chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up on 3/16/21 feeling my heart beating rapidly. I was slight dizzy upon standing from bed. I took my blood pressure at 6:06 -- readings were 112/84 and 120BPM. My usual BPM is between 60 and 75.   I meditated and took my readings again at 7:44 a.m.. They were 105/78 and 95 BPM. I verified this on an oximeter.
No additional AE; PEDVAXIB was administered post temperature excursion; Temperature 9.2C; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-NOV-2020, the patient was vaccinated with improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T001207, expiration date 09-JUN-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. There was no adverse event (AE) reported. Administered dose of the vaccine was stored in the temperature of 9.2 degrees Celsius (9.2C) for 9 minutes. There was no previous temperature excursion. Digital data logger was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA000913: US-009507513-2012USA000976: US-009507513-2012USA000834: US-009507513-2012USA000997: US-009507513-2012USA001384:
severe headache beginning after a few hours and still occurring 26 hours after injection, minor injection site pain beginning morning after
Cellulitis; Cellulitis; superficial blood clot in arm; This spontaneous report has been received from a consumer via Pfizer, regarding a 56-years-old female patient. The patient's pertinent medical history included Small lymphocytic lymphoma (SLL), previous drug reactions or allergies and concomitant medications were not reported.  On 25-FEB-2017, the patient was vaccinated with one shot of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, and a shot of pneumococcal vaccine conj 13V (CRM197) (PREVENAR 13) intramuscularly in the left deltoid (lot number: R12276), both as prophylaxis.   Then on the same date, soon after receiving the vaccination, the patient's arm had a rash and was hot, which continued growing (Cellulitis). The patient took oral antibiotics with no relief and then an antibiotic shot from ER. But then, on an unspecified date (reported as next day) she had to be admitted the hospital, where she spent two days for intravenous antibiotic treatment.   On 25-MAR-2023, the patient was vaccinated with a single dose of pneumococcal vaccine conj 20v (CRM197) (PREVNAR20), intramuscularly in the left deltoid (lot number: GF7610) as prophylaxis.  On that same date, after receiving the vaccine, the patient experienced again rash and a felling of warmth (Cellulitis) again she was given oral antibiotics and then, the next day, the patient was admitted on 6-day hospitalization for IV infusion. It was reported that from that infusion she developed a superficial blood clot (thrombosis) leaving her arm extremely swollen.   The patient stated she only had cellulitis after receiving the pneumonia vaccines, therefore she would like to know the ingredients of the vaccines to potentially rule out an allergic reaction. It was reported that the patient was good by the time of the report(recovered).  The causal relationship between the events and the suspect therapies was not provided.   Upon internal review, the event thrombosis was determined to be medically significant.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
The patient came with his mom due to the fact that he does not due well with needles. He stated that he is aware that it is all in his head. I had his mom get him something to eat and drink prior to receiving the shot, while I went over the pre-vaccine questions. She was with him while he received the shot. A few seconds after I gave the shot he began to feel hot. He asked to lie down, but never lost consciousness. We had a yoga mat for him to lay on and placed a fan to cool him down. He laid down for a few minutes, but was able to talk and convey how he was feeling. He sat up maybe 5 min later and remained in the cubicle for a few more minutes. He again stated that it was all in his head and that he didn't even feel the needle.
3-4 days after injection patient developed itching and swelling of her whole arm, dark pink - there was no lymphadenitis or axillary lymph node swelling. No fever no chills. White count was 6.6 with 14% monocytes, 54% segs, 30% lymphs
Vaccine booster administered 12/09/21. Pain in shoulder started 12/11/21. Client stated it radiated down her shoulder and back. Ibuprofen was taken with no improvement. Pain is still present. Wasn't sure how far the injection was from her shoulder.
