chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching from neck down to knees; hives; soreness in the left arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD VACCINE) for prophylaxis.   The patient's past medical history included hives (when she was younger). Previously administered products included Zostavax (received in 2013).   On 28th August 2020, the patient received the 1st dose of Shingrix (intramuscular) and FLUAD VACCINE (intramuscular). On 28th August 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 5th September 2020, the patient experienced pruritus and hives. The patient was treated with steroids nos (Steroid Shot (Nos)), prednisone, hydrocortisone (Hydrocortisone Cream) and atarax (nos) (Atarax). On 29th August 2020, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the pruritus and hives were recovering/resolving.   It was unknown if the reporter considered the pain in arm, pruritus and hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported had hives when she was younger.  The patient reported received Zostavax vaccine in 2013. On 28th August 2020, the patient received first  dose of Shingrix vaccine and Fluad vaccine in left arm. The patient reported still has hives and itching currently but the Prednisone has helped with some improvement. The patient reported soreness in the left arm that happened later on the same day after receiving the vaccines and lasted up to 1 day and has resolved at this time.  On 5th September 2020, the patient developed hives and itching from neck down to knees. On 6th September 2020, the patient was seen by health care professional and received a steroid shot, oral Prednisone, hydrocortisone cream and Atarax as treatment.  On 8th September 2020, the patient reported went back to health care professional for a second time and the dosage of Prednisone was increased. The reporter consent to follow up.
We noticed that patient did not get her period for 3 months after having been regular 1 1/2 hrs.  Her period has since returned very heavy.  Upon receiving booster dose her period has once again skipped.  She also had minor chest pain that went away within 24 hours after. Dose 2 and booster.
The retractable needle did not retract but remained in the patient's arm. The pharmacist noticed it and removed it immediately. The patient was looking the other way and did not realize what happened.
Patient had vaccines on Apr. 24, 2009; took TYLENOL that day. On Apr. 25, 2009 patient reports fever, body aches, "feeling really bad, left deltoid very sore, red, hot and swollen-8" long redness/swelling area". Saw Doctor Apr. 28 as she was not better. Felt bad and arm red and sore still. Symptoms remained through April 30, 2009.
broke out into hives; Skin breakout; This case was reported by a other health professional via sales rep and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives and skin breakout. On an unknown date, the outcome of the hives and skin breakout were unknown.   It was unknown if the reporter considered the hives and skin breakout to be related to Shingrix.  Additional details were provided as follows: The patient broke out into hives after getting shingrix vaccination. The reporter consented to follow up.
Patient is pregnant and received the first vaccine dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first vaccine dose) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A71A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in October 2020 and the estimated date of delivery was 16-Jul-2021. On 06-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first vaccine dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 06-Mar-2021, EXPOSURE DURING PREGNANCY (Patient is pregnant and received the first vaccine dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, the patient did Genetic testing and the findings were normal. Estimated date of conception was reported as 20-Oct-2020. The delivery date of previous pregnancy was reported as 07-Sep-2016.                No treatment information was provided.
Patient had a bout of syncope without warning.  He awoke less than 3 minutes later disoriented.  He felt light-headed and nauseous for several minutes and vomited but produced nothing substantial.  Patient was monitored for 30 minutes and felt tired and light-headed for most of that time.  He recovered fully and left of his own accord.
