chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART POUNDING; SHAKING; FELT LIKE FLU; SKIN SENSITIVITY; This spontaneous report received from a patient 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced felt like flu. On 05-MAR-2021, the subject experienced skin sensitivity. Laboratory data included: Body temperature (NR: not provided) 101.7 F. On 05-MAR-2021 21:00, the subject experienced shaking. On 05-MAR-2021 23:00, the subject experienced heart pounding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart pounding on 06-MAR-2021, and was recovering from skin sensitivity, shaking, and felt like flu. This report was non-serious.
Approximately 4 hours after vaccine patient became chilled, felt numbness and tingling at fingers. At 8 hours after the vaccination patient had temperature of 102. Temperature up and down all week. On 10/17 went to Internist and temperature 104. Labs and CT ordered stat. The discharge summary received on 11/21/03 states adeno carcinoma.
Red raised rash on face, small clear pimples on fingers, eye irritation,,inflamed throat
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 08-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 48. The lowest recorded temperature was 32. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 15APR97 & exp swelling the size of an egg & warmth @ the in site;sx persisted for 4wk;
Weakness; Mild fever after second dose; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), PYREXIA (Mild fever after second dose) and FATIGUE (Fatigue) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), PYREXIA (Mild fever after second dose) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Weakness), PYREXIA (Mild fever after second dose) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Fatigue; Stomach upset; Headache; not getting second dose on time; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 5th October 2021, the patient received the 2nd dose of Shingrix. On 5th October 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the patient experienced fatigue, upset stomach and headache. On an unknown date, the outcome of the fatigue, upset stomach and headache were not recovered/not resolved and the outcome of the inappropriate schedule of vaccine administered was unknown.   It was unknown if the reporter considered the fatigue, upset stomach and headache to be related to Shingrix.   Additional details were reported as follows: This case was reported by the patient for herself. The patient experienced fatigue, stomach upset, and headache since received the shingrix vaccine. The patient enquired about if having these symptoms for almost two weeks was normal. The patient also enquired if symptoms could have been cause by her not getting her second dose of Shingrix on time, which led to inappropriate schedule of vaccine administered. The reporter did not consented to follow-up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215531:Same case
Guillain Barre syndrome, muscle weakness, anemia, low back pain, HT, psychosis NOS, Bell's Palsy, mastoiditis NOS, Sidalt and Rehabilitation Proc NOS. Receiving out-patient therapy. Will recover in about 2 to 3 years. Symptoms - numbness, headache, fever, loss of limbs control and weakness.
Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 91A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
A patient received Flublok Quadrivalent in error instead of Fluzone Quadrivalent, no AE; A 17 year old patient was vaccinated with Flublok Quadriavlent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via Global Medical Information (Reference number- 00341888) and transmitted to Sanofi on 02-Nov-2020 .  This case involves a 17 year old male patient who received 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ509AA expiry date: 10-May-2021) (Strength = Standard, form: prefilled syringe) once via intramuscular route in the right arm for prophylactic vaccination in error instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] for prophylactic vaccination on 01-Nov-2020 (wrong product administered and product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history was not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (latency same day).  The pharmacist stated that the prescription was written for Fluzone Quadrivalent 0.5mL. However when she went to grab the vaccine the Fluzone and Flublok were side by side and at 180 and over was not circled. She stated that the names Flublok and Fluzone and the boxes were too similar. She was in a hurry and accidentally grabbed the wrong box and as a result the 17 year old patient was injected with Flublok instead of Fluzone.  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
Patient came to receive his 2nd booster. LVN reported that when she inserted the needle in his arm and injected, the syringe popped off of the needle, the needle remained in his arm and she thinks none of the vaccine was administered. LVN used a leur lock syringe and a BD SafetyGlide Needle 25 g x1 inch.  She states she checked prior to administration that the needle was secured properly to the syringe.  Patient was informed of the situation. LVN was instructed to give the patient a ?repeat dose? immediately and document accordingly. Patient was understanding and agreeable to the plan.
Vaccines were given on 9/9/08. Pt was seen in the ER on 9/17. He was diagnosed with bilateral abscesses of the upper legs.
numbness of tongue & throat;felt like throat was closing up;numbness down to fingers in arm of inj;recv Atropine & DPH IM in injected arm & then again in other deltoid;transported ER but no further tx needed;
24 after (next evening) 3 bruises (spots) appeared at injection site area and further down her arm the arm became red, swollen & warm
Within a few hours of injection tenderness at the site and numbness throughout entire right upper extremity down into all 5 fingers developed.  23 hours later experienced sudden dizziness accompanied by visual "black out" that lasted a few minutes and was followed by fatigue the remainder of day.  Headache also noted which was relieved by ibuprofen.  Noted some ringing in right ear. All symptoms resolved by 11/05/2009 PM except slight subjective weakness right upper extremity.  Objective findings all normal.
