chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administration of an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5E43J, expiry date 30th August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th November 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 4th November 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's Comments: A pharmacist called to ask for information about the administration of an expired dose of Boostrix to the patient.  The reporter asked whether the patient had to be re-vaccinated.  The reporter did not consent to follow-up. Additional Supportive information: The vaccine was already expired and was administered to the patient, which led to expired vaccine used.
Patient reports warmth, redness, & swelling around site of injection and general feeling of being unwell
Edema of right arm. Subsequent chronic pain in forearm/wrist/metacarpals. Paresthesia on dorsal surface of right hand. Muscle atrophy of forearm, Weakness of right arm and grip strength.
Uncontrollable chills that night starting at 3am lasted for about an hour and a half; fever and shortness of breath and tightness in the chest the next day; tightness in the chest on Saturday.  Patient had previously recovered from Covid in August 2020.  First positive test for Covid was at the end of July 2020.  Out of work, sick with Covid for over a month.
I received does 1 and 2 in my upper right arm.  I experienced pain after a few days which emitted from the upper arm, spread to my breast area and I could barely lift my arm.  The pain has continued.  I was hospitalized because the pain spread from my upper arm to the chest area.  The doctors could not fine the source if the continuous pain in my arm.  I received the booster on 12/23/2021 in the left arm and now experiencing the same symptoms.  The pain is so severe I cannot lay on my right or left side for prolonged periods.  The pain radiates in the right arm down to my forearm, right breast and chest area.  The pain radiates in my left arm, shoulder area and breastbone.  Some days I can barely lift my arms to dress myself and perform chores.  Prior to taking the Pfizer Covid Shots and Booster I did not experience this symptoms.  I was prescribed Naproxen, have tried several medicated rubs, over the counter pain meds and nothing helps.  I need help.
Pt broke out with the shingles shortly after receiving the vaccine. Initially it presented as a rash and when I brought him into the physician he was diagnosed with shingles. No treatment was given.
Patient is experiencing worsening arm pain in the arm she received the vaccine. Especially at night making it hard to sleep. Patient said she will be contacting her PCP.
Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PYREXIA (Slight fever). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Slight fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Body temperature: 99-100.4 (High) Slight fever of 99- 100.4 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
I got the second does of the Pfizer. I had a massive headache and chills overnight. I had a fever of 100.1 at 7.10am the next morning. I was leaving my ground floor bathroom and I woke up on my basement floor. I fainted and fell down a flight of stairs. I passed out again, when I tried to get back up the stairs. I crawled back up the stairs and phoned my husband to come home, He did and helped me into the bathroom to wash my teeth. I fainted again and he caught me and carried me back into the sofa. I spent the rest of the day in bed. I am bruised and scraped all over. I am sore all over. I went to Urgent Care on 2/13/21 and got x-rays done.  I have a fracture in my right thumb and may have a dislocated left shoulder. I have to see more doctors tomorrow. I sill don't fell well and I have no appetite. I fell really weak.  I have dizziness when lying down, that may be related to the fall.
Injection site pain, followed by body aches, fever of 100.0, chills, nausea and headache.
Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves child female patient who was vaccinated with an expired dose of [PENTACEL] (batch number, Expiration date: 24-Jun-2018, dose, dose in series, route and site of administration were not reported) on 25-Jun-2018. It was a case of an actual medication error due to expired vaccine used. It was not known whether the patient experienced any adverse events or not. 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 and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none..
This case is 1 of a cluster of 3 patients who experienced similar adverse events following vaccination with DAPTACEL. The event for the first patient was captured in case number 2010-04790 and the second patient was captured in case number 2010-04791. A 5-year-old child (sex not reported) received on 31 August 2010 an injection (route and site not reported) of DAPTACEL, lot number C3473AA. On the 01 September 2010, the patient developed redness from the shoulder to the elbow on the arm that the injection was given. The outcome was not reported. Follow-up information was received on 25 October 2010 from a health care professional. The patient was reported to be male and had no illness at the time of vaccination. His past medical history was reported as "none". He had received a fifth dose intramuscular right deltoid injection of DAPTACEL and a fourth dose intramuscular left deltoid injection of IPOL, lot number LED204 on 31 August 2010. No further information was provided at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: None.
