chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; 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 patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    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 Department of Public Health, VAERS, Immunization Registry 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 contains information for the 31st of 104 adult patients described by the reporter.   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
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 03-SEP-2014, the patient was vaccinated with dose of ZOSTAVAX (LOT# unknown, expiry date unknown) that were exposed to a supported temperature excursion. Concomitant medication was not reported. There was no product quality complaint. No adverse experience has been observed. Outcome of the event was unknown. This case linked to other cases 1409USA002126 and 1409USA002419 (Same reporter link). Additional information is not expected.
At approximately 1340  Co-lead RN was notified that a medical consult was requested.  On assessment, Client communicated that after receiving her 2nd dose Pfizer COVID vaccine 4/30/2021, she experienced lip swelling and difficulty swallowing.  Client reports that she was observed for approximately 45 minutes at the vaccination center and then released from observation. Client  states she went home and took a benadryl and felt fine.  Client  reports that she did not have a reaction following her 1st dose of Pfizer COVID Vaccine.  Client did not follow up with her primary care physician following the 2nd dose reaction. Client  denies any underlying medications and not currently taking any medication.  Client does report an allergy to penicillin, codeine, and cinnamon air fresheners.  Client reports rash and difficulty breathing with these allergies.  At 1410 Co-lead RN elevated medical consult to Vaccination Operations team for review.  At  1601,  Co-lead RN received response from Doctor approving Pfizer Booster dose and observation for 30 minutes.  Client  was notified of the approval and at 1613 Client  was administered Pfizer Booster COVID Vaccine ( Lot # FF8841, exp 12/30).  Client was observed for 30 minutes and no adverse reactions nor symptoms were noted.  Client  educated on adverse reactions and when to seek care.  At 1645 Client  completed observation without complaints and left vaccination center with steady gait.
sudden onset hour and a half prior to arrival chills, nausea, shortness of breath, sharp stabbing global chest pain with cough only nonproductive, tachycardia 120 bpm, subjective fever chills after having received moderna vaccine 3 days ago.  Tachycardic to 120, active chest pain CTA negative
Pt with acholic stools noted approximately 10 days after vaccines administered at 2 month well check. Liver function tests normal, abd u/s normal. Discussed with ped GI, Dr, who states no further eval necessary. No palpable hepatosplenomegaly; no emesis; normal exam.
Report a side effect; Body is hurting; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a side effect) and MYALGIA (Body is hurting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report a side effect) and MYALGIA (Body is hurting). At the time of the report, VACCINATION COMPLICATION (Report a side effect) and MYALGIA (Body is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.   The reporter submitted AE via text.
This initial spontaneous report was received from a physician via a company field representative referring to a male patient in his 60's. Medical history, concurrent conditions and concomitant medications were unknown by the reporter. On unspecified Wednesday, the patient received PNEUMOVAX 23 (dose, route and lot # not provided). The patient developed Guillain-Barre syndrome five days later (also reported as "about two weeks ago" on 18-SEP-2017). The patient was hospitalized and passed away within the week after receiving unspecified treatment. The cause of death was Guillain-Barre syndrome. Causality assessment was not provided. The field representative found out that there may be legal action taken. Upon internal review, Guillain-Barre syndrome was considered medically significant. The physician felt Guillain-Barre syndrome was life-threatening. Additional information will not be requested as the reporter did not provide consent to be contacted. Reported Cause(s) of Death: Guillain-Barre syndrome.
Pt reports within 24 hr's after receiving vaccine they developed 5cm diameter circular, pruritic macular exanthem at injection site. No fever, no previous reaction to flu vaccines, no cold or fever symptoms 2 wks prior to receiving vaccine, No allergy to eggs. Pt was given 10 days antibiotic (Keflex) for cellulitis.
This spontaneous report as received from a registered Nurse via Company representative refers to a 2 year old patient. On an unknown date, the patient was vaccinated with PNEUMOVAX23 route reported as "injection" and dose of 0.5 mL, reported as "standard dose", (lot and indication were not reported). On an unknown date the patient had a "horrible reaction" which is believed to be "cellulitis". On unknown date, the patient sought medical attention and was hospitalized for 3 days and then discharged. Therapy with PNEUMOVAX23 was continued. The outcome of had a "horrible reaction" which is believed to be "cellulitis" was unknown. Additional information has been requested.
TOOK VIVOTIF WITH FOOD; This spontaneous case (PVX2019-1298) was received from a consumer on 22-May-2019. It describes an 18-year-old female consumer who "took Vivotif with food". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif with food on 19-May-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif with food" was considered as not applicable.
The following wednesday after receiving my covid vaccination I was getting in the shower when i noticed small red raised bumps all over my body. They were most prominent on my midsection, arms and upper thighs. Though the bumps were alarming most of y itching is in paces I don't see the rash such as my hands and feet. However, some of the bumps do itch as well. I've been treating at home with 24 hour claritin, and anit-itch creams. These remedies supress the intensity of the itch, however I am always somewhat itchy. Having had these symptoms for almost a week now the itch is beginning to lift somewhat, but not completely.
