chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The mother of the patient called to let the us know that her daughter's left leg above her knee started hurting once she got home shortly after getting her shots.  The patient was not having any chest pain, was not having any shortness of breath and was not having any difficulty breathing at the time of my call.  The patient's pediatrician is Dr.  I advised the mother of the patient to consult with the pediatrician.  I advised the mother to take the patient to the ER if new s&s develop and to also call the pediatrician.
On 9-12-22, patient inquired at the pharmacy due to symptoms from her vaccinations on 9-9-22.  She reported having low grade fever that began on 9-10-22 and was off an on since.  Her arm was red, inflamed and around 2-3 inches circle.  It was warm to touch and remained the same size.  I instructed her to contact her prescriber.  It was determined it was cellulitis and she was prescribed an antibiotic 9-13-22.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 29-SEP-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N017698, expiration date: 09-JUN-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
4/13/16 has a 6x8 annular local reaction at the injection site of the left deltoid. There is evident erythema, edema and warmth at the site. Pt. to take BENADRYL and ranitidine therapy as prescribed.
On 10/14/2022 HPV vaccine was administered inadvertently to this client (child) 1 yr and 11 month old.  On 10/17/2022 spoke with childs father he states his daughter is doing well, playing well, No Red, No swelling to injection site and No fever has occurred.
got Covid but caught it on day 1 since he was testing every day; got Covid but caught it on day 1 since he was testing every day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Old and over weight" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022 at 01:00, outcome "recovered" (14Jun2022) and all described as "got Covid but caught it on day 1 since he was testing every day". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: was testing every day; (10Jun2022) Positive, notes: got Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19 (treatment of Paxlovid from 10Jun2022 to 15Jun2022).  Clinical course: No known allergies. No other medication in 2weeks. The patient reported he just wanted to say Paxlovid was a miracle drug. His wife was so sick she did not have the energy to speak. She tested Negative so the Doctor said she did not have Covid, but he made her test again and she did indeed have Covid. Thankfully we heard about Paxlovid and 4 days after taking Paxlovid she went from to weak to move to doing light work around the house. He also got Covid but caught it on day 1 since he was testing every day. He also took Paxlovid and had no symptoms during the whole time. He was now on Day 7 and still no symptoms. He just wanted to thank Pfizer for this wonder drug. His neighbor was on day 20 of Covid and still having problems. Another fiend was on day 15 and still having problems. They did not know about Paxlovid. But thanks to Pfizer's medicine by wife who was severely sick recovered in 4 days and he never showed any symptoms despite being old and severely over weight. Pfizer's drug worked for them, and they thank Pfizer from the bottom of our hearts.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After I had my first dose vaccine I experienced swelling to my arm. Two days afterwards, I was involved in a MVA. I blacked out completely and had loss of consciousness. I do not know if the vaccine is related to me have had loss of consciousness at the time of my motor vehicle accident. I was in the hospital from 01-11-2021 to 01-12-2021.
Patient had injection site redness, felt warm, and patient mentioned mild pain and itchiness. Suggested patient use ibuprofen/tylenol and ice the area to help decrease the swelling. Also suggested use of benadryl tabs and/or cream
Patient was asked to wait 15 minutes in lobby. After ~5 minutes the person who was with him came and said he was having a reaction. When I reached the lobby the patient was lying supine in the floor with his feet on a chair. He had pallor in his face in arms, was diaphoretic, but alert to person and place. Upon questioning patient he said he had not eaten this morning. EMS arrived at 1059.
