chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2014, who stated that it would take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she might send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age reported as 5, units not reported) of unknown gender. On 29-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
face started tingling; face started swelling; lip was swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face started swelling), LIP SWELLING (lip was swollen) and PARAESTHESIA (face started tingling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced SWELLING FACE (face started swelling) and LIP SWELLING (lip was swollen). On 09-Feb-2021, the patient experienced PARAESTHESIA (face started tingling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Tingling, at an unspecified dose and frequency. At the time of the report, SWELLING FACE (face started swelling), LIP SWELLING (lip was swollen) and PARAESTHESIA (face started tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Patient reported that she experienced face tingling on 09-FEB-2021 and 26-FEB-2021.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received on 20-JUL-2021 and reporter information was updated
14 year old patient was given an expired TENIVAC, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via agency (Reference number- 00592731) and transmitted to Sanofi on 07-May-2021.  This case involves a 14 year old male patient who was administered 0.5 ml dose of expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot number: U6265AA; expiry date: 19-APR-2021) via unknown route in the left deltoid for prophylactic vaccination on 07-MAY-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to expired vaccine used (latency same day).  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.
Severe pain in left arm over 2 week; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 03May2021 12:00 (at the age of 60-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included meloxicam, pravastatin and cetirizine all taken for an unspecified indication, start and stop date were not reported. The patient has no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced severe pain in left arm over 2 week on 05May2021 08:00. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Unspecified therapeutic measures were taken as a result of the event on 17May2021. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was unknown.
had soreness in arm at injection site, where i couldnt sleep on my shoulder for 2 nights. had a headache day 3 after injection. no more symptoms
Upon charting the vaccination given it was found that the vial had expired 10/15/2021
pt recvd vax 10AUG95 & went for dental exam & later didn't feel good; sister stated pt had fallen to couch; grandma states had his teeth clenched & was making jerking movements, having a sz; grandma called 911; 7-8mins later pt responsive;
Had temp. & check lungs before giving shot. N.P. Within 3 hours had sore arm, fever, chills, headache, muscle aches. 4th day cough, wheezing, could not breathe. Went to E.R. admitted. Low oxygen level. Pneumonia. Still cannot breathe properly - wheezing, coughing, etc.
Within 2-3 minutes following meningococcal immunization, client had syncopal episode with mild seizure activity for a few moments.  Recovered within a few minutes with normal blood pressure and was aable to leave office after observation accompanied by her father.  Mother states she complained of drowsiness and dizziness the remainder of the day but was fully recovered by the next day.   Also, mother stated she had swelling and pain in arm around injection site for two days.
24 hours, post vax, pt experienced chills, fever and body aches. She was given Rocephin 500mg IM to be followed by Ceclor 500mg po tid.
Bilateral parasthesia to fingers 4 hours post injection.  This passed in 15 minutes, About 7 Pm on 12/28/20, bilateral parasthesia to hands & feet. On 12/29/20 (AM) foot pain--painful to walk, went away in about 5 minutes, but still felt tingling to both feet. Still having tingling sensation to both feet (constant) and both hands (intermittent)
red arm; This spontaneous report has been received from a lawyer and refers to a 60 year old female patient. The patient's concurrent conditions and concomitant therapies were not reported. The patient's medical history included ex-tobacco user.     On an unspecified date in 2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (manufacturer unknown) (lot #, expiration date, dose, strength, route of administration and anatomical location of vaccine were not provided) for prophylaxis. In the same year (unclear if prior or after pneumococcal vaccine, polyvalent (manufacturer unknown)), the patient was also vaccinated with zoster vaccine live (ZOSTAVAX) and started a litigation process due to Bell's palsy, anxiety and depression, (captured 1409USA001454). The patient reported that she had "now seen how many people have gotten Bell's palsy right after the shingle shot" on an unspecified date (captured 1803USA005554).  On an unspecified date in 2014, the patient experienced red arm (erythema). At the reporting time, the outcome for the event was unknown.      The causality assessment between red arm and pneumococcal vaccine, polyvalent (manufacturer unknown) was reported as related.  This is one of 2 report from the same patient.; Sender's Comments:  US-009507513-1409USA001454: US-009507513-1803USA005554:
A non-serious spontaneous report of inadvertently given half dose of H1N1 was received from a nurse/health professional concerning a 32-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Caller reporting that a dose of VARIVAX was administered after its expiration date. Date administered: 10Jun2022, date expired: 21May2022. Caller confirmed the vaccine has no previous temperature excursions. No PQC. No additional information.; This spontaneous report was received from a licensed practical nurse, and refers to a patient of unknown age and gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 10-JUN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), dose: 0.5 ml, lot # T017685 for prophylaxis. The dose expired on 21-MAY-2022 (route of administration was not reported).  The vaccine has no previous temperature excursions.
