chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delayed; fever; chills; headache; itchy; redness; swelling; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (delayed), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (redness). 05-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelling). On 26-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (delayed). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (delayed), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE SWELLING (swelling), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.      Concomitant medications were not provided.  Treatment information was not provided by reporter.   Action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: NNI
Swelling and mild pain at injection site on-going as of 06/09 Mild fever.  Oral temperature of 100.0 from 1:00 PM on 06/08  until bedtime.  Awoke on 06/09 with no fever, oral temp 97.2.
left arm, hand and fingers went numb/unable to make my fingers work; Continued paresthesia whole left arm and hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Aug2021 17:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "iron deficiency" (unspecified if ongoing); "anemia" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; VIIBRYD; LAMICTAL; BUSPAR; NEURONTIN; FLEXERIL [CEFIXIME]. The following information was reported: HYPOAESTHESIA (non-serious) with onset 12Aug2021 02:00, outcome "recovered" (Aug2021), described as "left arm, hand and fingers went numb/unable to make my fingers work"; PARAESTHESIA (non-serious) with onset 12Aug2021 02:00, outcome "recovered" (Aug2021), described as "Continued paresthesia whole left arm and hand". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, paraesthesia.  Additional Information: Got shot left upper arm. 2 days after shot left arm, hand and fingers went numb, unable to make my fingers work. Continued paresthesia whole left arm and hand. 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 COVID-19 vaccine. Since the vaccination, the patient had been tested "negative" for COVID-19. Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? Yes. If yes above, do you consider the Pfizer product had a casual effect to the adverse event? Yes I believe the vaccine caused this event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed COVID received 4th dose about 4 weeks before COVID; Developed COVID received 4th dose about 4 weeks before COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 62-year-old female patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Hypertension" (unspecified if ongoing), notes: Hypertension controlled by ARB. Concomitant medication(s) included: SYNTHROID; WEGOVY; DIURETIC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Developed COVID received 4th dose about 4 weeks before COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Developed Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Generalized body pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized body pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (Generalized body pain). At the time of the report, PAIN (Generalized body pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.
LPN in clinic presented with continued complaints of left shoulder pain. She reported receiving her annual influenza vaccine on 9/12/2016 to her left deltoid. (SKB Lot CS979). She advised a few moments later her shoulder began to ache and burn. The burning resolved within a few moments but she had a persistent dull ache and over the next week she noted issues with ROM to her arm, pain on lifting and extending. She advised her left upper third of deltoid was tender to palpation, there was no fever, swelling, site redness or trauma to area. She is right handed. She has been limiting use of her arm and has tried periodic use of NSAID 400 mg 1-2 times a day with minimal relief pain. She mention this issue to co-workers who recommended she seek further treatment. She completed course of oral steroids, use of warm/heat therapy and physical therapy and as of Jan 2017 symptoms have improved 99%.
tested positive for coronavirus; tested positive for coronavirus; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for coronavirus on 24Dec2020. The patient worked in a hospital. She got the first dose of Pfizer coronavirus vaccine on Tuesday, 22Dec2020. She tested positive for coronavirus on Thursday 24Dec2020 after exposure to patients and staff. She had mild symptoms. Her 2nd dose was scheduled for 12Jan2021. The patient was inquiry whether she should receive it, or should she take an antibody test first, but it would be less than 3 weeks from the onset of illness. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event tested positive for coronavirus based on the known safety profile. However the short duration of 2 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
pt recv vax; T 101.6 & urticarial rash 3 hr p/ vax; rash inc during next several hr requiring PO pred;rash was severe & lasted 3 days;
5AUG92 while administering Engerix-B some of vax went into pt lt eys; exp burning & tearing that went away the same day; that noc a rash appeared on chest & abdomen; 8AUG92 both eyes & face edematous, lt eye swollen shut; also measles-like
DRUG SCREEN POSITIVE. Information has received from a paralegal concerning her male coworker who was vaccinated with a dose of hepatitis b virus vaccine rHBsAg (yeast). Subsequently the patient tested positive for marijuana in a urine test. The reporter indicated that her client denies using marijuana, and "said that it may be a false positive because he recently received" a dose of hepatitis b virus vaccine rHBsAg (yeast). No medical attention was sought. There was no product quality complaint. No further information is expected.
I was first vaccinated with J & J; Pfizer is my 2nd shot.  I first became tired directly after,  had a slight headache, and then later around 7:00PM I had a pain in my left ear.  In the evening I noticed feeling dizzy when a went to bed and it still continues when I move my head to one side or the other, sit up, and sometimes when I lay down.  Today, November 1, 2021, I felt a bit ill, and my head feels tired, and slight nausea.  This is day 5 after the vaccine.
This spontaneous report as received from a physician refers to an adult patient of unknown age. In December 2012 the patient was vaccinated with a dose of VARIVAX (lot number unspecified) and a dose M-M-R II (lot number unknown). The physician reported that the patient never received their second dose of VARIVAX (Merck)  M-M-R II. No adverse effects reported. It was unknown if the patient had sought medical attention. Additional information is not expected.
