chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upper lips is slightly swollen and tingly just a lit bit; upper lips is slightly swollen and tingly just a lit bit; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot: number: unknown) via an unspecified route of administration in arm left on 31Mar2021 12:00 PM (Age at vaccination was 56 Years and patient was not pregnant at the time of vaccination) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vitamins C and D and multi vitamin are the list of other medications the patient received within 2 weeks of vaccination. No allergies to medications, food, or other products. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot: number: unknown) via an unspecified route of administration on unspecified date as DOSE 1, SINGLE for COVID-19 Immunisation. Consumer Stated, I got the Pfizer Covid vaccine yesterday my second one. The first one I just had the sore arm and the only questions I have was today it's been 24 hours since my second one and my upper lips is slightly swollen and tingly just a lit bit on 01Apr2021. I was wondering if I can take Benadryl, was it okay to take Benadryl. The outcome of the events was unknown.   No follow-up attempts were needed. Information about lot/batch number could not be obtained.
Information has been received from a physician concerning an 8 year old female who was vaccinated IM with a dose of Vaqta. Subsequently, the patient developed rash. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information received from a registered nurse indicating that "no one in the office recalls anything like this". No additional information expected.
On 09/21/2022 I received my Covid-19 vaccine. On 12/30/2022 I started having pain in my left thumb that traveled through to my wrist then arm. My thumb joint looks a bit dislocated. After reaching out to my doctor I received a cortisone injection in my wrist. I was diagnosed with De Quervain's Tenosynovitis.
Auto inoculation to left hand, erythema, intense itching, rash (Erythema multiforme) , onset approx. 7-10 days after vaccination. Tx with Ataract, Darvocet, Allegra
no ADVERSE EVENT.  VACCINE ERROR, PT CAME IN FOR MODERNA BOOSTER BUT ALSO INADVERTENTLY RECEIVED BOOSTRIX INJECTION.
This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (dose, frequency and indication were not reported; lot # L027726 with expiration date: 10-MAY-2017). Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Diagnosed with covid; Diagnosed with covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): PFIZER INC-202200000007 (pfizer), PFIZER INC-202101886107 (pfizer).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Diagnosed with covid".Reporter stated today (was nurse but was not involved/was not told in a professional setting). Males, all mid-late 20s (public figures - can find all info including birthdays online. withheld reporter think was almost 30.). This was a recent event. Not sure what vaccines are provided, but they are likely all vaccinated. Saw this article yesterday regarding withheld, last updated 24Dec2021 (includes people telling him to get well soon). Other medical history withheld had shoulder surgery last year or early this year to treat a longstanding injury  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101858742 same reporter/vaccine/event, different patient; US-PFIZER INC-202101872620 same reporter/vaccine/event, different patient.
black-outs; syncope; contusions; hypotension; fallen four times; five broken ribs; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program .  A 85 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "melanoma carcinoma on his scalp"; Bnt162b2 (Dose 2), for Covid-19 Immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "black-outs"; SYNCOPE (medically significant), outcome "unknown", described as "syncope"; CONTUSION (medically significant), outcome "unknown", described as "contusions"; HYPOTENSION (medically significant), outcome "unknown", described as "hypotension"; FALL (non-serious), outcome "unknown", described as "fallen four times"; RIB FRACTURE (non-serious), outcome "unknown", described as "five broken ribs". Clinical course: After his booster dose of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap), the patient developed a series of serious adverse events like black-outs, contusions, hypotension, and syncope. The patient has fallen four times and currently has five broken ribs. They cannot find a reason of why he is dropping, other than he received his booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hodgkins lymphoma", start date: 1975 (unspecified if ongoing), notes: Hodgkins lymphoma; "breast cancer", start date: 1996 (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LIPITOR. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Pavloxid as treatment for Covid-19. Other medication in 2 weeks: Yes  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information the possible causal association of suspect BNT162B2 and for reported events -drug ineffective and COVID-19 cannot be excluded
Soreness, redness and swelling in the arm where given, fever of 99.8, extreme tiredness, muscle aches. Took a hot shower and aspirin. Mostly clear by the next morning.
Moderna vaccine was administered to patient past the 12 hour beyond use time. No Adverse reactions were observed by the pharmacist within 15 minutes after vaccination. Patient did not contact us as of 6 hours after vaccination to report adverse reactions.  Moderna manufacturer was contacted and we are awaiting a return call from a vaccination expert.