Cold and shivering, painful arm, tiredness, nauseated, sweating. The next day she felt better but had no appetite.
Pt complained of pain at injection site the evening after appointment. Redness developed at site on right thigh with warmth developing through the night. Mother noticed a white center at injection site.
Initially just pain at injection site. (+ 7h post injection). By morning (+16h) generalized body ache and stiffness, shiveriness, felt cold, nauseous, no wish to eat or drink. Was incapacitated +16h-31h - unable to do anything but lie down, eyes shut. One Tylenol did nothing for me. Symptoms except for pain at injection site then all receded +31 h. I have not previously had any similarly unpleasant reaction to a vaccination. Usually I only have some pain at the injection site.
Pain in left arm at site of vaccine for 3 days then on day 4  8 cm erythema ongoing pain at site, also myositis of left side and back ache -ongoing.
A report was received from a health care professional on 11/22/2002 concerning a group of vaccinees less than 4 years old of unknown demography who inavertently received Fluvirin from approximately 11/07/2002 onwards. From 11/07/2002 Fluvirin was administered to vaccinees less than 4 years old. There were no adverse events. There was insufficient information to determine the reporters causality assessment.  Follow up 1. 12/10/2002: A follow up report was received from a health care professional indicating that a  2 year old female vaccinee was inadvertnetly administered Fluvirin intramuscularly on 11/19/2002. Cross Reference with: PJP200200848, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200864, PJP200200865, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.
On Monday afternoon I started feeling chest tightening. Shortness of breath. At the time I did not have headache or fever. I panicked and it made it worse. My hands became numb due to lack of oxygen. The next morning I had a terrible migraine, fever up to 102F, and body aches. Chest tightening continued around the heart/lung. On Tuesday I took home Covid test.
Reaction in her arm, Moderna arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Reaction in her arm, Moderna arm) in a female patient of an unknown age 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 LIMB DISCOMFORT (Reaction in her arm, Moderna arm). At the time of the report, LIMB DISCOMFORT (Reaction in her arm, Moderna arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
EXTREMELY sore arm first then fever, shakes, achy body, headache. The sore arm was better the next day but the flu like symptoms lasted the whole next day.
Pain ramped up quickly after receiving the vaccine and the site became very painful. By the next morning my entire arm was in pain, and swelling began at the site. The next day, the injection site began to itch and I took the bandage off revealing the swelling I had noticed was a baseball-sized red welt at injection site.
None. No adverse reaction, patient was given ROTATEQ immunization after 12 weeks of age.  Plan is to complete series now.
Injection site sore, pain in left shoulder radiating into neck. Headache after injection, gone after 12 hours.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: after injection pt complained of redness and swelling at and around injection site .advised to call md or visit urgent care
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. The diagnosis was acute blood loss anemia.
This is a spontaneous report from a contactable consumer (patient's stepdaughter). A 89-year-old male patient received the first dose of PREVNAR 13; (lot L99273, expiry date Feb2017) at 0.5 ml, single, in right arm and influenza vaccine (unknown manufacturer; lot UI443AA) at 1 DF single, in left arm, both via an unspecified route of administration, on 01Oct2015, for immunisation. Medical history included dementia (diagnosed for over 10 years), skin cancer on face (for over 7 years), skin cancer surgeries, stroke, short-term memory loss related to stroke. Past drug history included breaking out (rash) to bacitracin, neomycin sulfate, polymyxin b sulfate (BAND-AID), noted in the last 5 years. There were no concomitant medications. The patient experienced rash on Oct2015 for less than a week. The doctor stated that the rash looked like a rash caused by injection. Foot doctor recommended use of cortisone 10 cream which patient used and the rash went away on an unknown date in 2015. Prior to receiving the suspect vaccines the patient was ok and did not have any problems with flu shot.
Severe vomiting; Severe diarrhea; fever; pain in left ankle and foot; extreme cold hands and feet, fever on and off,; pain in left ankle and foot; extreme abdominal pain; dehydrated; lip started swelling; This is a spontaneous report from a contactable consumer.  A non-pregnant 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06May2021 14:45 (Batch/Lot Number: EW0172) as 2nd dose, single (at the age of 58 years old) for COVID-19 immunisation.  Medical history included high heart rate, bp and prediabetic. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]), hydrochlorothiazide, triamterene (MAXZIDE) and duloxetine hydrochloride (CYMBALTA), all taken for an unspecified indication, start and stop date were not reported.  The patient previously took VALIUM and experienced allergies;  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1, (lot number: EW0158) 14Apr2021 at 10:15 AM on left arm for COVID-19 immunisation and experienced lip swelling, bnt162b2 for covid-19 immunisation and experienced lower lip and chin swelling, Itchy chest, bumps, unable to walk and left knee severe joint pain.  The patient experienced 15 minutes after shot, lip started swelling on 06May2021 15:00. Severe vomiting, severe diarrhea, fever, extreme abdominal pain, extreme cold hands and feet, fever on and off, pain in left ankle and foot on 07May2021 12:30. The patient went to emergency room (er) 3 days after vaccine (dehydrated, extreme abdominal pain) 6 days later still have abdominal pain, diarrhea, vomiting and fever.  The patient received IV(intravenous fluids), potassium, abdominal CAT (computerized tomography) scan, Troponi (unknown drug). Prior to vaccination, was the patient not diagnosed with COVID-19 and been tested for COVID-19 (nasal swab) on 09May2021 and the result was negative. The outcome of the events were not recovered.
