chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a patient who on an unknown date was vaccinated with 10 mcg/mL of a dose of RECOMBIVAX HB (manufacturer unknown) (lot # and expiration not reported) and their titers are low. It was unspecified if the patient sought medical attention. Antibody level was testes and was low. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
Initial case was received on 03 November 2010 from a consumer who is also the patient. A 69 year old female patient received on 02 November 2010 an injection of FLUZONE HIGH DOSE (lot number not reported). On 02 November 2010 the patient experienced a temperature of "101.2", swelling and soreness at the injection site and back and neck aches. She also complained of a sinus infection. The patient stated she was "not acutely ill" at the time of the vaccination. She was allergic to pet danders, epinephrine and had a milk intolerance. She stated she "reacts to anything injected into her." Concomitant medications included ASTROPRO, ibuprofen and SYNDRIN. No physician evaluation was needed per the patient. The symptoms were resolving. Documents held by sender: None.
on 3/18/2021 at 8:30PM upper arm was swollen, hot to touch, raised and reddened, hard/firm to touch and painful. The redness took up about half of patients upper arm. on 3/19/2021 around 8pm fever developed of 101.6 degrees Farenhiet, patient was given Tylenol and went to sleep. She was uninterested in eating the evening of 3/19/2021 and was lethargic/sleepy.
PATIENT PRESENTED TO THE PHARMACY ON 10/12/19 WITH REDNESS AND SWELLING OF RT. ARM FROM ELBOW TO SHOT LOCATION. PT. COMPLAINING OF PAIN OVER WHOLE AREA.
She is bleeding out of her vagina; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 10:30 (Lot number: FL0007) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: VAGINAL HAEMORRHAGE (medically significant) with onset 24Jan2022 07:00, outcome "unknown", described as "She is bleeding out of her vagina".  The event "she is bleeding out of her vagina" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaginal haemorrhage, vaginal disorder.  Clinical course: The patient is now having vaginal issues. She is bleeding out of her vagina. She has never had this issue before the vaccine. For treatment they are currently working with doctors to treat.  Additional information: the patient had no other vaccine in four weeks, no other medications in two weeks, no covid prior vaccination and no Known allergies.
9:12 onset of nausea & dizziness, awake & oriented x4, skin tone normal for ethnicity, T 99.2, B/P 120/76, HR 55, 02 99% on room air, respirations 18, lungs clear to all, no signs/symptoms of respiratory distress.  Patient and niece state that she hasn't has anything to eat this morning and does receive chemotherapy every 21 days, next dose due March 10th. Within 3 mins patient nausea & dizziness resolved. Patient states she feels fine and is drinking small amounts of water. Lead nurse notified and assessed patient.  Patient discharged home with niece. Patient did get doctor ok to receive Covid vaccine.
Patient was fine after vaccination, only to next day report rash and swelling  on arm.  Not localized to injection site.  Swelling was up and down vaccinated arm.
Recurrent generalized seizures with fever.  He had one seizure by report previous to the vaccination. This was a five-minute seizure. we had at least 2 and perhaps 3 15-20 second generalized seizures associated with temperature of 104 which occurred six days after vaccination. he had no rash or other significant symptoms.
Did not receive their 2nd dose (missed 2nd dose); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive their 2nd dose (missed 2nd dose)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Exposure to COVID-19 (patient may have been exposed to their family member who tested positive).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive their 2nd dose (missed 2nd dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive their 2nd dose (missed 2nd dose)) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Swelling, pain in location of shot on day 1, swelling 10-12 cm diameters, no redness.
Patient developed redness, swelling, pain at injection site. Was seen and diagnosed with cellulitis and was treated with antibiotics.
1 Day after the injection, inside my mouth began to swell, my throat began to close up and limit my breathing, wheezing was taking place, my eyes were also starting to swell shut as well as sneezing and runny nose. Coughing also took place.  No rash was present and nothing present at the injection site.  Allergy symptoms subsided over the next few hours as a result of Zyrtec being taken. Swelling of eyes remained until the next day after the event.
