chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Greater than 2 months of pain at injection site/ painful lump in left deltoid; Vaccination site nodule; Arm infection; Information has been received from FDA (agency # 856906-1) on 04-FEB-2022  This spontaneous report was received from a healthcare professional and refers to a 16-year-old, no pregnant female patient. The patient's concurrent condition included allergy to penicillin, the patient developed hives. Concomitant therapy was not reported.  On 10-OCT-2019 at 10:30, the patient was vaccinated with a third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly in the left arm, lot # 1621926, expiration date 28-NOV-2021 (dose and indication were not reported). On the same date, the patient received third dose of influenza vaccine inact split 4v(FLUZONE QUADRIVALENT) intramuscularly in the left arm, lot # UT6681JA (dose, expiration date and indication were not reported).  On 10-OCT-2019, the patient experienced pain at injection site (vaccination site pain). The pain at injection site lasted greater than 2 months. On 04-NOV-20219, the patient with painful lump in the left deltoid was re-evaluated in the office and cephalexin was prescribed for 10 days. Next, the patient was reviewed again at the orthopedic office for a different concern, but the lump and painful shoulder brought the doctor attention. The pain continued and the orthopedist ordered magnetic resonance imaging (MRI) of the shoulder with a result of "small abnormality in the left deltoid presumably related to the patient's recent injection. The left humerus and left shoulder joint appear normal".  At the time of the report, the outcome of vaccination site pain was unknown.  Vaccination site pain was presumably related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and influenza vaccine inact split 4v(FLUZONE QUADRIVALENT).  Follow-up information has been received from a nurse manager on 22-FEB-2022.  The caller reported the patient's name, date of birth and the patient's address. She reported details about person who administered the vaccine, also the date and the site of vaccination was specified as left deltoid for previously mentioned third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and influenza vaccine inact split 4v(FLUZONE QUADRIVALENT). The caller said it was a privately funded vaccine. It was reported that patient sought medical attention 04-NOV-2019, and complained for pain and a nodule in her left arm and obtained previously described treatment with cephalexin, because the arm was treated as a possible infection. The caller stated the patient did not take any daily medications. It was reported that the patient was again at the office on 09-MAR-2020, and did not complain of continued pain at the injection site. The outcome of vaccination site nodule and localized infection was unknown.  Vaccination site nodule and localized infection were presumably related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and influenza vaccine inact split 4v (FLUZONE QUADRIVALENT).
Day following vaccination area was swollen and red, slightly itchy.  On Rt upper thigh had a large fading giant macule, 19.5x13 cm in size.
Severe headache, lethargic, nauseated, extreme tiredness started approximately 22 hours after 2nd vaccine was given and lasted for 4 days.
Side Effects: Pain at injection site; joint pain (fingers/hands); chills; fatigue; headache; nausea; dizziness (4 days) Fatigue, nausea  continued and extreme vertigo (day 4  for 4 more days).  Urgent care prescribed meclizine.  Unable to work for 9 days.
Fatigue - began about 14 hours after, lasted 12 hours Sleeplessness - began about 14 hours after, lasted 12 hours Headache - began about 14 hours after, lasted around 12 hours
Patient is a 65 year old left handed female who presents for right sided lateral rib and pleuritic pain. About 1 day after the pneumonia shot, she developed body aches and pains and she "hurt so bad" that she had to force herself to get up, felt feverish and cold. This improved spontaneously within 72 hours and she was able to go back to usual work and activities. The PNEUMOVAX site was unremarkable with no redness or tenderness. She states she had a similar reaction with the flu shot. About 1-1.5 week later: She started with left shoulder scapular muscular pain, worse with left shoulder movement "like you overused," 'so sore" and she could not lift her left arm >90 degrees. No redness, swelling or warmth. She had this for about one week. She states that it improved spontaneously and she shows me full ROM of the left shoulder. On Thursday, she had sudden sensation of right postero-lateral lung/rib pain, apparent with trunk movement and deep breathing. She could hardly sit or move. States that having had history of pleuritis and history of rib fracture, she states this is "like pleurisy." She denies cough, anterior chest pain, dyspnea, wheezing or hemoptysis. She denies ear pain, sore throat, nasal or sinus congestion. The patient denies fever, chills, sweats or rash. Friday and Saturday she had sharp pains. She was seen at clinic on Saturday. PERCOCET gave her nightmares (could not drive with that); ADVIL helped, as well as cool compresses. Since Sunday, generally better, just felt sore. Also tender to touch. No skin changes, redness or swelling.
Sever Uncontrollable Headache, Elevated and erratic blood pressure (186/101) for 7 days followed by Moderate- Bad headache with severe nausea and lightheadedness, erratic blood pressure,, still ongoing
1-25-21, at around 6  pm at work reported she had soreness and numbness to entire L arm and numbness at L side of jaw (upper and lower) and cannot chew with L side of jaw. Denied having any issues with R side, drooping of face, periorbital swelling, tongue/lip swelling, respiratory distressed, ALOC or altered vision, pain. She contacted PCP on 1-26-21 and informed her that side effects will subside gradually without further treatment.
