chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient mistakenly received a fluzone qiv np vaccine instead of a fluzone high-dose quadrivalent vaccine with no reported adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 71 years old female patient who mistakenly received a Influenza quadrival A-B vaccine (Fluzone QIV NP) instead of a Fluzone high-dose quadrivalent vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2022, the patient mistakenly received 0.5 ml  dose 1 of suspect Influenza quadrival A-B vaccine, suspension for injection (lot UT7681NA; expiry date: 30-JUN-2023) via intramuscular route in the left deltoid for immunization instead of a fluzone high-dose quadrivalent vaccine with no reported adverse event (wrong product administered) (latency: same day) Pharmacist initially stated that the patient had received a FLUBLOK vaccine but clarified that they did receive a FLUZONE QIV NP vaccine from pre-filled syringe during the visit after reviewing the case. Pharmacist asked how to proceed and whether or not the patient should be re-vaccinated with FLUZONE HIGH-DOSE QUADRIVALENT.  Action taken : not applicable.  Outcome : Unknown.   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 the 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.
Waiting under observation in Urgent Care Dept. 2 hours after injection IXIARO.
No side effects were reported; an adult received a pediatric dose of VAQTA inadvertently; This spontaneous report was received from registered nurse referring to a 69-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-OCT-2023, the elderly (also reported as adult) patient was vaccinated with a pediatric dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection inadvertently, 0.5 milliliter, lot #1971532 (has been verified to be a valid lot number for hepatitis A vaccine, inactivated), expiration date: 13-SEP-2024, as prophylaxis (strength and route of administration were not provided) (Incorrect dose administered). No side effects were reported. No additional information provided.
HIVES AND SEVERE ITCHING ALL OVER HER BODY. PATIENT TOOK PREDNISONE AND MANY DOSES OF BENADRYL TO RELIEVE HER SYMPTOMS.
Rash, itch, skin tightness, worst with cold weather or wind, It has been like this since the second day of the vaccine
COVID-19 vaccine (lot number FK5618) was given after beyond use date of 1/27/2022. Reactions/side effects due to this unknown.
Starting 12/19/2022, I developed a lot of fatigue, had a fever of 101 and coughing. I slept for a day and half. I took an at home COVID-19 test on 12/19/2022 and it was positive. I had a video chat with my doctor on 12/20/2022 and we went over the CDC protocols. I was prescribed PAXLOVID, which I started that night. After that, the coughing and fatigue eased a bit but the sore throat started and lasted for about a day and half with a mild cough and a fever of 101. By Thursday, 12/22/2022 the fever had dissipated and the sore throat started to decrease around that time. I was feeling pretty good by Friday. By Saturday, 12/24/2022, I felt pretty normal. I stopped taking the PAXLOVID that day due to losing my sense of taste. Since then I am feeling fine and I stopped isolation on 12/25/2022. Still testing positive this morning, but its a very faint positive. I am continuing masking at this time.
Sudden onset, fell once, no LOC, right arm felt like "spaghetti" then feeling came back  Refused ED, lasted about 2 days.  At f/u office visit on 4/20/21 - patient reported residual numbness right arm with difficulty grasping items, new numbness left leg
No adverse effect; Improperly stored dose of VARIVAX; This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 19-NOV-2019 (also reported as 20-NOV-2019), the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S002736, expiry date : 28-JAN-2021) for prophylaxis. It was reported that the vaccine experienced a temperature excursion of -0.2 degrees Celsius for 2 hours and 40 minutes (product storage error). There was previous temperature excursion of 4.25 degrees Celsius for 2 hours and 40 minutes. There were no adverse effects reported. There was no product quality complaint involved. It was reported that this call was reported due to a digital data logger.
Woke up with chest feeling tight and a pain underneath right breast, became difficult to breath, heart pains,  high temperature,  believed the vaccine flared her immune system aggravating her Lupus.
