chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For the past month "I" have had a menstrual cycle every 2 weeks which is very abnormal for "me"; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via intramuscular route of administration in the right arm on 09Oct2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included overweight. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via intramuscular route of administration in the right arm on 08Sep2021 at 12:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Since the past month from the time of this report, from 14Oct2021, the patient experienced menstrual cycle every 2 weeks which was very abnormal for her. The patient had regular menstrual cycles before receiving her second dose of the Pfizer vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle every 2 weeks which was very abnormal was unknown at the time of this report.
Information has been received from a physician concerning a 79 year old male who on 01-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (lot # 658083/0885U). There was no concomitant medication. On approximately 10-OCT-2007, 10 days after the vaccination the patient experienced shingles like rash on his torso. Unspecified medical attention was sought. at the time of report the patient had recovered. A product quality complaint was not involved. Additional information has been requested.
Fever, headache, muscle and joint aches, unsteady when walking, and shaky arms
Presented on 27June06 with reports of rash on back and chest x 6 days following receiving Smallpox vaccination on 15June06. Rash on body nonpruritic, however vaccination site is pruritic and painful. Diffuse rash is noted throughout back and chest measuring as 1x1mm papules. Also present on each hand are 1x1mm papules that appeared 2 days prior to visit. Immunization site notes a 3x3mm scab without redness, warmth or suppuration. Motrin ordered prn, keep site clean and rtc prn.
10 days after my booster shot (3rd), I broke out in full-body itching and hives that started on my scalp and then moved to every part of my body. I have never had an allergic reaction to anything in my life, including previous vaccinations. I am now on day 6 and the itchy rash comes and goes all over my body. I have been prescribed Methylprednisolone and I take Claritin every morning to try to counteract the itch. I am reporting this because I have not seen any guidance or a reason for full-body itching allergic reaction in response to the vaccine.
This spontaneous report was received from a registered nurse via field representative, and refers to approximately a 24 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On unspecified dates in 2008, the patient received three doses of Quadrivalent GARDASIL, intramuscularly for prophylaxis (strength, anatomical location, lot number and expiration date were not reported). On an unspecified date in 2010, the patient developed systemic lupus erythematosus and on an unknown date in 2015, she had an papanicolaou smear abnormal. The patient sought medical attention but it was unknown by the reporter if the patient received treatments for the events or if additional laboratory diagnostic or test were performed. The outcome of the events systemic lupus erythematosus and papanicolaou smear abnormal and the causal relationship between the aforementioned events and vaccination with Quadrivalent GARDASIL were not reported. Upon internal review the event systemic lupus erythematosus was considered to be medically significant.
febrile seizure-tx by ER on 8/9/99;no meds;
Vomiting, Diarrhea, headache & fever, intense back and leg pain, double vision and vertigo, symptoms such as Guillian-Barr
This is a spontaneous report from a contactable Female consumer (patient). A 69-year-old (non-pregnant) female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6208, Expiration date: unspecified), via intramuscular route, administered in left arm on 13Mar2021 at 11:15 (at the age of 69-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient received the first dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198, Expiration date: unspecified), via intramuscular route, administered in left arm on 24Feb2021at 15:45 as 1st dose, single dose for COVID-19 immunization. The patient medical history includes flu shots on unspecified date, the vaccine stopped the fractured sleep such bliss, bronchitis I had many times as child. Concomitant medications were not reported. No other vaccine taken 4 weeks prior. On 17Mar2021, after the vaccination, the patient experienced Tiredness/ suddenly exhausted, swollen lips after drinking green tea, Hay fever with little blooming in mountains, rashes, Welts on skin were brushed against things. On 18Mar2021, patient experienced mild headache, eyes and nose running, became allergic to nearly everything, On 20Mar2021, patient experienced Low Blood Oxygen when climbing Low hill 89% and 91%, On 22Mar2021 patient experienced Chest and upper back pain. on unspecified date patient experienced sneezing, shoulder started hurting, migraine and bad sleep. The patient continued to work around home but did not go down the hill again for another week all cleared up by 15 considered taking otc drug Benadryl but warred it might mess immune response of vaccine. Patient said he was migraine- free for about a month after 2nd vaccine had first migraine. Patient usually get 8 hrs of sleep fractured over a 12-hr period of trying to sleep the vaccine stopped the fractured sleep. Lab investigations include heart rate with reading 56 bpm and steady 56 bpm on unspecified dates and oxygen saturation 89% and 91 % on unspecified dates. Good effects were all pain in old injury in left shoulder is gone. Therapeutic measures were taken as a result of events sneezing, eyes and nose running, mild headache, Low Blood Oxygen when climbing Low hill 89+91%. The outcome of the events urticaria, pyrexia, lip swelling, hypersensitivity, chest pain, backpain, fatigue, rash, oxygen saturation and headache was recovered on unspecified date, whereas outcome of other events was unknown.  No follow-up attempts possible. No further information expected.
