chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious initial spontaneous case, was received on 08-Sep-2017 from nurse, concerning a 36-year-old, adult pregnant female patient. The patient had no medical history. The patient had no maternal and paternal history relevant to pregnancy. The patient had past 4 pregnancies and had 3 children. The patient had no still birth or miscarriage, birth defect or congenital anomaly and spontaneous abortion occurred in any previous pregnancy. The patient's concomitant medication included EFFEXOR for an unknown indication. The patient did not use any contraceptive methods. The patient's LMP (last menstrual period) date was 26-Apr-2017, gestation period and weeks at exposure were 19 weeks. On 08-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, batch number: XF30506 (as reported), expiry date: 26-Jun-2018), route of administration: intramuscular and anatomical location: not reported). On an unspecified date, the vaccine was exposed to temperatures up to 70-degree F, which was considered as incorrect product storage. The pregnant patient was administered with vaccine that exposed to temperatures up to 70F instead of storing at 36-46-degree F was considered as drug administration error and vaccine exposure during pregnancy. It was reported that, no adverse event occurred after the vaccination in the patient and foetus. The patient's estimated date of delivery was 18-Jan-2018. The outcome was a live infant with no complications. The reporter assessed the report as non-serious. Follow-up report received on 16-Apr-2018: The patient's estimated date of delivery was confirmed as 18-Jan-2018. The outcome was a live infant with no complications. Upon internal review, no adverse event which no longer exists and added special case scenario with no AE in general tab. Amended narrative accordingly.
MOM JUST REPORTED SEIZURE TO US ON 1/21/2021 MOM DID NOT CALL AFTER PT HAD SEIZURE
7 days after getting vaccine, I became short of breath & heart pounded hard whenever I exerted myself (even walking up stairs). It did go away in 3 to 4 weeks.
A non-serious spontaneous report of influenza has been received from a health professional concerning a five-year-old female, subsequent to FLUMIST. The patient has no significant medical history and does not have any concomitant medications. The patient did not receive any other vaccination on the day that FLUMIST was administered. The patient received FLUMIST on 15-Oct-2010. The patient tested positive for influenza on 28-Feb-2011, 136 days after receiving FLUMIST. The outcome was resolved. Additional information was received on 09-May-2011 and incorporated into the narrative: Reporter information, outcome of the event, medical history and concomitant medication.
Patient's husband came in stated that patient was experiencing muscle pain and hives around the area of injection. Spoke with employee at Dr's office who instructed the patient to use Benadryl and a warm compress and if symptoms do not go away within 24 hours to call their office to follow up.  I gave this information to the patient's husband who acknowledged his understanding of what to do.
dizzy; acid reflux; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), PYREXIA (fever) and NAUSEA (nausea) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizzy), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 98.9 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
red at the injection site; hot at the injection site; hard at the injection site; swelling at the injection site; swollen arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 44T97, expiry date 18th September 2023) for prophylaxis.   On 26th September 2022, the patient received the 1st dose of Shingrix. In September 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site induration, injection site swelling and swelling arm. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site induration, injection site swelling and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site induration, injection site swelling and swelling arm to be related to Shingrix.  Additional Information: GSK Receipt Date: 03-OCT-2022 and 04-OCT-2022 Reporter's Comment: The reporter reported that, a patient who received a Shingrix vaccine last week and was now experiencing a red, hot, hard swelling at the injection site. The symptoms were still present.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
A non-serious, spontaneous report of rash was received from a pharmacist/consumer concerning a 37 year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 24-Oct-2008. On 24-Oct-2008, five minutes after administration, a rash appeared on the neck which spread over the body. The patient took diphenhydramine and now the rash only appears in a "hot shower".
Patient experience a lot of bleeding and pain after the shot was administered. The next day their arm started  having severe bruises and the patient reported it to the pharmacist on 11/10/2020, patient will see doctor if symptoms become more severe.
