chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Feb 16, day 26 after dose 1, at around 7:30pm I started having continuous Chills suddenly and felt my body temperature rising. I confirmed with Thermometer every 15 minutes, going from 99.1F to 101 F in  the span of 2 hours. I took 2 Tylenols (500mg each) at around 9:30pm and started drinking  over 1 liter of water, fortified with Electrolytes... My temperature gradually started to go down  by 10:30pm and back to normal 98.7 F by midnight... I was worried that I have COVID (my Dose 2 was scheduled on 2/18). I went and did a COVID PCR test which thankfully came out "Negative" in the evening of 2/17.  I re-established my Dose 2 appointment  for today 2/18 same facility as Dose 1.  It is worth mentioning that on 1/29, 8 days after my first dose, I developed  sudden itching and redness at the site of the vaccine injection (right arm) and my skin was hardened around the site. Also,  this reaction lasted  24 hours and as if nothing happened in next day.
Pt. called into clinic that she had an itchy rash that is not spreading an a bump where the vaccine was given. Phone call made 10/31/2016.
swelling on the side of her neck; pain on the left side of her neck that went to her shoulder; Sore throat; Hoarseness; This is a spontaneous report from a contactable consumer(Patient). A 66-year-old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number EN6207) via an unspecified route of administration into arm left on 16Mar2021 as DOSE 1, SINGLE for covid-19 immunization (at the age of 66 year). The patient medical history had included Diabetes mellitus( from unknown to Ongoing and spasmatic fibrosis(from unknown To Ongoing). The patient concomitant medication included Rosuvastatin (20 mg) for the indication of High cholesterol and it has been used since 15 years.It was reported that the patient did not take any vaccination within four weeks of the vaccination and also reported that She saw her doctor 3-4 days before she received the vaccine. The patient did not received any prior vaccination within 4 weeks. No additional vaccine was administered on Same Date of the Pfizer Suspect. The doctor said since she was getting the vaccine he was going to hold off giving her a pneumonia shot. She switched doctors. The last time she had her cholesterol checked her doctor said it was fine. Since she has had two T strokes the doctor wanted her to stay on her cholesterol medication. The last stroke was 12 years ago. The first one was 25 years ago. She didn't know that she had a stroke until she fell and had an X-ray of her head. The X-ray indicated that she had the two strokes She was in her twenties when she had the first stroke. She remembers that her arm was numb and she had pain. She dropped the cup that she was holding. The numbness and pain went away after 1-2 minutes.On 17 Mar2021, the patient had experienced sore throat and Hoarseness. On 18Mar2021 the patient had experienced pain on the left side of her neck that went to her shoulder and swelling on the side of her neck. Patient applied alcohol twice for the event pain on the left side of her neck that went to her shoulder and swelling on the side of her neck and it went down. The outcome of the events were recovering .  No follow-up attempts are possible. No further information is expected.
I have had some shortness of breath but I think it is stress related.  I don't think it has anything to do with my vaccination.  Sorry!  Didn't mean to start a whole thing here.
After both shots, experienced body aches, chills, mild fever, intense tiredness, "covid arm" - red, feverish, slightly swollen about 4 inches in diameter around injection site.  After first shot also experienced nausea and intense headache.
Information has been received from a pt's mother concerning a 5 year old female with insect bite allergy who on 3/26/01 was vaccinated with MMRII. On 3/26/01, the pt was also vaccinated with DPT and poliovirus vaccine. Within 3 days, on 3/29/01, the pt's arm became swollen. In 4/01, the pt came down with 103F fever. On 5/10/01, the child was hospitalized and was released on 5/21/01. The child was readmitted on 5/23/01 and released on 5/25/01. The mother stated while the child was in the hospital, she was "dx'd with Henoch-Schoenlein-Purpura". Additional information has been requested.
