chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tear in his rectus abdominus; worst rigors of his life; abdominal pain; broken rib; positive carnetts sign; This case was reported by a physician via call center representative and described the occurrence of torn muscle in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th March 2020 10:00, the patient received the 2nd dose of Shingrix. On 9th March 2020 22:00, 12 hrs after receiving Shingrix, the patient experienced torn muscle (serious criteria GSK medically significant), rigors, abdominal pain and rib fracture. In March 2020, the patient experienced carnett's sign positive. The patient was treated with naproxen. On an unknown date, the outcome of the torn muscle, abdominal pain, carnett's sign positive and rib fracture were recovering/resolving and the outcome of the rigors was recovered/resolved.   It was unknown if the reporter considered the torn muscle, abdominal pain, carnett's sign positive and rib fracture to be related to Shingrix. The reporter considered the rigors to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient himself. The patient developed worst rigors of his life and took Naproxen which helped get the rigors under control.  The patient then developed abdominal pain on the right side which he believed was caused by a broken rib and a tear in his rectus abdominus, caused by the rigors.  The patient has been taking Naproxen 3-4 times a day and was slowly getting better.  The reporter consented to follow up. The reporter did not have the lot or expiry date for vaccine.
Pt. broke in hives on 10-8-09 after getting vaccines on 10-6-09.
Same day had shooting pains down arm all the way down wrist.  Later in the week had joint swelling in left wrist, left hand, left elbow. The following week had swelling in left ankle. Lower back pain about one week later. Swelling will not go down with any treatments - ice/heat, epsom salt soaks, ibuprofen, creams.  Did have a fever and headache the night after vaccine but I did expect that.
Allergy; Sinusitis; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (Allergy), SINUSITIS (Sinusitis) and HEADACHE (Headache) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergy), SINUSITIS (Sinusitis) and HEADACHE (Headache). At the time of the report, HYPERSENSITIVITY (Allergy), SINUSITIS (Sinusitis) and HEADACHE (Headache) 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.   No Concomitant Medications were  provided by Reporter No Treatment Medications were  provided by Reporter   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: TCR report : Additional events added. She don't want further follow-ups
Initial unsolicited report received from a physician on 05 Nov 2016. This case involves a seven years old patient (gender- unknown) who was vaccinated with a dose of FLUZONE QIV (Batch number, expiry date, dose, dose in series, and route of administration- unknown) at arm on 04 Nov 2016. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications was not reported. On 04 Nov 2016, on the same day following the vaccination, patient developed extensive widespread hives over the body and injection site swelling. Patient's upper lip was swollen. The patient had bilateral periorbital swelling, the injection site swelling covered the whole upper arm to the elbow. Hives were red, and itchy but no difficulty on breathing. The patient required Emergency room doctor visit. Laboratory investigations were not reported. The patient received corrective treatment with BENADRYL. The outcome of the events were recovering (reported as patient's condition was improving). List of documents held by sender: none.
Muscle under injection site is hard and has a lump. Injection site is red, itchy, and swollen.
Hight Fever (100.7),  chills, body ache,  joint pain, fatigue
Pt states he received a flu shot 2 to 4 weeks ago & now feels "20 yrs. older" - c/o site pain radiated to his left shoulder area & feels stiff in his hip areas - stiffer in morning - takes ASAP - denies need for medical attention.
pt recv vax 26MAR98 & 28MAR98 started feeling achy;29MAR98 noticed a light rash on arms & legs & the joints of fingers, elbows & knees were aching;30MAR98 pt reported puffiness of the joints of fingers, elbows & knees;
Immediately after injection: Arm pain/soreness, neck pain, migraine, heart palpitations  January 12th developed warm tingling sensation in hands and fingertips as well as sudden sore throat that burned. Developed fever, headache, muscle aches, and extreme fatigue Jan 13th and heart palpitations as well as shortness of breath. Fever spiked at 104 around Day 3 and subsided with tylenol. Shortness of breath and heart palpitations lasted for one month (even after testing negative for COVID), and fatigue has continued since then (has not gone away). I get tired by about 2/3pm each day and need to rest, but am often unable to because of work (I work in healthcare) and sleep very deeply now for >10 hrs/night but still wake up very tired each day. I still have COVID leave disability through work for days I cannot work an entire day. I've learned to adapt because I also have a young child to take care of.
Redness and swelling at injection site bilateral thighs. Left upper inquinal node-minor-no significant enlargement. Zostavax given Right thigh SubQ, Varicella given Left thigh Sub Q.
04/01/2003 pt c/o of dizziness on and off since SP vaccine Also reports "tightening of chest area" 2-3 times. Evaluated. Referred to UCI ED for evaluation. c/o dizzy and 4 days worse today. This is a 51 year old female who was sent from the health dept because she had diizziness and malaise for the past 4 days. Five days ago the pt reports that she had an episode of chest tightness that lasted 10 minutes. the pt has had no pain or discomfort in her chest since. The pt received a SP vaccine 1 week ago. The pt has no headache, change in mental status, change in vision, weakness, numbness, trouble thinking, talking or walking: no fever, no rash. Th health dept. doctor referred the pt here saying that her vaccine site appeared consistent with a normal reaction. The pt also has a history of having has SP as a child.
