chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sick; itchy all over my body; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick) and generalized pruritus (Verbatim: itchy all over my body).  The outcome of the sickness and generalized pruritus were not reported.   It was unknown if the reporter considered the sickness and generalized pruritus to be related to Shingles vaccine.     It was unknown if the company considered the sickness and generalized pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2022 The case was received from the patient interactive digital media. The patient reported that he/she got vaccinated and got sick and itchy all over his/her body. The follow-up could not be possible as no contact details were available.
Patient has a 10x10 cm hardened, indurated erythematous area surrounding vaccine of KINRIX and MMR vaccine on 9/8/15. Area developed within a few hours and I saw it on 9/10/15.
barely move; have had a terrible terrible time but I'm feeling better today; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 08Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer-sponsored program XELSOURCE from a contactable consumer (patient). This 71-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; tofacitinib citrate (XELJANZ XR) (strength: 11 mg), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 11 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient due for a refill. patient stated she was out of the tofacitinib citrate. She got the second dose of the vaccine and she can barely move. She got the vaccine and she have had a terrible terrible time but she was feeling better at the time of report. The patient was prescribed tofacitinib citrate 11mg. The action taken with tofacitinib citrate was unknown. The outcome of event barely move was unknown. The outcome of other event was recovered.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a healthcare worker refers to two patients of unknown age and gender. Concurrent conditions and medical history were not reported. On 05-JUN-2015, the patients were vaccinated with improperly stored doses of VAQTA with one of the following lot numbers: K014696 with expiration date: 11-NOV-2015, L001445 with expiration date: 15-FEB-2016 and L004439 with expiration date: 15-FEB-2016, (Strength, dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Lot numbers K014696, L001445 and L004439 have been verified to be valid lot numbers for VAQTA. This is one of several reports received from the same reporter. Additional information has been requested.
On day 8 after receiving the COVID vaccine, my left arm became swollen and a red rash was present. The area was hot to the touch. The next morning, the issue was still present. Ice packs were applied throughout the day and the swelling subsided. The area is still broken out with a red rash and is warm to the touch; the area itches, but is relieved for a short time when cortisone cream is applied.
Hives, increased blood pressure, swollen eyes & lips. Pt went to emergency room.
Metal taste in mouth the next day following the first vaccine. Last about 4 weeks. Dislike of some foods, especially coffee, since  first shot. Still present. Facial nerve pain about 2 months post vaccine. Still occurring intermittently.
tested positive on 01Jul; tested positive on 01Jul; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 35-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "tested positive on 01Jul". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jul2022) positive; (11Jul2022) positive; (Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxolovid from 01Jul2022 to 06Jul2022 administered orally. Clinical Information: COVID rebound: Patient developed symptoms on 01Jul and tested positive on 01Jul and began treatment with Paxlovid at the recommended doses for 5 days including on July 6. Patient became asymptomatic about day 4 today 5. Patient tested negative around day 7 but had recurrent symptoms beginning yesterday 11Jul2022 and tested positive via home antigen test. Presumptively, we assume that this represents a rebound COVID situation. Recommended he needed to restart isolation as recommended.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to  all the reported events Drug ineffective  ,covid 19 cannot be completely excluded based on temporal association and known drug safety profile
The patient's guardian marked the patient's age as 12 on the consent form, but upon processing the form (after the shot had been administered), it was discovered that the patient was only 11 years old.
Accompanying the common side effects (fever 102; chills; and fatigue), I suffered from severe muscle ache the night following my second dose of Moderna Vaccine. About three days after my second shot, I had a sudden electric shock on the inside of my left knee.  This was followed by constant pulsing (every 3 seconds, non stop) of the vein from back of left knee all the way up to my hip. The annoying pulsing went away in about two weeks, and debilitating muscle ache and feeling of heavy, swollen legs improved but localized burning (like fire ants biting) and muscle ache spread from one leg to both legs. To this very day, I am not able to walk for more than 10 minutes, without needing to lie down and rub my legs. There is constant localized burning and ache, which moves around in my legs. I use a massager to help relax the muscles and took a muscle relaxer, both of which help momentarily. I try to exercise (walk and ride a bike) to help the muscles but the symptoms persist after 8-9 weeks of my second dose. Though I am a big supporter of vaccines, I feel like my legs have been permanently damaged because of the vaccine.
