chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses) and NO ADVERSE EVENT (No adverse event) in an 11-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .15 milliliter. On 16-Aug-2022, the patient experienced UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses) 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 assessment was provided for UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses).    No concomitant medications were reported.  The patient received lower than authorized doses and received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml dose. The reporter stated that they had an issue and they incorrectly drawled up the doses.  No treatment information was provided by the reporter.
Headache, Fever, Chills, heavy feeling in the arm, low grade fever, fatigue, loss of appetite Narrative:
Vial was stored in refrigerator on 28-Feb-2022 and administered on 18-Apr-2022; Patients were administered an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 28-Feb-2022 and administered on 18-Apr-2022) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 28-Feb-2022 and administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 28-Feb-2022 and administered on 18-Apr-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vials did not go with any temperature excursions.  No treatment medication was reported.
Patient had swelling and redness at (L) arm) injection site and couldn't move that arm. She went to the doctor because she thought she had a rotator cuff issue.
Following each vaccine, the pt experienced flu like symptoms, sore arm at injection site for a day or two. Approximately 1-2 months post the 2nd vax, the pt started having right knee pain and right elbow. Shortly after 2nd shot, the pt was bitten by 3 ticks and the bite sites have not healed to this date (1 year later). They remain infected and itch. Most recently the pt has had pain in the right shoulder.
Pt recvd 1st dose of Hep B vax 06DEC89 & devel gastrointestinal cramps,diarrhea,nausea,dizziness & was unable to eat.
Injection site urticaria; Injection site erythema; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE URTICARIA (Injection site urticaria) and VACCINATION SITE ERYTHEMA (Injection site erythema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Injection site urticaria) and VACCINATION SITE ERYTHEMA (Injection site erythema). At the time of the report, VACCINATION SITE URTICARIA (Injection site urticaria) and VACCINATION SITE ERYTHEMA (Injection site erythema) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's medication history  and treatment information were  not provided by the reporter
Severe flu like symptoms; Massive headache; Constant chills; Bouts of intense sweating; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 at 17:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for an unknown indication on an unspecified date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Apr2021 at 17:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 02May2021 at 02:00, the patient experienced severe flu like symptoms like massive headache, constant chills, bouts of intense sweating and diarrhea. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe flu like symptoms, massive headache, constant chills, bouts of intense sweating and diarrhea was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came to HD for MMR with Dad. Patient had slight cough but no fever or other symptoms.  later in AM, patient was transported to Hospital per squad for fever, wheezing, paleness.  Seen in ER and admitted for pneumonia.  In talking to ICP at hospital, child had been sick but dad gave tylenol before coming to health dept. for immunization.  ICP stated that medcial record stated the MMR was incidental.
Fever from 9/23-9/25 Headache 9/23-9/24 Swelling in arm 9/24-9/26 Redness in arm 9/25-9/26
cant eat; This is a spontaneous report from a contactable consumer. A 37-years-old male patient (reporter brother) received bnt162b2 (PFIZER COVID 19, Solution for injection, Lot Number: unknown), 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 reporter called his parents his brother who was not blood related and, in another state, and 37 has similar symptoms-could not eat. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
At approx 2200 on 9/24/07, pt c/o "feeling hot" then chills - body aches for 2 days. On 9/26/07 pt c/o pain when walking - (R) leg pain on 9/27/07 - referred to primary MD on 9/27/07 for f/u.
This case was reported by a physician and described the occurrence of a medication error in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On the morning of 24 September 2008, the subject inadvertently received a 2nd dose of Boostrix. This was considered to be a maladminstration (asymptomatic/ extra dose given). It was also considered to be a medication error as Boostrix is not indicated for use in subjects over the age of 18 years and this subject received two doses of Boostrix in her 30's. The 1st dose was administered approximately one year prior in 2007. No adverse events were reported. The reporter commented that they have given Boostrix to many of their adult patients. No specifics were provided.  Follow-up information received on 24 October 2008 indicated that in October 2008, the subject developed hearing issues. The reporter stated that voices and everything sounds very loud and things are muffled and not clear sounding. The physician checked the subject's ears and reported that they were fine with no sign of infection. At the time of reporting, the outcome of the events was unspecified. 01 December 2008, follow-up information was received from the reporting physician. The subject did not use alcohol or tobacco. The first and second doses of Boostrix were administered intramuscularly. The second dose of Boostrix (0.5mL) was given on 17 September 2007 in the left deltoid. Onset date of the events was reported as "after vaccination?". The outcome of the events was unknown. Relationship to Boostrix was unknown. The physician considered the events could have been associated with erroneous administration: the subject received DTAP twice within one years time.
A report has been received from a physician concerning, subject of unknown gender, who had been receiving nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced expired FLUMIST which started on 13-JAN-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter. Corrected report 12-FEB-2014 case was suppressed.