Dizziness and fainting  Fell to floor without injuries  Dizziness disappeared in 15 to 20 minutes
Lump at injection site spreading to redness to entire upper arm over following 5 days with warmth and itching
Employee complains of dizziness approximately 15 minutes after receiving injections per employee report she got dizzy after smoking cigarette. Temp 97.7 resolved about 10:30 am.
This spontaneous report was received from a healthcare worker professional refers to an unspecified number of patients of unknown age and gender. Since 20-FEB-2015, the patients were vaccinated with VARIVAX (Merck) which was improperly stored and administered (dose, route of administration and lot # were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received flu shot at approximately 3PM - awoke 3AM with a swollen, red throat. Administered FIRAZYR to self to stop laryngeal attack. Also developed hives on upper left arm at and around shot site.
Left arm numbness, left arm itchiness. Lasted about 25 minutes. No medications given.  Dizziness, resolved within minutes. After waiting in observation for about 15 minutes, client reported feeling short of breath. No intervention done. EMS came to assess the client. She did not go to the hospital.
Narrative:  COVID infection following COVID vaccine series Refuses all COVID-19 vaccines (current and future) 12/20 COVID swab, result: detected 12/20 SARS-COV-2 Variant Sequencing: pending 12/20 CXR IMPRESSION: No acute cardiopulmonary disease. 12/18 pt cc: cough, rhinorrhea, fatigue, headache, nausea, congestion, diarrhea, chills exposure: unknown 12/31 clinically resolved
The Tdap expired on 9/12/20 and was inadvertently given. There were no complications. The patient will come in for another Tdap, ASAP, and education was provided for the staff.
Passed out got hives blood pressure went through the roof gave chewable benadryl started shaking could not control then ticket in thought next thing in ambulance and very hard to breath gave me shots ephedrine and steroids calmed a bit but came back at hospital gave albuterol HFA 108. Left 6 hours later with albuterol HFA 108 and 3 days of predniSONE 10 MG tablet.  went my doctor next day put me on 10 of predniSONEcetirizine 10 MG tablet and clartoncetirizine 10 MG tablet at night and clarton in morning continue hydroCHLOROthiazide 25 MG
Swelling of arm, large red welt, painful to the touch and producing heat. Consistent fever and body aches for 48 hours
Local reaction,  initially 7X5 Cm erythematous, warm reaction, extended to 15X11cm  of erythema 3 days after vaccine with central purplish discoloration, minimal pain
starting June 27th in the morning I started having trouble breathing. I checked my blood pressure throughout the day and it ranged from  150/96 with a heart rate of 113 to 203/109 heart rate 110. I went to the emergency room where I was advised that I have a saddle embolism in both of my lungs as well as a deep vein thrombosis in my left thigh. I had surgery to remove the saddle embolism and I am now on Eliquis twice a day to dissolve the clot(s) in my leg.
Information has been received from a certified medical assistant concerning an adult patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5 ml) (IM). Subsequently the patient experienced injection site reaction with injection site redness, warmth and soreness within a day of vaccination. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to a 15 year old female patient with asthma. No other medical history or relevant past drug history was provided. On 30-AUG-2014, the patient was vaccinated with PROQUAD (Merck), (Lot # reported as K0065546, Expiration date: 17-OCT-2015) Injection. Lot number K0065546 is an invalid lot number for PROQUAD (Merck). Concomitant therapies included FLOVENT and XOPENEX for asthma. On 30-AUG-2014, patient was vaccinated with PROQUAD (Merck) because the facility did not have the individual "MMR" and varicella vaccines available and then it was noted in the package insert it was only to be used in patients through 12 years of age. No relevant laboratory testing has been performed. No other adverse event was known at the time of the report. Additional information has been requested.
This spontaneous report as received from a pharmacy student refers to a male patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II. Dose and lot information were not provided. Other suspect therapies included Tdap (manufacturer unknown). On an unknown date the patient who was administered both the vaccines on an unspecified date, experienced anaphylactic reaction. The outcome of anaphylactic reaction was reported as resolved. The patient had sought medical attention of unknown type. The pharmacy student was unable to provide any further details. Additional information has been requested.