1/18/22: Started as mild itchiness, rash, and mild upper lip swelling. Resolved with one dose of Benadryl.  1/19/22: Itchiness worsened, generalized hives. 1/20/22: itchiness and hives persistent. Seen by PCP, I was itchy non-stop. She thought it was stress, gave me Xanax. No improvement. Went to dermatologist. Diagnosed with dermatographism. Started orapred, ranitidine, and Zyrtec. No improvement. Follow up a week after, instructed to continue allergy meds, Xolair was an option to consider. Feb 2022: seen by allergist, was instructed to stop all medications, started xyzal, hydroxyzine. Was told Xolair is for severe asthma, can use for chronic hives but doesn't think I need to. 2/6/2022: randomly started wheezing for the first time ever, no distress, Benadryl helped. 2/15/2022: Randomly started wheezing, audibly louder but no distress. Benadryl helped. Since May, I have been taking Xolair monthly, relieved symptoms but now starting to return. I am so uncomfortable and embarrassed in public.
approx 10 days p/vax broke out in rash;rash itchy red areas about the size of mosquito bites;t99-101 x 1wk;taken to family MD&dx erythema multiforme
This spontaneous report has been received from a medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on 16-MAR-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # M029680, expiration date 17-JAN-2018; dose and frequency were not reported) intramuscularly, for prophylaxis. This information was discovered as a digital data logger measured temperatures 47.5 °F, 47°F to 77°F for a total time frame of 16 hours. There was no previous temperature excursion. No adverse side effects were reported, and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013277: US-009507513-1703USA013287.
PATIENT HAD A RED RAISED AREA ON L THIGH A LITTLE BIGGER THAN A HALF DOLLAR WAS SEEN AT URGENT CARE. WAS SEEN IN CLINIC BY PCM AND WAS GIVEN A ANTIBIOTIC OINTMENT.
Chills, sweats, fever, headache, body aches, nausea but didn?t throw up, hard to fall asleep-only 1 hr sleep first night.
Very loose stool within 3 hours of vaccine; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the right arm on 24Jun2021 at 12:15 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included citalopram (MANUFACTURER UNKNOWN), vitamin d nos (VIT D), magnesium (MANUFACTURER UNKNOWN) and propylene glycol (MANUFACTURER UNKNOWN); all for unknown indication from unknown date unknown if ongoing. On 24Jun2021 at 15:30, within 3 hours of vaccine, the patient experienced very loose stool. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very loose stool within 3 hours of vaccine was unknown at the time of this report.
Headache, Severe Nausea, Body Aches, Fatigue @ 0800, Miscarraige at 4 weeks
1/27/2021-0200-chills, fever up to 102.6, body aches, nausea, headache, dizziness.  Relieved with Tylenol.  Resolved approx 24 hours later
Severe, continued arm pain with active movement, inflammatory myositis as preliminary diagnosis.  Started 1 week after vaccination in the left arm, unable to move it for a few days, which improved in that arm then returned a few weeks later.  He is currently able to move and use this arm but pain worsens every evening.  With the second injection same course, severe arm pain and unable to move the arm 1 week after the injection, initially improved but then returned a few weeks later.  He is unable to still use the right arm.  Most affected movements are elbow flexion and pronation.  Treatment has been through muscle relaxers, ibuprofen and rest with use of a sling for the right arm, heat and epsom salt.  This has only provided minimal improvement.
afternoon of vax area hot to touch swelling-soreness; felt like excess muscle work out w/exercise; sensation is improving but swelling still present;
Progress Notes  (Physician Assistant)  Neurosurgery Cosigned by: MD at 2/2/2021 10:51 AM Expand All Collapse All    STORMONT VAIL COVID VACCINE CLINIC  2/2/2021                                                                  DOB:  10/3/2000  Date:  2/2/2021                                                                                             MRN:  9054917     Subjective She is a 20 y.o. female who was seen at SVH COVID Vaccine Clinic today for her second  dose of the COVID 19 vaccination.        Prior to her second injection patient informed the RN that she had a rash after her first injectio. We premedicated with Zyrtec and will monitor for any post injection reaction.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms.     ALLERGY REVIEW OF SYSTEMS   Previous Reactions: Rash    Objective Vitals There were no vitals filed for this visit.          Physical Exam  No current rash    Assessment/Plan  Treatment included: antihistamines Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash)          Electronically Signed 2/2/2021 9:19 AM
NO taste 2nd dose on Monday, fatigue and nausea during week, then on Saturday afternoon: NO Taste
This case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a female patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 9th April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In April 2018, the patient experienced injection site swelling, injection site warmth, injection site erythema and headache. The patient was treated with ibuprofen and Cold Compress. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema, headache and intramuscular formulation administered by other route were unknown. The reporter considered the injection site swelling, injection site warmth, injection site erythema and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in an unknown arm subcutaneously in error, which led to intramuscular formulation administered by other route. Less than a week after vaccination, the patient experienced injection site swelling, injection site redness, injection site warmth and headache. The patient came back to office 48 hours later experiencing a sudden swelling of her arm at the site of the injection. The local swelling was the size of a softball, red in color, hot to touch, with no rash. The medical staff administered Ibuprofen and a cold compress to reduce swelling. No follow up with the patient had occurred since the office visit treatment or exam. The reporter did not agree to follow up contact.
