chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; Low grade temp 99.6, chills, tired, headache; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female received first single dose of BNT162B2, (Pfizer, Solution for injection, Lot number: EK 9231, exp date not reported), intramuscular (anatomical location: arm left) on 29Dec2020 09:15 for immunization. Medical history included asthma, hypothyroid, high cholesterol, and allergies: latex and shellfish. The patient was diagnosed with COVID-19 Prior to vaccination.Concomitant medication (Other medications in two weeks) include: magnesium sulfate, ibuprofen, cetirizine hydrochloride (ZYRTEC ALLERGY), levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR), simvastatin, and cimicifuga racemosa root, glycine max extract (BLACK COHOSH & SOY ISOFLAVONES). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility type vaccine: Hospital. The patient experienced low grade temp 99.6, chills, was tired, and headache on 29Dec2020 19:00. No treatment was received. Patient was not Covid tested post vaccination. The outcome of the events was unknown.
light-pink circle at the injections site; This is a spontaneous report received from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via unknown route of administration on 07Apr2021 as a single dose for Covid-19 immunization. Medical history included anaphylactic reaction to mango in the past and had to be at a hospital within 10 minutes and she blew up like a balloon. Concomitant medication included unspecified medications (reported as patient takes like 10 medications a day). She noticed around 14Apr2021 that she has a light-pink circle at the injections site, and it was not itchy or painful. Patient enquired whether it may be an interaction with her medications as she takes like 10 medications a day. Patient second dose was scheduled on the 28Apr2021. And her husband and daughter got the Pfizer COVID-19 vaccine on the same day, and had no injection site reactions, or any AEs. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sustained blood clots in left calf area approximately 6 days after receiving 1st dose.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients. On unknown dates, the patients were vaccinated with doses of GARDASIL, injection (lot #, expiration date and dose unspecified) that were exposed to 8.5 degree centigrade to 12 degree centigrade for 158.5 hours, which was an excursion  that was not supported by in-house stability data. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
On 7/12/99, 4 days post vaccine, the pt experienced acute asthma attack. He was hospitalized and administered standard asthma care for 9 days. He did well in the hospital and was discharged home w/out complications. The reporting investigator felt that acute asthma attack was possibly related to study therapy. No further info is available.
7-11-2021:  Mid chest pain, 7/10 PN scale with1. increase with deep breathing or lying down or increased activity and right and left shoulder pain into trapezial ridge..  Phone consult with ER Dr. at hospital resulted in Urgent Care visit at Urgent care.  ECG and CXR essentially negative.  Rx nitroglycerin, F/U with PCP.  One week  later (7-16-21), first arrhythmic episode, (subsequently Dxd as Afib), lasting 40 minutes, resolving spontaneously. During F/U for chest pain on 7-20-21, another episode of arrhythmia occurred and PCP sent me to ER.  There they did cardioversion, observed overnight due to 8 second flatline post cardioversion procedure.  Echo done, hospitalist    HPI continued:  Saw hospitalist MD, on 7-21-21 and he remarked he thought infection without elaboration. I agreed. I had had some preceding symptoms of sore throat and a temperature of 99.5 which felt feverish as I consistently run 97.3-6 F and I had taken my temperature when I felt quite unusually hot. Dr. Rx  1 tab metoprolol 25 mg PO prn Afib,.   Saw cardiologist at first available on 9-8-21.  MD, cardiologist thought pericarditis though she said no objective findings were evident, but my symptoms fit and began protocol of Colchicine .6 mg BID for 3 months with Ibuprofen 800 mg TID in a tapering protocol of 1-2 weeks.  I both felt and heard , with stethoscope, the cardiac rub off and on for a few days.  However, PCP in F/U did not get to hear as it resolved a week after pericarditis protocol of Colchicine and Ibuprofen were started. Now, two months into treatment for pericarditis it is much less bothersome.  Many days have no symptoms.  A 3rd booster dose of Pfizer Covid-19 vaccine was received on 10/06/2021 at recommendation of Cardiologist.  Another incident of the pericarditis pain began on 10-15-2021 with chest pain, ( 5/10 with deep breath) and SOB.  Symptoms have tapered off with a few days of increased pain by bedtime necessitating sleeping upright.  I am reporting because, as a completely healthy adult, these symptoms seemed to come out of the blue and I had been reading about pericarditis and myocarditis as conditions that matched my symptoms and had mentioned on several visits to medical providers previous to Dr.'s diagnosis.  Subsequently, I read of reports emerging that myocarditis and pericarditis have been seen as adverse reactions to the Covid-19 vaccine and decided to report.
