chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of dystonia in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included seizure. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced dystonia. On an unknown date, the outcome of the dystonia was unknown. It was unknown if the reporter considered the dystonia to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingles vaccine and had dystonia at the time of reporting. This report was filed after the call. Adverse event was discovered during call review and limited information was available for this report.
Pt received the J&J vaccine. A few minutes after receiving the vaccine the pt became pale, clammy, had blank stare, and rigid jaw. Pt responded to sternal rub. Would not lay down. Pt's wife sated she believes he had worked himself up over getting the vaccine. Pt's wife also stated he did not eat prior to coming. Pt had brief syncopal episode lasting less than 10 sec. Pt somewhat alert and talking/sluggish. EMS/911 called at 11:51a. 911 stayed on the phone with me until ambulance arrived. During phone call the pt became more alert saying he was better and needed to walk around. I did not let pt up; kept him seated. He became less diaphoretic/clammy, but still pale, alert and talking. Vitals at this point were reassessed and had improved. At approx 1205p report was given to paramedic and care transferred.
After receiving the flu shot, the patient experienced pain on 09/04/17 the day after. The pain persisted to the point where the patient called the pharmacy in tears because of the shoulder pain. The pain still persists even today (09/07/17). Since the patient underwent carpal tunnel surgery in the right hand, the patient mentioned that she will take her pain medications while she recovers and hopefully the pain will subside by next week.
Dizziness; tinnitus; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Dec2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (medically significant), outcome "not recovered", described as "Dizziness"; TINNITUS (medically significant), outcome "not recovered", described as "tinnitus". Additional information: Patient have some questions about getting second Pfizer. Patient had COVID-19 Virus in Dec2020 to an unknown date. Patient received the first COVID Vaccine Pfizer about a week and half ago. So, patient was long hours after patient had this COVID Vaccine, patient was left with dizziness and tinnitus for a 'month' but they were subsiding, so patient got first vaccine and it brought all the symptoms back and they hadn't gone away. So patient was questioning if patient should be getting the second one.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine was administered 11:45 am. Post vaccine (~30 mins) slightly nauseous and diaphoretic but resolved. Around 9:30 pm had 3 consecutive syncopal episodes. 911 was called and EMS arrived. Finger stick and BP were unremarkable; however, BP was slightly elevated for my usual (136/72 at time of reading where I am usually 110/80)
Arm redness, more than expected. Transferred to her armpit which is where she noticed pain.  Swollen, hot and red. Patient taking ibuprofen and BENADRYL. Complained of excessive fatigue the following day.
Headache; Dizziness; Body aches; Chills; Exhaustion; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 12Apr2021 at 15:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications of the patient were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 23Mar2021 at 14:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021 at 19:00, the patient experienced headache, dizziness, body aches, chills, exhaustion and brain fog. The events 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 reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of headache, dizziness, body aches, chills, exhaustion and brain fog was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Swelling on her face and chin.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling on her face and chin.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swelling on her face and chin.). At the time of the report, SWELLING FACE (Swelling on her face and chin.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications were reported.
Cough, went to the Dr. for breathing trouble.  I have not been able to walk with out sitting down to get so I can breath,  I was told that I now have fluid with my heart.  My feet have been swealing up so bad,  I feel sick all the time now..  If I knew this would happen i would not have gotten the vaccines.
Arm where shot was received, from shoulder to past elbow, was swollen, red, and hot to the touch.
Mother informs that the child's upper left limb became edematous, red and hot. The patient was evaluated by Dr. who ordered Benadryl. Fever started the second day. At the moment the area is free of edema but is a little rough to the touch than the rest of the skin.
2nd dose given too soon.  1st dose given 11/22/2021, Second dose given 12/6/2021
Redness; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Patient is under medication for the same) and Cholesterol (Patient is under medication for the same). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), THYROID and CHOLESTEROL for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
1. a low tone, audible in left ear 2 days after the vaccine. 2.slight dizzyness 2 days after the vaccine, and then extreme dizzyness 3 days after the vaccine.