pt recvd vax & w/in 3 hrs of inject exp h/a, bodyache, flushing, fatigue & nausea; pt is taking APAP for aches; h/a & flushing persist;
I can't think; Serious headache; Fever / It went from 100 - 101, and the top it reached was 102.4; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (I can't think), PYREXIA (Fever / It went from 100 - 101, and the top it reached was 102.4) and HEADACHE (Serious headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizure and Arthritis.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PYREXIA (Fever / It went from 100 - 101, and the top it reached was 102.4). On an unknown date, the patient experienced THINKING ABNORMAL (I can't think) and HEADACHE (Serious headache). At the time of the report, THINKING ABNORMAL (I can't think), PYREXIA (Fever / It went from 100 - 101, and the top it reached was 102.4) and HEADACHE (Serious headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines include seizure and arthritis medicines .  Treatment Medications were not provided by the reporter.
Dizziness on Thursday before Memorial day weekend. I talked to my doctor. I have never had issues with dizziness before this. It happens throughout the day. It lasts about 5 seconds and then dissipates and happens several times per day (dizziness spells). Dr wants to do a test for Vertigo to see about my inner ear. Haven't had that test yet. I haven't been able to pinpoint anything that triggers the dizziness. It's really bad for a few seconds and then goes away.
Swollen; Red; Hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen), ERYTHEMA (Red) and FEELING HOT (Hot to the touch) 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 05-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced SWELLING (Swollen), ERYTHEMA (Red) and FEELING HOT (Hot to the touch). At the time of the report, SWELLING (Swollen), ERYTHEMA (Red) and FEELING HOT (Hot to the touch) outcome was unknown.            No concomitant medication reported. No treatment information provided. Action taken with mRNA-1273 in response to the events was not applicable.
Lt arm swollen w/red/blue area 1 3/4  x 2 swollen; fever x 3days upper limits 102 gave Panadol/APAP for fever warm to touch; c/o soreness @ inject site;
This case was reported by a healthcare professional and described the occurrence of injection site cellulitis in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). The subject had no allergy and no reaction to previous vaccination. Concurrent vaccination included MMR vaccine (non-GSK, Merck) given on 10 June 2014. On 10 June 2014 the subject received 5th dose of KINRIX (intramuscular, left thigh). On 13 June 2014, 3 days after vaccination with KINRIX, the subject experienced injection site cellulitis. The healthcare professional considered the event was clinically significant (or requiring intervention). The subject was treated with AUGMENTIN. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. This was one of 3 cases reported by the same reporter.
pt recv vax 12OCT98 & 21OCT98 pt hosp w/dx of ITP;platelet count on admission was 2000;pt tx w/med;
she has already taken a total of 3 shots of the vaccine; she was prescribed Paxlovid when she asked her doctor if she could take it since she had covid; she has already taken a total of 3 shots of the vaccine; she was prescribed Paxlovid when she asked her doctor if she could take it since she had covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EN6201), on 09Mar2021 as dose 2, single (Lot number: EN6199) and on 25Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 75 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "she has already taken a total of 3 shots of the vaccine; she was prescribed Paxlovid when she asked her doctor if she could take it since she had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Caller stated she tested Covid Positive last Monday or Tuesday.
I had my Covid Booster on Wed, 10/26 at 5pm and by 6:30 am the following morning I had the following disturbing reactions: My right side was so so weak I nearly fell multiple times while trying to walk, I could not stand from the toilet without using my arms. I was so dizzy I was nauseous. I also had the following reactions: ran hot/cold, muscle aches, headache, and pain behind my eye, which I have experienced before.  I slept until 12:30 and the weakness and dizziness issues were mostly resolved by the next day, I had lingering fatigue, again, similar to previous booster experiences.
The patient received the wrong second dose vaccine.  He received a Pfizer vaccine instead of the Moderna.  His wife requested he get his second dose and told the pharmacy it was Pfizer.  Unfortunately, we did not verify this and when we processed his vaccine later in the day, we received a message that we couldn't process because it did not match his previous dose which was Moderna.  The patient did not report any side effects except a slight fever, a mild headache and soreness at the site.
Left-sided Bell's palsy - He was started on prednisone and valacyclovir. Had a recent COVID-19 infection. Treated in hospital and released.