Immediate rush of tingling in both hands. Minor reflux about  1 hour after injection.
Information has been received from a licensed practical nurse concerning a female (approximately 4 years of age to 15 years of age) who on 01-AUG-2007 was vaccinated with ZOSTAVAX (lot # 657558/0461U) instead of varicella virus vaccine live (MSD). Subsequently no adverse experiences have been reported. Unspecified medical attention was sought. This is one of several reports received from the same source. Additional information has been requested. The nurse reported in follow-up that the packaging for the ZOSTAVAX (Merck) and VARIVAX was similar and the 2 vaccines were stored in the same freezer. The VARIVAX vaccine had run out and the ZOSTAVAX vaccine (Merck) was picked mistakenly. The nurse hoped to avoid this event in the future. There have been positive results noted from the parents of the vaccinated child. This is one of several reports received from the same source. Additional infromation is not expected.
On Friday the 22nd of December the referral coordinator brought a packet to PH in ref a patient that now has a suspected adverse reaction to the flu vaccination.  The patient was vaccinated on 22 Nov 06 in conjunction with his PHA.  On the 29th he presented again with URI like signs.  After treatment  - 05 Dec he was cleared to fly.  The understanding is that he was not 100% and over the course of the next week his condition degraded until on the 13th when he presented to the hospital with pronounced neurological signs and a presumptive diagnosis of encephalitis was made.  A mass was located, suspected to be a glioma and not encephalitis.  Condition degraded and the patient went to surgery for mass resection - craniotomy with submission for histopathology.  The tissue that was removed had a marked histiocytic infiltrate consistent with an infarct, along with focal areas with mild gliosis.  Not seen in the right temporal lobe is palisading necrosis, marked neuronal atypia and vascular proliferation.  Presently we are waiting for the final report.  The patient can respond to verbal yes and no question and appears to have limited sensory/feel on left side.  The portions of the record and physicals have been sent to the manufacturer so they can begin their work on this case. Sir, this lot has also been associated with other complications and was placed on medical hold by us in November.  The reactions were mainly headaches, one member however had chest pains and cardiac catheterization was performed.  The lot was cleared.
pt states she developed pain in her arm after getting the vaccine.  Next morning her arms were glazed over.  The next thing she remembers she was laying on the ground.  She was laying on the ground with her next twisted.  She was able to get up but she passed out again and fell to the ground again.   She was hurting and could barely move but was able to get up.  Her phone was across the room .  She could look in the mirror and could see her head was tilted forward and continues to be this way.  She laid back down and could hardly get back up which took her about 5 hours to do.  She contacted her physician and they told her that her sugar low or blood pressure maybe high.  She was told to go to the ER and have X-rays.  Her doctor wants her to follow up with a cardiologist.  She is concerned she has myocarditis and that her neck is still tilted forward  and will not go back into the normal position.  She has difficulty getting into a comfortable position.
Approximately 9 days after receiving the shot I experienced redness, soreness , firmness and itching at the injection site.   It lasted about 4 days.
I took the first shot of the Pfizer COVID vaccine on January 16, 2021. Two days later I started to feel a fullness in my left ear. This continued nonstop, save for one day, until January 29, the, after inclining my head at an unnatural angle, I experienced vertigo, vomiting, and intense ringing in my left ear for hours. The following morning, all symptoms were gone. But that afternoon, the ringing in my left ear returned and got progressively worse. The next day, the feeling of fullness in the ear returned as well, and I experienced a second bout of vertigo, and the ringing persists. This suggested that the vaccine has triggered Meniere's disease, a condition that is related to Bell's Palsy, which has also been observed in patients who took the Pfizer COVID vaccine.
Chest pain that I have never experienced before.  It has not been treated at the time of reporting.
Swelling at shot site. Swollen and red. Went to urgent care and got antibiotic.
All side effects below  are from the 2nd shot - after the firs shot i was  just tired the second day.  -Severe body aches for  24 hours -Severe head ache for 3 days -Red, itchy rash appeared 2 days  after 2nd shot.  itchiness still exists 7 days later but redness  and bumps gone -Loss  of appetite for 4 days -Fatigue and brain fog for 2-3  d ays -Disruption of menstrual   cycle -  caused  spotting
At 2:30 am on Friday 3/5/21 my left jaw started hurting and my lips started developing extremely fever blisters completely around my mouth and on my lips. I developed a rash on my right hand, left thumb, left hand, and forehead. I have a 1.25" lump in a lymph node under my left chin. I went to an Urgent Care on 3/6 and they surmised that I was having a reaction to one of the meds I've been on for years. On Monday 3/8/21, I went to my dermatologist and she's telling me NOT TO GET THE SECOND SHOT, because of the severe allergic reactions I'm having to the FRIST SHOT.  I've been taking steroids, doubled up on my Valacyclovir to 1000 MG/day until these outrageous fever blisters are gone and cleared up. The blisters were up to one inch x 1/2 inch x 1/2 inch. The dermatologist has me putting Aquaphor on my lips and rashes. She gave me a shot of Kenalog 80 MG. She says the lump will take over six months to go away!!!!!!!!!!! I'm absolutely terrified to get the second shot and don't want to die. MORE IMPORTANTLY, what do I do now to indicate that I'm fully vaccinated if I can?t take the second shot?????