Breakthrough COVID infection. Symptoms of worsening generalized fatigue, fevers, cough. Unsure symptom onset. Tested positive 08/10/2022
he has had a flare up since then; multiple bowel movements daily (3-4 per day); received a booster vaccine for coronavirus; received a booster vaccine for coronavirus; This is a spontaneous report from a contactable other hcp (patient). A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Sep2021 (at the age of 36-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included tofacitinib citrate (XELJANZ XR) takes 22 mg by mouth once daily for ulcerative colitis from Nov2020 and ongoing. The patient previously received dose 1 and dose 2 of COVID-19 Vaccine for immunisation. The patient reported he had been having 1 bowel movement daily for the past few months. He received a booster vaccine for coronavirus, and he has had a flare up since then. He was having multiple bowel movements daily (3-4 per day). The outcome of events was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Started with a small rash, went to Doctor on February 15, 2021, he did not know what it was.  Went to a Detmatologist on February 28, 2021. She  did not know what its  was either.  Gave me  prescription for Triamcinbolone Acetonide for rash.  This medication did not  really help, Doctor gave me Hydroxyzine, and told me to take Zyrrtec.  Rash has taken over entire body with red sore blister like bump.  Also took all of my hair out.  I need help ASAP, I am really suffering as it about to take over my face.
2021.05.18 @ 0858 hrs. Upon discharge patient reports sudden nasal congestion. Denies any other symptoms including N/V/D, swelling of lips/mouth/tongue/throat, CP, SOB, difficulty breathing, or hives. Per,FNP verbal consult will observe 15 more mins (total of 30 mins) and if no further symptoms patient is to take some antihistamine (due to patient HX of seasonal allergies) when she gets home. After 30 mins, no other sxs reported by patient or observed by myself. She also reports improvement of nasal congestion. Strict 911/ED given if sxs were to worsen or new symptoms were to arise. She verbalized understanding and agrees with plan. MA translator,RN
Fever per patient's mother (temp not actually taken; was 97.2 orally on 8/31/09), generalized rash, loss of appetite, lethargy.  Mother noticed these s/s on 8/29/09 but patient told her she had not been feeling well for several days. Pt. was assessed by Dr. on 8/31/09.  No treatment ordered.  I spoke with pt's mother today.  She noted that patient was "much better" and rash, etc. resolving.
two bad episodes of Atrial Fibrillation; slept for like a day and a half; Felt lethargic; A spontaneous report was received from two consumers and a healthcare professional concerning a male patient of unknown gender, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced  two bad episodes of Atrial Fibrillation, Slept for like a day and a half and Felt lethargic.  The patient's medical history included Atrial Fibrillation. Products known to have been used by the patient, within two weeks prior to the event, included Multaq, at 400mg two times a day for Atrial Fibrillation.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number: not provided).  On 14 FEB 2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 029K20A) intramuscularly in for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced two bad episodes of Atrial Fibrillation, slept for like a day and a half and felt lethargic. No treatment was given for the reported events.   The action taken with mRNA-1273 in response to the events was considered not applicable, as the patient received both the doses of Moderna's COVID-19 vaccine prior to the events.  The outcome of the events was unknown.; Reporter's Comments: This case concerns a male patient, with medical history of atrial fibrillation, who experienced a serious unexpected event of atrial fibrillation, after receiving second dose mRNA- 1273 (Lot# 029K20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Noting the patient's history of atrial fibrillation. Further information has been requested.
This case was reported by a healthcare professional via a distributor and described the occurrence of flu-like symptoms in a female subject aged between 50 and 59 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (0.5 ml, unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced flu-like symptoms, red and swollen arm. Medical attention was not required. At the time of reporting the outcome of the events was unspecified. At the time of reporting, the healthcare professional reported five other adult female subjects who experienced side effects from FLULAVAL injections at her practice (see case id's A0887614A, A0887616A, A0887617A, A0887619A, and A0887620A for specific details on these other subjects). It was unknown if all six subject's FLULAVAL was administered from the same vial. Follow-up information was received on 29 October 2010. It was reported that the subject was 37 years old and that FLULAVAL was administered on 01 October 2010. On 02 October 2010, the subject developed flu like symptoms and red, swollen arm. The symptoms resolved.
14 days after vaccination, 2 cm induration/tenderness, diffuse swelling.
Brutal sore throat, feeling of a chest cold, heavy chest, mild headache, a feeling of constant and desperate dehydration even though urine runs clear.
Fever of of 102; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of of 102) and NAUSEA (Nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Fever of of 102) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever of of 102) and NAUSEA (Nausea) outcome was unknown. Not Provided          No relevant concomitant medications were reported. Treatment details included Advil.
hives/stiff neck 21OCT96 & 6NOV93 sx of encephalitis (105 fever); cont weakness;spasms in neck & torso; 18DEC93 high fever,v, dx of hives & pneumonia 23DEC93;signs of neuro deterioration;1AUG96 catatonic state;diff speech;unable to walk;
Pt recvd 1st dose of HEp B vax on 18DEC91 & devel achiness, sl fever, nausea, upper resp infection, bronchitis; pt recvd 2nd dose of vax & 2 days later devel fatigue, nausea, dizziness & GI upset;
This spontaneous report has been received from a consumer also the patient's mother, and refers to a 20 year old female. Amoxixillin allergy was reported as concurrent conditions and a "flu shot" was reported as concomitant medication. No information was provided regarding the patient's medical history. On an unknown date in December 2013, reported as "4 years ago", the patient was vaccinated in her arm with an only dose of GARDASIL to prevent cancer (dose, route of administration, lot number and expiration date were not reported). On an unspecified date in December 2013, reported as "4 years ago",  after the administration of GARDASIL, the patient experienced being "Light headed" (dizziness) and recovered the same night without treatment. The patient did not sought medical attention and laboratory diagnostics or studies were not performed; besides, the reporter did not assess the causal relationship between vaccination with GARDASIL and the event of dizziness. There was not product quality complaint involved.