Pfizer Bivalent given as a first dose in a 17 year old.  No previous COVID-19 vaccines have been given.
c/o eye swelling and rash with dryness of skin within 24 hours of vaccine
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M010212, expiry date 21-JAN-2019, dose, strength, dose number, vaccination site, route not provided). The temperature excursions were reported as 1.6 C for 39 minutes on 09-AUG-2016, 0.6 C for 1 hour 40 minutes on 10-AUG-2016, 1.5 C for 55 minutes on 11-AUG-2016, 1.5 C for 1 hour 7 minutes on 28-AUG-2016. No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
The sore arm and mild fever of 100.6 24 hours after vaccination wasn?t a surprise, but the blood sugar spike for four days after was. I monitor glucose with a fasting check every morning, and went from a steady average in the low 130s to a peak of 162, with four days running at 150-plus.  My levels haven?t been that high since shortly after I was diagnosed, and my diet did not change. Just something I think has likely been under-reported.
Patient received vaccination that was expired (expired on 9/30/22 and administered on 10/3/22). No adverse effects
Diarrhea, body aches, flu symptoms. Patient had a sinus problem on the day of the flu shot, but his doctor told him it was still ok to get the vaccine.
pt recvd vax; fever, muscle aches, ha; redness, swelling at site p/ dose 1; redness, swelling at site p/ dose 2;
Patient felt dizzy and lightheaded after receiving the Spikevax vaccines while she was waiting her 15 minutes. We gave her ammonia salts to prevent her from passing out and also some ginger ale to drink. She sat around for about 10 minutes and felt better. She was able to leave after waiting when she felt good.
dominant hand and wrist swollen up with extreme pain; dominant hand and wrist swollen up with extreme pain; Extreme pain; can't use that; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 29Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first of the vaccine on 29March2021 and during a night her dominant hand and wrist swollen up with extreme pain and the patient still have it and it has been 8 days now. The patient just wants to know that was that common. Oh there was my question. Was that patient's conditional side effect on receiving a shot. When consumer informed about Medical Information Department, consumer stated, "Well it was my right hand. The patient can't use the patient can't use that. The patient would not be able to write it down, could you help someone call me. Oh that was a person giving you my phone number, you can give that. The patient can't right with my hand. The patient wouldn't be able to report it. Can you send me message with the number. The outcome of the events was unknown.  No follow up attempts are needed. Information about Lot/Batch number cannot be obtained.
Developed fine red rash and itching about 20 minutes after receiving Hep B #2. Seen by MD and treated with Allegra 3 days later per mom.
About 12hrs after the vaccine was administered, I was at work and wearing nitrile gloves. After 10 minutes, the gloves began burning my hands so badly that I couldn't wear them any longer. I have never had an allergy or an adverse reaction to the gloves I was using. I washed my hands and attempted a different pair of nitrile gloves by a different manufacturer and had the same reaction. I then put on latex gloves, which still caused a burning sensation, but not to the same degree as the nitrile.
Onset of generalized rash on 8/9/22  with mild congestion, rhinorrhea, Fussiness. Rash worsened by 8/12/22, generalized including palms and soles, but more severe over torso & face where papules & macules are pale
Pt to ED 10/4 for abnormal EKG, today heart palpitations onset. Pt COVID+ 10/4, no anti-COVID rx needed. 10/7 pt reports shortness of breath with minimal exertion but improving. 10/8 A&O x4, vital signs stable, denies any pain. 10/8 pt doing well, has not had chest pain, SOB, or palpitations. 10/12 no CP, no dyspnea, no N/V. 10/13 pt doing well, denies palpitations. 10/14 pt discharged.
2nd phizer vaccine- normal side effects started around 9-10 am but progressively got worse during day and into evening. Aches, chills, fever, headache- around 5:30 pm had an issue with blurred vision in my left eye for approx 15 mins, similar to a migraine apparently (never had one before)- blood pressure spiked to 164/104 and resting heart rate was between 90-104, normally 52-60. Headache persisted for nearly 9-10 hours and all symptoms improved dramatically after two Tylenol
Had three days of fever after the first shot, but most of the time it was a low fever; only took Tylenol  once Had two days of fever after the second shot, and this time the fever was higher than last time, reaching 102 F, took Tylenol multiple times 12 days after the second shot, had 4 days of fever. This time the fever was high in general, going to 102 and even 103. Had to take Tylenol  multiple time everyday. Also began to cough ....Not sure if this is a delayed effect of the vaccine.
