chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 09-NOV-2023 The reporter is the patient. The patient received shingrix 2 dose series. The reporter developed a sore arm after receiving the first dose. The reporter confirmed she received shingrix and not other vaccine for shingles but she did not recalled the dates. No other information was provided. Did not consented to follow-up.
12/17/08 mom took patient to ER for nausea and vomiting. 12/19/08 mom took patient to ER for shortness of breath. Diagnosed with acute myeloid leukemia.  2/18/09 Received ER medical records of 12/17/2008. FINAL DX: vomiting w/o dehydration. Records reveal patient experienced N/V x 3 days, no BM x 2 days.  Able to tolerate oral fluids.  Tx w/antinausea meds & d/c home on additional antinausea meds.  3/23/09 Received hospital medical records of 12/19/08-remains inpatient. FINAL DX: acute myeloblastic leukemia; respiratory failure; severe thrombocytopenia & anemia w/severe neutropenia; pneumonia; renal failure. Records reveal patient experienced flu-like symptoms, bone aching, bruising & petechial rash, pale, fatigue, SOB, low grade fever & abdominal pain w/vomiting x 3-5 days w/conjunctival hemorrhage.  Developedencephalopathy, respiratory distress, renal failure, tumor lysis syndrome, metabolic derangements, ARDS, labile BP.   Heme/onc, Pulm, ID, Nephro consult.  Admitted PICU, intubated followed by tracheostomy, initially CVVH followed by peritoneal dialysis, multiple transfusions, antibiotics, chemotherapy. Developed pancytopenia secondary to chemotherapy.   10/1/09 Hospital discharge summary received DOS 12/19/08 to 8/4/09. Additional information abstracted. Assessment: Acute myeloid leukemia. Acute Respiratory distress syndrome with pulmonary fibrosis, refractory thrombocytopenia, recurrent infections and bacteremia, muscle contractures, renal insufficiency. Patient on TPN. Chemotherapy. Physical therapy. Discharged to rehab center. 11/5/2009 MR dated 7/30 is aprogress note stating that patient is in remission per bone marrow done 7/1/2009. Patient had a tracheostomy 2/2009 and now wears a trach collar. Patient underwent Chemotherapy x 3 cycles with remission. Patient is off TPN 7/2009 and is eating and drinking. Patient still has low paltelet and hemoglobin counts and is transfused for this on a regular basis. Patient is now undergoing intense rehab.
3 weeks after the vaccine-patient developed a large macular, vesicular, blistering rash around the lesion, and other blisters throughout her body-arms, legs, upper chest, some on back, face, on her ears bilaterally. Most were yellow-fluid filled blisters- she also had erythematous papules throughout her body. +intensely itchy. no other systemic sxs.  She was given Zyrtec and Atarax TID for breakthrough itch. Follow-up with dermatology in am-to evaluate for any superinfection.
Hives and behavior change after flu vaccine 12/5/03. Tx Benadryl.
Side effects of swelling at injection site; Redness at injection site; Warmth at injection site; Itching at injection site; This case was reported by a consumer and described the occurrence of injection site swelling in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 9th July 2021, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth and injection site itching to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received the 1st dose of Shingrix in left deltoid muscle and next day the patient developed swelling, redness, warmth, and itching at the injection site. The patient experienced these side effects for 5-6 days post vaccination and later they got resolved. The reporter did not give a consent to follow-up with HCP (health care professional), Therefore, contact information to HCP was not collected. The reporter was not given any information from the pharmacy regarding Shingrix, therefore, she does not have lot/exp date and dose. The reporter did not consent to follow up.
Redness, swelling approx 10 cm tender, given 6/3, reaction 6/5.
Patient reported headache, night sweats, uncontrolled shaking, and chills the night of the vaccine. Pt states the next day she only has a headache.
Patient received Moderna COVID vaccine on 12/30/2020 at a Pharmacy clinic where he was a resident. Nurses at the facility reported that he was responsive and showed no signs of any adverse effects until 1/2/2021 when he was observed slightly unresponsive and staring at the ceiling and trembling. He had a fever of 101F at this time. The facility ordered labs and a rapid COVID test (all of which came back normal) and started IV antibiotics. A few hours later, patient began bleeding from his eyes, nose, and mouth and was sent to the local ER. The patient refused being admitted to the ICU for possible sepsis/hemorrhage and died the following day on 1/3/2021. All healthcare professionals involved agreed that this was not likely due to the vaccine, but needed to be reported nonetheless.
