chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right arm extremely achy for several days (4) after the event without improving.  I have never had a shot be so sore and so severely for so many days following an immunization.  I would rate the pain as a "6" on a scale of 1-10.  The pain was so severe it would wake me up in the middle on the night several times when the ibuprofen would wear off.  My range of motion stayed intact.  I recognize a sore arm is an expected side effect, but this seemed very severe.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Mild
Patient was accidently given 1mL of Moderna Bivalent instead of 0.5mL. Patient is being called to inform them of error and being recommended to reach out if an adverse side effects happen and will be recommended to use Tylenol/Ibuprofen if needed. Staff will be reminded of the high importance of taking their time to check correct vaccines/doses before administering to prevent errors.   No adverse side effects reported at this time.
Information has been received from a physician concerning her 18 month old white son with no previous exposure to this or related drug, who on 23-MAY-2007 was vaccinated SC with a dose of varicella virus vaccine live (Oka/Merck) (lot number: "03394"). There were no concomitant medications. On approximately 30-MAY-2007 the patient developed chicken pox "from the chicken pox vaccine." On 31-MAY-2007 (for a duration of 10 days) the patient developed a fever of 102.7 and a rash over entire body. The rash had the appearance of chicken pox but did not seem to itch and the lesions never crusted over. The rash gradually disappeared. On 10-JUN-2007 the outcome was reported as recovered. Additional information has been requested.
pt states about half hour after getting vaccinated he started getting a severe pounding head ache and developed flu like symptoms. Had chills, and body aches that made him so weak he had to stay in the bed for about 2 weeks. He took pain killers to help with the pain. He spoke with his PCP about his reaction to this flu vaccine.
headache/sneezing/runny nose occurring  16hours after vaccination lasting 24hours total fever/chills/fatigue, highest reading 100.7, occurring 19 hours after vaccination lasting 12 hours total generalized GI distress without nausea/vomitting starting within 2 hours of vaccination and lasting over 36hours; difficult to discern from my typical GI issues but certainly seemed to be heightened
Pt recvd vax & 12-16 hrs p/vax noted a very itchy red erythema dermis; treated w/DPH;
Syncope, dizziness; Pt hit her head on the stairs. No open wounds, neuro check wnl. BP 93/69; HR 65 RR 17 SpO2 100%
Contracted Covid-19 (5mths after vaccination) . Hospital visit for a day. Received medication: Benzonatate 100ml.  Stopped coughing. Has lung damage presently.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-APR-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursions (R/F) for each time were 2484, unknown and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 18-DEC-2014 the patient was inadvertently vaccinated with ZOSTAVAX lot # J014851, which expired on 24-OCT-2014 (via subcutaneous route of administration, dose and anatomical location were not reported). It was reported that this dose was supported. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Bad cough; Loss of Appetite; Dizziness; Having a hard time talking; Congestion; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Bad cough), DECREASED APPETITE (Loss of Appetite), DIZZINESS (Dizziness), SPEECH DISORDER (Having a hard time talking) and NASAL CONGESTION (Congestion) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included AMLODIPINE, LORATADINE and LOSARTAN for an unknown indication.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced COUGH (Bad cough), DECREASED APPETITE (Loss of Appetite), DIZZINESS (Dizziness), SPEECH DISORDER (Having a hard time talking) and NASAL CONGESTION (Congestion). On 02-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, COUGH (Bad cough), DECREASED APPETITE (Loss of Appetite), DIZZINESS (Dizziness), SPEECH DISORDER (Having a hard time talking) and NASAL CONGESTION (Congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided
Information has been received from a health professional concerning an 11 week old female who on 09-MAR-2007, at 11:30 a.m., was vaccinated with a first oral dose of Rotateq (Lot # 656189/1239F). There was on illness at the time of vaccination. On 09-MAR-2007 immediately after receiving the vaccination, at "11:00 a.m., the patient experienced projectile vomiting. It was noted that the physician may not complete the vaccination series. There were no laboratory or diagnostic tests performed. Medical attention was not sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Pt received a COVID vaccine instead of pneumonia vaccine.  Pt confirmed name and dob prior to receiving the immunization.  Pt had previously completed series of Moderna. is currently not experiencing any signs or symptoms.