Pt rec'd 3rd DTaP, 3rd IPV,2nd Prevnar 1/13/03 at 2pm. PE WNL at time of visit. Had seizure activity (Nystagmus, lip smacking, tonic posturing) About 10pm that evening. Taken to ER by which time pt was normal.
Primary smallpox vaccination. Maculopapular rash on trunk, and extremities (sparing face, palms and plantar surfaces) erupted 8 days after primary vaccination.  Initially accompanied by fever, malaise, and myalgia.  Rash persisted and fever, body aches resolved within 48 hours of beginning treatment with keflex, benadryl, and naproxen.  Rash progressed to various stages of vesicular, pustular, and crusted pustules.  Some of the rash had appearance of maculopapular erythematous lesions. His lesions on the first day were maculopapular/vesicular.  The lesions that were vesicular evolved to pustular/crusted very quickly - maybe 2 days.  There were very few that were true pustules.  Only one of the lesions looked like a smaller version of the vaccine site. It was on his back and had a central pustule of about 2 mm diameter and a base of erythema that was about 1cm diameter.  I took a photo of it but it didn't turn out well.  Over 2-3 days is crusted and looked like acne.  Now his lesions are very much dissipated to mildly erythematous macular lesions on his dorsal hands.  They look somewhat urticarial.  After the initial day he has had no fever or malaise. He returned to work today (5 Feb 03) and will be flying within 4-5 days.
I started to feel very weak and dizzy.  I had cold chills and my temp usually runs low, 96.8 and I had a fever of 100.2.  Slept right through the night which I don't usually do.  This morning I feel all rung out.
Information has been received from the patient's mother reporting on his 13-year-old son. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 22-MAR-2018, the patient received the second dose of GARDASIL for prophylaxis, lot # 0420AE and expiration date 12-JAN-2014 (strength, dose and route of administration were not reported). On 05-APR-2013 (reported as "about 2 to 3 weeks after vaccination"), the patient developed a wart (skin papilloma) on his left elbow. The patient did not receive treatment for the adverse event or sought medical attention. The outcome of the event skin papilloma as well as its causal relationship with GARDASIL was not reported.
Local urticaria and pruritus near injection site, 2 days after the injection, improving but still present after several hours.
Dizziness, vertigo, loss of balance, nausea, vomiting lasting 5+ days
Patient called next day on 03/10/2010 stating he got a bad headache that began 2 hours after shot was administered.  On 3/10/10 woke up with nausea and dizziness.  Patient advised to seek medical attention at PCP or ED.
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. On unknown dates these patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route and lot# were not reported). No adverse effects were reported. This is one of several cases reported by the same reporter. Additional information is not expected because the reporter would not like to be contacted.
No pain at injection site nor abnormal symptoms that day (Friday) Next day (Saturday) had general body aches and light chills but no fever and slept all day on the couch On the second day (Sunday) felt ok again except did not sleep well the night before Monday felt agitated and could not sit still: I had to be "doing something" to feel like I wasn't going crazy, slept very poorly that night or the prior night Symptoms described above worsened each day and night up until today.  I have slept very little each night and because I have to be "doing something" I am worn out by late in the day. Yesterday (Tuesday 4/20/2021) I felt a little better and slept reasonably well last night.  Today I am feeling restless and agitated again but not as severe as it was earlier....
Having troubles sleeping, projectile vomiting at 5 am 8/7, runny nose.
pt recv vax; had fever; crying almost continuously; legs were purplish, red, hard raised areas larger than the site of a quarter' cry is high pitched; screams at times; mom said pt was very hot;
Information has been received from a 78 year old female with blood pressure, drug reaction to amoxicillin and CIPROMAX and a history of bad case of chicken pox, who 3 years ago, in September 2007 was vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (Merck). Concomitant therapy included "blood pressure pill" (unspecified). The consumer stated that "4 weeks ago" (on approximately 23-AUG-2010) she developed shingles around her waist; although she had been vaccinated with ZOSTAVAX (Merck). She stated that ever since she had developed shingles, she also had developed a cold that she "could not get rid of". The patient's shingles were healing. There were not lab diagnostic studies performed. The patient sought unspecified medical attention. Additional information has been requested.
