chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergic Reaction to this injection; arm hard to touch; arm turned red; arm swollen; arm hurting; arm itchy; feels like a bruise on her arm; bump the size of a dime on her arm/hard to the touch; arm sore/rm slightly soar; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm turned red), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), PRURITUS (arm itchy) and CONTUSION (feels like a bruise on her arm) in a 70-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 Chronic obstructive pulmonary disease, Asthma, Brain tumor and Heart disease, unspecified (heart condition). Concomitant products included PARACETAMOL (TYLENOL) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2021, the patient experienced ERYTHEMA (arm turned red), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), PRURITUS (arm itchy), CONTUSION (feels like a bruise on her arm), MASS (bump the size of a dime on her arm/hard to the touch) and MYALGIA (arm sore/rm slightly soar). On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic Reaction to this injection) and SKIN INDURATION (arm hard to touch). At the time of the report, ERYTHEMA (arm turned red), PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (arm hurting), PRURITUS (arm itchy), CONTUSION (feels like a bruise on her arm), MASS (bump the size of a dime on her arm/hard to the touch), MYALGIA (arm sore/rm slightly soar), ALLERGY TO VACCINE (Allergic Reaction to this injection) and SKIN INDURATION (arm hard to touch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication information was not provided.   This case was linked to MOD-2021-264349.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: 2nd dose information has updated.
Post vax, the patient reportedly developed Bells Palsy with left facial nerve paralysis. The patient was evaluated by a physician, underwent an MRI and a lumbar puncture. Steroid therapy was prescribed. The resolution is unknown.
Developed a right lower extremity DVT and bilateral PE 8 days after second Moderna vaccine
No additional adverse event; Caller reported VARIVAX was administered after temperature excursion.; This spontaneous report was received from an office manager concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 12-JUL-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U030161, expiration date: 28-SEP-2023, administered subcutaneously for prophylaxis (strength was not provided), after a temperature excursion of 2 hours and 45 minutes at a temperature of 41.5F (product storage error). No previous temperature excursions were reported. No additional adverse events were reported.
Same day post vax, the pt experienced arthralgia. It was reported that the pt continued to have joint pain when she lifted her arm above her head.
fever up to 103.6 24 hours after vaccine and lasted x 2 1/2 days.
Refusal to eat solid foods started in July 2000-June 2001. Unable to sleep for more than 3-4 hrs at a time (previously slept throught he night) this began in July 2000 until February 2002. Chronic diarrhea began in October 2000 and lasted until June 2001 when we began a Gluten and casein free diet. Fine motor skills ceased to continue to develop beginning in July of 2000 until September 2001. Occupational therapy for treatment. In July 2000 speech ceased to continue to develop. Speech problems continue today. Speech therapy for treatment. Sensor issues became obvious in August 2000 and continue to a mild degree today. Occupational therapy for treatment. In April 2002 the measles virus was found in pt's spinal fluid. No treatment known for this. The 60 day follow up received on 7/24/03 states seizures, chronic measles virus in brain, continued behavioral problems, GI problems. This is a chronic life long illnes. No cure. Life expectancy could be compromised due to MMR.
Headache, Fever & NauseaVomiting Narrative:  dose 2-day 1-3- chills; fever-102.4 to 100.3; ha; sore arm;nausea  Other Relevant History:
Received second dose of Pfizer vaccine on Fri 5.14.21. On Tuesday 5.18.21 started to develop chest tightness and pressure (like someone was pushing against the center of my chest). Also experienced some shortness of breath. Went to Emergency Room Fri 5.21.21, all tests came back fine. Went to cardiologist in early June 2021 and in early June a cardiac MRI found everything to be normal. Cardiologist has me taking advil and prilosec at the moment. Have experienced these symptoms since 5.18.21 and has not gone away.
Information has been received from a physician concerning an approximately 50 year old male who was vaccinated with a dose of PNEUMOVAX vaccine. Later in the vaccination evening, the patient had pain, redness, hot to the touch and cellulitis that went from the injection site down his arm. The physician reported that the experience got progressively worse over the next couple of days. The physician reported that the patient had recovered on therapy. The physician reported that he gave this sale vial to two other patients who had a similar experience (reported in 0902USA01696 and 0902USA01706). The patient called physician for medical attention. Additional information has been requested.
Pain the next day at site of injection; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, via an unknown route of administration in the right arm on 23Jan2021 at 15:30 (at the age of 75-years-old) as a single dose for Covid-19 immunization. Medical history included aneurysm and pacemaker from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. It is unknown if patient received any other vaccines within four weeks prior to the vaccination. On 24Jan2021, the patient experienced pain at the site of injection. Treatment was not given for the event. The clinical outcome of the event vaccination site pain was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Left facility after waiting 15 minutes.  Within next 15 minutes while driving home, I had difficulty swallowing.  It took three or four attempts to complete a swallow.  Right ear had slight tingling.  Upon arriving home, I was able to swallow water but without water I had difficulty swallowing, three to four attempts to swallow.  This continued for three hours after receiving the vaccine.
