chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Administration error: patient administered with the full vial of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Administration error: patient administered with the full vial of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced ACCIDENTAL OVERDOSE (Administration error: patient administered with the full vial of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Administration error: patient administered with the full vial of bivalent vaccine) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Administration error: patient administered with the full vial of bivalent vaccine).    The reporter was not aware of any concomitant or regular medication for the patient. Patient had received first and second dose of COVID-19 Vaccine on an unknown date. It was reported that no adverse events had been reported until the time of report. Treatment information was not provided.
COVID 19 Treatment / Drug ineffective; COVID 19 Treatment / COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Adenomyosis" (unspecified if ongoing); "bowel obstructions" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nulev, reaction(s): "Known allergies: Nulev". The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment / COVID-19 "; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown", described as "COVID 19 Treatment / Drug ineffective". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Apr2023 to 22Apr2023.  The information on the batch/lot number for (BNT162B2 NOS), has been requested and will be submitted if and when received.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events  drug ineffective and COVID 19 and the suspect drug  cannot be excluded. ,Linked Report(s) : US-PFIZER INC-202300175646 same reporter/patient, different drug/AE;
Patient felt unwell after receiving vaccine. She complained of feeling lightheaded and felt as if she were going to pass out. Patient hyperventilated. Paramedics were called in and patient was transported to Hospital. According to paramedics her blood pressure was fine 142/70. Patient stated she was feeling better but still insisted on being transported to emergency department.
The healthcare worker felt a systemic sensation of warmth and tingling throughout the entire body immediately following injection.  The sensation of warmth remained with onset of weakness and dizziness requiring rest period.  Noticeable rubor- flushed skin on the chest and torso area.  Weakness followed by episode of tachycardia and pulse rate of 120 bpm.  Episode lasted 30 minutes and fully resolved with no residual effects.  No emergency or follow up medical treatment needed.
There was no adverse event. Patient had received a third vaccination. Patient received 2 doses of the Moderna Covid vaccine at our location on 3/10/21 and 4/7/21. Patient received 1 dose of Pfizer from store number 10329. We were contacted to complete a VAERS report for the 3rd dose given. After contacting the patient to confirm their dose with  they let us know that they were not even aware a dose was given nor were they given any documentation/screened by . The then told the patient that the dose he received was not valid and the patient would have to get 2 more doses of a vaccine somewhere since they had covid a week prior to  receiving the Pfizer vaccine. The patient was not screened correctly by , was not given proper documentation by  and was misinformed by the village.
Aside from flu-like symptoms following both vaccine doses lasting 24 hours. Following the second dose I have experienced intermittent/consistent dizziness since February.  Some aural fullness in L ear, significant for 3 day Valentines weekend. The fullness comes and goes. Have not seen a doctor. Saw a PT - negative for BPPV.  Dizziness worse with head movement.
Patient complained of pain in left shoulder following shot. Swelling and redness morning. He put ice and was told to continue treatment with Ibuprofen on 9-8-20. Swelling subsided in 3 days, but pain continued. As of 9-16-20 patient said only limited range of motion in left shoulder pain only when sleeps on left side.
Hives, treated with Benadryl 50mg q 4 hours with xyzal for 3 days after which pt advised to just use non-drowsy antihistamine till reaction ceases.
Info has been received from an LPN via a company representative concerning a male roommate in his "twenties" with a possible history of seasonal allergies and a history of vaccination with a dose of MMRII (lot unknown), whose roommate "went on a trip to another country and developed mumps when he got back home to the US". It was reported that "subsequent to his arrival home, he infected his roommate, who in turn infected a sibling". No additional info was available. There was no product quality complaint involved. The recovery status of the male roommate is unknown. Additional info has been requested.
anaphylaxis; ALOC/decreased level of consciousness; This is a spontaneous report from a contactable Pharmacist (patient). a 40-year-old female patient (no pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140) via intramuscular at Left arm on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history included known allergies to egg, seafood, azithromycin, orange and seasonal allergies. The concomitant was reported as cetirizine hydrochloride (ALLERTEC) and PRN 1371. The patient with no known past medical history brought in by CODE Team to RUH ED with concern for ALOC after getting the COVID vaccination 30-40 minutes PTA. Patient was a nurse and experienced decreased level of consciousness following her COVID vaccination. Patient reports h/o anaphylaxis. She was given epinephrine PTA. Denies SOB, oral swelling, CP. Blood glucose (BGL) within normal limits. Patient denies any other complaints or symptoms at this time. Adverse event start date: 23Dec2020. Treatment was unknown for decreased level of consciousness. The outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis /decreased level of consciousness cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
PATIENT IS HERE TO GET THE SECOND DOSE OF PFIZER. AND EXPERIENCE SIDE EFFECTS INCLUDING: NAUSEA/ PASSING OUT/ SWEATING. ONCE PATIENT STARTS GETTING DIFFICULT BREATHING, WE GAVE HIME ONE DOSE OF EPIPEN 0.3MG AND HE STARTS TALKING AGAIN. 911 WAS CALLED AND HE IS DELIVERED TO HOSPITAL ER.
