chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 19 September 2009 from a healthcare professional (physician). A patient, whose age, gender and medical history were not reported, received FLUZONE (lot number not reported) on an unspecified date. An unspecified amount of time later, the patient developed redness and discharge from both eyes. Corrective treatment and the patient's recovery status were not reported. Follow up information received on 22 September 2009 from a health care professional concerning a 62 year old male patient with an allergy to sulfa, cataracts, dry eye syndrome, hernia, and a history of prostate cancer. Concomitant therapy includes multivitamins, aspirin, NASACORT, ASMANEX, PULMICORT, and XOPENEX. The patient developed a reaction one day after receiving FLUZONE (U3185AA) intramuscularly in the left deltoid on 17 September 2009. On 18 September 2009 the patient went to the urgent care center with a complaint of eye redness and discharge which caused his eyes to be shut when he woke up. No other information was provided. The recovery status was unknown. Follow-up information received on 13 October 2009 from a health care professional. The patient completely recovered from the adverse events on 24 September 2009. The number of previous doses of FLUZONE, dates of administration and any observed symptoms were reported to be unknown. No further details were provided. List of Documents held by Sender: none.
Mother reports that child experienced pain and swelling in the arm of the influenza vaccination administration (LD).  Child was see by Dr. on 11/05/2012 for left arm pain.  Per physician report "left shoulder pain; s/p flu shot. Plan Motrin, local heat.  Probably self limiting but could involve deltoid nerve.  Will give it time and tx as described.  If Sx persist we can do an EMG w/Peds Neurology.  Tylenol ok for breakthrough pain.  Call or Return if symptoms worsen or persist.
administered 0.1 mL dose of Adacel to a patient instead of Tubersol via intradermal route/No AE; Initial information was received on 09-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 29 year old female patient who administered 0.1 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of TUBERCULIN TEST [TUBERSOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were none.   On 08-Jul-2020, the patient received a 0.1 mL once dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5661AA, expiry date- 08-Aug-2021) via intradermal route in the left arm for prophylactic vaccination.  It was a case of an actual medication error due to wrong product administered.  At the time of report, no adverse event was reported.  Treatment reported in the case were TRIAMCINOLONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and FAMOTIDINE (PEPCID [FAMOTIDINE])  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.
FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced fever. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 2021. This report was non-serious.
Extensive lymph node swelling g (under arm, throat), sore throat, premature menstration
Patient states: "severe muscle pain, lower back pain, joint pain, and just hurt all over, including neck and shoulders, can't even make a fist, or hold my child's hand without pain".  Also complains of tenderness to touch on arms and back.
Headache started immediately following injection  2 and booster. Also after booster within 2 days slight fever/chills/continued headache.  Day 5 skin clammy, epigastric pain, chest flutter, cough
Initial unsolicited report received from a pharmacist on 12-JUN-2017. This case involves a 67-year-old male patient who was vaccinated with a dose of INFLUENZA VACCINE (unspecified influenza vaccine) (manufacturer unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified date (in the late 70's). The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient diagnosed with Guillain-Barre syndrome. Lab data was not reported. The patient received unspecified corrective treatment. On an unspecified date, the patient recovered from the event. It was reported that the patient was advised by another physician never to get a flu vaccine again. Upon internal review, the company decided to consider the event serious because of important medical event Guillain-Barre syndrome. List of documents held by sender: none.; Sender's Comments: Sanofi Company comment dated 19-Jun-2017: This case concerns 67 year old male patient who vaccinated with INFLUENZA VACCINE (unknown manufactuer) and developed Guillain-Barre syndrome. Time to onset was compatibility is unknown with role of vaccination. However in this particular case very limited information has been provided. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
Varivax given on 12/03/2002. Chicken pox dx 03/09/2005.
Pain and ashiness  on right side of body. Neck pain and pain in shoulder arm and liver as well as kidney. most pronounced pain in liver. when I got my period it was the most extreme pain I've ever felt and I had to go to hospital to get pain medication as I wasn't responding to Advil. I almost passed out on the train to the hospital the pain was so intense.
COVID Arm pain developed 7 days after injection followed by full body viral type rash on day 10.
