chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed a rash on the back of my left arm. Since then, the rash has spread to the palms of my hands, ankles and soles of my feet.; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 55-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 10Apr2021 08:00 (Age at vaccination: 55-years-old) as single dose for covid-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, Lichen Planus from an unknown date and unknown if ongoing (I have an autoimmune skin disorder called Lichen Planus. It was in remission for the last 15 years). Concomitant medication included metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 on 20Mar2021 08:00 in left arm for covid-19 immunization. Patient was not diagnosed with covid prior vaccination. Patient had no Known allergies. It was reported as patient have an autoimmune skin disorder called Lichen Planus. It was in remission for the last 15 years until after he received the second dose of the Pfizer vaccine. Approximately two weeks after receiving the second dose, On 23Apr2021 12:00 AM patient developed a rash on the back of his left arm. Since then, the rash has spread to the palms of his hands, ankles and soles of his feet. Patient was not tested for covid post vaccination. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with Topical Cream. The outcome for the event was reported as not resolved at the time of this report.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (24Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored MMR II. Strength, dose, route and lot number were not provided. MMR II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014: Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on 14-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the MMR II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per Lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The MMR II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476, 1405USA012478 to 1405USA012482 and 1405USA004216). Additional information has been requested.
Vaccine coordinator reporting the administration of improperly stored VARIVAX. See Temperature Excursion case 02298756. No PQC reported.   ?    Names of vaccines involved: VARIVAX (W018830 06/14/2024)         ?    Temperature: -5C         ?; This spontaneous report was received from a physician referring to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 01-DEC-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot #W018830 had been verified to be a valid number; expiration date  14-JUN-2024, and upon internal validation established as the same date) (dosage, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number and expiration date were not reported). The administered dose of the vaccine was stored at a temperature of -5 degrees Celsius (C), during a time frame of 12 hours, as recorded by a digital data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA003157:MSD
6  days after first dose, went for checkup with (cardiolist).  Afib  was acting up for the first time in seven years. Dr. increased his carvedilol. After the second dose of covid, we checked his pulse rate and it was  34 beats per minute. Irregular heart pattern  was occurring.  Went to NP, who told him to go back to original dosage.  Still reading in the thirties, so called (Internal  Medicine doctor)  He told him to get off medicine.  It took 10 days to get to 70 beats per minute with no afib. Still not taking the carvedilol.
CDC revised administration of Covid vaccine by eliminating the monovalent and advising to administer with first dose bivalent. Days later it was advised to increase the initial dose of 6 months- 5 years bivalent Moderna to the 6 years and up. This vaccine was administered prior to the increase being communicated to us. It was only recognized when we attended a Moderna information session. This was not communicated until April 28th through the local Health Dept..
Approximately 11:00pm on Tuesday, April 20th, patient experienced red, itchy splotches on abdomen and chest. As of Friday April 24th, rash has started to subside, but still present.
Client Employee called to say today that her Lt arm above the elbow is red, sore and swollen since site had the flu vaccination Monday 10/14/02.
Injection site was swollen, itchy and had a red spot; Injection site was swollen, itchy and had a red spot; Injection site was swollen, itchy and had a red spot/now little red dots; Felt tired; Forehead was a little warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Forehead was a little warm), INJECTION SITE PRURITUS (Injection site was swollen, itchy and had a red spot), INJECTION SITE SWELLING (Injection site was swollen, itchy and had a red spot), INJECTION SITE ERYTHEMA (Injection site was swollen, itchy and had a red spot/now little red dots) and FATIGUE (Felt tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CITALOPRAM, TAMOXIFEN, VITAMINS NOS and CALCIUM for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced FEELING HOT (Forehead was a little warm) and FATIGUE (Felt tired). On 08-Mar-2021, the patient experienced INJECTION SITE PRURITUS (Injection site was swollen, itchy and had a red spot), INJECTION SITE SWELLING (Injection site was swollen, itchy and had a red spot) and INJECTION SITE ERYTHEMA (Injection site was swollen, itchy and had a red spot/now little red dots). On 07-Mar-2021, FEELING HOT (Forehead was a little warm) and FATIGUE (Felt tired) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site was swollen, itchy and had a red spot), INJECTION SITE SWELLING (Injection site was swollen, itchy and had a red spot) and INJECTION SITE ERYTHEMA (Injection site was swollen, itchy and had a red spot/now little red dots) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) in response to the events was not applicable.
