chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness/numbness in the back of neck; blurry vision/blurred vision/vision is so bad her eyes are almost shut; dizziness; couldn't walk; arm swelled way to elbow; pain at the back of her neck; swollen eye; red in the eye; pain in the eye; no energy; had a red spot on the same arm; tiredness; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness/numbness in the back of neck), VISION BLURRED (blurry vision/blurred vision/vision is so bad her eyes are almost shut), DIZZINESS (dizziness), MOBILITY DECREASED (couldn't walk) and SWELLING (arm swelled way to elbow) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) 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 reported medical history). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and LORAZEPAM for COVID-19 vaccination.    On 01-Mar-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 HYPOAESTHESIA (numbness/numbness in the back of neck), VISION BLURRED (blurry vision/blurred vision/vision is so bad her eyes are almost shut), DIZZINESS (dizziness), MOBILITY DECREASED (couldn't walk), SWELLING (arm swelled way to elbow), NECK PAIN (pain at the back of her neck), EYE SWELLING (swollen eye), OCULAR HYPERAEMIA (red in the eye), EYE PAIN (pain in the eye), ASTHENIA (no energy), ERYTHEMA (had a red spot on the same arm), FATIGUE (tiredness) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) for COVID-19 vaccination, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for COVID-19 vaccination, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness/numbness in the back of neck), VISION BLURRED (blurry vision/blurred vision/vision is so bad her eyes are almost shut), DIZZINESS (dizziness), MOBILITY DECREASED (couldn't walk), SWELLING (arm swelled way to elbow), NECK PAIN (pain at the back of her neck), EYE SWELLING (swollen eye), OCULAR HYPERAEMIA (red in the eye), EYE PAIN (pain in the eye), ASTHENIA (no energy), ERYTHEMA (had a red spot on the same arm), FATIGUE (tiredness) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: No specific follow-up information recorded.
soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (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: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "soreness". Patient experiencing soreness this evening. Her 2nd dose will be on 15Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, patient s were vaccinated with GARDASIL (lot # K008931, expiry date 04-MAR-2017) (dose, route and site of administration were not reported) that was improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Nausea, profuse sweating, weakness, dizzyness that led to blacking out. Blacked out for about 5 minutes. Recovery to feeling o.k. took about 20 minutes.  Felt weak for another couple of hours.  ~6 hours before feeling completely normal. No treatment.
I was totally A symptomatic and had no symptoms I went with my wife to get tested for COVID19 and while I was there I decided to go on and get tested and I tested positive for COVID19. I  had very light symptoms and was in quarantine for 5 days  and I thank the COVID vaccines for that.
pt presented to ED with AHRF requiring BiPAP; two weeks prior pt was hospitalized for COVID; PE, A Fib, COPD, AKI; given solumedrol and antibiotics; eventually went into septic shock and treated with vasopressors; DNI/DNR; pt found unresponsive with dilated left pupil; comfort measures; pt died in the hosp
Had Covid inJanuary 2022, still continues. I think result of Covid, not vaccine.
Got my first shot March 8 Janssen vaccine no reaction. On 10/31 got my booster shot Moderna and started with normal vaccine symptoms  fever, weak, and had to rest afterI got home. On Nov 1 swelling of left side near neck. Uncomfortable. Nov 14 swelling continue to growth now both side neck, under arms, and groin. Left side more swelling than right side. Also numbness in left hand and left groin area. Pain that comes from the head to the next and continue to the elbow, and hand feels numb from time to time. Lack of sleep due to the pain left side and inflammation. ER 11/12 due to chest pain and pain neck.11/15 seek medical attention lack of primary care doctor and Sent me to the ER again.
PATIENT WAS GIVEN VACCINE IN THE AM AND WAS IN THE ER LATER THAT AFTERNOON AS PATIENT DEVELOPED A SWOLLEN FACE, SOB, AND DEVELOPED HIVES. PATIENT WAS TREATED WITH STEROIDS AND BENADRYL.
Rash/hives on lower legs very itchy in morning and evening. Started 3 days after vaccination, symptoms mostly gone after being present for 3 weeks. No treatment seeked.
felt nauseous, achy all over, flu-like sx, finally vomited & cont to feel weak & h/a for 2 days;third day @ work had migraine type h/a & vomited;
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received BOOSTRIX (batch number 7B222, expiry date 23rd April 2017). On 26th December 2015, the patient received BOOSTRIX (intramuscular), .5 ml. On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter if the reporter considered the injection site pain to be related to BOOSTRIX. Additional details were received as follows: At the time of reporting, the patient was continuing to experience soreness at the injection site. The patient was seen by her primary care physician and had physical therapy for the reported symptom.