Patient had exposure to COVID at home.  Tested although asymptomatic.   PCR + for COVID-19.
I have had severe diarrhea the past 4 days. Starting Friday morning around 2am, by the time it was 6 am, I have already gone 6 times. I have gone 25 times from Friday am-sat night. It calmed on Sunday and picked up Monday and this morning. I have been following the BRAT diet and have been drinking fluids. It doesn?t make sense why I?m still feeling this way. I also had a fever for three days,  throwing up Friday/Saturday, and have had headaches since Friday.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included omeprazole and lisinopril. On 24th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a week after receiving SHINGRIX, the patient experienced fatigue, dizziness, hoarseness and cough. On 24th September 2018, the patient experienced injection site pain and injected limb mobility decreased. On 25th September 2018, the patient experienced erythromacular rash and vesicular rash. On 26th September 2018, the patient experienced blister. The patient was treated with TYLENOL. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovering/resolving and the outcome of the erythromacular rash, fatigue, dizziness, hoarseness and cough were not recovered/not resolved and the outcome of the blister and vesicular rash were unknown. It was unknown if the reporter considered the injection site pain, injected limb mobility decreased, erythromacular rash, blister, vesicular rash, fatigue, dizziness, hoarseness and cough to be related to SHINGRIX. Additional details were provided as follows: The reporters were husband and wife. The patient was the wife and the husband was a physician. The patient current condition includes reflux. The patient stated that she received the 1st dose of SHINGRIX on Monday, 24th September 2018. The patient stated that her right arm was very sore on Monday and was so sore that she could not lift her right arm above her head on Monday and Tuesday. The patient had been taking TYLENOL for the soreness. The patient stated that on Tuesday that is 25th September 2018 she noticed red spots or bumps on her face and they grew in number throughout the day. The patient stated that she had approximately 12 on her face and when she woke up this morning there were more of them. The patient stated that by Wednesday on 26th September 2018 some of the bumps had blistered and the patient's husband (physician) stated that the red spots look like chickenpox. The patient also reported feeling fatigued and stated that the fatigue came and went. The patient reported that she experienced dizziness that came and went and goes. The patient stated that she had developed a cough and had some voice hoarseness. The patient stated that the hoarseness and cough could be related to her not taking her reflux medication regularly.
Patient arm red and inflamed. Patient said she was up all night Friday after the shot was given. She says she has pain and then it goes away. Sunday 10/12 she started taking Benadryl and says it is getting better.
DTAP, Comvax, Prevnar and IPV administered in Immunization Clinic at 09:00 on 5/15/01. Pt cried inconsolably for 6 hours afterward. Normal exam. Treated with 2 doses of Tylenol and didn't help. Finally fell asleep at 15:00.
Patient received Hepatitis A (1st dose) and HPV (1st dose). C/O arm pain - sat down. Felt dizzy. Passed out then noted to have rhythmic tonic clonic movement of upper arms followed by enuresis. Lasted approximately 1 minute.
Symptoms started the night of the shot and have persisted since. Didnt go to school at all last week.  Feeling Dizzy, nausea, fatigue and feels like she cannot stand up sometimes.  Appetite back to normal.  Occ Headaches, pounding with some ringing.  No h/o migraines. + Myalgias.  No abdominal pain.  No diarrhea.  No chest pain + Neck pain today .  Pallor.  Took some curcumin and felt better.  Pulse ox normal at home.   Tried to go to school today but could only make it through half a day.
has a horrible headache; Sore arm; fatigue; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller states she received the first dose of the Pfizer COVID vaccine on Saturday 30Jan2021. Caller states she had typical side effects to include a sore arm and fatigue on an unspecified date in 2021. Caller states today (01Feb2021) she has a horrible headache. Caller would like to know if she could take one of her regular medications that she takes when she gets a headache called Sumatriptan. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Patient stated that she had fever, chills achiness all over and muscle type pain in her throat when she tried to swallow, similar to a muscle spasm for a few days after.
Pt. passed out, diaphoretic and nauseated. Pt fell to floor hit left side of head.  Pt given water and snack then recovered went home with mother
Public health nurse received call from patient on 12/4/13 that still having pain at site where flu vaccine given (L deltoid). Shot was given on 11/6/13 at clinic. Area still sore to touch or with arm movements. Denies fever or swelling. Referred to PCP - patient saw on 12/4/13 and doctor thinks shot may have been given too high and went into joint or tendon. Recommend to take ibuprofen and follow-up if still bothering patient.
After receiving vaccine, patient complained with light headed and dizzy feeling.  She sat for an additional 15 minutes, drank water ate candy and put a cool towel on her head.  Called patient 3 hours after and she stated she felt better.
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 08-MAR-2021, the patient was vaccinated with one Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number R036177, which has been verified to be valid, the expiration date was reported and validated as 08-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2104USA001297:
I had a pretty major histamine reaction, similar to a bee sting. My arm was swollen, red, hot, and itchy from the injection site down to my elbow. It resolved after about 2 weeks, the worst of the symptoms were during the first week after my second dose on 1/26/21. I work in the biomedical research field (I was working on Pre-Clinical research on Covid at the time). I have photos if needed.
day after vax pt said she had injection site was red, swollen and painful pt had a fever rash on her chest  pt got headaches and chills
Pt vaccinated with DTP/OPV developed limp, unconscious, pale, clammy, blue around mouth & eyes, heart murmur found on exam.