Mania and hypomania triggered since 2 days post injections in a bipolar naive patient. Positive mental health diagnosis of fluctuating major depression and dysthymia and PTSD for ~20 years. No cyclothymic, no bipolar dx or any other mood disorders present in history.
her throat had mucus or phelgm; her teeth were shivering; her arm was a little bit red; This is a spontaneous report from a non-contactable consumer (parent). A 16-year-old female patient received BNT162B2 (PFZIER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included anaphylactic allergy to treenuts. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced her throat had mucus or phlegm, her teeth were shivering, and her arm was a little bit red. Benadryl was given as a treatment for the events. The patient is scheduled to take the second dose of the vaccine. The parent wanted to know if the first and second dose of the vaccine is identical in composition and in strength. The parent of the patient wanted to know if they should expect the same type of reaction for the second dose of the vaccine. He wanted to know if there would be exponentially worse reactions or less reactions because the body is already familiar with the vaccine with the second dose of the vaccine. Is it better to eat before and after getting vaccinated to dilute the vaccine out in the body? He wanted to know if it is ok to give Benadryl or Zyrtec before vaccination and what is the percentage in immunity after the first dose of the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PFIZER-BIONTECH COVID-19 VACCINE EUA.  ADMINISTRATION ERROR:  Resident documented as receiving 3 doses of vaccine.  First dose of Pfizer COVID-19 vaccine on 1/12/21.  Second dose on 2/2/21.  Resident was vaccinated on 2/23/21 with paperwork showing only had 1 dose previously.  Patient has no adverse reactions reported to date.
Information has been received from a health professional concerning a 15 month old female with a history of eczema, fevers, rashes who on approximately 03 MAR 2001, was vaccinated with MMR. Two weeks after vaccination, on approximately 17 MAR 2001, the patient experienced high fever and rash. Unspecified medical attention was sought. Additional information has been received from a health professional who reports the child's rash was concerning and a IgM titer was drawn which was positive. She reported she expected it to be positive because the child was just vaccinated with MMR. It was noted that the child had been seen multiple times for fever and rashes therefore it is unknown if the rash was really an adverse reaction to the vaccine. The child's rash resolved. No further information is expected.
Fever. Pain where the shot was given. Headache, nausea, body aches, dizziness.
Arm is reddened around injection site the size of a 50 cent piece with some redness extending up to the neck. and neck lymph nodes are swollen
Dose number: 3; Arm pain at the site of injection; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).  A 18-year-old female patient received bnt162b2 (BNT162B2), administration date 15Jan2022 (Lot number: FE3594) at the age of 18 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? : Yes. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EW0171, Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Jan2022, outcome "unknown", described as "Dose number: 3"; VACCINATION SITE PAIN (non-serious) with onset 15Jan2022, outcome "recovering", described as "Arm pain at the site of injection". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Injection site pain, lymph node on the same arm very swollen and painful, slightly feverish (next day only and for a few hours at a time), and fatigue.
stated itching last night(4/20/21), noticed red blotches the next morning and worsened throughout the day, worst of it was on the back and sides
VERY LARGE AREA (COVERED ENTIRE UPPER ARM) OF REDNESS AND SWELLING - ALSO WARM TO TOUCH. APPLIED HYDROCORTISONE CREAM. ATARAX AN BACTROBAN OINTMENT PRESCRIBED.