No adverse event; 8-month-old patient received an expired 2nd primary dose of Moderna Bivalent COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8-month-old patient received an expired 2nd primary dose of Moderna Bivalent COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (8-month-old patient received an expired 2nd primary dose of Moderna Bivalent COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8-month-old patient received an expired 2nd primary dose of Moderna Bivalent COVID-19 vaccine) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (8-month-old patient received an expired 2nd primary dose of Moderna Bivalent COVID-19 vaccine).    It was reported that the patient does not had information about previous COVID-19 vaccination doses. No concomitant medication was reported. No treatment medication was reported.
mom reports unconsolable cry > 12 hrs; also dime sized redness & warmth @ inject site & fever 103; pt receiving APAP & uses comfort measures;
tightness in my chest; coughing; ear ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Oct2021 03:00 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 03:30 AM), administration date: 27Sep2021, when the patient was 38 years old, for Covid-19 Immunization. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 19Oct2021 18:00, outcome "recovering", described as "tightness in my chest"; COUGH (non-serious) with onset 19Oct2021 18:00, outcome "recovering", described as "coughing"; EAR PAIN (non-serious) with onset 19Oct2021 18:00, outcome "recovered"(2021), described as "ear ache". Therapeutic measures were not taken as a result of chest discomfort, cough, ear pain.  The Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced tightness in my chest and if breathing quickly would cause coughing.  Experienced this for about 12 hours during the following day. Also had an earache that started up within 6 hours of getting the vaccine and went away approximately 24 hours after shot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (25Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Reddened; swollen area at injection site on right thigh. Onset was 34 hours prior to office visit on 10/21/05.
Information has been received from a pharmacist referring to a 63 year old female patient with no pertinent medical history or drug allergies/reactions. On 10-DEC-2015 the patient was vaccinated with ZOSTAVAX (lot # L028285, expiration date 28-OCT-2016, 0.65 ml/once, subcutaneous) to prevent shingles. On unknown dates in December 2015 the patient developed itching, redness, soreness and a "hard bump or hard area" at the injection. The patient called in to the pharmacy on 12-DEC-2015 to seek medical attention. No lab diagnostic studies were performed and no treatment was given for the events. The outcome of the events and causality assessment were not reported. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 26-JUL-2016, the patient was vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received Fluzone, Pneumovax and Shingrix on the same day. Fluzone and Pneumovax was given in her left arm and Shingrix was given in her right arm. She ended up going to the emergency room due to severe back pain, fever, muscle aches, headache and elevated WBC. They were able to resolve her WBC and fever and prescribed her migraine medicine. She went to ER on the 11-15-19 and was discharged on 11-17-19.
pain in arm for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain in arm for 3 days) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included ATORVASTATIN, OMEPRAZOLE, FAMOTIDINE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced MYALGIA (pain in arm for 3 days). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, MYALGIA (pain in arm for 3 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068266 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068266:2nd dose of vaccine
Broke out with blisters and pain on left buttock. Intense itching for several weeks. Took Acyclovir 800 mg 1 tab 5 times daily.
The same day of the vax, the pt developed hives. She was treated with antihistamines. The next day she experienced difficulty swallowing and a drop in her diastolic BP to 60. The pt was admitted to the hospital and treated with prednisone and epinephrine. As of 11/27/00 the pt had been discharged from the hospital. Follow-up information received 12/18/00 indicated that the pt was seen in the ER and then hospitalized for 5 days. Follow-up information also included the state and county of the vaccine administration and the correct phone number of the reporter.
72yr old patient was ordered Flu vaccine, 65 yr high dose IM (Trivalent) vaccine. CMA prepared and administered vaccine IM in patient's right deltoid on 11/7. On 11/9, patient contacted office complaining of swollen right arm, redness size of baseball, warm to touch, no fever, no shortness of breath. Symptoms started on 11/8. Patient presented for MD followup on 11/9. MD noted "erythema and swelling right upper arm about 15 x 9 cm in size. area is warm, no streaking". No evidence of systemic allergic reaction. MD recommended ice, OTC hydrocortisone cream, loratadine/ZYRTEC for itching. MD prescribed prednisone 20 mg tablets, take 2 tabs PO daily x 3 days if symptoms worsened. Allergies updated to include Influ.
