chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen eyes; rash present on neck and shoulders; debilitating headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jan2022 15:45 (Lot number: FK5127) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "dairy allergy" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D3. The following information was reported: EYE SWELLING (non-serious) with onset 22Jan2022 18:00, outcome "recovered", described as "swollen eyes"; RASH (non-serious) with onset 22Jan2022 18:00, outcome "recovered", described as "rash present on neck and shoulders"; HEADACHE (non-serious) with onset 22Jan2022 18:00, outcome "recovered", described as "debilitating headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eye swelling, rash. Therapeutic measures were not taken as a result of headache.  Additional Information: No other vaccine in four weeks. Other medications in two weeks: Vitamin C, Vitamin D3. The patient received the first dose on Friday afternoon. By Saturday afternoon she had a debilitating headache. Sunday, she had swollen eyes and rash present on neck and shoulders, no signs of respiratory distress. Benadryl had to be given for 48 hours every 4 hours to help reduce rash and eye swelling. Throughout the week rash present on body. No covid prior vaccination. Covid tested post vaccination.
Left arm stiff and sore at injection site - axillary lymph glands swollen.
Softness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PAA156051) via an unspecified route of administration in the left arm on 11Mar2021 at 13:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included desvenlafaxine/succinate monohydrate (PRISTIQ) 25 mg, ethinylestradiol/ ferrous fumarate/ norethisterone acetate (JUNEL FE) and paracetamol (TYLENOL); all for unknown indication from unknown date and unknown if ongoing. The patient previously received acetylsalicylic acid (ASPIRIN) and ibuprofen (MOTRIN), for an unknown indication on an unknown date and experienced drug allergy. On an unknown date in Mar2021, the patient experienced softness at injection site, lasting about 48 hours after vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event softness at injection site recovered on 13Mar2021, after the duration of 48 hours.   No follow-up attempts are needed. No further information is expected.
Fever (102), chills, terrible body aches (muscles and joints), tired, very very nauseous.  Arm was so sore I couldn't move it - made me light-headed to move it enough to even put my shirt on the next day.
Information has been received on 02-JUL-2018 regarding a case in litigation from a lawyer and a male 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 at a pharmacy, 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. On or about 24-FEB-2016, the patient was treated by a physician at a medical center for a severe vesicular outbreak, which was diagnosed as herpes zoster along with neurological pain from shingles. The patient was prescribed ZOVIRAX and prednisone for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient 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.
Pt was complaining of swollen jaw area (pointing right in front of her ear where sideburns would be) pt also claimed her teeth no longer lined up.
pt recvd vax 18DEC92 & devel painful cry that lasted all afternoon & noc-would not sleep or eat; had swelling & redness lt leg; fever no higher than 100; red dot rash;
This spontaneous report as received from a certified medical assistant to an 11 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; Dose number 1: Moderna; Dose number 2: Moderna; Dose number 1: Pfizer / BioNTech; Dose number 1: Moderna; Dose number 1: Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Lot number: FH8020), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Jan2021 as dose 1, single (Lot number: 013L20A), on 06Mar2021 as dose 2, single (Lot number: 003A21A) and on 03May2022 as dose 4 (booster), single (Lot number: 049L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis in left hip" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 16Aug2022, stop date: 22Dec2022; MELOXICAM, start date: Jan2022, stop date: 12Jan2023. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2021, outcome "unknown", described as "Dose number 1: Moderna; Dose number 2: Moderna; Dose number 1: Pfizer / BioNTech; Dose number 1: Moderna; Dose number 1: Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient received Pfizer Covid Vaccine and went to sit in the waiting area.  Immediately upon sitting down, patient said she felt dizzy and fell on the floor and bumped her forehead.  Patient is responsive and pharmacist observed patient for 30 minutes. Offered to call 911 for the patient, but mother refused and they are going to see their PCP after leaving the pharmacy.