Rt. upper arm swelling and tender. It happened after Dtap vaccination. No fever. Treatment: Hydroxyzine 6 mg TID PRN x 3 days. MOTRIN 150 mg Q6hours PRN.
I am the epidemiologist reporting on behalf of 84-year-old female patient. The patient received two doses of the Moderna vaccine on 3/11/21 and 4/8/21. The patient tested positive for COVID-19 on 8/23/21 via PCR. On 8/26/21, nurse at facility where patient resided reported the patient?s only symptom as ?a bit of weakness.? The patient died 8/30/21 and the cause of death is listed as ?Acute Respiratory Failure; Pneumonia; Covid-19?. I do not have further information regarding immunodeficiency status or underlying health conditions.
SHINGRIX vaccination.......About 24 hours after receiving dose, a red itchy, raised area about the size of 4 inches wide appeared at the injection site. The patient came into the pharmacy to seek advise from me, as I was the adminstering pharmacist. I advise her to take otc diphenhydramine for the symptoms to watch the area, and let me know if there were any changes in the appearance of the area. I also let her know I would report the event.
Fever of 102; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included still's disease (auto immune diease).   On 20th March 2020, the patient received Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had a fever of 102 degree F after vaccination with Shingrix.
Information has been received from a consumer concerning her 19 year old daughter who in Summer 2007 was vaccinated with the first dose of 0.5ml GARDASIL. No information was provided for the second dose of 0.5ml GARDASIL. On 06-NOV-2007 the patient was vaccinated with the third dose of 0.5ml GARDASIL. There was no concomitant medication. On 31-JUL-2009 the patient developed "Idiopathic Thrombocytic Purpura". The consumer stated that "when blood passes through the patient's spleen the antibodies are killing her platelets causing massive bruising and internal bleeding". The patient was hospitalized on 31-JUL-2009 for 4 days. The patient's platelet count was back up after hospitalization, but was going back down again. Laboratory included blood work without result. The patient had not recovered. Additional information has also received from a medical assistant reported that the patient was vaccinated with the first, second and third dose of GARDASIL separately on 05-MAR-2007 (lot # 655849/0263U), 06-JUL-2007 (lot# 658100/0525U) and 06-NOV-2007 (lot # 655154/1210U). No other vaccines given concomitantly. In September 2008, the patient was placed on birth control. Information has also been received from a physician reported that in November 2007, the patient's blood work was normal. On 03-OCT-2008, the patient's platelet count was 190,000. On 30-JUL-2009, the platelet count decreased to 21,000 and the patient was hospitalized the next day it's on 31-JUL-2009. The patient was treated with IV immunoglobulin and steroids. Patient was currently on the titrating dose of prednisone. The physician considered the condition to be disabling but not life threatening. The physician dose not know if GARDASIL was the cause of this event. The patient referred to a hematologist. The receptionist of the hematologist reported that their office was not treating the patient so that the patient might have been treated elsewhere. Additional information has been requested.
Pt states rec'd flu shot in right arm. Next day arm sore. Pain never went away pain traveled from shoulder to elbow. Pt primary MD feels rotator cuff issue due to flu shot. Pt scheduled for MRI.