This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization or PNEUMOVAX 23, via an unspecified route of administration on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced nausea, headache, and fever for two to three days after receiving the vaccine. The outcome for the events of nausea, headache, and fever was unknown.
Red rash that  is itchy  arm is swollen in the  shape of an oval on the  upper arm
My dust mite allergy which was inactive has become very active for past 1 month.  I had dust mite allergy since 2010 however past 3 to 4 years it was almost dormant.  However, this year I have been feeling very itchy through out my body specially scalp, legs and arms.  I have also even started to get hives which lasts for days.
Debilitating sore upper arm near injection site.  Injection on Monday, by Wednesday arm sore but hardly noticeable.
Seizure; Headache; Couldn't feel lower legs; Extreme chest pains and chills; Extreme chest pains and chills; Arm swelling; Pain; Itching; This is a spontaneous report from a contactable healthcare professional (patient). A 23-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration (left arm) on 02Mar2021, 16:15, as single dose for COVID-19 immunisation. Medical history included ongoing epilepsy, covid back in Dec2020, known allergies to flu vaccine and TB test and seizure (have history). Concomitant medications included levetiracetam (KEPPRA), lamotrigine (LAMICTAL), cenobamate (XCOPRI) and magnesium. The patient had no other vaccine in 4 weeks. On 02Mar2021 16:15, the patient experienced arm swelling, pain, itching, couldn't feel lower legs, extreme chest pains and chills. On 02Mar2021, at 17:15, the patient experienced headache an hour later. On 03Mar2021 01:00, the patient experienced seizure at the middle of the night around 01:00. The events resulted in emergency room/department or urgent care. The patient had Covid prior vaccination; and was not Covid tested post vaccination. Outcome of event seizure was not recovered; outcome of the rest of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The patient had underlying epilepsy. However, based on the close temporal association, a possible contributory role of bnt162b2 to the development of seizure cannot be excluded. 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.
Joint aches, nausea, dizziness and retro-orbital pain. Started 2-3 days ago. Instructed to go to ER for eval.
The next day after the vaccine I developed a low grade fever. Body aches and pains and severely tired feeling. Couldn't sleep for 2 nights in a row but the 3rd night I slept for over 10 hrs in a row. The heel of my left foot begin to ache and has gotten worse over time. I saw my Podiatrist today who injected the heel with cortisone and it is currently being monitored with an appointment scheduled in the next 4 weeks.
My menstrual cycle came a lot heavier than it has ever been, including large blood clots. Additionally, my premenstrual symptoms were much more painful and intense
Admitted to hospital with weakness secondary to COVID-19 on 8/10/21. Discharged home on 8/11/21. Did not require oxygen during admission.
Syringe was prefilled outside in room temparature; Patient received the dose which was prefilled syringe from (26Apr2021 to 29Apr2021); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the dose which was prefilled syringe from (26Apr2021 to 29Apr2021)) and PRODUCT STORAGE ERROR (Syringe was prefilled outside in room temparature) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the dose which was prefilled syringe from (26Apr2021 to 29Apr2021)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Syringe was prefilled outside in room temparature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the dose which was prefilled syringe from (26Apr2021 to 29Apr2021)) and PRODUCT STORAGE ERROR (Syringe was prefilled outside in room temparature) had resolved.        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 medications were not reported. Treatment information was not reported.
Patient experienced a Vasovagal reaction while standing in the laboratory when sibling was having his blood drawn. Pt fainted and hit head on door jam and fell to the floor.
Couple of hours after started feeling body aches, chills, subjected fever, never had a response like that to a previous vaccine. Took some advil, feel about 95% better now.
Patient developed a rash that extended down the arm from the point of injection to the elbow.  She said the rash stings and itches, but seems to be getting better.  The patient developed fever, nausea and diarrhea as well.  Patient also said she was having chills and would randomly start sweating.
p/vax pt presented to urgent care center 6/8/99;pt had hx 5 days fever to max 102;3 days prior to presentation devel irritability of colicky nature, loose mucous BM's & blood tinged BM;x-ray eval nl & sx improved w/in 24hr of eval;
vaccine was expired, no temperature excursions occurred and moderna determined the vial "maintained the activity necessarty to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
No adverse event; got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD).    Patient registry ID was reported as Unknown.  No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Completely passed out/fainted and was ill, semi-blacking out for around 30 minutes. Called 911. EMT said it was the 4th reporting of a fainting after the HPV vaccine that they had received.
LOOSE BOWEL MOVEMENTS; UPSET STOMACH; ACHY; TIRED; FEVER; NAUSEA; WEAKNESS; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced loose bowel movements. On 18-JUN-2021, the subject experienced upset stomach. On 18-JUN-2021, the subject experienced achy. On 18-JUN-2021, the subject experienced tired. On 18-JUN-2021, the subject experienced fever. On 18-JUN-2021, the subject experienced nausea. On 18-JUN-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, achy, fever, nausea, upset stomach, and weakness, and the outcome of loose bowel movements was not reported. This report was non-serious.
