chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to Medical Group for second Pfizer vaccine dose. Patient received second dose at day 14 after initial dose, one full week prior to due date.  Patient was not schedule, came in as a walk-in patient through the Medical Group's mass vaccination line. Patient put the date he thought he received first dose on the the DHA 207 screening form. The technician on the computer didn't know that the patient was too early for second dose and proceeded to update the electronic medical record, and the patient was processed further into the vaccination line. Pt received their Pfizer vaccine and waited for 10-15 minutes in the waiting area for observation. Pt came to the Immunization clinic for the CDC COVID vaccination card, but couldn't remember when they received their first Pfizer dose. I looked the patient up in the EHR and discovered he received the second dose too early. RN and Medical Director notified of incident, patient notified at time of discovery. Pt instructed to self monitor and we would contact him in 24-48 hours to check on him.
Leg cramps; Knees and back hurting; Lightheaded with headache; Knees and back hurting; Lightheaded with headache; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of an unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 02Apr2021 at 12:00, as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Patient had no known allergies. Concomitant medications included diphenhydramine hydrochloride (ALLERGAN), and acetylsalicylic acid (BABY ASPIRIN) from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 16:00, the patient experienced leg cramps, knees and back hurting, lightheaded with headache, nausea. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events leg cramps, knees and back hurting, lightheaded with headache, nausea was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The morning of 1/8 I noticed my scalp was quite itchy, which continued throughout the day and got worse at night. I woke up at about 2am 1/9, itching like crazy. I had a rash around my torso and on my legs. I took Benadryl and went back to bed but woke up a few hours later and the rash had spread further. I went to urgent care and they diagnosed Contact Dermatitis and prescribed Prednisone and Hydrocortisone. Over the next couple days, my hands and feet began to swell badly and I developed a fever of 102 degrees F. on the morning of 1/11. At that point, I went to the ER and they did bloodwork (which came back normal) and diagnosed Erythema Multiforme. The swelling subsided after a couple of days and the itching has decreased but is still present. When I scratch my skin or apply sharp pressure, a red raised mark develops. I now recognize this as being dermatographia and it has been present from the first rash. I honestly didn't think this had anything to do with the vaccine until I was searching reddit for information about dermatographia and found that there were tons of people all talking about how they had just developed it 10 days after their Moderna booster with all the same symptoms that I had.
Pt recvd 1st dose of Hep B vax w/no noted problem; pt recvd 2nd dose of Hep B vax on 18AUG92 w/an hr following the vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
refused to move the leg or walk; This spontaneous report was received from the physician, via company representative, and referred to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dosage form, administered in her leg (unspecified), for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, the patient was administered hepatitis a vaccine, inactivated (VAQTA) and "36-48 minutes after administration into leg, the patient refused to walk", "refused to move the leg or walk". The physician stated there was no redness, swelling at injection site, or fever observed. The physician reported that the patient did not go to emergency room, and was now walking on the affected leg (considered as recovering) No additional information provided. The action taken with the suspected vaccine regarding refused to move the leg or walk was reported as not applicable.   The causal relationship between the event of ''refused to move the leg or walk'' and hepatitis a vaccine, inactivated (VAQTA) was not provided.
Vomiting at every feeding (breastfed only, 2 week old). Vomiting started at 8:00 PM until 11/08/2011 4:00 AM. Some heavy vomiting (through nose and projectile, with bile). No treatment.
I received the Johnson and Johnson/Janssen Covid-19 vaccine at the vaccination pod on Thursday, April 8th, 2021 (04-08-2021) at around 12:45 pm.  The next morning, Friday, April 9th, 2021 (04-09-2021), I woke up around 9:30 am and felt fine at first.  But after taking a drink of water, I felt nauseous.  I also had a pressure sensation in the center of my chest below my collarbone.  After contacting my doctor's office, my family called 911 at around 11:40 am to have the emergency squad take me to the hospital to be evaluated for a heart attack.  At the hospital, I was diagnosed with an acute ST elevation myocardial infarction.  I was taken to the catheterization lab for a heart catheterization and a stent was placed in my left anterior descending artery (LAD).  I was admitted to the hospital on Friday, April 9th, 2021 (04-09-2021) and discharged from the hospital on Saturday, April 10th, 2021 (04-10-2021).
RECEIVED VACCINE 10/29 AFTERNOON. REPORTS HE STARTED HURTING THAT EVENING. WOKE UP DURING THE NIGHT AND "COULDN'T MOVE HIS ARM. ON 10/30 DEVELOPED HEADACHE AND FEVER. ON 10/31 HE DEVELOPED NAUSEA. HE CAME INTO THE OFFICE AND WAS TESTED FOR CREACTIVE PROTEIN AND CBC. HE WAS PRESCRIBED AUGMENTIN 875 BID X 10 DAYS.