elevated blood glucose; Headache; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 06Mar2021 (Lot number: EJ1686) at the age of 78 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Arthritis" (ongoing), notes: in her shoulder, occupational related, possibly diagnosed about 20 years ago; "Type 1 diabetes" (ongoing), notes: diagnosed when she was 70 years old; "Blood pressure high" (ongoing); "thyroid imbalance" (ongoing); "seasonal allergies" (unspecified if ongoing); "pain" (unspecified if ongoing); "thinks she already had COVID", start date: Jan2020 (unspecified if ongoing); "lost her taste and smell", start date: Jan2020 (unspecified if ongoing); "lost her taste and smell", start date: Jan2020 (unspecified if ongoing). Concomitant medication(s) included: INSULIN taken for type 1 diabetes mellitus, start date: Apr2013 (ongoing); LOSARTAN taken for hypertension, start date: 2013 (ongoing); SYNTHROID taken for thyroid disorder, start date: 1987 (ongoing); VITAMIN D NOS (ongoing). Past drug history included: Anacin for pain; Claritin for seasonal allergies, notes: will be starting around the end of MAR2021 and beginning of APR2021; this is what she normally does. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset Mar2021, outcome "recovering", described as "elevated blood glucose"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient also takes a multivitamin for general health and takes the vitamin D supplement for bone density. Her headache seems to occur when she wakes up. She is due to take the next dose of BNT162B2 on 03Apr2021. The patient was scheduled to see her endocrinologist in about 2 to 3 weeks.  No follow-up attempts are possible. No further information is expected.
Muscle soreness and weakness that lasted 36 hours, fever, headache, fatigue, loss of appetite. Essentially had to be in bed the whole next day.
Pain on my legs is constant; Pain on the breast comes and goes; This is a spontaneous report from a non-contactable healthcare professional. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0158) via an unspecified route of administration in the left arm on 09Apr2021 at 09:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient did not receive any concomitant medication. 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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm, on unknown date in 2021, as a single dose for COVID-19 immunisation. On 14Apr2021 the patient experienced pain on the breast (pain on the breast comes and goes) and pain on her legs (pain on her legs was constant). No therapeutic measures were taken as a result of reported events. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain on the breast and pain on her legs was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Dose administered 24 hours post puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post puncture). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided. This case concerns a patient of unknown age and gender with no details on relevant medical history, who experienced Expired product administration after mRNA- 1273 Moderna vaccine. The event was associated with the first dose of mRNA- 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender's Comments: This case concerns a patient of unknown age and gender with no details on relevant medical history, who experienced Expired product administration after mRNA- 1273 Moderna vaccine. The event was associated with the first dose of mRNA- 1273 vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report
Systemic: Fainting / Unresponsive-Severe, Additional Details: After receiving vaccination during the waiting period, the patient got up to walk down the aisle and started feeling faint. He sat down then fainted. Pharmacist rushed to him. He was alert and oriented. Pulse was strong. He was alerted to the date, his name, and location.  Clinic nurse came and evaluated. We called an ambulance to be careful. His bp at that time was 100/58. He continued to be monitored by EMT on arrivial. He did indicate he has passed out after vaccination in the past
*Within first week of initial vaccine, onset of migraine became present and remained to this date without cease of pain.
child left deltoid reddened & swelling;no tenderness;rocephin;augmentin;motrin;swelling & redness in lt arm;induration;cellulitis secondary to inj;
pt recvd MMR vax as a child & currently exhibited a lack of response to mumps; no further details were provided;
Started in the evening with tingling in arms, hands, legs and feet.  Hand and feet were freezing cold and sweaty at same time. As the days progressed, I also experienced joint pain, muscle pain, muscle spasms, muscle weakness.  I was diagnosed by Dr. with damaged sensory nerves due to the flu vaccine.  This is practically 4 months later after the flu shot.  I am still suffering today.
1 wk p/recvd MMR/HIB, pt devel a high fever (sudden onset 104); pt then had generalized seizure lasting 10-15mins; postictal state 15'; seen in Er & said to have sl URI & OM; no tx of szs; no further szs;
4 to 5 days following vax, pt devel fever,diarrhea & generalized hives. MD initially stated that "Typhoid was the cause".Pt to allergist 08/14/97; allergy testing negative. Pt recv 2nd dose Typhoid vaccine w/no adverse rxn.
A few hours receiving my 4th vaccine shopped in the pharmacy for about 15 minutes then I went home. I started having joint pian and hurting all over. I thought it was normal and the pharmacist told me to expect Flu like symptoms. I took Tylenol when I got home, and I started having pain in the upper right side of my abdomen and in my lower back as well. I was also very hungry but nauseated so I was having issues eating. I have been drinking plenty of fluids and plenty of water just naturally (sugar free stuff only) because it is very hot this time of year. I was feeling so crappy so finally Monday I called my family Dr but they didn?t tell me anything because they didn?t know what was going.  My dr thought I had a uti and then she ran some test. Blood work CVC and a comprehensive metabolically panel These test looked fine with the exception of my liver so she said no more Tylenol . I am currently feeling really crappy
No adverse symptoms reported; patient was administered a dose of MMR II  (unknown lot/exp date) on 07/27/2016 and then was administered a dose of VARIVAX (unknown lot/exp date) on 08/10/2016; Information has been received from a registered nurse referring to a 12 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.     On 27-JUL-2016, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose detail, route, lot # and expiration date were unknown) for prophylaxis. On 10-AUG-2016, the patient was administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail, route, lot # and expiration date were unknown) for prophylaxis (inappropriate schedule of product administration). No adverse symptoms were reported.