Rash + Vomiting reported to provider. Provider indicated urticarial reaction at injection site with no other symptoms. mother stated aprox 2 hours after receiving vaccines the child broke out in rash (entire body) with vomiting.
The pt developed a fever and vomiting with cyanosis on evening of immunization. In the ER the pulse ox was 50% (normal for her is 78). The pt developed bradycardia and respiratory arrest. Full CPR performed for 70-80 minutes before pronounced.
pt recv vax & devel generalized hives immed post vax;pt observed only no med given;hives resolved;
Heart Palpitations; Shortness of Breath; This case was reported by a nurse via call center representative and described the occurrence of palpitation in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2018, the patient received the 1st dose of Shingrix. In May 2018, 1 day after receiving Shingrix, the patient experienced palpitation and shortness of breath. On an unknown date, the outcome of the palpitation and shortness of breath were unknown.   It was unknown if the reporter considered the palpitation and shortness of breath to be related to Shingrix.  Additional details were provided as follows: This case was reported via chat. The age of the patient could be 68 or 69 years old. 24 hours after vaccination with dose of Shingrix, the patient experienced palpitation and shortness of breath. The reporter consented to follow up.
PATIENT COMPLAINED OF NUMBNESS FROM ELBOW DOWN TO FINGER TIPS IN LEFT ARM.
Vaccine site (L arm) red, very swollen x5 days, hot to the touch, itchy. High temperature of 102 x2 days. All joints ached for several days. Resolved 7/6/15.
Raised bumps around injection site, spread out over upper arm. Has gotten increasingly more itchy and painful.
Received vaccine in left arm. Injection site became itchy and red approx 12 hours later.
I did not have a menstrual cycle for 3 months following my 2nd dose in the vaccine series. I normally have a regular cycle. I also did not have a period for 3 months following the 3rd vaccine dose which was given 9/3/21.
Information has been received from a registered nurse concerning an elementary school aged child who was vaccinated with a dose of VARIVAX (Merck). On approximately 23-FEB-2006, the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Positive COVID-19 test; Positive COVID-19 test; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) single dose, on 24Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. She is scheduled for the 2nd dose on 17Mar2021 (exactly 21 days apart). She is trying to reschedule the 2nd dose appointment because she went COVID-19 positive after the first dose (on an unspecified date, in 2021). Clinical outcome was unknown at time of this report.   The information on the lot number has been requested.
pt recv 2 doses of vax & antibody titers drawn pre-vax & 4mo post vax were negative;
17 year old patient received Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2022, the patient received Shingrix. On 15th August 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comment: Nurse reported that a 17 year old patient received Shingrix vaccine. No symptoms reported. The HCP (Health Care Professional) did not have the lot number and expiration date at the time of report. The reporter consented to follow-up. Additional Supportive Information: The 17 year old patient received Shingrix vaccine, which led to inappropriate age at vaccine administration.
Heart racing; Cold sweats; Chills; Sleeping through the day; Had to leave work on Tuesday; Very sore in the left shoulder; Tired and drained; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), COLD SWEAT (cold sweats), SOMNOLENCE (sleeping through the day), IMPAIRED WORK ABILITY (Had to leave work on Tuesday) and ARTHRALGIA (very sore in the left shoulder) in a 43-year-old male 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.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced ARTHRALGIA (very sore in the left shoulder) and FATIGUE (tired and drained). On 10-Aug-2021, the patient experienced SOMNOLENCE (sleeping through the day) and IMPAIRED WORK ABILITY (Had to leave work on Tuesday). On 10-Aug-2021 at 2:00 AM, the patient experienced PALPITATIONS (heart racing), COLD SWEAT (cold sweats) and CHILLS (chills). At the time of the report, PALPITATIONS (heart racing), COLD SWEAT (cold sweats), SOMNOLENCE (sleeping through the day), IMPAIRED WORK ABILITY (Had to leave work on Tuesday), ARTHRALGIA (very sore in the left shoulder), FATIGUE (tired and drained) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided by reporter. No treatment medications are provided by reporter.
Have been having strong stomach discomfort ever since the second dose on 4/15/21. Symptoms are dull pain to sharp pain sometimes to an extremely tight stomach.
This spontaneous case, initially received from pharmacist on 05-Oct-2018, concerns a 94-year-old, elderly female patient. The patient did not have any medical history and did not take any medications at the time of vaccination. On 05-Oct-2018, the patient was administered expired FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, batch number: 179303, expiry date: 30-Jun-2018, route of administration: intramuscular] (explicitly coded as expired vaccine used). At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious. This case: 201804321 was linked to case: 201804319 due to the same reporter.
Nausea/vomiting, fatigue. Hospitalized the next day. Doctors say she may have had a mini stroke