chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 24-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. On or about 01-FEB-2014, the patient was treated at a medical office for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
FLUZONE Quadrivalent administered approx. 4:00 p.m. Patient awakened at approx. 12:00 a.m. with numbness/tingling of tongue and lips. Symptoms resolved spontaneously after approx 1 hr.
Initial and follow-up information has been received from a registered nurse concerning her 18 year old daughter with no known allergies or pertinent medical history and no illness at time of vaccination, who on 13-AUG-2008 at 0900, was vaccinated with the second dose of VARIVAX (Merck) (Lot #657787/0718U) subcutaneously at the upper left arm.  Other concomitant therapy include, on 13-AUG-2008 at 9:00 AM was vaccinated with the first dose of tuberculin purified protein derivative (manufacturer unknown) (Lot # C2808AC) intradermal into the left forearm.  Vaccines were administered at another primary care provider's office.  There was no illness at the time of vaccination.  Post vaccination, on 13-AUG-2008, at 1800, the patient experienced hotness, tenderness, swelling around injection site which looked like cellulitis like reaction with some lesions on the entire upper arm near the injection site, no fever.  On 18-AUG-2008, the patient recovered.  Additional information has been requested.
Approximately 24 hrs after flu vaccination L deltoid, experienced "tenderness to glands-neck bilat-and L upper arm tenderness." "Mild tenderness to L armpit." Tenderness to all areas resolved 10/30/03.
Big painful lump in armpit. Painful to move arm. Painful to the touch. Two days after-current.
Right parotitis, barely tender, not red, moderately swollen, No fever No Rash
This spontaneous report was received from a 66 year old male physician referring to himself. With concurrent conditions of asthma, hypertension, increased blood cholesterol, congenital spinal stenosis and seasonal allergy, additionally the patient was vaccinated with PREVENAR 13, 14 months ago. No other medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 19-APR-2018, the patient was vaccinated with PNEUMOVAX 23 lot # N003993, expiration date 20-OCT-2018, (strength was not reported) in the left arm for prophylaxis. On the same date, within a few hours after the vaccine, the patient reported he began to experience pain, warmth, swelling and redness in the left arm within a few hours after receiving the PNEUMOVAX 23, and 5 to 6 hours after receiving the vaccination the symptoms extended to his left bicep. On 20-APR-2018, the patient experienced fatigue. The reporter stated that the pain, redness, swelling at the injection site "progressed from the antecubital fossa to the anterior, medial aspect" of his left elbow on 21-APR-2018. On the same date, the physician reported the pain from his left shoulder to the left clavicle. The pain from his left clavicle extended to the mediastinum that increased in severity when he was lying down. The physician reported he began to experience chills and esophageal discomfort that made it difficult to eat and drink. On 21-APR-2018, the patient took 80 mg of prednisone (unknown manufacturer) and on 22-APR-2018, he took 60 mg of prednisone (unknown manufacturer). No lab tests were performed to the patient. The outcome of generalized pain, oesophageal discomfort, fatigue, injection site warmth, swelling and erythema was reported as recovering, "reported as symptoms improved by 50%". The outcome of chills was reported as recovered. The reporter considered the events to be serious due to disability. The causality between the events and the therapy was not reported.
HEADACHE AND BODY ACHE, took ibuprofen and kept moving. Bump size of marbel where shot was given, as of 1/31/2021 did shrink in size but still present.
This case was reported by a healthcare professional (also a GSK representative) and described the occurrence of shortness of breath in a 37-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included asthma and LEVAQUIN allergy. Concurrent medications included Metoprolol (slow release), VENTOLIN HFA, ZYRTEC and PRILOSEC. On 19 January 2011 the subject received 2nd dose of TWINRIX (1 ml, intramuscularly, left arm). On 19 January 2011, less than one day after vaccination with TWINRIX, the subject experienced shortness of breath and dizziness. On 22 January  2011, the events were resolved. It was reported the symptoms resolved 3 days post-injection. The vaccination course with TWINRIX was discontinued. The healthcare professional considered the events were possibly related to vaccination with TWINRIX. Follow-up information was received on 07 February 2012. It was reported that the events of shortness of breath and dizziness resolved on 21 January 2011 after a three day duration;. No additional details were provided.
She has had a wart on her nose for 10 years that started to dissipate after receiving her second dose of the vaccine/it was kind of shriveling up. It went from a 10 to a 1; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (She has had a wart on her nose for 10 years that started to dissipate after receiving her second dose of the vaccine/it was kind of shriveling up. It went from a 10 to a 1) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (The patient had attempted using anti-wart medication and surgery to address the wart prior, however it had not helped). Concurrent medical conditions included Wart (The patient had a wart on her nose for 10 years.).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She has had a wart on her nose for 10 years that started to dissipate after receiving her second dose of the vaccine/it was kind of shriveling up. It went from a 10 to a 1). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She has had a wart on her nose for 10 years that started to dissipate after receiving her second dose of the vaccine/it was kind of shriveling up. It went from a 10 to a 1) outcome was unknown.            It was reported that te patient had a positive side effect. She had a wart on her nose for 10 years that started to dissipate after receiving her second dose of the vaccine. The wart was a flat thing and she had attempted using anti-wart medication and surgery to address the wart prior, however it had not helped. Within a couple weeks after receiving the second dose of the vaccine it was kind of shriveling up. "It went from a 10 to a 1. The wart came back around August or September.  No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-380171 (Patient Link).
