chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had a headache; my joint are killing me; numbness occurred right away in my arms and hands; Very lethargic; weak; Starting at 11pm I have had severe diarrhea and vomiting; Starting at 11pm I have had severe diarrhea and vomiting that hasnt stopped; This is a spontaneous report from a contactable consumer, the patient. A 48-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 30Apr2021 at 11:45 (at the age of 48-year-old), as a single dose for COVID-19 immunisation. Medical history included known allergies to latex and abs whole wheat. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) and estradiol (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and unknown if ongoing. On 30Apr2021 at 23:00, the patient experienced severe diarrhea and vomiting that had not stopped. On same day at 23:45, the patient experienced headache and patient's joints were killing her, numbness occurred right away in her arms and hands, felt very lethargic and weak. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe diarrhea and vomiting that had not stopped, headache, joints were killing her, numbness occurred right away in her arms and hands, very lethargic and weak was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received vaccine after 30 day beyond use date), PRODUCT STORAGE ERROR (Vial initially stored in the refrigerator on 06-Dec-2022/ Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.     It was unknown if patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Vial initially stored in the refrigerator on 06-Dec-2022. Caller said when they received the vaccines they were refrigerated so they put them in the refrigerator. Vial size was 2.5ml.  Dates of administration of vaccine were 12-Jan-2023 for 2 patients, 16-Jan-2023 for 2 patients, 20-Jan-2023 for 1 patient, 24-Jan-2023 for 1 patient and 01-Feb-2023 for 1 patient.  Vial did not undergone any temperature excursion issue.  No treatment information was provided.  This case contains information for the 3rd of 7 patients described by the reporter.
I started getting an itchy rash on  my right side and hip on July 25. It spread over the next few days, so I saw my nurse practitioner on July 28. Based on her visual inspection, she diagnosed me with shingles. She prescribed valacyclovir (three 1-g pills per day for 7 days) and recommended calamine lotion. I took the full course of medicine. After about 10 days, the rash started to diminish. 2 1/2 weeks later it is still visible but no longer itchy and raised.
I got a flu shot got sicker than a dog; Initial information received on 11-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via social media.  This case is linked to cases 2020SA294125, 2020SA294157, 2020SA294158, 2020SA294166, 2020SA294144, 2020SA294173 and 2020SA294145 (same reporter).  This case involves a patient of unknown age who got a flu shot got sicker than a dog (illness), while patient was treated with influenza usp trival a-b subvirion no preservative vaccine [Fluzone].  Medical history, past medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patients got a flu shot got sicker than a dog (illness).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 15 years old male patient and reported that Flublok Quadrivalent given to a 15 years male patient, while he received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 25-Oct-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1816 and expiry date: 20-Jun-2018) (dose in series and route was not reported) in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if the patient had any adverse 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 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. List of documents held by sender: none.
Headache on one side of the head; Anxiety; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021 and was forwarded to Moderna on 27-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache on one side of the head) and ANXIETY (Anxiety) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Anxiety.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache on one side of the head) and ANXIETY (Anxiety). At the time of the report, HEADACHE (Headache on one side of the head) and ANXIETY (Anxiety) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 189/90 (High) high.         Concomitant medications taken were blood pressure medications and anxiety medications. No treatment medications were reported. Action taken with mRNA-1273 in response to the events were Not Applicable.