Caller is a Merck employee who reports one of her offices told her that there was an expired dose of VAQTA that was given to a patient. They refused to provide any further information to the employee and said they would report the AE on their own. No; No other AE/no PQC.; This spontaneous report was received from a company Representative and referred to a patient of unspecified age (reported as child) and gender.  The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) administered for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided)(Expired product administered). No other adverse events were reported. They wanted to know immediately whether the child would need to be revaccinated. The office manager was not satisfied with the instruction to call for revaccination information.
On provider's note, pt had SHINGRIX vaccine 5/25/18. Pt was home when he got up to urinate and while returning to bed he felt a "massive cold shot through my entire body". Pt verbalized "I felt like I dive into a very cold pool". This was accompanied by his heart racing and dyspnea, resolved after lying in bed for about 15 mins. This had never happened before and has not happened since. He feels fine now.
Patient was given 2nd Hep A 5 months early.  Will need another Hep A 4/22/11
This spontaneous report as received from a Licensed Vocational Nurse regarding an 1 patient of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 09-SEP-2015, the patient was vaccinated with improperly stored dose of (Merck) PROQUAD lot# L005297 and expiry date: 17-AUG-2016. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Headache , nausea, extremely fatigue, Back and neck swelled up.. Lymph Nodes in neck and back  lasted about a week and a half
Moderna COVID-19 Vaccine EUA I started running a low grade fever about 24 hours after my 2nd Moderna dose. This was managed with Tylenol and has subsided. About 36 hours after the injection, the lymph nodes under the arm on the side where I was injected have swollen up to be about the size of one half of a baseball.
This medically confirmed spontaneous report (initial receipt 06-OCT-2014) concerns a male patient. On 06-OCT-2014, the patient was administered excursioned AFLURIA (batch number: T50507). AFLURIA pre-filled syringe was kept at 57 degrees Fahrenheit for 48 hours and was administered to the patient. Outcome was not reported. Reporter's comments: The reporter believed that the patient was fine.
Large circular reaction at site of seasonal flu vaccine injection (left thigh).  Area about 3" diameter.  Red, warm to touch, slightly raised and firm.  Similar reaction to last year's flu vaccine, but we forgot about it until this reaction.
Pt recvd vax 5AUG91 11AM then was playful 1 hr, then vomited, grayish color, 10% 02 SAT, listless, AP 135; APAP given; t101.3; r/o reaction to HIB/early meningitis;
Within a couple of hours of receiving the vaccine I had a sore arm and was tired plus my body was aching I took a nap and after waking up I took an ADVIL and felt better but later in the day I began to feel bad again and a pain occurred on my sides or hip area and in my lower back area, it felt like I had pulled a nerve and it radiated pain through my hips. On Monday I called my doctor and after a discussion about taking more ADVIL and when it did not work I was prescribed a prescription of methylprednisolone. I am slowly recovering but the pain in my hips are still bothering me, I am unable to sleep well and I have difficulty getting out of a chair or bed. This is a condition have never had before.
Headache, body ache, fever, chills, fatigue, pain in lymph nodes, sore arm. Symptoms were moderate for first 24 hours, then mild next 24 hours, and gone by day 3.
Information has been received from a physician concerning a 15 month old female with no pertinent medical history or drug allergies, who " a couple of weeks ago" (approximately in December 2007) was vaccinated with a first 0.5 mL. subcutaneous dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. On an unspecified date "a week after the shot" (approximately in December 2007), the patient developed 3 days of high fever and bouts of irritability that was described by the physician as "2 hours of screaming." It was indicated that the patient sought unspecified medical attention. No laboratory or diagnostic studies were performed. On an unspecified date, the patient recovered. A product quality complaint was not reported. Additional information has been requested.
