chrisvoncsefalvay/vaers-outcomes huggingface dataset:
receiving 2nd dose of the Moderna COVID19 vaccine 9 months after receiving 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving 2nd dose of the Moderna COVID19 vaccine 9 months after receiving 1st dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069f21a and 042b21a) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving 2nd dose of the Moderna COVID19 vaccine 9 months after receiving 1st dose). On 14-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving 2nd dose of the Moderna COVID19 vaccine 9 months after receiving 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient will be received an Evusheld injection as patient was immunocompromised. Patient did not had COVID19.   Reporter did not allow further contact
Information has been received from a health educator concerning a male teenager who on 30-DEC-2008 was vaccinated with VARIVAX (Oka/Merck). Concomitant therapy included MENACTRA. On 11-JAN-2009, 12 days post vaccination with VARIVAX (Oka/Merck), the patient developed redness and swelling at the injection site. The patient had sought medical attention from the school nurse. The patient's redness and swelling at the injection site persisted. No further information is available.
Information has been received from a physician concerning a female patient who was vaccinated IM with a first dose of Gardasil (yeast). Subsequently, the patient developed a few hives in the upper abdominal area. It was noted that the patient plans to continue with the vaccine series by getting the second and third dose as recommended. Unspecified medical attention was sought. On 04 Dec 2006, the patient recovered. No product quality complaint was involved. Additional informatio has been requested. This is in follow-up to report (s) previously submitted on 1/5/2007.  Information has been received from a physician concerning a 26 year old female patient who on 15-NOV-2006 was vaccinated IM into the left deltoid with a first dose of GARDASIL (lot # 653938/0954F).  On 17-NOV-2006, the patient developed a few hives in the upper abdominal area.  It was noted that the patient plans to continue with the vaccine series by getting the second and third dose as recommended.  The patient was treated with BENADRYL.  On 04-DEC-2006, the patient recovered.  No product quality complaint was involved.  The physician stated that it was highly unlikely that hives were from the vaccine because hives developed 48 hours later.  Additional information is not expected.
Information has been received from a physician concerning patients who were vaccinated with hep B vaccine recombinant. Subsequently the patients experienced burning feeling at injection site, nodule formations and redness. Unspecified medical attention was sought. Additional info has been requested.
Erythematous area around the injection site and small pinpoint papules in the center of rash. (Left SQ arm).
I have an IUD and have not had a menstrual cycle in over four years.  That said, I do 'spot' when my body is fighting something.  The morning following shot two, I spotted.  My other symptoms were general fatigue and just a 'bleh' feeling.    This morning, four weeks and four days after the spotting incident, I spotted again.  I have no symptoms and feel 100% ok.   Nothing alarming, just unusual for my body.  Wasn't sure how deep the reporting was going, so thought I would share.
Pt recv vax on 10/07/98; on same day pt exp pain at vax site, pain from left hip to knee, headache, nausea, vomiting & Coryza x 24 hr
Fever x 2 days, Fatigue/slept x 24 hrs, Severe Insomnia for past 24 hrs
This spontaneous report as received from a medical assistant refers to a 5 year old patient of unknown gender. The patient's pertinent medical, concurrent conditions and concomitant medications were not reported. No drug reactions or allergies were reported. On 13-DEC-2016 the patient was vaccinated with expired dose of VARIVAX (dosing details were not reported) (lot # K016131 expiry date: 13-DEC-2016) for prophylaxis (expired vaccine used). No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a physician concerning a 6 year old white female who on 03/11/97 was vaccinated SC in the arm with Varivax. On 02/18/02, the patient experienced a mild case of breakthrough varicella. It was on her trunk, genitals and ears. The patient recovered with no prescription drug treatment and no hospitalization..
Patient presenting with complaint of tightness to chest sore throat. VS BP: 116/76 HR: 95 RR:12 02: 98% Patient assessed by provider ordered Benadryl 12.5mg PO. Per provider notes patient complained of tightness to chest weird sore throat. Patient admits history of anxiety and seasonal allergies. Has not taken claritin in 3 days not consistent with it. Vitals WNL. No murmurs, no wheezing rales, rhonchi. Tonsils 1+ bilateral tonsillith right side PND cobblestoning of posterior oropharanx. Patient states immediate relief after Benadryl. Patient monitored for 30 min sent home with no further complaints.
