chrisvoncsefalvay/vaers-outcomes huggingface dataset:
can´t sleep; Couldn't turn head; Could not drive a car for approximately 3 days; Severe pain both sides of head and back of head; almost passed out; very bad neck pain; unbearable pain that wont go away; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (almost passed out), NECK PAIN (very bad neck pain), PAIN (unbearable pain that wont go away), INSOMNIA (can´t sleep) and MOBILITY DECREASED (Couldn't turn head) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pacemaker insertion (cardiac) in 2017. Concurrent medical conditions included Atrial fibrillation since February 2005, Contrast media allergy (allergy to dye - not specified) and Blood pressure high. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, METOPROLOL SUCCINATE (TOPROL) for Blood pressure high.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PRESYNCOPE (almost passed out), NECK PAIN (very bad neck pain), PAIN (unbearable pain that wont go away) and HEADACHE (Severe pain both sides of head and back of head). 03-Mar-2021, the patient experienced MOBILITY DECREASED (Couldn't turn head) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive a car for approximately 3 days). On an unknown date, the patient experienced INSOMNIA (can´t sleep). The patient was treated with TRAMADOL on 03-Mar-2021 for Pain, at an unspecified dose and frequency. At the time of the report, PRESYNCOPE (almost passed out), NECK PAIN (very bad neck pain), PAIN (unbearable pain that wont go away) and INSOMNIA (can´t sleep) outcome was unknown and MOBILITY DECREASED (Couldn't turn head), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive a car for approximately 3 days) and HEADACHE (Severe pain both sides of head and back of head) had resolved.            Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow Up information received on 26 Jul 2021 contains updated patient demographics, relevant medical history, batch #''s, new events (couldn't turn head/couldn't drive a car), reporter causality and event outcomes.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
2 days after Flu vaccine, had bad headaches (not migraines). 3 days after started w/ tonic-clonic seizures that were under control for past 4 yrs. This lasted daily (twice a day) for 2.5 weeks. Increase and constant muscle spasticity. 2 weeks post vaccine and seizures have stopped, but muscle spasms have not.
1 of 3 pts vaxed from the same vial who devel redness & itching w/in 24 hrs of vax; site was red, hot & swollen; seen in ofice dx cellulitis; tx included ceclor for 5 days;
Pt immediately had swelling, redness, tenderness up thigh (same day of vaccination) with limping. She was same today (+) 12x8cm swelling with redness and tenderness left thigh.
Stroke in third branch of middle cerebral artery and intramural clot of right carotid artery
Pt developed a golf ball sized, red welt at injection site, with a smaller, hard knot under the skin, about 24 hours after injection. Area itched for 3-4 days. Today (7 days after injection), skin is still red, but no knot or itching reported by patient.
hard knot; warm to the touch at the injection site; red; bump the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PUSTULE (bump the size of a quarter), VACCINATION SITE INDURATION (hard knot) and VACCINATION SITE WARMTH (warm to the touch at the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LAMOTRIGINE, ROPINIROLE, METOPROLOL, ATORVASTATIN and PANTOPRAZOLE for an unknown indication.    On 03-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 VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PUSTULE (bump the size of a quarter). On an unknown date, the patient experienced VACCINATION SITE INDURATION (hard knot) and VACCINATION SITE WARMTH (warm to the touch at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE PUSTULE (bump the size of a quarter) had not resolved and VACCINATION SITE INDURATION (hard knot) and VACCINATION SITE WARMTH (warm to the touch at the injection site) outcome was unknown. Not Provided      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.   o No treatment medications provided by the reporter.
Dizziness.  Started out as dizzy/lightheaded that only lasted seconds and occurred a few times throughout the week.  A week later (after the 1st dose of Pfizer vaccine), feeling light dizziness/lightheaded off and on that lasts longer.  Not debilitating, more nuisance.
EXCRUCIATING PAIN IN THUMB JOINTS STILL HAPPENING. NEED TO WEAR BRACE ON THUMB AND SOOTHE THE PAIN WITH HEAT
Ill feeling, few scattered maculo-papules across R face and head cheeks flushed, fever, decreased appetite, fussy.
