chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired vaccine was administered to a patient with no adverse event; Initial information was received on 17-Dec-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 45 year old male patient who was administered with expired Haemophilus type B (HIB) vaccine (ACT-HIB). (Expired product administered). Caller said the diluent and powder had different expiration dates and she didn't realize that the diluent expired on 26-Nov-2020. The powder was what she checked and it would expire on 26-Feb-2021 so she by mistake used the diluent to mix the powder and gave this patient a dose. Caller was asking how to proceed if they gave an expired ActHIB yesterday.  At the time of the event, the patient had ongoing lung cancer. Had spleen removed in a month (Splenectomy)  Concomitant medications included Meningococcal Vaccine a/c/y/w conj (dip tox) (Menactra); Men b and Pneumococcal Vaccine conj 7v (crm197) (Prevnar).  On 16-Dec-2020, the patient received a once dose of suspect HAEMOPHILUS TYPE B (HIB) VACCINE (single dose vials) at a dose of 0.5 ml via intramuscular route at the right deltoid (lot UJ135ABA and expiry date 26-Nov-2020) (Powder lot  UJ135AB expiry was 26-Feb-2021, Liquid part  lot U6477AA expiry was 26-Nov-2020) for prophylactic vaccination.  It was also a case of actual medication due to expired vaccine used (Latency: same day)  At the time of reporting, patient had no adverse event.  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
On evening of day of vaccine (Feb 6th) my left arm started to swell and got red  and very sore at site. Arm did not hurt to move just hurt when touched at site.   It continued to swell for 48 hours.  I treated with Benadryl, zyrtec, tylenol, and ice. All went away by Tuesday Feb9th.  It grew to be about the size of an orange.   Then when I woke up Saturday Feb 13th, I noticed  my arm was itchy at site and looked in the mirror and noticed that it was red and starting to swell again.  Again treated the same way and the swelling and redness lasted until Monday Feb 15th. Did not swell as large as last time.   Now it looks just like a purple bruise the size of a small tangerine/small apple around the site.
Pain in the right arm started 2 days after the patient got the vaccine. She describes the pain as coming and going. A shocking pain that is especially in the morning, and that her fingers go numb at time. When the pain gets bad she takes tylenol for it. She went to the ER once for it, but did not recall the date she went. Was going to go to ER today because the pain was bad today.
a wk p/vax pt had a fever x 4 days;on the 4th day pt had a rash on neck & looked like mosquito bites;did not come to a head;now are fading;did get some spots on abd, back, face;did not bother the child;
Headache within 3 hours. Extreme low back and hip joint pain began approximately 8 hours  after shot and continues to be present almost 23 hours after injection. Slight fever onset aprox within 12 hours of injection,  skin tenderness (likely secondary to fever.)
Dose 1 given 2/25/2021 Pfizer Lot # EN6198  Patient hospitalized with covid 19, discharged home
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: respiratory symptoms-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Error: Wrong Dose of Vaccine - Too High
Admitted 1/22/22 - 1/25/22 with COVID-19 causing acute hypoxic resp failure and acute COPD exacerbation. Tx w remdesivir, decadron, doxycycline. D/C w 2L o2. Readmit 2/11/22 c/o SOB on 5L o2. New afib in ED tx w metroprolol. PE ruled out. high flow heated BIPAP. Patient declined intubation. On 2/16 went to PEA cardiac arrest. CPR initiated but later discontinued after discussion with spouse. Discharge Dx: acute hypoxic resp failure d/t COVID PNA, COVID PNA, New onset paroxysmal afib, COPDE, acute on chronic thrombocytopenia.
She felt really dizzy. She was still awake. She had to be laid down on the floor. We called 911 and they took her to the ambulance and she was fine.
Just over one week after the booster, my neck and scalp broke out in hives. They quickly spread to my shoulders, sides, waist, groin, face, arms and stomach. It was excruciating. My chest hurt and it was hard to swallow. Not like I couldn?t swallow, it was just painful. I vomited. Fever like chills but no fever. Prednisone 80 mg pack did not touch the hives. It was completely debilitating.  After receiving a 600 mg prednisone pack and taking antihistamines around the clock, they subsided. It has been 7 weeks and I?m still experiencing / struggling  daily with dermagraphia, heartburn, and sporadic hives. I feel like I?m still swollen and my mind is not clear.  Have never had covid. My brother also had the exact side effects 2 weeks after his booster. We all thought he was environmental until i received my booster 2 months later and experienced the same symptoms.