Big pink area where the injection was and it is still there and it is itchy; Big pink area where the injection was and it is still there and it is itchy; She just had her booster on Friday; she has big patches; Anxious; She is freaking out; Had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A 67-year-old female patient received bnt162b2 (COMIRNATY), administration date 12Nov2021 (Lot number: 3302680) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Lot Number: EL9269), administration date: 16Feb2021, when the patient was 67 years old, for Covid-19 Immunization; Bnt162b2 (2nd dose, bad flare up of her Psoriasis /psoriasis went nuts and it has never calmed down, NOT RECOVERED/NOT RESOLVED, Lot Number: EN6205), administration date: 09Mar2021, when the patient was 67 years old, for Covid-19 Immunization, reaction(s): "bad flare up of her Psoriasis", "feeling like you have the flu", "Breast Cancer". The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "she has big patches"; ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 13Nov2021, outcome "not recovered" and all described as "Big pink area where the injection was and it is still there and it is itchy"; ANXIETY (non-serious) with onset 2021, outcome "unknown", described as "Anxious"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "She is freaking out"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Had a sore arm"; IMMUNISATION (non-serious) with onset 12Nov2021, outcome "unknown", described as "She just had her booster on Friday". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: No product information was obtained or provided for the mentioned Advil.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot# M037770 with expiration date on 01-JUN-2019; and lot # M017983 with expiration date on 30-MAY-2018) (formulation, strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 2 and 8 Celsius degrees (also reported as 1.8 Celsius degrees) for 48 minutes, and a previous temperature excursion between 9 and 25 Celsius degrees for 320 minutes; a digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of several reports received from the same reporter. Additional information has been requested.
"Very" sore arm; could hardly move it; severe pain, numbness. Took extra strength TYLENOL for the pain and ice packs on arm.
A consumer report has been received. The report concerns a 2 year old male consumer, height: 39.0 inches; weight: 32.0 pounds. No medical history and no concomitant medication were provided. The patient had been receiving FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, once/single administration. FLUMIST QUADRIVALENT (intranasal) started on 24-Oct-2014. It was reported that patient started having seizure like activity, MRIs and EEG all came back normal. She reported however that it had progressed more into behavioral problems that include hand movements, staring spells, ticks, extreme activity and extreme anxiety. She reported that his behavioral issues were more than a toddler, he had vocal and motor ticks all after the FLUMIST. She believed that the medication may have triggered this reaction in him. She stated her son was put on Oxcarbazepine 9 ml per day for seizures but now is being weaned off the medication and currently on 2 ml daily. She reported that was no longer classified as seizures but diagnosed as abnormal behavioral episodes, stereotypy. She reported he also had seasonal allergies now. The outcome of the event of seizure like activity, staring spells, abnormal behavioral episodes-stereotypy, seasonal allergies, motor ticks/hand movements, vocal ticks, extreme activity and extreme anxiety was unknown. The Az physician upgraded the event seizure like activity, staring spells and abnormal behavioral episodes, stereotypy to serious due to important medical event. The Az physician identified the events motor ticks/hand movements, vocal ticks, extreme activity and extreme anxiety from the narrative of the source document and assessed them to be non-serious. The reporter assessed the event seasonal allergies to be non-serious.
Patient was given first COVID-19 vaccine, Janssen J&J. Approximately 1-2 minutes after administration patient fainted. Patient denies fainting episode previously with any vaccine. Patient fell and hit her head as she passed out. Emergency services were called in and the patient was evaluated for appropriate treatment of cut in head as well as low blood pressure.
presented 23JAN93 w/bulging (tented); fontanelle, fever 102, LP clear fluid, low WBC, few RBC, neg stain & culture; also devel otitis;
3 mo, 1-2 days after Hib vaccine, Fever. P PO intake dropped from 5-6 oz Q8 to 1-2oz Q2-4 hours with turning face away when offered bottle. Pt still requires significant coaxing to eat 3 months later. Pt taken still only 2-4 ox Q 3-4 and some days only 1oz Q3hrs, Now on Axid Prevacid, but with GERD sx prior to vaccine.
Tested positive 12/23/2021. Became asymptomatic 12/25/2021.
Symptom onset 7-20-2021. Symptoms included cough, shortness of breath and fatigue. Patient was hospitalized from 7-22-21 through 7-26-2021 at Hospital.
Anxious, Shaking, Jittery ,fast heart beat. ill at ease.
