chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Severe itching), ERYTHEMA (red mark appeared in the wound area, redness mostly in his upper body, the trunk and his scalp) and SLEEP DEFICIT (Impossible to sleep) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20a) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history.). On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PRURITUS (Severe itching), ERYTHEMA (red mark appeared in the wound area, redness mostly in his upper body, the trunk and his scalp) and SLEEP DEFICIT (Impossible to sleep). At the time of the report, PRURITUS (Severe itching), ERYTHEMA (red mark appeared in the wound area, redness mostly in his upper body, the trunk and his scalp) and SLEEP DEFICIT (Impossible to sleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment: Benadryl (diphenhydramine HCL). Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient's address added.
Fever on evening of vaccine (TMAX 100.7), Headache (6/10 pain scale) beginning on evening of vaccine and continuing to clinic visit date 12/11/21, body aches. Nausea on day of vaccine only.
pt hx of kidney transplant, previous moderna vac (1/24/2021 and 2/24/2021). kidney transplant doc informed patient to get JJ shot due to titers. Pharmacist verified the janssen auth to get the shot. Office said yes.  the JJ shot was administered at 3:00 pm.  Due to not EUA, reporting.
Patient c/o Cough, Headache, Fatigue Body aches x 2 days
Information was received from a claims examiner regarding a female who was placed on therapy with ZOSTAVAX. On 24-SEP-2012, the patient experienced an allergic reaction due to this vaccine. The outcome of the event was not reported. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M041770, expiry date 26-JUN-2018, lot # M040270 expiry date 29-APR-2018, lot# M038724,  expiry date 24-APR-2018, lot# M032643, expiry date 04-MAR-2018, M007298, expiry date 19-NOV-2017, M025568, 07-NOV-2017) for prophylaxis since 15-MAR-2017. No adverse events were reported. Temperature of 47 degree Fahrenheit to 77 degree Fahrenheit and time frame was 6.5 hours. There was no previous temperature excursion. It was stated that it was because of data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
Diarrhea, loss of appetite, sore legs, fever, vomiting - Pedilayte.
10/1/14 That night "felt funny". Next day 10/2/14 - (L) upper arm swollen/no redness, no fever. Arm cont. to hurt mildly during day - worse at night.
Lightheadedness, cannot stand on feet, dizziness (happened at home) after vaccination. Went to ER, detained for 3-4 hours. Back to hospital and detained for 4 days.
NeuroPsych symptoms- anxiety, OCD, anger, heightened sensory- started about 1 week after first shot and continued to worsen.  Worsened after second shot.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Nausea-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT STARTED FEELING NAUSEATED AFTER SHOT  BECAME PALE ,STUNBLED HAD DIFFICULTY BREATHING AND  HE LAID DOWN X 30 MINUTES . AFTER WE CALLED 911 HE SAID HE DIDNT NEED IT BECAUSE  HE HAS A REACTION AFTER EVERY IMMUNIZATION
Within approximately 5 min of receiving Flu shot the recipient felt drowsy and warm on face. Recipient had makeup on so didn't notice rash or skin color changes, nor swelling. At 5:30PM while driving to her home she noticed eyes and face swelling, burning in face and chest pressure.
patient was inadvertently given second dose in series at 15 days vs 21 days. no adverse reaction was recorded and upon contacting Pfizer a redosing is not considered necessary.
Information has been received from a certified medical assistant concerning a male pt over the age of 60 who on an unspecified date was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The medical assistant reported that the pt developed a "sever local reaction" within hours of receiving the pneumococcal 23v polysaccharide vaccine; and described the reaction as localized, not systemic, red, swollen and warm to touch. The pt had to be treated with Keflex. It was reported that the pt recovered within a couple of days. The assistant also stated, that this reaction has occurred over the past year intermittently, but no lot numbers could be obtained for the other rxns. Unspecified medical attention was sought. Additional information has been requested.
Dizziness; Hallucinations; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 11:45 as unknown, single for COVID-19 immunization. Medical history included other medical history: asthma, known allergie: shell fish, thyroid, COVID prior vaccination: Yes, known allergie: bee stings, and known allergie: codine. Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D), and fluticasone propionate (FLONASE). Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced hallucinations on 30Apr2021, and dizziness on 30Apr2021 15:30. No treatment was received for the events. The outcome of the event hallucinations was recovered on 30Apr2021 and for dizziness was recovered on 01May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Roughly a few minutes after the vaccine patient started feeling dizzy, she was given water and orange juice
My injection site has become swollen (2cm diameter) itchy, warm, and red. This is above the dermis and just occurred today.
