chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine EUA: patient has a mild urticarial, erythematous, macular rash on face, neck, and exposed area of chest that started four days after receiving vaccine. Lymph nodes are also swollen. Denies chest pain, shortness of breath, flu-like symptoms, fever, itching, or swelling at injection site. Patient has experienced urticarial symptomns with upper repiratory infections in the past. Provider recommended diphenhydramine and home management.
Patient had come in for second Moderna vaccine. Incorrectly administered Pfizer vaccine instead.
My SPMS flared up for more than 4 days and caused me to be bedridden much more than usual
Menactra reached at 33.5C; 16 years old patient received second dose of Menactra; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from an other healthcare professional.  This case is linked to cases 2019SA192618, 2019SA192651, 2019SA192652, 2019SA192653, 2019SA192654, 2019SA192655, 2019SA192657, 2019SA192658, 2019SA192659 and 2019SA192660 (same reporter).  This case involves a 16 years old patient (gender not reported) who was vaccinated with a 0.5 ml second dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6208AB and Exp. Date 08-Jul-2020) via intramuscular route in unknown administration site on 09-Jul-2019. This vaccine was reached at 33.5C.  The patient's medical history not reported and concomitant medications not received.  It was an actual medication error case due to extra dose administered and incorrect product storage.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Batch number of first dose is requested.  List of documents held by sender: none.
This spontaneous report was received from a nurse pre scriber concerning a 13-year-old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (also reported as GARDASIL) injection, lot # N007931 with expiration date 17-NOV-2019 for prophylaxis (dose # and route of administration were unknown). The vaccine experienced a temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 1 hour. The digital data logger was involved in recording the temperature excursion details. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1801USA004687.
After vaccine administration, pt. developed redness and itching at site and 1 hive noted at MMR site. 8 mL BENADRYL given in office. 20 minutes after BENADRYL, hive resolved and redness and itching improved.
Good morning, I received my 2nd shot yesterday at approximately 9:15a.  I had no issues during the observation period.  Last night at approximately 9:45p I started to feel as if I was catching a fever due to my joints aching and bland taste in my mouth.  At approximately 10:15p I started to shiver, had a headache and had tightness in the lower left side of my back.  So I took my temperature and I had a low grade fever 99.7.  At the point I went and had a hot shower.  After that I laid on the heating pad for 30 minutes and my back tightness subsided.  I stopped shivering at roughly 11:15p but continued to have a headache and aching joints.  My temperature right now is 100.3, joints are still aching but not as bad as last night, headache and chills.  Is there anything that I can take, Advil etc?  Also, I forgot to mention the arm soreness as well but I had that on the 1st shot as well.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 15-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degree for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Post Covid vaccination patient appeared to be starting to fall from chair. He appeared lethargic and unable to speak or hold himself upright.  Vitals where taken and 2 liters Via mask administered. Increased to 4 liters after no improvement in pulse o2. wife who stated he was released from the ED yesterday and stated he needed a stent. Patient nodded that he was having substernal chest pain without radiation. four 81mg Asa given and nitro administered after  verbally ordered. EMS arrived and transported patient.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  EPILEPSY, PARTIAL IDIOPATHIC TRANSIENT CEREBRAL ISCHEMIA
On 9/26/95 pt recv vax and on 8/8/98 pt broke out with pox for one week.  Pt exp 50 pox w/ low grade fever for three days.  Pt tx=oral Benadryl and Calamine lotion.
mild eczema on left hand that persists - first dose caused same reaction that lasted until the second dose, but was almost gone by then, second dose caused slightly more intense eczema that lasted two months - booster has caused milder eczema which has lasted over a month to date  eczema abated after second dose
pt recv vax; questionable sz; neg EEG; neurologist doubts related, found to have Reflux;
Developed shingles five months after taking the ZOSTAVAX vaccine - low grade fever, right ear bright red and painful.
Ringing in ears-tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm left on 27Mar2021 at 14:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medication within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 06Mar2021 at 14:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 12:30, the patient experienced ringing in ears-tinnitus. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the ringing in ears was not recovered.   No follow-up attempts are needed. No further information is expected.
HIVES---FROM HEAD TO TOE, TREATMENT: BENADRYL 25MG Q4H , ZANTAC 150 Q12
Information has been received from a consumer and a school nurse concerning 41 child pts who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the pts developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 pts were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 6 year old pt who on 06APR1998 was vaccinated with a dose of varicella virus vaccine live. On 06MAR2003, the pt developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other pts that developed chickenpox post vaccination with varicella virus vaccine live were also identified.  Additional info is not expected.