Blood pressure jumped to 239 over 135; This is a spontaneous report received from a contactable consumer.   A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), via an unspecified route of administration, administered in left arm on 03Mar2021, at 10:30 as single dose for covid-19 immunization when the patient was 72-years-old . Medical history included hypertension from an unknown date. The patient was not pregnant Prior to vaccination, the patient was not diagnosed with COVID-19;  since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Concomitant medications included metoprolol tartrate (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; losartan (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; indomethacin sodium (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; aspirin (ASPIRIN) taken for an unspecified indication, start and stop date were not reported.  The patient experienced blood pressure jumped to 239 over 135 on 12Mar2021, at 14:30. Treatment received for the adverse event included additional amlodipine 10mg tablet given to lower blood pressure. The patient underwent lab tests and procedures which included blood pressure measurement: 239/135  on 12Mar2021  at 3:00 pm.  The clinical outcome of blood pressure jumped to 239 over 135 was recovering.
anaphylactic reactions; heart arrhythmia; Initial information was received on 23-Nov-2021 regarding an unsolicited valid serious case from social media via consumer/non-healthcare professional.  This case involves a patient (demographics unknown) who experienced anaphylactic reactions (anaphylactic reaction) and heart arrhythmia (arrhythmia) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient's medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious anaphylactic reaction (anaphylactic reaction) and heart arrhythmia (arrhythmia) (unknown latency) following the administration of INFLUENZA VACCINE.   The reporter stated that he/she will never take this poison again.   These events were assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the events.  The reporter did not report causality of events with suspect.  At time of reporting, the outcome of the events was unknown.  Information on the batch number for this case was requested.; Sender's Comments: This case involves a patient (demographics unknown) who experienced anaphylactic reaction and arrhythmia after receiving INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination and lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Pt came in clinic 10/08/09 c/o headache, facial pain, and crying. Ambulance called after pt fell in floor. No injury. Vitals were normal, oxygen sat 100%.
Fever, chills, sore/tender arm. Fever lasted about a day, and went down after taking ibuprofen and did not return. Arm was sore for about a week. Symptoms were overall mild
Pounding headache for one day. General malaise, sensitive skin, and fatigue (again for one day only).
Elevated heart rate as high as 150bpm at rest for 24-36 post administration
Within 15 minutes of receiving vaccine, pt reported dizziness and stated that he did not feel good. Pt's skin tone turned ashen gray and had syncopal episode with tonic clonic movements. Pt regained consciousness within 10-15 seconds with a few moments of rigidity and repetitive right facing head movement. Vital signs were monitored for 30 minutes and pt was released home once vital signs were stable and pt reported feeling better.
Patient of 17YO received the vaccine; A spontaneous report was received from a health care professional concerning a 17 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event patient of 17YO received the vaccine was resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown with no associated AEs.
This spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L045956, expiration date:17-NOV-2017 (Strength, dose, frequency and route were not reported), which experienced temperature excursion of -12.9 Celsius degrees, for 16 hours and -14.2 Celsius degrees for 14 hours and 30 minutes on unknown dates. Data logger was not involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Nausea Fatigue Fever Chills Acute Pain Soreness, swelling and itchiness at injection site
patient reports feeling nauseous, sleepiness and pain. patient took tylenol for symptoms. patient will make appointment with medical doctor
pt was given  1cc Typhoid vax instead of 5cc; pt exp h/a, chills, n/v/d x 1 day;
Abdominal pain and vomiting starting the night of April 20, 2021. Went to the emergency department on April 21, but was not diagnosed to be appendicitis. Went again on April 22 and was diagnosed to be appendicitis with possible perforation.
Pt recv vax on 2/23/98; on 2/24/98 pt exp esotropia & conjunctivitis. Annual follow-up received on 11/27/00 provided no additional data.
This case was reported by a consumer via call center representative and described the occurrence of aphthous stomatitis in a 56-year-old patient who received SHINGRIX for prophylaxis. On 27th November 2018, the patient received the 1st dose of SHINGRIX. On 28th November 2018, 1 days after receiving SHINGRIX, the patient experienced aphthous stomatitis. On an unknown date, the outcome of the aphthous stomatitis was unknown. It was unknown if the reporter considered the aphthous stomatitis to be related to SHINGRIX. Additional details were reported as follows: On Tuesday, the patient received SHINGRIX. The night before the date of reporting and on the day of reporting, the patient's mouth was filled with canker sores about 20. The patient asked if this was a side effect. When asked for physician details for follow up, the patient stated that, vaccine was administered at a pharmacy.