Malaise; Stomach pain; Dark circles under eyes; Both arms go numb all the way to pink; Diarrhoea; Fever; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), ABDOMINAL PAIN UPPER (Stomach pain), DARK CIRCLES UNDER EYES (Dark circles under eyes), HYPOAESTHESIA (Both arms go numb all the way to pink) and DIARRHOEA (Diarrhoea) 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.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise), ABDOMINAL PAIN UPPER (Stomach pain), DARK CIRCLES UNDER EYES (Dark circles under eyes), HYPOAESTHESIA (Both arms go numb all the way to pink), DIARRHOEA (Diarrhoea), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, MALAISE (Malaise), ABDOMINAL PAIN UPPER (Stomach pain), DARK CIRCLES UNDER EYES (Dark circles under eyes), HYPOAESTHESIA (Both arms go numb all the way to pink), DIARRHOEA (Diarrhoea), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medication information was provided.
Patient was given a potentially expired vaccine. Vaccine was mixed on 1/22/22 but was given on 1/24/2022
pain immediately upon the shot; unable to sleep through the night; temperature of 103F; lethargic; dry heaved; severe chills -Shivering; really tired; Body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain immediately upon the shot), INSOMNIA (unable to sleep through the night), BODY TEMPERATURE INCREASED (temperature of 103F), LETHARGY (lethargic) and RETCHING (dry heaved) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN for an unknown indication.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain immediately upon the shot), INSOMNIA (unable to sleep through the night), BODY TEMPERATURE INCREASED (temperature of 103F), LETHARGY (lethargic), RETCHING (dry heaved), CHILLS (severe chills -Shivering), FATIGUE (really tired) and MYALGIA (Body aches). At the time of the report, PAIN (pain immediately upon the shot), INSOMNIA (unable to sleep through the night), BODY TEMPERATURE INCREASED (temperature of 103F), LETHARGY (lethargic), RETCHING (dry heaved), CHILLS (severe chills -Shivering), FATIGUE (really tired) and MYALGIA (Body aches) outcome was unknown.            The patient's medical history was not provided.  patient lab test data not reported. Treatment information was not provided.
pt ran fever & had febrile sz approx 8hr p/vax;adm to hosp 27AUG96 discharged 28AUG96;
This spontaneous report was received from a registered nurse via company representative, and refers to a 21 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On an unknown date in June 2018, reported as "the last week", the patient received a dose of GARDASIL 9 for prevention of human papillomaviruses (HPV) related cancers and diseases (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). It was reported that the patient fainted, immediately after receiving the GARDASIL 9. It was unknown if the patient sought medical attention, if received treatment or if laboratory diagnostics or studies were performed. The outcome of the event syncope was unknown and the reporter did not assess the causal relationship between vaccination with GARDASIL 9 and the event. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1806USA005535.
Day 2..and 3, headache base of skull Day day 2 to present time. Soooo sleepy. Sleep 12 hours a night, nap in day.  June 2 start of stomach or gut hurt, constipated, until June 9,  June  2, beginning of all leg, ankle, knee, hip lower spine pain could barely walk. Lasted until June 10. June 15,soreness and roughness inside cheeks,  June 16, Terrible pain in left knee ,the leg with varicose veins. Feels like nerve knee, up to hip. Leg swelling. Can only walk for a little. Still happening. Also, drinking water goes right through me, comes out almost clear.