2/3/07 RX'd with Keflex 250/5ml 101/2 tsp TID x 10 days, swollen erythematous R lower thigh and knee around and below site of Dtap which was given 24 hours ago. 2/4/07 much improved. Erythema resolved, leg normal.
pt recv vax & devel an inj site rxn characterized by erythema & tenderness;also devel ax lymphadenopathy;
Sore arm for 4 days, extreme fatigue, severe body aches for 2 days, all muscles weak and hurting for 2 days, headache for 2 days, not able to sleep for 2 days
Severe headache, muscle aches, diarrhea, severe lower back pain for more than 10 days
Pain started I think the next morning. Pain in lt arm and shoulder, worse at night, wakes from sleep. Some difficulty raising arm, undressing and reaching for items. Pain and discomfort persist 3.5 months later. Orthopedic Surgeon recommended MRI. Insurance denied.
30 min post vaccine, patient developed slight dry cough and feeling of tightness in back of throat.  Noted hoarseness of her voice.  Brought to medical area where she then noted flushing, warmth of skin on face, neck, upper arms and chest.  Slight nausea.   On exam, no abnormalities except flushed skin.  Vitals remained normal and stable. Monitored vital signs, had epi pen ready and elected to send her to ED via EMS for further monitoring, esp given her long hx of anaphylaxis.  No other tx provided at site.
Coughing; loss of taste; anorexia; loss of smell; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), AGEUSIA (loss of taste), DECREASED APPETITE (anorexia), ANOSMIA (loss of smell) and PYREXIA (Fever) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced COUGH (Coughing), AGEUSIA (loss of taste), DECREASED APPETITE (anorexia), ANOSMIA (loss of smell) and PYREXIA (Fever). At the time of the report, COUGH (Coughing), AGEUSIA (loss of taste), DECREASED APPETITE (anorexia), ANOSMIA (loss of smell) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Changes to menstrual cycle - used to have 1 1/2 day cycle - now it is closer to 6 days with increased flow, cramps, and duration
allergic reaction; contact dermatitis; Local reaction; Rash; widespread body skin eruption; eczema; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. In April 2019, 1 day after receiving Shingrix, the patient experienced rash, widespread rash and eczema. On an unknown date, the patient experienced allergic reaction, contact dermatitis and local reaction. On an unknown date, the outcome of the allergic reaction, widespread rash, eczema, contact dermatitis and local reaction were unknown and the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the allergic reaction, rash, widespread rash, eczema, contact dermatitis and local reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was 50 years old at the time of reporting. The reporter reported that, the patientb experienced widespread body skin eruption (rash, eczema) the day after, which was unmanaged and uncontrolled. The reporter stated that, the patient had pretty impressive local reaction after vaccination which they figured was expected. Less than 5 months, the patient experienced allergic reaction, contact dermatitis and local reaction. The reporter did not suspect the rash to be shingles but, rather a spongiotic dermatitis or contact dermatitis, as the patient never had rashes in the past. The patient stated that, has been misdiagnosed with Scabies and treated unsuccessfully. The patient reported that, did not have chickenpox as a kid and was inquiring if this could make a difference with him getting the vaccine. The patient asked, if tghis was an allergic reaction and how long would the symptoms last. The reporter consented to follow up.
There was an apparent burning sensation when the needle was injected. The next days, I developed a hematoma on the site of the injection and a  large dark red/purple bruise followed.
This spontaneous report was received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. From 14-AUG-2017 to 19-SEP-2017, the patients were vaccinated with improperly doses of VARIVAX lot number M033212; expiration date 13-JUL-2018 or lot number N008828; expiration date 16-MAR-2019 or lot number M038858; expiration date: 14-SEP-2018 (strength, dose and route of administration were not reported) for prophylaxis. The patient's concomitant therapies included sterile diluent (MERCK). The temperature of excursion with VARIVAX was -14 to -10 Celsius degrees during 876 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA010549.
patient inadvertently received undiluted vaccine at a dose of approximately 20mcg (twice the intended dose).  Parents contacted on 7/21/22 and reported that "fever and headache had been relieved with Tylenol".  No other reactions reported.