Information has been received from a consumer, concerning her 22 year old daughter with no previous medical history reported, who was vaccinated with the complete series of GARDASIL (Lot # not reported). On beginning of summer 2008 (approximately 01-AUG-2008) the patient had her yearly pap smear and her physician advised her that she needs to come back to the office because she was positive for HPV. The reporter stated that the physician did not specify what type of HPV does the patient have. The patient also experienced bladder infection recently. As of 27-AUG-2008, the patient had not recovered. The patient sought medical attention with the physician. There was no product  quality complaint. No additional information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 03-FEB-2015, the patient was subcutaneously vaccinated with a dose of PROQUAD (Merck) (lot # K007156, expiration date 12-NOV-2015, 0.5 ml once) that was improperly stored. No adverse effects were reported. This is one of several reports from the same reporter source. Additional information has been requested.
RN on my team vaccinated 16 year old and vaccine is only approved for 18 and up.  The patient experienced no side effects shortly after vaccine administration, which took place today.
Extremely itchy and painful arm with a red rash and LARGE swollen knot at the injection site. It's been 5 days and my arm is still sore, itchy and has a hard knot at the injection site, though smaller than 3 days ago. I iced the injection site every day to help reduce the swelling and pain.
patient seeking 3rd covid vaccine (booster).  Pt wanted Pfizer .  was administered Moderna.
This is a spontaneous report from a noncontactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), at the age of 62, via an unspecified route of administration, left arm, on Apr 7, 2021, at 09:45, single dose, for COVID-19 immunisation. Medical history included asthma, hypothyroidism and pseudocholinesterase deficiency. Concomitant medications included levothyroxine from an unknown date and for an unknown indication. The patient previously took tetracycline hydrochloride on an unknown date and experienced allergy. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 7, 2021, at 16:00, patient experienced stuffed nose, fatigue, left arm pain, swelling, swollen lymph nodes (opposite arm), breast rash (opposite-side) and trouble breathing. The adverse events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures taken as a result of reported events included treatment with topical creams, inhalers and ice from unknown dates. The clinical outcome of the events stuffed nose, fatigue, left arm pain and swelling, swollen lymph nodes (opposite-arm), breast rash (opposite-side) and trouble breathing: unknown (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained.
We believe that the VARIVAX was inadvertently mixed with MENACTRA instead of the diluent. 7-7-15 Nurse spoke with patient. No adverse effects noted.
This spontaneous report as received from a physician refers to one of 1 year old male twin infants. On an unknown date the patient was vaccinated with the first dose of (Merck) VARIVAX (Lot# not reported). On an unknown date both of the twin infants developed a raised area and local reaction rash at the injection site. The outcome was unknown. The patient sought medical attention through seeing the physician. This is one of two reports received from the same reporter. Additional information is not expected.
sweating, heart racing, rapid heart rate, chills, fever, face flushing, abnormal body sensation, dizzy, dry mouth, headache
Some wheezing when exhaling, diarrhea, nauseous (w/o vomiting). No rx-all symptoms resolved in <24 hours.
Fever beginning night of vaccine, fever lasted 24 hours, headache lasting 24 hours, large red area on arm below site of injection, tender to the touch and slightly itchy lasting 4 days after injection, sore arm at site of injection
Pt was to receive Gardasil #1, Fluvirin, and Menactra. She did receive Gardasil and Fluvirin but was given Prevnar in error. Had soreness of both arms the day of injection. The next morning she developed fever initially to 100.2F, chills, and dizziness. Over the next 3 days she had fever to 102F, and nausea as well.
Information has been received from a certified medical assistant concerning a 3 year old male who on 22-MAY-2006 was vaccinated with second dose of Vaqta (lot number 653616/0201F) 0.5 ml intramuscular into left deltoid. The first dose was given on 10-APR-2005. The patient has no illnesses at the time of vaccination. On  approximately 22-MAY-2006, the patient vomited within 1/2 hour of receiving Vaqta. The outcome was not reported. Follow-up information was received from the certified medical assistant who reported that the child was hospitalized and has since recovered. Additional information was received from the certified medical assistant. It was reported that on 22-MAY-2006, at 1130 hours, the patient started vomiting with 30 to 40 minutes after receiving the vaccination. The patient was taken to the emergency room (previously reported as hospitalized), was observed and was doing fine. On 22-MAY-2006, the patient recovered. No additional information is expected.
Reported feeling hot flashes, nosebleed, chills, lifht headedness, nausea, fatigue, body aches, swollen lymph under jaw on neck.
Headache, HYPERtension, Body aches (unspecified), fatigue, face flushed Narrative:
6cm X 10cm reddened area, minimal swelling. Improved after 24 hours.
vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022.; Vaccine were administered after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022.) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-May-2022 at 3:00 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 20-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine were administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Patient neither diagnosed with COVID-19 nor tested positive.  Six vials of lot number 027L21A was initially stored in the refrigerator on 08-Mar-2022. The vials did not undergo any temperature excursions.  The patient had not reported any symptoms.   Treatment medications were not reported.
