chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Sick sick. Fever muscle aches. Swelling 3 days at injection site. Unable to perform daily functions for 36 hours
Pt felt unwell on 6/25 PM. Developed fever of 101 and vomited x 2 early on 6/26. On 6/26-no->headache, myalgias, fatigue and arm pain.
axillary lymphadenopathy b/l (resolved as of exam 18 OCT 2021), also with persistent generalized fatigue / non progressive and worsening of previously well controlled (with allergy shots for) seasonal allergies
This spontaneous report as received from a medical receptionist (healthcare worker) refers to a 9 months old patient of unknown gender. On 12-MAR-2014 the patient was inadvertently administered a 0.5ml dose of VAQTA (lot# unspecified) ("injection 25/0.5 U/ml" as reported) location and frequency unspecified, route as intramuscular. No adverse event reported. Additional information has been requested.
schizophrenia; already received the Janssen Covid vaccine; already received the Janssen Covid vaccine; supposed to receive an antipsychotic injection/got a Pfizer BioNTech Covid vaccination; This is a spontaneous report from a contactable pharmacist. A 71-year-old male patient received the second (booster) dose of BNT162B2 (COMIRNATY, Lot#: FF8839, NDC: 59267-1000-01, Expiration Date: 31Dec2021) at single dose on 27Oct2021 at the age of 71-year-old for COVID-19 immunization; the first dose of COVID-19 VACCINE JANSSEN at single dose in Mar2021 for COVID-19 immunization. Medical history included ongoing schizophrenia; ongoing hypertension. Ongoing concomitant medications included haloperidol; amlodipine for hypertension; lisinopril for hypertension. Patient had schizophrenia came in today and was supposed to receive an antipsychotic injection, but the pharmacist was confused and thought he wanted the Covid vaccine because it was a Covid vaccine clinic and got a Pfizer BioNTech Covid vaccination on 27Oct2021, happened around noon. Patient received the Pfizer Covid vaccine and then they found out he already received the Janssen Covid vaccine in Mar2021. Patient stated his mother was concerned and wondering if it would cause issues. Patient asked if there were any interactions with Haldol Decanoate injection with the Pfizer BioNtech Covid-19 vaccine, it confirmed as not serious. The event reported as schizophrenia on 27Oct2021. The outcome of events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event (Schizophrenia aggravated) cannot be excluded but consider also ongoing condition of Schizophrenia.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
This was a medication error.  The wrong student was vaccinated at the school.  School pulled this student from class and brought him to the on-site vaccine clinic with the paper consent of another student.  These two students have the same first name and same first surname, but different second surnames and DOBs, and they are in the same class.  Our vaccinator administered flu mist to this student.  The student who was vaccinated did not have a consent signed by his parent.  No adverse outcome.  The school contacted both families (the family of the child who should have been vaccinated with flu mist and was not and the family of the child was was not scheduled to be vaccinated and was vaccinated.  Our vaccine branch staff made several attempts to reach the family of the child who was mistakenly vaccinated, and has not connected with anyone to date.  Our vaccine branch staff looked the child up in Vaccine System, and this child had not yet received his flu vaccine for this season.
telephone call from mother of child states child has 12 chickenpox lesions in arm pit on arm shot given;mom was to call clinic 27JUL98 but did not;28JUL98 phone # left by mom is not in service;
Pins and needles on the left thumb and face, Subjective facial paralysis sent to ED for eval
A sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A sore arm) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and INFLUENZA VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (A sore arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (A sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.   Reporter did not allow further contact
Severe Abdominal pain that over the counter medication did not help severe headaches. Now they are treating me for ulcers and saying ulcerative colitis which ive never had before. They kept taking my blood over and over stating it was drawn too fast.
12/28/2021 - Brought to ED SOB. Hypoxic to 91% en route. Placed on 2L O2NC - sat 96%. WBC 11.9, D-dimer 772. Vitals WNL. Admit for respiratory failure secondary to Covid 19.  Started on Decadron, Ceftriaxone, Doxy, Remdisivir. Avoiding Baricitinib due to elevated LFTs AST-352 and ALT-337. Chest XR reveals clear lungs.  12/29 - Changed Ceftriaxone to Zosyn due to possible anaerobic coverage in the setting of pneumo/abdominal source. Continued all other treatments. Weaned to 02 to RA sat 95%. 12/30 - Planning for discharge. Respiratory status normal.  12/31 - Asymptomatic. Discharged to home with Augmentin.
COVID break through report. I received my booster shot on 12/06/2021 and my adverse event started on 05/14/2022. I had a scratchy throat in the evening at 17:00. The next day I had a cough, chills, sore throat, chest pain and a headache.   I called my doctor and he prescribed me anti viral medication. On May 14, 2022, I tested positive for COVID. I am still recovering.
knee pain; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (knee pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included CORTISONE for Arthritis.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (knee pain). At the time of the report, ARTHRALGIA (knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.   Reporter did not allow further contact
PT WAS GIVEN 3RD VACCINE 3 MONTHS TO EARLY.  2ND SHOT WAS GIVEN IN SEPTEMBER 2021.