This case was reported by a consumer and described the occurrence of worsening of hepatitis C virus (unspecified manufacturer) plus a separate injection of hepatitis A vaccine (unspecified manufacturer) for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included depression, hepatitis C infection and renal surgery. On 06 February 2007, the subject's medical history also included hepatitis B "25 years ago" and the subject reported that she is "now immune". On an unspecified date the subject initiated therapy with (Cymbalta. On an unspecified date before 31 October 2006, the subject initiated therapy with Ribavirin and Peginterferon alfa-2a (Pegasys). On an unspecified date in November 2006, after 4 weeks of treatment with Ribavirin and Pegasys, hepatitis C viral load was 2 million. On an unspecified date in November 2006 after the blood for the hepatitis C virus titer was drawn, the subject received 1st dose of hepatitis B vaccine and 1st dose of hepatitis A vaccine. On 26 January 2007, approximately 2 months 1st doses of hepatitis B vaccine and hepatitis B vaccine and hepatitis A vaccine, the subject  was seen by a physician and a hepatitis C viral, load was 5 million. Therapy with Cymbalta, Ribavirin, and Pegasys was discontinued. Upon discontinuation of Cymbalta, Ribavirin, and Pegasys, on an unspecified date on or after 26 January 2007 and n or before 06 February 2007, the subject experienced diarrhea, dizziness, dehydration, nausea, shortness of breath (exertion) and feeling faint. The consumer considered the events to be disabling. The outcome of the events was unspecified.
swelling & redness @ inject site lt arm-started day of inject worsened w/swelling into arm pit by 2 days later; numbness;
pain,swelling, reddness,hot to touch with some firmness to site..Treatd with OTC motrin at home prior to receiving vaccine and after.
5-6 after vaccination, my mouth broke out in canker sores. all of mouth and tongue. I had added nothing new - no meds etc.  It still hurts on 9-16 (a week after it started).   Doctor told me to report it since vaccination/boosters after effects are still unknown.
No adverse effects reported; an improperly stored dose of PROQUAD was administered to a patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On an unknown date, an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), subcutaneously, with lot # S007069 and expiration date on 06-SEP-2020, for prophylaxis (dose, dose number and anatomical injection site were not reported) was administered to the patient. It could not be verified if the sterile diluent (strength, dose, dose number, route of administration, anatomical injection site, lot number and expiration date were not reported) was properly stored.   It was reported that on 15-OCT-2019, the vaccines were exposed to a temperature excursion of -11.5 degrees Celsius (C) degrees for 76 hours. There was no previous temperature excursions. The call was placed because of a Digital Data logger report. No adverse effects reported.
Swelling of lymph nodes; Itching at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHADENOPATHY (Swelling of lymph nodes) and VACCINATION SITE PRURITUS (Itching at the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced LYMPHADENOPATHY (Swelling of lymph nodes) and VACCINATION SITE PRURITUS (Itching at the injection site). At the time of the report, LYMPHADENOPATHY (Swelling of lymph nodes) and VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.
Started Monday, October 25th around 4:00pm. chills & fever, moderate sore throat.  Tuesday bottom of  feet broke out in blisters & fingers started tingling with pins & needle affect. Ran a fever off & on.  Blisters still on feet & are very painful today, Wednesday, October 27 Th.., no fever.
Received Moderna vaccines on 1/28/21, 2/25/21 Tested positive for COVID on 8/25/21. Admitted toHospital on 8/25/21, to ICU for 1 day, transferred to floor 8/26. 3 day h/o DOE, orthopnea, mild cough, mild fever
Moderna vaccine was administered to the patient past the 12 hour beyond use time. No adverse reactions were observed by the pharmacist within 15 minutes after vaccination. Patient did not contact us as of 6 hours after vaccination to report adverse reactions.
57 year-old male with no known prior cardiac hx, with hx of HTN off BP rx, admitted with Covid19+ and atrial fibrillation, unclear if new. He had fevers 4 days ago and the next day had a covid19 + test. He was started on 8 medications by an Urgent care center, one of which is Prednisone. He states states that after taking the first dose of Prednisone, he started to have fluttering in his chest which seemed to be more persistent than usual. He was scheduled to come to the ED today for monoclonal antibody infusion and when he had his EKG taken, he was noted to be in atrial fibrillation w/ controlled VR, for which he was admitted to the Observation Unit.
erythema, ecchymosis, pain & edema at inject site are reported in a pt who recvd 1 dose of flu vax; above sx occurred 12 hrs p/flu vax given & resolved w/in 48 hrs;
When I woke up the next day after the shot I had a severe headache, fever between 101 and 102,  sleepy for 2 days, drippy nose, my arm hurt and had a big red bump 3 inches wide on vaccination site.  It felt like I had COVID-19.  I took Tylenol for my symptoms. This happened to me after every COVID-19 shot. I developed cellulitis after 2 bug bites and when I cut my feet. I have never had to do this my whole life.
Extreme, concentrated stomach pain--which lasted for about 1.5 hours. This stomach pain has recurred often and sporadically to present day. The next day (10/04/2011), fever, chills, sweats presented. General flu-like symptoms, which lasted for 5 days.
Has happened for 3 months now on both arms; fall asleep; pins and needles sensation/ tingling in my feet; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:15 (Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included migraine (hormone triggered). Concomitant medications included diclofenac potassium (CAMBIA); rizatriptan benzoate (MAXALT) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced has happened for 3 months now on both arms, fall asleep, pins and needles sensation, tingling in my feet on 25Mar2021 22:00. Clinical course reported as: If I lay on my side the arm will fall asleep and pins and needles sensation will continue for hours even after no longer laying on the side. Has happened for 3 months now on both arms. Also tingling in my feet. Outcome of events was not recovered. Treatment included Gabapentin not working. The patient underwent lab tests and procedures which included nerve study: normal. events resulted Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19.