Rapid, extreme and whole-body alopecia,  Treatment provide was by a dermatologist - treated with oral and injectable steroids
Paresthesias of R face, perioral paresthesias followed by left arm parasthesias.  11/14/09 paresthesias of R face R arm. 11/14/09 ongoing paresthesias of L arm with right thigh and lower extremity paresthesias.  11/15/09 ongoig parasthesias of limbs.  Paresthesias continued from 11/13/09 through 11/23/09.  This led to 2 appointments with my my internist, referral to a neurologist and subsequent MRI of the brain.  I was unable to work for 2 days.
Sore arm at injection site a few hours after injection.-took ibuprofen. Around 12am was woken up with chills. Took my temperature and it was low grade (99.6)- took ibuprofen . Woke up at 6am with body aches, nausea and dizziness. Took temperature and it was 100.6-took ibuprofen. Symptoms cleared up around 3pm 1/22
S/P #1 and #3 Anthrax vaccination. Each time progressive vertigo, nausea, vomiting for 2 days after shots. Treatment with IV fluids and antibiotics.
My daughter was given her last dose of the PCV series. The person who administered the vaccine did so on her inner thigh. She now has leg pain and will not walk. She also is telling me that she has things crawling on her legs and that it really hurts. This all started immediately after receiving the vaccine and has not gotten better despite giving her Motrin. It has now been over 24 hours.
fever to 104; onset 6 hr p/vax & cont w/minimal abatement & w/o other sx for 4 days; hospitalized for eval midway because listless & WBC inc; mild rash;
This spontaneous report as received from a other health professional refers to a 5 year old patient. On 11-AUG-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT). On 11-AUG-2017, 1 day after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event. Additional information has been requested.
Patient had redness, swelling, warmth, pain at injection site 1 hour after the immunization was given.  About 9 hours later, she felt some chest tightness with shortness of breath and palpitations.  She did not feel bad enough to go to ER.  She felt chills and had a headache also.  Patient felt the arm redness, swelling peaked around 48 hrs after the injection and began to subside.  When I saw her in the office today, about 72 hours later, her left deltoid was swollen, indurated, warm to touch, slightly tender  and the redness size was 8" x 5.5".  She was not wheezing.
Information has been received from a medical assistant concerning a female patient with no known medical history who was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #658555/0964U). The patient developed redness and inflammation at the injection site. The symptoms appeared either one or two days after the vaccination. It was reported that three patients all received the same vaccination, two females and one male, all from the same lot number and they all developed redness and inflammation. Only one of the three patient's recovered from the symptoms. The other two patients are either recovering or unknown. One patient received the flu vaccine along with pneumococcal 23v polysaccharide vaccine (lot #658555/0964U) on a different arm. No further information is available. Additional information has been requested.
I was tired and my arm was sore for about a day after receiving the vaccine. I tested positive for COVID-19 on 12/31/2022. I had a really bad sore throat, congestion, postnasal drip and I felt like I was choking. The stuff dripping in my throat made me feel like I was choking. I went to an urgent care center and got a prescription for PAXLOIVD. I tolerated the medication without any complications. As of today, I continue to have periods of feeling fatigued.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medication were not reported. On 06-AUG-2017, the patient was vaccinated with improperly stored ZOSTAVAX lot # M042850 and expiry date: 18-JAN-2018 (dose and route were not reported) for prophylaxis. The pharmacist was unable to provide the lot number and expiration date for the properly stored sterile diluent that were used to reconstitute the vaccines. The vaccine was exposed to a temperature frame of 15 Fahrenheit to 46 Fahrenheit for 11 hours and 2 minutes. There were no previous temperature excursions. The call was because of a digital data logger. No adverse effects were reported. No additional information is available. No product quality complaint involved. This is one of the two reports from the same reporter.; Sender's Comments: US-009507513-1708USA006430:
Patient returned to the pharmacy the next day complaining of soreness in the arm in which she received the vaccination. She was recommended to take OTC acetaminophen. Her doctor treated her with prednisone for lingering symptoms in late October. The patient also came by the pharmacy at this time with tingling in her lips and asked for a recommendation on a lip balm. She was tested for neuropathy at her doctor's office and was told the lip tingling was a reaction to the flu shot and an "extreme immune response".