chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions.  Additionally, as of 19-Nov-2021, no adverse reactions to the vaccine reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: In additional information included suspect administration date were updated On 19-Nov-2021: Follow-up information included about patients details On 19-Nov-2021: Correct information about the dose administration received. On 22-Nov-2021: Follow up received with no new information
Mother reported that pt broke out in hives on back and arms. Advised to go to primary care doctor or ER.
Cellulitis, given antibiotics, 4 1/2 diameter erythema and induration.
This spontaneous report was received from a 60 year old female patient, who was also a registered nurse and was reporting on herself. The patient did not have any pertinent medical history, drug reactions or allergies and did not take any concomitant medications. On 04-JUN-2017, the patient was vaccinated with ZOSTAVAX injection, 19400 plaque-forming units(PFU), subcutaneously (dose, lot # and expiration date were not reported). The ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown). On 06-JUN-2017, the patient developed a rash at the injection site, which worsened. The rash looked like shingles, and did not feel good. On the same date, the patient also experienced flu symptoms, congestion and little body aches. The patient sought medical attention by calling a physician's office on 07-JUN-2017. No treatment was given for the adverse events and no laboratory diagnostic studies were performed. The outcome of the adverse events was reported as not recovered. The relatedness between the adverse events and ZOSTAVAX was not reported. Additional information is not expected as no permission to contact the physician was given.
Presented with SOB x2 days; dx with Covid 9/1 and recovered initially; no hosp required at that time, intiially used Zinc & Vit C at that time.  Has had negatvie test since then; started feeling bad 2 days PTA with SOB and hypoxia again; Covid + ED..unsure if from previous infection or new infection; Admit 9/24 tele with Covid PNA; TX: 9/24 Steroids, Vit C, symbicort, maxipime, singulair, zinc started O2: maintained at 2 LPM during stay, weaned to RA by d/c.
This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-MAR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius)for a total of 144 hours and then at 33 Fahrenheit (F) Degrees (0.555555556 Celsius)for a total of 16 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
After receiving the second shot on 01/20/2021 the shot site has raised and I have a red hot rash that keeps getting bigger.
Information has been received from a physician concerning a female patient who was vaccinated with a first 0.5 ml dose of Gardasil.  Subsequently the patient experienced fainted.  Unspecified medical attention was sought.  On an unspecified date, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Patient came to the pharmacy today on 06/02/2023 stating  he had allergic reactions after receiving the vaccines. Patient states that he started to have swollen arms and itchiness all over his body about 6 hours after receiving the vaccine. He was not able to move his arms or do daily activities for 2 weeks, and pain lasted for month. Patient also states he started to have swollen lips and swollen hard palate on 05/25/2023 (after 23 days of receiving vaccines), which makes him difficult to swallow and eat food.
Chills, fever, body aches, nausea, headache, bruise at injection site.
Vaccine Administered at Inappropriate Site; erythema at injection site; warmth at injection site; induration at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 24-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 2LL97, expiry date 30th June 2020) for prophylaxis.   On 24th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season (intramuscular). In September 2019, less than a week after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site erythema, injection site warmth and injection site induration. On 24th September 2019, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site induration were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site induration to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were reported as follows: Caller was a nurse practitioner in a hospital.  One of the hospital employees received a dose of Fluarix and caller states that the vaccine was not injected into the deltoid muscle.  The vaccine was injected in the left arm below the deltoid, and more in the tricep area, which led to vaccine administered at inappropriate site. The patient had developed erythema and induration at the injection site and the injection site was warm to the touch.  The erythematous area was approximately 9 cm by 7 cm in size. Emergency room visit required. Caller did not provide any additional details.
After a week or so the skin over my left bicep started to itch.  A mild rash appeared that has a number of nodules (maybe 6 or 8) that protrude above the skin.  The itching comes and goes and varies from severe to unnoticeable.  Most of the time it's unnoticeable but maybe once or twice a day it's quite severe.  There's also a light tingling feeling below the skin in the area where the rash is present.  I've never felt a tingling like this either.  It's been at least two weeks and the itching and tingling still come and go but they are not as severe as they had been.  I've never experienced anything like this before.  I looked at pictures of shingles rashes and my rash looks like a very very mild case of what a shingles rash looks like.  My rash is barely noticeable to anyone but myself.  The itching is by far the most unpleasant symptom.  I thought it would be gone after nearly two weeks but it's still here although not as noticeable as it had been when it first started.  If it continues to decline at that current rate I think it should be completely gone in another two weeks.  The itching and tingling are only noticeable over a short period of time (15-30 minutes) several times a day.  I haven't applied anything to the rash.
"Bumps" on face, No itching, fever. Denied hives or respiratory problem.
