chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red rash at injection site; itching at injection site; red rash at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (red rash at injection site), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (red rash at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (red rash at injection site), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (red rash at injection site). At the time of the report, VACCINATION SITE RASH (red rash at injection site), VACCINATION SITE PRURITUS (itching at injection site) and VACCINATION SITE ERYTHEMA (red rash at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not provided.
expired dose of Daptacel was inadverently administered/no ae; Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case was linked with 2019SA145240.  This case involves a 1 years old female patient who received expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT HIB) for Immunisation.  On 23-May-2019, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation: unknown, lot: C5190AA and expiry date: 24-Apr-2019) via intramuscular route in left thigh.  It was an actual medication error due to expired vaccine used (expired dose of daptacel was inadverently administered).  None adverse event symptoms reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
I had pain in the left side of my chest. Pain and stiffness in both legs and both arms, in my neck and also my back.
Post vax, the pt complained of swelling and redness of left deltoid about 2 days.
Initial report received on 11 January 2011 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. This is one case in a series of 11 cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in an 11 month old, male subject was identified by the investigator based on review of data from the Agency. The subject's vaccine history included 3 doses of PENTACEL received on 12 August 2009, 22 October 2009, and 23 December 2009 (route, site of administration, and lot numbers were not reported). Approximately 6 months after the last dose, on 15 June 2010, he developed a paroxysmal cough. He also experienced symptoms of cold-like illness, posttussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 17 June 2010. Chest X-ray findings were negative for pneumonia. Corrective treatment consisted of AZITHROMYCIN for 5 days starting on 17 June 2010. The subject was not hospitalized. At the time of final contact on 04 July 2010, the subject's cough had been resolved. The duration of the cough was reported at that time as 19 days. Investigator causality assessment is not required as per protocol. No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. Documents held by sender: None.
4 days low grade Nausea; Sore (L) Arm x24 hours; This is a spontaneous report received from a contactable physician (who is also the patient). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247, Expiry date: 14Jan2021) on 14Jan2021, 14:30 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231, Expiry date: 23Dec2020) on 23Dec2020, 14:30 both via intramuscular route of administration in left arm as a single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore in left arm x24 hours on 14Jan2021 21:00 and 4 days low grade nausea on an un-specified date. The reporter assessed the events as non-serious. The outcome of the event was unknown.
Information has been received from a physician concerning a female in her eighties who was vaccinated with a dose of ZOSTAVAX (Merck) (0.65ml, SC). The patient experienced "a severe case of shingles" about a year after vaccination. Shingles was considered to be disabling. At the report time the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Rash started in the arm where I received the dose and then armpit. Then blisters and finally some pimples with pus.
Symptoms started on 4/10/04 AM red & hot to the touch. On 4/11/04 the area had blisters.
Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 59-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an undisclosed date, the County Health Department received the vaccine and stored the product at 38.2 degrees Fahrenheit.  On 24 Dec 2020, the health care provider received the vaccine and stored the material at -20 degrees Celsius.  The thawing procedure was followed prior to administration.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, Exp. date: 25 Feb 2021) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273. There were no reported AEs associated with this case of product storage error.
A report was received from a health care professional on 11/19/03 concerning a male vaccinee more than 65 years old who experienced sniffles, cough, fever, and sore throat up to 1 week after receiving Fluvirin on approximately 11/6/03. On an unspecified date, up to one week after vaccination, the vaccinee experienced sniffles, cough, fever, and sore throat. Results of a chest x-ray taken on an unspecified date were negative. The outcome of the event was reported as unknown. There was insufficient information to determine the reporter's causality assessment. Update 3/22/04: Follow up information received from a health care professional indicated that the 78 year old vaccinee received Fluvirin on 11/3/03 and also experienced on 11/12/03 a high temperature of 99 degrees, moist cough, emesis and shortness of breath. The vaccinee recovered from these events on 11/17/03. Follow up pending.
A serious report of encopresis has been received from a study investigator concerning a four-year-old male participating in a post-marketing study for 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. Medical history and concomitant medications were not reported. On 08-Jan-2009, the subject received FLUMIST. The subject was admitted to the hospital for encopresis on 20-Jan-2009. The length of stay was two days. The outcome of the event was not reported. The investigator assessed the causality for the event to FLUMIST as not related. The severity of the event was mild. The sponsor also assessed the causality for the event as not related to FLUMIST.
8/22/14 Rec'd Tdap vaccine. 8/23/14 Patient reports pain, swelling and redness along with firm and tender lump at injection site. 8/25/14 Patient reports symptoms worsened and reports to OHS at hospital center.
This case was reported by a healthcare professional (nurse) and described the occurrence of "FHA IgG" increased in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX (details unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced "FHA IgG" increased and cough. The nurse stated that the subject had a cough and they did a pertussis panel, "and his panel came back on the FHA IgG, it was 16, it was a little bit higher, but not a lot". The nurse asked if "FHA" was in the vaccine, which would cause the number to go up, or if it was due to exposure. At the time of reporting the outcome of the events was unspecified. Follow up received from the nurse on 31 July 2012. The nurse reported that she made an "inquiry not a report of reaction", but she did not say the events did not occur. She listed date of adverse event onset as unknown. She noted "does not apply" for concomitant medications and that it was unknown if the vaccination series was discontinued.
This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming unit (PFU), 0.65 ml once, subcutaneously (anatomical place of vaccination, dose number, lot# and expiration date were not provided), for prophylaxis. Information regarding concomitant therapies was not reported. Therefore, the patient seek for an unspecified medical attention. On an unknown date, following the ZOSTAVAX administration, the patient experienced redness (injection site erythema)and swelling at the injection site. At the time of reporting, the outcome of injection site swelling and injection site erythema was unknown. The reporter did not provide a causality assessment between ZOSTAVAX, injection site swelling and injection site erythema. Additional information has been requested.
I saw on U tube that people who received the vaccine were finding magnets stuck to their insertion site. Not believing it, I put a magnet on my arm and it stuck and only stuck to where the vaccine was given. My boyfriend who has not received the vaccine heard the vaccines shed so we tested to see if the magnet would stick to him. The magnet stuck to both arms, his chest, and his penis which are all areas  where I frequently come in contact .
24 hrs after hepatitis A vaccine, pt developed a localized rash which over several hrs became generalized rash, still present 72 hrs later.
VOMITING; SWEATING; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced vomiting.  On APR-2021, the subject experienced sweating. On APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 09-APR-2021, and had not recovered from sweating, and chills. This report was non-serious.
One of the patient was given undiluted pfizer vaccine in the family of 3. patient is doing fine.
Brief acute change in mental status. GCS 12/15: E3, V3, M6.
migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 18:00 (Lot number: FK5127) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset 09Nov2021 06:00, outcome "not recovered", described as "migraine". Therapeutic measures were not taken as a result of migraine.  No follow-up attempts are possible. No further information is expected.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that one of the kids had a fever, vomiting, nausea for a week. another one of the kids had a few migraines, third child had migraine as well for one day as of right now. The patient was neither diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 Since the vaccination. Vaccine Facility information, ethnicity and race information was available.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101609878 same reporter/drug/AE with different patient
Thursday, Jan 6th, 2022: He came home from school complaining of headache and just wanted to lay down. I gave him ibuprofen and he went to sleep. Woke up to eat dinner and then went back to sleep. At 10:30PM that night I gave him more ibuprofen. The next day he still had a headache and congestion and elevated temperature 99.8, I continued to give ib. Saturday He had a cough, Sunday his throat hurt. His dad looked at and his tonsils appeared to swollen, we gave him honey. January 10th I took him to his pediatrician's office. He was swabbed for Covid, flu and strep. The next day they told us he tested positive for Covid. Symptoms. He felt better on Wednesday the 12th, but symptoms continued off and on for about a week. Brothers and Father were tested and they were Negative. Mother tested Positive.
Patient came into the clinic for family planning services. Patient had not missed a period and wasn't due for a period for a few more weeks. Menquadfi was due and was administered before the patient was seen by the practitioner. Once the patient was seen by the practitioner, the practitioner ordered a pregnancy test because she was going to place a Nexplanon in the patient. The pregnancy test came back positive. Patient's last period was June 2, 2023 and menquadfi was administered June 27, 2023. Patient tolerated the vaccine well. Patient's due date is determined to be 3/8/24.
Soon after vaccine, my arm that injection given became uncomfortable, like there was a tournaquet around my arm, then my arm became heavy and sore, I had tingling in my right arm and my right leg, I went to the emergency room that night, I had a CVA.  I reported this to the nurses at Occupational medicine, but I'm not sure that an adverse event form was filed. Follow UP: Pt states left arm and leg affected.  Nurse follow up on 10/30/04 states: "cerebellar infarct; Subcortical ischemic change." Follow up 01/26/05: I continue to have numbness and tlingling along with imtermittent "heavey feeling" in left arm and leg. My balance is also affected, I loose my balance very easily.
About 2 weeks after the vaccination  [DTaP, Polio, Hep B, HiB, Pneumococcal], he developed a sudden shivering / shaking / convulsion of his almost whole body, [head, limbs etc] for a few seconds [less than 10seconds], once or twice a day for about 7 days now. [Dont know if he has this convulsion more often when we are not noticing]
Severe vomiting, chills, fatigue, body aches and shakes lasting 7 days
I am having pain, tingling, weakness, burning all over my body. I am having motive issues. I have lack of appetite. This symptom has been going on for about week. It has gotten worst since the shot. I went to the ER. They did blood work. They told me to follow up with my primary care doctor.
pt recv vax & devel ITP & was hosp;MAY95 pt devel ITP for a 2nd time & died;
Arm felt weak, tingling in hand especially in small, ring, and middle fingers, loss of motor skills in hand, weak grasp/pincher grasp/inability to manipulate small objects, i.e. tying shoes, buckling pants etc.
Case number PHEH2014US024311, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. Her medical history and concomitant medications were not reported. She had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 12 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Information has been received from a nurse concerning her daughter (age not reported) who on an unspecified date was vaccinated with the first dose of Gardasil (lot # not reported). Subsequently, the patient experienced injection site pain for three days after receiving the vaccine. The pain was treated with an application of ice to the injection site. Subsequently, the patient recovered from injection site pain. No other information was provided. Additional information has been requested.
SIGNIFICANT BACK AND SIDE PAINS. RASH ON BACK, AROUND RIB CAGE AND TO FRONT CHEST AREA DEVELOPED SHORTLY THEREAFTER. SOUGHT MEDICAL ATTENTION ON 5/2/2014 WHEN IT WAS REALIZED THIS WAS A CASE OF SHINGLES.  APPROXIMATELY ONE YEAR AFTER RECEIVING THE SHINGLES SHOT.  COINCIDENT WITH TIMING OF EXPERIENCE OF AN ACQUAINTANCE WHO DEVELOPED SHINGLES 1 YEAR AFTER THE SHOT.  CURRENTLY UNDER TREATMENT.
Per mother's verbal report, the child experienced convulsions on 2/7/02, 8 days post vax. Vaccines were given on 1/30/02 and child was admitted to the hospital on 2/7/02. She was discharged on 2/10/02. Proceeding medical tests, the physician concurred that the vaccines were the cause of the child's low immunity status, hence attributable to the convulsions and the cold the child is presently experiencing. Rash "like an ant bite" was reported on arms, legs and knees, 7 days post vax. Decreased activity level was noted following immunizations; duration 1 week.
Lingering numbing pain limiting the movement of her arm; Lingering numbing pain limiting the movement of her arm; Joint issues; discomfort; This is a spontaneous report from a contactable pharmacist. An 84-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (lot# CD0208, Exp date Jan2022, NDC 0005197102), intramuscular in the arm, in Oct2019, at 0.5 ml single, for immunisation. Medical history included ongoing joint disorder (since several years). Concomitant medications were none. The patient experienced lingering numbing pain limiting the movement of her arm, joint issues and discomfort all in 2019 with outcome of unknown.
This case was reported by a consumer via other manufacturer and described the occurrence of allergy in a 44-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included ankylosis, spondylitis, gastroesophageal reflux disease, cystitis interstitial and restless legs. Concurrent medical conditions included epilepsy, rheumatoid arthritis, drug allergy (allergy to Fursemide), drug allergy (allergy to Diltiazem) and drug allergy (allergy to Levofloxacin). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergy, hives and facial swelling. On an unknown date, the outcome of the allergy, hives and facial swelling were unknown. The reporter considered the allergy, hives and facial swelling to be related to Shingles vaccine. Linked case(s) involving the same patient: US2022AMR090272. Additional Information: GSK Receipt Date: 07-Jun-2022. Reporter's Comments: The patient was as allergic to the shingles shot, presented with sever Hives and facial swelling. Additional Supportive Information: This case has been linked to US2022AMR090272, reported by the same reporter, same patient. Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR090272:Same Reporter.
Headache-which lasted approximately 3-4 weeks.  Had CT of head: which was normal.  Treated with Prednisone-Headache went away after taking Prednisone.
R leg red, swollen, hot hive the size measuring 85mm in diameter. No systemic reaction only localized. Treated with 50mg of Benadryl po q 6 hrsx.
Information regarding PREVNAR 13 was received from a healthcare professional regarding an unknown number of patients who may have received PREVNAR 13 that was stored improperly on 2 occasions. The patients may have received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product may have been administered on an unspecified date. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patients may have received PREVNAR 13 vaccine that was stored improperly on 2 occasions. No adverse events were reported. No additional information was available at the time of this report.
The patient was scheduled to receive a 3rd Hepatitis B Vaccine to complete the series. This was a catch up dose. The 3rd Hepatitis B vaccine was given 4 weeks earlier instead of at the required 8 week interval. I spoke with the patient, explained what happened and asked if she was experiencing any adverse reactions or symptoms. She stated she feels fine and is not experiencing any adverse reactions. She will be in to receive her 3rd Hepatitis B vaccine at the correct time next month.
Redness and bruising at injection site. Extreme pain and inability to put pressure on the leg that was injected.
Pt developed right facial numbness and transient diplopia 1 day after receiving the vaccine. This report was sent to VAERS as well. Symptoms: 1. Facial numbness and transient diplopia.
Wednesday itching began and she start Benadryl , Thursday the itching continued, Friday her throat almost swelled shut,