FEELING SICK POST VACCINE ADMINISTRATION; This spontaneous report received from a consumer 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the Patient was feeling sick post vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling sick post vaccine administration was not reported. This report was non-serious.
Initial unsolicited report received from a pharmacist on 01-Nov-2017. This case involves a patient of unknown age and gender vaccinated with FLUZONE HIGH-DOSE (batch number, expiry date, dose in series, route, site were not reported) on an unknown date. Patient medical history not reported. It was also reported that patient had no known drug allergy and chronic illness. Concomitant medications were not reported. On an unknown date, after the vaccination, the patient's arm had swelled up. Lab data and corrective treatment were not reported. The event's outcome was not reported. List of documents held by sender: none.
Ear ache; arm swelling; arm soreness; Tachycardia; felt lousy; flu-like muscle soreness; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (Tachycardia), ILLNESS (felt lousy), PERIPHERAL SWELLING (arm swelling), PAIN IN EXTREMITY (arm soreness) and EAR PAIN (Ear ache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Hepatitis: Hepatitis vaccines (Patient reported tachycardia post hepatitis vaccines.); for Flu: Flu vaccine (Patient reported tachycardia post flu vaccine.). Past adverse reactions to the above products included Tachycardia with Flu vaccine and Hepatitis vaccines. Concurrent medical conditions included Mitral valve prolapse and Anxiety (Due to anxiety from episode, patient also experiences a strong loss of appetite that evening.). Concomitant products included METOPROLOL for Mitral valve prolapse, METOPROLOL SUCCINATE (TOPROL XL), AMLODIPINE BESILATE (AMLODIPINE [AMLODIPINE BESILATE]), ESCITALOPRAM OXALATE (LEXAPRO), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), HYDRALAZINE and MIRTAZAPINE for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced TACHYCARDIA (Tachycardia), ILLNESS (felt lousy) and MYALGIA (flu-like muscle soreness). On 01-May-2021, the patient experienced PERIPHERAL SWELLING (arm swelling) and PAIN IN EXTREMITY (arm soreness). On 02-May-2021, the patient experienced EAR PAIN (Ear ache). On 30-Apr-2021, TACHYCARDIA (Tachycardia) had resolved. On 01-May-2021, ILLNESS (felt lousy) and MYALGIA (flu-like muscle soreness) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swelling) and PAIN IN EXTREMITY (arm soreness) was resolving and EAR PAIN (Ear ache) outcome was unknown.        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.   Treatment information included rest, ice on arm and metoprolol for tachycardia.
Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. On unknown dates, the unspecified patients were administered improperly stored doses of VARIVAX (Merck) (lot reported as L026411, expiry date 15-FEB-2017; lot L020004, expiry date 02-JUN-2017). No adverse effect was reported. Additional information has been requested.
LEFT UPPER ARM AND ARM PIT VERY PAINFUL AND REALLY SWOLLEN AFTER SECOND DAY, CALLED THE PHARMACY TO REPORT AND ASK FOR ANY ADVICE. LASTED ABOUT 5 DAYS. AT ABOUT DAY 15 I STARTED COUGHING  UP BLOOD FOR ABOUT 6 DAYS. WENT TO ER. DIAGNOSED WITH MULTIPLE BLOOD CLOTS/PULMONARY EMBOLISMS.
I had a rash on my arm, which spread to my torso. It was very itchy. I also had terrible hives.  Treatment: Mupirocin 2% ointment, Triamcinolone ointment
1 week after receiving vaccine c/o pain 5-6/10 arm injection site radiating to rt elbow tried ice packs, heat, Ibuprofen without relief. Returns several times/day lasting for a month. Refer to PCP.
Red pimple rashes by mouth and across jawline, neck, chest, shoulders, and back. Had rash, congestion, left side head pain, cough, sneezing 5 days after vaccine. Was tested for Covid and negative. Given Doxycycline for sinuses and from urgent care and to follow with family doctor if not gone. Rash is still present after 8 days of it starting and visted my family doctor today and was told to report this information.
Soreness in arm; Seems much heavier than what happened with a flu shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arm) and LIMB DISCOMFORT (Seems much heavier than what happened with a flu shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (Flu Shot). Concurrent medical conditions included Migraine. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication, ACETYLSALICYLIC ACID (BABY ASPIRIN).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm) and LIMB DISCOMFORT (Seems much heavier than what happened with a flu shot). At the time of the report, PAIN IN EXTREMITY (Soreness in arm) and LIMB DISCOMFORT (Seems much heavier than what happened with a flu shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient uses baby aspirin for silent migraines. Patient also takes Several Supplements and Vitamins
Starting 08/10/2022, she started having yellow sinus drainage from her nose and fevers. The next day, she developed redness and swelling of her left cheek and under the eye. Also, she had a small amount of yellow drainage from her left eye and more fevers. On Friday, 08/12/2022, she got in to see the doctor and she was diagnosed with bacterial rhinosinusitis and a right ear infection. She was started on a 10 day course of antibiotics. We just finished her antibiotics yesterday and she seems to be back to normal.