Patient was in the office yesterday afternoon, 10/11/22, for his COVID booster and Influenza Vaccine. He has tolerated all vaccines well in the past. Nurse noted that he was a little nervous prior to getting the vaccines but the administration of the vaccines was unremarkable. The patient, sister, and dad were sent to the waiting room for 15 minutes. I was in my office and heard commotion and hollering for help in the waiting room. When I arrived, the patient was sitting on the floor with some other helpers around him, and he was crying. He apparently had been sitting near dad when he slumped over to the left and hit the side of his head on the chair next to him. He quickly came to, dad reports that he was out for less than a second, and then started crying and hyperventilating. Patient reported that he felt "really weird" and that it was like he "was in a dream." Several nurses, MAs, and staff members were present and helping with him laying down, applying a cool cloth and fan, and taking vitals. BP initially was 120/90 shortly after the syncopal/near-syncopal episode. Heart rate 88, regular. After resting for 15 minutes and calming down, BP was 98/42. Patient remained in the waiting room with family and was able to leave without further incident after staying for another 15 minutes. He reported feeling fine at that time. Chart note was placed in the Immunization Record from 10/11/22.
Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was reported by reporter.  Crosslinked to MOD21-137073
My Father received the first dose of CV19 on 03/02/21 and the second dose on 03/03/2021 in the morning, and at night he had a stroke, we called 911 they hospitalized him within a week he was out of danger and had physical therapies for a month at facility he got out on the 31st of March 2021 and on April 4th he once again went into the hospital for lack of oxygen, they detected blood clots in his legs and his lungs and also an aneurysm in his heart.
On May 8, 2022 I noticed a rash on my abdomen area. I waited a few day to contact my doctor. I contacted her on May 11th 2022 and had a in person appointment on May 12th, 2022. Dr. prescribe me an ointment I don't recall the name of the ointment. She wasn't sure what kind of rash it was. She may thought is was shingles.
3-4 weeks post vax, the pt experienced arthritic joint pain which started in her ankles and as of 3/28/00 was in all her joints. She also complained of progressive joint stiffness and swelling. She also has felt tired. She presented to the reporting pediatrician on 3/4/00, but upon examination, he did not detect joint swelling, tenderness, warmth, restriction of motion, or overlying erythema. On 3/15/00, the pt consulted a rheumatologist who noted mild left ankle swelling.
Pt came in on 07/31/09 for vaccines. Discussed med hx of seizures. Father stated that his son has seizures with stress or fevers. He stated that last set of vaccines was given with no problem. Client had no immune systems problems or allergies. Gave shots. Child started to cry and then his father stated "it's starting". Child's eyes rolled back, he became pale and stopped breathing for approximately 20 seconds. Father stated that this was normal for his seizures. Used smelling salts with no response. Patted child and called his name with no response. Father stated he was having a seizure. Child gasped and started breathing. Color returned to his face. Child started to cry but appeared weak. Child continued to be tired and whiny. Father stated that this was normal and child would be fine. Child A&OX3. Mother requested cold pack for child's chest. It was provided. Child was also given juice. Parents sat with child in clinic for approximately 10 minutes. Advised parents to watch child for next hour and take him to the emergency room if he did not improve. Client's father stated that he just needed to sleep it off. Called child's parents 08/03/09 and father stated that child was fine. Stated that he took a 5 hour nap on 08/02/09, but has no other problems.
4 vaccines given total. 1 correct 3 incorrect Incorrect vaccines are: HEP A MMR Varicella MMR GSK Lot # 3247X 0.5ml Expires 5/11/2024 Subq Varicella GSK Lot# W039697 0.5ml Expires 12/13/2024 Subq LPN administered the 3 vaccines and reallized error. She immeidalty notifed the physician and practice manager. LPN owned error and stated that she just had given 12 mo shots working with another provider and didnt pay attention. PM and provider spoke with parents while they were still in an exam room, explained the error and provider reassured there wouldnt be any harm. However gave examples of what to look for and how to notify the practice. PM present during conversation and parents were understanding of the error. PM advised LPN to call family today 6/13 to follow up on the baby. GSK Rep will be notified of the error should there be any recommendations from the manufacture. Parents will not be charged for the vaccines. In summary,   LPN was working with a 12 month old pt prior to seeing this pt for a 4 month old well check. LPN pulled 12 month old vaccines without looking at the current pt chart/order and administered 12 month old vaccines to a 4 month old pt. Pt received 3 incorrect vaccines.
Received pneumococcal and flu injections ins (left) arm on 10/26/07, Friday.  Saturday morning - was sore, site was puffy, "swollen red". Body was achy, chills/warm, fever? - temp not taken".  By Sunday was feeling better.  Reaction site measure on Monday at doctor's office as 16.5 cm across by 8 cm downward - about the size of a hand print. On 10/31/07 - Wednesday, having started Keflex treatment on Monday, everything is fine, site reduced to about 2 in circle of a sore, reddened lump.
Patient claims that vaccine was injected into tendon. He says he tried ibuprofen and ice and saw chiropractor. He says function is at 60% at best. Dr. is referring him to an orthopedic surgeon. When I administered the vaccine the needle was in longer than usual because the bevel would not push in, but I finally was able to push it in all the way; he received the full dose. I apologized to him for discomfort of needle being in longer than usual.