pt received the incorrect vaccine. pt received Moderna Pedicatric Monovalent vaccine NDC 80777-275-99 instead of Moderna Bivalent Vaccine NDC 80777-0282-05
First dose of Moderna given 1/7/2021. Second dose given 2/4/2021. Booster dose given 11/10/2021. No adverse reaction noted immeadiately after vaccination. Restlessness noted 11/12/2021. Resident with low grade fever, tachycardia and tachypnea on 11/13/2021. Resident expired on 11/14/2021.   Weakness, poor PO intake and weight loss noted since October 2021. Resident was enrolled in hospice care on 11/1/2021.
headaches; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: Age/Date of birth was reported as 80-84 years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This was my second shot. Other than soreness on my arm, I have a fever and I feel cold. After the first shot, I only had soreness which disappeared in 3 days.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: pt witness previous pt receive vaccine and was nervous, we offered to reschedule him, but he insisted on getting the vaccine anyways
CAN'T SLEEP; SCIATICA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced sciatica. On JUN-2021, the subject experienced can't sleep. Treatment medications (dates unspecified) included: tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sciatica, and can't sleep. This report was non-serious.; Sender's Comments:   Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Syncope & sweating. Client laid down with feet up and fan on her for about 20-30 minutes with this nurse and her mom.
No reaction at all to the vaccination for the first 10 days.. Day 10 had tenderness and swelling in arm at injection site., Day 11 arm was red, swollen and painful, also had chills, fever and fatigue. Day 12 temperature is back to normal, body aching,  headache and cough.
Information has been provided that a pt had been given a pneumococcal vaccine and influenza vaccine in the same syringe. The pt experienced some cellulitis at the injection site but no other symptoms were noticed.
Flushing, uncontrolled shaking near syncope w/BP 90/60, Pulse 120.
Patient noticed a triangle patch hair loss  on her left temple. Primary care doctor referred her to a board certified dermatologist. Dermatologist diagnosed her with Alopecia areata and said it was a genetically linked autoimmune disease. He said that stress can exacerbate this condition. Patient admitted she has had several stressors. She also developed numbness in her great big toe. All of this occurred between the 2nd vaccine and 1st booster dose.   Patient was speaking to coworkers who were nurses who told her this autoimmune disease was caused from the vaccine and advised her to not get the 2nd booster. Patient was NOT directed by specialist or primary care doctor that these disease states were likely linked to vaccine. Patient just going by what friends said.
a patient who is 14 years old was administered a dose of PROQUAD; No adverse effects reported; This spontaneous report was received from a nurse and refers to a 14 year old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unknown date in December 2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (product administered to patient of inappropriate age) lot # S008571 and expiration date 16-SEP-2020, for prophylaxis (dose, strength, route of administration and frequency were unknown).         No adverse effects were reported.
patient had difficulty swallowing and increased dizziness shortly after vaccine was administered. Symptoms progressed, EMS had to be called and epinephrine was administered. Symptoms abated and patient was able to leave on her own accord to go for further evaluation at a nearby medical facility
Severe chills from 10am-3pm on 3/13/21 along with fatigue.  At 4pm I got extremely hot and started with back and chest pain along with not being able to get a good breath in.
Palpable, non-painful, LEFT supraclavicular lymph node swelling noticed 3/10/21, 3.5 weeks after second Moderna COVID vaccination administration (2/15/21) in LEFT arm. No prior history of lymph node swelling in that particular region.  Ultrasound done the next day, on 3/11/21, at Hospital.  Results were consistent with "reactive lymph node" from Moderna vaccine.
BRUISE AT THE INJECTION SITE; SIDE EFFECTS; PAIN IN LEGS AND ARM PAIN; CHILLS; FEELING OF WEAKNESS; SLIGHT HEADACHE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included lyme disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced bruise at the injection site. On APR-2021, the subject experienced side effects. On APR-2021, the subject experienced pain in legs and arm pain. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced feeling of weakness. On APR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in legs and arm pain, and the outcome of bruise at the injection site, slight headache, chills, feeling of weakness and side effects was not reported. This report was non-serious.
rash; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 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 medications were not reported. The patient experienced rash on an unspecified date. Outcome of the event was unknown.  There is no product complaint associated with this case  Follow-up attempts are needed, further information is expected.
pt came in w/mom c/o foul smell in stool, sleeping a lot & eyes crossing;
Soreness, red swelling--growing from 3"x3-1/2" red raised spot hot to touch to 3" x 5" raised red spot hot to touch.