PATIENT IS NOT DUE FOR THIS DOSE UNTIL 7/20/22 OR AFTER
49 y.o. female who presents with abdominal pain. She reports a three week history of epigastric pain and nausea. Today she was at work and going up the stairs when she became diaphoretic, pale, and reports that she felt like she was going to "black out." During this time she was also short of breath. A coworker was nearby with a wheelchair and she recovered well. She reports that the pain is 7-8/10 in severity and is sharp and radiates to the right upper abdomen. S
Pt reports onset of severe vertigo, tinnitus, cold sweats, nausea and vomiting, feeling of being off balance, blurry vision with nystagmus. Unable to drive times 3 1/2 weeks due to incapacitating vertigo, relieved by lying flat in quiet room.
Provider wrote order for COVID-Moderna  0.25 ml 6mo-11yrs. Medical Assistant administered COVID-Moderna Spikevax  0.5 ml for ages 12 and up No adverse reactions at time of report. Contacted manufacture (Case Number) and was instructed to report case to VAERS. RN and MA notified patient's father at 99/28/230 3:48 p.m. via interpreter. (Patient and father's IDs were verified.) Per patient's father, the patient is normal.  MA called patient's father again (09 29/23) at 2:30 p.m. No interpreter. (Patient and father's IDs were verified.) Per patient's father, "she (patient) is doing really good."
Developed a red raised area at MMR injection site 7 days after vaccine was given. Area became indurated 2 days later. 13 days after vaccine was given patient developed a red spotted macular rash on the face and shoulder which rapidly responded to Benadryl.
No adverse event; 113 Bivalent doses administered after the BUD to o patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to o patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 47-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to o patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to o patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to o patients 12 and up).    It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that 113 Bivalent doses administered after the BUD to patients 12 and up. Breakdown of doses was as follows 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.  Treatment information was not provided.
This spontaneous report as received from the nurse practitioner via company representative refers to 3 female patients, who, at the time of vaccination, all were over the age of 70 (elderly). On an unspecified date in 2014, the patients were vaccinated with a dose of ZOSTAVAX 1 single shot (dose, dose number, lot/batch number, expiration date and route of administration were not reported) in September 2014 (reported as in the last month), the patients developed shingles within one month of receiving ZOSTAVAX. The patients sought medical attention (unspecified). The outcome of shingles was reported as recovered/resolved (in approximately 2014). The relatedness between the event and ZOSTAVAX was not reported.  Additional information has been requested.
Swollen lymph nodes in right arm. Main lump about 3 inches from injection site. Pain travels down arm, even past elbow a few inches. Inflammation in vein past elbow too, was difficult to straighten arm. Now, just have the lump 3 inches from injection site.
redness, warmth and soreness at injection site. Redness doubled in size 48 hrs after . Prickly sensation reported without itching.  Hard lump under reddened area.
Vaccine administering error: At our COVID vaccination clinic, patient was accidentally given Moderna COVID vaccine (18 and up) 0.3 ml instead of 0.25ml as the 2nd COVID vaccine booster.  Patient was contacted the same day and notified this vaccine administering error. Then patient was contacted again the next day to follow up. Patient did not have any other signs or symptoms except pain in the injection site.
Painful left supraclavicular lymphadenopathy, onset approximately 6 hours after vaccination. No current treatment. Persisting at this time.
Jan 28,2021 Developed raynaud syndrome in fingers of left hand Feb2-March 23,2021 Raynaud syndrome continued intermittently.  Tingling on hands and feet with selling to point that I could not open water bottle.  Swelling so significant that could not wear shoes or wedding ring March 23,2021 Dr office;  labs drawn results with increase ANA and referral to rhuematology May 13,2021 Dr appt;  started steroids and hydroxchloroquine;  ck 1272, alodose 30.7, ast 66; alt 82 June 8,2021 Consult to Dr;  EMG results inconclusive;   June 16,2021 Appt with PA with Dr office;  discussed muscle biopsy,  referral made;  June29,2021 Referral Dr for muscle biopsy July 2,2021 Muscle biopsy July 6, 2021 Telemed appt. Increase prednisone to 40mg qd July 20,2021 Telemed; increase prednisone 60 mg add cellcept;  ck1710, aldolase 33.9 August 9 Labs ck 1760, aldolase 30.6  increase cellcept
Extreme pain and stiffness in arms at injection site; all over body aches, dizziness, weakness, headache, hoarseness, hot "flashes", rapid heart beat, extreme fatigue. Symptoms still present as of 11/14/2011.
