chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching like crazy; she experienced a bad skin reaction; rash that was not only at the injection site but on both arms; Bad skin reaction or rash that was not only at the injection site but on both arms; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching like crazy), SKIN REACTION (she experienced a bad skin reaction), VACCINATION SITE RASH (rash that was not only at the injection site but on both arms) and RASH PRURITIC (Bad skin reaction or rash that was not only at the injection site but on both arms) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030372) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, the patient experienced VACCINATION SITE PRURITUS (Itching like crazy), SKIN REACTION (she experienced a bad skin reaction), VACCINATION SITE RASH (rash that was not only at the injection site but on both arms) and RASH PRURITIC (Bad skin reaction or rash that was not only at the injection site but on both arms). At the time of the report, VACCINATION SITE PRURITUS (Itching like crazy), SKIN REACTION (she experienced a bad skin reaction), VACCINATION SITE RASH (rash that was not only at the injection site but on both arms) and RASH PRURITIC (Bad skin reaction or rash that was not only at the injection site but on both arms) had not resolved.            No relevant concomitant medications were reported. It was reported that the patient had been receiving Moderna vaccines since the beginning of COVID.  She saw a dermatologist on the day of report who recommended a topical steroid treatment and oral antihistamines. She was planning on taking Benadryl at night on the day of the report.   This case was linked to MOD-2023-748128 (Patient Link).
I started to have a shoulder and the neck sore and this I couldn't turn my head aside evenly; I started to have a shoulder and the neck sore and this I couldn't turn my head aside evenly; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Mar2021 (Lot Number: EN6199) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.The patient had the vaccine on 06Mar2021 and on 16Mar2021, started to have a shoulder and the neck sore and patient couldn't turn head aside evenly. So that last till the time of reporting, it had been 4 days. The outcome of the event unknown.  No follow-up attempts are possible. No further information is expected.
Raised hives since 1/22. Has been all over my body. My hands were completely swollen and couldn?t make a fist in 2/2. The hives/rash has been most commonly found on my arms and thighs, and also my calves and buttocks.
Received HIB vaccine all by itself in the afternoon, by morning of the 13th she had a fever that continued until 12/14 at 2am it spiked to over 104 and she was lethargic with a nasty sounding cough. She was diagnosed at the ER in pneumonia and given a nebulizer to be taken every 2 hours for 5 days with a follow up appointment to her pediatrician. At her 8 month appointment 12/17 she was back in the ER on oxygen as her breathing was so shallow and stressed and her oxygen levels were low. 3/29 She was given the Dtap vaccine and had the same exact reaction within 48 hours.
I have had extreme muscle pain and tightness in my left arm, shoulder and neck since 12-30-2020.
Pt. states she had heat rash on her arm 2 hours after receiving flu vaccine. She took OTC BENADRYL & rash went away. She feels fine. No other problems were reported.
Patient did not experience any adverse symptoms from the IPOL vaccine.  Reporting because vaccine was administered past the expiration date. Expired on 10/3/2021 but administered on 10/05/2021.  Data review of vaccination reports in March 2022 is how the administration of the expired vaccine was noticed.   As directed by CDC guidelines and Sanofi Pasteur, patient was asked to return to office for an additional dose, which she received on 3/7/2022.
Patient received a covid and a influenza vaccine in our vaccine clinic.  Within 4 minutes of administration she started to experience intense low back/let cramping.  It lasted a few minutes and then subsided and went away.  She denied any other symptoms during the episode and declined the recommendation she be evaluated by a clinician in our clinic today..
I began to have a very high fever and uncontrollable chills.  I have never had a reaction to a shot before in my life.  I felt I was getting the flu and fighting it for all I was worth.  I never vomited; however, I had to lie under a heating blanket and at around 1:00 AM I was better.
12 hours post injection: fever (102.7), chills, aches (mostly elbow and wrist pain), strong headache, fatigue, difficulty walking (only first 24 hours), heartburn.  All symptoms except difficulty walking lasted 4 days.
This spontaneous report as received from a Medical Assistant refers to a female patient of unknown age. On 03-DEC-2009 the patient received her first dose of GARDASIL. The patient received her second dose of GARDASIL on 14-MAR-2012 and her third dose of GARDASIL on 14-MAY-2013. Dosing information, route of administration and lot numbers were not provided. No adverse effect was reported. Additional information has been requested.
feels burning when something brushes against it; It is itchy when it is touched; rash about 2 inches at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (feels burning when something brushes against it), VACCINATION SITE PRURITUS (It is itchy when it is touched) and VACCINATION SITE RASH (rash about 2 inches at the injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced SKIN BURNING SENSATION (feels burning when something brushes against it), VACCINATION SITE PRURITUS (It is itchy when it is touched) and VACCINATION SITE RASH (rash about 2 inches at the injection site). At the time of the report, SKIN BURNING SENSATION (feels burning when something brushes against it), VACCINATION SITE PRURITUS (It is itchy when it is touched) and VACCINATION SITE RASH (rash about 2 inches at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants products were reported. No treatment information was provided.
Hot flashes, nausea, headache did get sick, headache linger x 1 day took TYLENOL - did help with headache.
NUMBNESS AND TINGLING IN EXTREMITIES POST VACCINATION. HYPERVENTILATING. DENIES PAIN OR SHORTNESS OF BREATH. ALERT/ORIENTED, VITALS NORMAL. SECONDARY/NEUROLOGICAL EXAMS NORMAL. REFUSED TRANSPORT.
Tingling, throat feels like it is closing up - (scratchy, hoarse) shortness of breath, muscles/nerves twitching, jumping, pains in ankles, malaise - cannot eat or drink certain foods. (Still experiencing).
STOMACH IS HURTING; NAUSEA; DIARRHEA; BLOOD IN STOOL/BLEEDING WITH DEFECATION/POOPING BLOOD FOR THE PAST FEW DAYS; ARM IS HURTING; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: UNKNOWN) 1 total, dose was not reported, administered on 29-DEC-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported. The patient claimed that his arm hurt after taking the vaccine (29-Dec-2021). Patient experienced some nausea and diarrhea afterwards. On 09-JAN-2022, the patient experienced blood in stool/bleeding with defecation/ pooping blood for the past few days. This prompted him to go to the emergency room. The patient was in perfect health before the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood in stool/bleeding with defecation/pooping blood for the past few days, and the outcome of nausea, diarrhea, stomach is hurting and arm is hurting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20220113776-COVID-19 VACCINE AD26.COV2.S-blood in stool/bleeding with defecation/pooping blood for the past few days. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sore arm at injection site; This is spontaneous report from a non-contactable consumer, the patient. A 60-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: Unknown), via an unspecified route of administration and in unspecified anatomical site on 10Mar2021 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. Patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in Mar2021, the patient experienced sore arm at injection site. The patient did not receive treatment for the event. The clinical outcome of the event sore arm at injection site was resolving at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Exhibiting symptoms of Tourette Syndrome; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOURETTE'S DISORDER (Exhibiting symptoms of Tourette Syndrome) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced TOURETTE'S DISORDER (Exhibiting symptoms of Tourette Syndrome) (seriousness criterion medically significant) . At the time of the report, TOURETTE'S DISORDER (Exhibiting symptoms of Tourette Syndrome) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Computerised tomogram head: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.; Sender'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
Major taste change; taste like it has a blood/metal/acid; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: ep6955) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications (other medications in two weeks). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: en6198, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination. The following information was reported: TASTE DISORDER (disability) with onset 25Jun2021, outcome "not recovered", described as "Major taste change"; DYSGEUSIA (disability) with onset 25Jun2021, outcome "not recovered", described as "taste like it has a blood/metal/acid". Also reported that food does not taste good. The events "major taste change" and "taste like it has a blood/metal/acid" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of taste disorder, dysgeusia. Events resulted in disability or permanent damage.  No follow-up attempts are completed. No further information is expected.
Information has been received from a nurse practitioner concerning a female who in August 2007, was vaccinated with GARDASIL. Recently the patient experienced swollen lymph gland. It was unknown whether the patient sought medical attention. The patient's outcome was unknown. Additional information has been requested.
Systemic: Seizure-Mild, Additional Details: Patient fainted and seized immediately after recieving the Moderna Booster (1/2 dose).  She has no history of seizures after recieving either of the 1st 2 doses of the moderna vaccine or any flu vaccine that she has recieved in the past.  In less then 1 minute the patient came out of the seizure state and was able to communicate clearly with me. She stated later that she had had a seizure this summer after not having eaten for an entire day.  She stated she had a doughnut for breakfast.
Pediatric dose to adult patient; Pediatric dose to adult patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 29-year-old female patient who received HAV (Havrix 720) (batch number yg7yg, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th March 2022, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 14th March 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product 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: 28-Mar-2022 Reporter's Comments: Medical assistant reported that the patient received a pediatric dose of Havrix. The consent to follow up was given. Additional Supportive Information: The adult patient received pediatric dose of Havrix which led to, underdose and adult use of a child product.
stroke; Initial information received from RA on 19-Oct-2022 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who experienced stroke, after receiving vaccines COVID-19 VACCINE and INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) and COVID-19 VACCINE (not produced by Sanofi Pasteur)  lot number not reported at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date(latency: unknown), the patient developed a serious stroke (cerebrovascular accident) .   Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (stroke). At time of reporting, the outcome was Unknown for the event stroke.  Seriousness criteria: medically significant for the stroke; Sender's Comments: Sanofi company comment dated 28-Oct-2022: This case involves an unknown age female patient who was vaccinated with Influenza vaccine( produced by unknown  manufacturer ) and covid 19 vaccine (not manufactured by Sanofi) and experienced stroke. The time to onset is not reported with the role of the vaccine. The clinical course was not provided. Furthermore, additional information regarding condition at the time of vaccination, diagnostic workup, would be needed for a complete assessment of the case. The case is confounded by multiple vaccines administered. Based upon the reported information, the role of an individual vaccine cannot be assessed.
hard; painful; hard, painful bicep "charlie horse"; itching at the injection site; chills; warm skin rash; warm skin rash below the injection site; This case was reported by a consumer via call center representative and described the occurrence of chills in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 4RF5J, expiry date 25th April 2022) for prophylaxis.   On 8th September 2020, the patient received the 1st dose of Shingrix (intraparietal) .5 ml. On 8th September 2020, less than a day after receiving Shingrix, the patient experienced chills. On 11th September 2020, the patient experienced induration, pain localized, charley horse and injection site itching. In September 2020, the patient experienced skin warm and skin rash. The patient was treated with paracetamol (Tylenol) and camphor + diphenhydramine hydrochloride + zinc oxide (Benadryl Lotion). On 10th September 2020, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the skin warm, skin rash, induration, pain localized, charley horse and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the chills, skin warm, skin rash, induration, pain localized, charley horse and injection site itching to be related to Shingrix.  Additional details were reported as follows: On 8th Sep 2020 the patient had chills until 10th Sep 2020. 48 hours after receiving the injection, the patientg developed a warm skin rash below the injection site, this rash was still ongoing at the time of reporting.  On 11th Sep 2020, the patient developed a hard, painful bicep "charlie horse" and itching at the injection site, these symptoms were ogoing at the time of reporitng.  The patient treated these with heat, tylenol and benadryl lotion. The reported batch number 4RFSJ for Shingrix did not exist and was updated to 4RF5J as per the sales database. The reporter consented to follow up.
This initial spontaneous report was received from a physician referring to a 8 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 11-SEP-2015 at 16:15 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Had Varivax per Immunization records on 7/31/1997 and had varicella on 2/2/2000.
Site: Swelling at Injection Site-Mild, Additional Details: Two Benadryl 25mg tablets given to take later if the patient experienced further swelling or a rash. The patient did not take them at the site of care.
At 1736 RN  signaled that client was not feeling well. Client leaned forward and gave emesis bag. Client had 1 vomit episode. Client was already sitting on anti-gravity chair due to history of syncope with vaccinations. RN  stated client first complained of headache and dizziness within a minute of vaccination. Vitals at 1738 by RN: blood pressure 101/65, pulse 58. Client appeared pale, alert and oriented x4. RN gave client water. Per client phobia of medical procedures and did not want blood pressure to be taken and it made her symptoms worse. Client reported no other medical history, no medications and no allergies. Client reported feeling "headache, dizziness and nausea ." Client denied blurry vision, chest pain or shortness of breath. At 1743 client asked to eat her  chocolate, per client it helps her. Pulse 57 at 1749. Client reported all symptoms had resolved. Client's boyfriend present and stated he would drive her home.  asked client if we could recheck blood pressure and client accepted. At 1558 vitals: pulse 77, oxygen sat 100%, blood pressure 138/94. RN reviewed with client ER precautions. Last vitals at 1806: blood pressure 132/87, pulse 71. Client stood up at 1807 and walked a few steps without any complaints. Client left facility at 1807 with steady gait.
L arm had a "small knot" at the injection site that mother felt had enlarged over the weekend. Inj given 12/4/09 @1345. Dr visit on 12/7/09. Dr stated no s/s of infection. No treatment needed.
The child had blood in their stool; The father does not want to get any remaining doses of ROTATEQ now; The father does not want to get any remaining doses of ROTATEQ now; child's ROTATEQ; This spontaneous report was received from a nurse practitioner (who obtained information from a patient's father) via a company representative and refers to the child patient of unknown exact age and gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On an unknown day, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency, route of administration, lot number and expiration date were not reported) as prophylaxis.  On an unknown day (after the first dose of the suspect vaccine), the patient had blood in their stool. At that time, their father did not want his child to get any remaining doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The outcome of blood in stool was not reported.  The causality between the event of blood in stool and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.  Upon internal review, blood in stool was considered to be medically significant.  This is one of several reports from the same reporter (MARRS # 2102USA001245).; Sender's Comments:  US-009507513-2102USA001245:
pt became nauseated and vomiting 1 day after getting vaccine,  reported on Mon  2/22/21 but states was getting better,  received call from sister on 2/25/21 that pt could not get out of bed on own -  was sent to ER at that time
Red bumps on neck and chest, cold symptoms, lymph nodes swollen. Symptoms began 26 Mar 2003. Cold Started 24th March.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 18-AUG-2016, the patient was vaccinated with improperly stored VARIVAX (0.5 ml, once, lot # M006157, expiration date 05-FEB-2018) subcutaneously. The vaccine had been stored under an unspecified temperature from 11-JUL-2016 to 20-SEP-2016. There was no digital data logger involved or prior excursions. No adverse effects were reported. Additional information has been requested.
*unknown if this is due to the vaccine or unrelated Multiple chronic hive-like rashes all over my body. Responds to antihistamine treatment. Have had this reaction occurring since 10/4/21. Allergy testing showed a reaction to all allergens so I was diagnosed with dermatographia which the allergist suggested may be related to my booster on 9/25/21.