Pain, swelling, and rash at injection site. Severe headache, fever, muscle aches, and joint pain. Symptoms lasted 3 days.
a 10 years old patient was given expired vaccine; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 10 years old male patient received a expired dose of RABIES (HDC) VACCINE [IMOVAX RABIES] lot N1B901M and expiration date: 18-Mar-2019 via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  Adverse event not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Tired  after first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired  after first dose) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Malaria in 1970. Concurrent medical conditions included High cholesterol.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (Tired  after first dose). On 13-Feb-2021, FATIGUE (Tired  after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.    This case was linked to MOD-2021-412766 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported.  This case was reported by the patient's husband. The healthcare professional stated that the patient experienced little bit of sore arm lasting a day or two days after the dose of SHINGRIX. The healthcare professional did not want to provide details about the patient (reporter's wife). This case is one of the four linked cases, reported by the same reporter.
This patient telephoned the office in mid afternoon complaining of face and chest redness and shortness of breath. She stated the sickness began approximately an hour after receiving her vaccine. She was instructed to report to the closest ER. She was treated and released from the hospital for an allergic reaction.
Had TIA within 15 minutes. Had 13 TIAs over next 45 days. Changed dose of Xarelto.
Mid-grade fever, headache, muscle soreness, body aches - all starting 18 hours after injection and lasting 24 hours Delayed/unusually heavy menstrual cycle
I had severe nasal congestion, throat drainage, achy and tender glands. I also was coughing and was congested with sneezing.
Patient given Moderna COVID19 shot in left arm and was seated after administration for a 15 minute observation period. 2 minutes after being seated, patient fell out of seat and lost consciousness until pharmacy staff came to rescue. Patient promptly regained consciousness and said that he does not remember falling out of chair and that he feels okay aside from some sweating, anxiety, and lightheadedness, which he attributed to being dehydrated. Patient was not given epinephrine because he promptly regained consciousness and was able to have a conversation with us. 991 was called and paramedics came.
Onset of lightheadedness, vertigo, nystagmus, and struggling to walk straight ~12 hr after vaccine.   Took Claritin every 4 hr, Antivert every 8 hr, and ibuprofen 800 mg every 8 hr to reduce side effects. Required almost full 24 hr of lying down to prevent falls and nausea.
ALLERGIC REACTION, INIT  3/9/2023 &  2/12/2023 -- RECURRENCE OF SAME SYMPTOMS
Pt has redness, swelling, and pain at injection site. Dx of cellulitis. Tx with ibuprofen and KEFLEX x 7 days, starting today. Per pt. sx started 9/6.
Early cellulitis left thigh area were immunizations received x 1 day redness to area.
The patient's arm was swollen and red especially on the underside of his arm (injection was on top side) from his whole shoulder to elbow. No pain. Lasted 3 days then went away. He didn't take anything for. He gets flu shot every year and this is his first reaction.
5-26-07 Tdap administered in ED. Later that day arm sore. 5-27-07 nausea, vomiting, chills, fatigue, headache 5-28-07 same symptoms. 5-29-07 fatigue headache only - feels a little better.
The patient called me at 9:09AM on 9/14/2023 and told me about a rash that showed up on 9/13/2023 on her left arm below the injection site.  The rash is not raised; it is not hives, according to patient.  The rash is warm to the touch.  Also, her arm still hurts at the injection site.
Positive COVID-19 test result 09/27/2021, 09/28/2021 and 09/29/2021.
Pt seen on 11OCT93 for well baby exam; PE was nl; no hx of recent illness; was circumcized 2 wks ago; recvd 1st Hep B approx 1030-11AM; taken home 1245-1PM limp, apnic & cyanotic;
An hour after after receiving the injection, the patient experienced numbness and tingling in his arm that later spread to his face.
Information has been received from a practical nurse concerning a 14 year old female with pertinent medical history and drug reactions/allergies reported as none, who on 20-FEB-2008 was vaccinated with the first dose of GARDASIL vaccine (yeast) (lot # 658556/1060U). Following the first dose of GARDASIL vaccine (yeast), the patient experienced difficulty breathing. The second dose of GARDASIL vaccine (yeast), (lot # 660391/0063X), 0.5 ml, IM was given on 03-JUN-2008. The patient also experienced difficulty breathing following this vaccination. These episodes reportedly lasted for less than 5 minutes shortly after receiving each dose. The patient was seen at the physicians office and recovered on the same date of the vaccinations.
Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A, 012A21A, 077C21B and 058A22-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA. Past adverse reactions to the above products included No adverse event with INFLUENZA. Concurrent medical conditions included Kidney failure. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) from 18-Jan-2023 to an unknown date, LISINOPRIL (VEROXIL [LISINOPRIL]), L-THYROXIN [LEVOTHYROXINE], COLESTIPOL HCL, ATORVASTATIN, ALLOPURINOL (ADCO ALLOPURINOL) and LIOTHYRONINE SODIUM (LIOTHYRONINE SOD.) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient reported back in September 2023 my wife and I traveled in September and when we came back we were diagnosed with Covid-19. On January 19, 2023 the patient got into bed and the room started spinning. The patient got so dizzy that he could not stand to get up. In the morning the patient took his blood pressure. The patient relaxed and self monitored his blood pressure throughout the day of January 20, 2023. On January 21, 2023 the patient blood pressure returned normal. No treatment medication information was reported.   This case was linked to MOD-2023-706791 (Patient Link).