Case number PHEH2014US003809 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This report refers to a 15 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: 004011A and expiry date: JUN 2014), at dose of 0.5 ml intramuscularly on an unknown date in DEC 2013. No adverse event was reported following this administration error. No additional information was available.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
full blown shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2019, the patient received Shingrix. On 6th January 2020, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as an adult as per vaccine indication. The patient received shingrix and experienced a full blown shingles.
(L) thigh had rash and blistering 5-7 inch area of redness and swelling with hardening and pain at injection site.
Presented self with "H/A".  no blurred vision or difficulty breathing.  Stated she had just a "lil blurred vision".  Also stated had not eaten since breakfast.  Came directly to get vaccine after work.  Husband driving car, advised if HA worsens, pull over and dial 911.  Stated feel better.   she thinks it was just nervousness.  Allowed to leave observation area.
Itchy rash on same arm as injection (in area of injection) presenting 4 days after vaccination.
no additional adverse effect reported; vaccine was administered on 28-OCT-2014 and vaccine expired on 18-OCT-2014; This spontaneous report was received from a nurse referring to a 13-month-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.   On 28-OCT-2014, the patient was vaccinated with a dose of expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: rHA) for prophylaxis (lot # H018948 with expiration date: 18-OCT-2014; strength, route and anatomical location were not reported) (expired product administered). No adverse effect was reported. No product quality complaint (PQC) was involved.   This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA006771:
DIFFICULTY TALKING; TROUBLE BREATHING; SPLITTING HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included cancer.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced difficulty talking, trouble breathing, and splitting headache. The action taken with covid-19 vaccine  was not applicable. The outcome of the splitting headache, difficulty talking and trouble breathing was not reported. This report was non-serious.
18 x 10cm area of redness, induration; warm to touch; itchy; slightly painful - able to walk. Small cluster of vesicles around injection site 10 day course of Cephalexin; Ibuprofen warm compress.
Side effects increased rapidly. Began with a rash on the hand of the arm which received the injection. Rash emerged quickly and began to diminish within an hour. Joint pain came with intensity, from elbow to feet. Then shortness of breath. Was panting trying to breath normally. I would succeed in breathing normally for awhile, then pant again. Nausea led to repeated vomiting overnight. I could not get out of bed to vomit, though I was able to lean over the side of the bed (bucket placed there) and eventually to sit up in bed to vomit. The joint aches began to subside but the nausea lasted for 24 hours. Walking I tripped/stumbled on four occasions the next day. (Am athletic; that was an anomaly.) Speech was affected; I used the wrong words  and found it challenging to find the correct one.  Short term memory is a little odd to date. The physical symptoms subsided within 48 hours.
Information has been received from a health professional concerning a male pt who was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 640577/0995L). Subsequently, the pt experienced severe cellulitis from his shoulder to his elbow. Unspecified medical attention was sought. Follow-up information indicated that within 1 day, post vax, the pt called the office complaining of swelling, redness and heat at the injection site extending down his arm. He was seen in the office and it was reported that he experienced swelling, redness and heat from the injection site to past his elbow. The pt was treated with antibiotics and Medrol. It was reported that the pt did not require hospitalization and he subsequently recovered. It was reported that the pt received his 1st dose of pneumococcal vaccine 23 polyvalent approx. 8-10 years ago. The nurse reported that 2 other pts had similar experiences following exposure to pneumococcal vaccine 23 polyvalent (WAES0201USA00520 and WAES0201USA02827). The reporter expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Upon internal review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested.
This is a  female with history of anemia who presents to the emergency department as a rapid response after feeling fatigued, nauseated and slightly lightheaded after receiving the first dose of the Covid vaccine. Patient is in no acute distress, non-toxic appearing. Vital signs stable, patient afebrile. No focal neuro deficits. Answering all questions appropriately.
Presented with fall and worsening shortness of breath, clinical impression that hypoxia secondary to HFpEF rather than COVID infection.  Patchy infiltrates on Chest CT- Rx with dexamethasone.
The patient is a 68 yo female with a history colitis and GYN CA in remission who experienced a new dermatitis with onset temporally related to receipt of Shingrix #2 (receipt 24 SEP lot # 7AS54). The dermatitis is a macular, papular erythematous, pruritic dermatitis with sites to scalp, arms, back, chest, abdomen. There are no vesicles, pustules, petechiae or oral/mucosal lesions. She reported onset day 8 (verbalizes lesions present earlier, this was when she sought care) and was seen in ER day 9, 11 & 15 and saw PCP day 11 and 19. She has reported systemic symptoms of headache, dizziness and nausea(immediate post receipt) diarrhea with hematochezia (day 2-4), dyspnea, CP, difficulty swallowing and vision blurring (day 11), EKGs, CXRs, and lab work is essentially normal (including troponin T and CRP) or explained by steroid. Treatment has included famotidine, antihistamine, oatmeal baths and 3 courses of steroid (60 mgs x5 days, 20 mgs x3 days and 60 mgs x 7 days). We added cetirizine, labs for inflammatory markers and punch bx (see prior notes). On 28 OCT 2020 she reports dermatitis is mostly gone. She has stopped cetirizine because it was interfering with sleep. Oatmeal baths continue to be helpful. She is otherwise feeling well.
