chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A consumer report has been received. The report concerns a 4 year old, Female consumer, who had been receiving Nasal FLUMIST. FLUMIST started on 08-Nov-2012. The two children was administered with FLUMIST twice, once at a clinic with mom on 15-Nov-2012 and the other the doctor office with dad on 08-Nov-2012 which started on 15-Nov-2012. The outcome of the event of RECEIVED FLUMIST TWICE is unknown. The report was considered to be non-serious. Corrected report 30-Nov-2012: Coding of event 'received FLUMIST twice' changed from Intentional drug misuse to Extra dose administered, narrative updated.
patient reported arm pain starting day of vaccination that has persisted for 4 days. pain is reportedly causing weakness of arm between sholder and elbow. patient has reached out to Dr and will be seen in office at future date
Mother stated patient got 2nd HPV vaccine, then after vaccine she had 2 nodules/mass next to each other on injection site and it hurts to the touch.  Was seen by provider on 07/03/2023 and stated it was getting better nodule/mass was getting smaller, and no longer in pain. Called mother on 07/05/2023 to check in on pt. and mother stated nodule/mass still there, but is doing a lot better.
Dizziness elevated heart rate HA . Dizziness and elevated HR resolved later per the patient nad did not feel like her MS
feeling pain; fingers are numb; The shoulder that got the shot also numb and pain; feeling pain on the right arm were got the shot; The shoulder that got the shot also numb and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (feeling pain), HYPOAESTHESIA (fingers are numb), HYPOAESTHESIA (The shoulder that got the shot also numb and pain), VACCINATION SITE PAIN (feeling pain on the right arm were got the shot) and ARTHRALGIA (The shoulder that got the shot also numb and pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (feeling pain), HYPOAESTHESIA (fingers are numb), HYPOAESTHESIA (The shoulder that got the shot also numb and pain), VACCINATION SITE PAIN (feeling pain on the right arm were got the shot) and ARTHRALGIA (The shoulder that got the shot also numb and pain). The patient was treated with PARACETAMOL (TYLENOL) on 08-Apr-2021 for Pain, at a dose of 1 dosage form. At the time of the report, PAIN (feeling pain), HYPOAESTHESIA (fingers are numb), HYPOAESTHESIA (The shoulder that got the shot also numb and pain), VACCINATION SITE PAIN (feeling pain on the right arm were got the shot) and ARTHRALGIA (The shoulder that got the shot also numb and pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information, if any, was not provided by the reporter.
after about 15 minutes (on my way out of office), Dark red flush Slight trouble breathing pain in central lower back intense enough not to be able to walk or stand for about 15 minutes(on my hands and knees on little white boxes outside office door ) (pain began tapering off enough to stand made my way to my car (15 feet away) sat leaning on door (open) for 15 more minutes until a nurse came out on her way home and asked if I was ok , took me back upstairs had doc check me out  , nauseous for hours, dizzy for hours, small amount of itching for several weeks with small amount of hives on mostly on back of hands in between fingers for about, Still now have mostly healed hives present on back of hands), (benadyrl helps with the itching)
Fainting, dizziness, anxiety, lost consciousness at time of injection, low blood pressure, headaches
The employee received flu vaccine in our employee health office. She did not complain of any pain,  discomfort, or any other adverse reaction at the time of the vaccine administration on 12/1/21. On 12/4/21, the employee reported the following reaction via the risk reporting software at the facility; "I received the flu vaccine on 12/1/21. During administration of the vaccine, I experienced an immediate deep pain in my shoulder and continued soreness x 24+ hours unlike any other time I have had the vaccine. I noticed a new onset of  L lower leg, foot and toe numbness the following evening when shaving my legs in the shower. The next day (48 hours post vaccination) I am still experiencing the same numbness. It is not worse but it is unchanged. I am currently not experiencing any other symptoms other than the unchanged L lower leg, foot and toes numbness. I would like an adverse reaction report be filed on my behalf with the company that manufactures the vaccine as well as a report be filed with the governing body. I would also to receive a call from employee health and a copy of the vaccination administration paperwork."
achiness; tired; felt bad; This case was reported by a consumer via call center representative and described the occurrence of pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 20th April 2019, 1 days after receiving Shingrix, the patient experienced pain, tiredness and feeling bad. On 21st April 2019, the outcome of the pain, tiredness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, tiredness and feeling bad to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient  felt badly after receiving 1st dose of Shingrix. The patient felt achy and tired on the day after Shingrix vaccination.  These effects resolved by the 2nd day after the vaccination. This case has been linked with case US2019116903 reported by the same reporter.
