chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tiredness; headache; felt out of it; tingling tongue and lips; tingling tongue and lips; body spasms in abdomen throughout the night; This is a spontaneous report from a contactable other healthcare professional, the patient.  A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3248, via an unspecified route of administration on 18Jan2021 at 10:15 (at the age of 44-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included Fluoxetine hydrochloride (PROZAC), valaciclovir hydrochloride (VALTREX), Cetirizine hydrochloride (ZYRTEC ALLERGY) all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took iodine and experienced drug allergy. On 18Jan2021 at 12:00, the patient experienced tiredness, felt out of it, tingling tongue and lips, headache, body spasms in abdomen throughout the night. The patient did not receive any treatment for the events. The clinical outcomes of tiredness, felt out of it, tingling tongue and lips, headache, body spasms in abdomen throughout the night were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Itchy, red spot appeared at vaccine site one week after 1st dose. Slight pain, swelling and hardness noted. No appearance of infection. Spot has continued to increase in redness over the past three days. No other symptoms noted; no treatment necessary.
Pt received both Fluzone and Pneumovax. Had red, swollen arm; was feverish according to pt. Pt found in grand mal seizure around 2000. Pt found to be hypoxemic, wheezing, tachycardic, tachypnic in ER. Inj site was red and swollen.
Nausea; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2022, the patient received the 1st dose of Shingrix. On 1st September 2022, 1 days after receiving Shingrix, the patient experienced nausea and dizziness. On an unknown date, the outcome of the nausea and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the nausea and dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: The reporter was a patient's husband. The reporter reported that the patient received Shingrix vaccine. On the day of reporting, she started to experience nausea and dizziness. Symptoms had not resolved. Did not consent to follow-up.
Chills; Fever; Pain at Injection Site; Nausea; Severe Headache; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received Shingrix. On 17th July 2019, 1 days after receiving Shingrix, the patient experienced chills, fever, injection site pain, nausea and headache. On an unknown date, the outcome of the chills, injection site pain, nausea and headache were unknown and the outcome of the fever was recovering/resolving.   It was unknown if the reporter considered the chills, fever, injection site pain, nausea and headache to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient who was also a pharmacist. The patient experienced chills, fever, pain at injection site, nausea, severe headache following administration of Shingrix vaccine. Fever was 102 degree F, which came down to 99.5. The patient's normal temperature has been reported as 97.6 degree F. The patient reported that the patient never remember chills like last night post SIngrix. The reporter did not consent to follow-up.      Lab Comments: The patient's body temperature on an unknown date was 99.5
coughing; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported for a 15-year-old male patient (Reporter's Grandson) that: A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 17May2021 as dose 1, single for covid-19 immunisation. Medical history included ongoing asthma. The patient's concomitant medications were not reported. The reporter stated that patient took his first dose of the vaccine last Monday, 17May2021 and was "now" coughing. "PRIVACY" called to ask if coughing was one of the side effects of the vaccine though she mentioned that "PRIVACY" has also an underlying condition, asthma. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was accidentally given a high dose flu shot instead of the normal under 65 year old dose.
Client stated, "I am having heart beating fast, I feel hot, and I feel like it's hard to breathe."  symptoms lasted 2 minutes, then completely resolved after rest, water, snacks given and laying supine in gravity chair.
This spontaneous report was received from a Medical Assistant, and refers to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 04-AUG-2016, the patient was vaccinated with an improperly stored VARIVAX (lot # M000996, expiration date 07-JAN-2018 (concentration, dose and administration route were not reported). The patient's concomitant medication was not provided. Additionally, No adverse reactions were reported. This is one of two reports received from the same source. Additional information has been requested.
So far: Extreme body aches-left side only Severe Joint pain-left side only Headache  Nausea  Chills-bad chills like shivering really bad  Fatigue   My body is hurting like I feel like I got the flu.    All symptoms began at 3:00pm on 5/7/2021, and progressively worsened as the day/evening/night went on.  The symptoms still have been going on as on 5:11pm today, 5/8/2021, now coupled with:  Sweating Loss of appetite
I was diagnosed with chicken pox (varicella without complication)  at the Hospital Urgent care facility on 2 August 2021.  within 14 days, on 14 August - I went to the emergency room with severe abdominal "Right Upper Quadrant" pain.  It was diagnosed one day later as shingles - herpes sine zoster
right abdominal vesicular rash with erythema, pruritits for 8 days turning into dry scaly skin (not painful)
Extreme fussiness. 101.6 degree temperature 3/22/13, 3/23/13, 3/24/13. 99 degree temperature 3/25/13. Fussiness. Diarrhea 3/26/13.