Patient received the high dose flu vaccine on 9/27/17 and patient presented approximately 2 days after treatment with what was thought to be a cerebellar syndrome, possibly related to 5FU infusion. However, he developed progressive weakness. The working diagnosis was Guillain Barre related to the flu vaccine on 9/27/17. The patient is doing better. He can now lift his legs and stand.
expired vaccine is stored on refrigerator on 22-Sep-2021 and then administered on 30-NOV-202; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored on refrigerator on 22-Sep-2021 and then administered on 30-NOV-202) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vaccine is stored on refrigerator on 22-Sep-2021 and then administered on 30-NOV-202). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (expired vaccine is stored on refrigerator on 22-Sep-2021 and then administered on 30-NOV-202) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 22-Sep-2021.Vial did not undergo any temperature excursion.   No adverse event was reported.  No treatment medications were reported.
Cellulitis of the posterolateral deltoid region characterized by redness, swelling, induration, and pain.  Also had a headache and fatigue following vaccination - relationship unknown.
A few days after the vaccine, I woke up feeling "drunk" and unable to move without being extremely dizzy and falling over. I was driven to Urgent Care and they referred me to a specialist. I was ultimately diagnosed with a severe case of vertigo. I was given a ton of medication for it: Meclizine, anti-nausea medicine and Valium (low-dose) which allowed me to function more normally. I was unable to do normal activities for about a week. I no longer need any medicine for it.
No adverse effects reported; Tested serologically and determined to have a negative titer result; This spontaneous report was received from a pharmacist refers to a currently 43 years old female patient. The patient's pertinent medical history, concomitant medication, drug reaction and drug allergies were unknown. On 03-JUN-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) of one dosage form via subcutaneous route with lot # R036581 and expiry date: 17-DEC-2020 for prophylaxis. Therapy type of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was rHA. On an unknown date in June 2019, the patient was tested serologically and determined to have a negative titer result (Antibody test negative). No adverse effects reported (no adverse event). No treatment for the event was received. It was reported that, the patient sought for the medical attention to the pharmacy. No product quality complaint (PQC) was identified. The outcome of the event was unknown. Causality assessment for the event was not provided by the reporter.
She received her second dose one week before she should have been scheduled.  Side affects include sore arm and tired, same as the first dose.  I informed her of the error and informed her she did not need to repeat the dose.  Staff were unable to verify 1st dose d/t unable to get into Impact SIIS, and the date on her card was incorrect. Rose
During administration, patient pulled away and received 0.5ml or 0.3 ml of Fluzone vaccine
1 1/2 inch round bruise on arm, not warm to touch, not hard to touch, purple/bruise. Patient claims hurts a little when moves arm
Began about 8:30  am morning of 12-8-2021. Achy hurting muscles all over, foggy brain, no appetite, feeling dizzy when trying to get up or sit up, sleeping off and on all day and most of the next day of 12-9. Much nausea 12-8 and tapering off on 12-9. Had fever, felt cold, left arm hurt somewhat. Rested at home in bed.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that the patient inadvertently was administered of more than one dose of ZOSTAVAX (dose, routes and lot numbers not provided). First dose was given "last year", approximately in 2013, and second dose was given September 2014 (exact dates not specified). No adverse effects were reported. Additional information has been requested.
pt stated feeling dizzzy when standing, elevated heart rate and a little shaky.  vitals at the time of the reaction: hr 98 o2 100% bp 130/85  Pt stated they felt better after 15 mins of siting. Pt was cleared to leave.  Vitals after 15mins: hr 84 o2 100 bp 125/80
Fever, Vomiting- Information has been received from Wyeth-Ayerst Research concerning streptococcus pneumoniae vaccine (prevnar) and assigned manufacturer control number HQ1662902Oct2000.  The report concerned a 15 month old male, who on 27 Sept 2000, was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation route, site and lot number unknown.  Concomitant therapy included the first dose of streptococcus pneumonia vaccine  (prevnar) administered IM lot number unknown and HIB conjugate vaccine manufacturer and lot number unknown.  On 27 Sep 2000, that day, thepatient developed a fever of 102.3 degrees F. and had one large vomiting episode.  as of 28 Sep 2000 the patients fever of 102.3 degrees F. presisted.  The physician also noted that he was concerned about the fever that his son developed post vaccination with streptococcus pneumonia vaccine and not the measles virus live - mumps virus vaccine live rubella virus vaccinelive second generation.  This information was originally received from a physician, the father of the patient.
