chrisvoncsefalvay/vaers-outcomes huggingface dataset:
metallic taste in mouth; thick/heavy feeling of tongue; feeling of "fat lip"   First noticed approximately 90 minutes post injection.   Took Benadryl (1 capsule).    Metallic taste faded to dry mouth and other symptoms lessened throughout evening (over course of 3-4 hours).   Woke up next morning and all symptoms were resolved.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 8-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent vaccination included meningitis vaccine, strain not specified (Sanofi Pasteur MSD), MMR II (Merck) and VARIVAX (Merck) all given on 13 July 2011. There were no concurrent medications. On 13 July 2011 the subject inadvertently received unspecified dose of BOOSTRIX at 0.5. this was the wrong vaccine for administration. At an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling injection site and injection site redness. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.
Pt given prescription to get VIVOTIF at pharmacy. Began 1st dose Sunday 10/23. On Tuesday evening 10/25 began with fever. No other symptoms. Still with fever 10/26, 10/27-Saw PCP-? Viral.
Patient received Tdap vaccine on 3/15/19. Patient should of received Dtap considering she is age 3. No adverse affects reported to date 4/2/19.
About 12 hours after receiving the shot, I am experiencing muscle and join aches, sore throat, popped ears, headache. The injection site is extremely painful. Still experiencing the symptoms since they began at 1 am and I lost out on sleep.
24 hrs after flu shot, dizzy, severe aches in joints especially one knee, fever and cold chills then hives, starting on back then neck, arm, eye lids and ankle.  Have had flue shots for years with NO adverse effects.  I am in good health, no major problems except Macular Degeneration of one eye and minor back pain. The reaction lasted approx 24 hrs. I did not call the Doctor nor go to the ER.
pt recvd vax 22JUL94 & exp swollen arm & blood shot, urine problem & pain all over body aching;Couldn't move, temp 102 F;
Patient received their vaccine and waited in the store for 10 mins. Upon exiting the building they felt dizzy and fainted for a few seconds, which was witnessed by patient's mother. Patient quickly came to and was brought into the store and monitored for 30+ minutes. No harm noted.
Soreness at the site about 3 hours after the injection followed by headache about 24 hours after. Then about 48 hours after, developed diffuse myalgia and drowsiness
Fever of 100.6 that began about 12-13 hours after injection. Followed by 24-36 hours of fatigue and generalized body aches.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from non health professional reported as office staff. This case involves a 20 months and 3 days old male patient who received 5th dose of 0.5 ml of ACT-HIB (batch number: UI969AAA) (expiry date: 13-Mar-2020) (route and site of administration were not reported) on an 29 Oct 2018. (reported as 29-Oct-2019). Patient had received had received the recommended 4 doses of ACTHIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunization. It was case of actual medication error due to Extra dose administered as Patient received an extra ACTHIB (5th dose), that was administered by the HCP. No adverse event was experienced. 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 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.
Headache; This is a spontaneous report from a contactable physician. An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient also received upadacitinib (RINVOQ, Batch/Lot number was not reported), oral from an unspecified date to an unspecified date for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported.  It was reported that solicited report by a consumer of an adult female with an event of non-serious headaches after covid vaccine with RINVOQ (Upadacitinib). On an unknown date, the patient experienced headaches after covid vaccine. COVID-19 VACCINE was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer. Causality for RINVOQ(Upadacitinib). The reporters causality for the event of headaches after covid vaccine with RINVOQ(Upadacitinib) was no reasonable possibility. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
One of our Pfizer vials was diluted and 6 doses were taken out of the vial then re-diluted the vial. Patient was given mostly normal saline. Patient was contacted and came back in and received a second correct vaccine.
Severe muscular pain in the arm where I received the vaccine. Putting on a jacket and lifting my arm are very painful. It's been 10 days and my arm is just as painful. Ice has not helped and neither has Advil.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On 31-AUG-2015 the patient was vaccinated with an improperly stored dose of oral, ROTATEQ, (dose and frequency were not provided), lot # K019370, expiration date 16-JUL-2016. No concomitant medication was reported. At the time of this report, no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Numbness of (L) chest wall, (L) axillary area. No local reaction at injection site (L) deltoid.
headaches bad for 3 days, now just mild. diahreaa after 1 week for 3 days, not sure if its over
pain on the left breast; sore arm; back is sore; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (pain on the left breast), PAIN IN EXTREMITY (sore arm) and BACK PAIN (back is sore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Heavy menstrual bleeding (During vaccination) and Menstrual cycle abnormal (menstrual bleeding for three weeks).    On 13-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 BREAST PAIN (pain on the left breast), PAIN IN EXTREMITY (sore arm) and BACK PAIN (back is sore). At the time of the report, BREAST PAIN (pain on the left breast), PAIN IN EXTREMITY (sore arm) and BACK PAIN (back is sore) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not inform her vaccination provider that she had heavy menstrual bleeding for three weeks at the time of vaccination. Concomitant medications were not reported. Treatment information in response to events was not provided.
