chrisvoncsefalvay/vaers-outcomes huggingface dataset:
right ear hearing loss; serous otitis media; tinnitus.; posterior capsule opacification; posterior vitreous detachment; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 04-AUG-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Defendants' zoster vaccine live (ZOSTAVAX) vaccine, patient suffered right ear hearing loss, serous otitis media and tinnitus. Additionally, patient suffered vision loss and was diagnosed with posterior capsule opacification and posterior vitreous detachment. Later, patient began to experience an itching and burning rash on the back of her left shoulder and was diagnosed with herpes zoster.   As a direct and proximate result of zoster vaccine live (ZOSTAVAX)  vaccine, patient symptoms have resulted in physical limitations not present prior to using this product. Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries, further, as a tragic consequence of this wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Defendants' conduct, patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, deafness, vitreous detachment and posterior capsule opacification were determined to be medically significant.
Felt warm flushed after covid-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of HOT FLUSH (Felt warm flushed after covid-19 vaccine) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product HUMIRA for Crohn's disease.    No medical history was provided by reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and HUMIRA (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HOT FLUSH. At the time of the report, HOT FLUSH had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HOT FLUSH to be possibly related.    No concomitant medications reported by investigator. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: No new information was received.
Initial report was received on 17 October 2011 from a healthcare professional. A cluster of two pediatric patients had received FLUZONE (lot number, route, site and date of administration not reported) and unspecified amount of time later, experienced cellulitis. According to the report, the patient's had received the same lot number of "sanofi flu vaccine". No further information was available at the time of the report. The patient's outcomes were not reported. Documents held by sender: none.
After the second dose, the next morning I had a low grade fever and slight headache. But extreme pain in my bones. It felt like they were all about to break. As well as extreme pain at he injection site. Symptoms lasted roughly 12 hours. Now 6 days after the vaccine, I am still having whiplash like neck pain.
My arm is all swelled up and not extremely by it; Pain; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number EW0182, expiration date was not reported) via an unspecified route of administration on 15Jul2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient stated "I took the COVID 19 the last shot this past Thursday the 15th, now that I am having, my arm is all swelled up and not extremely by it in Jul2021. But is there anything I can do for that, do I need to ice it down or?". The patient stated "Okay I have got swollen my in arm and when I took the shot. Do I need to ice it down or what do I need to do?" In Jul2021 the patient stated "You mean my pain, my pain level?" The outcome of events was unknown.   Follow-up attempts have been completed. No further information is expected.
Started w/fever as high as 102 ax 3 hrs p/vax given; Screamed for almost 24hrs; quieted 5 min of each hr; High pitched scream; seemed listless & incoherent; Mom had trouble getting to take APAP;
About 27min after receiving vaccine, client began feeling itchy all over and hives were observed. Benadryl was given to pt. About 15min after receiving benadryl client began to feel better. No hives were observed and she was not have any difficulty breathing. Client deemed safe to go home per RN.
This case was reported by a pharmacist and described the occurrence of tongue feels thick in a 63-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 6 October 2011 at 11:45 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 6 October 2011, less than one day after vaccination with FLULAVAL, the subject experienced tongue feels thick in the back, painful feeling ("feeling achy") and throat discomfort ("uncomfortable almost like a sore throat"). The subject had no trouble with her breathing. At the time of reporting the outcome of the events was unspecified.
8 days after the 2nd dose of the pfizer, I started having heart rate increases where my heart rate increased from my normal rate all the way up to 160bpm+. This has continued now for almost 2 weeks and also the start of additional symptoms where I feel flush, my body tingles, chest tightness, heaviness in my legs, shortness of breaths.
Expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a male patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was reported as 05-Mar-2022. It was reported that vial did not undergo any temperature excursion.  No treatment medications were reported.    This case was linked to MOD-2022-532663, MOD-2022-532746 (Patient Link).
I received my Covid-19 vaccine on 01/25/2022. On 09/04/2022 I started feeling extremely tired, my tastebuds wasn't normal, and felt dehydrated. After testing positive for Covid -19 I contacted my doctor online care. Was not giving any treatment.
Information has been received from a registered nurse concerning a 29 year old female nurse with no allergies or medical history who in 08/2000 and 11/2000 was vaccinated with a first and second dose of hepatitis b virus vaccine rHBsAg(yeast)(manufacturer unknown). There was no concomitant medication. It was noted that the vaccinations were received at another facility. The nurse reported that the patient developed fever, myalgia, fatigue, and a headache for five to seven consecutive days after each immunization. Unspecified medical attention was sought and it was unknown if treatment was required. Subsequently, the patient recovered. It was also reported that the patient had a negative titer in 08/2003 and in 06/2004 and she had no antibodies. A product quality complaint was not involved. No further information is expected.