I first noticed a slight red rash this morning, which is 10 days after I received the vaccine, on my left arm and precisely at the site where I received the shot. I took another look in the mirror at 8pm tonight and noticed the rash has become larger, slightly raised, warm, and more pronounced. The rash is not itchy and does not hurt.
Painful, swollen hands, splitting, cracking on fingers and palms with deep fissures forming near joints, pain on bending joints of thumbs. Initially used bacitracin ointment and bandages. Showed cardiologist who said it could be dishpan hands. Self treated with minor success, then went to primary Dr., 6/24/15. diagnosed as psoriasis on hands and knees. Prescribed mometsone cream. Since then have applied cream daily and now have pain and cracking in area of heels on both feet.
moderna for his first vaccine, pfizer for his second vaccine; Received doses more than 21 and 28 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (moderna for his first vaccine, pfizer for his second vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received doses more than 21 and 28 days apart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02YC21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 14-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (moderna for his first vaccine, pfizer for his second vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received doses more than 21 and 28 days apart). On 14-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (moderna for his first vaccine, pfizer for his second vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received doses more than 21 and 28 days apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Received doses more than 21 and 28 days apart.   Reporter did not allow further contact
BALL UNDER ARMPIT; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced ball under armpit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ball under armpit. This report was non-serious. This case, from the same reporter is linked to 20211260992.
Feeling cold in the afternoon 1/28/2021. 101 fever on 1/29/2021.
Headache, Myalgia, Fever, SORE PAIN AT INJECTION SITE, CHILLS Narrative:
Employee received the second dose of the vaccine and was fine. He awakened the next morning with severe chills and a temperature of 101.1 that would not come down. He had aches all over and general malaise.
At about 1050, After receiving 2 nd dose of pfizer, patient reported feeling slightly dizzy, and feeling of fast heart rate. Brought patient back to observation gurney. Vitals taken BP 180/106, P 88, o2 sat 99% RA. 02 applied and advised patient to rest.  Patient  stated, she did not take her BP meds this morning, has hx of high BP. After few minutes of rest patient felt better, BP came down to 195/93. Within few minutes she reported feeling of heart racing again and upper back pain. Called 911, supervisor was notified. After 911 call patient reported having chest pressure, called 911 again to notify change in patient's condition.  At about 1135 paramedics arrived, BP 191/86, patient stable, husband at bedside. At about 1150 patient transferred to emergency room by paramedics, belongings given to husband.
COVID Vaccine-  Tachycardia- Pt advised seek immediate medical attention should symptoms persist.,Pt reports hx of shellfish allergy, has had to use an EpiPEN in the past.   Pt's symptoms resolved in minutes. Initial pulse taken 101. Final pulse taken by this provider was 86 BPM,  O2
Client reported 4 days after vaccination, to the pharmacist, that she formed a red circle around the administration site. She mentioned that it was itching her previously. She placed ice on it twice that day. It was getting larger in diameter. It measured 5 to 6 cm in diameter. There was no red streak that exited from the site. It was not swollen.  She was told to go to the neighboring walk-in clinic:  She did. The health care provider, at the clinic, told her that it is an administration site redness. She was given Benadryl 25 mg at the office.  The provider marked the circumference of the site with black Sharpie ink. She was told to observe the outline of the area, and if it does get larger, she needs to report back to the site or any doctor. Client reported that to the pharmacist. She had no other problems to report. She will be contacted further, for future progress.
The patient had a near syncopal episode after receiving his 2nd Pfizer vaccine. He reports having a similar reaction with the 1st vaccine but this time it was worse. BP was 196/120. Reports not being non-compliant with BP medication has not taken today. 911 called BP was 164/98 95% 18 R when patient left with EMS.
FYI, Approx. 1:00 AM woke up with high fever and could hardly move. Whole body hurt very bad. Shaking from chills . Bad headache. Very thirsty. Definitely flu like symptoms, but worse. Turned electric blanket on, very cold, and just tried to sleep. Only getting out of bed to use restroom and more water. Straight back to bed. I did not vomit, nor did I have diarrhea.  Could not stand it any longer Saturday PM approx. 10:00 took two Advil. Woke up Sunday 8:00 AM felt much better. Still had slight symptoms, but I could do chores. My brother kept checking on me. Came to let my dog out. My brother wanted me to call 911 but I can not afford that.  It was holiday weekend,  I wanted to die, didn?t care.  I get the flu shot every year. I have a high pain tolerance, very rare for me to be sick.  If I needed a second dose. I would NOT get it. If I would have known it was that bad, I would not have signed up to get it. Thank you.