On 1-4-05 our son had the MMR, DTaP/DT/Td, and HIB shot.  On 1-22-05 he started to develop a red, blotchy rash all over.  We took him to a urgent care center on 1-23-04, and they suggested the rash was an allergy to penicillin.  He had been perscribed Augmentin on 1-21-05, for an ear infection that had not gone away with Amoxicillin.  The next day on 1-24-05, he had to be taken in an ambulance to the hospital because he woke up and was so swollen that he was unrecognizable, we were worried about his ability to breathe.  He still had the red rash and his entire body was swollen, especially his hands, feet, and face.  We were told it was, Erythema Multiforme.  I never thought that the rash looked like the pictures I later looked up and he had taken Amoxicillin several times in the past.  We have since found out that he is not allergic to Penicillin.  We believe this was an adverse reaction to the shots given to him on 1-4-05.  He was sick at the time the shots were administered with an ear infection. DX: erythema multiforme (lip blisters but no symptoms of Steven Johnson) suppurative otitis media without rupture of the TM Complaint: allergic reaction, possible: patient experiencing hives, generalized redness, onset of symptoms gradual, duration about 3 days. Patient states symptoms worsening. Allergic reaction Augmentin prescribed for ear infection last week. Seen in urgent care on Sunday before this ER visit, given steroids and Z pack. Symptoms worsened and spread since that time.  Physical Exam: temp 99.7 (R), O2 sat 100% on room air. Patient appeared attentive and exam WNL. Ears: tympanic membrane on right red landmarks distorted with diminished light reflex bulging: on left, gray with normal landmarks. DC to home.
Pt. developed a 2 inch area of mild edema and erythema to right thigh - symptoms lasted 5-6 days. Parent gave BENADRYL and MOTRIN for symptoms.
7 pm- fatigue, headache, arm starting to feel very sore 9 pm- 1230 am- fever, chills, headache, burning eyes, tachycardia HR 120-150, can no longer abduct left arm past 90 degrees due to pain  1 am- fever broke, only mildly tachycardic HR 110-120 3-5 am- severe heartburn alleviated only for 30 mins with otc tums.  2 hrs of severe heartburn with midline chest pain radiating to back.
This is a spontaneous report from a contactable nurse or medical assistant communicated to a Pfizer sales representative. The  other hcp reported similar events for two patients, this is the 1st of two cases. A patient of unspecified age ethnicity and gender received PREVNAR 13 (Lot Number: T36368, Expiry: Jul2019), via an unspecified route of administration in Jan2018 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced in Jan2018, 7-10 days post vaccination, a warm, red, induration or lump where the injections went with outcome of unknown. It was like a latent reaction. The administered product contained excessive sediment. The reporter explained that the office reported that it took 2 hours to get close to dissolving the sediment in the product and it was unlike it normally was. It was mentioned that normally they can get rid of it quickly. The reporter did not know if the 2 hour time frame was specific or meant to explain how difficult it was to get rid of the sediment. The product was properly stored and was sealed and intact with no damage when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2018037240 same drug  same event, different patient.
Five weeks after the vaccine I am still having  Body Ache and very Sore. The day after I got the vaccine it was vary hard to walk because of the body ache
Reported a buzzing in the ears that has been constant started 3 days after shot in the morning on 5/1/2021 and has not stopped since. She called today to report (5/5/2021) and it has not stopped she is currently still experience non stop tinnitus, pharmacist recommended visiting her physician to follow up.
12/07/2021-5 minutes post vaccine (booster) - I felt light headed and dizziness. It resolved with a few hours later. I went to bed by the time I woke up it resolved.  12/07/2021, that evening, I felt chest tightness was sort of intermittent, it was uncomfortable, not painful. It remained for several days after that.  I felt the usual fatigue and body aches, but I did not pay too much attention since those are typical side effects.  I went to the urgent care on 12/09/2021- because the chest tightness was not a normal symptoms, it would get a little more intense and back to a lower level, and  because it was not getting better. I went to the urgent care to get it checked out and  just to be safe. The urgent care was a normal examination-- blood pressure, checked the heart, no EKG, no blood draw. I was told to take it easy,  take ibuprofen or over-the-counter antihistamine, I did not take the antihistamine. I was told if it did not resolve in a couple of days then to seek medical care. The chest tightness has gone away. I have exercised since then. I have had some other stuff, like stomach issues lately  that have not resolved, but I do not think they are related to the vaccine.  Note: I received the Johnson and Johnson for my 1st vaccine.