pt had a positive  COVID test 6/21/22 at Pharmacy; did not require hospitalization; did see PCP (name not mentioned in medical records) and was given Bactrim, Zofran, Atorvastatin; since COVID positive, pt has had issues with concentration and malaise; to ED via EMS on 7/11/22 after being found down in pt's driveway; respiratory failure, metabolic encephalopathy, septic shock, AKI; again tested positive for COVID; given Dexamethasone; was intubated and on mechanical ventilation; eventually able to be extubated and weaned to RA; planned to be dc'd to SNF (name of facility not mentioned in medical records) on 7/22/22; pt passed away at home on 8/5/22; not sure if pt ever went to SNF
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 23Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1; unknown manufacturer), for Covid-19 immunization. The following information was reported: INFLUENZA (non-serious), DYSPNEA (non-serious), outcome "unknown" and all described as "Had a flu last February and mentioned that she couldn't breathe"; VACCINATION SITE HAEMORRHAGE (non-serious), outcome "unknown", described as "Took the vaccine there was blood dripping after the vaccine"; MYALGIA (non-serious), outcome "unknown", described as "Still experiencing muscle pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Unable to drive for 4 months"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Already lost around 30 pounds on her weight". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Transferring agent stated "We have a caller, so the caller mention that she took her second Pfizer COVID-19 Vaccine 23Jun2021 and when she took the vaccine there was blood dripping after the vaccine and almost after a year she mentioned that she is still experiencing muscle pain and she also had a flu last February and mentioned that she couldn't breathe because of the flu. And she also mention that she was unable to drive for 4 months and already lost around 30 pounds on her weight. And she was also asking on when the vaccine will 'wear off'? That's all information and she did not provide any phone# or address. I think she already hung up I apologize then." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. developed high fever one day after immunization and then developed prolonged seizure after two days.  Pt. then needed Anti-Seizure medicines to stop the seizure.  Because of medicines pt. needed to be intubated and transferred to a PICU.  Pt. then needed Lumbar Puncture and CT Scan of Head to rule out any infections.  8/17/09 Hospital records received DOS 8/13/09 to 8/14/09. Assessment: Fever induced status epilepticus. Patient developed fever, generalized tonic-clonic seizure which lasted almost an hour. Apnea. Respiratory failure.
Symptoms started Thursday night 10/15 with itchy legs, feet and hands during the night, no rash identified. After the second night(Friday 10/16), small faint red bumps appeared on lower legs. Sunday morning 10/18 woke to severly itchy rash/hives all over legs, feet, arms, hands and belly. Gave dose of benadryl @ 12:10 pm. At this point, almost 3 hours later (2:40 pm) rash and hives are gone. Do not know if they will return after Benadryl wears off.
Deep Pain through your my entire arm, under my arm pit and into my rib on the left side Not sore to the touch  The pain is bad enough to wake me up every two hours
MIC form document lot # AHAVB532AA - adult dose Hep A. In chart document AHAVB532AA - shows < 19 yo unsure of dose given.
First vaccine was given on 09/08/2018. Very painful arm pain (immediately after shot and last three days). 10 hours after the shot, I began to have shakes, shivering, aches and pains, fever that went as high as 101 degrees, headache, fatigue and indigestion. These side effects lasted approximately 24 hours. Fatigue was for 3 days. The second vaccine was given on 12/28/2018.  Arm pain was not as severe. Last night (again approximately 10 hours after shot), I had the same side effects as above - shakes, shivering, aches and pains, fever (only up to 100 degrees), headache and fatigue. In addition, I did have nausea and began vomiting/dry heaves which lasted approximately 7 hours. A general feeling of having the flu. Today things are improving, however the aches and pains and fatigue are still rather severe. Fever is down to 99 degrees.
Two weeks after my injection I developed facial And ocular pain and burning on the right side. Sensitive to the touch and tingling as well. It is still painful.
Fever up to 102.6 on Tylenol Chills to sweats, mostly extreme chills Every muscle in my body ached, could not lay or sit without pain Extreme fatigue, hard to even hold a cell phone Piercing headache Running nose from crying Could not watch tv, lay, get comfortable, get up to eat. Drank lots of water and peed alot
lethargy; flu like symptoms; This spontaneous case was reported by a pharmacist and describes the occurrence of LETHARGY (lethargy) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013l20a) for COVID-19 vaccination.     The patient's past medical history included Crohn's disease on 01-Jan-2000 and Cold symptoms from 2020 to 06-Jan-2021. Concomitant products included 6-MERCAPTOPURINE MONOHYDRATE for Crohn's.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargy) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, LETHARGY (lethargy) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.   This case was linked to MOD-2021-003502 (Patient Link).
pt is 12 y/o and received a Pfizer pediatric dose 0.2 ml, Patient has no symptoms. Patient should haved received adult dose 0.3ml.