6hr p/vax pt devel an allergic rxn characterized by gen hives & swelling of the lower lip, eyes & rt hand;pt was seen by MD & tx w/DPH & medrol dosepak;
Patient received both shots in the left arm, approximately 1 inch apart.  After about 2 minutes of sitting, patient briefly passed out for about 30 seconds before regaining consciousness.  He became very pale and heated.  He remained seated for 10 minutes, drank some water, and felt better.  Was able to leave on his own and was driven home by mother who had accompanied him.
dry mouth, fatigue (died 2/14/2021) Narrative: Patient received COVID-19 vaccine on 2/5/21. Contacted nurse triage line 2/12/21 with complaints of dry mouth and fatigue that he felt were related to COVID vaccine. Self treated with tic tacs, cough drops, biotene, mouth wash and salt water. Patient NPO (G-tube). Patient encouraged to increase free water to increase hydration. Utilize oral saline spray and stay rested. Patient died 2/14/2021 at home of unknown causes. Multiple co-morbidities as noted in history.
Information has been received from a pharmacist referring to an unspecified patient of unknown age and gender. On 15-JAN-2016 the patient was inadvertently vaccinated with ZOSTAVAX (lot # J014851, expiration date 24-OCT-2014, strength, dose and route were unknown) which was expired on 24-OCT-2014 (Expired product administered). No adverse effects were reported. Additional information is not expected because there was no consent to contact physician.
03/04/2021 03/25/2021 BOOSTER 10/08/2021 DX COVID 01/10/2022
Mild blotchy raised redness over right upper arm, started 1 week after vaccination. Area was itchy.  Resolved in 2 days with loratadine and topical hydrocortisone cream.
Patient was agreeable to Moderna; parental consent was given; patient is 17 years old and Moderna is specifically for individuals 18 yo and older There were no complications nor post-injection reactions; patient reported only a sore arm the following day and went to the beach to enjoy himself. No adverse reaction thereafter. Vaccine was administered
redness; Swelling/knot; itching at site; general joint pain; Dose Number : 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Dec2021 15:45 (Lot number: 331308A) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 04May2021, when the patient was 59 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 15Apr2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 15:45, outcome "unknown", described as "Dose Number : 3"; ERYTHEMA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "redness"; SWELLING (non-serious) with onset 15Dec2021, outcome "not recovered", described as "Swelling/knot"; PRURITUS (non-serious) with onset 15Dec2021, outcome "not recovered", described as "itching at site"; ARTHRALGIA (non-serious) with onset 15Dec2021, outcome "not recovered", described as "general joint pain". Therapeutic measures were not taken as a result of erythema, swelling, pruritus, arthralgia.   Additional Information: Patient dose not have covid prior vaccination. Patient was not tested covid positive post vaccination.
Confusion; Falling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 19Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pituitary gland removal" (unspecified if ongoing), notes: Caller states that she had this procedure done 25 years ago. Concomitant medication(s) included: HYDROCORTISONE. Vaccination history included: BNT162b2 (Dose: 1, she had no issues with the first dose of the vaccine., Lot Number: EM9810, Anatomical Location: right arm), administration date: 11Feb2021, when the patient was 76-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 2, Lot Number: EN6199, Anatomical Location: right arm), administration date: 05Mar2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "confusion", "falling"; BNT162b2 (Dose: 3/First booster , hospitalized twice and spent a day in the Emergency Room, Lot Number: 3203080, Anatomical Location: right arm), administration date: 20Oct2021, when the patient was 76-year-old, for COVID-19 Immunization, reaction(s): "confusion", "falling". The following information was reported: CONFUSIONAL STATE (hospitalization) with onset Jul2022, outcome "unknown", described as "Confusion"; FALL (hospitalization) with onset Jul2022, outcome "unknown", described as "Falling". The patient was hospitalized for confusional state, fall (start date: Jul2022, hospitalization duration: 4 day(s)). The event "confusion" required emergency room visit. Clinical course: Caller states that she was instructed to, and did, increase her dose of Hydrocortisone each time she received a dose of the vaccine. Caller states that she is calling about the Pfizer Product: Pfizer COVID Vaccine. States that she had no issues with the first dose of the vaccine. She had problems after the second dose and both booster doses. Caller states that after the second dose of the vaccine and the two boosters; the following day after all three them she experienced confusion and falling. After her second booster dose on 19Jul2022, the caller states that she was hospitalized for 4 days. Caller states that she takes Hydrocortisone because she has no pituitary gland. States that her pituitary gland was removed 25 years ago, and she has been taking Hydrocortisone ever since then. Caller states that she was instructed to, and did, increase her dose of Hydrocortisone each time she received a dose of the vaccine. Investigations: Caller denies any labs, testing, or treatments relevant to these events. None Vaccines Administered on Same Date of the Pfizer Suspect.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201049977 same patient/drug/event, different dose;