First hour, major headache, fuzzy minded, tired First 24-48 , abdominal cramping with menstrual bleeding, body aches, fever, chills, super sleepy, & nausea
PHARMACIST THAT WAS ADMINISTERING IMMUNIZATIONS AT SITE WENT TO MEMORY CARE UNIT WHERE EVERYONE WAS SEATED AT TABLES . PHARMACIST ASKED AIDE IN ROOM TO IDENTIFY PATIENT AND AIDE POINTED TO PATIENT. PHARMACIST ADMINISTERED TO INCORRECT RESIDENT
Initially I had a headache, congestion and a fever of around 100.0. A week ago I developed a cough and I was staying home from work but it got to the point where I was not able to complete an online call so I called the doctor. I tested on September 02, 2022 and it was a faint positive. I have been testing myself every 3 days since and just tested negative on 09/17/2022. I talked to the doctor on September 13th or 14th and they recommended that I take benzonatate, SUDAFED, an albuterol sulfate inhalation aerosol and a cough medicine with codeine to take at night. It is helping because I can talk more but I still have the cough. I have congestion, cough and tiredness. No additional tested was requested by the doctor.
within 24 hours of the GARDASIL injection, she had paralysis of her left arm and the left side of her face; within 24 hours of the GARDASIL injection, she had paralysis of her left arm and the left side of her face; they were unable to determine the cause of the paralysis but thought it may be related to allergies/it was discovered that the daughter had multiple food allergies; she still has some tingling in her hands; This spontaneous report has been received from a Nurse Practitioner (N.P.) (also reported as HCP) via company representative, and refers to her daughter, a female patient of unspecified age. Her pertinent medical history, concurrent conditions, past drug reactions or allergies and concomitant medications were unknown by the reporter.  In approximately 2011 (reported as approximately 11 years ago), when patient was in college, she was administered the first dose in the series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (strength, dosage, vaccination scheme frequency, route of administration, anatomical site of application, lot number and expiration date were unknown by the reporter) as prophylaxis. Then, whitin twenty-four (24) hours of the vaccine, she had paralysis of her left arm (monoplegia) and the left side of her face (facial paralysis).   On an unspecified date, the patient was hospitalized due to the events and treated at hospital for four to five (4-5) weeks, after the hospital discharged, she had months of physical therapy. It was reported that she had made almost a full recovery, but she still had some tingling in her hands (paraesthesia). Additionally, it was discovered that the patient had multiple food allergies (food allergy).  It was unknown by the reporter if any lab diagnostics or studies were performed. Also, it was stated that the reporter had another daughter who received the complete quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) series without any issues.  The outcome of the monoplegia and facial paralysis events was assessed as recovering, for the paraesthesia event it was assessed as not recovered, and regarding the food allergy event it was unknown. The action taken with the suspect vaccine was withdrawn since due to the monoplegia and facial paralysis events the series was not completed, for the rest of the events it was assessed as not applicable.  The causality assessment between the monoplegia and facial paralysis events with the suspect vaccine was unknown since it was stated that it was unable to determine the cause of the paralysis but thought it may be related to allergies, further explained as multiple food allergies; regarding the rest of the events information was not provided.  Upon internal review, monoplegia and facial paralysis events were determined to be medically significant.
No medical action. Symptoms are  red rash, sore arm after a week, diarrhea and sore throat.
Itching, rash, pain, unable to lay on my arm without having intermittent pain.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:26, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M011665) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1702USA000237:  US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000505:
DIZZY, LIGHT HEADED, NAUSEA, VOMITING, TINGLING AND WEAKNESS IN EXTREMITIES, DRY MOUTH AND TONGUE, CHILLS, CHANGES IN SPEECH, HEAVINESS IN CHEST {FELT LIKE MY HEART WAS GOING TO JUMP OUT OF MY BODY}, HIGH BLOOD PRESSURE, FELT LIKE I WAS GOING TO HAVE A STROKE OR HEART ATTACK.
