chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gone longer than two months between injections; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gone longer than two months between injections) 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 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gone longer than two months between injections). On 06-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gone longer than two months between injections) had resolved.            No concomitant medications information was reported. No treatment medications were provided.
pt recv vax 29NOV95 & 2OCT96 pt devel herpes zoster @ rt C6 dermatome w/greater than 100 vesicular lesions on rt index finger & rt upper forearm toward elbow;a viral cult was positive for varicella zoster;
Muscle pain, arm pain, fever, chills, nausea, diarrhea.
This spontaneous report was received from a registered pharmacist refers to a patient of 75 years old and unknown gender. The patient was vaccinated intramuscularly (IM) with dose of PNEUMOVAX 23 (lot: 0491AE, exp. date: 15-SEP-2012) (dose not reported) on 04-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist mentioned that during intramuscular administration of PNEUMOVAX 23 to the patient, the syringe malfunctioned and most of the PNEUMOVAX 23 ran down the patient's arm. No adverse experienced had been observed or reported. Additional information has been requested.
Erythema, warmth, edema, and pain starting within several hours of vaccination and continuing for more than one week.  Appears most concerning for cellulitis, but cannot rule out an inflammatory reaction to vaccine or one of its components/diluents.  Antibiotic therapy initiated.  No other symptoms to suggest hypersensitivity or allergic response.  Treatment ONGOING.
pt recvd vax;approx 30 mins later devel redness, a hot sensation & hives all around thigh; f/u indicated pt had urticaria on lt leg; dph given;
resolved and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medications were not reported.
4 x 1 1/2 " rash noted this am. Denies pain or swelling in the area
Patient reported getting flu shot last month on 9-15-18 and is still experiencing pain in his arm. Patient advised on 10-10-18 date of reported to contact is PCP.
This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a 87-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 31st March 2020). On 8th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th March 2018, 1 days after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of shivering was unchanged. The reporter considered the shivering to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on an unknown arm. On the morning of 9th March 2018, the patient reported shivering. She had shivered since the injection, and it occurred more in the morning, but it still comes and goes throughout the day.
Headache  with au occipital and  frontal sinus pressure starting 8hr after injection,  sustained for 48hrs mildly relieved by aspirin. Morning of 9th day after vaccine began sore throat, suboccipital HA with pressure in head, mild mucus in throat and sinus congestion. Increased to severe headache 36hrs later and overall fatigue. Use of magnesium threonate and aspirin/Tylenol was only way to be able to sleep due to headache.  Symptoms peaked on 12th day after vaccine and moderate HA with pressure in head has remained along with mild congestion. Sore throat relieved around 12/13th day after vaccine.  Pressure in head has also increased pressure in ears and continuous need for opening jaw to relieve pressure in ears. Aspirin no longer provides benefit for headache. Decongestants reduce sinus pressure and mucus production but if don?t take for one day, it all returns.
RN reporting that high dose was given in error, patient only 63. No adverse symptoms reported.
Received vaccine 1/30/13. On 2/6/13 experienced fever, sore throat, body aches & joint pains, itchy rash. Treated with OTC ADVIL, pushed fluid intake, rest. Wanted report made. No tx required at time of reporting.
A lump on the inside of the same arm NOT at the inoculation site; Large red warm patch with an enduration of 2 X 2 inches; Large red warm patch with an enduration of 2 X 2 inches; Large red warm patch with an enduration of 2 X 2 inches; Tired; Arm hurt the first day; This spontaneous case was reported by a consumer and describes the occurrence of LIMB MASS (A lump on the inside of the same arm NOT at the inoculation site), VACCINATION SITE WARMTH (Large red warm patch with an enduration of 2 X 2 inches), INJECTION SITE PAIN (Arm hurt the first day), VACCINATION SITE INDURATION (Large red warm patch with an enduration of 2 X 2 inches) and VACCINATION SITE ERYTHEMA (Large red warm patch with an enduration of 2 X 2 inches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced INJECTION SITE PAIN (Arm hurt the first day) and FATIGUE (Tired). On 13-Mar-2021, the patient experienced LIMB MASS (A lump on the inside of the same arm NOT at the inoculation site), VACCINATION SITE WARMTH (Large red warm patch with an enduration of 2 X 2 inches), VACCINATION SITE INDURATION (Large red warm patch with an enduration of 2 X 2 inches) and VACCINATION SITE ERYTHEMA (Large red warm patch with an enduration of 2 X 2 inches). The patient was treated with DOXYCYCLINE at a dose of 100 mg twice a day. On 06-Mar-2021, INJECTION SITE PAIN (Arm hurt the first day) and FATIGUE (Tired) had resolved. At the time of the report, LIMB MASS (A lump on the inside of the same arm NOT at the inoculation site), VACCINATION SITE WARMTH (Large red warm patch with an enduration of 2 X 2 inches), VACCINATION SITE INDURATION (Large red warm patch with an enduration of 2 X 2 inches) and VACCINATION SITE ERYTHEMA (Large red warm patch with an enduration of 2 X 2 inches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.