Soreness at injection site, mild nausea and low grade fever. Onset 6 hours post-injection. Duration: 24 hours from onset
"incessant crying, unconsolable for 4 hours". Was given Tylenol every 4 hrs - unsure of fever. Occurred the evening the shot was given at 2 month old WCC.
Hives; Skin rash; This spontaneous case was received on 24-Aug-2023 from a pharmacist via Communications (reference number: SEQW23-01845) and concerned a 72-year-old, female patient.  The patient's concurrent conditions included cancer and allergy to H1N1. The patient's procedures included chemotherapy or radiation. The patient's concomitant medications included B12 (cyanocobalamin) injection, used for an unreported indication.  On 19-Aug-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for influenza prevention vaccination. The batch number reported was 346336.  On an unspecified date in Aug-2022, reported as 24 hours after receiving Fluad Quadrivalent, the patient had hives and skin rash appeared. The patient took anti-histamine to improve symptoms. The patient felt better.  On an unspecified date, the patient recovered from all events. As reported, no issues after resolution of skin problems.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 72-year-old, female patient was vaccinated with Fluad Quadrivalent. Reportedly, within 24 hours following vaccination, patient experienced rash, and urticaria. Patient took antihistamine and felt better. The patient's concurrent conditions included allergy to H1N1. Causality is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A 72-year-old, female patient was vaccinated with Fluad Quadrivalent. Reportedly, within 24 hours following vaccination, patient experienced rash, and urticaria. Patient took antihistamine and felt better. The patient's concurrent conditions included allergy to H1N1. Causality is assessed as possibly related, due to plausible temporal relationship.
Donated 880 CC, consent for tetanus signed approx 6-8 min after injection donor sat in chair and passed out pale, diaphoretic, hypotensive. Asst to floor, no seizure activity. Donor stated prior to passing out his chest hurt, with SOB. Donor only unresponsive approx 15 sec. Donor did not have any incontinence. Donor became responsive and way aware of person, place and date. Donors feet were elevated vital taken, ice packs to back of neck. Blood sugar taken by EMS 118. Donor had no food or liquid since the previous night. Transported by EMS to local Emergency dept. Follow up with Emergency dept no medical treatment done, no lab work, only a food tray given and donor was released home.
I do not think these symptoms are related to vaccine.  I carried a box that seems to have been contaminated with some irritant because I got a 20 cm by 15 cm red, inflamed, itchy rash in the antecubital area of my right arm.  It was increasing in size after one week of self  care with topical Caladryl.  I went to my primary care doctor, and she prescribed Prednisone for what she diagnosed as contact dermatitist.  On the day I reported to V-safe, I had taken 2 days of high dose Prednisone and had not slept well and had a headache, so I reported that I didn't feel well.
Information has been received from a registered nurse concerning a 5 year old patient who on 20-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not reported) instead of a second dose of VARIVAX (Oka/Merck). No adverse effect reported. This was due to a nursing staff error. The two vaccines were next to each other and the wrong medicine was obtained and administered by accident. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 66 year old male patient with none drug reactions or allergies. On 04-AUG-2014 the patient was vaccinated with ZOSTAVAX (injection, dose, units, route of administration, anatomical location, lot number were not reported). On 04-AUG-2014, after receiving one dose of ZOSTAVAX the patient experienced flu like symptoms. The reporter stated that the reactions began after eating and on 04-AUG-2014, about an hour after receiving the injection. The patient also experienced vomiting, diarrhea, was not able to sleep well, was sweating, having the chills and experiencing a low grade fever. The reporter stated that the reactions lasted all day on 04-AUG-2014. The patient went in for a visit with his physician, the next day on 05-AUG-2014. The outcome of adverse events was reported as recovered on 05-AUG-2014. There was none lab diagnostics studies performed. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
pulmonary fibrosis, O2 dependent, dementia, heart murmur, respiratory failure,
1044 - c/o lips tingling w/inner lips swelling BP 110/70, HR 92 RR 18 O2 99%. 1044 Benadryl 25mg PO administered 1045 119/71 88 18 100%, NAD 1050 118/70 82 18 100% NAD 1100 116/75 84 20 100% NAD, pt states swelling gone, numbness around mouth 1113 107/71 82 18 100% lips numb 1115 states a small amount of numbness remains, NAD 1127 107/62 16 100%, ststae she feels much better, dc to home. advised pt to notify PCP of incident
possible expired dose of Typhim Vi was administered to patient, No AE; expiry date illegible on syringe label, no AE; Initial information received on 29-Oct-2019 and additional information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 46 years old male patient who received an expired 0.5 ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI].  The medical history, medical treatments, vaccinations and family history were not provided.   On 25-Oct-2019, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (Injection Suspension, lot N1K811M Expiry date: 19-Nov-2019) via unknown route in the left deltoid.  It was a case of an actual medication error due to expired vaccine used.  It was also a case of Product expiration date illegible.  At the time of report no adverse event was reported.  PTC Number: 100005853 Batch number: N1K811M Expiry date: 19-Nov-2019 Sample Status: Not Available. Issue status: in process  The nurse reported that the administering Medical Assistant (MA) did not know the expiration date due to the date on the syringe appeared to be smudged and the box the syringe was taken out of was not located; that the date was either 19Oct2019 or 29Oct2019; that the MA reported the date to be smudged but the syringe was disposed before anyone else could see the syringe; that the date was looked at after the injection was given.  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.