booster doses given at a higher dose; immunocompromised patient not given a 3rd dose; no adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INCORRECT DOSE ADMINISTERED (booster doses given at a higher dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient not given a 3rd dose) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer, Immunocompromised and Multiple myeloma.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 INCORRECT DOSE ADMINISTERED (booster doses given at a higher dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient not given a 3rd dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (booster doses given at a higher dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (immunocompromised patient not given a 3rd dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            No concomitant drug were reported.   It was also reported that, patient had the 1st 2 doses followed by the 2 booster doses.   The patient was not on chemotherapy  No treatment drug were reported.
site was sore; Brain fog; Fatigue; rash on his hand; Extreme anxiety; Headache; This is a spontaneous report from a contactable consumer (patient). An adult male patient with age at vaccination of 33-years-old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EJ1685), via an unspecified route of administration, on 30Dec2020, at single dose for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient stated he got the shot on 30Dec2020. There was no allergic reaction however, the site was sore, sore for a couple of days from an unspecified date. The patient added that from an unspecified date, he did have kind of brain fog, fatigue, and headache for 3 days. Those symptoms subsided after 3 days. Additionally, 2 or 3 days ago in Jan2021, he started getting a rash on his hand and have also now been suffering from extreme anxiety, fatigue and brain fog. He informed that he went to the emergency room yesterday and he was prescribed some Xanax for the anxiety and a steroid for the rash. The patient was currently taking those now. He also did some basic lab testing yesterday, 13Jan2021, and all his labs were pretty much okay. The outcome of the events site was sore, and headache was recovered on an unspecified date; the outcome of event rash on his hand was unknown; while the outcome of the other remaining events was not recovered.
Within 60 seconds of receiving 6 month immunizations IE Dtap 3, Hep B 3, Hib 3, Prevnar 3 Pt developed pallor, airway compromise and numerous hives over abdomen, arms, legs. 10/26/06-records reviewed for DOS 10/02/06-Assessment by PCP in hospital: anaphylaxis. Evaluation by allergy requested. Keep overnight for observation.
PT STARTED FALLING OF A CHAIR , FAINTING. AMMONIA INHALANT ADMINISTERED AND PT FEELING FINE.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 74-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 10-Oct-2018, the patient was administered FLUAD (TIV) which underwent temperature excursion [route of administration: intramuscular, anatomical location: left deltoid, batch: 250802, expiry date: 30-Jun-2019 and dose: not reported] (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805508 was crossed linked to original case 201804863 due to same reporter.
Two weeks post-vaccination, patient reported feeling muscle spasms, blips, jolts, and twings in his lower extremities. Patient reported feeling tightness in his lower limbs, bilaterally but more tightness and pins/needles on the left side. Patient is being followed by his physician as well.
05/03/2014 Moderate other Pt had severe swelling, redness with heat. Had fever for 4-5 days. Arm stayed extremely sore.
sore arm; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation .  The patient medical history and  concomitant medications were not reported.  The patient experienced sore arm  on an unspecified date with outcome of unknown.  The reported event was considered non serious.  Information about lot/batch number has been requested.
Patient reported facial swelling & inflammation in face & extremities. Advised patient to take BENADRYL - followed up with patient the next morning 10/19 - patient symptoms improved.
Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Nausea-Mild, Additional Details: Patient felt light headed, nauseaous with abdominal cramping and little confusion. He felt exhausted. Called ambulance and paramedics monitored the patient's vitals and send him after he felt better
The patient is complaining about a sore in the are of injection site (from the upper right arm to her elbow) starting one day after her injection. She does not have any fever, but complained about occasional headaches. She has taken ibuprofen to relieve from her pain. She still complains about her sore as of today (09/28/2019). She visited a walk-in clinic on 09/28/2019 and was prescribed doxycycline and medrol tablets.
Patient have chest and arm pain after 3 days of the second dose of P-fizer, and later on August 4 presents the same chest pain and arm, treated at home with ibuprofen, and then august 7, present a very intense chest pain and arm, patient admitted to the Emergency hospital, where after intensive tests and chest X-ray doctor find mild inflammation of heart, and elevate enzymes.
Developed bilateral elbow pain without swelling or redness within a few weeks of receiving the anthrax vaccine during war in 1991.  The pain was severe enough that he could not fly (pt was a pilot).  He reports that the pain continues TO THE PRESENT - 17 years - with lifting objects.  Symptoms: Joint Pain, isolated.
Injection site to left deltoid noted to have moderate edema, erythema to a 3in by 5in area - marked with sharpie. Site hot and extremely tender to touch. Weakness noted to left arm. Pulse, motor, sensory intact distal to site. Cap refill < 3 sec. C/O weakness and fatigue. Site is local only. Denies any shortness of breath, difficulty breathing, nausea, vomiting, or diarrhea. Reports headache and triple vision in the morning.
Mom reports pt developed face paralysis (unknown side) 1 day after rcvng HPV. Was seen in ER 4/16/15 and dx Bell's Palsy with no noted correlation.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of PEDVAXHIB (lot # K015464 with expiration date 09-JUL-2017, lot # K026533 with expiration date 07-AUG-2017, lot # K025006 with expiration date 22-JUL-2017 and lot # L004740 with expiration date 16-NOV-2017; dose and route of administration were not reported). No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.