This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported. On 06-DEC-2021, the patient was vaccinated with improperly stored Varicella virus vaccine live (oka/merck)(VARIVAX) (Lot# U015680 and expiration date 18-MAY-2023) (exact dose and frequency were not reported) as prophylaxis. (product storage error). The vaccine underwent a temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 13.6 Celsius) for 0 hours 45 minutes and 0 seconds and minus 14 degree Celsius to minus 10 degree Celsius (minus 13.5 Celsius) for 0 hours 45 minutes and 0 seconds. There was no previous temperature excursion. No additional adverse event reported, no further information provided. This is one of 8 reports from the same reporter.
Chest pain and swelling of the left arm near armpit near the back Starting the day after the shot and continue thru today, day 3
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-AUG-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5ml, lot # L044475, expiration date 12-MAY-2017, route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
24 hours post vax, the pt developed a fever of 103 (rectally). The pt had persistent vomiting through the night. Was seen in the office 48 hours post vax. Pt had dehydration and the site of injection was hard with redness, warmth and wheals.
BURNING SENSATION IN THE GROIN AREA; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included groin discomfort, and covid 19 infection. The patient was previously treated with steroids for drug used for unknown indication, diphenhydramine hydrochloride for drug used for unknown indication, and antibiotics for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On DEC-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 12-APR-2021, the subject experienced burning sensation in the groin area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation in the groin area. This report was non-serious.
Pain in leg; Nausea; fatigue; headache; Pain in hip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in leg), NAUSEA (Nausea), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (Pain in hip ) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in leg), NAUSEA (Nausea), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (Pain in hip ). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in leg), NAUSEA (Nausea), FATIGUE (fatigue), HEADACHE (headache) and ARTHRALGIA (Pain in hip ) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not  reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow-up is  received , patient reported she took 2nd dose and she is fine and   Events outcome for 1st dose  were updated from unknown to recovered , and Reporter declined further follow-up.
back pain 'chronic"; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain 'chronic") in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arrhythmia (NOS), Degenerative disc disease and Cardiac ablation.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced BACK PAIN (back pain 'chronic"). At the time of the report, BACK PAIN (back pain 'chronic") outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications were not provided.  Treatment information was not provided by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Additional information received as Patient's wife stated that her husband didn't report any adverse reactions. Didn't want to give email address.
Moderna COVID-19 Vaccine  1. fatigue 2. headache 3. nausea/diarrhea 4. chills 5. joint pain 6. muscle aches 7. runny nose 8 sore throat
Day of immunization - mild aches pains/headache - took Advil and went to bed. Next day - rash/hives - tried treating with Claritin which helped for 36 hours; then awoke with severe hives & heartburn & mild chest pain - went to ER - treated with Zyrtec, Prednisone 40mg then 20mg every day for 5 days; Pepcid for heartburn.
Information has been received from a physician concerning an 11 year old female who was vaccinated with the second dose of GARDASIL (dose, route, and lot not reported) one month ago (on approximately 03-AUG-2009). There was no other concomitant immunization medication. The patient experienced an an adverse event post vaccination with GARDASIL. 40 minutes post vaccination the patient had a "tonic clonic seizure event" in the car with her parents. The patient was taken to the doctor office for follow up. The patient recovered. It was noted that the patient was nervous about vaccinations and she had passed out after the first dose of GARDASIL. Upon internal review, "tonic clonic seizure event" was determined to be an other important medical event. Additional information has been requested.  9/29/2009 Received PCP medical records of 5/8/09-8/13/09  which reveal patient in usual state of health on 5/8/09.  RTC on 8/13/09 w/report of 2nd episode of LOC & seizure w/jerking movements of arms/legs & incontinence lasting approx 1 min after receiving 2nd HPV. No further medical treatment was sought.
Headaches started within 1 day of vaccination and persisted for 3 weeks before ending; Lightheadedness started 3 days after vaccination and has not subsided; periodic tingling and short bursts of pain in feet and hands started ~4 weeks after vaccination and have been decreasing in intensity but are not gone; small yellowish bruises have unexplainedly shown up ~4 weeks after vaccination (top of right foot), ~5 weeks after vaccination (left forearm), ~8 weeks after vaccination (right side upper back), ~9 weeks after vaccination (lower left abdomen); occasional instances of chest discomfort started 6 weeks after vaccination and still occur infrequently No specific diagnosis; treatment has included increased daily walking, increasing water intake, occasional wearing of compression socks (knee high)
Patient presented with 2cm, deep red, tender firm lesion on left thigh. Also had fever of 100.6 axillary in office. Patient was treated with Keflex 375mg BID for 7 days.