feeling a little weak; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling a little weak) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21A, A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (feeling a little weak). At the time of the report, ASTHENIA (feeling a little weak) outcome was unknown.            On 29-Dec-2021, the patient had a swab test done because there were a lot of people in her job who were getting sick. On 31-Dec-2021, the result came, and it was positive.   Other than she was feeling a little weak and she did not have other signs and symptoms.  Concomitant product use was not provided by the reporter.   No treatment information provided.
Patient with bells palsey history experienced flare up after receiving Fluad vaccine; Patient with bells palsey history experienced flare up after receiving Fluad vaccine; This spontaneous case was received on 16-Nov-2022 from a pharmacist (reference number: SEQW22-05861) and concerned a 66-year-old, male patient.  The patient's current condition included Bell's palsy. The patient's concomitant medication included lisinopril used for an unreported indication.  On 10-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration: intramuscular, anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in Sep-2022, a couple of days after receiving Fluad Quadrivalent, the patient experienced flare up of Bell's palsy. The patient did not receive any treatment.   At the time of initial reporting on 16-Nov-2022, the patient had not recovered from the event.   The reporter did not provide causality assessment.  The event of Bell's palsy and 'condition aggravated' was considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 66-year-old patient was vaccinated with Fluad Quadrivalent. A couple of days after receiving Fluad Quadrivalent, the patient experienced flare up of Bell's palsy. The patient did not receive any treatment. The patient's current condition included Bell's palsy. No more relevant information was provided. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A 66-year-old patient was vaccinated with Fluad Quadrivalent. A couple of days after receiving Fluad Quadrivalent, the patient experienced flare up of Bell's palsy. The patient did not receive any treatment. The patient's current condition included Bell's palsy. No more relevant information was provided. Causal role of the suspect vaccine is assessed as possibly related.
she has taken her second shot and her arm has red to it where she got her shot; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration, in the arm, on an unspecified date, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced she has taken her second shot and her arm has red to it where she got her shot on an unspecified date. She clarified the product was Pfizer. She also inquired what to put on it if it gets worse as it was just a little red. She also stated that she will just call her doctor and ask her doctor what they put on it. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient called to inform the pharmacy that his second dose of Pfizer vaccine was not showing on the database; yet his Johnson & Johnson shot does. So therefore, it was discovered that patient received Johnson and Johnson initially and still came to get his 2 doses of Pfizer.
client given pediatric dose of HEPB vaccine, client notified 020905; scheduled him in public health department Friday 021102; 2/10/05 medical advisor contacted CDC/ACIP recommendation will be followed.  Peds dose disregarded adult dose to be given on patient return 3-8-05
This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT.  Additional details were reported as follows: The reporter explained that several staff, about 8, who received FLUARIX QIV vaccine had developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were provided. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
I am experiencing a ringing in both ears after getting my booster shot of Moderna. I have mild tinnitus from before but now it is more intense with also a feeling of slight ear stuffiness. I don't recall having any condition like this from my previous shots.
ITCH ON BACK LATER THE SAME DAY AS VACCINE, DEVELOPING INTO PATCHES OF RAISED COALESCENT PAPULO-VESICULAR RASH ON BUTTOCKS AND FLANKS 2 DAYS LATER AND STILL PRESENT 4 DAYS AFTER VACCINATION
Left arm (arm that received injection) was slightly painful when used to left or push push a snow shovel for two (2) days.  3 day was fine. On 3rd day, Sat. 2/6/2021, felt a bit tired and listless most of the day.  Next day felt 100%
Information regarding Prevnar was received from a healthcare professional regarding a 5-year-old male patient who developed pneumococcal meningitis. The patient received the fourth dose on an unspecified date. In Aug-2006, the patient was hospitalized with pneumococcal meningitis, which was considered by the reporter to be a vaccine failure. The child was initially treated with unspecified intravenous antibiotics and then continued on oral therapy. He reportedly recovered "fully" with very little neurological damage and with some ataxia. Reporter was unaware of the serotype that caused the infection and noted that the patient's IGG levels were "low". No additional information was available at the time of this report.
