chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed transient SOB on 4/16 that resolved on 4/18. Developed left leg pain and swelling on 4/19. LE ultrasound revealed extensive DVT. Does report a 4 hour plane ride 4 weeks ago.
Broke out with vesicular rash on wrist, stomach, and face. Itchy on wrist area.
14 days after first shot, Pt had stinging/burning pain in her right big toe at bedtime. She thought she hurt her toe working out. As days went on, pain got so bad she went to urgent care for an x-ray. They found nothing wrong. The foot started to swell. Went to the school to see dr there. They said not broken just irritated the sesamoids under her big toe. 4-6 weeks to heal in a soft boot. The on April 16th she got her second shot.  As she sat there waiting her 15 mins, she said her right foot went numb. We then went home. That night we iced her bad right foot and I noticed both feet were purple!! I looked up reactions to shots and it actually said it is a side effect. I called my doctor and he said the fact that the toes turn purple and then back to normal was ok. 9 days after the second shot she said the same pain started in her left foot. She can't walk on either foot!!! It is neuropathy from the shots!!! My doctor is scheduling tests for her.
Whole arm was hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Whole arm was hurting".  Additional information- The patient was taking Covid 19 vaccine to prevent covid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. The patient received chemotherapy 5 years ago for a duration of 1 year. No further details provided. All or most of her family members had been vaccinated for Covid and nobody had any issues other than pain at the injection site. Relevant tests was reported as none. She mentioned during the family history question of the vaccine supplemental form that they had experienced pain at the injection site. Caller declined as she states that there was too many of them, like 15 people had pain at the injection site and she attributes that to two things. A: how it was administered and B, it was a 1 inch needle. She also states that she had a friend girl who said her whole arm was hurting after getting the Pfizer Covid vaccine. She declined to fill out a safety report on her behalf as well. She wants to know if had the two doses makes her fully vaccinated or was she not considered vaccinated unless she gets the third dose. Patient's Medical History (including any illness at time of vaccination) reported as none   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
4 days after the vaccination I started having breathing problems and a racing heart. I first went to Urgent Care and they sent me to the E.R. immediately.  They x-rayed my chest and ran 3 EKG's which all came out normal. However, they wanted to check my into the hospital to run a heart stress test the next day. I chose to go see and cardiologist and a pulmonary specialist. Those are appointments are being scheduled.
Vaccination administration error: child received 0.2mL of the 5-11 orange top bivalent booster instead of 0.3mL of the gray top product for 12 +.
During a flu vaccine clinic for employees, this employee was inadvertently given expired influenza vaccine.  The vaccine administered was for the 2021-2022 season and expired on 6/30/2022.  The employee was made aware of the this mistake, did not present with any adverse clinical reaction, and will be administered the influenza vaccine for the 2022-2023 season as soon as clinically appropriate.
Local erythema and swelling at injection site 2 hours after administration; swelling of lips, gums, and around eyes at 4-6 hours; facial swelling with left arm and hand (shot given in left deltoid) after 12 hours; maximal facial and lip swelling occurred at approximately 24 hours; patient did not have difficulty breathing.  She took alleve x 1 the morning after injection, as well as 2 mornings after injection.  She took benadryl x 1 24 hours after symptoms began.  Symptoms were largely resolved by the time she was seen by a physician approximtely 36-40 hours after reaction began.  No further treatment was given.  No emergency room visit occurred.
Information has been received from a 54 year old female. Post vax, subsequently, the pt experienced weakness in the left hand. The pt called a healthcare professional and was advised to continue to monitor the situation. Progressive symptomatology was noted with a spread of weakness of the right arm and then the left leg. In October 1999, she experienced aphasia. A dx of lateral sclerosis was made.
Fever 101.1 degrees , chills, joint pain, dizziness, pain at the injection spot that made it very hard to move my arm.
10 yr old given Pfizer Bivalent pt's mother reported that pt had decreased sensation in bl legs, general weakness, fatigue, ha, and peri-injection area soreness that began several hours after receving the vaccine, and lasted about 24 hours
Case number PHEH2044US003621 is an initial spontaneous report received from a physician on 21 FEB 2014. This report refers to a 13 year old female patient who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly on an undetermined date in DEC 2013. No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Non significant follow up report received from physician on 21 MAR 2014. No medical information was available.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug use in unapproved population".
Patient received vaccine dose 5/13/21 at 1754.  The patient reported extreme pain and soreness on 5/14/21.  Two days after her second vaccine shot (5/15/21) she presented with a rash on her right facial cheek and chest.  Her right ear was also red and the patient complained of having an "itchy tongue."  Patient received tylenol and benadryl.  A few hours later, the patient reported the pain was getting were and the RN did a full assessment and found that the patients rash had become worse on her ear and that the patient's speech was slurred.  Vital signs were obtained and WNL.  No respiratory distress.  Pt sent to ED for evaluation and returned later that evening to Rehab facility.