This spontaneous case was reported by a consumer and describes the occurrence of DYSPNEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy) and FEELING ABNORMAL (going to die) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.  Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), PREDNISONE, METHYLPHENIDATE HYDROCHLORIDE (RITALIN), PIMOZIDE, POTASSIUM and BUMETANIDE (BUMEX) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy), HEART RATE INCREASED (elevated heartbeat), PAIN (pain across chest and shoulders), SWELLING FACE (face swelling), JOINT SWELLING (ankle swelling), DIZZINESS (Dizziness) and DIARRHOEA (horrible diarrhea). On 19-Mar-2021, the patient experienced AGEUSIA (loss of taste), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme tiredness). On 11-Apr-2021, the patient experienced SWELLING (toe become swollen). On an unknown date, the patient experienced FEELING ABNORMAL (going to die). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DYSPNOEA (Difficulty breathing), FEELING COLD (felt cold), DYSGEUSIA (metallic taste), COLD SWEAT (clammy), FEELING ABNORMAL (going to die), HEART RATE INCREASED (elevated heartbeat), PAIN (pain across chest and shoulders), SWELLING FACE (face swelling), JOINT SWELLING (ankle swelling), DIZZINESS (Dizziness), DIARRHOEA (horrible diarrhea), SWELLING (toe become swollen), AGEUSIA (loss of taste), PYREXIA (fever), CHILLS (chills) and FATIGUE (extreme tiredness) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
SHvering, muscle pain, tiredness, groggy head, and racing heart from 12 am - 12 pm.
Blood clot behind left knee found on 3/11/21 and traveled to lungs.  Admitted to hospital for Heart Failure from Chemo, PE and pneumonia.
Mother notified physician that around 3:00 PM patient would become silent and start to roll eyes into the back of the head. She denied any fevers or shaking. Patient's eyes would roll into the back of the head a couple of times. Time between episodes  was around 30 min. - 1 hour. Mother states it is noticeable between 3-6:00pm. This happened daily for the next 6 days. No treatment at home. Patient was referred to neurologist.
Hard at site of injection; Swollen underneath site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard at site of injection) and VACCINATION SITE SWELLING (Swollen underneath site of injection) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-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 05-May-2021, the patient experienced VACCINATION SITE INDURATION (Hard at site of injection) and VACCINATION SITE SWELLING (Swollen underneath site of injection). At the time of the report, VACCINATION SITE INDURATION (Hard at site of injection) and VACCINATION SITE SWELLING (Swollen underneath site of injection) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Patient developed fever of 102 degrees 4 hours after the vaccine, significant rash, induration and erythema at the sites of BOTH inoculations (Deltoids), with swelling that extended over the anterior chest wall on the left side. She also complained of localized pain bilaterally and has been fussy.
Eight days after receiving the Moderna shot I woke up in the morning  (3/22/2021) with irregular heartbeat.  My family doctor confirmed via EKG that I was in Atrial Fibrillation (Afib).  Blood samples were taken, test results were normal. Blood thinners were described. Went to see a cardiologist (3/23/2021) where the Afib was confirmed. Following that visit an echocardiogram of the heart was performed, results were normal. Afib turned into persistent mode and I decided to undergo a cardioversion (4/21/2021) to bring my heart back into regular sinus rhythm. Even though the cardioversion turned out to be initially unsuccessful, I experienced the last Afib episode at the end of last month (4/28/2021).
This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of an unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 25-JUL-2016, the patient was vaccinated with the second dose of MMR II (lot # K008625, expiration date: 16-JUN-2016, dose, route of administration and frequency were not reported), that was expired. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Neck pain, fatigue, headache 48 hours after flu shot, (negative exam for meningitis). Treatment: rest, ice, MOTRIN, massage of neck, monitor Sx, push fluids.