Longer than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 49-year-old female patient who received HAB (Twinrix) (batch number X239D, expiry date 22-SEP-2023) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 30th September 2022, batch number: X239d, expiry date 22 September 2023).   On 31-MAR-2023, the patient received the 2nd dose of Twinrix. On 31-MAR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended interval). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19 Jul 2023 The pharmacist called in to report that a patient was looking to receive the 3rd dose of Twinrix but there was a 6 month period between dose 1 and 2. They provided information about event, vaccine and patient.  Follow-up was accepted. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The patient looking to receive the 3rd dose of Twinrix but there was a 6 month period between dose 1 and 2, which led to drug dose administration interval too long.
R facial edema and pruritus,  headache, chest pressure, dizziness,  cough. Treated with diphenhydramine 50mg IM in clinic, Benadryl at home.
7 cm x 7 cm reddened area slightly indurated on Rt. deltoid
This is a spontaneous report by a contactable nurse via Pfizer Sales Representative. A female nurse reported for a patient who received PREVNAR 13 at single dose on arm on 21Jul2014. Relevant medical history and concomitant medications were unknown. Vaccines given on the same day or within the last four weeks were unknown. On 23Jul2014 the patient had cellulitis at the injection site. Relevant lab data and sibling information were unknown. The patient was placed on an unspecified antibiotic as therapeutic intervention for the above mentioned event in Jul2014. At the time of report clinical outcome of the above mentioned event was unknown. The causality of the event in relation to the product was unknown.
Pt received COVID vaccine one hour prior and presented to the ED after developing burning in her throat, warmth in chest, and rapid heart rated. Pt began to feel better after another hour. Idiosyncratic response not expected from normal pharmacological mode of action (MOA) Pt had received the COVID vaccine one hour prior, so it is likely the rxn was due to the vaccine. Pt has additional allergies to amoxicillin, azithromyzin, and sumaxin.
severe allergic reaction to booster; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ALLERGY TO VACCINE (severe allergic reaction to booster) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (severe allergic reaction to booster). At the time of the report, ALLERGY TO VACCINE (severe allergic reaction to booster) outcome was unknown.            No concomitant information was reported. It was reported that patient had received booster dose of vaccine. No treatment information was provided.   Reporter did not allow further contact
Fatigue; body aches; She just had a sore arm as well that was super mild at the injection site.; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration, administered in Arm Left on 04Jun2021 (at the age of 42-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical History (including any illness at time of vaccination) was None. Family history was none. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 04Jun2021, the patient experienced fatigue, body aches. On Jun2021, she just had a sore arm as well that was super mild at the injection site. It was reported that if the patient was hospitalized, how many days was the hospital stay. No vaccine administered at military facility. Therapeutic measures were taken as a result of fatigue. The clinical outcome of she just had a sore arm as well that was super mild at the injection site was unknown and other events were recovered on 09Jun2021.  Information on Lot/Batch number was available. Additional information has been requested.
Severe fatigue, muscle aches, joint aches, injection site swelling, severe itchiness, large hard lump under the skin
Dizziness, very pale, fainted getting out of the bath father caught patient before he hit the floor.
Narrative:  75yo male patient with hx of niddm, htn, hld, anemia/thrombocytosis, b12 def, tinnitus died on 11/9/2021 with no info given on cause or circumstances of pt's death. Pt received most of his medical care outside of clinic. Pt had received covid vaccines on 2/2/21 & 2/25/21 from outside clinic. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
Dose 1 on 07Apr2021 and dose 2 on 07Jul2021; Body chills but hot to touch; Body chills but hot to touch; armpit swelling/neck swollen; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jul2021 at 11:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The patient had no known allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously 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 07Apr2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Jul2021 at 07:00, the patient experienced body chills but hot to touch, armpit swelling and neck swollen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body chills but hot to touch, armpit swelling and neck swollen were not recovered at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.