chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Congestion; Warm Eyes; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (Congestion), ABNORMAL SENSATION IN EYE (Warm Eyes), CHILLS (Chills) and HEADACHE (Headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RESPIRATORY TRACT CONGESTION (Congestion), ABNORMAL SENSATION IN EYE (Warm Eyes), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT CONGESTION (Congestion), ABNORMAL SENSATION IN EYE (Warm Eyes), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.
"Started fri 8/15 started off as a light ring and progressively has gotten more red measured in office at a 50 mm welt/wheel by 23mm has gotten smaller in appearance since Fri 8/15.
Information has been received from a physician concerning an 11 year old female who on 02-JUL-2007 was vaccinated with Gardasil (lot # not reported).  Concomitant therapy included MENACTRA.  On 02-JUL-2007 the patient experienced a fever that lasted 24 hours after receiving Gardasil.  Subsequently, the patient recovered from the fever.  The patient sought unspecified medical attention with the physician.  Additional information has been requested.
Within a week of receiving the vaccine, I began to experience weakness in right hand fingers and arm.  The weakness has persisted for 13 months, and has gotten worse.  The concurrence of these symptoms with the administration of the vaccine may or may not be related. That is to say that the neurological symptoms occurrence may not be related to the Covid vaccine,
A few hours later, right arm was painful, slightly swollen and hard. Taking ibuprofen. Patient states she thinks it's related to how it was given, not necessarily the vaccine itself.
Fever daily for 12 days  range - 99.0 to 101.4
Information has been received from a licensed practical nurse concerning a 7 month old patient and twin sibling (WAES# 0802USA00512) who on 14-JAN-2008 was vaccinated PO with the third dose of ROTATEQ (lot# 657516/1128U).  The patient did not seek medical attention.  No symptoms were noted.  There was no product quality complaint.  This is one of several reports from the same source.  Additional information has been requested.
The customer administered MMRRII intramuscularly instead of subcutaneously; No other AE; This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.      On 04-DEC-2020, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) formulation not reported but defaulted to subcutaneous injection, Lot # S036662, expiration date not reported but upon internal validation established as 14-NOV-2021 for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered intramuscularly instead of subcutaneously.  No other adverse event was reported.
Noticed a swelling and tightness of neck muscle (sternocleidomastoid) on right side accompanied with difficulty swallowing and swelling in the throat on right side.  Right shoulder muscle rigid and tight.  Symptoms continued reaching maximum intensity in the evening of 9/21/2011 at 8 p.m.  By 9/22/2011 in the morning, the symptoms were same in intensity as when they started.  I called my doctor at 12 noon and left a message.  She returned the call at 2:30 p.m. on 9/22/2011 and stated that these were not normal side effects of the tetanus toxoid vaccine; they sounded like an allergic reaction.  She suggested taking Benadryl.  By 4:30 p.m. the symptoms were mostly gone with some sensation of tightness in the throat persisting until 2 a.m. 9/23/2011.
Notice significant enlargement of lymph node in right clavicular region near clavicle bone/neck. Tender to palpation and when turning head side to side. Also had pain in right armpit but never located enlargement.
Body aches; Flu-like symptoms; Headache; Stomach hurts; Weakness; Tired; Shivering; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received in March 2019, refer case US2019AMR120858).   On 20th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced general body pain. On 20th June 2019, the patient experienced influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering. Rechallenge with Shingrix was positive. In June 2019, the outcome of the general body pain was resolved with sequelae. On an unknown date, the outcome of the influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, stomach pain, weakness, tiredness, shivering and general body pain to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix in the left arm. In the evening, less than a week after vaccination, the patient experienced flu-like symptoms, including headache, general weakness, tired, stomach hurt, nausea and fainted later the same day after vaccination. The patient experienced shivering but more severe than 1st dose. In June 2019, all of these symptoms resolved within four days. The reporter did not consent to follow-up. The outcome of the reported events was discrepantly reported in the structured field of source document as recovered/resolved with sequelae and while, it was reported as recovered/resolved.