Patient was fine after injection.  She was talking, laughing, and walking around.  Suddenly about 5-10 minutes later, she passed out for a few seconds then came back around and was fine again
This spontaneous report as received from a registered nurse, via a company representative, refers to two patients of unknown age. On 18-MAR-2014 two patients were vaccinated with ZOSTAVAX, single dose, in the arm. The patients were also administered TDAO in the same arm on 18-MAR-2014. This case refers to patient one of two patients. In March 2014, the patient developed "localized reactions". The patient sought medical attention and visited the office. The outcome of localized reactions and causality assessment were not provided. This case is linked to case 1404USA004017 (patient two of two patients). Additional information has been requested.
Total body hair loss. - 5 days before had mammogram, ultra sound to check leakage of implants. Test were OK. - Correct spelling of last name.
Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult patient who received a pediatric dose of vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is a case of vaccine underdose. List of documents held by sender: none.
Occlusion on right eye; Can't see out of his right eye; hemorrhage in right eye; Case reference number MOD-2021-012734 is a spontaneous case report sent by a Non-Healthcare Professional on 09-FEB-2021, which refers to a male patient who received the first dose of Moderna's COVID-19 Vaccine (mRNA-1273) and experienced occlusion of the right eye and blindness in the right eye which required hospitalization and the event of hemorrhage in the right eye.   The patient's medical history included a shunt installation for hydrocephalus.   The patient's medication history included amoxicillin, omeprazole, potassium citrate, sertraline hydrochloride, tamsulosin, amoxicillin trihydrate, benzydamine hydrochloride, bromhexine hydrochloride, trospium and unspecified sinus medications.   On 15JAN2021, the patient received the first dose of Moderna COVID-19 (mRNA-1273) Vaccine (Lot: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 17JAN2021, the patient's wife reported that the patient couldn't see out of his right eye. He went to the emergency room and his ophthalmologist reported that the patient had an occlusion on the right eye which was not a result of the vaccine.   On 19JAN2021, the patient left the hospital. Later that same week, the patient visited another ophthalmologist that observed a hemorrhage on his right eye with an unknown etiology.   On 04FEB2021, the patient went to the dentist where multiple infections and molars were identified. Treatment included amoxicillin 875mg for 10 days.   Action taken for the events of occlusion of the right eye, blindness in the right eye and hemorrhage in the right eye associated with mRNA-1273 was not reported.   The outcome of the events was unknown.; Reporter's Comments: This case concerns a 73-year-old male patient, who experienced a serious unexpected events of vascular occlusion, blindness, and eye hemorrhage, after receiving first dose of mRNA-1273 (lot # 041L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.
pt recvd vax 8JAN93 rash waist up & arms 21JAN93; lasted 2 days; 23JAN pain in joints, temp w/rash 99.6;
36 hours after receiving the 1st dose of Pfizer vaccine I experienced extreme dizziness in the morning, nauseous, chills, hot flashes, racing heartbeat and was very weak.  Had some lapses in thought process. I did not have a fever.  These symptoms persisted for 5 days.  On 2-2-21 I started to get a migraine, so took a prescription medication (Sumatriptan Succinate Tablet 50 mg) and this helped with the nauseousness.  My symptoms seem to decrease around 3pm in the afternoon, but never completely go away.  Each morning, the cycle repeats with dizziness, nauseousness and chills and some thought lapses.  It's been one week since my first dose of the vaccine, and these symptoms are lessening but are still prevalent.
Client called on 6/23/2021 to report the onset of a severe headache at 03:00 the morning after her vaccination.
Nothing immediately happened after the shot. February 17, 2021 I had started to have a fever, chills, and a rash. That lasted for 5 days. It was similar to 8 other episodes of an undiagnosed illness I have had since 2019. I have had nine episodes of this ever since 2019.
12 hours after 2nd shot I was paralyzed for 36 hours.  I wasn?t terrified because I am on a group for the medication ocrevus and I saw a few people where paralyzed after the 2nd shot. By paralyzed I mean I could not move
Arm pain the first week. Then on the eighth day, I had twitching (whole body) like I was having a seizure but it wasn't. It only happens when I lay down. Then I had a headache, maybe a little that first week after, but when the twitching the headache got worse. When the twitching was severe it was every couple of minutes. The headache could be associated with other problems. I wasn't sleeping. The headache gets worse at night time. If I lay on the left side where the headache is on it gets way worse. Then my hip hurts if I lay on other side because I had hip replacement. My blood pressure got so high, went up to 212/110. I went by ambulance to ER. At one point, 240 over 110 (the ambulance guy told me it got up that high). But then at hospital it was back down to 212/110. I had been taking my blood pressure was not going down and that's why I called. I got to the hospital and they took all types of tests and blood and x-ray of my chest. Then they gave me one shot in the IV of Ativan. That helped a lot. It stopped the twitching for 24 hours. But now the twitching is back but it's less often. The next day after the hospital I slept all day and didn't twitch. Just last night I couldn't sleep at all. Not just the twitching but I was just restless. I have a headache today, too, and have been in bed all day. I'm trying to stay calm because I don't want the blood pressure to go up. No new meds after the hospital. I still feel pretty bad and will see my doctor on Monday follow up. I'm nervous to take blood pressure reading, trying not to take it.
