chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt very light headed like I could hardly think; Low grade fever; Fatigue; Body aches; Swelling lymph nodes; Joint ache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (it is reported lot number looks like: EL3249), via an unspecified route of administration on an unspecified date at single dose on left shoulder for covid-19 immunisation. Medical history included ongoing hypertension and ongoing asthma. Concomitant medications included hydrochlorothiazide, simvastatin and budesonide/ formoterol fumarate (SYMBICORT) for asthma. Initially and hour after the shot, patient felt very light-headed, like patient could hardly think.  And then, evening of the day, she had a low-grade fever but just didn't take anything because it wasn't that bad and then starting the next day patient had fatigue and body ache. Patient had to take paracetamol (TYLENOL) and Ibuprofen for 6 days every day in the evening and now.  Patient notice in the evening a lump over left collar bone where the swelling lymph nodes were and joint aches too. Treatment received for light-headed, a low-grade fever, fatigue and body ache. Couple months before, patient had blood test and it was normal. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
This spontaneous report as received from a registered nurse refers to 4 patients of unknown demographics. On an unknown date the patient was vaccinated with GARDASIL and VARIVAX (Merck) (dose and route unspecified). The nurse reported that since an unknown date the 4 patient have ben administered both GARDASIL and VARIVAX (Merck) which reached a temperature outside the prescribing information. No adverse effects were reported. Additional information has been requested.
Achy, nauseous, headache, sore throat, rash (solid red area) at site of injection that appears to be spreading.
Imm  Friday- Saturday had fever 102, headache, swelling at MENACTRA injection site with pain shoulder to elbow, fatigue. Fever resolved Monday. Headache resolved Tuesday.
Second shot kicked my butt for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for an unknown indication.   Previously administered products included Shingles vaccine (patient received 1st dose on an unknown date and did not experience anything).   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient experienced nothing with first shot but the second shot had kicked his/her butt for 3 days.
the patient reeived 1 ml dose of IPOL instead 0.5 ml, no AE; Initial information received on 07-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a four years old female patient who received 1 ml fourth dose of IPV (VERO) [IPOL] instead 0.5 ml (lot: P1F491M, expiry date: 30-Jun-2020) via an intramuscular route in the right vastus lateralis on 07-May-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) on 07-May-2020 for prophylactic vaccination.  It was a case of overdose.  At the time of reporting, adverse event was not 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.
Post Phizer Booster.  Left eye became infected.  Treated with Erythormycin ointment and oral antibiotic Cephalexin along with increased eye hygiene.
After receiving the shot around 11:30am from my local CVS pharmacy, hours later (around 5pm) I began to experience chest pain. Due to the holiday coming up I went to the ER on 11/24 before Thanksgiving. They found me to have 2 abnormal EKGs, but blood test showed fine. It is currently December 5, and I am still experiencing chest pain.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. 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 medication was provided No treatment information was provided; Sender's Comments: This is a case of product exposure during pregnancy 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Injection site left arm, Slight heaviness in arm following injection. The day after injection soreness in left arm in morning with soreness increasing thru the day. Developed slightly raised red circle surrounding the injection site, Approximately 2 inch in diameter.
Numbness and tingling to nose, throat, face starting 10 min after injection and lasting two days past and ongoing.  Leading to entire left sided numbness and tingling in leg and itching.
2 days p/vax w/DTP, pt devel spells w/rolling u p of eyeballs for few secs assoc w/head nods or drops lasting 1-2mins; pt seen by MD 6AUG91 & routine sz work up done; poss infantile spasms; on meds therapy & doing OK;
The day after receiving a tetanus vaccination, I acquired a headache that lasted for 2 days.  I was also nauseous, chilled, achy, and sleepy.  The site of injection became streaked and red, and also itched.  This happened a few days after the shot was administered and lasted for several days more.