Slight bumpy, itchy rash 2 inches below injection site. No redness. Lasted 3 or 4 days. Periodic itching/bumps 3 weeks after first shot. No treatment.
Patient at facility stated that he had already received both doses of the vaccine. The pharmacist consulted with the nursing staff and reviewed the vaccine administration card. Both the staff and the card did not have record of him receiving the second dose so the pharmacist administered the vaccine. The pharmacist returned to the store for processing and found that the patient had documented both doses and was mistakenly dosed for a 3rd time.
SWELLING OF THE HAND; SWELLING OF THE ANKLE; SWELLING OF LEFT TOE; GOUT; This spontaneous report received from a patient concerned a 63 year old male. 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced gout. On 23-MAR-2021, the subject experienced swelling of the hand. On 23-MAR-2021, the subject experienced swelling of the ankle. On 23-MAR-2021, the subject experienced swelling of left toe. Treatment medications (dates unspecified) included: colchicine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of the hand, swelling of left toe, gout, and swelling of the ankle. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Next day reaction, site swollen to size of golf ball per patient description, red with a temperature of 102 degrees F. Patient felt nauseated but no vomiting.
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored PEDVAXHIB, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling (slight) in arm after 4-5 hrs. Used ice/overnight. Swelling to elbow in AM after approximately 18 hrs.
10-15 minutes after innoculation, patient experienced lightheadedness, SOB, choking sensation, diaphoresis. Relieved with 25mg IM Benadryl, then 25mg IV Benadryl. Reviewed e-mail update from reporter on 3/16/04. Final diagnosis was anaphylaxis.
Moderna vial was punctured 21 times and the patient listed received the 21st dose. No adverse reactions noted.
Muscle aches; Low grade fever (100.1 for 24 hours); Swollen lymph nodes; Chills; headache; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN8720), via an unspecified route of administration in the left arm on 24Mar2021 at 11:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and migraines. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included hydroxychloroquine (MANUFACTURER UNKNOWN), vitamins (MANUFACTURER UNKNOWN), ethinylestradiol; ferrous fumarate; norethisterone acetate (LO LOESTRIN FE) and escitalopram oxalate (LEXAPRO), all for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the left arm on 03Mar2021 at 14:30 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 18:00, the patient experienced muscle aches, low grade fever (100.1 for 24 hours), swollen lymph nodes, chills and headache. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 09Mar2021 and 16Mar2021 which included Covid PCR test via nasal swab and the test result was negative. The patient did not receive any treatment for the events muscle aches, low grade fever (100.1 for 24 hours), swollen lymph nodes, chills and headache. The clinical outcomes of the events muscle aches, low grade fever (100.1 for 24 hours), swollen lymph nodes, chills and headache were recovering at the time of the report.   No follow-up attempts are needed. No further information is expected.
This second dose resulted in a slight headache; joint pain; fatigue; nausea but no vomiting. Please note: I previously reported AFTER MY FIRST DOSE that my right eyelid is drooping. This condition is still a problem and causing me to have double vision.
Large sore on Left tonsil. No response to home treatment. Slow improvement commenced after once-daily 3-day treatment introduction of steroid, Prednisone (20 mg). Improvement continues but condition has not resolved.
Injection site swelling which turned into rash and itching on 04/13/2016. The area of rash was 4 1/8" by 5" which extended down the arm. Took Benadryl as instructed by the administering NP.
Mid-Saturday afternoon - 10/2 - Patient reports a temperature of 100F.  She understands as a former nurse that a fever is part of side effects.  Today she said her fever peaked on Saturday to 104 F,  but temperature now normal    She has fever blisters in her mouth that makes it difficult for her to talk.  Also, she says her vaccinated arm is red, swelling, and hot to touch from elbow to shoulder.  I counselled her to see her PCP ASAP.   She said when she woke up today she took some benadryl and valacylovir for her fever blisters.   Patient finally said that she'd call her PCP after speaking to me.
Flushing 2-5 minutes after the injection;  numbness in tongue and difficulty swallowing 20 - 25  minutes after infection
Throat closure, trouble swallowing.  Severe nasal/sinus congestion. Still not completely gone despite taking benadryl, then Mucinex
This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 37-year-old female subject who was vaccinated with FLUARIX, (GlaxoSmithKline).  On 20 October 2008 the subject received a dose of FLUARIX (.5 ml, unknown, right arm).  On 20 October 2008, less than one day after vaccination with FLUARIX, the subject experienced injection site soreness.  The subject reported she experienced soreness at the injection site after receiving FLUARIX.  She stated the soreness resolved about 6 to 7 hours later, before she went to bed.  She stated she had also been lifting some items between receiving the FLUARIX vaccine and the time the soreness resolved.  On 20 October 2008, the event was resolved.  The healthcare professional considered the event was probably related to vaccination with FLUARIX.