A report has been received from a Health Professional concerning a 10 year old, Female subject who had been receiving Nasal FLUMIST QUADRIVALENT (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started on 14-Jan-2014. Nurse reported that they had four siblings that inadvertently received expired FLUMIST QUADRIVALENT. None of the patients had reported any symptoms. The outcome of the event of EXPIRED FLUMIST/INADVERTENTLY RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 62-year-old male patient received BNT162b2 (BNT162B2), on 17Dec2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: Rebound COVID symptoms following negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
Information has been received from a mother and a physician concerning a 13 year old boy with asthma, allergy to penicillin and severe allergies to milk, beef and pork, who on an unspecified date was vaccinated with the first dose of  VARIVAX (Oka/Merck) and on 15-APR-2008 was vaccinated with the second dose 0.5 ml injection. Concomitant therapy included montelukast sodium (MSD). The patient's mother reported her son experienced cellulitis infection after getting the second dose of  VARIVAX (Oka/Merck). The patient did not experience an adverse event from the first dose The physician called afterwards and mentioned the patient had enormous red indurated area on the left thigh. The area was tender and went from the "puncture towards the feet". There was an expanded levels of redness and dependent edema. The physician initially thought this reaction was cellulitis but the physician now thinks it was an allergic reaction. The patient had no anaphylaxis and no hives. The physician mentioned pork was recently reintroduced and the patient did not experience any7 problems. As of 29-APR-2008, the patient's allergic reaction to varivax persisted. Additional information has been requested.
Small pustule L deltoid.  Erythema in band 2 cm wide extending to L axilla;; slight tender node L axilla.
Progressive Redness, swelling, itching and tenderness at injection site (worse at 1 week post injection).  Increasing body aches and neck stiffness.
day p/vax devel redness, swelling around site of immun ( 7 x 20 cm) & extreme fatigue, felt hot but did not take temp;
Father states the patient ran a low fever on 06/26/2001 and on 06/28/2001 the patient had a "seizure like" episode. The patient stopped breathing and was transported via ambulance to the ER.
I am in menopause. I experienced what felt like an ovulation cycle with tender and swollen breasts, and viscous discharge from my vagina. I then had breakthrough bleeding, like a very small period. The symptoms eventually passed like an ovulation cycle and I had no more bleeding. I saw my primary care doctor and she recommended we do an endometrial biopsy. These are her notes - Endometrial Biopsy Procedure Note: Performing Provider: MD; Pre-op DX: Post Menopausal Bleeding; Post-op DX: Post Menopausal Bleeding; Anesthesia: PCB; Complications: none.   Patient is a 59 YO P1 who presents for endometrial biopsy for PMP bleeding in 5/21 (PMP x 2yrs).  She is currently using PMP for contraception.  She is currently sexually active w/ partner of 18yrs.      U/s 5/13/21: Uterus measures 6.6 x 3.9 x 4.7 cm and is retroflexed.  There is a subserosal 7 x 3 x 5 mm hypoechoic lesion posterior aspect of the fundus indicative of a small fibroid.  Otherwise, no focal abnormality. Endometrium measures 5 mm and appears normal. There is no free fluid in the cul-de-sac. Urinary bladder is empty. Pelvic vessels appear unremarkable on this examination. Unable to visualize the right ovary.  The left ovary measures 1.7 x 1.1 x 1.5 cm with internal flow.
2 days following receiving Pneumonia vaccine noticed swelling and redness at injection site.  3 days later went to ER and received IV antibiotics.  Diagnosis was cellulitis.