Asymptomatic. Community exposure from positive (8/27/21) grand-nephew.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated improperly stored GARDASIL 9 (lot # L026602 with expiration date 19-OCT-2017; dose and route were unknown). The vaccines were exposed to temperature excursion of minimum (Min) -0.5 degrees centigrade for 3 hours and 39 minutes and maximum (Max) 15.9 degrees centigrade for 16 minutes on 28-SEP-2016; Min 0.8 degrees centigrade for 5 hours 19 minutes on 29-SEP-2016; Min 0.7 degrees centigrade for 5 hours 37 minutes on 30-SEP-2016 and Min 1 degrees centigrade for 2 hours 26 minutes on 01-OCT-2016. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
GI disturbance; inadvertently received 5 times the normal dose of the Pfizer Covid 19 maroon cap for his second dose; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team. The reporter is the parent.  A 2-year-old male patient received BNT162b2 (BNT162B2), on 19Aug2022 as dose 2 (maroon cap), 15 ug single (Lot number: FT9142) at the age of 2 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FT9142), administration date: 28Jul2022, when the patient was 2-year-old, for COVID-19 Immunization.  The following information was reported: OVERDOSE (non-serious) with onset 19Aug2022, outcome "unknown", described as "inadvertently received 5 times the normal dose of the Pfizer Covid 19 maroon cap for his second dose"; GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "GI disturbance".  Additional information: Serious criteria reported as no. Doctor stated that instead of 3mcg the patient received 15 mcg. The doctor was seeking any information available on this happening. Higher-than-authorized dose volume. Poor training was the contributing factors to the medication error.The medication error didn't affected the patient or consumer with clinical consequences. The reporter said there have been no adverse events experienced by the patient. The reporter felt the overdose event occurred due to poor training. Upon follow-up on 29Aug2022, the patient seemed to have done very well following the vaccine overdose. He never had any injection site reaction, and there was a small chance that the GI disturbance he experienced was related to the vaccine, but it is hard to say with a 2 year old. The patient was exposed to covid Wednesday 24Aug2022, and tested positive yesterday 28Aug2022 via PCR test, and was doing quite well. He has some Covid symptoms but nothing too bad. The patient has a runny nose and a cough (upper respiratory, not a lower chest cough) so the physician felt he was relatively well protected from more severe Covid symptom by getting the vaccine.  No follow-up attempts are possible. No further information is expected.  Follow-up(22Aug2022): This is a Follow-up spontaneous report from a contactable Physician in response to HCP telephonic follow-up activity.  Updated information included: Vaccine facility information added; additional information updated.  Follow-up (29Aug2022): This is a spontaneous follow-up report received from a contactable Physician. This physician reported in response to HCP telephonic follow-up activity which included that:  Updated information included: New event added and clinical course updated.
After the first dose I was very tired and I could not get out of bed the next morning. I did not have a fever but I was sweating a lot. I had joint pain but that lasted only for a day. Then, I got the second vaccine in the morning and at night I was very tired and I felt there was something weird in my body. I felt the same way as I did with the first dose. The only difference is that I still have joint pain and fatigue. I am very tired. I have low energy. I am a very active person but this is keeping me from doing my daily activities since it takes a lot of energy off me. On 08/11/2021 I went to the doctor and they did some tests, Sedimentation rate, PCP IGG ABS, vitamin D, lipid panel, CMP, RA test qualitative, ultra PSA third generation, complete blood count, and everything came back normal. When the doctor examined my joints it really hurt.
