chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: Patient is a 23-year-old male who presents to the emergency department for possible allergic reaction after the COVID-19 vaccine. This is patient's second dose. States he received it about 1 hour ago. States about 30 minutes ago he started feeling flushed in the face with puffy eyes and states that his eyes were burning. Patient is very anxious. States he does feel a little short of breath but denies any throat swelling or drooling. Otherwise prior to this states he has been in his usual state of health
Information has been received from a health professional concerning a 57 year old female who on 26-SEP-2008 was vaccinated with PNEUMOVAX, mistakenly intradermally (lot # 659487/1960U). On 26-SEP-2008 the patient experienced local reaction. The patient sought unspecified medical attention. The patient outcome was unknown. Additional information has been requested.
RN diluted the vaccine with 1/3ml sterile diluent and administered a 0.2ml dose. The vaccine is supposed to de deleted with 2.2ml. Incorrect dilution caused vaccine to be an incorrect dose.
09/14/22 presents to ED for "altered mental status". PMHx of "dyslipidemia, thyroid disease, anemia and chronic shoulder pain"
2 days after vaccination, pt complained of dizziness, fatigue, and swelling with erythema around the injection site. There was a raised area of reddened skin about 4cm in diameter on her left deltoid.  She reported it was not itchy but was painful and tender to the touch. There was no discharge or streaking, and no pain in the shoulder joint.  Vital signs were normal.  Pt was advised to apply cold packs and rest, and to go to urgent care if her symptoms worsened.
pt began 101 fever 24hr p/vax;48hr later began w/hives, sore throat, itching, fever cont;seen by MD 14SEP98 @ clinic;given DPH & APAP s/s improved-99 temp 15SEP98;
On  and off chest pain over the past 2 weeks since my shot. Feels like someone is sitting on my chest.
Left arm pain began after receiving vaccine. The day prior to ER eval pain worsened in the elbow. On 819/19 at 10PM pain worsened further, becoming severe and with associated numbness and tingling in the ring and pinky fingers. Referred to ER. Placed in a sling.
Information has been received from a registered nurse her 19 year old daughter with CECLOR allergy who on 29-JUN-2008 was vaccinated IM with a 0.5 mL first dose of GARDASIL and in December 2008 received the third dose of GARDASIL. Concomitant therapy included unspecified control pills. One or two days after receiving the third dose of GARDASIL, the patient developed a rash which was distributed across her chest and resolved without treatment. On 21-JUL-2009, the patient experienced the onset of a widespread rash on her breast, thigh, legs, buttocks, right arm and left anticubital area. The lesions were red and vesicular. The patient initially self-treated with CALAMIN, BENADRYL, CLARITIN and ZYRTEC. On 27-JUL-2009 the patient was examined in the office and was diagnosed with possible poison ivy. She was given KENALOG injection and prescribed bethamethasone cream (unspecified). The rash initially improved but worsened on 29-JUL-2009. The patient contacted the physician's office by phone and was prescribed a MEDROL dose pack. At the time of the report, the patient had not recovered. Additional information has been requested.
Tingle in Left side of tongue. Pressure on Left side of face. Left jaw muscle feels like I have been clenching it for a long time.
mom called & stated that pt was having some weakness, n&v, diminished appetite, abd cramps, chills, t102 & swelling @ local vax site;cold pack was applied to local site & APAP given for fever but fever cont;instructed to call MD;
I originally did not think this was an adverse event due to my h/o eczema, but decided to report this due to new onset of hives and sudden abnormal spike in TSH levels after taking the vaccine.  1/13/21: noticeable rash over L eye 1/18/21: Onset of hives on face, hands, and forearms. Originally thought trigger was kiwi from a couple sips of a smoothie.  Hives on forearms have persisted.  Also developed upset GI system.  2/1/21: Started on two Zyrtec at night, one Pepcid twice daily, two Allegra in the morning., one Montelukast at night - for hives. 2/11/21: f/u with endocrinologist. TSH levels increased to 3.970 (was 0.066 8/3/20, target was 0.5-2.0). 4/1/21: Synthroid adjust to 125 mcg daily. Despite consistent use, TSH level increased to 18.300. Unclear why TSH is spiking.  I suspect possible relation to the COVID-19 vaccine, as TSH numbers began to spike shortly after.  Decided to report this after finding out some patients with COVID-19 have had sudden spikes in TSH levels.