Fever, coughing, rash, irritability.  Seen 11/21/03 and 11/06/03.  Chronic cough 12/08/03.  Recurrent M/P rash 02/16/04.
2 x 2 red hot itchy localized reaction at Tdap 9/15/15 site which started 1 day after injection.
redness; heat; soreness; Initial information received on 27-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an adolescent male patient who experienced redness, soreness and heat, while he received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE].  The patient's medical treatments, vaccinations, concomitant medications and family history were not provided.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date on Friday, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date on Sunday, the patient developed a non-serious redness (erythema), soreness (pain) and heat (feeling hot) two days following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Reported Adverse Event Information: It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: FLUZONE MULTIDOSE VIAL (MDV). It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  The outcome of events was reported as unknown.  There will be no information on the lot number for this case.
Myalgia, NauseaVomiting, Fatigue, chills Narrative:
Patient fainted and had seizure activity lasting approximately 5 seconds (approximately 5 mins after administration). Patient had never had side effects with previous HPV-9 admin. No prev. HX of seizures. Only HPV-9 given at this appointment.
1/8/21 Left arm,  right leg soreness. (Resolved)  1/11/21 headache, vomiting, chills  (resolved) 1/11/21 Left under arm soreness,  lymph node swelling thru 1/20/21.   Today Underarm soreness had resolved, swelling has decreased, but still somewhat swollen.
Adult pt thought that 1st dose was Pfizer and requested 2nd dose in series be Moderna. Moderna 0.5 ml dose was administered based on this. It was discovered later that pt had actually not received Pfizer but, Janssen (one dose) given on 2/10/2022.  Pt reports that he has been experiencing frequent headaches since receiving the 1st Covid vaccine on 2/10/2022. He denies any changes since receiving dose on 3/26/22. I recommended that he see a medical provider d/t reports of headaches.
ELEVATED LIVER ENZYMES; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have any medical history. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-SEP-2021, the patient experienced elevated liver enzymes. Laboratory data included: Blood test (NR: not provided) Elevated liver enzymes (did not tell the exact number). The action taken with covid-19 vaccine was not applicable. The outcome of elevated liver enzymes was not reported. This report was non-serious.
Patient started with a rash and itching of the head. He then started with a rash and itching of his back. Patient went to bed and when he woke up this morning, patient still had rash and itching of head and back, but now includes face, arms, and legs. Patient took 25mg of Benadryl PO.
Pt recvd vax 20AUG92 & 24 hrs following vax pt devel 3 to 5 little pin-point pimples @ inject site which later scabbed & resolved in 1 wk; also devel some trunk flushing or hot flashes which persisted for approx 2 wks;
Patchy red skin on both thighs. Slightly itchy.; Patchy red skin on both thighs. Slightly itchy.; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 21Jan2021 at 09:45 at a single dose on left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced patchy red skin on both thighs, slightly itchy on 21Jan2021. Therapeutic measures were taken as a result of both events (steroid cream). The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Pt never had a reaction to the flu vaccine.  Pt had received an adult dose.  That is the reason  it was reported.
Approximately 6 minutes after receiving vaccination patient begin to complain of left neck pain radiating to lower back/waist.
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves female patient of unknown age who experienced headache from her head to the bottom of her neck and had a swollen gland under her armpit not on the same side where she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site. On unknown dates, the patient developed a non-serious headache from her head to the bottom of her neck and had a swollen gland under her armpit (latency was not reported) following the administration of INFLUENZA VACCINE. (Other relevant tests included No lab data.) Final diagnosis was has a swollen gland under her armpit and headache from her head to the bottom of her neck. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for headache from her head to the bottom of her neck and as Not Recovered / Not Resolved on an unknown date for had a swollen gland under her armpit.
Felt dizzy; Elevated heart rate; throat felt like it was getting tight; A regulatory authority report was received from a 72-year-old  white female consumer who received Moderna's COVID-19 vaccine and experienced dizziness, elevated heart rate to 151 and throat tightness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 19-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273(Lot number:013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 19-JAN-2021, 2nd day after receiving vaccine, the patient felt dizziness, elevated heart rate and tightness in throat. She went to ER for treatment.  Treatment details were not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome for the events dizziness, elevated heart rate to 153 and throat tightness were not resolved at the time of report.