Case number PHEH2014US010430, is an initial spontaneous report received from a pharmacist on 20 May 2014. This report refers to a patient of unknown age and gender. It was reported that the patient received only the Men CYW-135 liquid component of MENVEO (batch number: unknown) on 17 May 2014. No adverse event was reported. No further information was provided.
hardness at injection site; Itching at injection site; Swelling at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and HEADACHE (Headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and HEADACHE (Headache). At the time of the report, VACCINATION SITE INDURATION (hardness at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Swelling at injection site) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taking concomitant medication not specified.  Treatment details included Used ice pack on effected arm.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: No new information
No additional AE reported; Caller reported a dose of GARDASIL 9 that experienced a temperature excursion was administered to a patient; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 09-AUG-2021, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 0.5 milliliters (ml) (vaccination scheme frequency, route and anatomical location of administration were not reported; lot number T029522, expiration date reported as 13-MAR-2022, but upon internal validation established as:13-MAR-2023) as prophylaxis (product storage error).  The involved vaccine underwent, on an unspecified date, a temperature excursion between -4.8 degree Celsius (C) for a time frame of 20 minutes (min). There was not reported previous temperature excursions. It was unknown if the digital data logger was involved. No additional adverse events (AE) were reported.  This was one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T029522; expirationdate: 13-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA003135: US-009507513-2108USA003288: US-009507513-2108USA003314: US-009507513-2108USA003100: US-009507513-2108USA003267: US-009507513-2108USA003288:
Extreme chills and moderate fever (99.5F) approximately 4.5 hours following administration. Fever escalated up to 102.4F approximately 5.5hr following administration.
This is a prospective pregnancy case. This female subject was enrolled in a study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV Dresden .5 ml on 1st October 2018, for prophylaxis. The subject received Flu Seasonal QIV Quebec .5 ml on 1st October 2018, for prophylaxis. The subject's estimated date of delivery was 2nd October 2018. The subject received Flu Seasonal QIV Dresden at week 40 of the pregnancy and during the third trimester of pregnancy. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden and Flu Seasonal QIV Quebec, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details were provided as follows: The age at vaccination was not reported. The patient was 40 weeks pregnant and received flu shot, which led to vaccine exposure during pregnancy. The patient did not have lot number available and could not confirm if product was FLUARIX or FLULAVAL. The birth date and personal healthcare professional information was not obtained. The patient received flu shot at the clinic at the office where she worked. The patient did not ask for permission to follow up with healthcare professional. Follow up information received from a consumer on 2nd January 2019: On 26th December 2017, the patient had her last menstrual period (LMP). The expected due date of delivery was 2nd October 2018. The patient had 28 hours labor (date unspecified) due to which she had an emergency C-section and gave birth to a baby (details not reported). The baby had cord double wrapped around neck and heart rate went into the 60's for 7 minutes which was unnoticed by the medical staff. At the time of this report, the baby was healthy. It was unknown if the reporter considered the C- section to be related to the FLUARIX or FLULAVAL.
A report has been received from a Health Professional concerning a 4 year old, male subject, who had been receiving nasal FLUMIST started on 04-DEC-2012. The patient experienced tested positive for influenza which started on 15-DEC-2012. The patient recovered from the event of Tested Positive for Influenza on an unspecified date. The report was considered to be non serious.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concomitant medications, pertinent medical history, drug reactions and allergies were not reported. On 18-JUL-2017, the patient was vaccinated with VAQTA (dose, concetration, route of administration, frequency, lot #, expiration date were not reported). No adverse effects were reported. Additional information has been requested.
fever, head ache, eyes hurting, stomach upset, very tired, sleepy, arm extremely sore, entire body ache.
This spontaneous report as received from a pharmacy technician refers to a 3 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-FEB-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX) temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
This is a spontaneous report received from a noncontactable consumer or other non-HCP. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Sep 1, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunization. The patient developed pyrexia/fever up to 101.8ºF, onset Sep 2, 2021, with outcome of unknown. Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Red, bruise and swelling leg. Place ice, rest and close monitoring for infection. Reaction to Hep-A vaccine.