Tired the next day......2nd day after a small rash, firmness a couple/ few inches before the vax site, redness at vax site a d reduces with small rash and where it feels firm.  Have not taken tylenol today but did yesterday.  Just once extra strength caplet
After receiving the vaccine, the patient had a mild panic attack. The patient has a history of panic attacks and the feeling on the vaccine in his arm is what started the attack. The patient laid down for a few minutes and calmed himself down. After about 5 minutes, he was able to sit back up again and was feeling better.
Drooling, very slurred speech, loss of appetite. Vaccine was given 7 weeks ago, week by week condition deteriorated, no diagnosis made.  7/7/09 Hospital records received DOS 3/25/09 to 4/4/09. Assessment: Delirium Encephalopathy with possible association with gouty arthritis. Patient presented with mental status changes, confusion, hallucinations, delirium. Poor appetite, weight loss. Broad based gait.  ICD-9 Codes: 599.0, 348.30, 784.3, 293.0, 263.9, 414.01, 403.90, 427.31, 332.0, 9V5861, 331.82, 294.10, 296.80, 600.00, 553.3, 412, 585.9, 530.81, 780.9, 296.40, 790.6, V5869, 294.10
approx 13mos p/vax pt exp chickenpox w/20 lesions all over body, also had fever 100f
had the vaccine. Got shingles 3 times/ Suspected Vaccination failure; Got shingles 3 times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received the vaccine and got shingles 3 times. The reporter wonder why it didn't work for him/her. The reporter was told there was a new 2 step one that would be better. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 63 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in right arm, on 15Apr2021 as dose 2, single (Lot number: EW0158), in right arm, on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 05May2022 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa based antibiotics" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jan2013, stop date: Jul2023; LOVASTATIN, start date: Jan2013, stop date: Jul2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 03Jul2023 to 06Jul2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250657 same reporter/patient, different drug/event;
seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 21Nov2021, outcome "unknown", described as "seizure". The event "seizure" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of seizure. Clinical course: On 21Nov2021, the patient experienced his first seizure that lasted about 1 minute. On 28Nov2021, the patient had two other seizures, one seizure in the morning that lasted about 30 seconds and another seizure in the evening that lasted about 2 and a half minutes to 3 minutes. The caller took the patient to the ER after the last seizure in the evening of 28Nov2021 where he was prescribed anti-seizure medication. The caller wanted to know if anyone else had experienced this side effect and wanted to know if there were any treatment recommendations. The lot number for bnt162b2 was not provided and will be requested during follow up.
On 5/20/2000, had flu-like symptoms with stiff neck. Treated with heat and Motrin and was better by 5/23/2000.
Hives/welps/open wounds about 30 mins after shot. Still today have hives that itch on neck and face with blistering welps (4/8/21). Covid arm very painful still today.
pt father devel obvious case of chicken pox 4 days p/vax given to child;
Right side facial droop, eye droop, swelling in cheek, couldn't drink on right side, difficulty speaking
Significant lip swelling more than 24 hours after injection. Also itchy, swollen eye.
Gave patient a MPSV4 without parents consent.  Resulted in him passing out.
Mom reports she was at grocery store, infant in car seat, noticed his face, arms, legs shaking for few seconds, picked him up and did it again. No cry. Was awake. Placed in car to go to ER, mom noticed eyes crossed once. Event occurred about 15-20 min after leaving office.
erythema nodosum, pain legs, chest, vaginal lesions;low grade fever 31JUL97-2SEP97;tx rest, lidocaine topical APAP #3, percoat, vitrex, pred;
No additional AE.; Customer reporting improperly stored vaccine administration of PROQUAD.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 20-OCT-2020, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 1 dose, as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T015600, which has been verified to be valid, expiration date reported and validated as 02-NOV-2021). The vaccine administered experienced a temperature excursion of 10 degrees Fahrenheit, for a time frame of 2 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010221: US-009507513-2010USA010255: US-009507513-2010USA009997:
mom reports high fever began 6hrs p/shots & continued for the next 30hrs; APAP given; also noted pt irritable & cried much of time, shaking & eyes rolling up; dx OM  diarrhea;
Rashes; Blister; Difficulty in sleeping; I had such drug, that Pfizer injection that poisoned me and spread infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rashes"; BLISTER (non-serious), outcome "unknown"; INSOMNIA (non-serious), outcome "unknown", described as "Difficulty in sleeping"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "I had such drug, that Pfizer injection that poisoned me and spread infection".  Additional information: Call was transferred from Transferring agent stated, "I do have a caller on the hold. I do have a caller on the hold. This caller needs an interpreter. The concern is he is experiencing side effects from the COVID-19 vaccine such as rashes, blister and difficulty in sleeping." While paraphrasing the name, consumer stated, "My name? I need to speak the interpreter. I don't understanding this sorry, I need the translator. Yeah, I need to speak with translator, I need someone who speak my language." No, I do not understand. I had such drug, that Pfizer injection that poisoned me and spread infection. Call my cell phone .QR Comment: Reporter type could not be probed over the call. Hence, captured as consumer or other non health professional by default.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extremely Achy; Vomited 4 times; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extremely Achy) and VOMITING (Vomited 4 times) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (Extremely Achy) and VOMITING (Vomited 4 times). At the time of the report, PAIN (Extremely Achy) and VOMITING (Vomited 4 times) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The relevant concomitant medications are Allergy shot twice a month. Treatment details was not reported by the reporter.   Reporter did not allow further contact; 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.
