chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of hearing loss in a elderly female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown. It was unknown if the reporter considered the hearing loss to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was the reported for reporter's grandmother. The patient stated that the patient was given SHINGRIX, and after vaccination, the patient had lost the hearing (a woman who could hear anything prior to the injection). The reporter was curious if the company had any way to help them since it was this product that caused the issues. This case has been linked with case US2018GSK219942, reported by the same reporter.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium
From telephone contact received at manufacturer on 01/23/2003, it was reported that a 56-year-old female pt received 3rd dose of Imovax Rabies (PEP series) (lot #U0961-2) in the left deltoid at 12:00 PM on 01/15/2003. The pt also received 1st and 2nd doses of Imovax Rabies (lot numbers not reported) on 01/08/2003 and 01/11/2003 respectively. In the evening of 01/15/2003, the pt experienced pain at the injection site, no redness or swelling were reported. Additionally, the pt reported having a fever of 102-103 degrees F, which lasted for 3 hours. Info was reported when the pt came in for her 4th dose of Imovax Rabies appointment. The pt reportedly recovered from the event. No illnesses at time of vaccination were reported. Case is closed.
Patient received a third booster dose of Pfizer but his first two doses Moderna.  No adverse reaction known.
About 10 days after the injection, I experienced severe joint swelling and pain in my shoulders, neck, wrists, hands, hips and knees. The knee and hip pain made walking difficult. My doctor ordered blood work that showed my CRP marker at 57.6 and she diagnosed polymyagia rheumatica. I am on a six day regimen of prednisone. Swelling and pain have decreased.
The day after the vaccine, 04/03/2021 I was at the park and then I couldn't get up. It felt like I had weights around my ankles and spine. I went to  to buy a walker and shower seat and have been using that ever since. I experienced no other symptoms other than trouble walking and exhaustion after physical exertion. I did go see a doctor, I do not know exactly when. I went to a respiratory health center thinking it was something to do with that. The doctor visit came up with no findings, I was given no medication. I am still not strong enough to walk without assistance, but stronger than I was in the beginning.
Pt recvd vax & 30 mins later pt returned to clinic w/hives on all body; VS t99.2, R26, p128, BP 92/50 no resp distress noted; mom was advised to seek medical care;
Information has been received from a pharmacist concerning a female patient of unknown age. The patient had a history of shingles. On 04-MAR-2015, the patient was vaccinated with ZOSTAVAX (dose, strength and lot # were not reported, subcutaneous). On 06-MAR-2015, the patient called to the pharmacy for medical attention and complained the injection site was sore and red, and raised about 3 cm in diameter. The patient stated that it "felt like a shingle". She also raised a rash about 3 cm in diameter which was stated "felt like a shingle" by the pharmacist. The outcomes of the events were reported as not recovered. Causality between the events and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 10-NOV-2012 09:40, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Needle dislodged as 3rd dose was being administered, full dose was not given; Needle dislodged as 3rd dose was being administered, full dose was not given, Regarding the dose "part went in and part went out"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Needle dislodged as 3rd dose was being administered, full dose was not given) and UNDERDOSE (Needle dislodged as 3rd dose was being administered, full dose was not given, Regarding the dose "part went in and part went out") in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 21-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced DEVICE CONNECTION ISSUE (Needle dislodged as 3rd dose was being administered, full dose was not given) and UNDERDOSE (Needle dislodged as 3rd dose was being administered, full dose was not given, Regarding the dose "part went in and part went out"). On 21-Oct-2021, DEVICE CONNECTION ISSUE (Needle dislodged as 3rd dose was being administered, full dose was not given) and UNDERDOSE (Needle dislodged as 3rd dose was being administered, full dose was not given, Regarding the dose "part went in and part went out") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was immunocompromised. No concomitant product information was provided. No treatment information was provided.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction (after a mosquito bite he reacted with an allergic like response all over the body,last for a couple of days and this last weekend happened again).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (headache). On 25-Mar-2021, HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-279707 (Patient Link).
Mom called after hours telecommunications for office practice to inform clinician that patient had a prolonged episode of tremors/shaking which continued in same intensity for at least an hour then gradually started to diminish over the next couple hours until resolution. Asymptomatic by mid afternoon/evening. Patient describes being alert at the time but unable to control the shaking. Felt a hot sensation, and had flushed cheeks as noted by her dance instructor and other dancers. Brief period of time whereby she did not dance, but was able to do some activity while continuing the tremor. Denies chest pain nor difficulty breathing. Had a headache, some transient dizziness, and a stomach ache. Felt stomach ache could be related to menstrual cramps she had at the time. Had breakfast that morning. Did not have any seizure activity, No LOC. At the time of occurrence, mom informed but did not connect that her symptoms could be related to the influenza vaccine. Called telecommunications at 7:01 pm on 10/27/2012 to report event. Discussed bringing patient to the ER, but mom felt symptoms resolved by the time. Mom described plans to consult with patient's primary provider.
Very sore about 2 inches below the injection site. The next morning (5/7/2019) a splitting headache, still sore and hard to move my arm, tired (fell asleep for about an hour), slight nausea. Took ibuprofen and it helped.
Pt was feeling uneasy, looked pale, then passed out.  He came to a minuet later and reported sweating, feeling clammy, vision was blurry.  Gave him water and apple juice, elevated his feet on another chair,  and fanned the pt.  After about 5 minutes he was feeling better and vision was returning to normal.  Pt texted his parents and they came and walked him home.
R delt-pink area 2v 3/4" wide-seen 12/26/02 1:30pm for reaction from TD given 12/23/02 10:30am.
Headache, fever, body aches, swollen body (everywhere), red arm, hot arm, itchy arm, swollen knot at site of injection
Started feeling a little dizzy and pain on my right shoulder, then the pain in the right shoulder had become severe by the following day, on the third day I couldn?t even lift my arm and was in severe pain had severe migraines, had body aches, excessive sweating, chills and tingling burning sensation on the right side of my body, red almost rash like extending from below the injection site down my  bicep to elbow. I currently still have the redness covering my bicep and still experiencing muscle weakness. It will be a week tomorrow since the injection.
Pt reported on set of itching 15-30 minutes after injections with subsequent development of raised, erythematous rash.  No current facial swelling, SOB, fevers, syncope.
at 1805: associate c/o throat tightness, increased heart rate, and slight facial edema. VS: 144/103 (BP), HR 101, oxygen sat 99%.  at 1807: associate took own dose of Alegra and oral Benadryl.  at 1808: given two puffs of Albuterol inhaler 90mcg/puff at 1815: BP 135/96. HR 86.  at 1830: BP 139/95. HR 82. associate up without any problems to restroom. at 1840: symptoms not completely resolved so took dose of own Benadryl at 1850: oxygen sat 97 and HR 76.  at 1900: BP 140/91. HR 77. Associate back to baseline and discharged to home.
Pt was in clinic w/mom no illness was given DTP/OPV/HBOC; w/in 10min red splotchy areas appeared on face arms & trunk 17JUL91; Seen by MD & rash had faded no breathing problems;
Inconsolable crying for 48 hours and then lethargy for another 24 hours.
Severe Hives occured within 24 hours of MMR vaccine administration.  Within 48 hours of MMR administration hands and feet were extremely swollen, temperature rose to 102.5 degrees and hives on thighs and feet turn purple.  Hives receded after 7 days, but reappeared on 8th day.  Mild hives continue to come and go for over 30 days.
Body aches, joint pain, nausea and cold sweats. Used heat, massage, stretching, Tylenol & Ibuprofen. Symptoms lasted about 14 hours but eased up after about 6 hours.
Patient was fully vaccinated and tested positive for Covid on 22Sep2022.; Patient was fully vaccinated and tested positive for Covid on 22Sep2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Sep2022, outcome "recovering" and all described as "Patient was fully vaccinated and tested positive for Covid on 22Sep2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was fully vaccinated and tested positive for Covid on 22Sep2022. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
left sided facial swelling, redness, severe pain started 06/30/2021,.  Went to ER 06/03/2021 treated with Kflex QID without improvements
Information has been received from a registered nurse concerning an infant female who was vaccinated with oral Rotateq. Subsequently, the patient experienced blood in stool after receiving Rotateq. Unspecified medical attention was sought. Upon internal review blood in the stool was considered to be an other important medical event. Additional information has been requested.
Rheumatoid arthritis flare up; This is a solicited report from a marketing program "FACILITATED COLLECT" based on information received by Pfizer from AbbVie. (MFR Control No. 21K-163-4129645-00). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported), intramuscular on an unspecified date as single dose for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Lot number not reported), subcutaneous from an unspecified date to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. The patient's medical history included rheumatoid arthritis. It was unknown if patient was enrolled in a covid-19 vaccine trial. Concomitant medications were not reported. The patient experienced rheumatoid arthritis flare up on an unspecified date. The action taken in response to the event for adalimumab was unknown. Outcome of the event was unknown.   The reporter's causality for the event of rheumatoid arthritis flare up with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of rheumatoid arthritis flare up with BNT162b2 was (adalimumab) was possible.  No follow-up attempts are possible; information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event  rheumatoid arthritis flare up and the suspect drug BNT162B2  cannot be ruled out. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a female who was vaccinated with the Gardasil, 0.5 ml. Subsequently, the patient developed a fever sore on her mouth after receiving the vaccination. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ oral, Lot # K004468 with expiry date of 08-DEc-2015 or lot # K013410 with expiry date of 27-FEB-2016, or lot # K015831 with expiry date of 18-APR-2016. No adverse effects were reported. The nurse confirmed that no vaccines were administered after the labeled expiration dates. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Mild Fever for one day, the remaining symptoms developed on day 2. Lips pursed, unable to open mouth or vocalize, a strained humming through nose. Tongue twitch with tongue extremely extended, appears not controllable in 15 min intervals. No vocal chatter (stopped normal chatter that existed before event), no crying day or night. Appears to struggle to use mouth but can't start on her own. Symptoms lasted 6 days before improving, resolving over additional 2 days.
My period was 6 days late. I have never experienced any delays in the 20 years I've had my period. And no, I am not pregnant.
Received smallpox vaccine in (L) posterior deltoid on 03Feb2011. Beginning on 10-11Feb, patient developed lymphadenopathy in (L) axilla and erythema in entire (L) deltoid/axilla region; these sxs resolved after two days. She arrived abroad on 12Feb and on that day developed numerous pustules on her chest. Evaluation on 15 Feb noted headache, fatigue, joint pain and swelling (described in separate VAERS). Rash described as erythematous "spots" on chest, back and a few on abdomen. Exam noted: Tamp 98.2, HR 70, BP 130/79, RR 18, normal exam except skin noted to have macules, papules and pustules to trunk and back, with acneiform eruption on face and back. Eschar on arm. Assessment included: 1) Arthralgias, c/w possible low-grade, concurrent viral prodrome - Naprosyn. 2) Headache - Acetaminophen two tabs twice daily. 3) Malaise, c/w hypothyroidism and jet lag and possible concurrent, mild viral prodrome. Patient reports rash and headache resolved within 3-5 days and fatigue gradually resolved over 2-3 weeks.
Patient presents to the pharmacy about 1 week after getting a flu shot with complaints of arm soreness, reduced range of motion, and occasional tremor in the left arm; same arm that he received his flu shot.
Patient had her vaccines in office 01/20/2020. She had a fever that day of 102 temporal. Mom states that she had given patient Tylenol over night and she did not sleep through out the night either.  Patient is taking normal bottles and having adequate amount of wet diapers. Mom states that at 5 am she did give her Ibuprofen. She states that after giving the Ibuprofen, patient slept 3 and a half hours. I advised her to call back at four pm after she checks her temp again and if it is over 102, head to ED, She has been alternating the Tylenol and motrin every 3 hours and a referral to Dr (allergiest) has been sent. Mom notices that she jerks when she falls asleep - may be her arm, head, leg - always a different extremity.
Case number PHEH2012US023532, is an initial spontaneous report received from a healthcare professional on 28 Nov 2012: This case refers to a 14-year-old female patient. She was vaccinated with MENVEO (batch number: A11082 and expiry date: May 2014), at dose of 0.5 ml intramuscularly on 17 Sep 2012. The MENVEO vaccine was stored at multiple temperature excursions above 46F (on 27 Jul 2012 55 F for 1.5 hours, on 08 Sep 2012, 52 F for 3 hours and on 09 Sept 2012, 49 F for 1 hour and 50 F for 2 hours). No adverse reaction reported following this administration error.
tingling sensation on her left arm several weeks after getting the vaccine; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer- sponsored program Support. A 61-year-old female patient received  BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, several weeks after getting the vaccine, the patient experienced tingling sensation on her left arm, further reported that, it was at first unnoticeable but progressed in time and also mentioned that it is not painful and not stopping her to do her daily activities, that is why she is waiting for 2 weeks until her scheduled doctor's appointment. The patient would like to know if this has been a commonly reported side effect of the vaccine. The outcome of the event was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Full body ache; Dry mouth; Dizziness; Drowsiness; Fever; Headache; Chills; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 29Apr2021 at 15:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. 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 COVID vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 08Apr2021 at 15:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 02:30, the patient experienced chills, fever, full-body ache, headache, drowsiness, dizziness, dry mouth, nausea which started approximately 12 hours from vaccine dose and lasting over 24 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, fever, full-body ache, headache, drowsiness, dizziness, dry mouth, nausea were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
rash on arm of injection, right neck and right thumb; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm of injection, right neck and right thumb) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced RASH (rash on arm of injection, right neck and right thumb). At the time of the report, RASH (rash on arm of injection, right neck and right thumb) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 09-Mar-2021 rash was recovered but on  21-Mar-2021 mild rash came back.  No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Vaccination error. A non-serious spontaneous report of "18 month child received FLUMIST" was received from a consumer, the patient's parent concerning an 18th month old male. The patient's medical history and concomitant medications were not reported. On unknown date, the patient was administered FLUMIST. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.