Information has been received from a physician concerning a 75 year old female who in July 2007, was vaccinated with a single dose of Zostavax (Oka/Merck).  It was reported that on 05-JUL-2007, after vaccination the patient developed a rash.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Site: Pain at Injection Site-Medium, Additional Details: reaction to fluad flut shot on 9/23, arm sore for 3 weeks after
off tasting of food; Dizziness; Exhaustion; Body aches; This is a spontaneous report from a contactable consumer, the patient. This is the second of two reports. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the arm right on 08Apr2021 at 15:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatism, vitiligo and allergy to "many and many things" and a coworker tested positive for COVID from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (ACETAMINOPHEN), ubidecarenone (COENZYME Q10) and calcium (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and stop date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 11Mar2021 at 15:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation and experienced nausea and dizziness. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 10:30, the patient experienced all foods and beverages taste 'off'/off tasting of food. Sweet foods and beverages were so much sweeter that they were not even comfortable to eat. Savory foods and beverages were quite bitter. It made her not want to eat anything. The patient inquired that how long would this weird taste continue. After the second dose, the patient also had dizziness, exhaustion and body aches. The patient previously never experienced COVID symptoms but was tested months ago on unknown date after a coworker tested positive for COVID and the result came back negative. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events off tasting of food, dizziness, exhaustion and body aches was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Chills started evening of. Progressed into fever (101), shivering while sweating, extreme loss of energy, dizziness, and lack of cognition
knot and lump on face; swelling of lips; swelling of face, cheek; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling of face, cheek), MASS (knot and lump on face) and LIP SWELLING (swelling of lips) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced SWELLING FACE (swelling of face, cheek) and LIP SWELLING (swelling of lips). On 02-Apr-2021, the patient experienced MASS (knot and lump on face). At the time of the report, SWELLING FACE (swelling of face, cheek), MASS (knot and lump on face) and LIP SWELLING (swelling of lips) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were reported.  Patient reported that his symptoms appeared worse at night and swelling goes down in the day.  No treatment was provided.   This case was linked to MOD21-068892 (E2B Linked Report).; Sender's Comments:  MOD21-068892:Crosslink
Patient received vaccine after removing needle from RD a large amount of clear fluid was observed from patients injection site.  unsure of amount of vaccine patient received .  Notified Branch manager LPN who advised to offer patient re-vaccination.  Patient declined re-vaccination.  Nurse advised patient that he received vaccine just unsure  of amount.  Patient advised to get 2nd dose .  Patient verbalized understanding no questions  finished 15 observation no issues.
pt developed mild erythema surrounding injection site on bilateral thighs on lateral side of each thigh. no SOB, reaction happened 5 minutes post injection, recommended Benadryl and observation to parents and go to ER or ICC if any concerns or rash worsens.
Large local reaction L arm deltoid to middle of upper arm, raised, hot, also wheezed. Has had flu shot before with no significant problems. No egg allergy.
after injection, pain at site, 4 hrs later, headache,  4 hrs after headache, arthralgia, 4 hrs after arthralgia, chills.  In the morning at 0600, woke up with nausea  and BM urgency.  Shortly after N/V, chest pain and delerium start.  Chest pain caused anxiety. No SOB. Upon standing, I blacked out and fell to ground.  When I came to ( 5-10 minutes later ) nausea disappeared but arthralgia and chills still present.  I did not take any OTC/ pain relief meds at all since I did not want to blunt my body's immune response.  Nausea does not return and the CP/ hypotensive/shock episode made me stick to sitting on the couch for the remainder of the day.  I took 400mg IBU around 8 am and all SX disappear by 1800.
pt came into office w/a measles-like rash beginning around neck & ear & cont down onto back & arms-pt was given prescription for atarax fr itching & given DPH;
Extreme fatigue, loss of appetite, dizziness,  some confusion of surroundings. Lasted about 24 hours.
At 6:00 pm start to cough real bad, then around 8:30 start having a problem breathing until 11:00 pm was real difficult, that's when we call 911.
This morning, patient's entire right deltoid region was swollen and reddened; hot to touch. No other complaints. Patient referred to NP for further evaluation.
Arm red and swollen below the injection site.  Very tender and rigid.  Painful to move arm fully.  Came on slowly all evening.  Woke painful near 11 pm.  Took acetomeniphin.  Iced muscle for 20 minutes.  Then applied heat for about 20 minutes.  Was able to get to sleep but couldn't lay on the right side as the arm hurt.  The next day was still rigid and red but swelling was down some.  Not as painful.  Took another acetomeniphin.  Painful when moving but not as bad as the night before.  3rd day.  Still a bit of swelling.  Most of redness gone.  Slightly tender but not painful.  Almost full movement without pain.
Initial report received from a healthcare professional on 22 AUGUST 2013.  This case concerns one among the  two 11-year-old male patients, whose medical history and concomitant medications were not reported, had received a dose of ADACEL (batch number, dose in series, route and site of administration was not reported) on an unspecified date. On an unspecified date, the patient developed unspecified local side effects and was worse than usual. Laboratory investigations and the corrective treatments were not reported. The outcome of the event was not reported. Documents held by sender: none
COVID arm after first shot; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE REACTION (COVID arm after first shot) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (COVID arm after first shot). At the time of the report, ADVERSE REACTION (COVID arm after first shot) 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 were reported. No treatment details were reported.     This case was linked to MOD-2021-021631 (Patient Link).