Shot was given at about 12:40 pm on 12/8/2008. During the evening at about 5:00 pm I felt fatigue, dizziness, weak knees and a very sore arm at the injection area. When I woke up on the morning of 12/10/2008 I experienced tingling in my left hand. Over the weekend the tingling turned to pain in the left hand and arm. I saw Dr. on Monday, December 15th for diagnosis. He referred me to the clinic where I was tested at 9:45 AM on 12/19/2008. I believe when the shot was given my Ulnar nerve was nicked and that is what is causing the tingling and pain in my hand.
Patient was in the domiciliary and seen multiple times for this rash. He was also sent to a dermatologist and a biopsy was done. He made multiple trips to urgent care also. They attributed the reaction to RANITIDINE. Patient stated he had started the RANITIDINE ON 12/25/09. The ZOSTER was given on 12/24/09. RANITIDINE was stopped on 12/29/09. All medications were stopped 1/4/10. RANITIDINE was given Solu-Medrol and started on doxepin 50 mg at bedtime. On 1/15/10 he started back on his normal med. He was diagnosed with scalded skin syndrome and a diagnosis to polyester. The rash appeared two days after the ZOSTER vaccine. He had ZOSTER noted in his chart from 3/9/07.
pt recv vax 27JUN95 & 10JUL95 pt c/o itchy swollen hand bilat which lasted two weeks;pt hands cont to feel warm;AUG95 devel joint inflammation all over which treated w/pred;30SEP96 vax had not recovered;
bloody stool; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 42; unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 21Apr2021 (batch/lot number and expiry date not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced blood in his stool for 2 days since getting the vaccine, not just a little bit or a spot of blood but a lot. The patient would like to know whether his side effect; bloody stool, is related to the COVID vaccine. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Headache, Fever 101.0, sore at injection site. Treated with Tylenol. Headache lasted all day. Fever lasted 2 hours.
received vaccines on 3/30/20-.  Parents reported Fevers, rash and diarrhea starting  4/2/2020.  Rash was on trunk and extremities.  They were seen at an ER on 4/4/2020.  Fever ( up to 103) persisted  until into the night of 4/6 (now resolved)  but rash appeared to be fading and diarrhea continued.  They had a telehealth visit on 4/7 and an office visit on 4/8.  The visit  on 4/8 was due to worsening or change in rash parents had seen and child acting like he did not feel as well and threw up twice in the morning.  In the office on 4/8-- the rash appeared to be c/w  urticaria and responded to oral benadryl in office.  As the rash faded the child's temperament in the office improved as well.  Currently treating w/ combination of kids Zyrtec  daily and benadryl for breakthrough rash. .    Vital signs were stable and lungs were clear.
Random bruises and pains in my legs . Random bruise on hands and feet. Heart palpitations. Repeating Sharp spleen pain.  Headaches . Shoulder pain .
Bad headaches for 5 weeks; 4 weeks of Vertigo; Dizzy; Off balance spells/Spent 4 weeks lying down most of the time; Migraines; Sore arm; Pain so bad she can't go to sleep; 79-day gap of both doses; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INSOMNIA (Pain so bad she can't go to sleep), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (79-day gap of both doses), CLUSTER HEADACHE (Bad headaches for 5 weeks) and VERTIGO (4 weeks of Vertigo) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 00621A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine, Kidney disorder and Allergy to plants (trees and shrubs). Concomitant products included ELETRIPTAN HYDROBROMIDE (RELPAX) for Migraine, LEVOTHYROXINE for Thyroid disorder, ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), INSOMNIA (Pain so bad she can't go to sleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (79-day gap of both doses). On an unknown date, the patient experienced CLUSTER HEADACHE (Bad headaches for 5 weeks), VERTIGO (4 weeks of Vertigo), DIZZINESS (Dizzy), BALANCE DISORDER (Off balance spells/Spent 4 weeks lying down most of the time) and MIGRAINE (Migraines). On 23-Feb-2021, INSOMNIA (Pain so bad she can't go to sleep) had resolved. On 07-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (79-day gap of both doses) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved and CLUSTER HEADACHE (Bad headaches for 5 weeks), VERTIGO (4 weeks of Vertigo), DIZZINESS (Dizzy), BALANCE DISORDER (Off balance spells/Spent 4 weeks lying down most of the time) and MIGRAINE (Migraines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment included extra doses of Relpax.     Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: FOLLOW UP RECEIVED NO NEW INFORMATION WAS FOUND.