Fluarix Influenza Vaccine: resulting in adverse event Patient received Fluarix on 10/3/22. Patient reports feeling dizzy and foggy brain for the rest of the day. Symptoms were followed by joint soreness and the following day awoke with neck stiffness and shoulder stiffness on same side she received vaccine. Pt treated herself with Tylenol and has not reported additional symptoms
Angioedema stated had tingling and tightness in throat after vaccine and still has swollen gland in throat Narrative: took OTC Benadryl on the day of the reaction
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-JAN-2013, the patient was vaccinated at a Medical Center with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. During 2014, the patient was treated at the same center for blistering vesicular outbreaks that were diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
15 minutes after receipt of dose #1 patient developed blurred vision and dizziness.  I arrived to the patient's side and conducting an abbreviated history as well as a neuro exam.  Patient had new onset tremor in upper extremities, positive Romberg, and ataxia.  HR ranged from 130-140 w/ SPO2 at 99.  No signs of difficulty breathing noted.  911 was called and an ambulance was dispatched.  Patient's symptoms remained unchanged upon EMS arrival and she was evacuated to a healthcare facility.
Wife states that patient was "fine after the vaccine.  Had PT that week and did well".  "He was tired and went to sleep".
I had chest pain accompanied by racing heart, shortness of breath,  fever, chills, fatigue,  profuse perspiration. I saw my primary care physician the following day and was told it was possible pericarditis . I was given an EKG, blood work and provided a course of prednisone.  2 months later and the chest pain has continued. Scheduled to see cardiologist May 19th 2022.
sick; Initial information received on 20-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves adult patient (unspecified age and gender) who experienced sick (illness), while he/she received vaccine INFLUENZA USP TRIVAL A-B WHOLE VIRION VACCINE [FLUZONE (WHOLE)].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B WHOLE VIRION VACCINE (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness), unknown latency following the administration of INFLUENZA USP TRIVAL A-B WHOLE VIRION VACCINE for prophylactic vaccination.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
COVID Arm....Red lump beyond injection area and eventual red rash.  Itchy, redness for about ten days
BACK PAIN IN KIDNEY AREA, BRUISING THAT LOOKS LIKE LIVER SPOTS.  REPORTS THAT THIS BEGAN RIGHT AFTER VACCINE.
A few days post vax the pt developed a fever and small bumps on his chest and diaper area. Subsequently the bumps spread down the legs, arms, back and ears.
expired ACTHIB given to a patient with no reported adverse event; Initial information received 14-Feb-2023 regarding an unsolicited valid  non-serious case received from  other health professional.  This case involves a 1 year old female patient to whom expired haemophilus type B (HIB) vaccine (HIB (PRP/T) vaccine) (ACT HIB) given to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination (immunization).  On 14-Feb-2023, the patient received 0.5 mL dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection, (lot number: UJ740AAA: expiry date: 11-Feb-2023) via intramuscular route in the left thigh for immunization with no reported adverse event (expired product administered) (latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Since getting the vaccine and COVID I have been to 2 doctors and the ER on one occasion recently as I thought I may be having a heart attack. I have had blood work done in May and June as I was experiencing symptoms starting in late March, 2021 of headaches (March/April/May), dizziness (March/April May), nausea (March/April/May), severe head rushes (April/May/June), severe anxiety  (May),  low/high pulse rate (May/June), chest pain/pressure (June) and weakness (April/May). Bloodwork done in late May and late June shows low RBC and enlarged RBC and low lymphocytes. Was tested in May/June for B-12, Folate deficiency,  thyroid and liver issues, all came back normal.  I also had an EKG at the ER in late May which was normal.  It is unknown at this point why I have been having issues on and off,  but for the last week I have only experiencing some minor chest pains/pressure and feel normal otherwise.  Just seems like I have not been myself since getting the vaccine and/or COVID-19.
