chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme tiredness; nauseated; night sweats; felt weak; light-headed; brief rapid breathing; This is a spontaneous report from a contactable consumer reported for himself.     A 34-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 16:30, at the age of 34 years, as single dose for covid-19 immunisation. Medical history included drug hypersensitivity to penicillin. The patient's concomitant medications were not reported. The vaccine was administered at the hospital. On 31Mar2021 17:00  the patient experienced extreme tiredness, nauseated, night sweats, felt weak, light-headed, brief rapid breathing all with outcome of recovering.  The patient didn't receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.   Information on lot/batch number has been requested.
Admitted for COVID pneumonia. Fully vaccinated. Steroids, O2, vefepime, vanc, remdesivir, baricitinib, vit-c, singulair, zinc, intubated 9/17 and remains on vent support. Dialysis for AKI 2/2 COVID pna. She was given a course of paralytics and underwent proning protocol. She required significant amounts of sedation to assist with vent synchrony. She developed acute renal failure required renal replacement therapy starting 9/25. In working up the etiology of her septic shock, she was found to have positive blood cultures for S epidermidis, S hominis, bacillus species which was found to be a contaminant. She was gradually weaned to minimal vent settings however had issues with hypoactive delirium and would not  demonstrate adequate GCS. Septic shock was presumed secondary to COVID.    On day of passing, patient acutely became hypo-tensive and had worsening shock post-renal replacement therapy. Family made the patient comfort care and she ultimately passed
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick), PERIPHERAL SWELLING (Arm is very swollen, black and blue), SKIN DISCOLOURATION (Arm is very swollen, black and blue) and DYSPHONIA (Voice is shaking) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006BZ1A) for COVID-19 vaccination. The patient's past medical history included COVID-19 (And was worse) in December 2020. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ILLNESS (Very sick), PERIPHERAL SWELLING (Arm is very swollen, black and blue), SKIN DISCOLOURATION (Arm is very swollen, black and blue) and DYSPHONIA (Voice is shaking). The patient was treated with PARACETAMOL (TYLENOL) for Sickness, at an unspecified dose and frequency. At the time of the report, ILLNESS (Very sick), PERIPHERAL SWELLING (Arm is very swollen, black and blue), SKIN DISCOLOURATION (Arm is very swollen, black and blue) and DYSPHONIA (Voice is shaking) had not resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product were not provided by the reporter. After second dose patient experienced headache. This case was linked to MOD-2021-269008. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Patient medical history includes COVID was added.
Pain, erythema and swelling at site where DTAP, Prevnar, HIB administered 11x7 area of erythema.
Dizziness; Bad Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Bad Headache) and NAUSEA (Nausea) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029a21a) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 06-Apr-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Bad Headache) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Bad Headache) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications included for birth control. Treatment details was not reported by the reporter.
Since both vaccines I have yet to feel ok  I have daily headaches, worse than normal fatigue, my Reynauds disease has flared up that is causes me problems coulee times throughout the day where I need to stop working and tend to my symptoms  Joint pain throughout my body (this is only  since my second vaccine)
Vertigo; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 08:30 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. The patient's medical history included asthma and vertigo. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not receiving concomitant medications. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 17Mar2021 at 18:00, two days after vaccination, the patient suffered from severe vertigo and nausea. The patient did not receive any treatment for the adverse event. The clinical outcome of the events nausea and vertigo was recovered in Mar2021.   No follow-up attempts are needed. No further information is expected.
Flu-like symptoms experienced from approximately 12 hours after  injection until about 40 hours after injection (approximately 28 hours total of reactions/symptoms). Symptoms experienced included  site-of-injection arm soreness, nausea, fever (100.2), alternating chills and sweating, headache, fatigue, inability to sleep, and various body aches and pains. Aches and pains included: broad muscle aches, joint aches and skin pain (skin hurt/very sensitive to touch, but did not have rashes).
Thigh swelling developed day after administration; improving as of 11/17. Patient still walking normally.
The patient received a COVID vaccine booster shot the morning of 11/2/21. The patient had been in fine health for a number of months. The patient died suddenly in the evening of 11/2/21. The patient was at his home when he died. Emergency services was contacted. However, by the time medics arrived, the patient was declared dead. The patient was not transferred to a medical facility. The patient's body instead was transferred to an area morgue.
Developed hives on left lower arm (same arm as shot given in), developed a cherry red mark on left and right jaw line and red dots on upper cheek bones-both left cheek and right cheek-mom gave Benadryl for treatment.