My adverse event is that I contracted Covid two months and one week after being fully vaccinated.   I received my first dose of Moderna on 3-20-21 and my second dose on 4-17-21, but I tested positive for Covid on June 9, 2021, after symptoms started on June 6, 2021.   I contacted Health Department to ask why I got infected when I was supposed to have 94% protection. I was concerned that a new variant may be circulating in our community.  She suggested that I report my experience via this form.  Additionally, I believe I contracted it from my 14 year old granddaughter, who was also fully vaccinated, but had just received her final dose of the Pfizer vaccine on June 4, 2021, from the same pharmacy where I was vaccinated months earlier, when she became ill and also tested positive for Covid on June 9th, 2021.  Just seems odd that in one household we'd have two "break through" events and we received our vaccinations from the same pharmacy.
sick for a week; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-APR-2022 Reporter's comments: This case was reported by a patient via interactive digital media. The patient got the single shot and was sick for a week Additional Supportive Information: Follow-up would not possible as no contact details were available.
The pt experienced itching and swelling to the left arm which was twice the normal size.  Follow up:  Patient recovered from adverse event.  Patient is on full duty.  Patient received further shots since reported event, the events were: swelling and itching of arm."
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734; Expiration Date: Jul2021), via an unspecified route of administration, administered in Arm Right first dose on 30Mar2021 at single dose for covid-19 immunisation. There were no medical history and concomitant medications. It was reported that patient positive between the first and second doses of the Pfizer Covid 19 vaccine. The patient was scheduled to receive the second dose today. The patient was outside the 10 day quarantine window, doesn't think he is contagious, has a little cough that he doesn't think is going away anytime soon, and his taste and smell are returning. The patient wanted to know if he can get the second dose today. He doesn't want to show up to get the vaccine and be turned away. The patient tested positive for COVID on 12Apr2021. His symptoms started around the 08Apr2021, but he tested positive on 12Apr2021.  The outcome of the events was unknown.
Hospitalized 11/25/21 and illness onset 11/19/21 with headache and congestion
immediately got very hot and extremely sweaty, lightheaded, and brain fog like when i had covid. nurses had me lay down and i was able to walk to my car by 11:40. brain fog lasted all day. developed chills by 12:00 that day.
patient received vaccine, came to register to sign and said his arm hurt. signed release, and crouched down. said he felt a little funny. i went to get him a chair, and as he was getting into the chair he passed out. patient was unconscious but was moaning. rolled him onto his back , and patient came to in about 15 seconds. he sat upright, was disoriented, and remained on the floor for 10 minutes. upon further review, patient had not had anything to eat or drink, so we got crackers and orange juice for him, and also an ice pack. patient moved to a chair and sat for about 30 more minutes. ems was called but patient refused treatment. offered to call friend or relative to pick him up, but patient refused. store  management stood with him until he was feeling better. he described feeling like he was in another dimension.  patient seemed cognizant at time of departure. called patient at number and he said that he felt better and had made it home ok.
I had swollen lymph nodes under both arms. It did got down and then my lymph nodes in my breast became swollen.  My breast was so swollen and hot to the touch. I went to a specialist about this. It keeps going up and down on the swollen for about 4 weeks. It got infected. She did a breast exam. She gave me antibiotics. I have an order for a mammogram and ultra sound for the mass on my breast, which I am going to be scheduling an appointment for.
This spontaneous report as received from over 65 year old male patient refers to himself. The patient's medical history was not reported. On an unknown date, afew years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and site of vaccination were not reported). No concomitant medication was reported. On an unknown date, the patient experienced a mild outbreak on his right buttocks, small rash, internal shingles in the T10 vertebral area with severe pain throughout the left side and moving to the right side as well. Pain was excruciating and lasted for 6-8 weeks. The patient had Magnetic resonance imaging (MRI) and X-rays, there were no signs of stenosis or compression. No disc bulging of herniation ID. The outcome of event was reported as recovering. The patient could get out of bed and cough, laugh, sneeze. The relatedness between the event and ZOSTAVAX was not reported. A call was placed back to the consumer-an unspecified female consumer stated that the patient had "no idea what you're talking about, it must be someone else". Additional information has been requested.
Pain and swelling under right arm at lymph node upon waking.  Lasted 48 hours.
Suspected vaccination failure; Shingles; Excruciating. Pain killers aren't working; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with analgesic, nos (Pain Killer). On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient. The age at vaccination was not reported. The patient received 2 doses of shingles vaccine and got shingles right now on the inside not outside and stated it was excruciating. Pain killers were not working. The patient would not wish this even on people taking care of their country. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown.