chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse and refers to a 9-week-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 22-AUG-2016, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported) and ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916.
Unknown - Notified by subpoena for records from coroner of child's death on day following vaccinate administration.
Booster dose received < 5 months from 2nd dose/Patient received booster dose a month or 2 early per HCP/Booster dose administered early; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received < 5 months from 2nd dose/Patient received booster dose a month or 2 early per HCP/Booster dose administered early) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received < 5 months from 2nd dose/Patient received booster dose a month or 2 early per HCP/Booster dose administered early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Booster dose received < 5 months from 2nd dose/Patient received booster dose a month or 2 early per HCP/Booster dose administered early) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  The hcp who stated that a patient had received primary series but received their booster dose a month or 2 early from their 2nd primary series dose which was on 19Nov2021 per the HCP. The HCP stated that she is aware that booster dose should be at least 5 months later after the 2nd dose and asked if they should be looked for any adverse reactions.  Treatment information was not provided.   This case was linked to MOD-2022-515204 (Patient Link).
had "loose stools" and  bad diarrhea/worst diarrhea episode/very serious diarrhea; needed to lie down; exhausted; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), DIARRHOEA (had "loose stools" and  bad diarrhea/worst diarrhea episode/very serious diarrhea), ASTHENIA (needed to lie down) and FATIGUE (exhausted) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Pityriasis rubra pilaris (Pityriasis Rubra Pilaris (PRP) diagnosis 5 or 6 years ago.), Flu (Flu infection that caused diarrhea.) from February 2020 to March 2020, Salivary gland cancer (Cancer of parotid salivary gland that involved surgery, chemotherapy and radiation.) in August 2019, Dialysis (Patient was hospitalized and was placed on dialysis.) in September 2020 and Heart attack in September 2020. Concomitant products included ALLOPURINOL, AMIODARONE, ATORVASTATIN, MACROGOL 3350 (CLEARLAX [MACROGOL 3350]), APIXABAN (ELIQUIS), FLUOROURACIL, FOLIC ACID, LEVOTHYROXINE, METOPROLOL SUCCINATE, MIRTAZAPINE, OMEPRAZOLE, LIOTHYRONINE SODIUM (THYRONINE), TIMOLOL, AMLODIPINE BESILATE, ATENOLOL (BETACAL [AMLODIPINE BESILATE;ATENOLOL]), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), USTEKINUMAB (STELARA) and LISINOPRIL for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced LETHARGY (lethargic), ASTHENIA (needed to lie down) and FATIGUE (exhausted). On 10-Mar-2021, the patient experienced DIARRHOEA (had "loose stools" and  bad diarrhea/worst diarrhea episode/very serious diarrhea). On 15-Mar-2021, DIARRHOEA (had "loose stools" and  bad diarrhea/worst diarrhea episode/very serious diarrhea) had resolved. At the time of the report, LETHARGY (lethargic), ASTHENIA (needed to lie down) and FATIGUE (exhausted) outcome was unknown.            No treatment was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
a 4inch red ciricle around the injection site that is raised, hot to the touch, red and itchy
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 18-NOV-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.   This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, DIZZINESS, COUGH, HEAD DISCOMFORT and CHILLS 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL, DIZZINESS, COUGH, HEAD DISCOMFORT, CHILLS, PYREXIA  and NAUSEA. At the time of the report, FEELING ABNORMAL, DIZZINESS, COUGH, HEAD DISCOMFORT, CHILLS, PYREXIA and NAUSEA had not resolved. Concomitant product used was not provided by the reporter. Treatment information was not provided.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/08/21 2nd dose01/29/2021 Diagnosed covid positive:08/24/21 Symptom onset:08/23/21 Exposure:travel Symptoms:fever, fatigue,sorethroat,muscle aches, runny nose, HA
1st dose in 2020, another dose today (03Nov2022); This case was reported by a consumer and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2020).   On 3rd November 2022, the patient received the 2nd dose of Shingrix. On 3rd November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The patient had forgotten about dose that until he/she checked online records through the vaccination website. The patient went on the day of reporting and had a first dose again. The patient asked that he/she should still get the second dose in December especially since it's been so long after the first one in 2020. Additional supportive information: The patient received the second shot later than the recommended interval, which led to lengthening of vaccine schedule.
Patient experienced tachycardia after  receiving the first dose of the COVID-19 vaccine.
Pain in left arm; Weakness in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm) and ASTHENIA (Weakness in left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm) and ASTHENIA (Weakness in left arm). At the time of the report, PAIN IN EXTREMITY (Pain in left arm) and ASTHENIA (Weakness in left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-138367 (Patient Link).
I95.9 HYPOTENSION 3/21/2023 PARTIAL SMALL BOWEL OBSTRUCTION I95.9 HYPOTENSION 3/21/2023 ATAXIA, LATE EFFECT OF STROKE
Day 3: Swollen painful  lymph nodes under left arm (injection side)?swelling down day 4/5 102.8 fever?lasted 1 day Day 4: Terrible  ongoing headaches for more than a week Day 6: 3 episodes of becoming disoriented and falling
Approximately 5 minutes after IMZ the patient slouched in the chair.  I did not see any loss of consciousness.  He lost color but regained it.  He sat about 20 minutes in pharmacy area and I walked him, his mother and brother to their car.
Vial expired on 04-Apr-2022, vial thawed on 26-Apr-2022 and administered on 26-Apr-2022; Doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Vial expired on 04-Apr-2022, vial thawed on 26-Apr-2022 and administered on 26-Apr-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 04-Apr-2022, vial thawed on 26-Apr-2022 and administered on 26-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Vial expired on 04-Apr-2022, vial thawed on 26-Apr-2022 and administered on 26-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's weight was reported as 233. The patient received booster 1 on 26-Apr-2022. Concomitant medication list was not provided. The vial was initially stored in the refrigerator: vials thawed on the same day of administration, 26-Apr-2022. Number of doses/vials- 27 doses.The vial did not undergo any temperature excursions. No known adverse reactions in office. Treatment information was unknown.
Started itching on her face, then developed a hive. Itchiness spread to neck and chest. Small bumps appeared as well. Also developed a headache that lasted 3 days.
Redness and induration apprx. 2 in in diameter at site of injection. Resolved in 1 week.
Her arm at the site of injection and extending from shoulder to elbow became inflamed, hot to touch, indurated, and the skin was "so sore to touch that it felt like I was burned." She experienced intense sensitivity which lasted for 4 days, and stated it was very painful to move her arm and even touch it. She also developed a band of erythema around her arm above the elbow, that lasted for several days, turned yellow, and eventually disappeared. She increased her fluid intake, applied ice and took Tylenol. She felt flushed, but had no fever. It took 7-10 days to normalize.
Early onset of menstrual period-14 days early-lasted 11 days versus normal 5 and heavy bleeding including large clots for 10 days.
an HCP reported to her a patient "recently received the Varicella vaccine" and "later" told the office that "she thought that she might have experienced some kind of 'anaphylactic reaction' after receiving the vaccine; This spontaneous report was received from a registered nurse via a company representative, referring to a female patient of unknown age. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), and recently she received another dose of varicella virus vaccine live (oka/merck)(VARIVAX) (formulations, strengths, doses, vaccination schemes, routes of administration, anatomical sites of vaccination, lot numbers and expiration dates were not reported, for any of the vaccines), both vaccines were administered as prophylaxis, however; after the vaccination, she notified that, she thought that she might have experienced some kind of "anaphylactic reaction" after received the vaccine, as she had previously done before when she received the vaccine as an infant.    The health care professional, was currently asking if it was ok for the patient to receive the influenza vaccination.   The outcome and the causality assessment between varicella virus vaccine live (oka/merck)(VARIVAX) with anaphylactic reaction was not provided.   Upon internal review, anaphylactic reaction was determined to be medically significant.
24 hours after initial injection, a "silver dollar sized" red circular skin discoloration occurred at the site of the shot. 2 days later the edges of the red circle raised and became itchy. I began applying a topical ringworm treatment ( Ointment). During my second dosage appointment when asked if I had a reaction, I showed the nurse my arm and explained what had occurred. She stated that "...it's probably just ringworm" and proceeded to give me the second dosage (4/7/21). On 4/19/21 I noticed several red and dry spots around my torso. Upon my examination on 4/20/21 I was informed that what I had was not ringworm. I was in fact experiencing Pityriasis Rosea. I have no history of Pityriasis Rosea. I believe the location correlation of the initial shot and the "herald patch" are not coincidental.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-JUL-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sweating; Swollen lymph node in neck; Short of breath; Chest pressure; Classified by HCP as "severe" reactions; Body aches; Fevers; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (Sweating), LYMPHADENOPATHY (Swollen lymph node in neck), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest pressure) and VACCINATION COMPLICATION (Classified by HCP as "severe" reactions) in a 66-year-old male patient 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), LYMPHADENOPATHY (Swollen lymph node in neck), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest pressure), VACCINATION COMPLICATION (Classified by HCP as "severe" reactions), MYALGIA (Body aches) and PYREXIA (Fevers). At the time of the report, HYPERHIDROSIS (Sweating), LYMPHADENOPATHY (Swollen lymph node in neck), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest pressure), VACCINATION COMPLICATION (Classified by HCP as "severe" reactions), MYALGIA (Body aches) and PYREXIA (Fevers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   relevant concomitant products usage were not reported by the reporter. Treatment details not included.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Fever and myalgia are consistent with the known safety profile of the vaccine.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chicken pox mostly on her back and arms, but it's spreading. The pts sibling experienced a similar reaction subsequent to vaccination.
-Chills, fever, sore arm at injection site for 36 hours following shot. -Diarrhea 1 time a day on days 3-4 after eating full meal. Continued lower gas pains in lower abdomen.   -Headache starting at back of neck on night day 5. Continued on day 6. Tylenol helped relieve headache and neck ache.
Accidentally gave Moderna vax instead of Pfizer to a 16year old. Parent authorized to be boosted vaccinated by facility since the minor works. No adverse effects noted.  Just usual side effects after vaccination.
pt reports onset of swelling in posterior rt arm on 24NOV98 in the vicinity of pneumococcal vax;swelling cont to an approx 10" x 3" area above the elbow & was accompanied by soreness & sl redness;
EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: 02-OCT-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-OCT-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20211028555.
After very little reaction on the day of besides some weakness and fatigue. The next evening I developed a swollen supraclavicular lymph node on the right  side (same side as injection site) It became hard and painful.
Patient developed nausea, vomiting, was admitted to hospital overnight. C.T. scan showed possible inflammatory bowel disease.
Shingles outbreak a few weeks following second dose. Proceeded to worsen over three days before being prescribed anti-vitals and resolved within a week. No previous shingles outbreaks.
Caller states she received the first dose on 10 APR 2021 and her arm is still severely sore; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 10Apr2021 (at the age of 61-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously had historical vaccine of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration as a single dose for covid-19 immunization. Caller states she received the second dose on 10Apr2021 and her arm was still severely sore. Left arm still severely painful, cannot raise arm. Caller states she went to the doctor on wednesday and she needs to have an X-ray done because your product has done something to my arm. Treatment was pain pills, which was not working. As of 11May2021 she was still experiencing pain in her arm. She does not think this is normal. She saw her primary care last Wednesday. She was in so much pain she had to seek out help and was placed on pain medication. That is how severe the pain is. She cannot raise her arm above her head. She reached out to Pfizer since it's their medication to seek assistance and to try and find out what is going on with her arm. She wants to know why she is still in pain and it's a month and a day later. Caller upset when informed even though this agent is a registered nurse would have to transfer to Medical Information. She stated the number she called previously asked if she was calling about COVID and if any questions to select #1 and that is what she selected. Caller questioned whose fault is that hers or ours. Caller confirmed she has reported this event to numerous people here at Pfizer and stated it's unfortunate we do not keep good records. She confirmed she reported these events yesterday. No reference number provided from previous report. Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Right arm pain and swelling. Treatment included pain medications, antibiotics, antihistamines and continued therapy.
Starting evening after vaccination, some redness and swelling developed on L ant. thigh where Kinrix was given. 4/1/23 > 48hrs later redness and swelling spread to most of ant L thigh and pt reportedly had a fever with fatigue. Pt was referred to ER where she was afebrile and d/c dx was "local T vaccine reaction" but cephalexin prescribed (250mg TID)/ By 4/3/23, 120hr post vaccination ( symptoms were resolving per mom and she was back to normal behavior.