Diarrhea and cramping is completely uncontrolled, even with prescription Immodium 2mg up to 2 prn and Dicyclomine 20mg up to 4 prn. Patients flare began with first dose and this made a flare on a flare.  She is exhausted after 6 weeks of diarrhea every couple hours. The clinic closed and we have no family doctor to help. Please advise?
Within a week of the shot and extending for a month patient developed panic attacks.  Occurred with all three doses of Gardasil vaccine.
Patient reports about 30 seconds after receiving vaccine her throat felt dry and small. Tongue felt numb. These symptoms resolved by the next morning. Patient did not tell vaccinator about her symptoms and just went home.  She reports not taking any medicine i.e. benedryl for symptoms (although she takes zyrtec regularly).
Administered orange cap (5-11yrs) Pfizer dose rather maroon (6m-4yrs). No s/sx at this time, will follow up with mother in a couple days to confirm child doing fine.
scratchy throat, dry eyes, skin felt like Niacin Flush, small blisters on tongue. Took Benadryl and side effects went away in about an hour. Muscle pain in injection site that shoots down arm and causes stiffness in arm. Treating with warm compress and pain meds
FLU LIKE SYMPTOMS/ TIREDNESS; COLD SYMPTOMS/ NASAL CONGESTION; RIGHT SIDE NOSE BLEEDS; RIGHT SIDE EAR ACHE; This spontaneous report received from a patient concerned a 60 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to Vectrum, Keflex. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced right side nose bleeds. On 18-MAR-2021, the subject experienced right side ear ache. On 18-MAR-2021, the subject experienced cold symptoms. On an unspecified date, the subject experienced flu like symptoms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cold symptoms, had not recovered from right side nose bleeds, and right side ear ache, and the outcome of flu like symptoms was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Rash on left thigh, slightly itch. Consistent with varicella vaccine site.
been 47 days on the second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (been 47 days on the second dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (been 47 days on the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (been 47 days on the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist called today, patient received 1st dose on 29Jan2021, She said the patient is 59 years old and had multiple health conditions so he was in and out of the hospital which caused a delay to his second shot.   This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # not reported  with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up case received but it does not contain new information. Case is possible NNI; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # not reported  with no associated AEs.
Sore arm that increasingly became more painful as the day went on.  During the night, I woke up from the pain in my arm, my head hurt and I was shivering.  Now my arm continues to be extremely painful and  feel a general malaise: achy, headache, weak. I have been taking extra strength acetaminophen since 9:30 pm last night.
Redness & induration on left arm measuring 3 1/2 X 5 1/2.
immune system did not respond to her anxiety and depression medicine; A spontaneous report was received from a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event immune system did not respond to her anxiety and depression medicine.  The patient's concurrent medical conditions included anxiety and depression. Concomitant medication included sertraline.  On 29 Jan 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 26 Feb 2021, prior to the onset of the event the patient received their second of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient experienced the event immune system did not respond to her anxiety and depression medicine. The patient called her doctor and mentioned that she started taking double dose according to doctor but did not work. And on 05 Mar 2021, a week after the second dose of vaccine, the patient again experienced the same thing and felt her medication was not working.  No treatment information for the event was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of event was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Local reaction to left arm that is red and warm to touch around the injection site of the DTaP vaccine.
I tested positive for Covid 19 on 6/14/2022.  Coughing, fever (102.5 at its highest), runny nose, congestion I isolated at home for 5 days and managed symptoms with Advil, Tylenol, Nyquil, Mucinex
When lifting left arm, stiffness + unable to lift arm higher than usual causes pain when lifting arm. Started about a week after injection. Injection site doesn't hurt.
Per mother, states child became lethargic 2 hours after vaccine, vomited 6 times on 03/01/17 with continued lethargy-no fever- resolved on 03/01/17 in evening.
joint stiffness; muscle pain; nausea; symptom of really bad headache.; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (joint stiffness), HEADACHE (symptom of really bad headache.), MYALGIA (muscle pain) and NAUSEA (nausea) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (symptom of really bad headache.). On 30-Mar-2021, the patient experienced JOINT STIFFNESS (joint stiffness), MYALGIA (muscle pain) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, JOINT STIFFNESS (joint stiffness), HEADACHE (symptom of really bad headache.), MYALGIA (muscle pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details: Tylenol and Heat pad
Information has been received from a woman in a pediatric office concerning a 39-month-old female with no pre-existing allergies, birth defects or medical conditions who on 28-APR-2006 was vaccinated subcutaneously in the left tricep with a dose of varicella virus vaccine live (Oka/Merck) (lot# 652722/1127R). There was no illness at the time of vaccination. On 05-JAN-2008, the patient developed a chickenpox rash "for 2 days"; however, it was reported that the patient recovered on 15-JAN-2008. It was not specified if medical attention was sought. No relevant diagnostic test or laboratory data were performed. Additional information is not expected.