Pt had a febrile seizure on 7/2/01 and 2 episodes of breaking out with pruritus in same place on body.
had allergic reaction within 2 mins of receiving Pfizer vaccine dose 2; needle pricks on face; numbness in face; increased blood pressure/high BP (170/100); tested positive for COVID; tested positive for COVID; seeing spots on face/chin/neck; vertigo; nausea; diarrhea; exhaustion; Elevated thyroid, blood sugar, cholesterol; Elevated thyroid, blood sugar, cholesterol; Elevated thyroid, blood sugar, cholesterol; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included diabetic, known allergies: sulfa, statins and environment. The patient is not pregnant. The patient's concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization. On 20Jan2021, the patient had allergic reaction within 2 mins of receiving Pfizer vaccine dose 2 (needle pricks on face, numbness in face, increased blood pressure). The patient was taken to the hospital by an ambulance, given fluids and then sent home with instructions to take benadryl. One month later (15Mar2021), patient started experiencing COVID symptoms. On 17Mar2021, after seeing spots on face/chin/neck, vertigo, nausea, diarrhea, high BP (170/100), exhaustion, the patient went to the ER and tested positive for COVID. Elevated thyroid, blood sugar, cholesterol were normal 2 weeks prior (Mar2021). The patient received treatment for the events allergic reaction, needle pricks on face, numbness in face and increased blood pressure. The outcome of the events was recovering.  Information about lot/batch number has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmness at the injection site), COUGH (bad cough which she believes has nothing to do with the vaccine), RASH (rash) and PYREXIA (fever is from after getting the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Allergic asthma (The patient being around her home with all the air pollutants.). On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warmness at the injection site), COUGH (bad cough which she believes has nothing to do with the vaccine), RASH (rash) and PYREXIA (fever is from after getting the second dose). At the time of the report, VACCINATION SITE WARMTH (warmness at the injection site), COUGH (bad cough which she believes has nothing to do with the vaccine), RASH (rash) and PYREXIA (fever is from after getting the second dose) outcome was unknown. Treatment medication use was not provided by the reporter. The concomitant medication included steroid inhaler for allergy induced asthma. Reporter did not allow further contact.
Information has been received from the mother of a 15 year old female with acne and no history of drug reactions/allergies who on 06-SEP-2007 was vaccinated with the first dose of 0.5 ml Gardasil intramuscularly. Concomitant therapy included unspecified acne medication. On 06-SEP-2007 the patient experienced a seizure while in the physician's office. Subsequently, the patient recovered from seizure on 07-SEP-2007. No lab testing was performed. Additional information is not expected. Upon internal review, seizure was considered to be an other important medical event.
Patient was given the wrong vaccine, he wanted Johnson and Johnson and received the Pfizer. Employee drew up the wrong vaccine and verified that it was in fact the Johnson and Johnson vaccine.  However, it was the Pfizer - he drew out of the wrong vaccine bottle.  The mistake was noted after the vaccine was given.  The MDH was notified about mistake.  Administration was notified and patient was going to contacted right away. The dose that was given was .5 ml of Pfizer pediatric dose.
Nausea, weakness, feeling cold and lightheadedness that seemed initially to improve but she returned to office 2 days later reporting persistent muscle pain in the legs and left arm and weakness of the legs such that she had difficulty walking.  She reported improvement on the second day.
was asymptomatic but has received a positive test result since receiving the 1st dose of vaccine; was asymptomatic but has received a positive test result since receiving the 1st dose of vaccine; This is a spontaneous report from a contactable Other-HCP.   An HCP patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on an unspecified date for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was asymptomatic but has received a positive test result since receiving the 1st dose of vaccine. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive. The outcome of event was unknown. The reporter queried whether the second vaccine doses have to be administered on the 21st day after the first dose, or whether there is a window of time in which it can be administered. The reporter queried whether this patient can continue with the normal vaccination schedule, or do they need to delay their second shot.   Information on the batch number/lot number has been requested.; Sender's Comments: There is no available injection date of vaccine BNT162B2 or event onset date. Based on the information provided, the Company considers that the asymptomatic carrier with positive COVID-19 is unlikely related to suspect BNT162B2 administration.
