chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got 2nd shot hurts like hell; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-Apr-2022 Reporter's comments: This case was received from social media page. The patient just got 2nd shot of shingles vaccine and it was hurt like hell but the patient was sure nothing compared to having shingles. The patient's pharmacist said that the 2 shot shingle series was somewhere near 98 percent effective. The patient had insurance and did not pay for the shots. The patient got them at the pharmacy. The patients know the friends that gotten shingles and had a horrific time. The patient did not want it. The pharmacist said that it was very effective at preventing another breakout if you previously had shingles. So everyone need to got it.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ "o or 0" A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder. Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Jan-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 June 2020 and the estimated date of delivery was 04-Apr-2021. On 26-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 26-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Patient is currently taking medication for Heart unison and pre-needles vitamins.
Information has been received from a physician concerning a female with no pertinent medical history and no drug reactions or allergies, who was vaccinated IM with the first and second 0.5 ml doses of GARDASIL, in September 2010 and on 21-JAN-2011 respectively (lot numbers not reported). There was no concomitant medication. The physician reported that patient experienced sore arm after receiving the first dose of GARDASIL in September 2010. At the time of the report the patient's outcome was not reported. Patient sought unspecified medical attention. Follow up information have been received from the physician concerning a 22 year old patient, who was vaccinated IM with the first and second 0.5 ml doses of GARDASIL; in September 2010 and on 21-JAN-2011 respectively (lot numbers not reported). It was reported that the patient was vaccinated late with the second dose of GARDASIL. Physician reported that there were no adverse events. It was also reported that the patient had recovered. Follow-up information was received which reported that the female patient was late for the second injection. On 21-JAN-2011, the patient was vaccinated IM in the left deltoid with the second dose of GARDASIL (lot# 667194/1081Z).  There was no adverse event. It was also reported that in the previous injection there was no complication. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Redness, swelling, hot to the touch and hard at the injection site the evening of the injections.  Complained that it was painful to walk on his left leg as well.
approximately one day following the event.  noticed that his left upper arm (vaccine injection site) deltoid area and elbow are purple in color, the area is swollen and raised and tender to the touch, especially around the elbow. there are also pale raised bumps in the area.
8/16/13 --> exam 8/19/13. (L) arm circumference = 8 1/2" (vs 7" on (R)) - swelling, redness, itching 8 1/2 length 5" width erythematous patch upper arm --> forearm. Blotchy erythema with serpiginous border volar surface forearm --> wrist
pt says her injection site was hot, red, and hard.  The redness moved down her arm to her elbow.  She could feel the injection moving down her body on the left side.   She had severe pain down to her hip and tail bone and then pain moved to the right hip.  She says it feels like an excruciating Charlie horse type of pain.  She was not able to move her legs without her moving them with her arms.  She had to be rolled from side to side. Pt was taking ibuprofen for her pain.  She contacted her PCP on 8/21/21.  She was told to take Tylenol as prescribed on packaging.  She can now stand and sit by herself but she still has trouble moving.  The pain comes back before time to take her Tylenol again.  She has tried contacting her PCP and is waiting on a CB.
on 10/21, received flu shot; that evening, patient woke up with pain in arm. By morning, arm had gotten "fire red", hurt. Throughout the day and evening, she used ice pack, which helped. On morning of 10/23, painhad gone down considerably. We told her that if it doesn't get better, or gets worse, to let her dr know.
Left arm tender and warm to touch (no swelling or erythema).  Overall bodyaches, headache and fever of 100.3 when presented to clinic 2 days after vaccine. flu test negative, no recent sick contacts, reports similar reaction to Tdap vaccine in past.
In February-March 2000, the pt developed pneumonia. The pt sought unspecified medical attention. Follow-up information received from the pharmacist on 11/6/00 indicated that in 2/00 and 3/00 the pt was sick with pneumonia. It was reported that the pt had chest x-rays, several doctor visits, and was treated with three different antibiotics. As of 10/00, it was reported that the pt "partially recovered" but still had a persistent cough and shortness of breath. The pharmacist indicated that the pneumonia resulted in a persistent or significant disability/incapacity for the pt. Additional information has been requested. Followup received from RN at doctor's office indicates pt vaccinated in October of 1998 (although initially reported in 1999) and has had intermittent difficulties with cough and was last seen in January 2001 with a 1 day history of cough. Pt diagnosed with bronchitis and antibiotics were ordered. Pt instructed to return if did not improve and he has not returned. No further info is expected.