Moderna Dose 1 2/20/21 (023M20A) Moderna Dose 2 3/20/21 (045A21A) COVID Positive 5/12/2021  5/12/21: Presented to ED. The patient is a 85-year-old male with a past medical history significant for coronary artery disease status post multiple drug-eluting stents, hypothyroidism.  Patient is coming in with chief complaint of weakness and fatigue which has been going on for the past 1 week.  Patient states that he received his COVID-19 vaccination and completed the course of COVID-19 vaccination at the end of March 2021. He has a history of drug-eluting stents and goes for cardiac rehab and states that he has been extremely weak unable to perform much in the cardiac rehab program.  At this current point in time he denies any fevers chills shortness of breath chest pain abdominal pain nausea vomiting diarrhea constipation.  5/15/21: Patient was admitted for generalized weakness and COVID-19 test returned positive.  He had been vaccinated and received 2 doses the COVID vaccine the last dose being in March.  Initially was on a couple L of oxygen however there was no evidence of pneumonia on chest x-ray.  Was able to be weaned to room air on hospital day 2. Did have some issues with low sodium which may be related to the COVID-19 infection.  Was placed on a free water fluid restriction of 1 L and sodium did improve at the time of discharge.  Will be recommended to have a repeat BMP in 1 week.  He was given 2 doses of remdesivir given his weakness as well as comorbidities making him at risk for worsening COVID-19 infection.  Patient worked with PT and OT and had improvement in his strength.  He does have a walker at home which she will use as needed.  He will follow-up with his PCP and no medication changes were made. Home health was offered but he declined.
Patient developed a severe skin rash with hives involving 80% of his body 9 days after the vaccine was given.  Initally his feet were spared.  He had sores on his face, but no facial edema.  The rash has felt like an intense burn.  He has been on oxcarbazepine since Sept, 2013 without any history of rashes or adverse effects.  There were no other new factors other than eating a strawberry 7 days before the rash, and he does not normally eat them.   He was seen in urgent care and started on a prednisone taper, now at day #6 of 9, plus hydroxyzine.  Hives have resolved, but his skin still is erythematous and burns.
Swelling, hard bump, redness, hot to the touch, itching, and is painful. This comes and goes. It's been 2 weeks already. I've put on neosporin cream. I've applied cortisone cream. Nothing seems to help enough.  It looks like a stripe. It is about 2 inches by 3 inches and raised up about 1/4 inch.
L arm swollen, erythema, warm, pruritus.  Rxn extends from L shoulder to below elbow & is nearly circumferential, marked edema.
Had minor side effects after PC and HIB in November 2015 and January 2016 of fevers and rashes on face and foot. After DTAP and ROTA in December 2015 had less frequent bowel movements. February 2016 he had DTAP again and the following day his bowel movements got worse. The entire next 2 months he only had a bowel movement once per week after we wpuld give him a suppository. Large hard stool that hurt him and made him cry. For months we tried over the counter remedies and nothing worked. Went to pediatric gastro intestinal doctor with no help. Severe constipation. Finally started him on magnesium supplementation in August 2016 which has helped.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. No medical history, concurrent conditions or concomitant therapy was reported. On 17-MAR-2016, the patient was administered with a dose of improperly stored ZOSTAVAX injection (lot # reported L027327, expiration date 21-OCT-2016; dose and route of administration not reported). The previous excursion was reported as 12.2 F for 694 hours (cumulative) and the new excursion was reported as 7.7 F for 16 hours (new total cumulative was reported as max temperature 12.2 F, total time 710 hours). No adverse effect was reported. Lot number L027327 is an invalid lot number for ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.
4-6 hrs following vaccine - increased severe abdom. pain - like broken glass in gut. No arm tenderness. Pain increased severe over next few days. Rigid belly - no appetite - nausea/chills. Seen in urgent care facility, next day Hosp. ER - Xray (-), Blood work normal - pain required I.V. DILAUADID - D/C home. Worked with GI - MD - CAT scan with contrast after premedic. Prednisone, BENADRYL. Endoscopy with biopsy. Increased fatigue, severe headache, joint pain over 3 wks.
Patient reports that is 6 weeks late for her menses since getting second dose of Pfizer Covid vaccine.  Prior to the second dose of vaccine, she has had 4 normal periods
Patient came in with redness and what seems to be a rash on the upper arm where she received the injection site. It is raised up at the injection site and warmer than usual, so I advised her to put ice pack for a bit and take TYLENOL for the pain. If the rash spreads, advised her to see the doctor today. Will follow up with patient tomorrow.
