chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129904, 2014SA129919, 2014SA129922, 2014SA129926, 2014SA129941, 2014SA129950, 2014SA129951, 2014SA129956, 2014SA129960 and 2014SA129963. A female patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose in series and site of vaccination was not reported) on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were unknown. On 16 September 2014, one day after vaccination, the patient experienced headache, chills and nausea. Corrective treatment and laboratory details were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow-up information was received on 12-Nov-2014 from the healthcare professional. A 63-years-old patient had also experienced fatigue after vaccination on an unspecified date. The patient had not received any other vaccine within 4 week prior to influenza vaccine. The patient had received ZOLOFT, lisinopril, metoprolol and HCTZ concomitantly. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies and birth defects were unknown. It was reported that 2 to 3 days later the patient was recovered.
Pt said she started to feel light headed an dizzy. She was givens snacks and was laying down on the cot for around 10minutes. She said she was better and wanted to go home, she was instructed to call 911 if she had a change in condition.
This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent booster), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Thinks that the pharmacist only gave her 0.25 ml) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent booster), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Thinks that the pharmacist only gave her 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent booster), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Thinks that the pharmacist only gave her 0.25 ml) 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 assessments were provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent booster) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Thinks that the pharmacist only gave her 0.25 ml).    No concomitant medication were reported.  Patient asked if dosage of the Moderna booster with the bivalent vaccine is half an ml. She thinks that the pharmacist only gave her 0.25 ml. She stated that she spoke with an infectious disease physician, who told to get the other 0.25 ml right away.  No treatment information was provided by the reporter.   Reporter did not allow further contact
At 48 hrs - 8 cm are of redness warmth and induration at injection site. Cold pack, BENADRYL.
NONE. GAVE EXPIRED VACCINE AND THE MANUFACTURER SAID FOR THE LOT#FL2757 " For doses administered between Oct. 1 and Oct. 19, with manufacturer data to support the stability and efficacy, revaccination is not indicated, and patient notification is not required."
presents with itching and urticarial rash all over his torso arms and legs.  He received a second Covid vaccine 3 days ago.  He denies any other exposures to new foods or other medications.  He did start having some eyelid swelling as well as some shortness of breath while going upstairs and therefore came to the ER for evaluation.  Patient denies any tongue or lip swelling.  He has no wheezing.  He states that the shortness of breath is improved without any intervention or treatment.  Patient does have Covid exposures on a regular basis as he is respiratory therapist and takes care of Covid patients.  No symptoms of cough or fevers.  No vomiting or diarrhea.
Periodic chills and tiredness. I had the shot at 12:33 PM and slept the entire day and didn?t wake up until 9:30AM the next day
Swelling around eyes and throat starting to swell - about 50mg liquid Benadryl was given and monitored for 20-30 minutes. Pt stated she started feeling nauseous and having a  hard time breathing so 0.3mg epipen was given in right thigh and called EMS. EMS showed up and evaluated the patient, her blood pressure, heart rate, and breathing was all normal. Patient refused to go to the ER to be monitored and preferred to go home.
The vaccination site became red, hard to the touch, warm and inflamed on 1/4/20 (similar to a bad sting). On 1/5/20, the left arm could not be moved without being in pain. On 1/6/20 there was slight eye swelling on the left eye that persisted until 1/7/20, but did subside. The vaccination site is still red, hard, and warm on 1/7/20, but the pain has subsided.
No adverse event; patient received Monovalent instead Bivalent in the month of January; Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received Monovalent instead Bivalent in the month of January), EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (patient received Monovalent instead Bivalent in the month of January) and EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received Monovalent instead Bivalent in the month of January), EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (patient received Monovalent instead Bivalent in the month of January) and EXPIRED PRODUCT ADMINISTERED (Patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.).    No concomitant medications were reported.  It was reported that, the patient received Monovalent instead Bivalent in the month of January and believes that it was from Lot 049L21A which expired 09-Sep-2022.   No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2023-709143 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-709143:Master case -Female
Approximately 45 minutes after injection mild onset of anaphylaxis response. Numb tongue, tingly lips, mild throat constriction but no issues swallowing or breathing. About 60 minutes post-injection, the patient self-administered two 25 mg tablets of Benadryl. Symptoms subsided 120 minutes later.
9/15 Slight discomfort at injections site, chills, headache, body aches. Lasted 24 hours. 9/17 Developed first cold sore ever. 9/20 Developed white, painful sores on tongue, gums, oral mucosa inside of cheeks, chills, bleeding, red sore gums. Resolved completely on 10/6/2018.
Patient received the Moderna Booster and was not 18+. After waiting 15 minutes post administration, patient did not report any signs of difficulty breathing, anaphalayxis, allergic, or other unintended outcome. Patient left with her parent/guardian.