Severe under arm pain on second, third and fourth day, enlarged lymph nodes.. Redness and swelling of shoulder on second day, Severe itching at injection site on third and fourth day, fever on third day. Urgent care thought it is expected symptoms for some.
Pt got the shot in his left arm and developed a stroke on his right side the following day.
1 hour after Hep B shot baby developed hives on stomach back arms legs.  2258 same date - hives faded.  No problems.  No treatments.  0105 - 092908 - hives gone.
after 2nd dose of vax I was sick, low grade fever, headaches, pain in my throat lymphnoids both sides, pressure in ears and now I cannot hear in my right ear and my left ear has pressure and I have headaches that are ongoing
Brain Fog Continuous.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 05:45(at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, type 2 diabetes mellitus, blood pressure high and cholesterol high. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (TIROSINT), semaglutide (OZEMPIC), lisinopril (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN) and colecalciferol (VIT D). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 05Mar2021 at 08:30 as a single dose for COVID-19 immunisation.  On 27Mar2021 the patient experienced brain fog continuous. The patient did not receive any treatment for the event.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event brain fog continuous was not recovered at this time of report.   No follow-up attempts are needed. No further information is expected.
Hives broke out on my torso, hips, arms and neck. Upon waking up in the morning my hands, arms, neck and ears are swollen. I took 1 Zyrtec before bed.
Itchy red rash on the left arm. Patients says it was larger and worse then when she showed it to me.
Patient was experiencing arm pain and ringing in the ears the morning after she received the immunization. She was still having these symptoms two days after the vaccine and called the pharmacy to report.
Employee received first Covid19 vaccination on 12/31/2020.  Five days post vaccination developed swelling in left neck per employee larger than tennis ball, tender to touch,warm to touch slightly painful to touch . Size has decreased daily to now the size of tennis ball today. Did not report until today.  Covid EHS notified and employee will also call them.
Patient was administered pediatric Moderna instead of the Moderna dosage appropriate for her age.   I let patient know that a mistake was made and I administered the correct dosage for the patient the same day.
Warm to the touch; Tingling; Dollar coin-size welt on my left arm where I received the vaccine; Itching; Small marking on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), PARAESTHESIA (Tingling), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SCAR (Small marking on my arm) and VACCINATION SITE URTICARIA (Dollar coin-size welt on my left arm where I received the vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced VACCINATION SITE SCAR (Small marking on my arm). On 18-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Itching). On 19-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), PARAESTHESIA (Tingling) and VACCINATION SITE URTICARIA (Dollar coin-size welt on my left arm where I received the vaccine). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), PARAESTHESIA (Tingling), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE SCAR (Small marking on my arm) and VACCINATION SITE URTICARIA (Dollar coin-size welt on my left arm where I received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Diarrhea; Dry Skin; Arm Pain; Redness; Itchy Sensation - All Over Body; Restlessness; Tingling Sensation - All Over Body; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DRY SKIN (Dry Skin), PAIN IN EXTREMITY (Arm Pain), ERYTHEMA (Redness) and PRURITUS (Itchy Sensation - All Over Body) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis, Inflammatory bowel disease, Osteopenia and Carpal tunnel syndrome. Concomitant products included PARACETAMOL (TYLENOL) for Osteoarthritis, Inflammatory bowel disease, Osteopenia and Carpal tunnel syndrome.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), DRY SKIN (Dry Skin), PAIN IN EXTREMITY (Arm Pain), ERYTHEMA (Redness), PRURITUS (Itchy Sensation - All Over Body), RESTLESSNESS (Restlessness) and PARAESTHESIA (Tingling Sensation - All Over Body). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form. At the time of the report, DIARRHOEA (Diarrhea), DRY SKIN (Dry Skin), PAIN IN EXTREMITY (Arm Pain), ERYTHEMA (Redness), PRURITUS (Itchy Sensation - All Over Body), RESTLESSNESS (Restlessness) and PARAESTHESIA (Tingling Sensation - All Over Body) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication included blood pressure medication. Treatment included "Tylenol", "calming lotion" and "body wash" to alleviate the symptoms.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 31-DEC-2015, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 800 hours, with the highest recorded temperature of 48 degrees Fahrenheit and -1.66 to 8.88 degrees Celsius. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.