On 12/24/20, I received my first COVID vaccine.  Immediately after receiving my vaccine, I felt dizzy and had a rapid heart rate.  After 15 minutes I felt better and brushed it off as being nervous/anxious.  I then received the 2nd vaccine on 1/14/21 while I was at work.  I walked to the vaccine administering site and received my vaccine.  Immediately after receiving the vaccine again I had a rapid heart rate, felt dizzy and then felt some tightness in my throat.  I stayed at the site for 15 minutes and during that time I asked for some water and told them how I was feeling.   After having some water, I felt a little better and they released me to return to work.  When I arrived to my unit to work, my throat felt tight and my voice was raspy.  I called pharmacy and they sent me a Benadryl tablet which I took.  After about 45 minutes the raspy voice had disappeared.  The only other symptoms I had with both vaccines was a sore area and body aches.  After to 2nd vaccine though I continued to have pain in my arm with movement and there was restriction in my rotator cuff.  After no relief from NSAIDS and PT, I received a steroid injection on August 2nd from my orthopedic physician.  The next day I was not feeling well and finally went to the ER due to the symptoms of lethargy, dizziness, vomiting and decreased LOC.  I was admitted to the hospital/ICU on August 4th with DKA and then diagnosis of Type 1 Diabetes.  Never have I had any abnormal labs, symptoms or no familial history of diabetes on either side of my parents family.  Then in November 2021 to present my liver enzymes have been very elevated with no etiology.  Never have I had any problems with my hepatic labs or any labs for that matter until after receiving the COVID 19 vaccine.   I am not a drinker, smoker, abuse recreational drugs.  I eat healthy, exercise and I am not overweight.  I did not receive the booster due to my allergic reaction from the first to vaccine and this also was recommended by my PCP
Allergic reaction to the Moderna COVID-19 vaccine, High severity - angioedema reaction. Reported by primary care.
Patient received Moderna dose #2 and was instructed to wait 15 minutes in waiting area. Patient felt light headed and was on his way to tell pharmacist when he fell and hit his head to the ground. He had a bleed on his right eyebrow area. Called 911 and paramedics came and took patient to the hospital.
pt recvd vax in 1984 & exp a high fever-106 & convuls;hospitalized pt is no 11yrs old no further szs;however, has an ADD;MD f/u pt hosp for febrile sz 22FEB95; no vax prior to episode
Patient received Kinrix (Dtap/IPV) instead of Tdap, according to age requirements
Lightheadedness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) and NAUSEA (Nausea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 01320A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced DIZZINESS (Lightheadedness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Lightheadedness) and NAUSEA (Nausea) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.
Mild rash on right forearm in the evening 1/23/21.  Mild dizziness, naseau, headache on 1/24 starting at 11am.  Itching at injection site, hard lump under skin, and red welt about the size of a half dollar.
Day 8 arm became increasingly sore Started itching and turned red Day 9 red circle tripled in size
This health authority case was initially received on 16-Dec-2015. The case report was received from a(n) Health Professional and concerns a(n) 61 years old female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced sore muscle (non serious, outcome: unknown). For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Linked case: 2016059680 (same patient).
Child was fine on P.E, 4 yrs, received KINRIX (Dapt and IPV) and PROQUAD (MMR/Varicella) 24 hours before the swelling and redness occurred. There were no CNS, respiratory distress. Infant child was playing well in office. BENADRYL 1 tsp TID for swelling.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown demography. Patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, lot#, expiry date, date of administration was not provided). No information on concomitant medications was provided. The nurse practitioner reported that a patient "waited too long" between the first and second dose of RECOMBIVAX HB. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
LIGHTHEADED Narrative: The patient reported feeling light headed, diaphoresis immediately after the second shot for COVID-19 Vaccine. He looked pale. His first Vs: HR: 45, BP: 114/63, RR: 20; after 15mins, rechecked Vs: HR: 65, BP: 106/66; RR: 18, The last check Vs: HR: 60, BP: 106/68, RR16 in 15 mins. The nurse lift his legs on a chair and put the ice bag under his neck.The patient reported getting better. The vaccinator got the patient sitting up, let him drink a bottle of apple juice, Sent him home.
Patient fainted 5 minutes after vaccination. Patient said she felt a little dizziness. She rested and we monitored her for 1 hour and patient said she felt better afterward. We instructed her boyfriend to take her home, and not allowing her to drive.
arm swelling and large nodule at injection site. Swelling still present 2+ months after injection when patient presented in June 2022. She could not lift her arm above her head by early June. I had her take ibuprofen q8H for 4-5 days and swelling did reduce but nodule is still present as well as arm pain.
Headache for 48 hrs within 30 minutes after injection, arm very painful, fever on and off for two weeks, body aches and pains, very low energy, infected throat which led to self check in due to inability to eat/ swallow.