Systemic: Allergic: Anaphylaxis-Severe, Additional Details: Patient develop reaction 1-2 days after recieving the shot. patient was admitted into ER. She called the pharmacy on 4/22/22 to report incident
After becoming fully vaccinated in January 2021, patient was admitted to Hospital after clinically worsening when 4 days prior tested positive for COVID-19 at an urgent care thinking it was sinus infection
Injection site papule; Chills; Flu like symptoms; Headache; Lethargy; Injection site pain; Device issue; Inappropriate dose of drug administered; On 22May2021, patient received 1st dose COVID-19 Vaccine/On 08Jun2021, patient received 2nd dose COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4182651-00 (regulatory authority).  A 36 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Jun2021 (Lot number: EW0178) at the age of 36 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous since 18Mar2021 (ongoing) (Batch/Lot number: unknown) at 40 mg for hidradenitis. Relevant medical history included: "Trigeminal neuralgia" (unspecified if ongoing); "severe itching" (unspecified if ongoing); "impaired vision" (unspecified if ongoing). Concomitant medication(s) included: DIAMOX SANKEN [ACETAZOLAMIDE]; TOPAMAX MIGRAENE taken for trigeminal neuralgia; GABAPENTIN taken for trigeminal neuralgia; TEGRETOL CR taken for trigeminal neuralgia; FOLIC ACID ALMUS; METRONIDAZOLE; JUNEL FE taken for contraception; LAMICTAL taken for trigeminal neuralgia. Past drug history included: Dilaudid, reaction(s): "Known allergy:Dilaudid"; Tetracyclines, reaction(s): "Known allergy: Tetracycline". Vaccination history included: Bnt162b2 (Dose:1, single, Lot number: EW0178.), administration date: 22May2021, when the patient was 36 years old, for COVID-19 Immunization.The following information was reported: INJECTION SITE PAPULE (non-serious) with onset 30Nov2021, outcome "recovering", described as "Injection site papule"; INJECTION SITE PAIN (non-serious) with onset 18Mar2021, outcome "recovered" (30Nov2021), described as "Injection site pain"; INFLUENZA LIKE ILLNESS (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Flu like symptoms"; HEADACHE (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Headache"; LETHARGY (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Lethargy"; DEVICE ISSUE (non-serious) with onset 2021, outcome "unknown", described as "Device issue"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 2021, outcome "unknown", described as "Inappropriate dose of drug administered"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "On 22May2021, patient received 1st dose COVID-19 Vaccine/On 08Jun2021, patient received 2nd dose COVID-19 Vaccine"; CHILLS (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "Chills". The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of injection site papule, injection site pain, influenza like illness, headache, lethargy, chills.  No follow-up attempts are possible. No further information is expected.
Arm, pinky and thumb went numb, red, swollen, pain. Trouble breathing
Next day patient awoke to a wet arm that was swollen & oozed pus. There was a square on arm where Bandage was removed. URGent Care provided an Antibiotic cream stating infection in the arm. UrGent care told him likely due to vaccine being administered too low.
she tested positive for COVID; PCR test that was positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date of COVID 19 vaccine: 31Mar2021), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included thyroid taken out. Concomitant medication included levothyroxine sodium (SYNTHROID) from Sep2019 and ongoing for thyroid taken out. On 05Jan2021, she tested positive for COVID. Her workplace told her to get the 2nd vaccine, she was due for the second dose on 11Jan2021, she needed to wait 10 days after the onset of symptoms to get it. Then, the health department called her and told her that with the Pfizer vaccine the caller needed to wait 90 days to get the second dose. She was scheduled this upcoming Friday to get the second dose so she was trying to figure out what to do. The reporter didn't have a prescribing doctor. She got the vaccine at work. She began to have Sars-Cov-2 symptoms 01Jan2021. Then on 02Jan2021, she had a rapid test that was negative. So on 05Jan2021 she had a PCR test that was positive. Her department was prioritized to get the vaccine. The outcome of events was unknown.
2:40PM 'TONGUE FEELS NUMB AND LIGHTHEADED'.  DENIES ANY SOB, DYSPNEA OR DIFFICULTY SWALLOWING. STATES SHE CAN'T TAKE BENADRYL. SPEECH CLEAR, A/O, NO CYANOSIS, W/D, RESP REG WITH EASE. NO ACUTE DISTRESS. SIPS OF WATER AND COMFORT GIVEN. 3PM 'FEELS BETTER NOW'. 3-5-21 3:30PM 'FEELS BETTER TODAY - LEGS ACHE SOME'.
wheezing, labored breathing, facial swelling i.e. rt periorbital & cheek;to Er via ambulance;given DPH in ER-to cont 10days ATB in ER x 1;no problems since
Sometime after the vax, the pt developed a rash that self resolved. The pt reportedly recovered from this experience.
she developed a pretty strong pain in her right ear cartilage; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location: right arm) on 19Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient stated that she had the vaccine in the right arm and about a day and a half later she developed a pretty strong pain in her right ear cartilage. Patient mentioned that it started at 4:30 yesterday (21Jan2021). It was really pretty strong and this morning (22Jan2021) it was about 80% better. Patient asked if this is a side effect that people reported. After verbal response was provided, patient asked if this was just a coincidence. Outcome of the event was recovering.  Information on lot/batch number has been requested.