Pt recv vax on unspecified day; post vax pt exp vax site rxn for several mon w/ tiredness &vesiculation area
Pt received pneumonia vaccine on 10/15/02. R deltoid IM in the am, she contacted me at the office later (the next afternoon) c/o redness with pain. I asked her to watch it if no better, next day contact me. She came into office R arm redness going around arm and down toward elbow.
Information has been received from a certified nurse concerning a 21 year old female patient with asthma, migraine and polycystic ovarian syndrome (PCOS) who on 17-SEP-2010 was vaccinated with the first dose of GARDASIL. (Lot number 667194/1081Z). Concomitant therapy included AVIANE. The nurse reported that the patient received the second dose of GARDASIL (Lot number 667194/1081Z, exp date 11-DEC-2012) on 14-JAN-2011 and immediately experienced, nausea, vertigo and for a short period of time. No labs diagnostics were performed. On 14-JAN-2011 the patient recovered from the experience. Additional information has been requested.
Red rash, rough texture with hard lumps at injection site and within 2-inches of site. hot to touch.
Nausea sore throat headache fatigue fever (100.5) body aches change in taste vision changes (cannot see items up close) injection site soreness with sharp pains that radiate down left arm
Patient started develop itchy rash on arm near injection site. The diameter of the rash was about 4 inches and developed in about  20 minutes after injection.  We gave her an ice pack to apply over the area and a tablet, crushed of Benadryl.
Low grade fever; generally aches and pains; unable to operate any machinery including automobile lasting 36 hours
Pt recvd 2nd dose of Engerix-B & had sore in mouth which could have been a canchre sore; tx over the counter products;
Pt initially got a very big, red, and angry-looking bump, 5-6cm in diameter. She iced it and it had gradually been going down. She also reported fever, fatigue, and sore joints over teh weekend. When she presented to the office on 9/21, she stated that it had gotten smaller but one of the little heads on it actually popped and drained some blood. MD advised her to use a hot pack on it to help the blood re-absorb faster, and advised her to just put an eye on it.
Debilatating shoulder/arm pain simple chores are extremely difficult.  Tried ice, heat, exercise, rest, non-steroidal anti-inflammatory OTC drugs.  Only minimal short term relief.
5 hrs after vaccine harsh reaction, hives all over body. Symptoms continue to present day. Vaccine caused allergy to dust, heat, and cat.
Monovalent doses administered after the BUD to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medication information was reported. 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A No treatment medication information was reported.
The 1st injection was in my upper left arm. I've had pain ever since in my shoulder. It is now partially frozen and impinged. I'm going to physical therapy for it. For my 2nd shot, I had her inject it lower on my upper left arm. It's been 2 weeks and my shoulder is still in a lot of pain. My arm also hurts at the injection site of my 2nd shot and my elbow joint. I have been unable to sleep on my left-side since I received either injection.
Fever, vomiting- mother brought patient to ER where she was given ibuprofen, juice, Tylenol.
14 hrs after dose I had intense chills.  2 hrs later woke up drenched in sweat.  Bad headache for 24 hours, nausea for 24 hours.  Very tired, could not get out of bed the next day, slept almost 36 hours.
FAST HEART BEAT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 805020, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 03:00 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heart beat on 09-MAR-2021. This report was non-serious. This case, from the Others is linked to .
Vaccine had expiration date of 5/2/2019. Vaccine was administered 5/4/2019 two days after the expiration date.
I went to the doctor on February 26, 2023, and started taking PAXLOVID. I had postnasal drip, sore throat, congestion, and body aches. After a few days I experienced chills and an overly weakness. I was taking ibuprofen, so I don't know if I had a headache. I started taking MUCINEX to assist with the congestion and it seemed to help. Overall, my symptoms lasted six days. After seven days, I tested positive again. I had a rebound case and all I experienced was congestion.