Pt. had a seizure witnessed by her sister, pt. was able to be kept up right in a chair with no injuries, vital signs WNL, BS 91,
This initial spontaneous case, received on 10-Nov-2017 reported by a pharmacist and concerns a 37-year-old adult female patient. The patient's concomitant medication included: Omeprazole and Hydrochlorothiazide for an unknown indication. On 02-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF32908, expiry date: not reported). On 03-Oct-2017 after the administration of vaccine, the patient experienced soreness on the injection site. At the time of this report, the event was not recovered. The reporter assessed this case as non-serious.
Passed the 6-month window without receiving 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Passed the 6-month window without receiving 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 9-Mar-2023 The medical assistant reported that a system audit had revealed a list of multiple patients that had received 1 dose of Shingrix and had potentially gone past the 6 month window without receiving a second dose.   The reporter was unsure of how many patients there were that were actually past due for second dose, she stated she had an 8 page list of patients to go through. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. Till the time of reporting, the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
We went in for the shots of the 15 months and they administered 4 different shots when it was only 3 different vaccines required.  Vaccine administrator dated 4 lines in the vaccine card but only signed 3.  As per her supervisor the following morning when I called to report the incident, she stated that there was record of only 3 vaccines being administered.
Client arrived to vaccine clinic with stomach ache. Denied fever or other symptoms and stated he thought he had food poisoning. Vaccine administered per client request. Client observed for 15 minutes and no other reaction noted. Patient left after 15 minutes. Later facility was told client returned to his apartment and called 911 to go the ER to be seen for stomach pain. Paramedics notified patient had received COVID-19 vaccine.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt nearly fainted/passed out. Had some tunnel vision/nausea/loss of hearing. Recovered after water and sitting for 15 minutes. Had some numb/tingling hands/arms.
My Blood sugar went down to a dangerous level. I was sweating and shaking  I passed out one day after getting the vaccine.  I had to drink lots of sweet juices then I felt better. (I do run low BS but never passed out or feel sick from it)
Transfer from Hospital on 2/17 with fracture hardware loosening in right hip and right ulnar fracture. Preoperative testing was COVID +. Treated with dexamethasone and doxycycline. Recovered with minimal pulmonary issues. Taken out of isolation but had developed osteomyelitis in right foot/ankle. ID consulted and placed on daptomycin and ertapenem. Went to OR for right hip fracture removal but due to acite illness and frailty, reconstruction was deferred. Wound vac ws place with PT whirlpool and wound care. CPK trended up and ID changed antibiotic to Teflora. Attempted SNF palcement but unable to due to antibiotic selection. Had intermittent difficulties with renal insufficiency and hyperkalemia. Pt. declined operative fixation for right ulnar fracture. Continued with pain and pressure wounds. Had increasing O2 requirments. Patient agreed to DNR status. Significant decline in mental staus and continued pain. POA decide to move to comfort care.
Onset of fever of 103 the night after vaccine administration, severe headache-without relief from medication
Severe body aches; low oxygen; fatigue; chills; nausea; vomiting; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 57-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 08Apr2021 12:15 (at the age of 57-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing Other medical history: Migraines sleep apnea pancreatic cancer remission umbilical hernia fibromyalgia, sleep apnoea syndrome from an unknown date and unknown if ongoing, pancreatic carcinoma from an unknown date and unknown if ongoing, umbilical hernia from an unknown date and unknown if ongoing, fibromyalgia from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing to Cymbalta, lyrica, savella, prednisone, morphine. concomitant medications were not specified. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient previously took unspecified Pfizer vaccine administered in right arm on 18Mar2021 for immunisation. On an unspecified date in 2021, the patient experienced severe body aches, low oxygen, fatigue, chills, nausea, vomiting. No treatment was taken as a result of events. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events were recovered with sequel.   Information about lot/batch number has been requested.
