chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 9 years old patient was administered FLUBLOK QUADRIVALENT with no adverse event; Initial information regarding this unsolicited valid non-serious case from a nurse was received and transmitted to Sanofi on 12-Oct-2020.  This case involved a 9-years-old male patient received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2042, expiration date- 30-Jun-2021) via intramuscular route in unknown administration site (Product administered to patient of inappropriate age) for prophylactic vaccination on 09-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. No other concomitant drug was given.  It was a case of an actual medication error due to inappropriate age at vaccine administration (Latency: Same day).  At the time of report no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
On April 12 I received the J&J vaccine, 2 days later I began having bruising on my arms and legs and pernio in my left index finger which resolved. From April 20 ? present, my symptoms are flushing in face/chest/arms, high blood pressure, fast heart rate, back pain, upper body muscular pain, headaches, nerve pain in limbs, bruising on legs and torso, body tremors, swollen lymph nodes, diarrhea, Raynaud's syndrome in toes, petechiae, paresthesia, neuropathy (burning, electric shocks in legs and groin). Post vaccine, I have been diagnosed with labile hypertension, deep vein insufficiency in the left CFV, connective tissue disorder unspecified, mast cell activation syndrome, depression, and Post traumatic stress disorder. Currently schedule to be tested for dysautonomia on October. There is no medical history in my family for autoimmune, disautonomia or mast cell issues.    Treatment is ongoing and includes blood pressure medication, Naltrexone for autoimmune, prednisone in past, anti inflammatory supplements, physical therapy, cognitive therapy, antihistamine diet, allergy medication, SSRIs.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-MAY-2004, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 06-SEP-2016, the patient was treated by a physician at an internal medicine office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. He was prescribed VALTREX for management for his painful symptoms and chronic pain.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of GARDASIL (Lot # not reported) (0.5 ml, intramuscular route). Concomitant therapy was not reported. On an unknown date the patient had a "syncopal episode" after getting a GARDASIL injection and "bumped his head". It was unknown if it was the patients first dosage of GARDASIL. The outcome of bumped his head and syncopal episode was reported as recovered. Additional information is not expected.
Information has been received from a registered nurse concerning a male patient "in his 70's" who on 20-NOV-2007 was vaccinated with 0.5 mL of pneumococcal 23v polysaccharide vaccine (lot #658447/1132U). There was no concomitant medication. On 20-NOV-2007, the patient could not move his arm due to pain after he received the vaccination. He had pain in his arm and shoulder. There was no redness or swelling. No further information was available. Additional information has been requested.
First symptom occurred four weeks after the booster shot with an intense deep pain in the right arm pit. Gastrointestinal symptoms began shortly there after along with discomfort from my neck to my groin. Discoloration of skin initially starting on left abdomen/stomach region then continuing to my groin area. Discoloration has expanded and the pain has intensified and expanded into both armpit regions radiating along my sides and in my upper forearms. The pain is 24/7 with no relief. If standing or walking for prolonged periods, intense pressure in my groin region.
Within five or so minutes of the shot, I felt my heart was racing and I felt sweaty and dizzy/lightheaded.  I called someone over and my pulse was measured at 96 and blood pressure at 136 (I usually am <110).  I stayed for a half hour for observation and my blood pressure lowered to 121 and I felt better.  I was not anxious prior to the shot or when the shot happened, and I have never had a reaction to vaccines (I regularly get the flu shot and did in 2020).  Several hours later I feel fine (except for a sore arm), but I saw on the handout that this is listed as a possible severe reaction and I want to know if I should get the second shot.  I didn't ask at the site because I was feeling better and didn't read the handout.
swollen upper lip/upper fat lip; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiry date: unknown), via an unspecified route of administration on 12Mar2021 as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient got the first Pfizer COVID-19 vaccine on Friday (on 12Mar2021). Two days later (on 14Mar2021), she has woke up with a swollen upper lip/ upper fat lip and it won't go away. She didn't see it as a reported adverse reaction with the vaccine and she called to have that confirmed. The patient has not seen that as a symptom listed anywhere. She has had no other problems, her arm didn't hurt, she had nothing else bother her. Her second dose was scheduled for 02Apr2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
I was nauseous from 8am until about 7pm. Couldn?t even get out of bed. Prior to 8am I felt fine.
