chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9 year old was given Infanrix instead of Boostrix; 9 year old was given Infanrix instead of Boostrix; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 9-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 15-NOV-2022 Reporter's comment: The reporter reported that 9 years old patient was given Infanrix instead of Boostrix.  No other information shared.  The reporter was consented to follow up. Additional Supportive Information: The patient received Infanrix instead of Boostrix at 9 years of age, which led Inappropriate age at vaccine administration and Wrong vaccine administered.
soreness on muscle in between the armpit and chest; soreness; redness; fever; Chills; headache; tiredness; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), PAIN IN EXTREMITY (arm sore), PYREXIA (fever), CHILLS (Chills) and HEADACHE (headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced FATIGUE (tiredness) and PAIN IN EXTREMITY (arm sore). On 17-Mar-2021, the patient experienced PYREXIA (fever), CHILLS (Chills) and HEADACHE (headache). On 18-Mar-2021, the patient experienced PAIN (soreness) and ERYTHEMA (redness). On 19-Mar-2021, the patient experienced MYALGIA (soreness on muscle in between the armpit and chest). At the time of the report, FATIGUE (tiredness), PAIN IN EXTREMITY (arm sore), PYREXIA (fever), CHILLS (Chills), HEADACHE (headache), PAIN (soreness), ERYTHEMA (redness) and MYALGIA (soreness on muscle in between the armpit and chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included cholesterol medicine.
Within a couple of hours after the Pentacel shot my son's leg turned very red and swollen at the injection shot and he started screaming. Nothing would stop him from crying, he was inconsolable and would not eat or sleep. The crying lasted 4 or 5 hours and then he fell asleep for the night. He slept the whole night. I checked on him several times because he didn't even wake up to eat. In the morning he was a little fussy but much better then the day before.
RIGHT ARM SWELLED UP (VERY HOT). SUGGESTED GOING TO URGENT CARE FOR FURTHER EVALUATION
From initial information received on 03/12/04 from another manufacturer, initially reported by the patient, regarding an adverse event occurring in the USA, it was reported that a female patient (age not reported) received a dose of Fluzone SV '203-'2004 USP, lot number unknown, administered intramuscularly in an unspecified site on an unspecified date. Two to three weeks later, the patient developed a flu. The patient went to see a doctor and was told that "2-3 weeks was too soon for her to develop immunity". Reportedly, the patient recovered from this event.
Information has been received from a Nurse Practitioner who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Subsequently the patient reported "I did take the shingles with prob." At the time of the report, the patient's outcome was unknown. Follow up information was received from a Nurse Practitioner with seasonal allergies and no known drug allergies at that time, who experienced foot swelling without pain after the first and second doses of vaccine. The patient experienced generalised edema of all joints and increased pain after the third dose of vaccine. The reporter also stated that "this reaction happen back in 1990 - 1994?". There was no illness at the time of vaccination. The patient had recovered after eight "+" months. The reporter considered her experience to be disabling. Additional information has been requested.
Swelling, redness, itching comprising entire tricep area down to elbow and portion of inner bicep, all on right arm.  Given antihistamine to reduce itching and swelling.
Pt phoned today stating that the day after receiving the flu vaccine she could hardly walk due to pain across her lower back. Stated had to go to doctor for medication. States after taking medication lasted for about 7 days.
pt recvd vax & 3 days post vax pt exp flu-like sx w/nausea,vomiting,sl fever,gen malaise,aches;sx resolved w/o treatment by 10APR95
Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Cellulitis in left leg may be acting up/Might have an infection in area of cellulitis in left leg; Questioned if she might have a blood clot in left leg; Might have an infection in area of cellulitis in left leg; pain in the left leg; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, expiration date 31May2021), via an unspecified route of administration on 01Feb2021 at left upper arm around 19:00 or a little later at single dose (at the age of 72-years-old) for covid-19 immunization. Medical history included bad knees and got injections for this and recurrent cellulitis of legs (cellulitis was not active at time of vaccine; but anytime her leg swells with bad knees she had a little episode with the cellulitis down around her ankles on both legs but left leg was more predominant. She had been keeping it at bay), mineral supplementation, bad knee pain, blood pressure medication (abnormal), urine output control (abnormal), dehydrated and dizzy. Concomitant medication included lisinopril as blood pressure medication, potassium for Mineral supplement, solifenacin succinate for urine output control, paracetamol (TYLENOL 4) for bad knee pain. She had taken potassium before and it calmed it down: she was little dehydrated, little dizzy, so was drinking some Pedialyte, water, and taking potassium. The patient had it once before but it kind of snuck up on her again. The patient called to ask if anyone had reported any type of blood clot on the same side of the body that the Pfizer COVID-19 Vaccine was administered. She questioned if she might have a blood clot in her left leg after having been administered the Pfizer COVID-19 Vaccine. She had recurrent cellulitis in both legs prior to Pfizer COVID-19 Vaccine. The doctor thought the cellulitis in left leg may be acting up and that she might have an infection in that area of cellulitis. She reported pain in the left leg when she rested her leg on a pillow; but did not feel any pain when she was standing and walking. The pain became a little too hard for her to bear so the doctor prescribed her Cephalexin 500m capsule every 12 hours-she was on the 3rd capsule now. Onset date for the events was approximately 03Feb2021 or 04Feb2021. The events were better since started Cephalexin. Second dose date scheduled for 22Feb2021 but did not give her time. The outcome of the events was recovering.  Follow-up (23Feb2021): New information received from the product quality complaint group includes confirmation of lot number (EL9262) and new expiry date.