10/21- 10:43 am received vaccine-painful than normal but thought it would subside.  10/23-08:30am woke up earlier than normal on my day off, with extreme right shoulder pain and burning nerve pain down my whole arm. Swelling was notable and extremely painful.  10/25-called Dr office for first avail appointment 10/27/21. 10/27/21-diagnosed with Vaccine induced Bursitis 12/3-Orthopedic Surgeon seen--xray taken 10/29 -MRI 1/7/21-Cortisone shot given and PT order  1/11-PT for Right shoulder pain and loss of ROM Right shoulder  Treatment:   Ibprophen, Volteran topical gel, Ice and heat as needed  Outcomes:  Loss of range of motion, swelling and pain continue.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of VARIVAX (lot number M006731, expiration date: 09-FEB-2018 and lot number M012990, expiration date: 14-MAR-2018) (dose, route of administration and anatomical location were unknown) for prophylaxis. The vaccine was stored at temperature more than 6 Fahrenheit degrees (F) to less than 14 F for 10 minutes. Previous temperature excursion was more than 6F to 14F for 10 minutes. The temperature excursions were detected by a data logger. The improperly stored vaccines were reconstituted with a properly stored sterile diluent (manufacturer unknown). No adverse effects were reported. This is one of two reports from the same source (MARRS# 1704USA009381). Additional information has been requested. Sender's Comments: US-009507513-1704USA009381.
Redness and swelling from right shoulder to halfway between R shoulder and R elbow. Area warm to touch. Child trying to scratch it. No fevers. Small blister 1 cm X 1 cm (from Band Aid- Mom left Band Aid on overnight). Dr. also examine child and site of immunization. Treatment: cetirizine PO. Epinephrine 1 mg/ 1 ml SC ordered by Dr.- to give 0.1 ml just below the reaction site right arm.
PATIENT NOTED REDNESS AND WARMTH IN RIGHT UPPER ARM AROUND INCISION SITE 3" IN SIZE.
I have what appears to look like bites throughout my body.  It reminds me of Chicken Pox; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in right arm on 06Apr2021 at 12:00 (at the age of 51-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing mixed connective tissue disease (MCTD). The patient had known allergies to Citrus. Patient's concomitant medication were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in right arm on 11Mar2021 (at the age of 51-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient did not receive any vaccination within 4 weeks prior to the covid vaccine. Patient had no covid prior vaccination and not tested positive post vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Patient reported that on 06Apr2021, I had what appears to look like bites throughout my body. It reminded me of chicken pox. The patient received steroid and BRM4 500Mg for the event. The outcome was not recovered for the event.   Follow-up attempts are completed. No further information is expected.
Fever up to 104F about 9 hours after administration with associated severe chills , headache, myalgias,
Large area of redness, tenderness, swelling, warmth @ site of DTP 7x5cm;
Systemic: Fainting / Unresponsive-Mild, Additional Details: Small laceration on right ear from falling into shelving area. Cleaned and applied pressure by who was first on scene.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for advanced age, malnutrition, pulmonary embolism, anemia, hypertension, coronary atherosclerosis, hyperlipidemia, COPD. Patient was 95 years of age. No notation regarding death or cause of death. Deceased 5/15/2021.
n/v;temp approx 101, sensitive to bright light & noise;h/a;irritability;rash;c/o neck pain when moving head;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 34-year-old male patient who received BOOSTRIX (batch number B4G4G, expiry date 5th November 2017). On 11th May 2016, the patient received BOOSTRIX .5 ml. On 12th May 2016, 1 days after receiving BOOSTRIX, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was not recovered/not resolved. It was unknown if the reporter considered the injection site bruising to be related to BOOSTRIX.
2 days post vaccination developed redness and induration of upper arm : 10cm x 6.5cm. Treated with Keflex. 3 days later symptoms were gone.