This is a spontaneous report from a contactable other healthcare professional (HCP). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiration date: unknown), second dose via an unspecified route of administration in her left arm on 12Feb2021 at 10:30 as single dose for covid-19 immunization. Medical history included asthma, gastrooesophageal reflux disease (GERD), attention deficit hyperactivity disorder (ADHD), depression from an unknown date and unknown if ongoing. Concomitant medication included trazodone, sertraline hydrochloride (ZOLOFT), methylphenidate hydrochloride (CONCERTA), omeprazole magnesium (PRILOSEC [OMEPRAZOLE MAGNESIUM]), all from an unspecified date for unspecified indication. The patient previously took her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 20Jan2021 at 10:30 on her left arm for COVID-19 immunization. On 12Feb2021 at 18:00, the patient experienced swelling/pain at injection site, low grade fever, muscle aches, neck and back pain, nausea, decreased appetite and malaise. The outcome of the events was recovering.
progressively weaker; no mental status change physician diagnos; Guillian-Barre. MR received from hospital stay revealing an 81 yr. old man who presented to the ER with worsening, progressive weakness in his lower and upper extremities several days after receiving flu shot. HPI: Pt. had several episodes of being unable to get up from toilet or out of chair due to leg weakness. Became unable to use walker due to weakness in his arms. Admitted to hospital for diagnosis.  A plueral effusion was noted and treated with thoracentesis. Patient progressed to dysphagia requiring PEG tube palcement. Due to worsening respiratory failure he was placed on a ventilator and trached 6 days after admission. DX: Guillian-Barre. MR received from vax. provider. No new COSTARTS, but received date of vax and date of AE (submitted). Received fax with Manufacturer Chiron Lot # 69480.
Fainted after getting up to use the restroom in the middle of the night. Fainting resulted in injury to my chin and head. Had to get 7 stitches in chin from falling into dresser. I have no memory of falling. Only remember using restroom and be woken up from the floor by my husband.
A week after receiving the shot I have a rash and swelling on the injection site. It is itchy and very hot.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 13-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ(lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
started feeling really sick; lightheaded; didn't feel well; felt hot; felt like she was going to pass out; vomiting; nauseated; right shoulder became very sore; right shoulder became tender; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like she was going to pass out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stevens-Johnson syndrome. Concurrent medical conditions included Allergy to antibiotic (Name unknown. Antibiotic caused Stevens-Johnson Syndrome.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore right arm). On 03-Mar-2021, the patient experienced TENDERNESS (right shoulder became tender) and ARTHRALGIA (right shoulder became very sore). On 17-Mar-2021, the patient experienced PRESYNCOPE (felt like she was going to pass out) (seriousness criterion medically significant), MALAISE (started feeling really sick), DIZZINESS (lightheaded), MALAISE (didn't feel well), FEELING HOT (felt hot), VOMITING (vomiting) and NAUSEA (nauseated). On 03-Mar-2021, TENDERNESS (right shoulder became tender) and ARTHRALGIA (right shoulder became very sore) had resolved. On 17-Mar-2021, PRESYNCOPE (felt like she was going to pass out), MALAISE (started feeling really sick), DIZZINESS (lightheaded), MALAISE (didn't feel well), FEELING HOT (felt hot), VOMITING (vomiting) and NAUSEA (nauseated) had resolved. At the time of the report, PAIN IN EXTREMITY (sore right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; 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.
Patient received vaccine  about 5 minutes later he was pale, cold to touch, slouching and sweating. reported not feeling well.  reported not being able to hear anything being said to him.  Pressure was normal but he  responsive but was almost to the point of passing out was  sweating profusely. After laying on ground for a few minutes he was responding better said he has poor response to needles . He has passed out previously with needle stick. Emergency services was called patient was evaluated and released in good condition.
Injection site reaction consisting of pain, redness and swelling through day 5. Redness, itching and pain are continuing. Contacted pharmacy where vaccine was given and pharmacist advised watching injection site and if continues to worsen or no signs of improvement to seek medical attention through local urgent care.
Pt vaccinated 2/25/01. Aprox 60-90 minutes after vaccination, pt noted feeling hot and itchy, she looked in the mirror and was red/blotchy all over. She took 25mg benadryl as she was driving home and took another 25mg benadryl 20-30 min later when she arrived home. She continued to feel hot and itchy so took benadryl for the next 48 hours before those symptoms resolved.  On day 4 after vaccine (2/29/01) pt began to notice redness in her right eye. The eye became more "bloodshot" as the day progressed and started feeling painful and "pressure" sensation. She went to see ophthalmologist urgently who diagnosed it as acute scleritis. She is currently on NSAIDs and topical steroid.  She notes that the eye is very photosensitive and has significant "pressure" sensation. She is still experiencing these symptoms almost 3 weeks later.