PATIENT'S MOTHER REFERS THAT AFTER VACCINATION THE WENT BACK HOME AND THE CHILD BEGAN EXPERIENCING EDEMA AND ITCH IN THE ARM THAT RECEIVED THE VACCINES. DR. SAW HER AND WROTE A PRESCRIPTION.
Initial unsolicited report received from a Pharmacist on 14 July 2016. This case involves a 40-year-old female patient who was vaccinated with a intramuscular dose of ADACEL (batch number U5318AA, expiration date 28 April 2018, dose was not reported) in right deltoid on 08 July 2016. The patient had no illness at time of vaccination, Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On 10 July 2016, two days following vaccination, patient experienced a quarter size, red area at injection site on right deltoid. On 11 July 2016, three days following vaccination, patient had red area increased and was red from elbow up to around injection site, was sore, stiff, and had fever. On an unspecified date, following vaccination patient was diagnosed with "Staph". Patient did see physician. Patient required emergency room or doctor visit. Lab data was not reported. The patient received corrective treatment with antibiotic. The patient was not recovered from red area of arm and soreness. Outcome of other events was not reported. Upon internal review the case was considered as serious because of important medical event: staph, red area increased and was now red from elbow up to and around injection site, was sore, stiff, quarter size, red area at injection site\red area increased and was now red from elbow up to and around injection site, was sore, stiff, fever. List of documents held by sender: none.; Sender's Comments: Patient had staphylococcal infection, stiffness, fever, localized pain and erythema following DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Time to onset is compatible, detail history regarding the aseptic technique, medical history, allergic history, past vaccination history and its tolerance are needed to further assess the case. Based on the available information role of vaccine cannot be ruled out.
3/24/21 ER: 77 y.o. female who presents with suprapubic abdominal discomfort.  Patient reports a 2 day history of increasing cramping and pressure in the suprapubic area.  Patient reports she felt this way when she had urinary tract infections.  However, patient denies any current urinary frequency, dysuria, hematuria, or urgency.  Patient does report some minor dribbling which she states is common for her.  Patient denies any fevers but does report an occasional chill.  Patient does report pain across her low back.  Patient denies any nausea, vomiting, constipation, diarrhea, melena, hematochezia.  Patient does have an extensive abdominal surgical history including colon resection, cholecystectomy, appendectomy, and hysterectomy
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Medical history, concurrent conditions and concomitant medical were not provided. On an unspecified date in 2015, the patient was vaccinated with the first dose of GARDASIL 9, injection, intramuscularly. (Dose, lot number and expiration date were not reported). In February 2016, the patient received her second dose of GARDASIL 9, injection, intramuscularly. (Dose, lot number and expiration date were nor reported). On 06-OCT-2016 the patient was vaccinated with the third dose of GARDASIL 9, injection, intramuscularly. (Dose, lot number and expiration date were nor reported). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
SHORTNESS OF BREATH SOMETIMES WITHOUT ACTIVITY; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no problem with the lungs or heart. T he patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAY-2021, the subject experienced shortness of breath sometimes without activity. On 17-MAY-2021, Laboratory data included: Chest X-ray (NR: not provided) Negative.  Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 96% to 98%. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from shortness of breath sometimes without activity. This report was non-serious.
lethary and altered mental status 2.5 weeks after COVID vaccine. Found to be septic (hypotension, hypothermia, suspected infection). Admitted to ICU. Required 15L vapotherm for respiratory support and several fluid boluses for blood pressure. Urine culture resulted positive for a bacterial infection. Started on antibiotics and improved. Concern for vaccine adverse event is low.
Seizure, lasted about 1 minute, generalized tonic clonic. 11/30/09 Medical records receoved for DOS 11/09.   PMD office notes. IFnal DX: Seizure Patient w/known seizure disorder seized s/p H1N1 vaccine at nurse's desk. Eye rolling, arm flexing/twitching. x1min. Sleepy post ictal. Last seizure 9/09.  refer to ER if not back to baseline w/in 30 min.  D/C to home.
Bell's Palsy; Quivering, shaking; This is a spontaneous report from a non-contactable other health care professional (NURSE) received via a Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bell's palsy, quivering and shaking on an unspecified date. Caller, a registered Nurse wanted to know more information about the vaccine, if there was a fact sheet or website to check. Caller was also asking about the ingredients because she was allergic to sulfur chloride and Benzalkonium Chlorides (which she experienced a heart attack). Caller was an immunocompromised patient. Caller was asking for the information if she and her patients should take the vaccine or not. Caller said from what I have heard, I am very much against this vaccine. I had a friend who had a neurological reaction. Quivering, shaking, Bell's Palsy. These people are not getting these reactions back to their doctors and it was not something that they were allowing other people to know about. I really need to know what was in this drug for myself and whether or not I participate in giving it to others. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event Bell's palsy and the suspect drug bnt162b2 cannot be excluded.  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.