Day 1 (4 hours after vaccine): Hives breakout all over body (legs, arms, stomach, back), pain in sternum Day 2: Pain in sternum, hives on arms Day 3: Swelling of lips, tongue and throat closure, hives all over body - went to urgent care Day 4: Swelling of lips, hives all over body, shortness of breath, pain in sternum Day 5: Hives all over body - blotchy, pain in sternum Day 6: Hives covering arms and legs, pain in sternum
ARM PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain. This report was non-serious.
Swollen lymph nodes on left side (left breast, underarm left side), swollen lypmph under lerft jaw and left side of face
This spontaneous report was received from a medical assistant regarding multiple unspecified patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medication was not reported. On multiple unknown dates, unspecified patients received unspecified doses of improperly stored GARDASIL 9 Lot# L038917 with expiry date: 20-FEB-2018, L000610 with expiry date: 31-JAN-2017 and M013636 with expiry date: 15-FEB-2018 (dosing details were not reported). No adverse effects were reported. Temperature: 52.7 F with time frame of 15 hours. There was no previous temperature excursion. The call was due to data logger. No product quality complaint (PQC) was involved. This is one of the several reports. Additional information has been requested.
Area round about 3 inches in diameter  looked red and warm to the touch.  Seems to have stop spreading .   4 days out.    Patient is taking antihistamine to help with redness. and was reccomended to seek medical attention if worsening.
A non-serious spontaneous report of two full vials of FLUMIST administered was received from a nurse practitioner concerning a 47-year-old female. The patient received two full doses, 0.2 ml of FLUMIST in each nostril on 06-Oct-2009. The patient had no complaints and no ill effects were observed. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Information has been received from a physician concerning an 83 year old female patient with a pertinent medical history (no details provided) who on Jun 10 2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 646322/0530N), in the right deltoid. Subsequently, the patient developed a red, swollen arm at injection site. Ice and analgesic treatment was reported. The reporting physician requested a lot check. No product quality complain. follow up information reported that the patient developed red, hot, swollen shoulder tender, The patient recovered. the records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for biologics Evaluation and Research and was released. It was also reported that two other patients had a similar reaction (WAES0407USA01800, WAES0407USA02327). Additional information is not expected.
Right arm induration - aching swelling redness golf ball size started on day 8 post vaccine and lasted until day 10- I have pictures if needed
Not concerned but wanted to share in case this is helpful in data collection. My text vaccination questions have already ended. On 4/4, I realized my arm was tender again at the injection site but I did not look at it. On 4/5, no longer sore but I noticed an irregular shaped, fairly circular, rash about 6 inches in diameter at the injection site. It is warm to touch but not bothering me otherwise.
tested positive for Covid; cold/feel like cold; flu like symptoms; bodyaches; Felt like fever but temperature range was normal; chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid), NASOPHARYNGITIS (cold/feel like cold), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (bodyaches) and PYREXIA (Felt like fever but temperature range was normal) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced NASOPHARYNGITIS (cold/feel like cold), INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (bodyaches), PYREXIA (Felt like fever but temperature range was normal) and CHILLS (chills). On 20-Apr-2021, the patient experienced COVID-19 (tested positive for Covid). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PIROXICAM (ZICAM [PIROXICAM]) at an unspecified dose and frequency. On 20-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, COVID-19 (tested positive for Covid), NASOPHARYNGITIS (cold/feel like cold), PAIN (bodyaches), PYREXIA (Felt like fever but temperature range was normal) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Coronavirus test: (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
B/L erythematous sclera with discharge (+) pharyngeal infections with erythema - no exudate. symptoms developed 6 hours after vaccine - treated with BENADRYL.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak), PAIN (Achy), HEADACHE (Headaches) and MALAISE (Not feeling well) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (Very weak), PAIN (Achy) and HEADACHE (Headaches). On 22-Jan-2021, the patient experienced MALAISE (Not feeling well). At the time of the report, ASTHENIA (Very weak), PAIN (Achy), HEADACHE (Headaches) and MALAISE (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
reporter states pt born 10MAR72 nl & healthy; pt becam epileptic & mentally disabled shortly p/having received DTP vax; although pt did not exp sz immed p/inject pt did have dangerously high fevers & a allerg react; several wks later szs;
Individual fully vaccinated with COVID-19 Moderna vaccines on 2/25/21 and 3/25/21 and tested positive for SARS-CoV-19 on 5/5/21.