Patient said face/eyes swelled (never felt throat swell). Felt like smothering but never felt trouble breathing. Patient was going to see primary care physician.
The patient experienced a syncopal episode 30-40 minutes post vax. The ER findings showed a normal physical exam. The patient is to follow up with non-invasive cardiology. It is not known if there  is any causal agent with the vaccine.
Palpitations and chest pressure post vaccine.  Patient was transported by EMS to area hospital for further evaluation.
Pt recv vax on 4/22/99; 4 min post vax pt exp fainting x 10-30 sec; on 4/23 pt exp earache, stomachache, rt ear drainage, perforated tympanic membrane, dehydrated; tx=IV fluids &antibiotics
This spontaneous report as received from a nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M011840, expiration date 01-FEB-2018 (dose and route of administration were not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Headaches - Migraines still going on now 6 months later, never had them before Running/restless leg can't sleep at night
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 08-JUL-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10PK-0.5 ml SD-PFS LLokwTip" (lot # M005286, expiration date: 08-OCT-2017, dose and route were unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 304 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
No adverse event.  Patient was too young.  Parents are aware.  Parent was aware of age when bringing child in for vaccine.
Immediately after receiving the influenza vaccine her right upper arm became red, warm and mildly swollen. Denies pain, or SOB.
Redness, warmth, and swelling to right upper arm. Pt's mother instructed to use warm compresses to area several times a day for 5 minutes at a time. Bactrim 40mg TMP component per 5 ml, 10 mg, BID  x 10 days.
The Moderna Bivalent was inadvertently administer as a 2nd dose instead of the Moderna Monovalent.  Pharmacy contacted patient and he will come back to the pharmacy to get the Moderna Monovalent per CDC recommendation.  No adverse event reported by patient.
Started with dry throat and nose. Then felt tired, sleepy, low energy. Muscle joint pain. Still chills. temp 97.4. Now having ear pressure.  SOB on Saturday.
Patient received a ZOSTAVAX vaccine on 1/14/11. She returned to store 1/17/11 requested that pharmacist check arm. It was red, swollen and patient claims it was warm to touch. She said it was extremely sore 1/15/11. Pharmacist recommended ice packs frequently throughout day and have it looked @ by physician.
In error, during the same vaccine visit on 10/14/2022 case was given two Hepatitis B (Engerix-B) Vaccines. Patient notified verbally and via follow up Email. At this time reports no adverse effects
I stood up from a sitting position after smoking a cigarette and got a headrush that traveled through  whole body , and then I fainted for a few seconds.  After the first event, I never fainted again but had several headrush like dizzy spells over the next few weeks. These spells would last for 1-2 minutes, originally only occurred after smoking a cigarette, but then began to happen when I would stand from a sitting position when not smoking, and I would need to sit back down until the headrush passed. This reaction occurred periodically up until one week before my second shot (01/23/2021), and I have not experiences it since, not even after my booster shot.  I understand  it may not be related, however, I have been smoking for 30-years and have never experienced a reaction such as this one before.
Tingling in mouth, teeth and tongue. Shooting pains in upper back and shortness of breath
On evening p/shots recvd 8APR91 pt exp t104.4 & had a generalized tonic-clonic sz of 5 min duration; taken to clinic for observation & sepsis work up;
Mom called MD & was referred to clinic; mom said pt recvd shot @ noon & @ 7PM had fever & @ 8PM would get occasional spasm in legs; would jerk once every 1/2 hr; legs only mom called the enxt morning & pt screamed if moved legs;
Pain at injection site; arm pain; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 15Apr2021 15:00 (Batch/Lot Number: EP7534) at age of 55-years-old as single dose for covid-19 immunisation. Medical history included aplastic anemia from 2001, myelodysplastic syndrome (MDS) from 2009, graves disease 1970s diagnosis, past myocardial infarction (MI), antiphospholipid antibodies (APLA), stroke, seizure due to stroke, bone marrow transplant in 2009. Prior to vaccination, the patient was diagnosed with COVID-19. Known allergies included mostly antiseizure meds, dilantin, depakote, CT contrast. Concomitant medication in two weeks included levothyroxine sodium (SYNTHROID); lifitegrast (XIIDRA) taken; estrogens conjugated (PREMARIN); acetylsalicylic acid (ASPIRIN); vitamin d (VITAMIN D NOS). No other covid prior vaccination. The patient previously took first dose of bnt162b2 (Lot # EL3248) on 03Mar2021 16:30 in right arm for COVID-19 Immunization. The patient experienced pain at injection site on 15Apr2021 17:00 with outcome of recovering, arm pain on 15Apr2021 with outcome of unknown. No treatment received for event pain at injection site. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
7 days after receiving vaccination my arm begin to hurt and itch.  Day 8 after vaccination arm developed hives on and around the injection site. No treatment received.
pt recv vax & exp fever, which may have been as high as 104 to 105 & which lasted for more than 24hr;pt also exp infrequent rash
red eyes, hoarse voice/sore throat, weakness, fever, muscle pain, dizziness
Temperature to 101 degrees, severe headache, myalgias, nausea and vomiting. Sx resolved with TYLENOL 48 hr after onset.
Discovered the rash under my right arm and on my right breast as I prepared to shower the morning after the injection. My lymph nodes also had a "tight" feeling to them. The rash was gone by the weekend. Unfortunately, I am now having trouble with rashes on my body that I never had previously. I have a chronic rash under my breasts now that I am currently being treated for, as well as rashes on the inside of my left elbow and outside of my right elbow. These started about 6 and 8 weeks, respectively, after the second Covid booster and may or may not be related. But I thought they were worth mentioning in this report.
received Pediarix instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th July 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th July 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: 27-JUL-2022 Reporter's comments: The health care professional (HCP) called on the day of reporting to report that a patient received Pediarix instead of the intended vaccine Infanrix. Medical Information given for future reference and warm transfer provided. The vaccine administration facility was the same as primary reporter. The consent to follow up was granted. Additional Supportive Information: As patient received Pediarix instead of Infanrix, which led to wrong vaccine administered.
Information has been received from a registered nurse concerning a female with no allergies, who on 2/13/89 and 3/1/95 was vaccinated with a first and second dose of MMR II. Concomitant therapy included Synthroid. The pt's antibody titer was negative for mumps. The pt sought unspecified medical attention. Additional info has been requested.
Narrative:  63yo male who presented to clinic to receive his 3rd COVID vaccine booster. He stated that on minute 12 he started to feel a "tightness" in his chest, which resolved after EMS gave him 324mg of chewable aspirin. Troponin was checked and was found to be negative x 2. His EKG showed no changes. Chest pain thought very unlikely to be an adverse reaction to COVID vaccine.
Patient had throat tightness and trouble swallowing within 7 minutes of injection.  30 minutes after developed tachycardia and hives.  Received prednisone and Benadryl IV symptoms resolved.   Patient is 16 weeks pregnant at this time
One week after injection. Arm pain in early morning, building over the day. Itchy, hot and swollen by early afternoon. Shooting pain down arm, with aching and tingling in wrist and hand by early evening. Visibly swollen and hot to touch in early evening, at time of submission.
PATIENTS MOTHER CALLED ON 04/15/2007 AND STATED THAT PATIENT HAD RECIEVED INJECTIONS ON 04/09/2007. SHE STATED ON 04/11/2007 THAT SHE NOTICED REDNESS AND A LUMP ON HIS RIGHT LEG AROUND THE INJECTION SITE.  sHE STATED THAT THE REDNESS HAD GOTTEN BETTER BUT THE LUMP IS STILL PRESENT.  AFTER EXPLAINING TO MOTHER, TO OBSERVE THE SITE AND USE WARM COMPRESSES TO AREA, SHE STATED THAT MAYBE THE REDDNESS IS STILL THERE.  DID ADVISE THE MOTHER TO BRING CLILD INTO URGENT CARE TO BE SEEN.