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patient post temperature excursion; Moderna COVID-19 vaccine administered to patient post temperature excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) 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 (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion).    This case contains information for the 54th of 104 patients described by the reporter.  Concomitant product use was not provided by the reporter.  It was reported there was a temperature excursion between 26-May-2022 to 30-Sep-2022 and lot AR5186C was affected between 08-Sep-2022 to 27-Sep-2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported to CDPH, VAERS, CAIR and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master case
Still being paralyzed; Guillian Barre syndrome; Losing all muscle strength; Dizziness; Severe numbness all over; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 51-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number JC9EM, expiry date 30th June 2020) for prophylaxis.   On 24th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). On 1st October 2019, 7 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), generalized muscle weakness (serious criteria hospitalization), dizziness (serious criteria hospitalization), numbness (serious criteria hospitalization) and paralysis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome, generalized muscle weakness, dizziness, numbness and paralysis were not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome, generalized muscle weakness, dizziness, numbness and paralysis to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2019-2020 Season and was ultimately being diagnosed with Guillian-Barre syndrome. Two weeks ago from the day of reporting, the patient was admitted into hospital where he spent 5 days and reports being administered IVIG to counteract reaction. The patient was losing all muscle strength and experiencing dizziness and sever numbness all over. The patient was still being paralyzed although he was currently home. The reporter consented to follow up. The patient was enquiring whether how to submit request for medical bill payments and mentions there was no way the VA hospital will cover current hospital bills.
The patient received her Pfizer 1st dose Covid 19 Vaccine (Lot # ER 8731) at 0930 on 14 APR 21. PT had a previous anaphylactic reaction to Morphine and was identified to be monitored for 30 minutes.  At 0957, the PT alerted the staff that her throat was dry. At 0958, began monitoring the patient. VS:     BP 131/87     HR 83     SpO2 100%     RR 24 Rapid Assessment:     -Pt alert and oriented. GCS 15. Distressed and diaphoretic. Complaints of throat dryness and sounded raspy. No complaint of throat swelling or tingling. No urticaria or erythema. Given water.  At 1007, after the patient's condition did not improve, 911 was called.
A interpreter is used for this intake. Client reports she is scheduled for second Pfizer vaccine tomorrow.  She reports nausea and vomiting for several days after her first vaccine.  She reports fatigue and has experienced heart palpitations since her first vaccine twenty days ago.  A MD call was made by the house supervisor and client was advised to have her fatigue and heart evaluated by a provider before moving forward with a second vaccine.  Two providers were provided to the patient.  Patient plans to travel back to her home by the end of the month and wishes to move forward with the second vaccine.  She was advised to see a provider first, but she wishes to have the second vaccine tomorrow and take the risk of having worsening symptoms.  Patient will return tomorrow with her uncle who is her driver and is staying at his home.  Patient advised to eat a full meal and drink plenty of fluids before her appointment.  She was also advised that she will need to stay in observation for 30 minutes.
Narrative:  75 y/o male with PMH of T2DM, COPD, HTN, bilateral lower extremity DVT (in 01/2020), OSA (on CPAP), and gout presented the ED on 08/16/2021 for a 2 week history of worsening SOB, cough (with clear sputum), and weakness. In the ED, he met SIRS criteria with a temperature of 103.5 and a HR of 105. CXR demonstrated a left basilar airspace consolidation, so patient was given 1 L of NS and was ordered empiric vancomycin (not administered) and cefepime as part of the sepsis protocol. COVID test in the ED was positive (he is 2/2 for vaccinations), so pt was admitted for treatment/evaluation of presumptive COVID pneumonia with possible concurrent bacterial pneumonia (08/17/2021 procalcitonin 0.940). While admitted, patient always remained on room air. On 08/16/2021, he would transiently become hypoxic during conversation but this did not persist after treatment was initiated (i.e. after treatment initiation, SpO2 was usually steady in the low-to-mid 90s%). For COVID pneumonia, patient received remdesivir and dexamethasone from 08/16/2021 - 08/18/2021. For possible concurrent bacterial pneumonia, empiric antibiotics from the ED were switched to ceftriaxone and azithromycin; ceftriaxone was changed to cefdinir on 08/17/2021. On 08/18/2021, patient was determined to be stable for discharge with no outpatient steroids or supplemental oxygen after a 6-minute walk test. He will complete 5 total days of antibiotic therapy (cefdinir and azithromycin) on 08/20/2021.