I had body chills, headache, congestion, chest pressure and felt fatigue. I thought I had heart arrhythmia. I had no appetite. I went to the urgent  care by my house, but they sent me home because I wasn't exhibiting all the symptoms of someone with COVID-19. They told me to go to the emergency room if I felt I couldn't handle it on my own. So I called my doctor and she prescribed me antibiotics Albuterol and Tylenol to take to help reduce my symptoms and body aches. After a couple of weeks of bed rest and antibiotics, I started feeling better.
I started developing swelling underneath my armpit and pain underneath my arm and on the exact opposite side of the injection. i am now 11 days out from the vaccine and still have noticeable swelling underneath my armpit
27DEC91 fever, fatigue, weak; 28DEC91 t102, ATB recvd; 31DEC91 fever, cough worse to hosp ER; cxr done; not admitted; 1JAN92  to hosp ER was admitted; heart stopped in ICU died 5JAN92;
Varicella #2 given 1/9/08.  Seen in clinic for indurated erythematous lesion at site of injection.  Unsure when lesion started.
Huge red area with a bump felt underneath. Pain and warm to the touch all within the injection site.
Swollen joints that have lasted now for 16 days......numb toes and foot and hands
I have blister looking rounded, red, inflamed lesions on my toes on both feet on all 3 middle toes. They are uniform in shape. No bumps seen. Red is continuous and uniform. This started mildly less than a week after the vaccination and has progressively gotten worse now 2.5 weeks post vaccine.
administered to 8 year old; This case was reported by a other health professional via sales rep and described the occurrence of off label use in a 8-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included asplenia (complex medical and family medical history).   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments:  The Bexsero vaccine was administered to 8 years old patient.  Health care professional was aware the use was off-label and stated risk vs benefit was assessed prior to vaccine administration. The patient was vaccinated with Bexsero without incident.  The reporter stated that if pharmacovigilance department needs additional patient-specific details, the patients care providers doctor details were given. No additional details available. The reporter did not consent to follow up. Additional Supportive Information: The patient received Bexsero vaccine at 8 years old, which led to Off label use.
1) Left axillary  lymphadenopathy. [Received vaccine in left arm) .  2) generalized itching
Chills; Fever; Fatigue; Vomiting projectile; Diarrhea; This is a spontaneous report from a contactable consumer or other non HCP (patient herself). A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER2613, Expiry date: Unknown) via an unspecified route of administration in Arm Right on 22Mar2021 15:30, as dose 1, single (at the age of 70-years-old) for COVID-19 immunization. Medical history included Psoriatic arthritis, from an unknown date and unknown if ongoing, immune system has to be suppressed and she takes medication for that from an unknown date and unknown if ongoing. The patient had not received any other vaccine within 4 weeks. There were no concomitant medications. On 22Mar2021 23:00, the patient experienced vomiting projectile, diarrhoea and on 23Mar2021 patient experienced chills, fever, fatigue. She took the vaccine 2 weeks ago at about 3:30pm. Around 11pm, she experienced projectile vomiting and diarrhea which lasted until about 7am. The next day, she had chills and fever. She has an autoimmune disease. She called her doctor's and was told that this was not a usual reaction, but she could decide either way. She was trying to go ahead and find out if she should receive her second shot. Patient was not taken to Emergency Room and Physician Office. The outcome of events was recovered on 24Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sudden onset chills/ fever, muscle aches, extreme fatigue - lasted 12-14 hours - still fatigue and sore throat at 72 hours.
11/19/07: 6pm.- states "began feeling dull/throbbing pain in L arm. L arm began swelling. 10:00pm continued to swell and get red. 11/19/07 Took Tylenol at 8pm. 11/20/07 Took Tylenol 2 am  and 8 am. Swelling has continued to worsen." Arm and redness measured upon report- 11/20/07 R Arm circumference 10", L Arm  circumference 10 3/4". Redness 4 1/2" length and 5 1/2" width L arm.
