chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; PROQUAD which was administered with expired DILUENT MRK JNJ; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 14-NOV-2018, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot# R015742 and expiration date 02-DEC-2019) (dose, frequency and route not reported) for prophylaxis, which was diluted in Merck's sterile diluent (MERCK STERILE DILUENT) (lot# L028663 and expiration date reported as 29-MAR-2018) (Expired product administered). No adverse effect were reported.; Sender's Comments:  US-009507513-1908USA001173:
Developed full blown rash on my lower back probably the size of a fist now.  I now have a rash across the back of my neck and scattered bumps on my arms and thighs.  Extremely itchy...
Half dollar sized red inflamed area at inj. site; Various pox spots on left hand, forearm, and bicep; Half dollar sized red inflamed area at inj. site; Impetigo/rash area under nose, right nostril.; Impetigo/rash area under nose, right nostril.; Information has been downloaded from Agency (US-CHIRONMA-PHHY2017US030612).  This spontaneous report was received from a other health professional referring to a 61 years old female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported.      On 23-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), 1 dosage form, subcutaneously (lot # M027117, expiration date not reported, but upon internal validation established as 26-JUL-2017) for immunisation. On the same date, the patient was also vaccinated with influenza virus sag 3v vaccine inactivated (FLUVIRIN) 1 dosage form, intramuscularly (lot # 1619521, expiration date was not reported) for immunisation.  On 26-OCT-2016, the patient experienced half dollar sized red inflamed area at injection site, various pox spots on left hand, forearm, and bicep and impetigo/rash area under nose, right nostril. The outcome of the events unknown. The causality between the events and both suspect vaccines was not provided.   The reporter considered all events to be serious for the following reason: medically significant.
So sick; allergic reaction; Chest crushing and Caving in; Bad itching; Dizzy; Weak; Shortness of breath; Sweating; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest crushing and Caving in), PRURITUS (Bad itching), DIZZINESS (Dizzy), ASTHENIA (Weak) and DYSPNOEA (Shortness of breath) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immune system disorder ("low immune system"). Concomitant products included DILTIAZEM, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), SULFAMETHOXAZOLE, TRIMETHOPRIM (TRIMETHOPRIM SULFAMETHOXAZOLE), PANTOPRAZOLE, MAGNESIUM and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced CHEST PAIN (Chest crushing and Caving in), PRURITUS (Bad itching), DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating) and ALLERGY TO VACCINE (allergic reaction). On an unknown date, the patient experienced VACCINATION COMPLICATION (So sick). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and PREDNISONE at a dose of UNK dosage form. At the time of the report, CHEST PAIN (Chest crushing and Caving in), PRURITUS (Bad itching), DIZZINESS (Dizzy), ASTHENIA (Weak), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweating), VACCINATION COMPLICATION (So sick) and ALLERGY TO VACCINE (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient contacted the health care professional and started nebulizer and steroid medication.  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.
Approx 15 minutes after injection  said she felt hot and dizzy and came in to our waiting room to lie down. She c/o feeling hot, dizzy, lips numb, nausea and indigestion. BP 134/75, HR 75, RR 16, SPO2 99%RA, FSBS 118. EMS was on standby and while assessing her she began vomiting and c/o feeling weak. She agreed to be transported to the hospital and care was turned over to EMS.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 4-year-old male birth twin who on 11-NOV-2003 was vaccinated subcutaneously with a 0.5 ml dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  Subsequently, on 11-JUN-2007, the patient developed pervasive developmental disorder.  The patient was seen by a physician for routine examinations.  The patient's pervasive developmental disorder persisted.  Upon internal review, pervasive developmental disorder was determined to be an other medical event.  The patient's twin brother developed an autistic disorder following vaccination with MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (WAES# 0804USA03984).  Additional information has been requested.
He reports increased and lingering soreness to the injection site as well as slight weakness; denies any swelling or redness.  He did not have anyone examine the site; states it was very sore to touch for several weeks after vaccination; as of 11/6/20, he states that the soreness is almost completely gone
Woke up Friday with terrific headache, darts shooting through head, sore neck, sore back, sore arm, pretty much sore all over, had temp of 101 in afternoon, felt weak and very, very bad, did not visit dr. felt really bad for 1 day and 1 night, am a bit afraid to take second dose, was much better on Saturday
pt recv vax 8JAN98 & 18JAN98 pt devel a measles-like rash all over body & a fever;
Approx 40 hrs p/1st DTP pt had 2 episodes of limpness & turning white; father was holding pt & thought had fallen asleep; t99.2R, pt more fussy than usual; father phoned MD; MD felt due to heat; not rxn to DTP;
Headache Swelling and redness of arm to elbow for 11 days fatigue nausea chills extreme pain at injection sight
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: ff2593) at the age of 24 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gastroperesis" (unspecified if ongoing); "Motility disorder" (unspecified if ongoing); "constipation" (unspecified if ongoing); "IBS" (unspecified if ongoing); "birth control" (unspecified if ongoing). Concomitant medication(s) included: LINZESS, start date: 20May2020; MOTEGRITY, start date: 20May2020; YAZ taken for contraception. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had received Anti-viral Paxlovid as treatment therapy from 05May2022 to 08May2022. Had to stop taking the medicine after day 3 because of extreme nausea. The nausea had persisted since patient stopped it for 3 days now and was there the whole day. Patient stomach was also extremely sensitive even to touch. So nauseous hard to eat, stand, and walk. Zofran, which usually helps for patient nausea, was not helping. No vomiting just nausea. patient experienced nausea on 07May2022 and received treatment of Zofran and patient was not recovered from nausea.
Extreme pain in left shoulder and left arm from the day of the injection to present.  The pain is continuous. I have tried recommended remedies of flexing arm, acetaminophen,and heat . Nothing has eliminated the pain.  It lessens some after taking pain pills but not for long.  It interferes with my sleep and ability to complete daily tasks.
A pink circle with a diameter of approx. 8 centimeters with a more red area in the center that had a diameter of about 3 centimeters. There was itching and it was warm to touch.
INJECTED 1-23-23; PT SAID FULL BODY HIVES STARTED 1-26-23, BY 1-29-23, PT STATED THAT SHINGLES BLISTERS BEGAN TO APPEAR UNDER THE PRIVATE MALE AREA
pt recv vax & 4 days later exp facial nerve paralysis;pt dx w/bell's palsy;tx w/pred & advil;
Called to see patient ~10 min after prime dose of Moderna COVID-19 vaccination. Patient reported acute onset of left eye swelling sensation and throat tightening. Was able to talk without difficulty. Normal salivation.    Moved immediately from observation area to treatment room. Reaffirmed that symptoms persisted and that time she also reported chest tightness. Vitals were normal and pulse oximetry = 99%. Exam conducted while vitals being measured. No wheeze or stridor. No rash. No obvious oral lesions or swelling. Eye lids not swollen. Epi IM given at once (within 1-2 min of arrival at the treatment room).    Symptoms resolved over the next 10 mins. Vitals were monitored frequently. Heart rate was increased before and just after Epi then dropped to ~70 b/m. Other vitals also remained normal and she was comfortable.   EMS was called and she was transported to ED for continued observation. Husband accompanied her.  She was seen in ED and observed for 4 hours. Benadryl, Pepcid and Prednisone taper prescribed. She was released from ED.
hoarse throat/her voice is going; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DYSPHONIA (hoarse throat) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included MONTELUKAST, FAMOTIDINE, PRAVASTATIN, OMEPRAZOLE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DYSPHONIA (hoarse throat). At the time of the report, COVID-19 (COVID-19) and DYSPHONIA (hoarse throat) 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.   No treatment products reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information was received on 10 May 2021 wherein event hoarse voice was added.
Around 08/01/2021 I started having intense amount of coughing. I also had chest pain and a hard time breathing. I went to the ER on 08/06/2021. They gave me Albuterol inhaler and a nebulizer. They did some medical tests, but I do not remember which ones. I just know they did a COVID-19 test, which came back negative.
Pt recvd 1st dose of Hep B vax in NOV90 & immediately thereafter, pt devel local rxn consisting of hives & edema @ inject site; sx persisted x 1 day & then remitted; MD felt that rxn was due to yeast component in Hep B vax;
It was reported that a 60 year old female, immediately post vax, "started with achy, sore left arm of vaccination and spread to both arms. She had chills, wheezing, loss of appetite and fatigue. Doctor treated her with anti-inflamatories which alleviated symptoms initially but symptoms still exist. They checked out her heart and everything looked ok. It is a month later and symptoms are still there."
Pt got Janssen COVID 19 vaccine and within 10 minutes of administration patient was fainting and EpiPen was administered immediately. patient started gaining consciousness within 5 minites of administration, 911 was already called and paramedics team was on its way. by the time paramedics reached pharmacy patient had gained conciousness and was more stable. within 15 minutes of EpiPen administration patient was trying to  talk and was trying to express his feelings. paramedics team checked the patient and did their evaluation. Patient was much better at that time so paramedics left, leaving patient at store. Paramedics confirmed that the patient is stable and do not need any hospitalization.
Became very tired and had to go to bed, flu like symptoms, pains, chills, and clammy with no fever, ice coldness going up and down arm. this lasted then a week later a rash developed at injection site, then the next day developed tinnitus and felt like a thousand bees in the head, and then heart beat went up to 107 when it's normally at 70BPM. Since then the tinnitus has continued and not gone away, can't sleep and very nervous. The doctor was called and we couldn't get an appointment until the 29th.  very distraught at this time. Second dose has not been taken yes, she's a very petite person and weights 90 pounds.
My skin started to get itchy a few days ago (about the 18th of January) and I initially thought it was winter dry skin,  but lotion wasn?t helping. It began to get worse and pop up in new places with bumps. I thought perhaps it was dust mites or bug bites. I checked all our upholstery and double-washed all the bedding but that didn?t stop new itchy spots from surfacing. By day 2 (January 19th) the spots were redder and more bumpy [possibly from scratching]. I happened to talk to a friend who was having the same thing; but we have not been any of the same places for months - partially because my family is so isolated for Covid prevention. She was prescribed steroids and told to take allergy medicine. Due to my childcare situation I was not free to go see a doctor but tried taking an over the counter allergy medicine which helped somewhat. She and I continued to text and found we both had our boosters the same day; which made me think this would be appropriate to report to vaers. My hives/rash does not seem to be as severe and irritating as hers so far. It seems like a few itchy spots will pop up and be irritating for a while, then they subside and a new place gets irritated and itchy. But it is still very irritating. At one point my scalp was so itchy I could not think about anything else.  OTC generic Zyrtec and wearing loose clothing seems to help.
Information has been received from a consumer reporting on her 72-year-old husband, with no pertinent medical history or allergies, who on 06-DEC-2007 and 09-DEC-2007 was vaccinated with a first and second dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 09-DEC-2007 the patient "developed a rash, which was itchy, on his left shoulder where he received the vaccine".  The patient sought medical attention via a phone call with his physician.  No diagnostic labs were performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
red blotch seems to be getting bigger; little pain on the injection site, right upper arm had pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotch seems to be getting bigger) and VACCINATION SITE PAIN (little pain on the injection site, right upper arm had pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (little pain on the injection site, right upper arm had pain). On 18-Mar-2021, the patient experienced RASH MACULAR (red blotch seems to be getting bigger). At the time of the report, RASH MACULAR (red blotch seems to be getting bigger) and VACCINATION SITE PAIN (little pain on the injection site, right upper arm had pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No comcomitant medications were provided. Treatment medications were not reported.
2nd dose: chills, fever 100., body aches, flu like symptoms. 1/13/21 injection site redness, swollen as a rock, hot to touch and sore. 1/15/21 injection site redness, swollen as a rock, hot to touch and sore; skin temp taken 100.0 at injection site, localized in area, not feeling well, weakness, neck stiffness, headaches Midrin taken for intense headache. Pt has been resting all week, off work returned today no fever.    1st dose: no ae to report
Neuritis - A pharmacist reported that a 55 yo pt rec'd an injection of Flu Shield (2000-2001 Formula) vaccine and, within 48 hrs post vaccine,pt developed neuritis/neuropathy in his R arm. The condition lasted 4 wks and completely resolved. This report was received from Aventis Pasteur (U2001-004830).
has felt crummy; the sniffles; didn't sleep well; chills; his head felt dull; This spontaneous case was reported by an other health care professional and describes the occurrence of CHILLS (chills), HEADACHE (his head felt dull), INSOMNIA (didn't sleep well), FEELING ABNORMAL (has felt crummy) and RHINORRHOEA (the sniffles) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021 at 5:00 PM, the patient experienced CHILLS (chills) and HEADACHE (his head felt dull). On 11-Mar-2021, the patient experienced INSOMNIA (didn't sleep well). On an unknown date, the patient experienced FEELING ABNORMAL (has felt crummy) and RHINORRHOEA (the sniffles). At the time of the report, CHILLS (chills), HEADACHE (his head felt dull), INSOMNIA (didn't sleep well), FEELING ABNORMAL (has felt crummy) and RHINORRHOEA (the sniffles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
symptoms of shingles; Tingling; Numbness; Pain; Blisters; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles, tingling, numbness, pain and blister. On an unknown date, the outcome of the shingles, tingling, numbness, pain and blister were unknown.   It was unknown if the reporter considered the shingles, tingling, numbness, pain and blister to be related to Shingrix.  Additional case details were provided as follows: The reporter was a pharmacy student. The age at vaccination was not reported. The patient started complaining of having symptoms of shingles, which included tingling, numbness, pain, and blisters. The reporter consented to follow up. No additional information was available.
5 min after pt received Moderna 1st dose, pt complained about hot, temp checked 100.4 F. BP and HR checked, BP 192/110 and HR 106. No SOB. pt drank water and felt better.  Rechecked vitals after 5 min, SBP down to 180s and HR down to 90s. pt drank more water, rechecked after 5 min, SBP down to 160s and temp down to 99 F. Pt sat for 5 min and said symptoms coming back. Rechecked, SBP up to 170s. Pt said she doesn't need an ambulance. pt has a friend with her and was instructed to go to  urgent care or ER to have more monitoring. Pt agreed.
Patient discharged after (2) day inpatient admission 11/22-11/24/2021. Patient is a 62 year male past medical history of severe chronic obstructive pulmonary disease on chronic prednisone and azithromycin (follows with Dr.), history of left upper lobe resection 2015, hypertension, prediabetes who presents today with worsening fevers shortness of breath since 11/15/2021.  Patient tested himself at home with an over-the-counter test on 11/19/2021 which was positive for COVID-19.  He is vaccinated and had his 2nd Pfizer dose 03/30/2021.  He did not yet receive the booster vaccine.  Patient's symptoms initially started with fever overall 102 F at home.     In the emergency department he was noted to be hypoxic requiring 3 L nasal cannula, worsening shortness of breath found to have acute on chronic hypoxic respiratory failure in the setting of COVID-19 pneumonia. Initial lab work notable for thrombocytopenia with platelets of 88, likely myelosuppressive manifestation of COVID-19. Chest x-ray demonstrated evidence of pneumonia with mild interstitial prominence.  He was febrile upon arrival as well to 39.4 it was given Toradol and dexamethasone.  He was admitted to Medicine no 11/22/2021 for further workup and management.   He had normal echocardiogram with EF 57% and normal BNP.  He was also noted to have sputum culture from August 2021 positive for Rhizopus and was evaluated by ID outpatient, thought to be contaminant versus colonization. He was treated with dexamethasone and remdesivir.  During his admission his oxygen requirements continued between 2 and 3 L nasal cannula.  Platelets eventually improved.  His blood glucose was mildly elevated on dexamethasone, secondary to steroid induced hyperglycemia, without need for at home insulin on discharge.  Pulmonary rehab was consulted, recommended 3 liters/minute at rest and 6 liters/minute with activity, of supplemental oxygen.  Patient instructed to complete steroid course for outpatient management of COVID-19.    Patient was discharged in stable condition, afebrile, in no acute distress, and with arranged home oxygen medical equipment and instruction of home use medical equipment.