chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Trouble catching her breath; like a migraine and light made it hurt worse; the patient was administered the entire vial as one dose; the patient was administered the entire vial as one dose; This is a spontaneous report from a Pfizer sponsored program via a contactable Nurse reported for a patient. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FC3182, Expiration date: Oct2021) via an unspecified route of administration, administered in left deltoid on 22Sep2021 at 15:00 pm (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. No additional vaccines were administered on the same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Sep2021 at 15:00 PM, the patient was given overdose as incorrect dose was administered and on 23Sep2021, the patient experienced headache, dyspnoea and migraine. It was reported that On 22Sep2021 around 15:00 pm, the patient was given a Pfizer BioNtech COVID 19 vaccine dose, the vial was diluted with the correct 1.8 ml of diluent but the patient was administered the entire vial as one dose. RMA (Registered Medical Assistant) gave an entire vial as a single dose to a patient. The vial was diluted with single dose of dilution. It was confirmed that there was only one patient involved. The patient received six doses instead of one because there were six per vial. The patient received the entire vial as a single dose. AE required visit to Physician Office for headache, dyspnoea and migraine. Please clarify the type of medication error.  overdose. Please provide the stage of medication error (e.g., prescribing, dispensing, preparation and administration). Administration. Please provide contributing factors to the medication error. The medical assistant thought it was a single dose vial so drew up entire vial and administered to the patient. Yesterday morning the patient had bad headache which felt like a migraine and light made it hurt worse. She also had trouble catching her breath, and was brought into the doctor office for monitoring. Her O2 was fine, however. Headache was not a intense today but still there. The breathing issues are much better today. On an unknown date, patient underwent laboratory test oxygen saturation (O2), and results were normal. The patient had reported previously that the headaches had been getting better. Outcome for the events headache and dyspnoea was recovering and for other events were unknown.  Follow Up (24Sep2021): This is a spontaneous follow up report. Added additional events and outcome.  No follow-up attempts are needed. No further information is expected.
Upon removal of needle there was slight bleeding. Immediately after administration injection site was swollen. Swelling of the area was as big as a quarter. Patient stated he felt fine. Was advised to sit in waiting room. An ice pack was offered but patient refused.
A report was received from a regulatory authority on 2/17/03 concerning a 71 y.o. female vaccinee who developed chronic diarrhea which was considered disabling for an unspecified length of time after receiving Fluvirin on 10/12/02. Concomitant medications taken included thyroxine and hydroxocobalamin. The vaccinee has a history of hypothyroidism and Addisonian pernicious anaemia. On an unreported date the vaccinee developed chronic and frequent diarrhea. Stool culture was negative. No cause was found. The vaccinee had not recovered at the time of the event. There was insufficient info to determine the reporter's causality assessment.
Patient received the vaccine for shingrix. After a little over a week (10 days later), he got a rash which appeared like shingles. Patient  already had shingles prior and stated it looked the same as his last outbreak.
Patient spiked fever, no evidence of pneumonia, hospital acquired COVID 19 positive test on 5/6
Initial information received on 13-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 years old female patient who received second dose of vaccine MENACTRA (Batch number: expiry date: 13-May-2018) in right deltoid on 13-Jun-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used as patient received a dose of expired MENACTRA, the date of expiration was 13May2018. The dose was given on 13Jun2018. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. Documents held by sender: none.
Chills; Headache; Nausea; Myalgia; Arthralgia; fatigue; pain at site of injection; Start Date/Time: (2nd dose) 15Jan2021 09:00 AM Start Date/Time: (1st dose) 29Dec2020 09:00 AM"; This is a spontaneous report from a contactable consumer. A 31-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at her right arm, via an unspecified route of administration on 15Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included escitalopram oxalate (LEXAPRO). Vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Dec2020 (first dose).  The patient experienced chills, headache, nausea, myalgia, arthralgia, fatigue, pain at site of injection; all on 15Jan2021 08:00. The patient did not receive any treatment for the events. The outcome of the events was recovering.   Information on the batch/lot number has been requested.
This spontaneous report was received from a mother regarding her child of unknown age and gender. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL dose 1, intramuscularly. The patient's mother reported that her child did not receive the GARDASIL dosage as scheduled after dose 1. No concomitant medications were reported. She was referred to her clinician, on the misuse. Additional information has been requested.