Nurse that administered immunizations to the child on  9/16/2021 did not document them properly in the system. The patient received Hep. A one month too early.  He also received  an extra dose of MMRV.  The error was not noticed until after the child received immunizations 3/18/2022.   No adverse events were reported.
Patient  G2P1001 is at  32w 0d admitted for symptomatic covid on 10/29/21 with headache, cough and dyspnea. Patient was admitted overnight for monitoring. Labs were overall reassuring and did not require oxygen. Patient was fully vaccinated for covid. Monoclonal antibody therapy was discussed and patient consented to receive if available. Expected delivery date is 12/25/21. Patient was discharged on 10/30/21.
Constant and loud Tinnitus started in the middle of the night in both ears on the 2nd day of VAX and has remained  constant and consistent currently, almost 2 weeks later. Also,  slight nausea began within 5 minutes of injection and has not totally diminished, but the MAJOR issue is the tinnitus!!
24 hours after first vaccine administration I developed was has been described as 'Covud Toes.'  Several Toes on right and left feet became swollen, red with visible signs of inflammation, and sore.  I had a similar response after having an unconfirmed covid infection two months earlier.  My symptoms have persisted for two weeks now, and I was advised by my PCP not to get the 2nd injection.
Information has been received from a registered nurse at the physician's office concerning a 4 year old female who on 07-JUN-2010 was vaccinated with VARIVAX (Merck), injection. On 08-JUN-2010 ("the next day"), the patient returned to the office with a fever of 101.5 degrees (taken orally), she was also vomiting however did not have any pain or diarrhea. At the time of the report, the outcome was unknown. Therapy with VARIVAX (Merck) was not reintroduced. Additional information has been requested.
My blood pressure started going up a week after my second dose. It was 180 over 104 for about a month and a half. Usually it was normal. I started my period on May 11th and it was super heavy, with really large clots. I had to go to the doctor for that. They are still monitoring my blood pressure. I am going back in August for a checkup, but I have had no more issues since that time
m.d. rpt pt on 03se98 was vax w/1st dose & on 08sep98 exp swelling & pain in both testicles & fever of 101.5, & abdominal pain & diarrhea. pt sought medical attention
This case was reported by a nurse via call center representative and described the occurrence of fever in a female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 3 days after receiving dTpa vaccine, the patient experienced fever and white blood cell increased. The patient was treated with Acetaminophen. On an unknown date, the outcome of the fever and white blood cell increased were unknown. The reporter considered the fever and white blood cell increased to possibly related to Dtpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. This case was received via form. The reported did not state if this was BOOSTRIX and was unaware if this was previously reported to GSK. As per reporter, the patient who was reluctant to receive the Tdap vaccine (dTpa vaccine, Reduced antigen) during her recent pregnancy. Her reasoning was that in her last pregnancy (two years before the date of reporting), the patient received dTpa vaccine 5 hours post partum. Three days later, the patient presented to the emergency room with a fever (body temperature 104 degree F). The patient was given a 1000 ml fluid bolus and 1000 mg of acetaminophen and her fever resolved in the emergency room and she was discharged within 5 hours. The patient had multiple tests within the emergency room including electrocardiogram (EKG), pelvic ultrasound (U/S) and blood panel was normal except abnormal test with slight increased in white blood cell count. An urine analysis that they did not treat a possible urinary tract infection because the patient was asymptomatic and was not treated for possible urinary tract infection, it was not considered as an event. No clarification was obtained for the same. The patient was discharged without prescription medication ordered. No further complications. It was told that the patient that the possible cause of this spike in fever was because of the dTpa vaccine.
Cannot walk, cannot speak, slow response time physically, cannot hold items with hands, leaning to far right. Slow response to audible commands
10 days after shot with ~30 blisters. Fever of 101-102 F the day before breakout. No health, did not go to the doctor, went away in about 3-4 days. C/O itching.
Began having symptoms on 11/29 with sore throat. Went to pharmacy to get PCR test and it was positive. Had chills, slight fever, head congestion, sore throat, and sinus drainage. Reached out to PCP and wasn't prescribed anything. Symptoms persisted for about 10 days.
Cellulitis on right forearm about 5cm diameter one day after shot. Seen in ED and Tx with Benadryl. Rash persist and increasing after 2 days.