Initial and follow up information has been received from a physician concerning a 4 year old male who on 16-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot#657559/0462U), instead of Varivax (Oka/Merck) (MSD), in the thigh or the arm.  Physician confirmed this was staff error and not quality complaint.  Unspecified medical attention was sought.  There was no adverse event.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
Was notified by the assisted living home he was living in on 7/7/2022 that patient was found unresponsive that morning and rushed to the emergency department. Administrator states that after pt vaccine tuesday that the patient began throwing up on the next day Wednesday. During the vomit process patient had fallen going to the trash can. He states pt denied injury at this time. Pt was currently taking blood thinners during this time. He states that family refused emergency services after this fall. The next morning on 07/07/2022 staff went into his room and found him unresponsive. Administrator states the pt would not respond to sternal rub and ems was called at this time. No further information of patient status at this time.
sore, stiff neck, severe, couldn't raise head off pillow;took ASA x 2 BID for 1 1/2wk;buttocks & upper legs ached-cont;neck began to improve 21NOV;no improved but still cannot fully turn head
102 fever, diarrhea, weak.  Took 1 Advil 4 hrs apart, drank liquids, rested. By 9:00 PM feaver back to normal, diarrhea continued till 01/19/2010.
Patient said she was "extremely tired, no energy, headache, my body feels like I have been working  out for weeks, hot and hold spells, and I know this sounds crazy but lips numb. "
On 1/28/2010:  Child, 3yrs old, was given incorrect H1N1 vaccine.  He was given his 2nd H1N1 dose as Novartis on his left deltoid.  Novartis  H1N1 is only used to vaccinate children aged 4yr old and above.  Child screamed and cried at time vaccine was administered and was cranky rest of the day.  Soon after vaccine was administered by nurse,  nurse informed patient's mother of mistake.  Patient experienced on 1/29/2010, approximately 8pm:  Runny nose, episodes of crying and unable to calm down, bruise on arm where shot was administered, diarrhea.  Diarrhea stopped 1/30/2010 Runny nose -still persists Crying and unable to calm down - lasted about an hour on 1/29/2010, continues to have episodes everyday.  Visited patient's physician today.  Physician is doing research to find out what to do about overdose to child.
8/27/08 mother called via phone and said childs LUA is very red and swollen from shoulder to elbow. Did not voice any other s/s. Instructed mother to use warm packs, Tylenol. Instructed mother to take child to see doctor and bring her by our office to complete VAERS form. Mother has been lost to follow up since. Has not returned phone calls or letters.
Dizziness, tingling and itchy skin, swelling and tingling of lips and tongue, slight throat swelling. Treated at home with 50 mg Benadryl  every 6 hours, Pepcid, and Predinsonl (steroid pack).
Pain, redness, and swelling at the injection site Flu like symptoms, arthralgias (specifically back pain) and myalgias, night sweats about 12 hours after vaccination. Treated with conservative care (ice pack, Celebrex, rest)
14 hours after receiving the booster, fever, chills, extreme fatigue, muscle aches and fainting.  Shingles developed on left forearm on 01/04/2022
Rash began on 01/05/2005 c/o itching and rash spreading. Child was exposed to varicella about 2 weeks ago.
Left Arm Pain Approx 5 hrs post vaccination lasting 48 hrs. Headache, shoulder, neck and back muscle aches developing overnight. Fatigue next day (approx 18 through 36 hrs post vaccination), ongoing muscle aches, low body temperature accompanied with chills (96.7-97.7°F) 30-36 hrs post vaccination.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-SEP-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml/five dose vial, lot # K007773 and expiration date 01-MAY-2015 (administration route was not provided). No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 1 Fahrenheit (F) (1 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
On 6/10/09 grandmother presented to Health Unit and reported that health care professional  went to pediatrician today & was sent to E.R. for "high fever, swelling of both legs and passing clear liquid out of her rectum." On 6/12/09, spoke with mother, mother states "she's fine". Clear liquid from rectum was just diarrhea.
Evening after pt received vaccines, he woke up with arm pain, cough and burping/hiccups. Pt took aspirin and returned to bed without problems. The next day pt was at coffee shop felt dizzy and lost consciousness. He woke up surrounded by pan medicine. Pt saw his PCP the next day.
Shortness of breath Chest Pain Headache Fatigue  Hives (face/legs) Severe Neck Pain Nausea  Night Sweats Anxiety
Information has been received from a nurse referring to unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. The nurse reported that on unknown dates improperly stored (temperature excursion) ZOSTAVAX (lot # K021953, expiration 10-FEB-2016) (dosage, strength, and route were not reported) had been adminsitered to unspecified patients. Number of doses administered was unspecified. At the time of the report, no adverse effects reported. This is one of several reports that received from the same source. Additional information has been requested.
shingles; scabbed over; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (shingles) and SCAB (scabbed over) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 HERPES ZOSTER (shingles) and SCAB (scabbed over). At the time of the report, HERPES ZOSTER (shingles) and SCAB (scabbed over) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Left arm with large area of redness, warmth and swelling from injection site to above elbow.