doses administered after temperature excursion events; doses administered after temperature excursion events; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion events) and PRODUCT STORAGE ERROR (doses administered after temperature excursion events) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion events) and PRODUCT STORAGE ERROR (doses administered after temperature excursion events). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after temperature excursion events) and PRODUCT STORAGE ERROR (doses administered after temperature excursion events) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. No Treatment medications were reported. It was reported that some vials were used during patient administration in early April and never went higher then a maximum of 4.4 degrees c.   Reporter did not allow further contact
This case was reported by a healthcare professional via sales representative and described the occurrence of hive in a 12-year-old female subject who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), DTP (A or W not known). Co-suspect medication included 100/50 ADVAIR and Amoxicillin (manufacturer unknown). Concurrent medical conditions included allergy to amoxicillin, penicillin allergy and pneumonia. Previous and/or concurrent vaccination included GARDASIL (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date; MENACTRA (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date. Concurrent medications included Z-PAK. On an unspecified date the subject received unspecified dose of Hepatitis A vaccine (unknown), unspecified dose of DTP (unknown). That same day the subject was diagnosed with pneumonia and prescribed ADVAIR (inhaled) at 1 puff(s) twice per day and Z-PAK dosing was unknown. At an unspecified time after vaccination with DTP, unspecified, Hepatitis A vaccine, and immediately after starting ADVAIR, the subject experienced hives. Treatment with ADVAIR was discontinued. The subject's hives were treated with BENADRYL. On an unspecified date the subject started Amoxicillin, dosing and indication unknown. At an unspecified time after starting Amoxicillin the subject experienced an allergic reaction. At the time of reporting the outcome of the hives was resolved and the allergic reaction was unspecified. The health professional considered the hives were almost certainly related to treatment with ADVAIR.  Nurse is father of a female about 12 or so that received annual vaccines and was diagnosed with pneumonia. ADVAIR and ZPAK were prescribed. Within the same day the child experienced hives. The ADVAIR was stopped and the hives resolved. The ADVAIR was not reintroduced. Also noted that the child was given 50mg of BENADRYL. During report it was noted that child had high sensitivity to some products, as her father does also. It was also stated the she had an allergy to penicillin and amoxicillin. Unknown manufacturer of the amoxicillin and no further information on the allergy reaction to the product. Per the rep, parents, who have medical background, feel strongly the reaction was related strictly to the ADVAIR.
Three hours after receiving COVID 19 vaccination, Patient oxygen level decreased to a  critical level and went into cardiac arrest. Staff performed full code but was unable to bring back patient from  cardiac arrest.
Patient was a resident who tested positive for Covid-19 on 01/24/2022.  Patient went on hospice with a primary hospice diagnosis of chronic obstructive pulmonary disease, respiratory failure with hypoxia, Covid-19, muscle weakness, anxiety, anorexia, repeated falls, oxygen dependence.  Patient expired on 02/12/2022.
A high fever around 5am 5/2/2013. Behavior that is associated with infant pain (the type of crying heard, arching back, irritability, restlessness, difficulty sleeping). Round the clock pain and fever relievers given but were not completely effective for pain.
On same day after vaccination at 2:15 pm, by 10:00 pm feeling flu-like symptoms: tired and very achy, and an upset digestive system.  This lasted for approximately 36 hours.  The evening of the day one day after (March 12), felt symptoms of a minor cold in the nose (itchy, drippy, tangy taste) which moved to chest cold symptoms the following morning (March 13), also minor.  Those symptoms lasted about 24 hours then subsided.
Shot given in left arm. Muscle fatigue in left arm, left side of neck and left chest.
patient reported itching and rash about 15 minutes after vaccine given, she was given 50mg im Benadryl and continued to progress with SOA and strider- Epi given and transported by EMS to ER for further evaluation