Acute anaphylaxis with urticaria pruritis and angioedema and tachycardia. Started minutes after IM injection. Given therapeutics in clinic and transferred to ER.
allergic reaction; SWELLING; arm is really hot; It's very hard; rash; size of a baseball/it's like a circunference; arm hurt really bad; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), SWELLING (SWELLING), VACCINATION SITE WARMTH (arm is really hot), VACCINATION SITE INDURATION (It's very hard) and RASH (rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm hurt really bad). On 04-Mar-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), SWELLING (SWELLING), VACCINATION SITE WARMTH (arm is really hot), VACCINATION SITE INDURATION (It's very hard), RASH (rash) and VACCINATION SITE SWELLING (size of a baseball/it's like a circunference). On 01-Mar-2021, VACCINATION SITE PAIN (arm hurt really bad) outcome was unknown. At the time of the report, HYPERSENSITIVITY (allergic reaction), SWELLING (SWELLING), VACCINATION SITE WARMTH (arm is really hot), VACCINATION SITE INDURATION (It's very hard), RASH (rash) and VACCINATION SITE SWELLING (size of a baseball/it's like a circunference) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
At 1403, RRT was activated for a 43 y/o F with c/o feeling dizzy, ringing in the ear, vision spots, and stating, ?I?m about to pass out.? Very diaphoretic. Vaccinated at 1355 on the L arm. Vitals: BP ? 112/68, HR ? 72, RR ? 18, 0/0 pain. Head-to-toe assessment completed. No PMH, NKA, and did not take any medications today. During monitoring period, client?s condition improved. At the end of observation period, client did not experience what she was experiencing initially and felt much better. Client left vaccination clinic at 1432 ambulatory, in stable condition, accompanied by her family (Husband and daughter).
Few hours after vaccination pt developed redness/swelling/pain on rt lateral aspect of Rt arm (site of injection Pneumococcal vaccine).  Decreased swelling/redness with local ice.
tongue became numb; lip became numb; right hand became numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (tongue became numb), HYPOAESTHESIA ORAL (lip became numb) and HYPOAESTHESIA (right hand became numb) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (tongue became numb), HYPOAESTHESIA ORAL (lip became numb) and HYPOAESTHESIA (right hand became numb). On 22-Mar-2021, HYPOAESTHESIA ORAL (tongue became numb), HYPOAESTHESIA ORAL (lip became numb) and HYPOAESTHESIA (right hand became numb) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants products were reported. No treatment information was provided.
8 MOS AND 29 DAY OLD INFANT PT ARRIVED AT CLINIC TO RECEIVE 6 MOS OLD VACCINE SET WHICH INCLUDES ROTATEQ VACCINE, BUT LATER FOUND OUT THAT ROTATEQ VACCINE IS NOT INDICATED FOR PATIENTS 8 MOS AND 0 DAY OLD AND ABOVE.
This health authority case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns an 11 year old male patient. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 08-Dec-2015 - unknown stop date, Batch no: U56606, Dose no: 3, Route of administration: Intramuscular, Dose: 0.5 ml, Site: Right arm (RA). Additional suspect drug(s): MENACTRA, Batch no: U5082AA, Dose no: 0, Site: Left arm (LA). Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced Oedema (non serious, outcome: Recovered/Resolved), Edema (pitting 2+) in left deltoid area (3 in x 3 in) (non serious, outcome: Recovered/Resolved), Erythema in left deltoid area (3 in x 3 in) (non serious, outcome: Recovered/Resolved), Warmth in left deltoid area (3 in x 3 in) (non serious, outcome: Recovered/Resolved), Pain in left deltoid area (3 in x 3 in) (non serious, outcome: Recovered/Resolved). Lab date: None. Reporter's assessment: Non serious. The health authority reported the symptom: oedema.
Sharp chest pain 4 days later started- similar to heart burn but not sure. Kept happening on and off for about a week. Had extreme anxiety and high blood pressure following week. Prescribed anti anxiety meds.  Had regular cbc at dr appt a week after when got anxiety meds and high Bp reading.  Extremely low vitamin d levels. Get winded, heart rate up for not too much activity at week three. May have had covid end of last February before they had testing out