Received flu shot and then developed fever, nausea, chills, and vomiting and weight loss from 11/1-11/7.
Patient is a 29 y/o male who recieved the vaccine on the 27 AUG 04 and began to develop adenopathy and fevers after one week.  On 05 Sept 04 he woke feeling ill and became very short of breath and began complaining of 10/10 chest pain that he described as a chest tightness that came in waves and was associated with arm numbness.  There were no EKG findings and his chemistry panel, CBC, CK level were all normal.  The patient was placed on O2, ASA, Nitro SL, Morphine, Lopressor, then Toradol.  The pain was well controlled for 36 hours with Toradol. When we attempted to spread out NSAID dose His returned and again he had an episode of 10/10 pain 8 hours after last Toradol dose. At that time he was give O2, Morphine and Toradol.  The pain is currently being controlled with IV Toradol.
third accidentally given; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in June 2018) and Shingrix (received 2nd dose of Shingrix in December 2018).   On 8th September 2021, the patient received the 3rd dose of Shingrix. On 8th September 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details provided were as follows: Age at vaccination was not reported. A third dose of Shingrix was accidentally given to a patient at the pharmacy which led to extra dose administered. Reporter consented to follow-up.
Pt presented to pharmacy today (9/19/19), stating that her arm is swollen, red, and warm to the touch. She showed the pharmacist the area. It was as patient stated. She said that it hurt a lot the first 2 days after the shot, but the pain has since subsided. Pt is going to take Ibuprofen and try cool compresses to see if swelling goes down and/or away. She will follow up with MD if the arm gets worse in any way.
8 days after 1st Pfizer COVID vaccine, woke up with both feet & legs numb. Has not be able to walk since then. Seeing a neurologist. Started PT yesterday. Physical Therapist thought it might be helpful to report the event in case others had had a similar experience. Received 2nd COVID Pfizer vaccine 2-17-21 with no other changes noted.
Two weeks after booster, onset left shoulder girdle fasciculations followed by weakness of rotator cuff muscles, especially infraspinatus muscle. Orthopedist consulted by primary care. Ordered Physical Therapy X 6 weeks. Minimal improvement in weakness. Then ordered MRI of left shoulder, which showed edema of infraspinatus muscle, and deep varicosity in suprascapular neuromuscular bundle.  Question therefore raised re: localized DVT.  PT continued at home, with gradual return of strength after 3 months.
Onset of febrile flu like symptoms some time after 1st dose HBV vaccine. 2nd dose hold for sxs noted increase ALT, AST which resolved. Pt presented with flu like sxs.
she is one month overdue to receive her second shingles vaccine; she is one month overdue to receive her second shingles vaccine; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient concomitant therapies included pembrolizumab (KEYTRUDA). No information was provided regarding the patient's medical history, concurrent conditions and drug reactions or allergies.  On an unknown date, the patient was vaccinated with zoster vaccine live (MANUFACTURER UNKNOWN) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). The patient stated that she was one month overdue to receive her second zoster vaccine live (MANUFACTURER UNKNOWN) dose (circumstance or information capable of leading to medication error  and  extra dose administered).
Shortness of breath and dizziness started May 30th around noon and lasted two days on and off. I would suddenly feel like I wasn't getting enough oxygen even though I was breathing deeply and then need to lie down so I didn't pass out. This happened about 4 times per day lasting about 20 minutes each episode. Not exercising or doing anything out of the ordinary at time of onset. I haven't noticed these symptoms today, so it might be over.
Severe outbreak of canker sores in mouth and throat occurred within one day of second shot. Condition resolved after about one week. After one week from second shot developed significant diarheia and abdominal discomfort. Condition is still unresolved, but improving. Recently diagnosed with lymphocitic colitus
I received the vaccine on 12/22 and I experienced a sinus infection on 12/24. I made an appointment with my PCP and was tested me for flu and strep. Both came back negative. I was prescribed clindamycin and sudogest. My sinus infection resolved within a week.
Slight fever, very dizzy,  vomited, chills, pain and shaking.   Lasted until next morning I was fine still a little dizzy.