This case was reported by a healthcare professional and described the occurrence of parotid gland swelling in a 58-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy to IVP dye, allergy to thimerosal and LIPITOR allergy. Concurrent medications included Tuberculin PPD. On 27 November 2012 at 13:30 the subject received unspecified dose of FLUARIX (.5 ml, unknown, right arm). On 29 November 2012, 2 days after vaccination with FLUARIX, the subject experienced parotid gland swelling, body pain, headache, stuffed sinuses and sore throat. On 30 November 2012, the subject experienced flashing in r eye, visual acuity decreased, loss of color vision, photosensitivity both eyes, blurred vision r eye, stabbing eye pain, tearing eyes and optic neuritis. The subject received FLUARIX on 27 November 2012 and he experienced body aches, headache, and parotid gland swelling on the morning of 29 November 2012. On 29 November 2012 his "maxillaries were packed and stuffed up" he also had a sore throat that extended to his Eustachian canals. On 30 November 2012 he experienced flashing in his right eye and decreased visual acuity and loss of color vision, with photosensitivity in both eyes. He experienced cloudy vision in the right eye "like looking through a cloud". He reported stabbing pain and tearing in both eyes, got worse on 01 December 2012, he went to the emergency department. He was admitted to the hospital on 01 December 2012 and discharged on 04 December 2012. The subject stated a physician (who was not the ophthalmologist) said he had optic neuritis secondary to the flu vaccination. He did see an ophthalmologist that said he could not diagnose neuritis and told him his retina was intact. The subject stated that all the symptoms continue. He was treated with IV steroid while in the hospital. The subject was hospitalised for 4 days and the healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events of parotid gland swelling, body pain, headache, stuffed sinuses, sore throat, flashing in r eye, visual acuity decreased, loss of color vision, photosensitivity both eyes, blurred vision r eye and optic neuritis were unresolved; the stabbing eye pain and tearing eyes were worse. The healthcare professional considered the events of parotid gland swelling, body pain, headache, stuffed sinuses were probably related to vaccination with FLUARIX. The subject also reported that years ago on an unspecified date the he received unspecified dose of Influenza vaccine unspecified (unknown) and it had Thimerosal in it. He reported he experienced shortness of breath and was told he had an allergy to Thimerosal; he could not remember an additional information about this experience as it was so long ago.
Perceived right side facial numbness directly after vaccination.  No apparent facial weakness/asymmetry.  No signs of anaphylaxis.  spO2 99% on room air, pulse 52 bpm, BP 108/72, resp 12 bpm.  Monitored for extended period, symptoms improved.  Allowed to leave with ER precautions and to call if symptoms persist.
Soon after vaccination had severe pain at vaccine area that began to extend to neck and to right side of body.  Patient called doctor but was not able to reach them; has not heard back from them yet.   Patient took Tylenol for pain and it did help.   Pain at vaccination site still there but not as severe and still having problems on right side of body.  Patient has been trying to rest most to recover.  Also had uncontrollable diarrhea which started night of vaccination.  Patient tried to control what she was eating and drinking to get better; there were a couple of episodes lasting through morning.
First three days after taking the 1st dose: Injection site pain On Day 10: pain in the shoulder joints, itchy patches of skin between my shoulder blades, and a nerve twitch between my shoulder blades  I took Tylenol and Advil.
Reports noticing some redness and swelling to deltoid area of patient's left arm the day after he received the TDAP, 10/12/2022.  Denies any other symptoms when asked.  States there is still a very small amount of redness present today, 10/17/22 at site.
Information has been received from a health professional concerning an 18 year old female with allergy to CECLOR who on 21-MAY-2010 was vaccinated with the first dose of GARDASIL 0.5ml IM into the right deltoid and on 16-JUL-2010 received the second dose of GARDASIL 0.5ml IM into the right deltoid. Concomitant therapy included LOESTRIN. The nurse reported that on approximately 16-JUL-2010, after the administration of her second dose, the patient developed a "tender knot" at the injection site of the right deltoid. The patient contacted the office by phone on 03-AUG-2010 and was suggested to use warm compresses. At the time of this report, the patient's outcome was unknown. Additional information has been requested.
This writer was drawing up 2 doses of Pfizer for this patient and their sibling. For one of these patients, I had to open a new Pfizer vial, but accidentally drew up the whole vial without reconstituting with 1.8 mL of water. As a result, one of the two siblings received a dose that was supposed to be worth 6 doses of the Pfizer vaccine. I contacted the patients' father 15 minutes later, who stated that the patients were doing okay and reported no symptoms. I also reported this incident to a district manager. Per my manager, I informed the patients' father about what happened, asked him to monitor his children for symptoms, and report to the ED if the experience anything severe. I also told them that this dose would not be valid and they would have to return to the pharmacy to have their 1st dose dose again. He understood and accepted this information. Bottom line, there was no actual symptoms reported, but I am concerned about the higher dose either of these kids (12 year-old female & 15 year-old male) may have received and pray they will be okay.