Information has been received from a physician concerning a 20 year old female who was vaccinated with the all three doses of GARDASIL vaccine (yeast). The patient reported that after receiving the third dose of GARDASIL vaccine (yeast) experienced decreased in energy level. The patient receive all three doses in anther physician's office, the reporting physician's office, the reporting physician in the case did not administer the of GARDASIL vaccine (yeast). The physician was performing blood tests. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-MAR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 136 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Mild throat irritation noted 29 minutes after administration of 2nd covid19 vaccine. Patient speaking full complete clear sentences. No escalation of symptoms and no new symptoms during monitoring period (extra 20 min). No shortness of breath. Suspect that recent steroid injection to hip 2/4/2021 may have helped diminish reaction to the vaccine. Diphenhydramine 25 mg PO x 1 given prior to discharge from clinic
PT called clinic stating she had a red area, the size of a quarter, and a firm knot at the inject site. Area only sore to touch. Denies fever, red streaks or swelling. Pt advised to use warm compresses and Tylenol for discomfort.
Deltoid area has swollen up severely about 4 times size, neuritic complaints with any motion or movement of shoulder IV Solu Medrol x 1 ordered with diphenhydramine 25mg po.
Large circular area developed 9 days after injection.  Arm is sore, area is tender to touch.  Area is swollen, red, and warm to touch.  Feels like hard knot.
Itch at injection site / unresolved; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received 1st dose of shingrix on an unknown date).   On 17th February 2021, the patient received the 2nd dose of Shingrix. In February 2021, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema. On 22nd February 2021, the patient experienced injection site itching. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details provided as follow: This case was reported by the patient's husband. Age at vaccination was not reported. There was no adverse event related to the first dose. The patient experienced redness at the injection site. The patient also began to itch at the injection site, which began 5 days after the injection. The events were unresolved. The patient was seen by a physician, who did not know how to treat it. The formulation of Shingrix was not known The reporter did not consent to follow up.
Case number PHEH2014US022369 is an initial spontaneous report received from a medical assistant on 05 Nov 2014. This report refers to a 16 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M14056) intramuscularly at a dose of 0.5 ml on 03 Nov 2014. It was reported that the vaccine administered reached 50 F for 30 minutes on 03 Nov 2014. No adverse events were reported following the inadvertent administration.
2 weeks after injection I developed multiple hermetic lesions on my lips.  3 weeks after developed shingles on left neck with neuralgia of face and shoulder  Also increased hypothyroidism.
Red, itching, swollen 12 x 17cm on left upper arm at site of injection. DX ice pack, Benadryl.
Rash all over the body after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over the body after first vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced RASH (Rash all over the body after first vaccine). At the time of the report, RASH (Rash all over the body after first vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Reporter reported that her husband had skin reactions after vaccinations. Patient had not anaphylaxis or other symptoms. The rash went away by itself.   This case was linked to MOD-2022-487144 (Patient Link).
Within minutes of receiving vaccine , patient became diaphoretic and had a vasovagal episode.  Patient returned to baseline and was sent home with mother.
given Bexsero instead of MCV4; 50 yo was given Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 50-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 50 year old patient was given Bexsero instead of MCV4 inadvertently, which led to wrong vaccine administered and inappropriate age at vaccine administration. The vaccine was administered at health department.  Health care professional had no information on the patient at this time. The reporter consented to follow up.
heart rate was 100BPM for 45minutes. I was immediately brought to the Emergency room because of my history of Anaphalxis twice from Sulfa drugs and IV contrast dye. My BP was 179/89 then returned to normal within 30 minutes after vaccine. I was given Pepcid and Benadryl at 5:15. I had a normal EKG and was re,eased by 6:25pm. The rest of the evening I was tires and had a metal tast in the back of my mouth. The following two mornings I woke up with a slight headache but resolved by the afternoon after taking Tylenol.
none. The follow up received on 1/5/04 states child given flu vax inappropriately (under age)-no adverse reaction.
no adverse event; they were administering the 2nd dose to this age group from the vial with the pink cap. Today, 27Apr2023, there were 3 babies all below one year old who were given that; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (they were administering the 2nd dose to this age group from the vial with the pink cap. Today, 27Apr2023, there were 3 babies all below one year old who were given that) and NO ADVERSE EVENT (no adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 27-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (they were administering the 2nd dose to this age group from the vial with the pink cap. Today, 27Apr2023, there were 3 babies all below one year old who were given that). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (they were administering the 2nd dose to this age group from the vial with the pink cap. Today, 27Apr2023, there were 3 babies all below one year old who were given that) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (they were administering the 2nd dose to this age group from the vial with the pink cap. Today, 27Apr2023, there were 3 babies all below one year old who were given that).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721697, US-MODERNATX, INC.-MOD-2023-721696 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721697: US-MODERNATX, INC.-MOD-2023-721696:
Patient was administered second dose of Pfizer vaccine in Nursing Home on 2/5/2021 around noon and was found unresponsive at 5:03AM the following day 2/6/2021. Patient arrived to Hospital in cardiopulmonary arrest and was pronounced dead.