Started 11/12. Warmth, induration, itching 4 cm, 2 cm.
pt recv vax;devel a pos test for Hep B as a result of vax;
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pharmacist mentioned a shipment of live ZOSTAVAX and live (Merck) VARIVAX were received with a 4 days shipping time period were given to patients (unknown date). Pharmacist stated the shipment was received and the ice packs were still frozen and the live ZOSTAVAX and live (Merck) VARIVAX were stored in the freezer. There were 9 patients who received live ZOSTAVAX. On 02-FEB-2013, one of the them was vaccinated with live ZOSTAVAX lot # H019040, Expire date: 17-JAN-2014 (route and dose not reported).No concomitant medication were reported. The patient was not experiencing any known symptoms. Patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Breakthrough case admission after 2 vaccines Moderna 3/10/21 Lot# 002B21A;  Moderna 4/7/21 Lot# 040B21A;
Stiffness in left arm, fever, extra warmth at injection area, muscle soreness (next day), fever (next day), body aches,  muscle weakness in left arm, swelling in left arm, skin flushed area at injection site
I received regular flu shot in sometime end of Sept from my employer facility. I am not sure from what clinic that they provided from or any main out source hospital.
9OCT98 approx 5PM 7hr p/vax had queasy feeling;12hr p/vax felt bad had chills, fever (temp not taken) inj site rt arm swollen & neck w/pain, heart rate rapid;sx duration approx 6hr;
Not until late in the evening after my vaccine I felt fatigue, congestion, and body aches. I think this lasted for like 3 to 4 days. The fatigue and body aches were bad, I did not have a fever that I can remember, I may have had chills. I had these same types of symptoms from Vaccine 1 and 3, but these were by far the worst.
Per patient's mother call 1-23-2017 at 0800, patient started with fever Saturday evening (1-27-17) alternating MOTRIN and TYLENOL Sunday evening 102.8 degree F at 6pm Monday 101.7 degree F at time of call 98.7 degree F. Mother reported vomiting.
Patient c/o feeling dizzy after getting the vaccine. Patient is currently pregnant and estimate due date is 4/8/2022.   Vital was taken BP: 108/62. HR: 91. Resp: 16. O2: 99%. Patient was recovered after 5 minutes. Left the site in stable condition.
My daughter started to get restless in the legs and had many headaches. She was twitching and couldn't stop from jerking movements in head and legs. We thought maybe she got a hold of some kind of drug. The doctors said she has rheumatic fever. This is triggered by strep throat. The only problem she tested negative for that. Now she can't even walk. She has no hunger and is very depressed. 10 years old and making drugs that take healthy kids and turn them into this. I didn't like the idea of my child taking this drug and my wife only did because the doctor said he highly recommended it. Well now that this has happened I have found out that they have had 21 deaths in 2 years. Thanks for telling us that in the side effects. I don't see anything mentioned about this. My daughter got only one dose and was set to get her second when this happened. This drug needs to be taking off the market. I don't want to see another family go through what we are going through. She has missed 3 weeks of school and I don't see her recovering anytime soon. 1 death is too many and I know that there are many out there that will be permanently disabled over this drug. PLEASE TAKE THIS DRUG OFF THE MARKET. I will continue to spread the word out to Family & Friends in hope that they won't put their child in the hands of this drug maker. GARDASIL needs to be stopped.
Client administered first dose Moderna without incident. Has allergy to sulfa and family history of anaphylaxis to peanuts and cephalosporin but client had no history of anaphylaxis. After waiting almost 30 minutes client stated she was feeling dizzy and was clammy.  Client laid down.  She stated throat felt funny but no swelling of lips or tongue, no SOB.  Face was flushed.  BP 156/84 P 88 R 16. Legs elevated. At 2:20 (almost 40 mins post vaccination) BP 130/80; P 70 R 16. Throat still felt funny. Still dizzy. Sat up and drank some Gatorade and dizziness decreased. BP 122/76 P 82; R 14. Client left in care of husband at 2:25 pm and nurse recommended that second dose be in PCP or hospital setting.
Dizziness;   Vital signs:  12:29pm 112/78 67 18 O2 96%;   12:39pm 116/80 67 18 O2 96%;   Patient stated he was no longer feeling dizzy after eating a snack and drinking water.   DISPOSITION:  Stable no longer feeling dizzy.
the diluent that came in the box with the ACTHIB, was not used, they used another diluent instead/No AE; Initial information was received on 08-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient with unknown demographics who was vaccinated on an unknown date, with using another diluent instead of the diluent that came in the box with the HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination (product preparation error).   Medical history, past medical treatment, vaccination and family history were not provided. Concomitant medication if any, not reported.  It was a case of actual medication error due to wrong solution used in drug reconstitution (latency: same day)   Reporter wanted to know if this is safe for the patient?  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.  There will be no information available on the batch number for this case.