Rec'd DTaP on 11-19-07. Next day developed fever of 101.4 and rash at injection site followed by cellulitis.
Approx 5am after injection Pt started with cough, chest pain, swollen eyes. Was given 1.5 SC Epinephrine, BENADRYL 25 P.O. 10 minutes after broke out in hives. Was given accidental Epi and SOLUMEDROL 40 IM - observed for 2 hrs and resolved.
Pt came to pharmacy on evening of 9-13-18 complaining of sore arm at injection site from day before....injection site was pink and swollen. I counseled pt to take BENADRYL and ADVIL for swelling and allergic reaction at site and ice tonight. Patient has no fever but complaining of sore back and shoulder. She will monitor reaction and call Dr. tomorrow. She was given the first shot at Dr.'s office and said there she never had any reaction to the vaccine. I told her we would report reaction and call us tomorrow to see how she is feeling.
Reported that he was in good health and feeling well when he developed the first of many blood clots in 2006. He was evaluated in 2006 where he was diagnosed with APS. He has had multiple clots, including bilateral PE and now with pulmonary hypertension. He separated from his employer in 2007. He denies any previous medical problems and family history and feels that it is related to the anthrax vaccine he received. Edema.
Patient received MMR and Varicella vaccine on 11/12/2020 and Hep A and flu vaccine on 12/03/2020 Pt developed easy bruising and petechiae on 12/09  dx Idiopatic Thrombocytopenia on 12/17/2020 treated at Med Ctr
pt recv vax 26JUN97 & 21JUL97 pt exp cold urticaria;7JUL97 pt exp Raynaud's phenomenon which consisted of numbness, coldness, pain, redness & swelling of fingertips;pt was last seen by MD 21JUL97;
the second dose after 36th day; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (the second dose after 36th day) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS (MVI [VITAMINS NOS]) for Supplementation therapy.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 27-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (the second dose after 36th day). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (the second dose after 36th day) outcome was unknown. Not Provided          Concomitant medications includes Asthma medications (spouse does not remember) along with above mentioned medications. No treatment drugs were reported.   This case was linked to MOD21-082878, US-MODERNATX, INC.-MOD-2021-092255 (E2B Linked Report).; Sender's Comments:  MOD21-082878:Spouse case US-MODERNATX, INC.-MOD-2021-092255:spouse case
This spontaneous report as received from a 49 male patient who was feeling sick reporting on himself. The patient was enrolled in a Patient Support Program. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, dose, lot # and expiration ate were not provided). On an unknown date, when the patient got the shot, the patient experienced malaise as he felt sick than before. At the time of the report the outcome of malaise was unknown. Additional information is not expected because the patient did not give his consent for follow-up.
The patient may have experienced a mild fever after the second vaccination; Route of administration: intramuscular (IM); This spontaneous report was received from the patient's mother concerning an approximately 5 year old female patient. The patient had no medical history, concomitant medications, drug reactions or allergies.  On an unspecified date in 2011, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, anatomical location were not provided), administered intramuscularly (IM) (incorrect route of product administration) as prophylaxis (reported as states mandated). After the second vaccination, the patient might have experienced mild fever (pyrexia). In consequence, she sought for medical attention and the patient was treated with ibuprofen. It was reported that the patient received separately the first 3 doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) and then she received the "follow up titers because it was a state mandated". No laboratory diagnostics or studies were performed. At the reporting time, the outcome of fever (mild) was unknown.   The causality between the event of fever (mild) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) was not reported.
Devel rash & fever on 28MAY92; called for appt 1JUN92, rash getting worse, pt very crabby, not sleeping; temp in clinic 99.8 ax; erythematous macular rash, eyes hurt, throat red, tonsils 1-2+;
13 month old who received Quadracel immunization; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 13 months old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  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 VACCIN); and INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT).  On 17-Oct-2019, the patient received 4th dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5635AA and expiry date: 18-Jun-2021 via intramuscular route in right thigh.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if the patient had any adverse 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 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.
The night after the shot I was woozy and unsteady on my feet when I got up to go to the bathroom. Small amounts of strong urine passed. Arm hurt a lot but was helped by icing it. The rest of the night and them morning after the shot I had extreme fatigue, severe  headache and backache. By noon the pain had lessened and I was able to eat and drink. Slight headache the second morning after the shot. Lots of diarrhea within 24-36 hours after the shot.