I had flu like symptoms with dizziness, fever, body aches. It felt like every muscle in my body was electrified and on fire with nerve pain. My muscles cramped up and would not release for 10 hours. Afterwards I was so sore. The burning sensation concerned me. I contacted my doctor. These symptoms lasted strong for 1 week then gradually went away some but not all the way. I still felt very tired and fatigued.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX lot # M039317 for prophylaxis. Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA011240: US-009507513-1708USA011238: US-009507513-1708USA011239:
This spontaneous report as received from a medical assistant refers to 3 year old patient of unknown gender. On an unknown date in April 2014, between 12-APR-2014 and 24-APR-2014, the patient was vaccinated with a dose of VARIVAX lot # J012210, expiry 28-SEP-2015 ("VFC" stock), 0.5 ml, once, intramuscular. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. There were no prior excursions. There was a site visit from local health department on an unspecified date. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: FATIGUE (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HBP states there are no symptoms; Pharmacist calling to report the administration of an expired dose of GARDASIL 9 on 10/30/2023.  Caller confirmed no previous temperature excursions for this product and stored in the recommended range.  HBP states there are no symptoms or further de; This spontaneous report has been received from a pharmacist, regarding a patient of unreported age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 30-OCT-2023, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (lot number: U032636, which was determined to be valid as syringe formulation, with an expiration date on 26-OCT-2023) (strength, dose, schemer, route and anatomical location of administration were not reported) (Expired product administered).  Caller requested if this Administration Period was Supported Beyond the Labeled Expiry  No additional adverse event was reported.
Initial report was received from a consumer on 07 January 2013. A 14-year-old female patient received an injection in the left deltoid of ADACEL vaccine (lot number C2774AA) on 19 February 2009 (route not reported). Three years later, on 15 December 2012 (also reported as future date 15 December 2013), the patient saw a physician and was diagnosed with pertussis. The patient was treated with azithromycin ("zpack") and cough medicine. The patient had blood tests and a chest x-ray (reported as negative) on 15 December 2012. the patient had four DTaP vaccines as an infant/child. The patient had no illness at the time of vaccination, no birth defects, and no allergy. The patient was positive for lactose intolerance. Three other family members had clinical pertussis including mom, dad, and 21-year old sister. Two brother, ages 19 and 16, did not get sick. The patient's outcome was not recovered. Documents held by sender: None.
Pt is a 25M with PMH of GERD, ADHD, obesity who presented to the ED on 5/11 for chest pain. That morning he had noticed increased substernal chest pressure associated with palpitations, nausea, diaphoresis, and left arm tingling. He notes that early last year he was very sick and though he had COVID but confirmatory testing was not available at that time. After recovering from the illness he noted that he had occasionally episodes of chest pressure and palpitations. However yesterday was the worst his symptoms have ever been. He did receive his 2nd COVID vaccine this past Saturday and experienced fatigue, nausea, weakness.  In the ED patient has HD stable, afebrile, saturating well on RA. Labs were notable for troponin of 5.2 which trend down to 3.1. ESR WNL, CRP elevated 2.4. EKG showed normal sinus rhythm with signs suggestive of possible pericarditis. CXR negative. CTA showed no pulmonary embolism, enlarged and prominent left axillary lymph nodes, nonspecific, cholelithiasis. Patient admitted for NSTEMI. Enlarged axillary lymph nodes likely reactive in the setting of recent COVID vaccine.    Cardiology consulted. Patient underwent cardiac cath which was unremarkable. Cardiology recommends short course NSAIDs for possible pericarditis, however EKG changes unimpressive per cardiology. Discharged home on ibuprofen 400 mg TID for 5 days. Advise follow up with PCP within 1 week.