1258 - VRemained in vaccine administration room lying on cot for 5 minutes because per mom she has a history of fainting with shots. After 5 minutes, patient reports feeling fine and was moved to observation area.   1308 - Patient states "mom I don't feel...." and begins to stand up. Patient fainted into mom's arms. 2 RNs in observation area helped mom lower patient to the ground. Patient had slight circumoral cyanosis, eyes rolling to back of head, body limp.   1309-1311 - Called rapid as patient was being assessed. +2 pulse. Patient regained consciousness as BP cuff and pulse ox attached. VSS BP 122/69, HR 92, O2 99%. Patient now A+O x4. Color remains pale and patient slightly diaphoretic.   1318 - BP 106/65, HR 91, O2 98   1323 - Patient reports feeling better, just tired. Helped patient to sit up. BP 104/57, HR 96, O2 98. Transport team arrived and took over care.  Following transport team taking over, patient had 1 episode of emesis. 1 low BP after standing up too quickly but that normalized. Was able to tolerate fluids and crackers. Vitals remain stable. Cleared from transport teams care and sent home at 1357.
Red pinpoint rash on lower left forearm and redness, pain, and swelling extending up to vaccine site
17 y/o patient received Moderna for dose 1 instead of Pfizer. No side effects were reported.
EXPERIENCE ABDOMINAL PAIN, NAUSEA, VOMITING.  VOMITED AT LEAST ONCE EVERY HOUR UP UNTIL 3:00 AM, DIARRHEA STARTED ALONG WITH VOMITING. VOMITED CEASED AT 4:30 AM. DIARRHEA WAS EXPLOSIVE AND INCONTINENT.  SPOKE WITH PT AT 11:00 AM.  FEELING BETTER, BUT STILL HAVING SOME DIARRHEA.
Dizziness, Headache, Soreness at injection site. Chills. Narrative:  Per nursing report: "Complains of vertigo, chills, headaches and sore arm. Employee at work today [1/28] with symptoms. "
This case meets criteria for vaccine breakthrough review. SxS include headaches, body aches, fevers, chills, weakness, decreased PO intake, N/V/D.
Presented to clinic on 08/20 for difficulty breathing and shortness of breath. States he received anthrax vaccine three days prior. Went to Hospital on 08/23 for worsening shortness of breath, mild productive cough, intermittent fever and chills was treated with azithromycin, vantin, albuterol PRN. Admitted with multifocal pneumonia, non-severe sepsis, bilateral pleural effusion, superimposed pulmonary edema, SEPSIS, ARDS, Acute hypoxic respiratory failure, and suspicion of hypersensitivity pneumonia. Treated with antibiotics and empirical steroids. Started on BIPAP in ICU
Patient received 2nd dose of Shingrix on 6/3/19. The next day, 6/4/19 patient reported to have a rash at site of injection, shivering for 10 minutes, and chills throughout the day. The next day, 6/5/19 all of the reactions were no longer existent.
Caller got her first dose of the vaccine on 26MAR2021/Caller tested positive on 29MAR2021; This is a spontaneous report from a contactable consumer or other non hcp (patinet).  A 59-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 12:15 (Batch/Lot Number: ER8733; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunisation. Medical history included neck surgery from 2007 to an unknown date, neck surgery from 2010 to an unknown date, migraine, cluster headache, rash on his upper back, feels a little bit itchy on his upper back on 16Mar2021. The patient's concomitant medications were not reported. The patient experienced caller got her first dose of the vaccine on 26Mar2021/caller tested positive on 29Mar2021, she had no symptoms but did not feel 100%, she's wondering if it's dangerous to get vaccinated while having covid, caller believes she might have had covid while she got the vaccine.  She's been doing a lot of gardening and working like a maniac" yet no coughing or sneezing. She would like to know if she would notify somebody or if it is safe for her to take the 2nd dose. She also mentioned that she didn't have any symptoms and she didn't know what she was exposed to. Caller stated there were no medical conditions for herself that she feels is related to the reported events but states she is on disability and had two neck surgeries and one was in 2007 and the other was in 2010, stating she had chronic migraines and cluster headaches that she sees a neurologist for and was diagnosed around 2010. Also stated that she had blood drawn the day before on 25Mar2021 just to test her cholesterol and for her thyroid as a routine thing.  She did not have results for that testing yet. The HCP only tested the cholesterol, thyroid and stuff so she could refill medications for that.  No vaccines administered on same date of the pfizer suspect. The patient underwent lab tests and procedures which included blood cholesterol and thyroid function test on 25Mar2021 whereas sars-cov-2 test was positive on 29Mar2021. The outcome of events was unknown.  Follow-up information requested.
HIGH FEVER, CHILLS, SWEATING, SEVERE HEADACHE, NAUSEA & VOMITING, FATIGUE AND GENERAL MALAISE