Administration date=17Jan2021, dose number=2/administration date=17Dec2020, dose number=1; joint pain throughout my body/continue to experience joint pain mainly in my knees and my ankles; This is a spontaneous report from a contactable other hcp (Patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK4176) via an unspecified route of administration at arm left on 17Jan2021 12:30 as single dose for COVID-19 immunization. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH989) via an unspecified route of administration at arm right on 17Dec2020 12:30 as single dose for COVID-19 immunization and celexa [celecoxib] and experienced drug hypersensitivity. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history was not reported. Concomitant medications included bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY), vitamin d nos (VITAMIN D NOS) and latanoprost (LATANOPROST). The patient experienced inappropriate schedule of product administration and joint pain throughout my body and continue to experience joint pain mainly in my knees and my ankles on 19Jan2021 12:00. The outcome of the event joint pain was not recovered, and rest was unknown.
Patient seen by Dr. Patient c/o symptoms for 2 days since Shingles Vaccination on Monday, May 7, 2012.  Rash started on Tuesday, May 8, 2012 around injection site and got swollen and very warm and then started to spread on the right arm.  Patient prescribed Acetaminophen 325mg tab PO q6h if needed for fever or mild to moderate pain.  Patient also instructed by Dr. to apply ice packs 3-4 times a day and try not to rub or scratch.  Patient seen by Dept of Internal Medicine on May 10, 2012. with c/o pain at site of Zostavax.  Patient dx with Cellulitis of right arm and Lymphadenopathy on axilla.  Dx with localized reaction to vaccine.  Labs ordered.  Instructed to follow-up as needed.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the long-term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 19-FEB-2016, the patient was treated for the onset of a vesicular rash which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
19 y/o female fainted following Pfizer vaccine.  VS: BP=108/64, RR=24, HR=45, 100% RA, BGL=90.  Pt monitored for over 30 minutes and felt better.  Repeat VS: BP=117/75, RR=18, HR=74, 100% RA.  Pt cleared by medical provider and went home with family.
Mom reports the patient experienced Diarrhea, rash, and swelling of the left leg. The leg was noted to be hot to touch. Mom gave the patient Tylenol on 09/25/2020 @ 0200. Benadryl administered in the office on 09/25/2020 @ 1145, cool compress applied, oral steroid medication started, patient to follow up on 09/28/2020
Nausea, diarrhea, pounding headache, fever (101.6), extreme fatigue, sore joints, aches, loss of appetite (3 days)....
Severe ear pain in my right ear; Some pain in the neck directly underneath my right ear; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 15:15 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. 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. The patient did not receive any concomitant medications. On 31Mar2021 at 21:00 about 5 - 6 hours after being vaccinated in left arm, the patient experienced severe ear pain in right ear and some pain in the neck directly underneath right ear. It was reported that ear pain took 3 weeks to subside and it was undoubtedly a direct result of the vaccine. The patient had never experienced an earache in life prior to being vaccinated. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe ear pain in right ear was recovered on an unknown date in Apr2021 and some pain in the neck directly underneath right ear was recovered on an unknown date in 2021. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Chest pains on right side of chest.  Pain continued until next day so I went to Urgent Care and they advised me to go to the ER b/c they would be able to perform any test necessary and they were worried about blood clots.  They determined it was most likely pleurisy.  Prescribed Naproxen and told me to follow up with my regular doctor.  Pain is still constant as of today.
MUSCLE ACHES; MINOR REACTIONS; This spontaneous report received from a pharmacist concerned a male of unspecified age. 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 (Dose number in series: 1) (suspension for injection, route of admin was not reported, and batch number: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced minor reactions and muscle aches (Dose number in series: 1) . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of minor reactions and muscle aches was not reported. This report was non-serious. This case, involving the same patient is linked to 20211233514 (Dose number in series: 2, Booster dose) This case, from the same reporter is linked to 20211233321 and 20211233061.
Became cool & clammy - blue around mouth; appr 45 min p/vax was given Decadron IM - DPH PO & O2 in ER & dismissed;