Shortly after receiving the vaccine I found it hard to breath for about 5-10 min.  Developed horrible chills,  headache and body aches soon after. I have had the the chills before but only with a covid shot and they didn?t happen right away like this did. Lasted for about 16 hours. This was for the Influenza Quadrivalent High Dose P-free
patient got 0.5ml of moderna booster dose instead 0.25ml. no adverse events were seen at this moment
Fatigue; chills; nausea; vomiting; This is a spontaneous report from a non-contactable other health professional. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm, from 30Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included anxiety and intermittent SVT (supraventricular tachycardia). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Concomitant medication included escitalopram and buspirone for anxiety. On 01Jan2021 19:00, the patient experienced fatigue, chills, nausea and vomiting. The outcome of events was recovered. No treatment was required/received due to the events.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
08/22/2003: Redness, swelling 4 cm x 6 cm, given Zyrtec and Tylenol.
5 days after shot I got a hot rash on forhead and chin, day 6 I woke up with itchy, red, hot and painful rash on arms after about a hour I could feel same rash on ankles then it moved up my legs about 8 hrs later rash moved to my somache and up the sides of ribcage and back. It currently is all over my body even ears and top of hands. The skin is  painful red, extremely Itchy and very hot to the touch
This spontaneous report was received from a Registered Nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-APR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX23 (therapy type digital data logger) (lot # L029073, expiry date 19-APR-2017) dosing details unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to a temperature excursion of 31 degrees Fahrenheit (10 cycles) in the month of April 2016 for a cumulative time frame of 200 hours. It was reported there were no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not filed. The outcome of temperature excursion was reported as not supported. This is one of the three reports received from the same reporter. Additional information has been requested.
flu-like symptoms; Feeling Sleepy; Headache; Body ache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th July 2019, several hours after receiving Shingrix, the patient experienced influenza-like symptoms, sleepiness, headache and general body pain. On an unknown date, the outcome of the influenza-like symptoms, sleepiness, headache and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, sleepiness, headache and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. On 30th July 2019 morning, the patient received a dose of Shingrix in right deltoid and at night, the patient started experiencing flu-like symptoms, feeling sleepy, headache and body ache (pain). The symptoms were still the same today at the day of reporting. The reporter consented to follow up.
About 5-10 min after imz administered, mom brought her out of the room with a red, blotchy macular rash on her head, face, neck, trunk & (L) leg. No resp. distress or wheezing noted. Taking a bottle in NAD. There was a large red area in the (L) upper thigh where the PREVNAR & Hep B was given. After 15 min observation the rash was clearing & still no resp. symptoms. Inc mom to give ZYRTEC.
anaphylactic reaction, 2 hours after vaccine administration, no foods eaten after; diffuse itching, feeling can't breathe, bronchospastic cough-frequent, prolonged expiratory phase; resolved after epinephrine/albuterol/benadryl
ACHY; HURT TO MOVE EYES FOR ABOUT  60 HOURS; RUNDOWN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced achy, hurt to move eyes, and rundown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, hurt to move eyes, and rundown. This report was non-serious.
Started experiencing dizziness on the day of the second dose (4/30/21). Dizziness continued for 2 weeks and then stopped for a week and came back and have been experiencing it for almost 2 months now. Have gone to 7 doctor visits including an opthemologist, the emergency room twice and my primary care physician and a walk in clinic. I have been prescribed servers medications which do not alleviate the symptoms including meclazine, hydroxaline, scopolamine, amoxicillin, prednisone, Valium, and reglin (for headache). About 3 weeks after getting the second dose I began experiencing headaches so I went for a CT scan in the ER on 5/24 which came back normal. I returned to the ER on 2/27 with blurry vision and was sent for an MRI on my brain and neck which also came back normal. I have upcoming appointments with a neurologist and an ENT next month. I have also been experiencing muscle aches for the past 3 days specifically in my joints, my arms, and legs. I have also had headaches that feel like my head it being sliced or stabbed on the right side.
Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced FATIGUE (Tiredness). At the time of the report, FATIGUE (Tiredness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. The reporter stated that the patient took a nap, got up and was fine. No treatment was provided.   This case was linked to MOD21-087572, US-MODERNATX, INC.-MOD-2021-110137 (E2B Linked Report).; Sender's Comments:  MOD21-087572:Wife case US-MODERNATX, INC.-MOD-2021-110137:Wife case