I had  muscle ache in my neck shoulder and back, some fatigue two days after the vaccine
Having lunch on  04/29/21, around 11:30 am. Talking with co-worker started noticing by vision went blurry. My hands & feet started tingling. I turned very pale in facial color. Had co worker call 911, paramedics to me to ER. All my vitals showed normal, ekg, blood work, platlet count all good !! Went home and over next few days felt a little off, made regular doctor appt. follow up. Doctor said all my vitals look normal. Not sure what the cause is, had a ultra sound done of my left leg pain also. Showed no blood clots. Waiting for a heart monitor appt.   On 05/03/21 woke up at 3 am  drenched in sweat.  Still feel a little off, for no reason  . At times I feel like I might pass out.  Had epilepsy as a you child. But out grew with medications. No seizures in 40 years.
This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6203), dose 2 via an unspecified route of administration on 19Feb2021 (at the age of 74years) as single dose for COVID-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL9262) on 28Jan2021 (at the age of 74years) for Covid-19 immunization and stated no reactions. Medical history included high blood pressure and diabetes but are all currently under control and feeling some leg pain before the vaccine was administered. It was reported that in the past the doctors thought he experienced TIA (transient ischemic attack) but wasn't sure if that was accurate. Concomitant medications included lisinopril (LISINOPRIL), trazodone (TRAZODONE), insulin (INSULIN), bupropion hydrochloride (WELLBUTRIN), and prednisone (PREDNISONE); all taken for an unspecified indication, start and stop date were not reported. It was reported that on 19Feb2021 the patient received the 2nd dose of Pfizer Covid vaccine and stated he remember feeling some leg pain before the vaccine was administered earlier. On Sunday 21Feb2021, the reporter (patient's wife) began noticing that the patient was showing symptoms of a stroke. The patient's one leg was rapidly kicking, and his speech began to slur. The patient was then rushed to ER (emergency room) and hospitalized. At the hospital it was confirmed that the patient was having a stroke. The patient recovered and was doing rehab for his leg. Few weeks later, the patient had an accident in his home while getting up to go to the bathroom and fell. The patient was rushed to the Trauma center. The patient's wife was upset as she carried their vaccine cards to the trauma center to confirm to staff that the patient did not need another Covid vaccine shot and later found out that the patient was given a 3rd (Moderna Covid vaccine) at the trauma center. The patient stated that he does not think the vaccine was related but was upset that the trauma center did not listen to her to take the info with the complete vaccine card present to avoid 3rd shot from another brand. The patient's insulin levels are under control, but the reporter was concerned when the patient does not eat within a certain timeframe. The outcome of events stroke and speech disorder was recovered on an unspecified date; outcome of event fall was unknown.
visual hallucinations lasting 18 hrs; 102º-104º fever lasting 36 hrs; loss of sensation from waist down for 12 hrs; This is a spontaneous report from a non-contactable other hcp (patient). A 20-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170), intramuscular on 21Apr2021 12:45 PM as single dose for covid-19 immunisation. Medical history not reported. Patient not pregnant at the time of vaccination and not diagnosed with COVID-19 prior to vaccination, not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient intramuscular received first dose of bnt162b2 (Lot number= EW0150) on 31Mar2021 12:45 PM. On 22Apr2021 patient experienced 102º-104º fever lasting 36 hrs, visual hallucinations lasting 18 hrs, loss of sensation from waist down for 12 hrs. The outcome of events was recovered. Patient has not been tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event visual hallucinations cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Upon awaking the next day I started out with a feeling of general body aches. Then a headache. Then full blown body aches, chills, mild fever extreme lethargy, headache and arm pain. I felt as though I had a bad case of the flu. I was whipped out for the entire day. I took Advil and lay in bad all day. I felt terrible that night while trying to sleep. My injection sight really hurt as well as my neck. I'm not sure if this qualifies for a report, but I thought it may be a good idea to let you know that the side effects were pretty bad. This is my second dosage for Shingles. My first dosage was ok. Arm hurt but not as bad, some chills but nothing like this. Today, two days after the vaccine, I feel pretty normal. A little tired and my arm still hurts some.
Dizziness, shortness of breath, itching of skin face, nose, and throat, rapid heart rate, cough, tightness in chest
fussy night after vaccine, lg temp to 100.  Next early afternoon fever to 103 and vomiting.  Increased sleepiness. Episode on-going
The night of the shot he ran a fever of 102, body shakes,  and couldn't breathe like an elephant was sitting on his chest. Convulsions then followed. Fever started about 6pm and all of the symptoms followed. At 1 am 8/15 symtpoms were so bad ambulance was called
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 28-month-old male. Neither relevant medical history no concomitant medications have been reported for this patient. The product expired on 18-Dec-2011. On 20-Dec-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.