I woke up with severe brain fog, cognitive impairment, weakness, vertigo (could not stand up or walk straight). I had chest pain, severe headache and eye pain. This was the worst for the first 48 hours after. I continued with same symptoms but on a 25% reduced intensity 1 week after. I had severe fatigue as well.  While I am feeling better, I continue to have short term memory loss, fatigue, headache and chest pain
Fever to 103F X 2 days. Simple febrile seizure and irritability.
Patient received the second dose of the Pfizer Covid vaccine. Patient has no adverse reaction after dose 1. Patient complained of "a hot feeling going through my body" less than 10 minutes into her observation period. Patient appeared redness on her chest, face and hands. Patient did not complain of any shortness of breath, chest pain, and was alert and oriented x4. patient was advised to check herself for any hives with the assistance of female nurse and complained of lightheadedness upon standing. patient was seated back down and reported the feeling went away. Patient remained A/Ox4 during the entire encounter. Patient denied feeling this feeling before. patient had a radial pulse of 60bpm and a BP of 110/palpation. patient was continued to be monitored as she attempted to contact her family member. patient now reported a headache which she described as "pressure". patient also reported feeling tingling in her hands. patient still had no complaints of difficulty breathing and had no angioedema. 911 was called and EMS arrived on scene. patient care was transferred to EMS.
bumpy rash on left side neck and chest; This case was reported by a physician and described the occurrence of papular rash in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 23rd November 2020, 4 days after receiving Shingrix, the patient experienced papular rash. The patient was treated with dermatologicals nos (Calamine Lotion). On an unknown date, the outcome of the papular rash was recovered/resolved.   It was unknown if the reporter considered the papular rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left deltoid and 4 days later the patient developed bumpy rash on left side of neck and chest, the patient self medicated using calamine lotion.  The adverse event reported as resolved lasting for 2 weeks. The reporter did not consent to follow up.
Pt entered observation @ 0840.  This nurse asked pt if she felt okay @ 0850.  Pt stated that her throat felt scratchy".  Water was offered.  Asked pt how did she feel @ 0900, stated that s/s were still the same.  This nurse administered Benadryl 25mg @ 0904.  @ 0912 pt stated to this nurse that s/s were somewhat better.  Pt remains in observation @ present time, time 0923.  Still remains to voice s/s of distress @ 0933.  States Benadryl 25mg did not alleviate the s/s.  States s/s were worsening.  Epi 0.3mg given @0934.  Administered in L thigh.  Pt sent to ER after administration of Epi 0.3mg. Pt alive and breathing @ 0947, when going into Registration @ ER, still continues to voice s/s of distress to throat.
(L) upper extremity - mild erythema from deltoid - proximal to the elbow with warmth and tenderness. No treatment. Symptoms resolved.
This spontaneous report was received from a physician refers to a 71 year old male patient. The patient's medical history included allergy to penicillin. In 2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (dose, site of administration, lot # and expiry date were not reported). Concomitant medications were not reported. On 29-AUG-2016, the patient developed shingles. He was treated with VALTREX, 1 gram three times daily for a week. The outcome of shingles was unknown. The patient sought medical at the physician's office. The relatedness between the event and ZOSTAVAX was not provided. This is one of two cases received from the same reporter. Additional information has been requested.
Numbness and tingling in both arms, starting within minutes of receiving vaccine. Left arm (opposite of injection arm) cramping/spasms also within minutes of vaccine. Fatigue and headache experienced within 2 hours and lasting throughout next day. Right arm (injection arm) soreness and pain starting about 4 hours after injection, pain plateaued at about hour 7/8 and slowly decreased over next 24 hours. Swelling of right cervical lymph node (under jawline) after about 6 hours. Brain fog started within about 4 hours and persists past 24 hours. Feelings of depression, listlessness began about 24 hours after injection and persisted throughout the day.