24+ hrs after vaccine fever 101.8. 36 hrs after vaccine significant swelling hip to knee - hot to touch, painful (right leg) left leg. Golf ball size swelling at injection site. Also 1-2cm mobile inguinal lymph nodes on (R) side. Admitted to hospital. IV CLEOCIN. No more fever. Redness improved but non-pitting swelling increased below knee. Started SOLUMEDROL - well in 24 hrs.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Dizziness Lightheadedness-Severe, Systemic: Exhaustion/Lethargy-Severe, Systemic: Fainting/Unresponsive-Severe, Systemic: Flushed/Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe. Additional Details: ER determined patient had a vasovagal syncope episode. At the time of the reaction, patient appeared to have trouble breathing (head back and making noises). I could not find a strong carotid pulse, so 1 dose of epinephrine was given.
A physician reported that a 1 month old male pt received Prevnar, Recombivax-HB and IPV vaccines on 10/2/00. He was taken to the ER on 10/9/00 after he developed irritability, decreased oral intake, spitting up and strange episodes of not focusing and unusual startling and looking to the right side. He was transferred to the ER for further evaluation and was admitted to the pediatric neurology unit. This is 1 of 2 pts from this facility who had an adverse experience following receipt of Prevnar (lot 473337). The pt was presented to a hosp for concern of possible infantile seizure, Mom reports that he has had a 3 day history of increased in jerking episodes. f/u info rec'd from a HCP reported that a prenatal ultrasound was questionable for pylectasis. A newborn ultrasound was normal. It was indicated that a second f/u ultrasound had not been done but that it was recommended. Additionally on 10/6/00 the pt was vaccinated IM in the R thigh with a 1st dose of Tripedia Lot #U0039CA, and a 1st dose of IM in the L thigh of Haemophilus B lot #622363A. On 3/12/01, the pt was given a physical exam, at 7 months old the pt was 29 inches in height, 19 lbs and 46cm head circumference. a physician exam reported as normal and the assessment was reported as well. On 3/12/01, a developmental questionaire was completed. When your childis on hisstomach on a flat surfave can he lift heis chest using his arms for suport? yes. No further information is available. Fax correspondence rec'd 7/25/01 and forwarded on 8/23/01 it was reported F/U information rec'd from hlth professional rwported that the pt recovered. This is an amended report. From follow-up correspondence received on 02/04/2002 it was reported, "01/28/2002 to date no additional information at this time. No other DTaP or Prevnar." Follow-u on 07/25/2001 states that the pt recovered.
DTaP given 8/27/03. Fever 101 degrees for 2 days starting several hours after administration. Positive erythema left deltoid at site of administration.
TDAP (L) deltoid 9/20/2010 Received vaccine - TDAP. 9/21/2010 woke up at 3:30AM c/o pain in arm. Arm not swollen or red. Mother gave TYLENOL & applied ice. In the morning client then c/o headache, stomach ache, had a fever - temp was unknown, arm slightly swollen red. 9/22 (L) arm deltoid area redness & swelling increased c/o stomach ache. Red area was reported to be from the front to the back of his deltoid area. 9/23 still c/o nausea - increased in redness & size. 9/24 - no nausea- mother states deltoid area is red swollen & increased size to about 4" x 6".
PARENTS REPORTED TO MD THAT PT HAS FEVER X 2 DAYS. HAD SEIZURE ON 3/2/05 X2 PT RECEIVED SHOTS 3/1/05 SEEN IN ER FOR FEVER ON 3/2/05 SEEN IN OFFICE AFTER SEIZURES ON 3/3/05 HAVING EEG AND NEUROLOGY APPT ON 3/4/05.
Rash appeared on arm around and below vaccination sport about 11-12 days later. Started to disappear as of date of report
Subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox with approximately 100 lesions.