6 am awoke fatigued, by12 pm started to have slight fever. By 1:30 fever of 100.3 continued to drink water at least 40 oz by 12pm. Layed down at 1:00 pm took 250mg of Tylenol. Still felt  fatigued, fever may have been higher i did not retake. Slight headache, chills, fever, slight congestion. I felt super cold. Slept for a couple of hours, Isolated my self in my bed room. By 6 pm I awoke to eat dinner in my room. I could taste my food but dont remember smelling it. Fever was coming down but I still felt fatigued. At arpund 10 pm ate a little cutie tangerine noticed that it smlled like pine.  Slept until 8am Sunday awoke rested no fever slightly fatigued. No other symptoms. Rested all day.
Per mom "fever at 4:45 101.8 and fussy, 5:00 decrease of energy did not want to be touched and had wheezing increase resp, increase pulse, turned ghostly white put in vehicle went to ER after becoming rigid. At ER HR=220, R=68-70, increase crying temp 105 rectal was given Tylenol and Motrin IV fluids. D/C from ER at 3am, resp. normal, less fussy, feels warm." Statement per mom.
sore throat; tiredness in her legs; insomnia; prev_dose_product=COVID 19, prev_dose_brand=Johnson & Johnson, prev_dose_dose number=1/product=COVID 19, brand=Pfizer, dose number=2; prev_dose_product=COVID 19, prev_dose_brand=Johnson & Johnson, prev_dose_dose number=1/product=COVID 19, brand=Pfizer, dose number=2; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson &Johnson (Dose Number: 1), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 23Nov2021, outcome "unknown" and all described as "prev_dose_product=COVID 19, prev_dose_brand=Johnson & Johnson, prev_dose_dose number=1/product=COVID 19, brand=Pfizer, dose number=2"; IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "Booster"; OROPHARYNGEAL PAIN (non-serious) with onset 24Nov2021, outcome "recovered" (27Nov2021), described as "sore throat"; MUSCULAR WEAKNESS (non-serious) with onset 23Nov2021, outcome "recovered" (27Nov2021), described as "tiredness in her legs"; INSOMNIA (non-serious) with onset 23Nov2021, outcome "recovered" (27Nov2021), described as "insomnia". Therapeutic measures were not taken as a result of oropharyngeal pain, muscular weakness, insomnia.  Additional information: The patient did not experience any fever. Patient not diagnosed with covid-19 prior to vaccination and since vaccination patient not tested for covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
burning primarily on feet and hands; Itching primarily on feet and hands; Hives primarily on feet and hands; This is a spontaneous report from a contactable other- healthcare professional, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 13:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included graves disease, blood pressure high (HBP) and overweight. The patient received other unspecified medications within two weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received penicillin and levofloxacin (LEVOQUIN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 06Apr2021 at 13:00, the patient broke out in burning and itching hives primarily on feet and hands. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with MEDROL dose pack. The clinical outcome of the events broke out in burning and itching hives primarily on feet and hands were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
running nose; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced running nose on an unspecified date. Reporter reported as, "Can I get my second dose while having running nose". Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Approximately one week after vaccine receipt, had fever up to 102 and chills. Fever lasted for about a week. Also had aches, pain, and pt. stated had dark urine. Office visit on 8/28/06 showed essentially normal physical exam.
Headache, Myalgia, NauseaVomiting, pain to injection site Narrative:
Pt had the Moderna Vaccine Booster on 12/28/2021. About 1 week later he began to itch all over and have a red, raised, rash and wheels all over his body, worse on hands and feet. Pt states he has no prior episodes of this and has no allergies to soaps, chemicals, detergents, meds or food. He states it is happening daily. It usually starts at upper back and comes around the front shoulder and then spreads over the entire body. Pt has had to be taken to the ER for this, because it was so bad. Has had facial swelling and throat swelling with some SOB. Has been taking Benadryl and has had steroid injections and ait will go away and come right back.
Concerned about new diagnosis of ALS in 2/2008 with receipt past AVA vaccine in 2000. SM had preexisting muscle weakness, joint pain paresthesia since 1988 when dx with sciatica, HNP, tendonitis, et el. AVA vaccinations began in Feb 1999 (10 years later). He continued with s/s for HNP over next several years with symptoms on ALS beginning in 2006 with diagnosis of ALS in Feb 2008. SM with strong family hx ALS: father, brother, paternal grandfather.