about 4 hours after started with pain in shoulder, really severe shoulder pain, no sleeping, took days off work, still going on  and is 9 days later.  Went to ED and then orthopedics also to eval what happened
A pharmacist reported that 80 employees received Daptacel vaccinations instead of Adacel when Adacel was incorrectly sent to the employee health department by pharmacy. No serious harm resulted but 5 employees reported a fever as a result of a mix-up in administration. Five employees reported a fever as a result of the mix-up in administration.
PATIENT CAME INTO PHARMACY REQUESTING MODERNA VACCINE. SHE WROTE ON HER FORM THAT SHE HAD NEVER RECEIVED A COVID VACCINE BEFORE. UPON RECEIVING MODERNA, SHE TOLD US THAT SHE HAD RECEIVED THE JANSSEN VACCINE BEFORE, BUT WANTED THE MODERNA VACCINE FOR "EXTRA PROTECTION" AS ONE OF HER FRIENDS HAS RECENTLY PASSED AWAY DUE TO COVID.
Three days of lethargy, unusual sleepiness and "floppiness".  Lack of appetite down by 10 ounces and increased fussiness.
Immunizations were administered on Wednesday, 10/30. Per video camera footage, immunizations were administered properly. Per patient, she woke up on 10/31 with her right arm swollen, red, and warm. Prior to seeing her health care professional on Monday night, 11/04, patient came to the pharmacy. She spoke to the pharmacist on duty. He observed her arm and recommended Benadryl, Tylenol and to follow up with her healthcare professional. Prescriptions for Bactrim DS, Diflucan, and Keflex were sent in that night (11/04). Prescriptions were picked up on Tuesday, 11/05 at 12:16 PM. Per PA-C, patient is being treated for cellulitis. Follow-up phone call was made to patient on 11/08. Per patient, her arm started improving not long after she started taking antibiotics. She also stated her health care professional shortened her duration of therapy from 10 days to 5 days due to improvement.
Received 1st dose of vaccine on 12/21/2020.  Developed rash and itchiness  on (R) hand between (2) middle and (3)ring finger a couple days afterward.  Started to go away.  Received second dose of COVID-19 on 1/11/2021.  Rash continued to worsen.  Noticed red rash on neck starting around 1/17/2021.  Describes as "just a few red bumps and really itchy".  "It felt like poison ivy itching".  1/20/2021, rash appeared to look like hives, swelling, and itchiness intensified.  1/22/2021,  swelling subsided some, continues with rash and itchiness.
12/15/2020 5:00 PM Nauseas(worst )  5:30 Pm Headache  6:00 Pm Stomach Pain
Large palm-sized raised and inflamed area around administration site. Felt ill on day 2. Redness still visible day 2.
pt admitted to hosp with COVID pneumonia requiring tracheostomy; acute or chronic HRF; hydropneumothorax and empyema; chest tube; septic shock; treated with ABX; DNR; made comfort care and pt died in the hosp
COVID-19 - MODERNA BIVALENT LOT #045H22A IM - LD - MEDICATION ERROR -  COVID VACCINE ADMINISTERED 3 DAYS past expiration date (Expiration Date-6/12/23) DOH and manufacturer MODERNA NOTIFIED ON - 6-15-2023 A response from the manufacturer (MODERNA) was received on 6/20/2023 An analysis of lot # 045H22A - showed that the vaccine was protective against (covid 19) virus at time of administration on 6/15/2023
Urticaria starting on 1/1/23 on neck. Progressed to scalp, face, and throughout body. Angioedema of face on 1/3/23. Responded partially to increased antihistamines (twice a day Zyrtec and famotidine). Started prednisone taper 1/4/23.  Symptoms improved, but returned after steroids complete. Now experiencing dermatographia approximately 10-12 hours after last antihistamine dose.
Pt recv vax on 1/19/99; on 1/20/99 pt exp vomiting, fever, abdomen pain, red/ raised/ tender area of rt arm; tx=cool compress & Tylenol
The patient received Meningcoccal B(Trumenba) for the second dose of the series instead of Meningococcal (bexsero) which the patient received as the first dose