Felling itchy and odd pins needles sensation throughout body. No rash; Felling itchy and odd pins needles sensation throughout body. No rash; This is a spontaneous report received from a contactable other healthcare professional (patient).   A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 11:30 (at the age of 56-years-old) as a single dose for COVID-19 immunization. Medical history included pituitary tumour and penicillin allergy from unspecified dates. The patient previously took ciprofloxacin (CIPRO) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications taken within two weeks of vaccination included cabergoline (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL), both from unknown dates taken for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 12:15, the patient experienced felling itchy and odd pins needles sensation throughout body. No rash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of felling itchy and odd pins needles sensation throughout body, no rash was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & 20 to 25 mins later pt exp a tightness in chest & lightheadedness; pt developed an inc pulse, tremors, wheezing, hives on face & inc resp; pt hyperventilating; nurse felt pt was having an anxiety attack
pt recv vax 27SEP95 & 14MAR96 pt devel 100 lesions, red macular/papular started on the palms of hands & progressed up arms;18MAR96 pt was seen by MD who examined ant extensive vesicular rash looking like insect bites;itching;tx w/meds;
This spontaneous case reported by a healthcare professional, describes the occurrence of vaccination site warmth (hot to the touch), vaccination site swelling (swollen injection site), pyrexia (fever) and chills in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 5, 2021, patient experienced pyrexia (fever). On Apr 7, 2021, patient experienced vaccination site warmth (hot to the touch), vaccination site swelling (swollen injection site) and chills. On Apr 6, 2021, pyrexia (fever) resolved. At the time of the report, vaccination site warmth (hot to the touch), vaccination site swelling (swollen injection site) and chills outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments. No concomitant medication or treatment information provided.
got a bump on injection site; This is a spontaneous report received from a contactable consumer (reporting for her husband) from a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 29Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine on 29Mar2021 and got a bump on injection site on an unspecified date. The outcome of the event was unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1.) 4 days after HPV9 #1 given: painful rash on chin and mouth, swelling around chin, testicular swelling and pain/itching. DX: Allergy reaction; TX: BENADRYL. 2.) 4 days after HPV9 #2, onset of wheezing, managed with inhalers. 2 days later, onset of red, painful rash on lower cheeks and chin, rash on chest.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021;    This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:31 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:31 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 28.54 for dose administered on 15-Apr-2021. No concomitant medications were reported.  On 15-Apr-2021, the vaccine with batch number 044B21A was moved to fridge on 06-Apr-2021, 18 vials were moved to the clinic on 15-Apr-2021 at 09:00 AM, vials underwent temperature excursion with temperature of 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 09-May-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Patient received bivalent booster dose instead of Pfizer monovalent dose 2 - no adverse events reported
Anemia onset started 2 weeks after my first vaccine found during a blood donation, I have never had anemia prior. my symptoms were just dyspnea with exertion not sudden onset which increased gradually. I had my blood checked every two months . In September my ferritin was 4% along with symptoms of anemia and i am now getting iron transfusions  4 herpes outbreaks within two months after first vaccine
The HCP reported about one week ago, his son's wife became infected with a mild case of Omicron; Pfizer COVID-19 vaccine for her first and second doses; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (The HCP reported about one week ago, his son's wife became infected with a mild case of Omicron) and INTERCHANGE OF VACCINE PRODUCTS (Pfizer COVID-19 vaccine for her first and second doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced COVID-19 (The HCP reported about one week ago, his son's wife became infected with a mild case of Omicron) and INTERCHANGE OF VACCINE PRODUCTS (Pfizer COVID-19 vaccine for her first and second doses). At the time of the report, COVID-19 (The HCP reported about one week ago, his son's wife became infected with a mild case of Omicron) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Pfizer COVID-19 vaccine for her first and second doses) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100 Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided.  Company comment: This case concerns a female patient of unknown age, with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the booster dose of mRNA-1273. Previously, the patient received dose 1 and 2 of Pfizer COVID-19 vaccine, so lack of efficacy cannot be concluded for this case. The patient's clinical presentation was an upper respiratory tract infection. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient of unknown age, with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the booster dose of mRNA-1273. Previously, the patient received dose 1 and 2 of Pfizer COVID-19 vaccine, so lack of efficacy cannot be concluded for this case. The patient's clinical presentation was an upper respiratory tract infection. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
MOM CALLED STATING CHILD HAD SEIZURE THE FOLLOWING MORNING ON 3/10/09. TAKEN TO EMERGENCY ROOM AND HOSPITALIZED.  4/27/09 MR received for DOS 3/10-12/2009 with DX: New onset seizure.   Pt presented after found by family member on the floor with bilateral upper extremity tremors, unconscious and incontinent of urine with mental status changes. Continued tremors noted in ER.  ID exam noted pt to be staring with decreased attention span and some inappropriate answers to questions. PE WNL. Episode of decreased responsiveness and agitation 3/11/09 with later confusion and disorientation.  Improved by 3/12/09 and d/c for outpt f/u.
Information has been received from a Physician Assistant concerning a 9 years old female who on 22-JUN-2009 was vaccinated with the first 0.5mL dose of GARDASIL (lot# not provided). There was no concomitant medication. On 23-JUN-2009 the patient developed facial edema like eyes, face and lips were swollen after getting the first dose of GARDASIL. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
I only experienced fatigue when i got my second shot and it went away however in May I experienced weakness in legs and hands and fatigue which has continued to this day.
Subsequent to vax, this child developed fever of 101 F and hives that lasted for one week. It was noted that medical attention was sought. No further details were provided.