Rt thigh had pain, swelling, inc warmth, induration on lump w/out abscess. Rash, generalized adenopathy, hives. Onset 30 min /p vax. Duration of rxn 3 days
At 4:15 pm, 10 minutes after receiving hepatitis A vaccine, the child was standing next to her mom for discharge and fell down hitting her head with lost of conciousness for approximately 3 seconds. The child had been very upset, prior to this episode and had not had anything to eat since 10:30 am. She was sent to the ER for evaluation.
A report was received from a health care professional on 10/28/2003 concerning a vaccinee of approximately 65 years of age who experienced overwhelming pain at the injection site immediately after receiving Fluvirin on 10/28/2003. On 10/28/2003 the vaccinee experienced overwhelming pain at the injection site after receiving 0.5ml of Fluvirin. An ice pack was applied and the pain decreased to soreness. The vaccinee had a prior history of influenza vaccination with no adverse events. The vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Up date 1, 03/01/2004: Follow up information received from a health car professional indicated that a 61 year old female vaccinee received Fluvirin on 10/24/2003 and experienced pain at the injection site which lasted approximately 10 minutes. No follow up pending. Cross reference with PJP20030926, PJP200300927, PJP200300928, PJP200300929, PJP200300930.
Swollen lymph nodes, fever, chills, fatigue, stiff neck, arm soreness
Information has been received from a registered nurse concerning a patient with an unknown medical history who was vaccinated with measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. Concomitant therapy on the same day included a dose of poliovirus vaccine inactivated and a dose of diphtheria toxoid + pertussis vaccine + tetanus toxoid. Subsequently, 2 days after the vaccination, the pt developed blotch bruising on hands and legs. The reporter indicated a possibility of child abuse. It was noted that the patient had not recovered at the time of the report. No further information was provided. Unspecified medical attention was sought. Additional information has been requested.
Information has been received from a physician concerning a 15 year old female with penicillin allergy, with no illness at the time of vaccination whose reported weight was 154 pounds and whose reported height was 62.5 inches, who on 20-SEP-2007 was vaccinated into the left arm with the second dose of Gardasil, (Lot # 658556/1060U), and concomitantly was vaccinated into the right arm with influenza virus vaccine (unspecified), (manufacturer "Sanofi"), (Lot # U2444AA). It was reported that the patient had received previously "multiple" doses. In the afternoon (P.M.) of 23-SEP-2007 it was reported that the patient developed severe right-sided abdominal pain requiring hospitalization. It was reported that all laboratory test and abdominal scans were normal. It was reported that all pain resolved in 4-5 days. Subsequently, the patient recovered from severe right-sided abdominal pain reportedly on 29-SEP-2007. Additional information has been requested.
Rash at the site of vaccine injection (left arm), occurred approx. 7 days after vaccine was received. Slightly itchy and a bit swollen.
developed chest pain with numbness radiating down left arm. Paramedics called, patient refused transportation to ED for evaluation. Patient instructed to seek care if symptoms continue or get worse. Patient verbalized understanding of all information.
On 1/29/99, the pt presented with a rash that was described as "covered with lesions." Follow-up information from a registered nurse indicated that the pt was diagnosed with "severe clinical varicella that consisted of greater than 400 pox." Subsequently, the pt recovered.
nausea and vomiting after 5 minutes of vaccine administration. observed x45 minutes with recurrent Nausea and vomiting. Transported to ER
Information has been received from a nurse concerning a female who was vaccinated with a first dose of GARDASIL. The patient called the nurse 4 to 5 weeks ago (approximately December 2008) and reported that she experienced swelling of her wrist and palm of her hands, the sole of her feet were very itchy, and had welt or hives on her hips and one breast. No additional information is available.
Patient reports left arm/shoulder issue after 2nd Pfizer vaccine back on 10/13/21, patient states that he feels technician administered vaccine "too high towards shoulder", and has had pain in shoulder joint when raising arm above his head (if there is something in his hand/weight in his hand), patient saw prescriber for treatment and is doing some exercises to try to strengthen/improve joint function and alleviate pain, reminded patient that they can request vaccine from RPh in future if he prefers, and that technician would be reminded/retrained on administration technique to ensure prevention of similar issues in future
Information has been received from a Licensed Visiting Nurse (LVN) concerning a 16 year old female patient who was vaccinated IM with her first dose of Gardasil. Almost immediately, the patient burst into tears. She commented on how much the vaccination hurt. She repeatedly said she was not dizzy although it took her a long time to get out of the chair. Medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Cardiac arrest, then seizure,  and possible CVA. with progressive weakness. Treated in ICU, on vent. 6 months later patient continues to have limited mobility and speech changes, with left-sided hemiparesis, requiring nursing home level care.
Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 2 aspirin. At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: FU makes case valid. NNI. Event start date updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.