This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Report Adverse Event Yes) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report Adverse Event Yes). At the time of the report, VACCINATION COMPLICATION (Report Adverse Event Yes) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant product use was reported. No treatment information was provided. Reporter did not allow further contact.
pt recvd vax 29JAN90 &  lab eval of multiple tests & labs including ANA, lupus panel, lyme titer & rheumatoid work-up were all found to be neg; WBC count dropped from 9.4 on 26FEB90 to 3.5 on 31JUL91 & lymphocyte count dropped;SGOT inc;
I received the first vaccine on 8/4/21. My eyes began to water uncontrollably the next day and continued for several days.  I began having headaches and heart palpation that continued for over a week. I woke up on a Saturday 10 days after the first dose and could not see out of part of my left eye. After the second dose on 8/25/21 my eyes began the same watering in the right but my vision did not change in that eye.
High fever 101.2 chills; muscle pain; injection site swelling; joint pain; headache; tiredness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6201) via an unspecified route of administration in the left arm on 31Mar2021 at 13:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. The patient was allergic to sulfur. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6201) via an unspecified route of administration in the left arm on 10Mar2021 at 13:45 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 18:30, the patient experienced high fever of 101.2 chills, muscle pain, injection site swelling, joint pain, headache and tiredness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department, or urgent care. Therapeutic measures were not taken as a result of events. The clinical outcome of the events high fever of 101.2 chills, muscle pain, injection site swelling, joint pain, headache and tiredness were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pain, swelling, heat and redness on right deltoid; reaction at injection site. Pain shoots down to hand and up to shoulder with movement of arm. Resolving vaccine reaction.
AT 5PM STARTED HAVING HEADACHE, FEVER, CHILLS AND NAUSEA WITH NO EMESIS.  AT INJECTION SITE SHE STATED IT WAS "HOT"
BACK PAIN WHICH HAS RADIATED TO THE LEGS; LEGS FEEL LIKE THEY ARE SLEEPING; This spontaneous report received from a consumer concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy, and other pre-existing medical conditions included the patient is not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802012, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced back pain which has radiated to the legs. On 10-MAY-2021, the subject experienced legs feel like they are sleeping. Treatment medications (dates unspecified) included: gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from back pain which has radiated to the legs, and legs feel like they are sleeping. This report was non-serious.
Stiff neck, pain in neck and shoulders, headache, cannot turn my head to the left without extreme pain.
patient received FLUZONE QIV NP from pre-filled syringes after a temperature excursion occurred, with no reported adverse event; Temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes, with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to cases 2022SA409520(CLUSTER), 2022SA409928(CLUSTER) and 2022SA409694(CLUSTER).  This case involves an adult patient (unknown gender) who received Influenza Quadrival A-B Vaccine [Fluzone QIV] np from pre-filled syringes after a temperature excursion occurred and temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient received 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation, frequency, route: unknown) (lot number: UT7689LA and expiry date: 30-Jun-2023) in unknown administration site for Immunization and patient received fluzone qiv np from pre-filled syringes after a temperature excursion occurred, with no reported adverse event (poor quality product administered) (latency: same day) and a temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes, with no reported adverse event (product storage error) (latency: same day).  It was reported, the cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case. Doctor states that she was told that the vaccines are no longer viable and has discarded all of them. Doctor asked for specific guidance on whether these patients needed to be re-vaccinated before they contacted the patients. This situation is reported as a medication error due to vaccines being administered post-excursion.   Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE QIV) was not applicable for all events.  At time of reporting, the outcome was Unknown for all events.   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 the 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.
Difficulty breathing for up to 7 days afterwards, headache for up to 7 days afterwards, headache for up to 7 days afterwards
Fever (101.5 F), chills, night sweats, injection site soreness, headache
No other AE.; received a dose of ROTATEQ on 3/29/2021. After administration, the customer noticed the expiration date was 2/14/2021.; This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 29-MAR-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally (exact dose, injection site and lot number were not provided; lot # s013890 has been verified to be a valid lot number with expiration date 14-FEB-2021) for prophylaxis. The product did not have any prior temperature excursions. The patient did not experience any other adverse events.