Patient called to say his left arm was injured after a vaccination. I looked in the file & it was Fluad. I asked him when he first started experiencing symptoms & he said about a week after. I asked if he could be more specific because we use this for documentation purposes & he repeated "about a week, it could have been 9 days it could have been 3 days." I asked him if he saw a doctor or if they did any imaging/scans or anything to confirm the injury & he said he did go to the Dr. & they told him to keep moving the arm & the pain should go away. I don't know when or where he went. I forgot to ask that. He said he's still in pain & mentioned it's hard to turn his steering wheel when driving. I did recommend if he's still in pain to see the Dr. again as they may be able to give a more definitive answer or at least refer to PT or something.
About 3 hours after the shots, patient woke up from a nap and ate. After he ate he was a bit fussy. The fussiness soon turned to screaming and crying uncontrollable for about 2 hours. We finally got him to sleep on our shoulder and he did for about an hour. He woke up screaming loudly. I tried to nurse him and bottle feed him and he didnt take either. He then screamed and cried for another 1-2 hours straight not being able to be controlled. He fell asleep again and woke up again...not interested in eating. We got him to eat around 9:30PM and the fussiness was better.
Pulmonary Embolism: presented with chest pain and shortness of breath found to have pulmonary embolism on CT angiogram.  Symptoms resolved after 3 weeks of anticoagulation.  No evidence of DVT.
Patient received flu shot at 7:58PM. Asked patient to stay in the store for 20 minutes after the shot. Patient returned to the clinic at 8:20PM complaining of mild itching over her extremities and back. No rash/hives/redness is visible on the extremities or trunk on examination. Patient denies dizziness or SOB. Patient stated that "it's an weird sensation". Patient given Children's Liquid Benadryl, 12.5mg/5mL, 10mL given by mouth in the clinic and monitored for nearly 40 minutes. Patient tolerated medication fine and symptoms not worsened. Instructed patient to continue to take Children's Liquid Benadryl, 12.5mg/5mL, 10mL by mouth every 4-6 hours for the next 24 hours. Patient instructed to call 911 immediately if symptoms of urticaria, angioedema, respiratory symptoms, dizziness or changes in level of consciousness occurs. Patient verbalized understanding of instructions.
product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 45-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 01Feb2021 as dose 2, single (Lot number: EL9262), in left arm and on 29Sep2021 as dose 3 (booster) single (Lot number: FF2588) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "overweight/obesity" (unspecified if ongoing); "hyperlipidemia (Untreated)" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN oral, start date: 06May2022, stop date: 09May2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "product=COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) positive, notes: Tested on binaxnow positive on day of symptoms (day 0) and 2 days after known exposure; (13May2022) negative, notes: Tested on binaxnow day 6 negative and symptoms improved; (17May2022) positive, notes: Retested, positive on rapid antigen I health test and symptomatic (worsening congestion/sore throat) on day 10 of covid after taking Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
This case was received from a health care professional on 01 May 2009. It was reported as one of a cluster of three patients; the other two patients' events are captured in case numbers 2009-01932 and 2009-01933. A five-year-old female patient received the following vaccinations on 29 April 2009: a left arm fifth dose of DAPTACEL (lot number C3084AA), a left arm fourth dose of IPOL (lot number B0475-2), and a right arm second dose of MMRII (Merck, lot not reported). On 30 April 2009, the patient's parent reported a red, swollen area on the left arm to the shoulder. The area was treated with cool compresses. Outcome was not reported. Follow-up information was received from the health care professional on 22 May 2009. The MMRII lot number was reported as 0152Y. All events had recovered. No additional information was provided.