Runny nose, sneezing and. Deep cough with mucus present. It felt like a cold. I got over it within 10 days.
after about 4 hours, I experienced chills, headache, aches and pains similar to flu Some time after injection, I noticed a dramatic decrease in my hearing when I could no longer hear the timer on my stove without being right in front of it.  I already had a hearing loss.  I had to increase the volume on the radio and TV quite a bit.
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: Em9809), in left arm, on 01Mar2021 as dose 2, single (Lot number: En6203), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: Fh8020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Cholesterol" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, start date: Jan2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Other medication in 2 weeks was reported as yes. No Known allergies.
No additional adverse effects were reported; Per the patient she received the MMRII via the incorrect route. Instead of receiving the vaccination subcutaneosly, she received the vaccination intramuscularly; This spontaneous report was received from a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 31-JUL-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), one vaccination intramuscularly instead of subcutaneously (dose, anatomical location, lot # and expiration date were not provided), for prophylaxis. No adverse event was reported.
Mother noticed Left lateral thigh swollen morning of 11/15/18, 11/15/18 lrg red hot area to LT lat thigh4" x 4" w/ "stamp" size area to center darker.
Lips and cheeks were numb and I had a headache and fever with body aches. It lasted two and one half days
Injections DTaP left thigh and Hib given 5/8/03. Later that night left leg hot, red, very hard and sore. Rash on chest 5/9 and 5/10. Third day 5/11 rash spread to abdomen. On 5/12 skin erythematous plaques coalesce over chest and abdomen 1-8 cm, non blanching and somewhat raised. Few small lesions about 1 cm on upper back and inner left anterior thigh, groin region 2-3 cm plaques of erythema as well. Also evidence at injection site left thigh, 3-4 cm area of edema slight induration and erythema almost ecchymotic in appearance. Right thigh where Prevnar given unremarkable.
Extreme fatigue, headache, fatigue, stomach upset, fever/chills lasting 24 hours.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
pt recvd vax;on 11oct94 exp weakness, tiredness, loss of appetite & not able to stand or walk;27OCT94 pt seen in ER; neurological exam was nl & pt was noted to be mobile;pt adm to hosp, tx w/ IVF;
Patient was given vaccine and immediately after was bleeding about 2 cottonballs worth. Bleeding stopped after about 1 minute then a small bump under the injection site developed. After 20 minutes the swelling at injection site went down and patient was asked to monitor and report to pharmacy/PCP if it doesn't go away. Patient denied any other reaction. Also denied taking any blood thinners.
The pt experienced a fever of 101-102, rash to left upper extremity and right wrist, joint pain and stiffness. Saw an MD on 6/19/01.
5 days after vaccination pt noticed her injection site or near her injection site it was red, warm, hot, and itchy. Pt states today, 5 days later, it is improving w/ hydrocortisone cream
The patients received doses of improperly stored Varivax.; This spontaneous report was received from a medical assistant and refers to a 5 patient of unknown age and gender. the patient's medical history and concurrent conditions were not provided.  The reporter stated that between 05-NOV-2019 and 27-NOV-2019, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (product storage error) lot # S014226, expiration date on 04-JUN-2021;  lot # S021926, expiration date on 15-JUL-2021 and  lot # S020159, expiration date on 15-JUL-2021, for prophylaxis (strength, dosage, frequency and route were not provided). The sterile diluent used for reconstitution of varicella virus vaccine live (oka/merck)(VARIVAX)was properly stored. It was stated that the vaccine was under 15°F to 46°F for 2 days 17 hours, 27 minutes and 32 seconds.There were not previous temperature excursion, data logger was positive.
Information has been received from a physician and a 62 year old female patient with penicillin and erythromycin allergy who on 24-MAY-2007, was vaccinated with a dose of ZOSTAVAX (lot # 657675/0618U), subcutaneous in her left arm. Concomitant therapy included TENORMIN, ALLEGRA and ESTRACE. The patient reported experiencing itchiness all over her body 5 months after receiving ZOSTAVAX, in October 2007; also reported by the physician in February 2008. A rash sometimes accompanied the itchiness and on unspecified date, after biopsy was done, it was diagnosed as hives. The physician reported that he thought they were not related to ZOSTAVAX. At the time of the report the patient has not recovered from hives but the physician reported that rash and itching were under control. The patient sought medical attention by her physician and dermatologist. This is one of two reports provided by the same source. No further information is available.