Aches; Chills; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (Aches) and CHILLS (Chills) in a 50-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches) and CHILLS (Chills). At the time of the report, PAIN (Aches) and CHILLS (Chills) outcome was unknown.            No concomitant medications were used. No treatment medications were used.    This case was linked to MOD-2021-236539, MOD-2021-236555, MOD-2021-236580, MOD-2021-236580, MOD-2021-236539, MOD-2021-239232 (Patient Link).
sore arm at the injection site; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2-100.4 for majority of day and decreased to 99.6 that night; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EK9231) , via an unspecified route of administration on 06Jan2021 at a single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient had her 1st dose on 16Dec2020 (lot no: EH9899) administered on left arm. Patient was not pregnant.  The patient has no COVID prior vaccination.  On 07Jan2021, patient stated "I had a sore arm at the injection site. I then woke up with a headache and had a fever with chills. Max temp was 100.7. Temperature maintained 100.2- 100.4 for majority of day and decreased to 99.6 that night. It only lasted the day after being vaccinated" The patient recovered on unspecified date from all of the events. The patient has not tested COVID on post vaccination.   No follow-up attempts are possible. No further information is expected.
vision loss; Information has been received regarding a case in litigation, referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot# and expiration date were not reported). On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for vision loss. As a direct and proximate result of the patient's zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of vision loss was not reported. The reporter considered vision loss to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of vision loss was considered to be medically significant.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/6/2021 and 4/1/2021.  Patient was diagnosed with COVID-19 infection on 07/16 and has been having intermittent fevers, fatigue, cough and was evaluated at Hospital on 7/16, 7/18, and 7/22.  Patient was discharged from the emergency room as he was nontoxic appearing, he was readmitted on 7/22 with hypoxia saturating 83% on 6 L, evidence of COVID pneumonia on CT.  Patient quickly escalated from nasal cannula to requiring high-flow oxygen and on 07/24 was also intubated.  Required norepinephrine for hemodynamic support. Completed remdesivir course and 9 days of Dexamethasone. Had worsening oxygenation and family decided to withdraw support and provide comfort care. He expired on 8/10/2021.
severe headache; body aches; This is a spontaneous report from a contactable physician. This physician reported same events for 3 patients. This is 1st of 3 reports. A 19-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, Lot Number: CN8296), via an unspecified route of administration on 12Aug2020 at single dose for immunisation. There were no medical history or concomitant medications. The patient experienced severe headache, body aches on 12Aug2020. Event details: The physician was calling to report the patient had experienced side effects after the meningococcal group b rlp2086 shot. Patient experienced severe headache and body aches within hours of receiving the meningococcal group b rlp2086 shot. He had treated the patient with ibuprofen (ADVIL) and diphenhydramine hydrochloride (BENADRYL). When asked about Concomitant products or other medical conditions the physician stated the patient was healthy. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020334218 same reporter/drug/event, different patient;US-PFIZER INC-2020334746 same reporter/drug/event, different patient
Today woke up with raised area  at injection site, about 1/2 dollar size, increased redness, increased warmth, itchy. Tender to touch.  She also reported fatigue, chest pain since yesterday with activity intolerance.  Noted irregular heart rate on my initial exam, converted to sinus by the time EKG was done.
Information has been received from a physician concerning a 6 month old male who on 01-MAR-2007 was vaccinated with a 2 mL PO third dose of Rotateq. Concomitant vaccination included a dose of pneumococcal, polyval (MSD), a dose of HIB and a dose of DTaP. On 19-MAR-2007 the patient developed intussusception and was hospitalized. Surgery was not required. Subsequently, the patient recovered from intussusception on 3/21/07. There was no product quality complaint involved. Additional information has been requested. 5/4/07 Received medical records from hospital which reveal patient seen in ER on 3/20-3/21/07 for vomiting, abdominal pain, inconsolable fussiness, lethargy & dark heme + diarrhea stools. Kept overnight for observation.  Did well, tolerated oral feedings & was d/c to home w/o complication. FINAL DX: Intussusception, reduced by air enema. 5/29/07 Received vax record which confirmed RO as reported.  VAERS database updated w/other vax info.
Pt recvd vax & exp h/a, nausea, arthralgia, myalgia, sore throat (pharyngitis), swollen lymph nodes/swollen inguinal lymph nodes (lymphadenopathy), fatigue, low grade temp, testicular pain; pt was seen by MD;
Boostrix given to a 18-month-old; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 18-month-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix given to a 18-month-old). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 16-MAR-2023 The reporter would like to report an adverse event.  The provider was busy with another patient so the information collected was limited but the health care professional (HCP) was willing to provide more information over a follow up later. The Boostrix vaccine was inadvertently administered to 18 month old patient, which led to inappropriate age at vaccine administration.