Suspected vaccination failure; Acute episode of shingles; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On 10th September 2019, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the pharmacy intern. The age at vaccination was not reported. After vaccination, the patient experienced an acute episode of shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. The reporter consented to follow up.
Sudden onset of allergic symptoms - anaphylaxis, hives, swelling of face and extremities. Visited urgent care for steroid injection, but symptoms got worse. Went to ER and was admitted. In hospital for 3 days treated with epinephrine, steroids, and antihistamines. Still experiencing hives after hospital discharge. Referred to allergy testing site for follow up.
swollen lymph nodes under his arm as big as a golf ball; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes under his arm as big as a golf ball) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes under his arm as big as a golf ball). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes under his arm as big as a golf ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-092212 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092212:for 2nd dose
8:30 am a few minutes after giving FLUVIRIN he said he felt like he was going to pass out. As he was sitting, he slumped over. I asked if he was ok, got him to sit back up and it seemed as if he was breathing heavier, sweating and possibly seizing. My tech called 911. Soon he was alert and talking, but unaware of what happened. He was still sweating for awhile. Paramedics said he did pass out, but not have a seizure. They took his vitals and they were fine. (After having him sit for awhile, they suggested I give him his Tdap vaccine while they were there). He told them he was nervous about getting the vaccines. His wife was in hospital and was going to have a baby, about a month early. He hadn't have a lot of sleep lately, and did not have breakfast. They waited while I gave him the Tdap and he was fine. I called him later that afternoon and he said he was fine.
This case was reported by a healthcare professional and described the occurrence of nausea in a 22-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), MMR vaccine (Merck). Relevant medical history included a previous vaccination with ADACEL on 26 November 2007. One day after the subject received ADACEL, she experienced fever and chills. This was the first vaccine that the subject had ever received. Not previously vaccinated with any of the childhood vaccines. Concurrent medical conditions included allergy to alum. On 30 November 2007, the subject received 1st dose of TWINRIX (1 ml, intramuscular, right arm) and 1st dose of MMR vaccine (subcutaneous, right arm). Three to four hours after vaccination with MMR vaccine and TWINRIX, the subject experienced nausea, vomting and fever. Medical attention was not required. It was reported that the immunization series was delayed. At the time of reporting the event were resolved.
No additional AE reported; VARIVAX and PROQUAD were inadvertently administered to the same patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 12-MAY-2021, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T031381 with an expiration date on 15-SEP-2022) and measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# T037958 with an expiration date on 09-MAY-2022) at the same time for prophylaxis (accidental overdose).    Strength, dose, anatomical location, and route of administration were not reported for both vaccines.       No additional adverse event was reported.
Pain, stiffness & swelling in right arm. Very warm to the touch with red spots. ER Iced packed arm. In ER from 6/30 11:00 pm to 1:00 am. Ultrasound test taken.
This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with a dose of ZOSTAVAX (lot#, expiry, route not reported). On unspecified dated, the patients experienced injections site reactions following vaccination with ZOSTAVAX in the past. The outcome of injection site reactions was unknown. This is one of 2 reports received from the same reporter. Additional information has been requested.
Headache (began day 1 - consistent through day 4 today), lightheadedness (day 1 - first reaction symptom), nausea (day 1 briefly), total body aches (evening of day 1 severe - through day 4 today but only mild), chills (evening of day 1), subjective fever (evening of day 1), swelling of injection site (noticed the next morning and worsened until day 4 today, started to decrease but still present), rash of injection site (noticed morning after and continued to increase until day 4 today it is less bright red but still present and baseball sized), swollen right axillary lymph nodes (day 3-4), today day 4 injection site began itching. I am continuing to monitor signs and symptoms.
NSTEMI - ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Believe shot was injected into vein - high heart rate for 24 hours (140 bpm)   Large bruise for 10 days after injection  Large rash / allergic spot lasted for 10 days
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 01-OCT-2014, the unspecified number of patients had been vaccinated with doses of oral, ROTATEQ (lot#, dose and frequency were not provided), which had underwent supported and unsupported temperature excursions, orally (on unspecified dates of 2014). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
No additional AE; The patient received an expired dose of VAQTA; This spontaneous report was received from a registered nurse and referred to an 18-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-JUL-2023, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA), 1 dose, (lot number W003118 has been verified to be a valid lot number, expiration date reported and validated as 13-JUL-2023), as prophylaxis (strength, route of administration and anatomical location were not provided).  No adverse event reported.