8 days after receiving booster, I broke out in hives. As of Feb 3, I still have hives.
Swollen ears  Redness and hives on back of neck Hives over arms (elbows and back of arms) and knees all by 7:00 am on 11/10 As the days have progressed hives have appeared on all parts of my legs, hips,  all parts of my arms, my face, my lips swelled up, my eyes swelled up, swollen cheeks and jawline area , swollen hands and wrist (from 7/10 to 7/12 which is today)  Hives are itchy, red, hot and swollen   Have taken Benadryl and fomotadine and zytrec
Booster Comirnaty; Tired; Chills; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 and dose 2 of COVID-19 Vaccine (unknown manufacturer) on unspecified dates for covid-19 immunisation. The patient reported he became very tired and had chills the day after booster Comirnaty vaccination on an unspecified date. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Inconsolable crying greater than 3 hours after the vaccination. Cough noted. Rash at injection site - red and indurated, high fever.
Large rash at injection site. The rash was red, hot, and hard and grew in size for approximately 24 hours. It slowly decreased in size over the next 5 days.
couldnot stand up straight; Cold; coughing; something is wrong with my throat; whole body aching; fever; feels like when I had COVID; tired; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (couldnot stand up straight), NASOPHARYNGITIS (Cold), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (something is wrong with my throat) and MYALGIA (whole body aching) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL, HCTZ, LEVOTHYROXINE, LORATADINE, VITAMIN B COMPLEX, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), CALCIUM, MAGNESIUM, VITAMIN E NOS (VITAMIN E + MAGNESIUM), UBIDECARENONE (COQ), CALTRATE + D PLUS, FOLIC ACID (FOLATE), MONASCUS PURPUREUS, NICOTINAMIDE, PHYTOSTEROLS NOS (RED YEAST RICE WITH PLANT STEROLS), ACETYLSALICYLIC ACID (BABY ASPIRIN), MELATONIN and CARBINOXAMINE MALEATE (OMEGA 100) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (tired) and INJECTION SITE PAIN (Soreness). On 11-Feb-2021, the patient experienced DYSSTASIA (couldnot stand up straight), NASOPHARYNGITIS (Cold), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (something is wrong with my throat), MYALGIA (whole body aching), PYREXIA (fever) and MALAISE (feels like when I had COVID). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Feb-2021, NASOPHARYNGITIS (Cold) had resolved. At the time of the report, DYSSTASIA (couldnot stand up straight), COUGH (coughing), OROPHARYNGEAL DISCOMFORT (something is wrong with my throat), MYALGIA (whole body aching), PYREXIA (fever), MALAISE (feels like when I had COVID), FATIGUE (tired) and INJECTION SITE PAIN (Soreness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 100.2 (Inconclusive) 100.2 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt experienced dizziness x 24 hr on day 5. Headaches start day 5 x 4 days. Constant headache. Pt went to ER on day 5 and clinic on base day 8. Is feeling better day 9.
This spontaneous report was received from a medical assistant and an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. From 26-MAY-2017 to 09-JUN-2017, the patients were vaccinated with improperly stored doses of VAQTA (lot number N003194 with expiration date of 28-OCT-2017, lot number reported as N005796 with expiration date of 26-MAY-2018, lot number N005274 with expiration date of 03-APR-2018, lot number M047658 with expiration date of 28-OCT-2017 and lot number M027879 with expiration date of 24-JAN-2018; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour at a temperature of 51.4 degrees Fahrenheit on unspecified dates. No previous temperature excursion and no adverse effects were reported. A data logger issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1706USA010930: US-009507513-1706USA010931:
I was about 5 weeks at time of  vaccine. After vaccine tongue started getting tingly I was give a banana about 5 minutes it did go away. I dint exp this symptom with the tongue after Dose 2. My (estimated date of delivery 10/1).
This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # reported as L020162 exp date 23-JUL-2017) (dose and route not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.