Large area of redness, induration, warmth and swelling. Measuring 16 x 17 cm. Advised to apply ice and give ibuprofen. Administered 1 tsp BENADRYL and RTC if no improvement/worsen.
Information has been received from a pharmacist concerning a female who on 09-NOV-2010 might have been vaccinated with a partial dose of ZOSTAVAX (Merck) (lot # 665524/1374Y, expiration date: March 2011) subcutaneously into her left arm. It was reported that at the time of administration on 09-NOV-2010, "a drop" of vaccine leaked from the injection site of the left upper arm. Overnight on 09-NOV-2010, the patient noticed "some wetness" on her arm which the pharmacist stated "might have been vaccine". It was unspecified if the patient sought medical attention. No further information is available.
FEVER OF 102; WIPED ME OUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced fever of 102, and wiped me out. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 102 and wiped me out was not reported. This report was non-serious.
Moderna Covid-19 Vaccine EUA Experienced moderate joint pain in left elbow, wrist, shoulder with extreme joint pain in left hand (knuckles). Was advised to take Ibuprofen. Inflammation traveled through to hips, knees and neck as  well as the right hand and wrist. Pain gradually decreased over the course of the evening. Moderate pain in wrists, elbows and knees is still present the morning of the 8th with mild pain in the neck.
Pt devel fever the evening of vax, took no antipyretics; slept poorly; awoke 0800 on 14AUG w/global h/a & fever, walked to kitche,  then collapsed, was picked up by family member; c/o SOB then had LOC x 2mins; taken to ER; ?hypovolemia
Received COVID19 vaccine at 730am, developed erythematous patchy rash on anterior neck and chest around 1130am. Initially began on neck, spread, then resolved over about 1 hour. No itchiness, no irritation, no fever, asymptomatic. No PMH, allergies, medications.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-JUN-2013, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. During January 2014, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. She was diagnosed with shingles after being inoculated with ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of her shingles and associated injuries. As a direct and proximate result of the ZOSTAVAX, 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 is unknown. Additional information has been requested.
Pt devloped an area of tenderness, warmth, redness, and induration at 7 pm the day after the immunization which continued to increase in size despite warm compresses and Motrin.  Low grade fever of 99.9 axillary.  Brought into the Urgent care clinic and admitted for cellulitis vs vaccine reaction. On hospital admission L ant leg had 9x13 cm area of tenderness, blouchy erythema with a 6x4cm area of hard induration.    By the next day had mostly resolved with a 2x2 area of induration, non-tender and minimal redness.
Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever) 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 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Mild fever). At the time of the report, PYREXIA (Mild fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: Event outcome and AE for husband reported. On 12-Apr-2021: Outgoing call to obtain email address, voice message left.
cold sweats; Weak; sore arm; nausea; headache; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 08Apr2021 at 13:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included and concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) in the left arm on 18Mar2021 at 15:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. 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 09Apr2021, the patient experienced weak, cold sweats, sore arm, nausea and headache. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the event weak, cold sweats, sore arm, nausea and headache was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Became tired and drowsy. Could not drive car home; wife drove. Took a nap for 1.25 h starting at about 3:00 PM. Still felt tired after the nap. Mucinex at 6:30 PM, Albuterol HFA (in use from previous condition). In the evening (~7:30 PM), congested sinuses, drainage, coughing. Bedtime at 10:30 PM; salt rinse sinuses, Albuterol HFA for wheezing, Fluticasone, tussin/DMA cough medicine. Retire to bed about 12:30 AM, 2nd dose of cough medicine. Coughing persisted until 12:45 AM then sleep.
