lips. Advised Rx with ibuprofen & cool compresses to site.
Patient received Pneumovax vaccine in his right deltoid on 11/09/04. The next day, he developed an apple sized, painful, erythematous, nodule at the injection site. Using Ibuprofen and ice the patient was able to control the swelling and pain. Physician examined patient on 11/12/04. The swelling and pain was much improved. Patient was advised to continue the Ibuprofen and ice.
Febrile seizure approximately 10 hours after vaccine administration.  Influenza A positive at time of seizure. 4/11/08-records received for DOS 3/19-3/23/08-DC DX: Respiratory failure. Influenza A pneumonia. Febrile seizures. Admitted on day of vaccination. Slept more than usual which is the same affect with pass immunizations.  Bumped head, crying with difficulty breathing noted, appeared blue. Intubated in ER. Abnormal movements of hand. Febrile seizure in ED.
My fever was so high that it caused hallucinations and the fever would not break until I took 1600mg of ibuprofen.  The vaccine also caused a migraine and sinus pain.
pt recv vax 21OCT95 & 31JAN96 pt broke out w/chicken pox p/being vaccinated;
I was in bed and I went to go to the bathroom and I couldn't walk. I felt like I was going in circles. My son came and checked on me before he went to work. I felt like I was going to throw up, and did and I still couldn't get up. My kids both tried to get me to go to the door so they could take me to the hospital but I was unable to, so they called the emergency number. I was taken to the hospital and they checked me for a stroke and other symptoms, so they wanted to rule that out. They did CT scans and MRIs just to make sure. I was in the hospital for 4 days and did a complete work up. They couldn't pin point the cause. I had to have someone with me for a little while after. The vertigo eased up, but my balance never let up. I had a total audiology and they thought it was due to an inner ear thing. They noted they couldn't do much about it. I've gone to PT and place for working on balance. Also a chiropractor and the balance is the primary thing. I'm not too light headed anymore but the balance has not really healed itself. I'm very cautious and I'm very active but I just have to be careful. I've never had that kind of vertigo since, but I do still get the light headedness and the imbalance. I don't want to have that happen again. I'm not sure if this is in relation to the vaccine, and the doctors noted it may not be related because it's been several months out.
Site: Pain at Injection Site-Severe, Additional Details: patient is syaing that she has constant pain in the vaccination area and she has been going to the nurse to ice it
Patient fainted about 30 seconds after the vaccination.  She regained herself after about 5 seconds.
cellulitis; bit by her dog and needs a tetanus shot; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 08Mar2021, as single dose, for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cellulitis. On 26Mar2021, the patient was bit by her dog and needs a tetanus shot/a dose of TDAP. The reporter was aware of the 14-day exclusion period for vaccines and knew that the tetanus vaccine trumps the COVID-19 vaccine in priority so the reporter would like to make sure what to do in this situation. The reporter wanted information about the patient getting the second dose longer that 3 weeks after the first dose. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of event cellulitis cannot be totally excluded.  The case will be reassessed if additional information becomes available.  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.
1222 98.3, 58, 18, 120/88, 99% room air, patient began slumping and sliding in chair. nursing staff x 2 assisted patient to floor, patient became more alert in lying position. c/o nausea, headache, denies shortness of breath, denies any other symptoms. no redness, swelling, or pain at the injection site, left arm first dose pfizer. 1225 h20 and 16 ounces, and yogurt coated granola bar for patient, stated last meal 0700. at 1230 nursing staff x 2 assisted patient to standing position to move out of middle of floor, c/o dizziness upon standing. patient sat in chair with feet elevated on another chair. 1232 patient education for symptom monitoring and follow up treatment at ER as needed. EUA factsheet provided. 1252 patient patient still being monitored, laughing, playing on phone, no redness, swelling at injection site, c/o mild pain at injection site, patient described it as a pinch. 1306 reassessed vital signs 98.3,78,18,102/52, 99% room air, denies symptoms, continues to complain about mild pain in left arm at injection site, no redness or swelling noted. patient assisted to standing position denies dizziness. released at this time with guardian.
Local symptoms at the injection site- Pain discomfort. General symptoms- chills, fever Narrative:
Patient Received both prevnar & Fluad vaccinations. Fluad in (L) arm & Prevnar in (R) arm. 1st fluad w/no complications 2nd prevnar & said was extremely painful down to hand, called next day & said couldn't sleep Hurts in shoulder area. Advised tylenol & warm compress
Chest pain; Arm Pain; Neck pain; Neck stiffness; Immunocompromised; Weird eye sensation; Head pain; Super Tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Arm Pain), NECK PAIN (Neck pain), MUSCULOSKELETAL STIFFNESS (Neck stiffness) and IMMUNODEFICIENCY (Immunocompromised) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (Immunocompromised.).    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Arm Pain), NECK PAIN (Neck pain), MUSCULOSKELETAL STIFFNESS (Neck stiffness), IMMUNODEFICIENCY (Immunocompromised), ABNORMAL SENSATION IN EYE (Weird eye sensation), HEADACHE (Head pain) and FATIGUE (Super Tired). At the time of the report, CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Arm Pain), NECK PAIN (Neck pain), MUSCULOSKELETAL STIFFNESS (Neck stiffness), IMMUNODEFICIENCY (Immunocompromised), ABNORMAL SENSATION IN EYE (Weird eye sensation), HEADACHE (Head pain) and FATIGUE (Super Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used included only vitamins.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: attached- Contact info updated
Patient had the 1st dose of the Pfizer COVID 19 vaccine on 02Apr2021, She only got her 2nd dose on 24Sep2021; headache; sore arm; a little bit of nausea; This is a spontaneous report from a contactable consumer (Patient, reported for self). A 64-year-old female patient received second dose of bnt162b2 ((COMIRNATY), COVID 19 Vaccine, mRNA, Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 24Sep2021 (at the age of 64-year-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had earlier received first dose of Pfizer COVID-19 vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Apr2021 (at the age of 64-year-old) and experienced miserable headache, stomach ache, nausea (mentioned that she was so sick). Patient only got her 2nd dose on 24Sep2021. On an unspecified date in Sep 2021, patient experienced headache, sore arm and a little bit of nausea. Patient reported that she thought she had to restart the series of vaccination since it had been months since she had her first dose. Vaccinator told her (not sure if pharmacist or nurse) that she is already fully vaccinated and no need to repeat the series - She was also advised to come back after 6 months for the booster, and she wanted to confirm if that was true. The clinical outcome of events was unknown  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This is a spontaneous report from a Pfizer sponsored program from a contactable Healthcare professional and from patient for himself. This male patient of unknown age and race/ethnicity received at 9:30 AM on 11Dec2017 a single dose of PREVNAR 13 for immunization. The patient did not have a history of low blood pressure or hypertension medication use. Concomitant medications if any were not reported. On the following morning after vaccination, on 12Dec2017, when patient woke up, he felt lightheaded as if the room was spinning around him. Since then, he felt lightheaded 6 to 8 times in the past week. He also stated he felt slightly hot in the head and may have a decreased appetite (Dec2017). Outcome was unknown.
Tingling, and shooting pains up and down arm. Pain in all old injury areas. Rash under arm. Leg pain on 3rd day.
Shortly after receiving vaccine, participant's wife summoned nurse, found him sitting in car with eyes open, but unresponsive.  After approx. 30 sec. he was responding to questions; c/o feeling light headed, nauseated and had 'limited' vision.  B/P 110/74,  O2 sat 87%,  HR 51.   EMS arrived and assessed participant.   Repeat B/P160/102  and BG 118.   Due to cardiac hx., participant agreed to be transported to E.D.  On 4/1/21 made a f/u phone call to participant and he stated that lab work in the E.D. indicated that he was anemic.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about September 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 08-JUN-2016, the patient was treated by a healthcare provider for zoster ocular disease. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, zoster ocular disease was determined to be medical significant. Additional information has been requested.
pt recv vax & w/in 24hr post vax pt exp a red circle around the inj site;circle resolved by the next day;
Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 12 years old patient (gender unknown) who received 0.5ml dose of suspect MENACTRA (lot U5984AB), expiry date not provided via intramuscular route in the right arm on 26-Jul-2018 at 13:31 that was out at room temperature. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that dose of MENACTRA that was administered to a patient that was out at room temperature. MENACTRA broke cold chain management after delivery service failed to get package to destination within 48 hours. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
woke up from nightmares; When I went to bed Tuesday night, my joints started aching; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9267, Expiry Date: Unknown), via an unspecified route of administration on left arm on 22Feb2021 12:45 PM at single dose for covid-19 immunization. Patient was not pregnant at the time of vaccination. Patient's medical history included asthma, obesity, and allergies to sulfa, penicillin, most native trees. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's concomitant medications included levocetirizine dihydrochloride (XYZAL),  methylcellulose (CITRUCEL) caplets (medications the patient received within 2 weeks of vaccination). On 22Feb2021 10:30 PM the patient experienced woke up from nightmares and when I went to bed tuesday night, my joints started aching. Event was reported as follows she got the shot on Monday and felt fine. When she went to bed on Tuesday night, her joints started aching. Several times throughout the night, she woke up from nightmares, but they all seemed to be related to the fact that her joints (it felt like all of them) hurt to move. From what she can tell, she did not move the entire night, yet she was fine by the time her alarm went off. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. Patient reported no for serious, seriousness criteria-results in death, seriousness criteria-Life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-Disabling/incapacitating, seriousness criteria-congenital anomaly/birth defect. Patient did not received any treatment for events. The outcome of events was recovered.
I had an adverse reaction 10 hours after getting the vaccine a month ago. I got a bad fever and started to uncontrollably violently shake for an hour and a half. I had sevier leg pain and soreness. I also had a terrible headache. The symptoms eventually eased after taking Advil and Tylenol after a few hours. The next day I still had all of those reactions again, but the shaking was not as bad and didn't last more than a half an hour. Symptoms continued to fluctuate, but generally got better over 4 days.
A few days after the shot, the injection site became very red, itchy, warm, and swollen. It has lasted 4 days now and is starting to get better.
Can?t lay flat have chest pains and pooling mucus in my throat since vaccine, and horrible headaches every day. I barely ever got headaches my period dramatically stopped after 2 days.
Pt developed a 12cm local erythema that was hard and tender. States rigors, nausea and vomiting and dehydration.
Dizziness, Headache & Myalgia Narrative:  Employee reported moderate headache 02/03/21, mild muscle  pain 02/03/21, moderate "lightheadedness" 02/03/21. Resulted in unable to  work 02/03/21 and did not seek medical attention.  Other Relevant History: