chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting 12 hours following the second dose on 4/23/20201 experienced chills; Starting 12 hours following the second dose on 4/23/20201 experienced chills, significant muscle aches; Starting 12 hours following the second dose on 4/23/20201 fever started which lasted for about 32 hours. The fever was between 99oF and 101.5oF during; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERZ735) via an unspecified route of administration in the left arm on 23Apr2021 at 11:15 (at the age of 42-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 vaccination. The patient did not receive any concomitant medications. The patient previously the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 02Apr2021 at 10:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 23:15, 12 hours following the second dose, the patient experienced chills, significant muscle aches and fever which lasted for about 32 hours. The fever was between 99oF and 101.5oF during that timeframe. On the same day, the patient underwent body temperature test and the result was between 99 degree Fahrenheit and 101.5 degree Fahrenheit. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events which included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, significant muscle aches was recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Burning & hot, sensitive to touch. Tx Doxycycline x 10d.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient came to the pharmacy with severe redness and pain in his left deltoid
Muscular weakness, muscular aches, back aches, started 2014 to present. Currently being treated with monthly IVIG via hospitalization, difficulty breathing and moving, hypersensitivity throughout whole body.
This spontaneous report as received from a nurse refers to an unknown patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (dose and route of administration were not reported, lot # M029919 with expiration date: 13-JUN-2018). No adverse effects were reported. Data logger was involved. There was a previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA004592: US-009507513-1705USA004591: US-009507513-1705USA004590: US-009507513-1705USA004589.
On 03/07/2001, the patient received MMR #2 and Hep B #1. From 03/08/01, he had a skin rash, maculo erythematous trunk and face. No fever, no systemic symptoms.
This spontaneous report as received from a medical assistant refers to a 14 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JAN-2016, the patient was vaccinated with an improperly stored dose of PEDVAXHIB lot # K004540, expiration date: 03-DEC-2016 (exact dose, route of administration and anatomical location were not provided). There were no adverse effect reported. This is one of several reports received from the same reporter. This is one of two reports concerning the same patient. Additional information has been requested.
Redness and itching away from the site of injection - gave shot in muscle of shoulder - elbow turned red and itched. Moderate headache and 100 degree fever next day.
Diagnosed w/ juvenile rheumatoid arthritis 1/09. Symptoms have been progressive since 2007. Also has asthma, scoliosis and migraine HA.  9/25/09 Medical records/ER visits received DOS 3/11/02 to 06/20/08. Patient presents with infection behind (R) leg. Fatigue.  9/27/09 Medical records received DOS 8/22/08 to 9/5/09.  Assessment: Juvenile Idiopathic Arthritis of Polyarticular Subtype / Arthritis Secondary to Bowel Disease. Finger pain and swelling. Loose stools, achiness, knees weak. Generalized pain. Morning pain, stiffness in back, toes, fingers. Shoulder pain. Stomach pain after eating. Nose sore, anxious and sad. Sacroiliac joint pain. Decrease in lumbar flexion. Sinusitis. Viral illness. Lips swelled.
DPT #5 given 15JUL91, mom called 18JUL c/o rash @ inject site, Pt then seen @ office Had approx 4cm area of urticaria;
It was reported that an infant rec'd a vaccine of TriHIBit (Tripedia (lot #U0542E) and ActHIB (lot # UA687AA) on 8/26/2002. the pt was seen in the Dr's office on 8/27/02 at which time exhibited a 6 X7cm area, which was red and swollen with slight induration at the injection site.
Intermittent fever of up to 101.3 degrees. Local swelling with no erythema. Good response to Tylenol and ice.
2 weeks post WCC with vaccines (listed above)  patient developed "pox style" rash on arm/leg/torso.  Spreading # for 2 days. Total # of lesions 6. Of note - 1 week post vaccines patient seen for 103 temp in urgent care at Hospital.
Pt received H1N1 in left deltoid. Woke up the next day with (R) side of face swollen and rash on stomach. Went to own doctor and received Prednisone for 6 days (Received the Novartis H1N1 on 12/15/09) - Had allergic reaction similar on 1/2/10 and went to ER and received Epi. Pt stated she is going for allergy testing at the end of January.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored dose of M-M-R II injection, lot # L024265, expiration date 01-JUL-2017 (dose and route of administration were not reported). No adverse symptoms were reported. The vaccine was exposed to temperature 47.1 Fahrenheit (F) for 4 minutes with previous excursion 46.8 F for 1 hour and 45 minutes. This is one of several reports from the same source. Additional information has been requested.
On 10/9/21  8pm  I developed fatigue, temperature of 99.8 ( my normal is 97.6), chills. Took Tylelnol 500: attempted to sleep, but restless and achy. Could palpate soreness in axilla area. Developed headache, which would not subside. Repeat temp several hours later and it was 99.9 Due to severity of headache I took a single Norco tablet. When I awoke at noon I felt much better, but experiencing periodic Chest twinges.
After lying down for the night severe burning and throbbing pain from the left shoulder to elbow, especially at the injection site. Unrelieved with MOTRIN or TYLENOL. Unable to sleep at all for lack of comfortable positioning.
After receiving other vaccines without incident, patient was injected with HPV vaccine. Within seconds the patient became unresponsive. Her body went completely ridged, her face became very pale, her eyes rolled, and her left arm twitched a few times. Patient was laid down on the table with knees up. After a few seconds the patient started talking and moving again. Patient was asked to stay lying down for 15 minutes. She was given 2 popsicles. Her vitals were recorded 3 times at 5-minute intervals. Initial BP was 96/42 HR 70, 2nd 108/70 HR 88, 3rd 102/66 HR 74. After second set of vitals were taken patient's color returned to face, she was speaking coherently, and eating her popsicle. Patient did start to shake when 2nd set of vitals were taken but parent said it was probably from the popsicle. After 3rd set of vitals was taken patient expressed that she felt ok and was ready to go home. Patient was allowed to leave ambulatory under her own power.
Pentacel comes in a 2 vial dose that needs to be constituted together for single administration. Once green cap vial (HIB) and one blue cap vial (DTaP-IPV).  It was discovered on 12/22/2022 that there was one blue cap vial in the box missing it?s companion green cap vial. It is assumed that this is one of 5 patients did not receive the blue vial (DTaP-IPV)
Patient had Pfizer vaccine dose 1 on 12/19/20 and Pfizer vaccine dose 2 on 1/12/21. She ended up getting COVID-19 virus on 2/21/21.
Have developed constant high pitch tone ringing in ears. Never had Tinnitus until after vaccination and now it?s non-stop.  Anxiety and/or accident has nothing to do with this NEW problem.
9/23 10-15 min after rapid heart beat, sweat, nausea & tired all day. Same nausea x 5 days. Next day nausea joint ache 9/25 severe stuffiness headache facial pain paleness.
arm hurts; headaches; This is a spontaneous report from a contactable consumer. A 58-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration administered in Arm on unspecified date (age at the time of vaccination was 58-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration as single dose for COVID-19 immunization. The patient experienced arm hurts from Covid second vaccine and headaches on an unspecified date. The outcome of the events was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
administered menquadfi post excursion with no reported adverse event; Menquadfi at a low of 33F out of range for a total of 21 hours with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA146318.  This case involves a 17 years old male patient where (meningococcal a-c-y-w135 (t conj) vaccine) menquadfi at a low of 33f out of range for a total of 21 hours with no reported adverse event and administered menquadfi post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 04-May-2023, the patient received 0.5 ml total (1x) dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (batch number- U7595AC and expiration date- 11-May-2025) via intramuscular route in the right arm (strength : not provided) for Immunization.  On 04-May-2023 menquadfi at a low of 33f out of range for a total of 21 hours with no reported adverse event (product storage error) (latency- same day) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  On an unknown date the patient got administered menquadfi post excursion with no reported adverse event (poor quality product administered) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 the guidelines. 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.
Started at dinner time (5;30 PM) aches and about an hour later chills.  I didn't take my temperature.  Lasted several hours.
Information has been received from a physician concerning a 13 year old male who on 10/25/2000 was vaccinated with a dose of varicella virus vaccine live. On 3/18/2005, the patient experienced few pox and was given acyclovir. Additional information has been requested. The reporter also indicated that the patients brother developed a red spots on his face after therapy with varicella virus vaccine live (WAES0504USA00679)
The patient was given his second dose of Moderna Vaccine at 1408 on 31MAR21.  At 1412, he was complaining of nausea, headache and generalized pain in bilateral shoulders and legs. His B/P 160/110, HR 75, O2 Sat. 96% and Temp. 98.1.  He laid supine on a cot for  RN observation.  He was given Benadryl 25 mg po at 1430 after which time his symptoms subsided.  His B/P was 150/100 at 1500.  At 1527, patient ambulated and states he was going home.
Localized swelling, erythema, itching/burning. Benadryl 125 mg x 2 doses 9/15/07.
Dizziness, nausea, diarrhea, headache, body aches (muscle and joint), fever  Felt sick a couple hours after injection, had first round of diarrhea Went to bed with a 100.3 fever Woke up Saturday around 4:30am completely soaked in sweat Kept falling asleep involuntarily (during a shower, while sitting upright watching a video) and realized I was probaby dehydrated from the fever, diarrhea, and not having been able tot eat/drink anything besides a couple of crackers since the shot Had trouble finding a phone number for a nurse line because I had just changed insurance and kept falling asleep Went to urgent care as soon as they opened Was treated with 1000ml saline IV and an anti nausea medication Went home and waited out the rest of the reaction  Returned to feeling normal Tuesday morning
Starting on Monday, 11/29/2021 (between 6 and 9:30 p.m.) a rash broke out first on the back of right hand, then above right knee, lower left thigh, and left arm. Later started on right shoulder.  Saw the doctor on Tuesday who did some bloodwork and advised to take antihistamine. Rash continued spreading up and down both arms, thighs, and below the knees as well as on back near waistband by Friday night. Very itchy.
10/20/08-Received PNEUMOVAX (L) deltoid area. Client not sure if IM or SQ. Developed pain the next morning with progression to swelling, redness, fever (102 F oral), Nausea/vomiting. Diagnosed as cellulitis. Treated with CLINDAMYCIN IV x1 and oral q6 hr x 7 days
Cognitive issues; This spontaneous case was reported by a consumer and describes the occurrence of COGNITIVE DISORDER (Cognitive issues) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COGNITIVE DISORDER (Cognitive issues). At the time of the report, COGNITIVE DISORDER (Cognitive issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were not provided. Treatment information were not provided
Began feeling extremely tired and running a temp around 6 PM the evening following my second shot; on 11/6, began experiencing chills, fever, headache, fatigue with temp reaching a high of 102.3. From 11/6 to 11/15, symptoms continued with fever temp varying between 99.9  to 102.3, usually higher at night. Headaches and chills persisted. Physician visit on 11/8 for treatment and to report my symptoms seemed a direct result of my second vax shot. He recommended vitamin C, D, Zinc and aspirin. Since 11/8 I have also experienced an almost total loss of sense of smell (anosmia) and corresponding loss of sense of taste; these symptoms continue today
Fever between 100-102 degrees; Nausea; Headache; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 05May2021 at 11:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. 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 vaccination. Concomitant medications were not reported. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the right arm on 14Apr2021 at 11:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 05May2021, after 12 hours of vaccination, the patient experienced headache and chills. On 07May2021 at 12:30, the patient experienced nausea and fever between 100-102 degrees through the following two days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On 07May2021, the patient underwent body temperature test and the result was 100-102 degrees (unspecified units). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, chills, nausea and fever between 100-102 degrees were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
SEVERE SPASM LIKE SHAKING OF ENTIRE BODY FOR OVER 2 HOURS WITHOUT FEVER OR CHILLS FOLLOWED BY EXTREME FATIGUE AND NAUSEA
In the first 72 hours after the vaccination, patient had significant muscular pain and difficulty with full range of motion. This improved slightly but at 17 days post-injection patient continues report significant discomfort and pain in the left deltoid region. She has used NSAIDs with some relief. Discussed ice/heat and activity with patient. We are continuing to follow-up regarding the case.
My 13 year old daughter received the 2nd dose of the GARDASIL shot and has experienced pain on the administration site since. She complains it hurts when raising her arm and shot site hurts. She complains it feels like a sharp needle stick.
L thigh (injection site) with swelling, erythema, induration, and small number of bullae over injection site. Extended ~ 8 inches in diameter. No bleeding, petechiae. No systemic symptoms.
No Adverse Event; bivalent first dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (bivalent first dose) and NO ADVERSE EVENT (No Adverse Event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     The patient had not received any of the doses of COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu shot on 01-Nov-2022. Past adverse reactions to the above products included No adverse event with Flu shot.    On 03-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 03-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (bivalent first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (bivalent first dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2022, Mycobacterium tuberculosis complex test: On 03-Nov-2022, no symptoms reported..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (bivalent first dose).    The concomitant and treatment medication was not reported. No additional doses, medications or treatments.
Arm sore; Red down the arm below elbow; Itching; Red spot; Arm swollen to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), ERYTHEMA (Red down the arm below elbow), PRURITUS (Itching), PERIPHERAL SWELLING (Arm swollen to elbow) and VACCINATION SITE ERYTHEMA (Red spot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen to elbow). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore), ERYTHEMA (Red down the arm below elbow), PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Red spot). At the time of the report, PAIN IN EXTREMITY (Arm sore), ERYTHEMA (Red down the arm below elbow), PRURITUS (Itching), PERIPHERAL SWELLING (Arm swollen to elbow) and VACCINATION SITE ERYTHEMA (Red spot) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Patient became pale and diaphoretic and passed out. Patient was placed on the exam table and vital signs were obtained. Cool compresses were placed on the child. VS were P-104, RR-38, 02 sat-99% B/P-80/60. The event started within a minute of the administration of the vaccines at 10:00am and Patient was fully responsive to verbal commands by 10:05am. )2 sat was 100%, RR-28, P-84 and B/P was 96/58. Patient was observed for over 20 minutes and released to Mother. Mother stated the child has this reaction every time he has an immunization.
Ear pain; Sore throat; Stiffness in her neck; Temperature was about 99.8 so nothing incredibly high so it is just elevated temperature; This is a spontaneous report from a contactable consumer reported for his wife.  A female patient of an unspecified age received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that, "My wife received the Pfizer vaccine 6 days ago and for the last two days she had pain in regards to ear pain and very sore throat as well stiffness in her neck and I just took her temperature and it was about 99.8 so nothing incredibly high so it is just elevated temperature and I was calling to see if the throat and ear and neck pain have been reported side effects or symptoms of the Pfizer vaccine and is it something which requires medical treatment." The outcome of the events was unknown.