After vaccine did not feel anything- I was a little bit tired and slight headaches- and over the sudden my arm was tingling and swelling.  I applied ice on it.
Sharp lower lung pain. Felt like when I had Covid last year (also when had pneumonia). It occurred 5x over the course of 8 hours. Other symptoms were expected: aches, chills, sweats, headache, nausea-all lasted 24hrs.
The second dose of Jynneos administered 23 days after the first dose; Jynneos vaccine administered intradermally; Case reference number US-BN-2022-003742 is a spontaneous case report initially received on 30-Sep-2022 from a nurse via Communications (reference number: USBAV22-1587) and concerns a male patient.  The patient's medical history and concomitant medication details were not reported.  On 07-Sep-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00019), at a dose reported as 0.1 ml, intradermally, for monkeypox prophylaxis (explicitly coded as 'intradermal injection').  On 30-Sep-2022, 23 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00019), at a dose reported as 0.1 ml, intradermally (explicitly coded as 'inappropriate schedule of vaccine administered' and 'intradermal injection').  At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 03-Oct-2022 included the local BN case ID.; Reporter's Comments: A male patient born in 1985 was vaccinated with the first dose of Jynneos, at a dose reported as 0.1 ml, intradermally, for monkeypox prophylaxis, which is considered as intradermal injection. Reportedly, on the day 23 after the first dose, the patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Intradermal injection and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Intradermal injection and inappropriate schedule of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient was vaccinated with the first dose of Jynneos, at a dose reported as 0.1 ml, intradermally, for monkeypox prophylaxis, which is considered as intradermal injection. Reportedly, on the day 23 after the first dose, the patient was vaccinated with the second dose of Jynneos, at a dose reported as 0.1 ml, intradermally, which is considered as inappropriate schedule of vaccine administered and intradermal injection. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Intradermal injection and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. Intradermal injection and inappropriate schedule of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
High blood pressure; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52-year-old female patient received bnt162b2 (BNT162B2), on 15May2021 as dose 4 (booster), single (Lot number: EW0167) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose: 3 (Booster), Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HYPERTENSION (non-serious) with onset 20Oct2021, outcome "not recovered", described as "High blood pressure". The event "high blood pressure" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypertension. Additional information: Dose received: More than 3. High blood pressure reported to Dr (name withheld) on 20Oct2021, and amlodipine prescribed by Dr 15Sep2022. Ae treatment: Amlodipine 10mg If No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Redness and swelling of right upper arm. Tx: Prednisone 80mg x1 dose.
Too Young,  Presented for 2nd dose and age contraindication was identified.  No report s/s of adverse medical event related to vaccination to early reported.
Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient?s guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient's guardian
Case number PHEH2014US025017, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 92 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that before administration, the FLUVIRIN had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperatures were in between 46 to 49 degree F. No adverse event was reported following this mal administration.
Night after vaccination: Chills & Fever.  Next day: Extreme brain fog (confusion), dissipating over next few days
ringing in both ears/Tinnitus both ears constant; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 11:30 (Lot number: EN6207) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; CALCIUM. Vaccination history included: Bnt162b2 (dose 1, lot number: EN6200/EN76200 (as reported), administration time 11:30 am, vaccine location Right arm), administration date: 26Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 24Mar2021 12:30, outcome "not recovered", described as "ringing in both ears/Tinnitus both ears constant". The event "ringing in both ears/tinnitus both ears constant" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of tinnitus. Additional information: Patient had other medications in two weeks: statin, multi vitamin, calcium supplement. Facility where the most recent COVID-19 vaccine was administered in other (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no COVID prior vaccination and was not COVID tested post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient had no allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
About 15 mins after pt received her Vaccine she reported that she was feeling a tightness in her chest.  Vitals were taken and they were  BP  130/90  witch pt stated was high for her and spO2  was normal. She was evaluated for another 30 minutes. Pt stated that tightness was very minimal now and she wanted to leave. Her mother would be driving her.  Pt advised to go immediately to the ED if her symptoms returned or became worse.
Received hep vaccine on 01/31/2002 at 11am. About 2 hrs later began itching on left arm and abdomen. Her arm felt sore and swelling. Also felt irritable. The itching lasted several hours. The sore arm lasted 3 days. Today 02/04/2002, the redness, swelling noted on warm, serious itching.