The patient stated they were fine for the first 15 minutes after the injection, but as they were getting up to leave I could see her color was not good and I made her continue waiting .  I got out an ice pack and put on the back of her neck and she leaned forward on another chair to try to get the blood to her head.  She started breathing heavier and complaining of her stomach hurting and not feeling well.  She was sweating and crying.  We called 911 and laid her on the floor with a cushion under her head until they arrived.  The patient continued to cry and complain of stomach pain and could not open her eyes.  She also had no strength to stay upright.  Her blood pressure was elevated at 163/100.  The patient was taken by ambulance to the hospital.
Information has been received from a registered nurse concerning her niece, a 17 year old female who about 2 years ago, in approximately 2006 was vaccinated with GARDASIL. It was reported that the patient had had seizure activity and had passed out since vaccination with GARDASIL. The niece had completed the GARDASIL series. The niece had been to the Emergency Room and may had been admitted to the hospital. She have been diagnosed with POTS syndrome (Postural Orthostatic Tachycardia Syndrome) . On unspecified dates, numerous tests including EEG and heart monitoring had been performed (no results reported). The patient had been seen by many doctors. At the time of the report, the patient had not recovered. Upon internal review, seizure activity was considered to be an other important medical event. Additional information has been requested.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660974 with expiration date 20-APR-2021) (strength and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
pt recv vax 17SEP97 & the next day pt exp a site reaction consisting of a 3-4 inch red welt, irritation & itching;
On 10/13/03 the infant received the DTaP and Prevnar vaccines.  On 10/14/03 she had fever that lasted one day. On 10/16/03 the parents noted significant erythema and swelling of the right thigh at the site of the Prevnar injection.  In the office she was noted to be listless and drooling.  She was started on Keflex for a presumed cellulitis.  The next day (10/17) the infant was brought back because she was not moving and could not lift her head up.  The right thigh redness and swelling was improved but she was found to have generalized hypotonia and weakness.  She was sent to the hospital emergency room and admitted to the pediatric intensive care unit for presumed Guillain-Barre syndrome (GBS).  Her lumbar puncture on admission (10/17/03) was normal, as were her CBC, blood, urine and spinal fluid cultures.  She did not develop respiratory failure and therefore was not placed on a ventilator.  Her strength and motor skills improved quickly over the 4 days that she was in the hospital.  One week after discharge (10/27/03) she is nearly back to her baseline function prior to the illness, though she is still slightly weak, most prominently in her neck muscles. Nerve conduction and EMG studies done about 5 days after discharge from the hospital were consistent with GBS.
no adverse event; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (no adverse event) in a 55-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    The   ID was reported as 80777027399.  Person number was reported as 127580.  Patient's age was reported as 55 Year 4 Month.  Concomitant product use was not provided by the reporter.  Completion date was reported as 14-Apr-2022.  The vaccine from the vial with lot number O70H21A was administered to the patient in between a period of 08-Apr-2022 to 15-Dec-2022.  Treatment information was not provided.
The Patient was given .1 ml of Influenza Virus Vaccine intradermally.
Extremely high fever; slight hallucinations  Unable to get out of bed  Severe shaking  Severe pain in muscles and bones, unable to walk Severe migraine
07/10/2022 Around 2:00 PM she became super cranky, her eyes became glassy, her nose started running, she was sneezing and coughing. I tested her with a home COVID test which was positive. Her temperature was 101.5 and we called her transplant team who told us to give her TYLENOL and increase her fluids. 07/11/2022 I called her pediatrician to let them know she had tested positive. They agreed to continue her palliative care, to try a NETTY POT, and continue TYLENOL and fluids. 07/11/2022 She seemed fine. Around 3:00 PM or 4:00 PM she was out of energy. 7/12/2022 She was a little sicker that morning and her fever went up. We gave TYLENOL and she was fine for the rest of the day. 7/13/2022 she seemed fine. Yesterday she seemed a little sicker. Throughout, her nose has been very runny and she has a deep cough.  She has not recovered.
ED visit for PVC - treated and discharged. 1 month later, Patient was brought to ED after intentional overdose on Tylenol, metoprolol, and alcohol between 1900-2000.  Patient was admitted to the ICU.  She remained on telemetry. Patient was hemodynamically stable on day of discharge.  Patient was discharged home under the care of her husband.  ED visits and hospital admission within 6 weeks of receiving the COVID vaccine,
Experienced moderate headache, pain at injection site, chills (chattering teeth), numbness in hands from 6:00pm to 10:30pm day of vaccination. Experienced diarrhea, weakness, and nausea the following day.
The night of 10/09/2003. Left thigh painful, swollen and red, measurment 3.5 x 2 inch.  Advised Benadryl, Tylenol and ice pack.
Pt was given the KINRIX pt's mother informed and was unhappy but had not further questions. Spoke with the pt's PCP and he stated there was no need for concern.
This spontaneous report as received from a Registered Nurse refers to unknown number of patients of unknown age and gender. Since 26-APR-2015, the patients were vaccinated with (Merck) VARIVAX (subcutaneous; dosage, lot# not provided) which had undergone supported temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 7/8/2011,  pt noticed skin patches on right shoulder, under arm. Right sided back area. On 7/15/11, seen physician and diagnosed shingles.
The pt experienced swollen glands, headaches, slight lightheadedness for 10 days.