Fibromyalgia fatigue flareup that lasted 2 days.  I am a Pastor & this is very busy week for me & the two combined may have been the culprit more than just the vaccine itself.  Not sure. But thought I should report it.
Initial report receiving from a consumer on 01 May 2012. A 04-year-old female patient without any medical history or known allergies and whose concomitant medication were not reported; had received fifth dose of DAPTACEL intramuscular (lot number: C4006AA) on the left deltoid area and 4th dose of IPOL (Lot number: G1500-1) subcutaneous in the left arm on 07 March 2012. Within 24 hours of vaccination the patient developed swelling that lasted for about 1.5 to 2 weeks. After this the area around the site appeared to be bruised. The area was of a size bigger than "pepperoni but smaller than salami". After the bruised area resolved, there was still a faint brown pigmentation area that of size of the bruised area. There was no complain of pain, however there was a small nickel sized area in the center of it which was dry and bumpy like eczema. The area recovered with the use of cortisone cream application. The patient had to once visit the doctor however no further details were reported. The outcome of event was not recovered. List of documents held by sender: none.
T102, on 4JUN91 given APAP; started gagging-like gasping for breath; grandma shook pt & was OK; Did not go to ER; Occurred again next AM;
Tingling/numbness in face, itching at injection site, fever close to 103, extreme body aches, extreme fatigue, extreme headache, lethargic, spiked fever off and on for 5 days after receiving vaccination, my face and neck were so hot and red that I wanted to peel my skin off and at the same time my extremities were ice cold.
Pt was sick from a nurse spreading rotavirus when first vaccinated at 2 days old with hep b.
Case previously recorded as MA2009-4153. Initial case repot received from a physician on 11 NOV 2009. A 3-year-old male patient was vaccinate with 0.5 ml of FLUVIRIN (batch no. 1008146P) i.m. on 05 NOV 2009, an off label indication. No adverse event was reported. Reference no: NA09-007993.
This spontaneous report as received from a pharmacist refers to a 75 year old female patient. On 07-NOV-2014 the patient was vaccinated with PNEUMOVAX 23 lot # K007825, intramuscular in one of the arm. No concomitant medications and medical history were reported. At the same time patient had an unspecified high dose flu shot administered on the other arm. On an unspecified date in the year 2014 the patient experienced sore shoulders followed by the administration. No lab diagnostic studies were performed. The patient was advised to treat the soreness with ice as needed. The reporter was requesting a lot check for the PNEUMOVAX 23. Patient sought medical attention through pharmacy call. No product quality complaint was involved. The outcome of event was reported as recovering/resolving. This is one of several reports from the same reporter. The pharmacist requested lot check for the PNEUMOVAX 23. Additional information has been requested.
Smallpox vaccine was administered to patient's mother on April 28, 2007. Mother reports good take with blistering lesions. She kept inoculation site covered as instructed. She developed one satellite lesion about 3 cm from inoculation site. Child developed skin lesion on R forearm approximately 5/27 which developed into multiple pustules; 4-6 days later developed multiple lesions on face, arms and legs. Later lesions were papular, some appeared to be deep pustular lesions but never blistered. The patient had intermittent low grade fever from June 3rd through June 5th. Many of the lesions healed with crusting. On June 4th the primary lesions were becoming scabbed over. On June 6th, the patient was noted to have two posterior auricular lymph nodes on L (same side as facial lesions) which were mildly tender, the skin over one was erythematous. Patient sleeps in bed with mother. Patient has been observed as outpatient; only treatment so far has been Benadryl for itching and calamine lotion.