1610 ~pt stated feeling numb left ear and left mandible. No sob. Symmetrical smile. Left arm has no symptoms. 1612 v/s 118/63, 89, 100%. 1700 pt states left ear remains numb as well as left mandible . Smile symetrical , no symptoms on left arm nurse leader made aware and contacted doctor. New orders to release pt. Pt reassessed, educated on interventions if worsening. Pt verbalized understanding . Pt left ambulatory , no sob, no distress
Extreme Swelling and bright red. Over several days it moved down my arm. Gone after 7 days
Headache, CHILLS, LOCAL LYMPH NODE TENDER/SWELLING, PAIN/SWELLING INJ SITE Narrative:
Fainting- patient reports feeling hot, feeling like her ears were going to pop, dizzy & lightheaded.   She was observed to lose all color in her face and was immediately assisted to a bench to lay down.
In July I started having diarrhea, I started having ulcers in my mouth. I have had to cancel my oral surgery as the ulcers have still not cleared in my mouth.
Totally paralyzed. Hospitalized for 12 days. Went blind x 48 hrs while in hospital. Went into rehab for 20 days. Then had PT till May 2018. Not 100% better. Currently has bad balance and no strength or stamina.
Received Td in Left deltoid 12/10/2004, pt went to ER on 12/24/04 for pain, swelling, redness at site and given diagnosis of cellulitis caused by Td injection. Rx'd cephalexin.
Started having a sore throat and stuffy nose and little cough. It didn't really get much worse than that. I waited a day I took an at home test and it was negative, but my wife had already been diagnosed with COVID-19. I then went to a clinic and after I got the positive reading a telehealth was scheduled. I was then prescribed PAXLOVID the symptoms didn't get any worse and by the time the medication was gone I had no more issues.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned 3 patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 21-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211006798 and 20211006371.
After receiving injection, patient developed a quarter sized area that was red, inflamed, and painful around the injection site. This reaction area continued to spread throughout the last week.
After receiving the vaccination I attended a cruise vacation and it was determined that I had COVID. I experienced a headache, lethargy and fever. I also needed to be quaratined.
Moderna COVID-19 Vaccine EUA  Patient came to vaccine clinic with her family member and received J&J vaccine at 1245. I took her to the back room to observe her for 30 minutes.  She reported history of anaphylaxis to Pfizer in January of 2021. I took her vitals at 1253. BP 119/64; HR 96, SpO2 97 % on RA.    At 1301 she reported difficulty breathing. I administered 3 mg of Epi via left lateral thigh. Vitals after first dose of Epi was: BP 120/63; HR 91, SpO2 99% on 6 liters via nasal cannula. Patient reported that her breathing was getting better.    At 1310 patient stated that she was having difficulty swallowing her saliva. I administered 50 mg IM Benadryl.    I called Dr.and reported patient had Anaphylaxis and was not improving. Dr. and his team came right away. Nurse called urgent care. Nurse called emergency services.    At 1315 second dose of Epi was given. Vital signs at 1318 were BP 92/73; HR 111, SpO2 100% on 6 liters via nasal cannula. She was shivering and coughing out phlegm. Silver blanket was applied to keep patient warm.   At 1320 the third dose of Epi was given and patient reported some relief.    Paramedics came around 1325. Patient BP was 160/100. Patient had two episodes of nausea and vomiting. She was taken to Medical Center via ambulance.   Nurse  manager was notified.
STATED SORENESS TO LEFT SUB-CLAVICULAR AREA, SWOLLEN LYMPH NODES NOTED. ICE APPLIED, FOLLOWED BY HEAT.
irritable & crying 2 days p/1st dose DTP 10AUG93;
Pt received Janseen COVID vaccine on 10/18/21. Pt presented to urgent care on 11/01/21 and was found to be COVID positive. She presented to ED on 11/07 with complaints of worsening symptoms. CXR showed faint focal opacities correlating with COVID infection. Pt was discharged home on 11/06/21 with robitussin. Pt presented to ED on 11/10 with worsening symptoms. CXR showed new faint focal opacities.