Day after, swollen eyes. 7 days later, eyebrows of both eyes fell out.
This case was reported by a physician via call center representative and described the occurrence of fever blister in a 65-year-old female patient who received SHINGRIX (batch number B57NG, expiry date 16th April 2021) and (batch number EY93J, expiry date 13th April 2021) for prophylaxis. The patient's past medical history included dental operation (at the same time of the vaccination). On 30th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the dose was an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown. It was unknown if the reporter considered the fever blister to be related to SHINGRIX. Additional details were reported as follows: The patient has never had fever blisters before. The patient experienced the listed side effects after dose of SHINGRIX.
SORENESS/INTENSE PAIN IN LEFT ARM AT INJECTION SITE WHICH INTENSIFIES WITH MOTION Narrative:
Low grade fever, body aches, stomach ache, and feeling lethargic and out-of-it.
There were no signs or symptoms. Patient received his last Covid19 vaccine on 5/13/21. He passed away on 06/15/2021. The diagnosis on the autopsy report shows that he died from Dilated Cardiomyopathy. There was no evidence of trauma and a clean toxicity report. He has no previous diagnosed health problems.
My left eye started experiencing a dull throbbing and then a white light moving up and down in my periphery vision. This is still occurring since December. I spoke with my ophthalmologist, and she also had the same side effects from the Pfizer vaccine, impacting the eye on the same side as where she received her vaccine also.
Booster given greater than 12 hours after vial was punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to Bactrim), Coronary artery disease, Low back pain, AFib, Hypertension and Hyperlipidaemia. Concomitant products included  Atorvastatin; Eliquis; Flomex [Fluorometholone]; Prozol [Metronidazole]; Potassium for an unknown indication.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured). On 13-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Booster given greater than 12 hours after vial was punctured) to be not related.    No treatment information was provided.    This case was linked to MOD-2021-416295, MOD-2021-435638 (Patient Link).
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 13 years old female patient who experienced typical body aches and low grade fever, while she received vaccine FLUBLOK QIV at the inappropriate age. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. Reported as no other vaccine was give. On 15-Oct-2018, the patient received a 0.5 ml dose of suspect Influenza Quadrivalent Recombinant Vaccine, lot QFAA1820 expiry date: 30-Jun-2019 via intramuscular route in left deltoid. On an unknown date (reported as last night), the patient developed a non-serious typical body aches (pain) following the administration of Influenza Quadrivalent Recombinant Vaccine. On an unknown date (reported as last night), the patient developed a non-serious low grade fever (pyrexia) following the administration of Influenza Quadrivalent Recombinant Vaccine. It was also a case of actual medication error due to inappropriate age at vaccine administration. (Other relevant tests included No lab data.) Final diagnosis was low grade fever and body aches. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovering. 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. List of documents held by sender: none.
Significant other reported that patient started feeling poorly after the booster on 11/12.  On 11/13 she was last seen at 1300.  Found unresponsive and asystolic at 1650.  No response to CPR, no shockable rhythm.  No response to epinephrine.  ED provider noted that ET tube was placed with large amounts of hemorrhage into the tube.  TOD 1749.  Autopsy revealed acute hemorrhagic pulmonary edema as the cause of death.  No evidence of adverse vaccine reaction after 1st 2 doses.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Bananas" (unspecified if ongoing), notes: Known allergies: Bananas, Other medical history: None. Concomitant medication(s) included: PROGESTERONE; ESTROGEN; ESTRADIOL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19 Includes Paxlovid from 07Jul2022 to 11Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After 15 min, patient began complaining of left arm itching and swelling as well as feeling dizzy.  Pt was monitored BP-134-160 Systolic and  diastolic in the mid 80s .pulse -64. Pt. was given diphenhydramine 25 mg oral as well as water. No improvement but pt. did not experience facial swelling ,tongue swelling or chest pain. Pt was picked up by husband to take home.     I spoke with pt. the next day and she said she is feeling better just a bit itchy and tired .
Seizures; Autism; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a male patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced seizure (serious criteria GSK medically significant) and autism (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure and autism were unknown.   It was unknown if the reporter considered the seizure and autism to be related to DTP vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter was patient's mother. The reporter trying to informed how the DTP vaccine injured every member of her family. The patient experienced autism and seizure. The follow up was not required. This is 1 of the 4 linked cases reported by the same reporter.
the HIB portion of the powder that gets reconstituted was not given, but only the d-tap portion of the Pentacel/No AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received only DTAP (DIPHTHERIA, TETANUS and ACELLULAR PERTUSSIS) portion of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot UJ7AAA, expiry date- 19-sep-2020 third dose via unknown route in right thigh on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V) for Immunisation.  It was a case of actual medication error due to inappropriate reconstitution technique.  The HIB portion of the powder that gets reconstituted was not given, but only the DTAP portion of the Pentacel.  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.