Injection site was red. On 3rd day, fever started (101). Felt very sick with muscle spasms all over body especially on left arm. Felt like if someone was stabbing it. Problems also affected the hands. It took almost 2 weeks for hands to feel better. The arm was swollen from shoulder to elbow. Redness has decreased gradually by 3rd week it is pink. Also has rash on upper part of chest and even to this day, have some pink spots. The doctor recommended to take 2 Advil every 4 hours but still has not been to the doctor's office yet. Had physical therapy a week after vaccine was administered but could not do her pool exercises for her surgery recovery, because area was red. After 4 weeks starting to feel better.
Very heavy period since second vaccine, extremely painful cramps. Very unusual and not what i am used to. Definitely feels different.
Upon review, it has been determined that Dtap-IPV was given to a 2 year old when indicated for children ages 4-6. This was patient's first dose of IPV and second dose of Dtap. Both doses are being counted as valid doses. Patient has been into our Health Department since this occurrence. Mother did not mention any adverse events from the vaccine administered on 11/3/22. Telephone call to mother to discuss findings. Telephone forwarding directly to voicemail and mailbox is full. Records used to look up additional contact information.
Patient received monovalent measles vaccine on 11-08-04. Within 24 hours, she bagan a low grade fever (~101) and clear nasal discharge. The low grade fever continued for about 1 week. However, the nasal drainage became greenish yellow and thick 5 days after the vaccine. The child was taken to the pediatrician - her ears were fine and she was given a flu shot at that time. She returned to the pediatrician at 9 days after the vaccine with a temperature of 103 and was diagnosed with otitis media. She was prescribed a Z-pack. Her symptoms did not resolve and she was prescribed a second Z-pack with good results.
The patient got a SHINGRIX vaccine, her arm became red and swollen after the vaccine below the injection site. It was hot to the touch at red area.
Sores in mouth.  Mostly on roof of mouth and gums.  The sores on the roof of my mouth form blisters that ooze pus and are incredibly painful when eating anything that rubs against the roof of my mouth.  The gums are sore when brushing teeth.
ARM SWELLED UP; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (ARM SWELLED UP) and PYREXIA (Fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced VACCINATION SITE SWELLING (ARM SWELLED UP) and PYREXIA (Fever). In 2021, VACCINATION SITE SWELLING (ARM SWELLED UP) and PYREXIA (Fever) had resolved.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
About 1 hour after receiving influenza vaccine the employee broke out in urticaria to the upper torso with itching. She was seen in the ED and given PREDNISONE 50mg 1 po Q x 5 days and ATARAX 25mg 1 po Q 4-6hrs.
This spontaneous report has been received from an approximately 45 year-old female patient reporting herself. The patient's medical history included chicken pox and shingles. Her concurrent conditions included trigeminal neuralgia, breast cancer and allergy to codeine. Concomitant medications included esomeprazole sodium (NEXIUM) and acyclovir. On an unspecified date in 2013 (reported as "about 6 years ago"), the patient was vaccinated with ZOSTAVAX vial, one shot/one time in her upper arm (strength, dose, route, lot number and expiration date not reported) for shingles. On an unspecified date in 2013 (reported as "about 2013"), the patient experienced re occurrence of shingles (herpes zoster). The singles had moved to the patient'seyes (ophthalmic herpes zoster) on a date not specified. Additionally, the patient's trigeminal nerve was damaged (Vth nerve injury). The patient sought for medical attentions and was hospitalized for three-four days at a local medical center. She received treatment for the events (unspecified) and blood test were performed but the results were not reported. At the reporting time, the patient had not recovered from the aforementioned events. The causal relationship between ZOSTAVAX and the events was not provided. Upon internal review, the event ophthalmic herpes zoster was determined to be medically significant.
First day, obvious swelling on left arm with bruise. Left side of the body experienced muscle pain. At night, fever started at 37.6. Second day morning, fever 38.5 degree. Fever lasts whole day. Sever headache. Taking Tylenol every 7 hours. Body temperature dropped half an hour to one hour after taking Tylenol but came back 3-4 hours later. Muscle with pinch pain. Short breath. Stomach ached. fascial muscle also pinch pain. Almost no food intake. Only water. Eye hurt when seeing light. Cooling forehead by cold wet towel. On third day, temperature dropped to 37.8. Sweating a lot. Felt weak. Headache when moving or coughing.