This patient developed a seizure disorder, consisting of eyes opening and closing, rhythmical shaking (1 min), deep sleep (5-10 min), bit his tongue, multiple drop attacks, jerking, head falls forward, loss of consciousness, stiffening. It could be possible Doose's Syndrome which occurs in children normal or mildly delayed development. On 12/19/00, the patient had a Prevnar injection. 12/21/00, fever of 102. 12/21 - 12/22/00, given children's Tylenol 4-5 times. 12/22-12/24/00, traveled by car to New York with his family. 12/24/12/25/00, the mother had a bug, throwing up and diarrhea. 12/00 - 12/31, sinus congestion. 12/25/00, 4:20 PM, had first seizure, whole body. Eyes initially open with movement. Limbs, torso and jaw all tight with some shaking. About 1 minute in length. Deep sleep for 5-10 minutes afterward. Ambulance to hospital ER. Few hour observation and back home. 12/25/00, 9:00 PM, second seizure. Not quite severe as the first. Still close to a  minute. Ambulance to the hospital ER. 12/26/00, 1:00 AM, third seizure in the hospital ER dept, given Ativan. Same day at , 4:00 AM, CT Scan. He had a fourth seizure while being moved from the ER dept to pediatrics; given Dilantin IV, also started on Depakote sprinkles. He was still having "mini seizures" a few times. Kind of like a momentary black out or twitch or grunt. On 12/27/00, at 3:00 PM, He had his fifth seizure. 3 hours after leaving the hospital. Shortly after waking up in back seat of the car, less than 30 seconds. Not as severe as the others, probably due to medication ramping up. Back to the hospital in an ambulance. They gave him Depakote IV at 6 PM, totaling 6 times. On 12/28/00, the hospital increased the Depakote sprinkles, the last Depakote IV was at midnight. On 12/29/00, He was given Glycerin suppository and discharged from the hospital with a fleet enema to take at home that night (it did the trick). 01/04/01, 4:30 PM, he had his 6th seizure for 1-2 minutes went to the hospital started on more meds.
Gave patient vaccine at 9:55 AM. Patient was instructed to hang out seated in the pharmacy department for 15 minutes. Patient was feeling fine and proceeded to head to customer service counter in store where he lost consciousness falling forward hitting his face on the counter, and then fell back hitting the back of his head on the floor.
High fever (101) within two days of the shot being administered; Severe arthritic pain; Severely swollen glands in throat and neck (difficulty swallowing); "ghost-like" color to my extremities.  All symptoms appeared within two days and are now continuing throughout the entire day (entire day of symptoms began on the 19th and still continue).  I have had this vaccine 4 times now.  Two of the others I could get no proof of.  I haven't had a MMR shot in 11 years until now.  I have seen no studies about over-vaccination. The proof of two shots were required by my university and given by them.  Will file again if condition worsens.
nurse inadvertently administered an expired dose of MENACTRA with no reported adverse event; Initial information received on 23-Jan-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old female patient and it was reported that nurse inadvertently administered an expired dose of meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   On 20-Jan-2023, the patient was inadvertently administered an expired dose (0.5 mL) of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection (batch/lot number: U7140BA and expiry date: 07-Nov-2022; strength: unknown; 1X) via intramuscular route in the left deltoid for immunization (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01456176:
Patient came to pharmacy with his son when had a drug RXn and also said he experienced nausea, vomiting, severe joint pain, extreme fatigue after his vaccination lated couple of days
Patient developed soreness, fever approx. 6 hours after Tdap.  Was OK during night.  Developed fever to 102 degrees with headache, chills, paleness.  Redness & tenderness at site.  Seen today in office.  Dx with cellulitis at injection site.  Put on Keflex 250 TID x10d, Advil 200 mg 1 6-8 hrs & Benadryl 125 q 6 hr.  Fever resolved today (1/11/08).
Patient received Moderna vaccine at age 17. Moderna is only approved for ages 18 and older. Patient was unclear about his age at time of vaccine with no ID.