Initial misuse report received from a healthcare professional on 07 June 2013. It was reported that a patient was administered fourth dose of PENTACEL at 10 months of age only 4 months after the 3rd dose, and then fifth dose was administered on 7 June 2013 when patient was 15-month-old. No adverse event was reported. Documents held by sender: none.
Patient was given proquad and had no reaction or adverse events. She was not immune to MMR and needed a dose. Was given Proquad to save a stick. Proquad is not indicated for over 6 years of age.
Patient stated vaccine was placed to high and caused severe pain to arm. pain in which arm was not specified. Patient stated she had a high fever as well.
REPORT OF 06/01/2022  18 year old male arrived at clinic with mother on 06/01/2022 to request Janssen Vaccine. Patient and mother provided with Janssen patient information packet to read and then allowed to ask questions. Both patient and mother stated they had reviewed the information and had no questions.  Prior to receiving vaccine mother requested to see and inspect vaccine vial.  Mother allowed to do so and was satisfied.  At 1405 on 06/01/2022 RN gave vaccine Janssen Lot# 1855195 to left arm IM.  At 1410 patient appeared to slump in a syncopal episode and did not respond to mother calling his name. RN called 911 to request assistance at this time with RN at patien
Slight tingling in lips.; Very puffy eyes; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 11:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included Hbp (High Blood Pressure) and shellfish allergy. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. 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 08Apr2021 at 12:30, the patient experienced slight tingling in lips and very puffy eyes. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slight tingling in lips and very puffy eyes was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
First adverse reaction noted with first dose (unreported). Small in area and presented days after first dose. Current issue includes large red rash at injection site, mild peeling of the skin, tenderness to touch, swelling, warm to the touch. Current rash has expanded since Tuesday for a 5?x3? patch to 6? in length (measured with outline of rash when first discovered to monitor growth)
HPV, Tdap and Menactra vaccines were administered to right and left deltoid while patient was sitting on exam table. Patient tolerated well until about 5 min after vaccine administration, patient was sitting in chair next to mom and patient slumped forward, fainted and mom was instructed by MA to wrap her arms around patient so she would not fall out of chair. Patient's head jerked back and legs extended for a very brief period of time after fainting. Episode lasted about 1 minute and patient was responsive afterwards. MA called RN in to monitor patient while MA got juice and crackers. After fainting episode, patient was very pale and said she felt weak, dizzy and nauseous. MA assisted patient to lay on exam table and was given a pillow, juice, crackers. Patient stated she was feeling better after some juice and crackers but remained in clinic for about 45-50 minutes after episode as she stated she was still feeling dizzy and nauseous. Dr. evaluated patient several times after episode. After 50 minutes in clinic patient felt comfortable standing up and walking out of clinic with mom.
Patient received an expired vaccine as a 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2021: Follow up received on 12-Oct-2021: Added facility type, Patient Initials and anatomical location of Suspect product.
rash around private area; bad headache; neck hurt; fever/fever went to 102; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing), notes: The only thing he has ever had an adverse reaction to is penicillin. There were no concomitant medications. The following information was reported: PYREXIA (medically significant) with onset Dec2021, outcome "unknown", described as "fever/fever went to 102"; RASH (non-serious) with onset 17Dec2021, outcome "recovered" (17Dec2021), described as "rash around private area"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "bad headache"; MUSCULOSKELETAL DISCOMFORT (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "neck hurt". The patient underwent the following laboratory tests and procedures: body temperature: (18Dec2021) 102, notes: his fever went to 102 that night; influenza virus test: (Dec2021) negative; investigation: (Dec2021) negative. Therapeutic measures were taken as a result of pyrexia, musculoskeletal discomfort, was treated with Advil and Tylenol.  Clinical Information: within 24 hours of first vaccination, the patient said he had a bad headache, that he had a crack in it, had a fever for the next 3 days, manageable with Advil and Tylenol, states on the second day in the evening, his fever did not go down because he could not take any more of the medication, he was at the maximum dose for each, states his fever went to 102 that night, states she gave him a luke warm bath and that worked to help break his fever. Stated the third day was manageable with Advil and Tylenol again but his neck hurt, states it did not hurt all day, just sporadically, and by fourth day he was okay. Caller state she had no other symptoms. States they went to his pediatrician's office on Monday and was checked at the doctor for flu and strep and was negative for both. Exact height was unknown, it was stated that he was over 3 feet tall.  The lot number for bnt162b2 was not provided and will be requested during follow up.
At 10pm the day of receiving 1st vaccine, I could not raise my arm, hard cough, and nasal drainage.  I took Tylenol and placed a therma pack on raised vaccination site.  I currently have a 2cm hard raised area on my lt arm that was measured by  employee health nurse.