12/23/20 - SEVERE stomach cramps, chills, low grade temperature, mild headache 12/24/20 - Fatigue
inadvertently received 2 doses of Fluzone high dose QIV instead of a dose of FLUZONE HIGH DOSE QIV and an RSV vaccination (with no reported adverse event); Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received via physician.  This case involves a 76-year-old female patient who had inadvertently received 2 doses of influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent] instead of a dose of fluzone high dose QIV and an RSV vaccination (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 29-Aug-2023, the patient received 0.7 ml dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form: unknown) (lot: UT8043AA, expiry date: 01-Jun-2024) via intramuscular route in the left and right deltoid for immunization and patient inadvertently received 2 doses of fluzone high dose qiv instead of a dose of fluzone high dose QIV and an RSV vaccination (with no reported adverse event) (incorrect dose administered) (latency: same day)  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-MAY-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Continual muscle weakness, pain at injection site, redness, swelling, firmness, bruising.
slight lightheadedness; she felt "pressure" in her head which resolved shortly after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "slight lightheadedness"; HEAD DISCOMFORT (non-serious), outcome "recovered", described as "she felt "pressure" in her head which resolved shortly after".  Additional Information: Consumer (57 y/o male) states he received his first Pfizer Covid vaccine on 07APr2021. He has a history of obesity, hypertension, asthma, and bronchitis. Consumer states his 87 y/o mother received her second dose on 07April2021. She experienced slight lightheadedness, but not dizziness, she felt "pressure" in her head which resolved shortly after.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness and swelling with some pain to the touch at injection site. Size about the size of two quarters.
Patient received a dose of expired Fluzone Quadrivalent, no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse practitioner via Medical Information (Reference number- 00405238) and transmitted to Sanofi on 23-Dec-2020.  This case involves a 41 years old male patient who was administered with a 0.5 ml standard dose of expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number UT6656KA and expiry date 30-Jun-2020) once via unknown route in an unknown administration site for prophylactic vaccination on 23rd December 2020 (Expired product administered).  Medical history, past medical treatment(s), vaccination(s), and family history were not provided. No other vaccine was administered concomitantly.  This was an actual medication error due to expired vaccine used [latency was same day].  No laboratory data reported.  At the time of reporting, no adverse event was reported.  Reporter asked for appropriate follow-up after expired dose of Fluzone Quadrivalent was administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Potential PTC (product technical complaint)- No
Patient was seen by a doctor on 12/14/17 for a reaction to Pne23 shot. Patient had swelling from shoulder to elbow. Warm to touch along with some redness and muscle soreness. Patient didn't have fever, rash SOB, trouble swallowing.
The only thing I have in the arm is that it hurts a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary series immunization, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The only thing I have in the arm is that it hurts a little bit".  Additional information: Reporter stated, I just had a question. Yesterday I just took the last booster, think number 0524 (Consumer was unsure) at the and live in (Withheld) and a little while ago got bitten by a wasp and was going to put some Benadryl but wasn't sure if should mix Benadryl with my shot and do not know, can you advise me. When paraphrased the concern, reporter stated, No I had booster (Clarified as Pfizer COVID-19 Vaccine) yesterday and today a little while ago about 15 minutes ago a bee or wasp bit me on my back. So my question was can take Benadryl. You know how they say, take Benadryl when a bee bite you. Am I able to take Benadryl or I am going to upset the shot, whatever it is. When again paraphrased the concern, reporter stated, No because got bit my wasp or a bee I am not sure but it just bit me really quick like the bees do in my back. What wanted to do and want to take Benadryl because usually they say when you have a bite and had several bite before, take Benadryl but I didn't want to mix Benadryl with my shot from yesterday and don't know how long the liquid or whatever it is, the shot has. Reporter do not know how long that's going to be in the arm. The only thing had in the arm is that it hurts a little bit, just a little bit but I can handle that. Reporter stated, That's the number I called and they gave me you, The number you gave me is the one I called and I am taking to you. Reporter stated, don't have a computer that's why I am calling you on this phone. What number you want me to call but cannot call tomorrow and had to know today because just got bit today and I do not want to mix it up whatever the shot booster I had yesterday, because received it at noon and now it's just a little bit noon, it's 24 hours. All want to know is can I take this Benadryl.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax 2APR96 & 22NOV96 pt to MD w/approx 4 dried lesions on abd & approx 4 to 6 lesions;