This is a 72y.o. female with osteomyelitis on IV antibiotics, systolic heart failure (EF 20%), CAD, PAD, hypertension, COPD, and chronic kidney disease who presents from ECF complaining of increased fatigue and weakness. She also complains of dizziness, but notes she hasn't been out of bed in several days and denies any dizziness at rest. The patient was discharged to facility - on 11/19/21 on IV daptomycin and Rocephin. Prior to that admission, she had been ambulating with an assistive device. She denies any known fever and does not complain of back pain. No shortness of breath, cough, nausea, vomiting, abdominal pain, dysuria, flank pain, or diarrhea. She denies any known exposures. She believes she's been getting her IV antibiotics as prescribed and has not missed any doses.   In the ED, the patient was hypotensive with BP as low as 80/47. She was also febrile with a temperature of 102.2. SpO2 100% on room air. Labs notable for WBC 9.0, CRP 164 (elevated from 11.3 on 11/11), creatinine 1.22, hemoglobin 9.7 (reduce from 12.3 on 11/19). COVID-19, influenza, and RSV not detected. Urinalysis negative. Chest x-ray shows moderate cardiomegaly without pulmonary vascular congestion. She had CT L-spine that shows sequela of previously described osteomyelitis/discitis, stable compression deformity of L4, and multilevel extradural defects with associated degenerative changes creating up to moderate to severe spinal canal narrowing. Blood cultures were obtained. The patient's IV antibiotics were resumed. ID and neurosurgery were consulted.
Pfizer vaccine administered after being  stored at regular freezer temps longer than recommended.  Doses determined invalid, client contacted and recommended repeat dose.
This spontaneous report as received from a healthcare worker refers to a 8 month old patient of unknown gender. On 09-JUL-2014 (reported as "today") the 8 month old patient was vaccinated intramuscularly with a dose of VAQTA (24/0.5, 0.5 ml, lot # and expiration date were not reported). No adverse effect was reported. The reporter stated that this event was related to staff error, but that the boxes for the prefilled syringes looked similar. SR was sent to the Quality department for review. No PQC (product quality complaint) was involved. Additional information has been requested.
Very oily forehead, slightly oily nose, watery left eye, a little watery right eye.
stiffening & aching of hands,knuckles,knees,elbows & shoulders;fatigue,listless & weak,no golf;drowsy all the time
This spontaneous report was received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient received subcutaneously live ZOSTAVAX in error (dose and lot not reported) on 24-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No known adverse effects. No treatment information was reported. The outcome of the event was unknown. The event was not related to live ZOSTAVAX. Additional information is not expected.
Patient's chief complaint was profound dizziness. She also complained of excessive body heat and feeling "shaky". Vitals showed that she had elevated blood pressure of 143/110 and a pulse of 85. He hands so visible signs of shaking and her face was slightly pale in color. We provided the patient with cold water, a cold compress to apply to her neck, and a small candy bar to help raise her blood sugar. We removed part of her long-sleeved shirt and fanned her with a paper to help cool her down. She refused to lay down on the floor so we instructed her to put her head between her legs to help with blood flow. We kept open communication with the patient about her symptoms and within 20 minutes she stated she was feeling better. Her vitals were rechecked at this time-her blood pressure returned to normal 124/80, but her pulse was still slightly elevated at 80. Her coloring in her face returned to normal and she did not appear to be shaking any longer. She felt comfortable leaving the pharmacy with her husband and stated she felt much better. She went to the restaurant in the store and ate a sub because she stated she had not eaten since early this morning and felt her blood sugar may be low. I called to check on the patient about 6 hours later and she said she still felt a little dizzy and had a headache. She was instructed to follow-up with her primary care physician in the morning if her symptoms persisted and if they became more severe in the night she was to go to the emergency room.
Patient came back for her second Moderna vaccine today and said that the day after her first vaccine she noticed small red spots on various parts of her body, mostly on abdomen - she said it might be related to her dog's fleas also. She also noticed pain in her left heel the day after the first vaccine. Since it was not an anaphylactic reaction I recommended that she get the second vaccine to complete the series.
I developed a lump in my left armpit. My 1.5 year old nursing baby developed a face rash on her cheeks and chin that is red and raised.
pt had swelling of tongue & tongue blisters about 6 hrs after getting pfizer vaccine #1; sx resolved w/in about 6 hrs w/out Rx
24 hours after vaccine, red patch 2" x 1".  Next day it was about 2" x 6 or 7 inches - hot - itchy.  Doctor gave me Domeboro to use twice a day along with Vanos 2 times a day.
Initial report received on 21 September 2009 from a health care professional. This case is part of a cluster of two patients from the same reporter. The other patient's information is reported in case 2009-03998. A 68-year-old female patient, who denied any concurrent illnesses, who had no known allergies, but has medical conditions of increased cholesterol, increased blood pressure and migraines, had received a dose of FLUZONE SV 2009-2010 (lot number U3198AA) on 04 September 2009. The route and site of administration and number of previous dose were not reported. Three days post-vaccination, the patient experienced dizziness and was evaluated by a physician and treated with Meclizine. The dizziness lasted at least 24 hours. The recovery status of the patient was unknown. Documents held by sender: None.