Arm was sore; 1st dose received on 2019 and second dose received on 26Apr2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 2019 received 1st dose).   On 26-APR-2023, the patient received the 2nd dose of Shingrix. On 26-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose received on 2019 and second dose received on 26Apr2023). On an unknown date, the patient experienced pain in arm (Verbatim: Arm was sore). The outcome of the pain in arm was not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt date: 15-MAY-2023 The reporter reported the patient received Shingrix vaccine and experience the arm was sore. The reporter consented to follow up. The patient received 2nd dose of Shingrix vaccine later than the recommended interval, which led to lengthening of vaccination schedule.
Tunnel vision, ringing in ears, extreme pain on left side from neck to knee, headaches, nausea, shortness of breath
Went to local ED   for R chest pain beginning within 24 hour of 5th COVID shot; labs unremarkable; told was dehydrated and had COVID; treated with IVF and bebtelovimab
Erythema papules on the L side of lower chest and L side of back on the same injection site of vaccine
Fever, UrticariaPruritus, extreme soreness,itching, warmth, redness, swelling at site;  right jawline sensation; loss taste/smell; fatigue; T100.4
After receiving the 2nd dose of Moderna I experienced a zinger of fiery hot pain. It felt like a zap in my body. Since I've been very weak and can't go 10 feet because my arms are weak and it hasn't gotten any better. I feel very limited as to what I can now do. I'm always in pain and it takes a toll on your body.
Information has been received from a consumer and a physician concerning an 8 year old male with "allergies" and allergies to nuts and tomatoes who on 25 Apr 2001 was vaccinated with a first dose of Varivax.  On 02 Dec 2006 the patient developed a moderate case of chickenpox with a "couple hundred" lesions (also reported as 500+ breakthrough chickenpox lesions). The lesions were reported to be "everywhere" including his mouth and tongue. The patient had difficulty swallowing. The patient did not have a fever. Medical attention was sought, no lab studies were performed. The patient was treated with topical Benadryl and Aveeno baths. It was reported that the lesions were not diagnosed as breakthrough chickenpox until 04 Dec 2006. At the time of the report the patient had not recovered thought the physician reported that he felt that the patient would recover and return to school in the beginning of the following week. There was no product quality complaint involved. The consumer considered the patient's chickenpox to be disabling. The physician reported that the patients chickenpox could be considered disabling since there are four other children that the patient lives in close contact with, therefore increasing the possibility that they may contract the disease. Additional information has been requested.
This spontaneous report as received from a Nurse refers to multiple patients of unknown ages and genders. The patient's pertinent medical histories, concurrent conditions and drug reactions were not reported. On an unknown dates multiple patients were vaccinated with improperly stored GARDASIL 9 lot # M011117 (dose, route, anatomical location and expiration date were not provided). Temperature excursion 0.5 Celsius degrees; time frame 9 hours and 30 minutes. No previous temperature excursions and the digital data logger was not involved. No adverse effects were reported. No other suspect or concomitant medications were reported. No product quality complain was involved. Additional information has been requested.
Case PHEH2016US025813 is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to 65 year old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1618521) at a dose of 1.0 ml (overdose accidental) intramuscularly on 03 Oct 2016. No adverse event was reported following this medication error.
Hospitalized 10/3/22-10/5/22 Cough, body aches, SOB, weakness, fatigue, dizziness, dyspnea,
pt recv vax 29OCT98 & by evening p/vax pt exp swelling in the inj are, redness & rash @ inj site, pain in arm;pt taken to ER that evening;pt visited MD next day;pt arm remained swollen @ time of report;MD felt there was no assoc w/vax & sx;Annual follow-up received on 11/27/00 provides no additional data.
It was reported that a 41 year old female pt received an Imovax IM and a Rig Imogam vaccination on May 2, 2000. Reportedly that same day the pt developed a headache, muscle aches and mild fever. The pt was self medicated with Vicodin. Pt was evaluated in hospital and held for 24 hours for observation and discharged. A neurologist evaluated the pt for a headache.
Patient received FLUZONE on 10/9/15 at approx. 11 a.m. then 6 hours later woke up from nap with itching and hives over neck, arms, which then spread to trunk, legs. Went to urgent care given DEXPAK and advised BENADRYL prn.