This spontaneous report as received from a pharmacist refers to a two patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (Lot number was reported as 444, Expiration date, dose and route were not reported). Concomitant medications were unspecified by the reporter. The pharmacist reported that she received a phone call from another pharmacy and was told that two patients had a bad reaction to the ZOSTAVAX and developed softball-sized injection site reactions that resulted in hospitalization (length of stay unspecified). Treatment was not reported. The outcome of softball-sized injection site reactions was unknown. Additional information is not expected.
headache; tiredness; slepiness; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (tiredness), SOMNOLENCE (slepiness) and MYALGIA (myalgia) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced HEADACHE (headache), FATIGUE (tiredness), SOMNOLENCE (slepiness) and MYALGIA (myalgia). At the time of the report, HEADACHE (headache), FATIGUE (tiredness), SOMNOLENCE (slepiness) and MYALGIA (myalgia) outcome was unknown.
flu like symptoms for 1 day after injection.  ..bruise/redness on injection site for over 3 days . Patient flu symptoms improved after 2 days.  She still had large redness on arm .. She received cephalexin 500mg on 6/26/19 for redness from urgent care PA
weakness; Unable to move; So weak he fell over on the carpet; Trembling,tremor; teeth chattering, chills; A spontaneous report was received from a consumer concerning a 94-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced asthenia, disability, muscular weekness, trembling, tremor and chills.    The patient's medical history was not provided.    No relevant concomitant medications were reported.    On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 023L20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection.  On 13 Feb 2021, at 21:00, patient experienced chills, trembling, weakness, tremor, teeth chattering ,so weak he fell over the carpet and unable to move.At 03:00 am the patient was hospitalized.   The reporter also added that the patient usually is a very active for a 94 year old man person .The reporter was worried when the patient was unable to move.  On 17 Feb 2021 the patient was discharged from hospital. The events weakness  and unable to move were considered as serious.   No laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. However, patient's advanced age may have been contributory for the event of asthenia.
both tested positive for covid; both tested positive for covid; This is a spontaneous report from a Pfizer sponsored Program. A non-contactable consumer (patient) reported similar events for 2 patients. This is a first of two reports.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that him and his wife received first vaccine and then both tested positive for covid on an unspecified date, they did quarantine and had no symptoms. He wanted to know if they should receive second vaccine or not. The outcome for the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021382886 Same reporter/product/Event, Different patient
Within 48 hrs developed a large mass on arm at injection site. Extremely painful, very warm to touch.
Patient states one day after receiving vaccine left arm red and painful, erythematous, temperature normal. Reported 3 days after, area pruritic, red. Treated with Benadryl, ice compress and hydrocortisone 1% cream.
Left arm pain starting the day after administration, progressed to redness and swelling and has continued to worsen over 10 days. No improvement over that time. Has no fever or oozing at site. Has not had any treatments.
Swollen red eyes, cough, fever, headache, difficulty breathing, difficulty swallowing, fast heartbeat, dizziness, fatigue and weakness.
I experienced headaches following vaccine administration. I had very increased fetal movement for several days (10/5-10/7). Then fetal movement became decreased and eventually stopped.
Patient became dizzy, pale and nauseated after shots. He vomited several times. His vital signs were stable and his color returned to normal. He left after 15 minutes.
This spontaneous report as received from a Healthcare Worker refers to an unknown number of patients of unknown ages and gender. On an unspecified dates, since 06-FEB-2015, the patient were vaccinated with an inappropriate storage of ROTATEQ, (lot#, expiration date, route and dose were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Admin - 2/12/13: vomiting with fevers 2/13/13 ice recommended, fever 2/14/13 PM 102.5; 2/15/13 IVF & antibiotics for cellulitis, sent to ED without improvement. Prescribed Clindamycin 300mg 2 tab Q8 hrs x 5 days.
At the beginning of May I began having trouble swallowing, hoarseness, sore throat that progressively has gotten worse.