3 hours post vax, the pt developed a fever to 101.5 for two days and crying inconsolably for 3 hours.
Headache, Myalgia, Clammy/Sweating, Right sore arm Narrative:
Case number PHEH2014US024958, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 21 years old male patient. Historical conditions were not reported. No concomitant medications was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 04 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Pt was given Gardasil injection. About 5 min after getting vac, pt got light headed and passed out, falling to the floor. Pt lost consciousness for less than 30 seconds. Pt's BP after the fainting spell was 92/50. Pt was given water and crackers and was moved to recliner located in office. 15 minutes after event, pt's BP had returned to normal 100/64. Lot # 1487U, exp 05AUG10. This was the pt's second Gardasil. Pt had no problems with 1st. Pt reports that she had not ate anything yet when Gardasil given at 10:00 a.m.
REDNESS AT INJECTION SITE; ITCHING AT INJECTION SITE; SWELLING AT INJECTION SITE; This spontaneous report received from a consumer concerned a female 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 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced redness at injection site. On 10-MAR-2021, the subject experienced itching at injection site. On 10-MAR-2021, the subject experienced swelling at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the redness at injection site, itching at injection site and swelling at injection site was not reported. This report was non-serious.
Extreme chest on left side and heart pain, shooting pain down entire left arm, like heart attack symptoms. I have never before had chest pain or heart pain before. I also developed pleurisy. I have no known heart conditions or prior issues with blood clots, heart attacks, hypertension, or chest pain.  -chest pain -heart pain -chest tightness -entire left arm pain -pleurisy
First injection: Sore arm that received initial injection for about one day. No treatments.   Second injection received on other arm (right): Sore arm. The next day arm was sore, perhaps sooner. Also, the next day I was lethargic/sleepy, had a slight chill and was sore in at least some joints, including ankles. No treatments other than staying in bed. The second day I was close to back to full energy.   Now a month later I'm occasionally naps these days, which I wonder whether are prompted by the vaccination.
10/23/16 - pt. woke up to her right arm being numb. This subsided through out the morning. Swelling with rash near the injection site extending down close to the elbow. Painful to close fingers - had little strength in hand. She couldn't make a fist with right hand, difficulty removing a ring that was worn. 10/25/16 - pain and difficulty brushing teeth, chopping vegetables, lifting tea pot. Burning sensation in upper arm where rash is. 10/24/16 - pt. was seen for OV. Ibuprofen 400 mg - 600 mg every 6 hrs recommended. 10/31/16 - still mild hand/finger swelling.
Mother stated first vesicle rash on arm - also had fever. Pt's fever was in control, but developed more vesicle rash on head, body and extremities about 20 vesicles rash and itchy now 8/19/09.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. There was no information about concomitant medications, concurrent condition and medical history of patients reported. On an unknown date, improperly stored doses of RECOMBIVAX HB (dose, site, route of administration, lot# and expiry date were not reported) was administered to unspecified patients. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever last night-stuffy and dripping nose that caused child to start shaking. Fever this morning was 103.6 Motrin was given.
Information has been received from a health professional concerning a 16 year old female who on 11-NOV-2006 was vaccinated intramuscularly with 0.5 ml of the first dose of GARDASIL vaccine (yeast) (lot#654510/0962F) and had no difficulties with the vaccine. On 13-JAN-2007 the patient was given her second dose of GARDASIL vaccine (yeast) (lot# not provided). Within a few moments of receiving the vaccine the patient experienced a seizure, had a very brief loss of consciousness and fell to the floor. The patient was sent to the emergency room for evaluation. The patient was not admitted to the hospital. While in the emergency room she had a CT scan, chest-x-ray and unspecified blood work. The results of these tests were all negative. The patient was seen for a follow-up appointment by the physician on 16-JAN-2007. The patient reported that she was tired, however had not suffered any additional seizures. The patient was referred for a neurology consult. The physician considered the event to be life-threatening. At the time of this report the patient had not recovered from the events. Additional information has been requested.
After patient received his 3rd immunization he became very pale and eyes closed and started to lean over this nurse grabbed client and hollered for help he was then lower to the ground. Ft elevated and put a couple fans on him to increase air flow. He then vomited, he was turned to his side and cleaned up. He remained at our facility about 1 ht w/ft elevated and air blowing on him.