Red, swollen deltoid muscle swelling radiated down to elbow area. Warm to touch, tender (left deltoid).
acid reflux; arms hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "physical therapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single.), for COVID-19 immunization, reaction(s): "injection site including itching"; Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "slight arm pain"; Flu shot (Dose number unknown, Manufacturer unknown.), for Immunisation, reaction(s): "injection site including itching", "slight arm pain"; Pneumonia shot (Dose number unknown, Manufacturer unknown.), for Immunisation, reaction(s): "injection site including itching", "slight arm pain". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arms hurt"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "acid reflux".  Additional information: Caller is a consumer that was calling about side effects and lack thereof with the Pfizer Covid-19 Bivalent Booster. For the first time in her life, she had no side effects. She called her doctor, and her doctor told her that it was normal and that some people do not get side effects. She is just concerned about the efficacy of the product. Caller has acid reflux. No email to provide. Caller declined to complete a report at this time and requested to be transferred to (Withheld) to have her questions addressed. Warm transfer to (Withheld). Caller declined report. Report was filed with the information provided by the caller. Caller provided the number to (Withheld) prior to transfer, (Withheld) option 3.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Meningococcal recombinant( trumenba) given at 11 yr old visit inadvertently
First vaccine received 3/27/21  Patient started to have irregular vaginal bleeding 4/22/21  Second vaccine received 4/24/21  Patient continued to have unscheduled irregular bleeding  Recently followed up this month, reports bleeding resolved but did not recall exactly when bleeding stopped.
Swelling, hardening at sites of injections lasting 6 days. Today swelling appears to be gone, no signs/sxs of infection.
c/o numbness & tingling in lt arm as soon as Td inject given; pt got Td about 3PM sometime that noc; pt had muscle aching in back, neck & head; severe h/a exp in temporal area & jaws; low grade fever, chills; took APAP, DPH & Advil
Rash: "circle 3 inches slightly raised."; Pain: "hurts a bit"; Itchiness. "it itchess"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Rash: "circle 3 inches slightly raised."), VACCINATION SITE PAIN (Pain: "hurts a bit") and VACCINATION SITE PRURITUS (Itchiness. "it itchess") in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Rash: "circle 3 inches slightly raised."), VACCINATION SITE PAIN (Pain: "hurts a bit") and VACCINATION SITE PRURITUS (Itchiness. "it itchess"). At the time of the report, VACCINATION SITE URTICARIA (Rash: "circle 3 inches slightly raised."), VACCINATION SITE PAIN (Pain: "hurts a bit") and VACCINATION SITE PRURITUS (Itchiness. "it itchess") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
In addition to extreme soreness in both arms (common) within the first 24 hours, I began experiencing symptoms of Covid on the 5th day following vaccination: chills, severe headache, body ache, chest congestion. After experiencing symptoms for 24 hours, took a Covid home test which was positive. Symptoms have continued for 3 days. Went to physician's office on 2nd day.  Advice was to continue with OTC meds (Mucinex, Tylenol, Ibuprofen), though prescription was written for Paxlovid in case symptoms worsen. Still have symptoms, but do not appear to be worsening at this time.
PT recd series of 3 Engerix-B vaxs (20mcg) on 4MAY90, 1JUN90, & 6NOV90 & was a non-responder;
I am a retired pharmacist, am very pro-vaccine and have had lots of various vaccines recommended for USA and for travel. After my 2nd dose of pfizer I had a horrible reaction that lasted 3 days and I thought you might need to know. It started with crazy extreme cold in both my hands and feet. I was unable to warm them up. In about 1/2hour, I was overwhelmed with extreme fatigue, dizziness, headache, nausea and diarrhea. I was so overwhelmed with exhaustion that I could barely walk to bed by 7pm. Symptoms lasted for a full 3 days. I have never ever felt that bad in my life and to have that reaction to just a vaccine has me very puzzled and I think something has to be wrong. Maybe it's a bad lot? Either that or I am at the extreme edge of the bell shaped curve! Yikes!! Thanks.
Currently pregnant; Sore arm; This is a spontaneous report from contactable consumer. A 32-Year-old female pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0176, Expiration: 01Jan1900) via an unspecified route of administration, administered in Arm Left (in the upper left arm) on 27Apr2021 as DOSE 1, SINGLE (age at vaccination was 32 years old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is currently pregnant and last menstrual period was on 06Jan2021 and is due on 17Oct2021. 27Apr2021 ( Post-vaccination), patient only had a sore arm.  Patient is to receive the second dose of the Pfizer COVID-19 vaccine next week. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.