Patient symptoms were chills, fever, loss of appetite, very thirsty and pain and soreness where the vaccine was administered.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: TYMLOS, start date: Jan2022. Past drug history included: Erythromycin, reaction(s): "Drug Allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient treated with paxlovid with start date 28Mar2023 and stop date 02Apr2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300154257 Same reporter/patient,different drug/AE.;
Both knees tightened up, with swelling (fluid on both knees), on 04/12/21, my right index finger had a sharp shooting pain in the mid knuckle that radiated up and down my finger.  My finger swelled up and was extremely painful to touch or use.  The pain increased and knuckle became itchy and tight as if I had a hive on it.  The pain and swelling lasted for 9 or 10 days.  Finger felt normal on or about 04/21/21.  Both knees continue to be swollen and painful in front and back, with going up and down steps, and sitting down and standing up. I have not yet contacted my primary care physician.  I was hoping my knee pain would go away on its own.
VOMITING; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination .The Batch number was not reported. The company is unable to perform follow up to request batch/Lot number.  No concomitant medications were reported. On an unspecified date, the subject experienced vomiting, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and vomiting. This report was non-serious.
grand mal sz (?) @ 330AM 20JUL96 lasted 5min;tx was rx for augmentin given @ ER 19JUL @ hosp;no infect identified, no fever;
Facial flushing and tachycardia on day 3-4 post vaccination. Self resolved.   Axillary lymphadenopathy on day 8-9 post vaccination. Self resolved.
NERVE TINGLING, TWITCHING, WEAKNESS. STARTED IN LEGS AND MOVED UP THOUGH UPPER LIMBS. PROGRESSED TO SYSTEMIC PAIN AND MUSCLE CRAMPS, PAIN, SEIZING, SWELLING, AND PARTIAL PARALYZATION OF ANKLE, KNEES, WRIST. HAD SPEECH PROBLEMS, VISION PROBLEMS DIGESTION PROBLEMS, BREATHING PROBLEMS. COULD NOT WALK, STAND, DRIVE OR BATHE. PROBLEMS ARE STILL PERSISTENT.
Hospitalization: 12/26/2022 - 12/30/2022 (4 days) Presentation to the ED: SOB w/ LLL pneumonia. COVID + date: 12/27/2022 Treatment: Remdesivir, Decadron, Levofloxacin Discharge to: home.   FD7 12/24/2021 FJ1614 2/5/2022
joint pain, nausea, stiffness in TMJ area-neck, wrist, hip, spine pain;diarrhea med for nausea, hard time moving.Dxed w/ arthralgia secondary to Anthrax reactions.
61 year year old male patient reported angioedema to the left side of hid face and mouth following his Pfizer COVID-19 vaccine 00/30/2021. Symptoms resolved after resolved after treatment prednisone. Patient had his first vaccine without problems.
On the drive home the pt eyes & nose started to swell; Had problems breathing-bronchiospasm;
Injection site reaction - an adult pt rec'd an injection of Flu Shield (2000-2001 Formula) in Oct 2000, and developed soreness at the injection site. With a day or two, the injection site pain extended to his shoulder and to his elbow joint which became sore at full extension or under load. As of 5/17/01, he reported that the condition has stabilized and continues to the current time and affects both shoulders. The second shoulder is affected to a minor degree. No further information was available at the date of this report.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient had none drug reactions/allergies. The patient's medical history included surgery for mitral valve repair. Concomitant therapies included CRESTOR and aspirin. The reporter stated that she received a dose of ZOSTAVAX (lot # J011882, exp. date: 04-JAN-2015, strength, dose not reported) to prevent shingles, on an unspecified date in an unspecified arm, that "may had been" administered via the intramuscular route instead of via the subcutaneous route. The reporter stated "a couple days after she got the shot her arm became sore at the injection site which developed into her entire arm feeling heavy like someone had punched me". There was no treatment of the events. No lab diagnostics performed. The reporter did not seek medical attention. The reporter stated "the soreness lasted about 3 weeks then just went away". The relatedness between events and ZOSTAVAX was not proved. Additional information has been requested.