Apx one week post injection the site started itching regularly.  24 hours after that the area approximately  one inch around the injection site is firm, hot to the touch, and broken out in a red rash.  The area also aches when the arm is used.  Itchiness comes and goes.
I did not have the same sensation with this injection as my last one and I remember I didn't feel the cooling sensation or tingles or numbness and it felt like a normal vaccination. I had the typical upper arm pain as usual. I don't remember but I think the generalized arm pain lasted for maybe about a week. I went to bed as normal and felt fine and the next day I was fatigued, but nothing extraordinary and I would say by lunch time the next day I started feeling rough. I just felt really weak, lethargic, swimmy headed and dizzy, tiredness, and I just couldn't go on and I just wanted to lay down. A little after lunch time the following day I remember just laying down on the floor because I felt so bad. I remember begging my husband to come home early because I just wanted to lay down and I felt pretty miserable the rest of the evening. It felt like flu symptoms with body aches, fatigue, and weakness. I didn't have cold like symptoms like sniffles. I felt like I had been hit by a truck. I didn't want to eat, speak, and my whole body ached and it was hard to sleep. The following night, I went to sleep and the next day I was much improved from the day before and I could walk around and not feel like I was gonna fall over. I still have a pain in left side of body that goes into leg and it's relatively recent and started in July. I seen a doctor about it. It's like a shooting sore pain that goes down the side of leg.
Tongue swelling not occluding airway; Fevers of 102-103F; Chills; Sweats; Fatigue; This is a spontaneous report from a contactable nurse (patient). This non-pregnant 37-year-old female patient received the second dose of BNT162B2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the left arm on 13Feb2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included postpartum 9 months c-section from an unknown date and unknown if ongoing. The patient had no allergies to medications, foods or other products and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included sunflower lecithin, fish oil and postnatal vitamin, all from unknown dates for unknown indications. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number EL9261) in the left arm on 23Jan2021 at 12:00 (at the age of 37-years-old) for COVID-19 immunisation. The patient reported that she experienced tongue swelling not occluding her airway starting 6 hours post second injection on 13Feb2021. She took diphenhydramine hydrochloride (BENADRYL) 25 mg and famotidine (PEPCID) 20 mg orally which resolved the symptoms after 1 hour. She also reported fevers of 102-103Fahrenheit (F) with chills, sweats, and fatigue for 36 hours. The events were reported as non-serious and did not require hospitalization. The clinical outcome of tongue swelling not occluding airway was recovered on 13Feb2021 at 17:00; the clinical outcomes of fevers of 102-103F, chills, sweats and fatigue were recovered on 15-FEB-2021 at 04:00. It was also reported the patient had not been tested for COVID-19 since vaccination.
Patient noticed hives on legs and arms and abdomen. HA and sore throat. Patient was advised to see provider.
During administration of the vaccine, the luer lock that connected the syringe to the needle became disengaged, causing some quantity of the vaccine to squirt out of the syringe and down my arm. The nurse administering the vaccine said she believed at least half of the vaccine was injected into my arm before the disconnect occurred.  I do not believe this to be the case based on (1) the pressure build-up that caused the disconnect / squirting out of vaccine was unlikely to occur half-way through an IM injection, and (2) after my first vaccine I experienced numerous side effects and this time I did not even have mild soreness at the injection site.
Given Pfizer COVID Vaccine after BUD of 10 weeks. No other adverse events reported.
This spontaneous report was received from a Licensed Practical Nurse concerning unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not specifically provided. On an unknown date, the patients were vaccinated with unspecified improperly stored doses of ROTATEQ oral (dose, frequency, Lot # and expiration date were unspecified). This is one of two reports from the same reporter. Additional information has been requested.
I went to the doctor in June and the doctor said that I have a very low count of white blood cells.