Pt recvd vax & 2 hrs p/vax screaming, rash, elevated temp-during nite t104 ax; given APAP by next morning; rash under skin, swelling around eyes & face had difficulty breathing seen by MD given DPh; t102.6 @ MD office;
Excessive crying with Tylenol dosages throughout 24 hours after. Knot in Left thigh at injection site for 1 week. Injection site on both legs red & warm to the touch for 3 1/2 days.
19Jan91 pt vax w/ MMR + H. flu vax;  devel urticaria.  Tx w/ Benadryl.  Pt reexamined on 09Feb91 due to worsening sx. pt had gen dermatographism + devel urticaria at points of contact w/ skin. Dermatographism continued to persist.
Flu like symptoms. Body and joint aches. Low fever. Tired. Chills. Headache. Eyes ache.
Patient was given refrigerated Moderna that was expired beyond it's 'Beyond Use Label' date of 01/27/2022.  Vial was placed into fridge on 12/28/2021.  Vial was not removed from fridge in time for 'Beyond Use' expiry date and inadvertently administered.  Manufacturer's expiry date is March 25, 2022.  Provider informed.  Moderna informed and stated that 'the vaccine administered on January 28 to February 7, 2022 from lot number 033H21A maintained the activity necessary to protect against the SARS-CoV-2 (covid 19) virus at time of administration'.   Patient informed and no adverse effects noted.
Patient fainted after vaccine but was assisted to the floor. States that he has anxiety. Patient carefully watched in observation and did deep breathing exercises. He stated he felt better and vitals were within normal limits
Provider ordered vaccine 2 months before second dose was due. Provider informed the patient regarding the error.
Vaccine area is warm to the touch, large and round red discoloration and it itches even though there is no pain when touched.
2 hours after Gardasil Administration pt developed inability to swallow. Advised to take Benadryl by covering physician and go to ER. In ER not given EPI but Solumedrol to take for 5 days.
1st dose - severe spinal pain from base of neck to bottom of tailbone lasted for 3 days. Severe arm pain at injection site for 3 days, severe headaches for 3 days
Given PEDIARIX and IPV together (= 2 doses IPV). No unusual adverse events.
The patient experienced "redness, pain, and swelling as a hole was starting to develop around the injection site for GARDASIL 9, the patient also experienced "a swollen injection site that was developing blisters and bubbles from the VAQTA [injection site swelling]. Information has been received from a physician via a company representative referring to a 14 years old female non-pregnancy patient. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (dose unknown) intramuscularly in one arm and VAQTA (dose unknown) intramuscularly in the other arm. On an unknown date, the patient experienced redness, pain, and swelling as a hole was starting to develop around the injection site for GARDASIL 9. The patient also experienced a swollen, purple injection site that was developing blisters and bubbles from the VAQTA. The patient had sought the physician twice and treatment had been given for the events. The causal relationship between the events and GARDASIL 9, VAQTA was unknown. Additional information has been requested.
experienced body aches; chills; medium to high grade fever; the injection site had significant redness and swelling that was painful; the injection site had significant redness and swelling that was painful; the injection site had significant redness and swelling that was painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: 330268D) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 17Oct2021. Vaccination history included: Bnt162b2 (Dose 2, lot number=EW0175, vaccine location=Left arm), administration date: 25Apr2021, when the patient was 34 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, lot number=ER8733, vaccine location=Left arm), administration date: 04Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 13Nov2021 20:30, outcome "recovering", described as "experienced body aches"; CHILLS (non-serious) with onset 13Nov2021 20:30, outcome "recovering", described as "chills"; PYREXIA (non-serious) with onset 13Nov2021 20:30, outcome "recovering", described as "medium to high grade fever"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 13Nov2021 20:30, outcome "recovering" and all described as "the injection site had significant redness and swelling that was painful". The events "experienced body aches", "chills", "medium to high grade fever", "the injection site had significant redness and swelling that was painful", "the injection site had significant redness and swelling that was painful" and "the injection site had significant redness and swelling that was painful" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain, chills, pyrexia, vaccination site erythema, vaccination site swelling, vaccination site pain.  Additional information: The patient did not receive any other medications in two weeks. The patient did not have Covid prior vaccination. The patient did not get Covid tested post vaccination. Known allergies were none. Other medical history was none. From late night of 13Nov2021, experienced body aches, chills, and medium to high grade fever. The symptoms persisted through most of 15Nov2021. Additionally, the injection site had significant redness and swelling that was painful.   No follow-up attempts are possible. No further information is expected.