Administered 0.3ml dose of undiluted vaccine. Mild symptom of chills approximately 24 hours after administration treated with ibuprofen.
Bad headache; muscle aches; shivering / shivers; 99.9 fever; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced headache, muscle pain, shivering and fever. On an unknown date, the outcome of the headache, muscle pain, shivering and fever were unknown.   It was unknown if the reporter considered the headache, muscle pain, shivering and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix dose yesterday at 9:30 am. The patient experienced bad headache and muscle aches, shivering, fever temperature 99.9 degree F, shivers.
Dizziness and Anxiety, felt like she was going to pass out. Never lost consciousness, Vital Signs stable
discovered 4/6/2021 that she was 16 years of age  this was missed at registration and at administration and at checkout after observation
This case was reported by a health care professional and described the occurrence of autism in a 1 yr old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. On 30Mar01, when the subject was two months old , he received the first dose of Infanrix (lot number 991A2). On 29May01, at four months of age, the subject received the 2nd dose of Infanrix (lot number 982A2). On 26Jul01, when the subject was six months old, he received the third dose of Infanrix (lot number 501A2). On an unspecified date in 2002, at 1 yr of age and six months after the third dose of Infanrix, the subject developed autism. He received a 4th dose of Infanrix (lot number 538A2) on 29April2002. The outcome of the autism was unresolved. Autism was assessed as medically serious by manf (OMIC).
Pt awoke the next morning, post vax, with right arm swollen from his shoulder to his elbow. His arm was red and hot to touch. The child was seen at Urgent Care and treated with Cephalexin and hydroxyzine. On Monday, the child's arm was still swollen.
Information has been received from a registered nurse concerning a 3-year-old patient who was vaccinated with a 0.5 mL dose of VARIVAX (Oka/Merck).  The RN reported that on approximately 23-MAY-2005, the patient developed a mild case of breakthrough chickenpox characterized by about 20 lesions. Unspecified medical attention was sought. Subsequently, the patient recovered from mild breakthrough chickenpox.  Follow-up info from the RN indicated that she was unable to remember details regarding this particular patient.  Additional information is not expected.  This is in follow-up to report(s) previously submitted on 5/12/2006.  Information has been received from a registered nurse concerning a 16-month-old female who on the morning of 19-NOV-2004 was vaccinated SC in the right arm with the first 0.5 mL dose of VARIVAX (Oka/Merck) (Lot #647717/0192P).  The RN reported that on 01-APR-2005 (also reported as approximately 23-MAY-2005), the patient developed a mild case of breakthrough chickenpox characterized by about 20 lesions.  The patient had a fever of 100.7F which lasted 1 1/2 days.  Unspecified medical attention was sought.  There were no other complications noted.  Subsequently, the patient recovered from mild breakthrough chickenpox.  Additional information is not expected.
Fever, Few small red elevated dots on face and trunk no blister no vomiting, no cough, started 10 days after varivax given.
Throat closed 30 minutes after vaccine on drive home, took antihistamines   I chose not to go to the hospital, had hives as well. 2 more doses of antihistamines stopped it.
13cm x 13cm, swollen over left thigh where DTaP and IPV were administered. Augmentin, cold compress over area.
Fever and muscle aches, from 12 hours to 48 hours after vaccine. 2 inch welt on left arm at site of injection, from 10 hours to 4 days after vaccine.
anaphylactic shock; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC SHOCK (medically significant), outcome "unknown", described as "anaphylactic shock".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This initial spontaneous report was received from a physician via a company field representative and refers to a female patient "around 60 years old". Medical history, concurrent conditions and concomitant medications were unknown by the reporter. On an unknown date, the patient received ZOSTAVAX (route and lot # not provided). In approximately May 2017 the patient had some sort of breakout/rash on her arm between the elbow and wrist. The physician reported that "it's been about two weeks and it is starting to clear up". Causality assessment was not provided. Additional information has been requested.
pt recv vax;arm swelled from shoulder to hand;hand blanched,numb and discolored;