Pt developed massive infrarenal aortic occlusion shortly after receiving the J&J COVID booster vaccine. Pt reports acute onset bilateral lower extremity pain ,weakness and cool skin which started 4 days prior. Patient reports that he was in his normal state of health until receiving his COVID booster 10 days prior. He reports feeling worse over the next couple of days with cough, SOB, body aches and diffuse weakness which has progressed. 4 days prior to arrival patient reports that his legs suddenly started to feel weak and has been unable to walk. Endorses decreased sensation of bilateral lower extremities and inability to move lower extremities.   CT scans showed a large infrarenal aortic occlusion. CT scans performed 1 year prior showed no occlusion.   IR advised that they were unable to relieve the clot, and vascular surgery was consulted. Vasc surgery performed emergent surgery.
A report has been received from a Physician concerning a 2 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. The patient experienced fever of 103-104F and bumpy rash/red rash on the body which started on 29-Oct-2014. The outcome of the event of fever of 103-104F and bumpy rash/red rash on the body is unknown. The report was considered to be non-serious.
Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). The consumer stated that "a few days after getting the vaccine" she got hives. Her doctor stated that it could be from an inactive ingredient in the vaccine, but there was no way of telling if the vaccine caused it. At the time of the report, the consumer's outcome was unknown. It was unknown if the consumer sought medical attention. No further information is available.
Red, swollen and painful on 9/22 eve. Better today. Less erythema today, no pain, no swelling. No Tx.
Day 1 & 2 after shot - left arm hurt around injection site.  Day 2 I felt very tired and some body aches.  By Day 5 or 6 - full body aches and my arms felt like there was pressure on them.  I was feeling very tired.   As more days passed; I was feeling tired, could not raise my arms, legs were weak and hurting.  If I did anything (shower or carry a simple laundry basket) my arms would hurt so bad, I was out of breath and my heart was pounding so hard.  By the week of March 29th - I was laying down in the middle of the day, no energy at all.  Called the doctor and because of the shortness of breath & Body aches, they would only schedule a video visit for Monday, April 5th.  After talking to me, they schedule to see me that day at 11:45 AM.  I had weak muscle response in my arms, pale, and out of breath.  They did blood work.  Two hours after getting home; they called and said I needed to get to the emergency room.  My red blood cell count was dangerously low, and they ordered a blood transfusion.  I sent 6 days in the hospital.
Immediate pain in left arm, sudden dizziness, increased heartbeat, and nausea with the first 5 minutes of administration. After waiting ~30 min felt less dizzy and went home.  Took a Tylenol and just had weakness and severe pain in the left arm. Next day around 9 pm had severe chills, fever, nausea, and a panic attack. Continued pain in left arm for another 2 days and continued feeling of weakness and fatigue until today.  Have suffered shortness of breath and randomly increased heartbeat and feeling hot last week. This week is just continued fatigue and increased anxiety.
Fever of 102 degrees, chills, muscle aches, bright red & tender & painful injection site, severe headache, lack of appetite. Persisted for 7 days. No treatment except bedrest & aspirin.
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    Concomitant medications were not reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. were reported.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.    Treatment medications were not reported.
5/11/2021   Client was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  headache.   Assessment : Time of assessment 0841. Alert and oriented and Anxious.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.  0841 Vs - BP-152/74. P- 81, O2- 98%, juice given- Blood glucose 115, recheck VS- BP- 159/78, P- 72, O2- 100%       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 45 minutes. Discharged home.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 5/11/2021  8:20 AM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc           Electronically signed by RN at 5/11/2021  4:06 PM  Immunization on 5/11/2021   Detailed Report  Note shared with patient
This spontaneous report as received from a nurse refers to a two patients of unknown age and gender, who completed the series of ROTATEQ in 2013 (orally, dose frequency and indication were not provided). The nurse provided lot numbers: J004944 (expiration date: 12-NOV-2014); J001815 (expiration date: 06-JUL-2014); J001257 (expiration date: 27-AUG-2014); H016249 (expiration date: 27-MAR-12014); H012981 (expiration date: unknown); H011458 (expiration date: 04-DEC-2013). The lot number J010928 is an invalid lot number for ROTATEQ. In approximately March 2015 (reported as "in the last two weeks") the patient were diagnosed with rotavirus infection. The outcome of rotavirus infection was unknown. The relatedness between ROTATEQ was not reported. This is one of the two reports received from the same reporter. Additional information has been requested.