Morbilliform rash developed on torso and back; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 at 14:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation.  Medical history of the patient was not reported. The patient had no known allergies.  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: EN6207) via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included escitalopram oxalate (LEXAPRO) and fexofenadine hydrochloride (ALLEGRA) both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 10:00, the patient experienced morbilliform rash developed on torso and back. 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 the result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event morbilliform rash developed on torso and back was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Female w/no significant past medical history presented to hospital on 12/5 with 2 weeks intermittent fever, chills, fatigue, dyspnea, intermittent rash, myalgias and joint pains. Tmax of 106 F; negative COVID previously. Treated with antibiotics for sinus infection and possible ear infection 1 month prior. Negative strep. After autoimmune and infectious workup there were 3 differential diagnoses: MIS-C due to recent COVID booster vaccine, JIA/Adult Onset Still's disease, Mycoplasma pneumoniae. Patient's COVID anti-spike IgG was positive, albumin was 2.6. She had elevated inflammatory markers (Ferritin/ESR/CRP/LDH). Remaining autoimmune workup was negative (ANA/ANCA/RF). Mycoplasma IgM was positive, she was started on azithromycin. COVID/Flu/RSV/RVP was negative. EBV/Infectious Mono/ASO/Blood cultures were negative. Patient states that a few days prior to admission she became short of breath and felt like she was going to pass out after minimal amount of walking at a grocery store. Patient works at a nursing home, there was one known case of COVID recently, but patient denies previous history of COVID or COVID exposures. Troponin, BNP were both normal, point of care echocardiography showed trace pericardial effusion and mild to moderately decreased ejection fraction.  CV: Tachycardia, trace pericardial effusion on POCUS, mild to moderate reduction in EF. No murmur on exam. Differential includes pericarditis, kawaskai disease, MIS-C, autoimmune disease.  Patient was discharged on 12/7/2022 with Azithromycin to complete a total of 5 days. Patient was otherwise stable on discharge.
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT. Patient 7 years old. Received Pfizer bivalent booster for 12+ years
Patient, 2-3 hours after DTAP had increase ? , excessive crying, very disoriented and confused.  As per mother, patient's eyes were glassy and glazed.  Patient refused to sit still for 6 hours.  He also had an elevated body temperature of 101.103 degrees F.
This spontaneous report was received from a physician referring a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unspecified date in 2014, the patient was vaccinated with ZOSTAVAX, lot # J013449, expiration date: 24-Jan-2015, (dose, route and anatomical location of administration were unknown. In approximately 2014 (reported as "around the same time"), the patient was also vaccinated with a dose of an unspecified influenza virus vaccine. Concomitant therapies were not reported. In approximately 2014 (reported as "shortly after receiving the vaccine", the patient experienced eosinophilia and eczema. At the time of report, the outcome of the eosinophilia and the eczema was unknown. The causality assessment between the eosinophilia and the eczema with ZOASTAVA was not provided. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 0/05 Janssen, dose #1 04/14 NASAL PCR COVID-19: NOT DETECTED 04/14 NASAL PCR FLU A, FLU B, RSV results: negative 05/10 CXR IMPRESSION: 1. Old calcified granulomatous disease. No pneumothorax evident. 08/03 pt cc: cough, myalgias, dyspnea, sore throat, rhinorrhea, headache, exposure: unknown 08/04 - 08/16 symptoms continue 08/11 COVID swab, result: detected 08/17 clinically resolved
Around the middle of April 2021, I developed shingles. I am not fully vaccinated with the 2 doses of Shingrix. I was treated with Valtrex. Then around the beginning of September 2021, I got shingles again. I was treated with Valtrex. On 9/14/2021, I came down with Covid like symptoms- I had nausea, vomiting, fever, chills, ear pain, headache, runny nose, sore throat, loose stools and stomach pain. I did a COVID test and currently waiting for results.
Sever nausea and vomiting starting day 3 after receiving the 2nd dose. Could not stand up without feeling like I needed to vomit again.  Severe epitaxis, so much so that the blood trickled down my throat and filled my stomach further increasing the nausea and vomiting. I required a visit to urgent care for prescription zofran
It was responded that a 45 year old female born 09/27/56 received a Fluzone injection administered IM in the deltoid on 10/30/. On 10/31/01, she complained of hot, painful, swollen arm at injection site, and that Tylenol was not helping. Today 11/01/01, patient went home from job ill with achiness, fatigue and congestion.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 04/01/2021 and 05/26/2021. They tested positive for COVID-19 on 02/02/2022. They were hospitalized out of state. They developed complications of bacterial pneumonia, ARDS, and respiratory failure and died out of state on 02/09/2022.