Redness was reported as worsened.; itchiness/ the injection site has become itchy; Redness/ the injection site has become red; Swollen/ the injection site has become swollen; Tender to touch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 13:00 (Lot number: FF2593) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2, Date: 29Mar2021, LOT: EPG955 , administered in left arm), administration date: 29Mar2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose:1, Date: 08Mar2021, LOT: EN6199, Expiration date: unknown, administered in left arm), administration date: 08Mar2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PRURITUS (non-serious) with onset 31Oct2021, outcome "not recovered", described as "itchiness/ the injection site has become itchy"; TENDERNESS (non-serious) with onset 27Oct2021, outcome "not recovered", described as "Tender to touch"; VACCINATION SITE ERYTHEMA (non-serious) with onset 31Oct2021, outcome "not recovered", described as "Redness/ the injection site has become red"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Redness was reported as worsened."; VACCINATION SITE SWELLING (non-serious) with onset 30Oct2021, outcome "not recovered", described as "Swollen/ the injection site has become swollen". Therapeutic measures were taken as a result of vaccination site pruritus, tenderness, vaccination site erythema, condition aggravated.  Additional information: No other products. No investigation assessment. She had at the injection site has become swollen, red, and itchy. The itchiness started yesterday. She added, the area was tender to touch. Tender to touch started soon as got injection, which was Wednesday 27Oct2021. Treatment was given as just apply ice on 27Oct2021. Additional vaccines administered on same date of the Pfizer Suspect was none. No emergency room, Physician Office visit. Prior Vaccinations (within 4 weeks) was None. Relevant Tests was None.  No follow-up attempts are possible. No further information is expected.
pt recv vax &  p/vax lab results showed that no seroconversion occurred;lab test used was varicella zoster antibody IGG-corning;
Information has been received from a physician concerning a male patient who was born prematurely who on 08-APR-2008 was vaccinated orally with ROTATEQ.  Concomitant vaccinations on the same day included PEDVAXHIB (MSD) and "other 2 month vaccinations."  On 13-APR-2008 the patient experienced a bowel obstruction and was hospitalized.  It was unspecified if lab studies were performed.  Subsequently, the patient recovered on an unspecified date.  It was noted that the patient's twin brother did not experience any complications after receiving ROTATEQ.  There was no product quality complaint involved.  Additional information has been requested.
Expanding swelling/redness (R) thigh after immunization given on 12/10/10 without fever. Pt given ANCEF shot & put on KEFLEX today (12/13/10).
Janssen COVID-19 Vaccine EUA injection was on Saturday. Injection site became hot and very painful late Sunday. The pain has not decreased over these several days and radiates down to my thumb. Monday the site became raised and has a hard bump under the skin.  Tuesday the raised hard bump has a slight peak similar to a mosquito bite and is becoming itchy. Today/Wednesday there has been no decrease in symptoms.
Throat swelling, trouble swallowing, chills, nausea, aches, sore arm
Arm slightly sore from the shot; I was fatigued the next day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm slightly sore from the shot) and fatigue (Verbatim: I was fatigued the next day). The outcome of the pain in arm and fatigue were resolved.   The reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the reporter considered the fatigue to be related to Shingles vaccine.  The company considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the fatigue to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles vaccine.  The patient stated that arm was slightly sore from the shot and he/she was fatigued the next day but he/she was good now.  The reporter further stated that he/she had done power yoga and spin, lifted and no issue. The follow up would not possible as no contact details were available.
Head rush when the shot was administered. Symptom subsided and returned 30 minutes later. I felt lethargic and irritable the rest of the day. The following day, on 12/29/20, I began to run a fever in the evening of 101.1 and a severe headache persisted from the previous day. On today?s date, 12/30/20, my temperature was 101.4 in the morning. Prior to receiving the vaccine, I felt completely normal and had no fever.
Fever (tmax 100.9), headache, and fatigue with body aches and chills that began the day after receiving the vaccine. 7x8cm area of erythema, warmth and induration at injection site.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: Gh9702) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive; (02Mar2023) Positive, notes: positive COVID test after recovery/ negative test; (2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 21Feb2023 to 26Feb2023).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken with ritonavir (PAXLOVID), from 04Jan2023 to 08Jan2023 for covid-19 treatment as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12Nov85 pt vax w/ MMR; 26Jan91 devel measles.