Soreness, swelling, redness, pain. Started in L deltoid and moved to medial aspect. Pt had PNEUMOVAX 5 yrs ago.
Patient received expired QUADRACEL with no AE; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Global Medical Information (Reference number- 00728548) and transmitted to Sanofi on 17-Aug-2021.  This case involves a patient with unknown gender who received expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 16-Aug-2021, the patient received a dose of expired suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number was not reported and expiry date: 13-Aug-2021) via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used (latency: on same day).  It was reported that "Caller did not have any other AE reporting information to provide and is only inquiring about if this dose is valid or if re-vaccination is needed and if so, how soon?"  It was not reported if the patient experienced 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 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.  There will be no information on the batch number for this case.
the powder component of the Pentacel was reconstituted with sterile water instead of the liquid that came with the powder and was then administered to the infant, with no reported adverse event; Initial information received on 22-Jan-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4-months-old male patient for whom it was reported that the powder component of the pentacel was reconstituted with sterile water instead of the liquid that came with the powder and was then administered to the infant, with no reported adverse event (product preparation error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine conj 7v (CRM197) (Prevnar).  On 21-Jan-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ337AAA and expiration date: 05-Jul-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of medication error due to product preparation error. (Latency: same day of vaccination).  It was reported that the powder component of the pentacel was reconstituted with sterile water instead of the liquid that came with the powder and was then administered to the infant. At the time of report, no adverse event was reported.   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.  There will be no information available on the batch number for this case.
pt had rash on back or arm onset approx 1 1/2wk p/vax 11FEB98;mom states never really cleared up;21APR98 mom noted dry, patchy bruised colored area on back of arms;
Interchange of vaccine products; contracted COVID-19; contracted COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 02245892.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "contracted COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Unknown results, notes: Contracted COVID-19. The reporter reported that the patient who received two of the elasomeran and bnt162b2 booster shots contracted COVID-19 around May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
1st vaccine - hypertension, tachycardia, full body tingling, lightheaded - resolved after 60 minutes of observation 2nd vaccine - within 2 minutes, similar symptoms started but gradually intensified. Additionally, had chest pressure, throat dryness, sensation of needing to breath faster (but not shortness of breath), presyncope, full body shaking (rigors) and hand numbness. Code medic called and wheeled down to ER. Symptoms (all of them) came in waves and intensified further in ER. Given IV solumedrol, benadryl and famotidine. Within a minute of IV meds, all symptoms resolved and felt fine for 15 minutes. The symptoms then returned in similar waves but with less intensity and further apart.
I administered 5-11 years biv-booster vaccine to a 12-year-old patient.  I will make sure to recheck the age before administering any vaccines.
Vaccines administered at 8:40 am. Immediately following vaccination patient leaned back on bed. Pupils dilated and arms stiffened for 3-5 seconds. Patient rolled onto side. Patient states she dreamed on eating chicken nuggets. Patient alert and oriented. States that her arms were sore. When asked why she was able to state that she got two shots in her left arm and one in her right. Patient rolled onto back and feet elevated. At 8:45 patient sat up in bed. States that she was fine. At 8:50 am patient given gatorade. Patient drank 2-3 ounces. No complaint on nausea, dizziness, or headache. Patient ambulated out of clinic at 9:08 am. Parents state they were taking her to the emergency room for follow-up.
Pt exp vomiting, irritability w/5 vomitings; no fever;
Case number PHEH2016US025943, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to a 92 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1517601) at a dose of 0.5 ml, intramuscularly on 04 Oct 2016. The nurse stated that, 02 patients were administered FLUVIRIN from last year. It was reported that, patient did not experienced any adverse effects and vaccinated with last year dose of FLUVIRIN. No adverse event was reported following this medication error (expired product administered). The case was assessed as non serious by the nurse. Follow up report received from a nurse on 02 Nov 2016: Added reporter comments.
3 days after vaccine dose number one. I woke up with hives covering my upper legs, partially lower legs, partial back, partial upper arms, entire side mid section and partial waste line. Antihistamine and cortizone ointment started immediately. Showing slight improvement from initial reaction time.
rxn -- severe headache, chills, fever, sweats, vomiting, body aches - 36 hours before starting to feel better
This 69  year old  black male received the Covid shot on  1/30/21    and went to the ED on 2/18 /21   with the following diagnoses listed below. U07.1 - COVID-19
On 4/5/01, woke in the AM with pain in cheek and behind ear, throat edema, pinpoint rash on body, temperature 100.6F and symptoms lasted until 4/7/01. Seen per doctor and treated with Augmentin bid.
Late evening of day vaccinated began to see rash on scalp & face with urticaria.  Hives spread across neck, shoulders, extremities