This subject is a two month old male, who developed a fever while enrolled. The subject received the study vaccine on 7/8/05. The subject developed a fever of 101 degrees F on the same date as the study vaccine was given. The parents took the infant to the emergency room. As per the subject's father, a septic work up was performed and the infant was admitted to the hospital overnight. The father stated that all labs were normal and the infant's temperature went down. Treatment provided was antibiotics for 48 hours. The subject recovered. The fever was reported by the investigator as related to the study vaccine.
Fever, chills, vomiting, diarrhea, sleepiness, lack of appetite, severe headache, body aches.  Severe reaction lasted three days.  Fever, headache and fatigue continued for eight days.  Arm where vaccine received was red, hot, swollen for eight days.
Long-term persistent dizziness since getting the second shot.  Light-Headedness and low energy.
committed suicide; an incurable adverse reaction; This case was reported by a consumer via interactive digital media and described the occurrence of suicide in a 81-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suicide (serious criteria death and GSK medically significant) and adverse reaction. On an unknown date, the outcome of the suicide was fatal and the outcome of the adverse reaction was not recovered/not resolved. The reported cause of death was suicide.   The reporter considered the suicide and adverse reaction to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's son/daughter via interactive digital media. The reporter stated that his/ her 81 years old mom committed suicide on 18th August after suffering an incurable adverse reaction to that poison. Additional Supportive Information:  The follow-up would not possible as no contact details were available. This case is 1 of 15 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104784:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter; Reported Cause(s) of Death: committed suicide
I had a few spots itching, particularly one that was close to the shot; It felt blistery like kind of little warm, almost sunburn feeling; I had a few spots itching, particularly one that was close to the shot; It felt blistery like kind of little warm, almost sunburn feeling; I had a few spots itching, particularly one that was close to the shot; It felt blistery like kind of little warm, almost sunburn feeling; I had a few spots itching, particularly one that was close to the shot; It felt blistery like kind of little warm, almost sunburn feeling; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 49-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via intramuscularly (reported as it was in the muscle) administered in left arm on 09Aug2021 09:00 as dose 1, single (at the age of 49 years-old) for COVID-19 immunization. Patient medical history included High Blood Pressure, psoriasis and infection from an unknown date and unknown if ongoing. The concomitant medications included amlodipine taken at a dose of 2.5 mg daily for hypertension, start and stop date were not reported. The patient previously took doxycycline hyclate 100 mg capsules for it but that ended like two days ago. The patient reported that patient had a few spots itching, particularly one that was close to the shot, it felt blistery like kind of little warm, almost sunburn feeling on 09Aug2021 20:00. Vaccination facility type was reported as Public Health Department (It was a health department). Patient did not receive any other vaccine in four weeks. Patient stated that patient had a breast monogram like a typical screening today, patient did that yesterday right few hours after I took the shot. The treatment of the event was reported as No, nothing out of the way for that. The outcome of events was unknown.  Follow-up (18Aug2021): Follow-up attempts are completed. No further information is expected.
PT HAD COMPLAINTS OF ITCHING OF THE THROAT, DIZZINESS, NAUSEA, AND DIAPHORESIS. PT WAS GIVEN 10MG PO ZYRTEC BUT REFUSED ANY OTHER TREATMENT OFFERED. PT WAS OBSERVED FOR ALMOST AN HOUR WHERE SYMPTOMS RESOLVED. PT WAS RELEASED TO HIS OWN CARE HOME
Patient was administered the ASO1B adjuvant of the Shingrix vaccine alone inadvertently; Patient was administered the ASO1B adjuvant of the Shingrix vaccine alone inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 2A54M, expiry date 21-MAY-2024) for prophylaxis.   On 22-AUG-2023, the patient received the 1st dose of Shingrix. On 22-AUG-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Patient was administered the ASO1B adjuvant of the Shingrix vaccine alone inadvertently) and inappropriate dose of vaccine administered (Verbatim: Patient was administered the ASO1B adjuvant of the Shingrix vaccine alone inadvertently).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2023 The reporter was a medical assistant. The reporter reported that the patient inadvertently received ASO1B adjuvant of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.