This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 22-SEP-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N011867 with expiration date on 08-NOV-2018 (anatomical route of vaccination was not provided) for prophylaxis. It was also reported that, PNEUMOVAX 23, was exposed to a temperature of 70 °F for a 120 hours time frame. The above mentioned vaccine, was not involve in any previous temperature excursion and the call was not made due to a data logger. Furthermore, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA014897: US-009507513-1709USA014851.
PATIENT CAME IN LOOKING FOR A 1ST DOSE PFIZER SHOT. REPORTED IT AS FIRST COVID SHOT. UPON BILLING DISCOVERED THAT SHE HAD ALRAEDY RECEIVED A JOHNSON AND JOHNSON BACK IN APRIL
Client received Jansen Covid Vaccine and was getting ready to walk to his vehicle when he felt "weak" and fainted. Client was supported by his wife along a  worker and he was slided to the ground, client did not sustained any visible injuries. BP was 89/44 p 52. Ambulance was called, client was evaluated and transported by Medic.
Nausea, chills, fever, pain/swelling in lower right abdomen lower right side and lower right back, headache, tiredness
L arm soreness and stiffness, full body aching, chills, headache, mild fever, fatigue
A missed period; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Mar2021 at 12:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food, or other products. 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 vaccination. On 05Apr2021 at 00:00, the patient experienced a missed period and reported that she was not pregnant. It was unknown whether any therapeutic measures were 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 a missed period was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
HIGH FEVER 101.4, HEAVINESS/WEAKNESS, CHILLS, BLOODY NOSE (AWOKE). ALL SYMPTOMS DISAPPEARED WITHIN 24 HOURS.
Patient received H1N1 vaccine on 12-29-09. Pt states experiencing a rapid heart rate on 1-2-2010. I encouraged her to see her doctor. She states she will be calling her doctor on Monday 1-4-10.
DTaP dosage was administered to a patient on 11/1/16. The DAPTACEL had an expiration date of 10/31/2016. The inventory sheet that has an alert to show that the vaccine is going to expire soon was not printed in color and did not show up red on the border.
Low-grade fever, fatigue, achy, felt horrible and was in bed for 2 days.
shot did sting a lot, arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR046924  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and his/her arm hurt for several days after the vaccination. The patient stated that the shot did sting a lot. The follow-up would not possible as no contact details were available. For tolerance to 2nd dose, refer case US2022AMR046924; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046924:Same patient, different dose
Pt c/o hard knot at injection site with slight soreness. No c/o redness or fever.
I am having a pounding and fluttering feeling in my heart.; I am having a pounding and fluttering feeling in my heart.; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (I am having a pounding and fluttering feeling in my heart.) and PALPITATIONS (I am having a pounding and fluttering feeling in my heart.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (I am having a pounding and fluttering feeling in my heart.) and PALPITATIONS (I am having a pounding and fluttering feeling in my heart.). At the time of the report, CARDIAC FLUTTER (I am having a pounding and fluttering feeling in my heart.) and PALPITATIONS (I am having a pounding and fluttering feeling in my heart.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company comment This spontaneous case concerns a female patient with no reported relevant medical history, who experienced the unexpected non - serious events of palpitations and cardiac flutter (AESI event). The patient received a dose of mRNA-1273 on November 22, 2021. The date of onset of the events was not reported. The rechallenge was not applicable as the outcome of the events is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event cardiac flutter was automatically upgraded as a serious event as per IME list. However, as per medical judgment based on the information available, it is classified as Non-serious.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient with no reported relevant medical history, who experienced the unexpected non - serious events of palpitations and cardiac flutter (AESI event). The patient received a dose of mRNA-1273 on November 22, 2021. The date of onset of the events was not reported. The rechallenge was not applicable as the outcome of the events is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event cardiac flutter was automatically upgraded as a serious event as per IME list. However, as per medical judgment based on the information available, it is classified as Non-serious.