SWOLLEN SINUSES BOTH SIDES WERE AFFECTED; SWOLLEN LYMPH NODE IN THE CLAVICLE ON THE RIGHT SIDE BETWEEN THE SHOULDER AND NECK; RINGING IN EARS, HIGH PITCHED, SOUNDS LIKE LETTING OFF STEAM ON A LOW LIGHT KETTLE; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 135 pounds, and height was 64 inches. The patient's concurrent conditions included: penicillin allergy, non alcohol user, and non-smoker, and other pre-existing medical conditions included: the patient was taking vitamins occasionally. The patient was having allergies to namycin and mycin's. The patient did not have any drug abuse or illicit drug usage. The patient experienced drug allergy when treated with prednisone for drug use of unknown indication, drug allergy when treated with levofloxacin, and prochlorperazine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: 18-AUG-2021) dose was not reported, administered on 05-AUG-2021 14:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-AUG-2021, the patient experienced swollen sinuses both sides were affected. On 05-AUG-2021, the patient experienced swollen lymph node in the clavicle on the right side between the shoulder and neck. On 05-AUG-2021, the patient experienced ringing in ears, high pitched, sounds like letting off steam on a low light kettle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen sinuses both sides were affected on 07-AUG-2021, and had not recovered from ringing in ears, high pitched, sounds like letting off steam on a low light kettle, and swollen lymph node in the clavicle on the right side between the shoulder and neck. This report was non-serious.
Initial unsolicited report received from pharmacist on 08 Jun 2018. This case involves a patient (age and gender not reported) who was vaccinated with expired dose of MENACTRA (expiration date: April, batch number, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used. No adverse event 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. List of documents held by sender: none.
When they gave me the shot 30 seconds in I started to taste metallic, could not lift left arm, very painful.
Information has been received from a health professional concerning an 83 year old white female with allergies to ofloxacin (Floxin), diltiazem hydrochloride (Cardizam), and horse serum who on Dec 22 2004 was vaccinated SC in her left deltoid with first dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). On Dec 24 2004 the patient presented to the office with erythema at medial part of her left arm, 3 inches diameter. The patient was prescribed azithromycin (Z Pak) and treated with warm compresses. Subsequently, the patient recovered. Additional information is not expected.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concurrent medical conditions included Pregnancy since August 2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 04-Feb-2021 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in July 2020 and the estimated date of delivery was on an unknown date. On 04-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 04-Feb-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Pregnancy test: positive (Positive) positive. On 03-Dec-2020, Ultrasound abdomen: normal (normal) normal. In January 2021, Glucose tolerance test: normal (normal) Normal.     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.   Patient estimated due date is on an unknown date in APR 2021.  No information was provided on concomitant medication.  No treatment information was provided.
Patient experienced sudden and severe sweating over every inch of his body, described as if he was leaking out of every pore all at once. He got dizzy as if blood was rushing to head and attempted to make it into his bedroom where he knew he could safely collapse on the bed if needed. He reported seeing the room wobble as he was stumbling to his bed. He barely caught the edge of it before falling onto it. After several minutes, the sweating and wooziness subsided. When asked, he said he had never experienced any of those adverse effects before.
This spontaneous report as received from a nurse refers a patient of unknown age. On an unknown date, patient was vaccinated with LIQUID PEDVAXHIB (lot #, expiry date unknown) exposed to 32F for 33 days. There was no product quality complaint. No adverse effects were reported. Outcome of the reported event was unknown. This case related to 1409USA001456 (same reporter link). Additional information has been requested.
pt seen in clinic 12APR96;mom states pt had sz p/last vaccine given last year;
Patient inadvertently received a Pfizer COVID 19 vaccine as a single dose booster and after administering the vaccine we realized that the patient had received Moderna as a primary series
(L) upper arm swollen, erythematous w/streaking-> (L) chest.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in an unspecified number of adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patients received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced injection site pain and injection site swelling. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The reporter mentioned on phone call that, another pharmacist asked about pain incidence associated with a dose of SHINGRIX. The reporter mentioned that, several people said the vaccine really hurt and the pain did not go away until a few days after the vaccination, some advised up to a week. The reporter did not have details as to who the patients were and who experienced the pain at injection site and could not provide any more details. The sales representative attempted to get more information but he did not have anything to add. The reporter was advised, in the future he needed to get specific information and provide the details to GlaxoSmithKline (GSK), for which the reporter said he would. It was stated that, all patients were over 50 years of age and some were men and some were women. The reporter did not agree to follow up.
headache, exhaustion, nausea, elevated blood pressure.  Received Naproxen and Zofran from primary care provider for symptoms.