Headache, fatigue, next. Morning heaviness in chest, severe muscle and joint pain two-3 days later. Large red hard, hot lump in injected arm
Ever since receiving the second dose of the Covid 19 vaccine, I have been exhausted all the time.  If I don't sleep for hours (after I get out of bed in the morning), I cannot stay awake and cannot get through the day.  The exhaustion is overwhelming.
Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 26-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
burning sensation in both arms and chest, full body muscle aches, joint pain, diarrhea for 2 days, headache still, arm pain,  head congestion
Site of injection swollen, red, and red streaks going away from site per mother. Swelling started approximately 2 (two) hours after injection and fever started about the same time. Fever reached 102 Wednesday and Thursday. Back to normal Friday. Swelling, redness resolved Friday.
neck lump; Left arm pain; swollen lips; This spontaneous case was reported by a physician and describes the occurrence of LIP SWELLING, NECK MASS, and PAIN IN EXTREMITY in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Ankylosing spondylitis, Drug allergy (Dicyclomine), Latex allergy and Drug allergy (metformin).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced LIP SWELLING. On 09-Jan-2021, the patient experienced NECK MASS and PAIN IN EXTREMITY. On 28-Jan-2021, LIP SWELLING, NECK MASS, and PAIN IN EXTREMITY 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 considered LIP SWELLING, NECK MASS, and PAIN IN EXTREMITY to be related.    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 got a tingling sensation in left arm (pins & needles) after receiving the 2nd dose of Moderna vaccine. Patient did sit and stay in store for 30 minutes and he felt better once he started moving it around more.
Painful site where injection; shooting pain going down the arm; lasting for 1 day; very unpleasant experience - will not get 2nd dose.
Within hour of administration patient hd vomiting. Later the same day the patient developed fever, body aches and continue dot have intermittent nausea and vomiting. Symptoms persisted for two days and then resolved. The patient was kept at home. She was provided rehydration fluids and fever reducing medications.
I woke up with a scratchy throat on 05/09/2022. I was informed by a close contact that they tested positive for COVID-19. So the next morning on 05/10/2022, my symptoms worsened, and I went to the clinic to get tested. The PCR COVID-19 test came back positive and was prescribed Paxlovid. I completed the course of the medication and tested negative on 05/15/2022.
Headache; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. A patient of unspecified age and gender started to receive meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date to an unspecified date at a single dose for an immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. The outcome of the event was unknown.
Intense, uncontrollable crying. Wouldn't sleep or eat. Cried for a week with maybe an hour of non crying per day.
Hospitalization - acute respiratory failure with hypoxia; pneumonia due to COVID-19 virus
Pt experienced widespread hives, inflammation/redness emanating from trunk - difficulty breathing, throat swelling.
Pt was to get Tdap and Peds Hep A. Pt was given Dtap & Hep A Adult.
neuropathy became worse; neuropathy became worse; she felt very heavy in her lower back; Fever; Eye pain; Headache; twitching in her arm and leg and the twitching on and off/twitching on the left side of her body; She is scared to go for her second dose; she is afraid to go for the second dose; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12May2021 (Lot number: ER8736) as dose 1, single for covid-19 immunisation. Relevant medical history included: "already had a neuropathy problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 2021, outcome "recovered" (2021) and all described as "neuropathy became worse"; BACK DISORDER (non-serious) with onset 2021, outcome "recovered" (2021), described as "she felt very heavy in her lower back"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; EYE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Eye pain"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "Not recovered", described as "twitching in her arm and leg and the twitching on and off/twitching on the left side of her body"; NERVOUSNESS (non-serious) with onset 2021, outcome "unknown", described as "She is scared to go for her second dose"; FEAR (non-serious) with onset 2021, outcome "unknown", described as "she is afraid to go for the second dose". Clinical details as follows: She had the Pfizer covid vaccine on 12May2021 at (Withheld) Hospital. She had an adverse reaction for about 5 weeks. She had symptoms. Reports she already had a neuropathy problem but it became worse and she felt very heavy in her lower back after the vaccine. She knows a fever was normal, she had a fever. She is scared to go for her second dose. She told the doctor and the doctor does not think it is the vaccine. She was not experiencing eye pain, headache, twitching on the left side of her body, reports she had twitching in her arm and leg and the twitching on and off. Because of the reaction she is afraid to go for the second dose. She had no symptoms before the vaccine.; Sender's Comments: Based on the reported information ,a causal relationship between the events NEUROPATHY PERIPHERAL, condition aggravated and suspected drug cannot be excluded.  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