Moderna COVID-19 Vaccine EUA Itchy vaccination site with hives one week after being vaccinated. No other symptoms.
05/2022 Within 12 hours of vaccination, I woke up in middle of night I was running a fever, felt like throat was swelling, achy, hot. Arm was sore. This continued to run fevers. I had husband take me for 2 COVID-19 tests. Blood pressure kept spiking to over 200's and then dipping real low below the 100's. I started wearing my cuff daily. Regular Dr. said to go to the ER.  Adjusted some medicines at the ER. Put on prednisone, high doses. Almost for 2 1/2 weeks. My blood pressure continued being off the charts. It only recently started to go back to normal digits. The worst was 216/116. Dr and ER said to never to take the vaccinations again. It delayed me getting my breasts MRI and biopsy, delaying my health care after the vaccination.
Mother calls in 4/30/12, reports client had 99 degrees temp starting 9 AM 4/24/12. Continued in spite of TYLENOL/Ibuprofen until evening of 29th to ER Dpt. Fever 102 at home, in ER 100.5. Ear infection not noted in ER, client to PMD this AM and (L) ear infection noted. Ordered antibiotic - to start now (2:30p). Child had been off antibiotics 5 days (for otitis) before vaccines given. Not eating well, drinking OK. Encouraged to increase fluids.
pt presents to ED with c/o increasing SOB, congestion, non-productive cough x 1 day; states had a positive COVID test on 9/30/21; has resumed chemotherapy; admitted to hospital;  bacterial pneumonia; started on ABX, steroids, O2 supplementation; respiratory status continued to worsen; pt transitioned to comfort care measures only and he passed away in the hospital
burning and discomfort at injection site, then discomfort under arm, down arm,forearm,  up neck, and behind shoulder area; same day toe joint pain; numbness and prickly sensation starting on top of feet then into lower shins/legs, then hands; runny nose, fatigue;  next day day added itching and rash at upper thighs; crawling sensations or sensation of bugs  landing on skin; joint pain, left hand tremor; continue with prickly/needles sensations, crawly sensation, joint pain, toe pain, itching, fatigue. Also had face rash briefly today.  Wondering if I might be allergic to some of the secondary ingredients
Patient given TRUMENBA vaccine at 09:50am this morning. Immediately nauseated, dizziness, and ringing in ears. Patient kept for 30-40 minutes post vaccination for recovery. Given water and allowed to sit. Symptoms subsided within the 40 minutes.
Suspected vaccination failure/I had the 2-shot vaccine and still get; Still get, just got over a bout; Exhausting painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the 2 shot vaccine and still get them. The patient was just over a bout. The patient stated that exhausting painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Took covid vaccine on 1/26/2021 first dose with reaction of fever on post vaccine day 1 and 2 and cough starting 3 days ago Fever free for last 24 hours . Last fever was 1/27/2021.   Dizziness today for 4-5 mins ,non since . No rapid or slow heartbeat, chest pain or other sx    Tingling of both upper extremities. Feels like the world is spinning around him.  Also gets some tingling in hands and arms which is mainly on the left.  Feels some spasms and body aches.  Legs hurt at times.  Feels like he is out of his skin..
Patient was administered with vaccine - post puncture that was exposed to non suitable temperature for over 24 hours.
No additional AE's; A caller stated that an expired dose of GARDASIL 9; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 29-AUG-2021, the patient was vaccinated with a expired dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 time dose, expiry date 23-JUL-2021 for prophylaxis (strength, route of administration, and lot number,were not reported).  The vaccine did not experienced temperature excursion and no additional adverse events were reported.
Soreness at injection site; dizzy; Heart raced; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), PALPITATIONS (Heart raced) and INJECTION SITE PAIN (Soreness at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, METFORMIN, ATORVASTATIN, LOSARTAN and HYDROCHLOROTHIAZIDE.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (dizzy) and PALPITATIONS (Heart raced). On 13-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness at injection site). On 15-Feb-2021, INJECTION SITE PAIN (Soreness at injection site) had resolved. At the time of the report, DIZZINESS (dizzy) and PALPITATIONS (Heart raced) had resolved.        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.
Side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects). At the time of the report, ADVERSE EVENT (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-049532 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up was received on 07-may-2021 and contains no significant information
Patient states that she woke up 10 days after her first vacation with an itchy left arm. Reported a 3-4 inch welt to her left arm and a headache that day. States she took come Tylenol and then felt better.