Redness from hip to knee joint. Blister at injection site on outer thigh. Pain with walking, no pain with touch.
Pt exp fever 101 & irritability w/in 48 hrs p/vax; tx included APAP; pt recovered & is asymptomatic; pt prev had high pitched cry following 1st DPT & was given DT for 2nd dose;
mom stated pt started crying; mom was unable to comfort or console pt no matter what she did; mom states gave APAP to child as directed-q 4 hrs; mom called MD who instructed her to keep giving pt APAP
Upon given the shot, I immediately had a painful left arm which I could barely move throughout the day. I gradually started feeling run down and by 7 PM on 4/17/18 (the day I received the vaccine), I felt sick. My symptoms included headache, chills, upset stomach, sensitivity to sounds. I could not sleep probably because of my thoughts. I can best describe as being delirious - restless and incoherent. By morning (4/18), I could barely move to even go to the bathroom and started vomiting from about 1 PM the following day until 7 PM. Therefore, I could not eat anything the entire day. Slept a little better that evening and feel better and I'm able to eat although not entirely recovered today (4/19). Overall, no one should have to suffer from these side effects. I can honestly say the suffering was worse than getting the shingles. (Maybe not as long, but worse!). I had the shingles!
Sore arm for a day; Was not able to sleep; Cold last night; Shivering for 3 hours; Fever all night like 101.5 F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for a day), INSOMNIA (Was not able to sleep), NASOPHARYNGITIS (Cold last night), CHILLS (Shivering for 3 hours) and PYREXIA (Fever all night like 101.5 F) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-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 PAIN IN EXTREMITY (Sore arm for a day), INSOMNIA (Was not able to sleep), NASOPHARYNGITIS (Cold last night), CHILLS (Shivering for 3 hours) and PYREXIA (Fever all night like 101.5 F). At the time of the report, PAIN IN EXTREMITY (Sore arm for a day), INSOMNIA (Was not able to sleep), NASOPHARYNGITIS (Cold last night), CHILLS (Shivering for 3 hours) and PYREXIA (Fever all night like 101.5 F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not provided.
Body aches; sore/stiff arm; Low grade fever,; Slight nausea; Tired; sore/stiff arm; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration at the left arm on 31Mar2021 at 12:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, anxiety and depression. The patient had received other medications (unspecified) within 2 weeks of vaccination. The patient did not have any allergies to food, medications, or other products. 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 medications or vaccines within 4 weeks prior to the vaccination. On 31Mar2021 at 13:00, the patient had experienced low grade fever, slight nausea, body aches, tired and sore/stiff arm. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events low grade fever, slight nausea, body aches, tired and sore/stiff arm was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other hcp. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 11Feb2021 (Lot number was not reported) as 2ND DOSE, SINGLE; dose 1 intramuscular on 21Jan2021 (Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypothyroidism (hypothyroid). Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient received 2 doses of Pfizer on 21Jan2021 and 11Feb2021 and went on to develop covid on 06Apr2021. Event result patient to doctor or other healthcare professional office/clinic visit. No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test via Nasal Swab: positive on 06Apr2021. The outcome of the events was unknown. The patient is not pregnant.  Information on the lot/batch number has been requested.
"believes that the vaccine decreased her immune system"; Fatigue; Diarrhea; Loss of smell; loss of taste; feeling; headache; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED IMMUNE RESPONSIVENESS ("believes that the vaccine decreased her immune system"), DIZZINESS (dizzy), DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell) and AGEUSIA (loss of taste) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (dizzy), FEELING ABNORMAL (feeling) and HEADACHE (headache). On 08-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell), AGEUSIA (loss of taste) and FATIGUE (Fatigue). On an unknown date, the patient experienced DECREASED IMMUNE RESPONSIVENESS ("believes that the vaccine decreased her immune system"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, DECREASED IMMUNE RESPONSIVENESS ("believes that the vaccine decreased her immune system"), DIZZINESS (dizzy), DIARRHOEA (Diarrhea), ANOSMIA (Loss of smell), AGEUSIA (loss of taste), FEELING ABNORMAL (feeling), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Follow up received on 19-Jan-2021, Contains non significant information
Information has been received from a medical assistant regarding a patient who on 06-AUG-2012 was vaccinated with a dose of PNEUMOVAX 23. (Lot number 672041/1477AA; expiration date 14-MAY-2013, also reported as 14-MAY-2012). It was reported that the patient developed cellulitis after receiving a dose of PNEUMOVAX 23. No further information was provided. No further information is expected.