Patient c/o tongue feeling numb and tingling after vaccination. No throat constriction or shortness of breath. Speech clear, no difficulty swallowing. Denied rash or itching. Given Fexofenidine 60 mg by mouth. Advised to go to ER for evaluation but patient refused. Vital Signs stable . O2 sat 98% and 99 %.Patient had vaccination at 2:37 pm. Reaction was reported at 2:55 pm.Patient left clinic at 3:28 pm
Patient reported swelling, rash and pain around injection site that remained for 4 days. causing inability to move arm comfortably
rash 1x1 size near injection site; burning near injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (rash 1x1 size near injection site) and INJECTION SITE PAIN (burning near injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (rash 1x1 size near injection site) and INJECTION SITE PAIN (burning near injection site). At the time of the report, INJECTION SITE RASH (rash 1x1 size near injection site) and INJECTION SITE PAIN (burning near injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Pt presented to Urgent Care following administration of second Moderna vaccine. Pt reported chest pressure, headache, dizziness, and swollen lip sensation; had similar but milder reaction following first vaccine. Patient immediately triaged; T 98.6, P 106, BP 160/87, R 26, O2 99%. Pt immediately received EKG and Doctor diagnosed anaphylaxis and EMS called. EKG unusual. Pt received 0.3mg epinephrine and 50mg Benadryl IM. Pt transported to  hospital via EMS. ER follow-up appointment made.
Fatigue, muscle and joint aches, cold chills, mild nausea, headache, injection site soreness involving arm and shoulder
Information has been received from a nurse practitioner concerning a 55 year old female, who on 31-OCT-2007 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine (Lot# 655592/1175F). Subsequently, the patient developed injection site swelling and redness. The patient contacted the nurse practitioner. The patient was treated with warm soaks to the affected site. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a other health professional refers to patients of unknown age. On unknown dates the patients were vaccinated with VAQTA for prophylaxis. On unknown dates the patients experienced incorrect product storage. No adverse event was reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to VAQTA. The reporter considered no adverse event to be not related to VAQTA. Additional information has been requested. Sender's Comments: US-009507513-1708USA008108: US-009507513-1708USA008109.
Extreme rash and itching on both upper arms, as well as, upper torso sides and upper and lower torso area.  Treating it with benadryl for 3 days now and still have a bad rash and itching.
Headaches; Redness, swelling, and heat in the injection area; Redness, swelling, and heat in the injection area; Redness, swelling, and heat in the injection area; This spontaneous case was received on 15-Oct-2021 from other non-health professional via Agency (reference number: SEQW21-03982) and concerned a 72-year-old female patient.  The patient's concurrent condition included hypertension.   The patient's concomitant medications included lisinopril, Montelukast (montelukast sodium), Cetirizine (cetirizine hydrochloride) and simvastatin, all for unknown indication. The patient's historical vaccine included unspecified Covid-19 vaccine after which no adverse event was reported.  On 12-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical: deltoid) for influenza prophylaxis. The batch number was not reported.  On the same day, the patient experiened redness, swelling, and heat in the injection area. The size of the reaction was about the area of the palm of her hand.  On 14-Oct-2021, the patient she had headaches, but have not experienced today (15-Oct-2021).  The outcome of the events was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 72-year-old female patient experienced warmth, erythema and swelling on vaccination site along with headache on the same date after receiving Fluad Quadrivalent vaccine. The patient's historical vaccine included unspecified Covid-19 vaccine after which no adverse event was reported. Based on plausible temporal relationship and information provided, causality for the events is assessed as possibly related.; Sender's Comments: A 72-year-old female patient experienced warmth, erythema and swelling on vaccination site along with headache on the same date after receiving Fluad Quadrivalent vaccine. The patient's historical vaccine included unspecified Covid-19 vaccine after which no adverse event was reported. Based on plausible temporal relationship and information provided, causality for the events is assessed as possibly related.