No additional AE reported.; ROTATEQ was improperly stored and administered; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 14-OCT-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally administered (lot number S040076 which has been verified to be valid, expiration date reported and validated as 15-JUN-2021) (dose and frequency were unknown by the reporter; vaccination scheme was not reported) as prophylaxis. The administered dose of the vaccine was stored at a temperature of 11.35 degrees Celsius (C), during a time frame of 40 hours, as recorded by a digital data logger. There were previous temperature excursions on 07-OCT-2020: 9.45 C, during a time frame of 1 hour and 30 minutes; on 09-OCT-2020: 11.86 C, during a time frame of 11 hours and 15 minutes; and on 10-OCT-2020: 10.23 C, during a time frame of 1 hour and 45 minutes. No additional adverse events were reported in the patient.
developed an allergic reaction; had difficulty breathing; This is a spontaneous report received from a contactable consumer (parent). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Three days later on 29Mar2021, the patient developed an allergic reaction and she had difficulty breathing. Events were assessed as non-serious by the reporter. The outcome of the events was unknown. The reporter was querying if the patient should get the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Using 1 inch needle during injection per patient weight and arm appearance, felt like needle him bone from past experience, pulled back slightly and injected full dose to patient.  By looking at patient arm thickness doesn't seem that the needle would have been long enough to hit bone.  To best knowledge patient got injection in muscle. patient himself counseled and denies having any metal or anything in his arm.  Patient reports "hard skin" due to diabetes and did not have any pain on injection or blood from injection site.
This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. No information was provided about the patient's concurrent conditions, pertinent medical history, drug and/or allergies reactions. The patient's concomitant therapy included sterile diluent (STERILE DILUENT). On 22-DEC-2021 the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (recombinant Human albumin) (PROQUAD) 0.5 milliliter (ml), lot # T021639, expiration date: 21-DEC-2021, subcutaneously for prophylaxis (expired product administered). No product quality complaint (PQC) and no additional adverse event (AEs) were reported
0944 Patient experienced nausea and vomiting after vaccine; vitals BP- 132/88, P-123, O2 saturation-97%.  Patient has history of same in the past post vaccine.  No other symptoms; no SOB, no diaphoresis.  Patient feels anxious with tingling in hands.  Patient was given water and is feeling better.  She does not want any further medical intervention.  Patient is advised to call 911 if further medical need arises.  Patient has girlfriend in the car to drive her home.  0954- vitals- BP- 110/78, P-98, O2 saturation- 98%.  Patient?s anxiety decreased, hand tingling is gone.  No more nausea and vomitting and feels back to normal.  Released home after monitoring.
On the evening of 1/15 patient went to bed about 10 PM.  woke up at midnight coughing and vomiting.  That finally subsided and at 3 AM awoke with severe diarrhea.  That subsided on saturday morning about 10 AM and has not returned
I received the high dose flu shot at 3PM on 9/10/14. Three hours later my tongue swelled on the left side. Pain and difficulty swallowing. Injection arm was red and warm to touch. I was put on prednisone and BENADRYL.
Headache, fatigue and nausea. No treatment and no improvement. Recommend patient get tested for flu.
Weight gain; Blood pressure high; Splitting nails; Pain in arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain), HYPERTENSION (Blood pressure high), ONYCHOCLASIS (Splitting nails), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and IBRUTINIB (IMBRUVICA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain), HYPERTENSION (Blood pressure high), ONYCHOCLASIS (Splitting nails), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue). At the time of the report, WEIGHT INCREASED (Weight gain) and HYPERTENSION (Blood pressure high) outcome was unknown and ONYCHOCLASIS (Splitting nails), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 160/90 mmHg and mmHg Increased. On an unknown date, Laboratory test: numbers are good. On an unknown date, Platelet count: Normal. On an unknown date, Weight: 5 pound weight gain. On an unknown date, White blood cell count: Normal.         No concomitant and treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
The lymph nodes along my neck are swollen; This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3246) on 11Jan2021 15:00 (at the age of 35-year-old) via an unspecified route of administration, administered in arm left as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included none. Patient had no allergies. Patient had COVID prior vaccination. Patient's concomitant medications were not reported. Patient has not received any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL0140) on 21Dec2020 15:00 (at the age of 35-year-old) via an unspecified route of administration, administered in arm left as 1ST DOSE, SINGLE for COVID-19 immunization. On 18Jan2021 12:00, the patient's lymph nodes along the neck were swollen. Patient did not receive any treatment for the adverse event. The patient underwent lab tests and procedures which included Nasal swab (PCR): negative on 23Jan2021. Outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Pt c/o of feeling tired, no pain, slight dizziness, no headache, no SOB. Pain score is 0. Pt is alert and oriented x3. Skin warm and dry. Walks with steady gait.
Initial information received on 25 September 2012 from a company representative. The information was reported to the representative by a nurse, who was informed of the events by a student nurse practitioner. Three unidentified patients (no individual patient identifiers provided) received FLUZONE INTRADERMAL (lot number not reported) on an unspecified date. The patients subsequently developed cellulitis. It was not reported if the patients required treatment or if they recovered from the events. Documents held by sender: none.