Pt calls pharmacy and complains of a high level of pain in right arm. She says skin is of normal coloration and doesn't note anything abnormal. She points out her vein, running the entire length of the arm is swollen, discolored of a red/purple tinge, and throbbing. She has tried ibuprofen for past few days with no relief. Advised pt to seek medical attention.
This spontaneous report as received from a nurse refers to an 18 year old patient. The patient's medical history was not reported. On 07-JUN-2017, the patient was vaccinated with PROQUAD, recombinant human albumin (rHA) or human serum albumin (HSA) (Strength, dose, frequency, route, lot/batch #, anatomical location was not reported) for prophylaxis (Drug administered to patient of inappropriate age). Other suspect therapies included sterile diluent (manufacturer unknown) which was administered on the same day. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved.
Severe Iron deficiency diagnosed 10/2/21 and maintained low through 12/21/21.  No other explanation has there was no change to diet, no bleeding issues, no explainable cause for the drop in iron levels.  The only change was the receiving of the vaccine.10/2
NAUSEA, SEVERE DIZZINESS A FEW HOURS AFTER ADMINISTRATION
Patient should have received Monovalent Pfizer Covid Vaccine but received the Bivalent Pfizer Covid Vaccine.
Lethargic lasted 3 days. Fatigue lasted 3 days. I was diagnosed with premature ventral contractions.
Feeling her eye sore/ It has gotten worse; It is swollen; Arm is really sore too; This spontaneous case was reported by a patient and describes the occurrence of EYE PAIN (Feeling her eye sore/ It has gotten worse), EYE SWELLING (It is swollen) and PAIN IN EXTREMITY (Arm is really sore too) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EYE SWELLING (It is swollen) and PAIN IN EXTREMITY (Arm is really sore too). On 02-Dec-2021 at 2:00 PM, the patient experienced EYE PAIN (Feeling her eye sore/ It has gotten worse). At the time of the report, EYE PAIN (Feeling her eye sore/ It has gotten worse), EYE SWELLING (It is swollen) and PAIN IN EXTREMITY (Arm is really sore too) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were taken by the patient.  The patient stated that she does not have any allergies and she is very healthy.
51 year old female patient received a pediatric dose of Engerix-B; 51 year old female patient received a pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 51-year-old female patient who received HBV (Engerix B pediatric) (batch number KR3XD, expiry date 17-FEB-2025) for prophylaxis.   On 27-JUN-2023, the patient received the 1st dose of Engerix B pediatric. On 27-JUN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 51 year old female patient received a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: 51 year old female patient received a pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 8-Aug-2023 The nurse reported that at the time of reporting, no additional dose had been administered. On 1st August 2023, the patient received adult dose of Engerix-B of lot number 39TZ2 and expiration date 7th September 2023. The vaccine administration facility was the same as primry reporter. The reporter gave permission for follow-up. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
PLAQUE PSORIASIS WORSENED; CONFIRMED POSSIBLE DECREASE IN IMMUNE SYSTEM; HEADACHE; SICK; SKIN PEEL; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (5 days before Christmas 2019 patient came down with the most bizarre cold-like thing patient ever had. It had none of the usual things, did not recognize it. It was very bizarre patient lost sense of taste, sense of smell and felt crappy), and spine surgeries (patient had 4 spine surgeries, rebuilt lumbar region due to a serious accident), and concurrent conditions included: plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested.  Non-company suspect drugs included: apremilast ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for plaque psoriasis; tretinoin (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for plaque psoriasis; and abrocitinib (form of admin, route of admin, and batch number were not reported) 100 mg, frequency, and therapy dates were not reported for plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced plaque psoriasis worsened, confirmed possible decrease in immune system, headache, sick, and skin peel. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with apremilast, tretinoin, and abrocitinib was not reported. The patient recovered from plaque psoriasis worsened, and the outcome of confirmed possible decrease in immune system, headache, sick and skin peel was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.