Poor Appetite; Drenched; Got sick; Felt like she was having a fever; Chills; Pain Injection Site; Fatigue/Tired; Anaphylactic shock; A spontaneous report was received from a nurse who was a 49-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fatigue/tired, poor appetite, pain, chills, drenched, felt like she was having a fever, got sick, and anaphylactic shock.  The patient's medical history included psych condition. No concomitant medications were reported.  On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A, Exp. date: 22 Jun 2021) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced fatigue/tired, poor appetite, pain, chills, drenched, felt like she was having a fever, got sick, and anaphylactic shock. Treatment for the events included one dose of acetaminophen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, fatigue/tired, poor appetite, pain, chills, drenched, felt like she was having a fever, got sick, and anaphylactic shockwas unknown.  The reporter did not provide the causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
A non-serious spontaneous report of "ears hurting bad" has been received from a Pharmacist concerning a male child, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history or concomitant medications were reported. The patient received one dose of FLUMIST on 16-Oct-2008. Thirty minutes after the patient received FLUMIST he returned to the pharmacy screaming stating that his ears hurt. The child stated that his, "ears are hurting bad." The Pharmacist described the event as tinnitus. The outcome of the event was not reported. The causality of the event was not reported.
NO ADVERSE EVENT. PATIENT RECEIVED THESE VACCINES WITH VIALS THAT WERE DRAWN UP WITH LIDOCAINE.
Warmth at injection site, muscle soreness, swelling of arm, general body aches. Patient woke day after injection with symptoms had been self treating but upon seeing the Dr for another reason was told that reporting was necessary so called the pharmacy. Pt has used ice but upon seeing dr has been recommended to use heat.
2.5 x 2 in erythema (L) thigh. Sl. increased warmth, no induration.
Insomnia after the 2nd dose.  I have always been a great sleeper, Never any problems falling asleep until the 2nd does of Pfizer vaccine.  Now, even 3 weeks later, I can not fall asleep and if I do, I only stay sleeping for maybe an hour at a time.  This appears to be a long term side effect that is not discussed anywhere.  This better go away soon, as it is really effecting my life
Post injection pt waited in lobby. Stated jaw & chest felt tight. Assessed Bp 130/80 p. 68 BSat 108. Pt stated she had not eaten today. Gave H2O & granola bar. In 15 min reassessed Bpat 114/76 P. 70. Stated felt better. Referred to her doc. Dr called & stated the tx was for VASO/VAGEL reaction.
generalized itching, localized hives. started about 1.5 hours after vaccination administration
pt recv vax 11JUN96 & 4JUL96 pt exp mild case of varicella w/15 pox, all very small pinpoint, the largest of which was vesicular prior to crusting;to MD 15JUL96;pt brother also devel chickenpox following exposure to sibling;
Tinnitus  Noticed tinnitus at the same time as onset of immune response to the vaccine (~8 hours after vaccine administration)  Uncertain if recovery has occurred.
Dizziness, Headache, Myalgia, Arthralgia, CHILLS, PAIN AT INJECTION SITE Narrative:
Patient might have accidentally received Kinrix Lot H9Y52, expiration 1/31/22. There is currently no way to verify. Contacted manufacturer, GSK, who stated "results from in-house analytical potency testing have shown that Kinrix remains  within the approved specifications for up to 30 days following the expiration date of the  vaccine if stored under appropriate temperature and storage conditions." Based on this, the patient would not need to be re-vaccinated even if they did receive the expired vaccine, as it was administered within 30 days of vaccine expiration. No further action taken.
Itchy rash appearing within 15 minutes of the incident. I was unable to observe a visible rash, but she says it was there. Spread over the next 15 minutes. Stable and patient notes not as itchy anymore.
Redness around the injection area; Itching around the injection area; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to plants.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was medical assistant who stated that there was a patient who received first dose of Shingrix and experienced redness and itching around the injection area. The patient was allergic to trees so she wanted to know if there was any tree component in Shingrix. The reporter did not wanted to provide further adverse event details, neither patient's details or vaccine detail's. The reporter did not wanted to provide address and said that patient did not receive Shingrix on the same facility. The reporter did not consent to follow-up.
had to have emergency appendicectomy due to acute appendicitis; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 11May2021 (at 39 years old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history was not reported. Concomitant medication included desloratadine (CLARINEX) taken for an unspecified indication. The patient had no history of COVID prior vaccination. The patient was COVID tested post vaccination. On 05Oct2021, the patient had to have emergency appendicectomy due to acute appendicitis on 04Oct2021. The patient was hospitalized due to the events for 3 days. The event resulted in an emergency room/department or urgent care visit, hospitalization; and was reported as a life-threatening illness (immediate risk of death from the event). Treatment for the event included emergency care and surgery (appendectomy). The patient underwent PCR test (Nasal Swab): both negative on 09Oct2021 and on 14Oct2021. The outcome of the event was recovering.   Information on the batch/lot number has been requested.
Numbness/tingling that started in both hands and both legs/feet and has now spread throughout body, including chest, back, neck, etc.
My muscles hurt all over especially in my lower back and mid back.  No nausea.  I didn't sleep well that night of, but I don't usually sleep well.  About 4:30 AM is when is seemed to start aching. Very tired. Temp 99.7.  Barely moved all day. Started feeling better around 6:00 onSaturday. (Had vaccination on Friday 10:30 AM.  My back hurt for a couple more days and very tired.  I did not report any of this cause they had told me I may have flu symptoms and I did.