chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blurry vision/eyesight is blurry; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "blurry vision/eyesight is blurry". The lot number for bnt162b2 was not provided and will be requested during follow up.
I woke up at about 1am midnight feeling like I was having a heart attack. I had chest pain that radiated to my left arm with flushing going up my neck to my head. I took two 81 mg aspirins, a second benadryl and drank two 8 oz. glasses of water. About a month later I had a huge floater over my left eye and went to the eye doctor to be checked. She noted I had a large floater covering my left eye. She also noted that I had the beginnings of narrow angle glaucoma which does not run in my family at all. Soon, after this I started to have bilateral ringing in both my ears which keeps me up at night for many months now.
On March 18th I work up with injection site very sore #8 out out of 10. It lasted 5 days which made sleeping difficult. When the arm pain left I got #* out of 10 pain in my right back shoulder blade. The pain was not surface pain it felt  deeper. It would even hurt to breath in deep. It lasted 6 days and than started to come and go  for hours at a time. Because I still had intermittent  pain I canceled the second dose. It  presently is  all but gone with just the feeling that I know where the pain was so maybe just a 1.
pt recvd vax & several hrs p/dose 3 exp nausea; sx was not treated;
Immediately bad  headache with eyes hurting; dry felt like they were glued; dry felt like they were glued; flushing of face and neck; Eyes felt really puffy; itching of neck and arms; extremely fatigued; Immediately bad  headache with eyes hurting; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 15:00 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic allergic rhinitis, eustachian tube dysfunction, autoimmune thyroiditis, allergies to some medications, additives, preservatives, chemical, food and environmental allergies since an unspecified date. Concomitant medications was not reported. 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 01Apr2021 at 15:00, the patient experienced immediately bad headache with eyes hurting, dry felt like they were glued, flushing of face and neck, itching of neck and arms, eyes felt really puffy and sore immediately. Lasted for almost three days. The patient was extremely fatigued and was asleep within two hours and did not wake up till next morning. Headache and eyes hurting lasted long. Therapeutic measures were not taken as a result of adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events immediately bad headache with eyes hurting, dry felt like they were glued, flushing of face and neck, eyes felt really puffy, itching of neck and arms and extremely fatigued was resolved on 03Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I had partial loss of vision in right eye. Went to Ophthalmologist a on 2/14. He prescribed prednisone. I have had numerous visits with other doctors and so far, no answers. Blood tests, cardiovascular work up, and MRI are all normal.
received a Menactra vaccine in the last two days. His mother states that he had received a Menactra vaccination within the last year and a half; Initial information received on 20-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an18 years old male patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] twice (within the last year and a half) (no details were available at this moment) on unknown dates.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to extra dose administered..Patient's mother stated that he had received a Menactra vaccination within the last year and a half. The reporter did not know when the earlier vaccine was given.  It was unknown whether adverse event was experienced..  Information on the batch number was requested.  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.
Information has been received from a physician concerning a pediatric patient who was vaccinated with 3 doses of RECOMBIVAX HB. The patient failed to seroconvert after receiving 3 doses. The patient received unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In February 2016, the patient was treated at a hospital for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Pt had a swollen RLE ,per mom, with "blotchness" approx. 7 hours, post vax. No fever. Gave Tylenol and Benadryl. On exam, 30 hours, post vax, no swelling detected. No reaction at injection site. Had petechial rash on entire RLE, distal to injection site. Otherwise normal exam.
Two instances of lip filler swelling; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient received steroid shot for an unknown indication on an unknown date one week after the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. On 30Apr2021 at 21:30 the patient experienced two instances of lip filler swelling. On 01May2021, the patient underwent Nasal Swab and the result was Negative. Therapeutic measures were taken as a result of the event with Benadryl and event went down within few hours after taking the medication. The clinical outcome of the event two instances of lip filler swelling was recovered on an unknown date in 2021.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sinus infection; Flu like symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). On an unknown date, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) was resolving.            No concomitant medication was reported.   Treatment information was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A 64-year-old male patient of an unspecified ethnicity, on 17Aug2016 received PREVENAR 13 (Lot# N05077) via an unspecified route at single dose. The patient medical history included diabetic, respiratory disease and hypertension. Concomitant medications were not reported. Begin 48 hrs after administration, the patient experienced left arm cellulites. The patient was hospitalized for the event for 1 week. The outcome of the event was unknown. No follow up attempts possible. No further information expected.
Information has been received from a nurse concerning a 15 year old female who on approximately 19-MAR-2008 was vaccinated IM with the first dose of Gardasil (lot# not provided).  Immediately after the vaccination the patient became nauseous.  That was resolved within few minutes and the patient was sent home.  The nurse was followed up with the patient the next day and the patient did not experience any other symptoms.  Unknown medical attention was sought in the office.  The patient was recovered.  No product quality complaint was involved.  Additional information has been requested.
Shortness of breath - Initial ED Comments:  Patient is a 63 y.o. male patient presenting to the ED via EMS with c/o shortness of breathin which began this morning. EMS reports that the pt had a bilateral lung transplant 1 year ago and has been on cyclosporine and cellcept. EMS also reports that the pt recently received his COVID vaccine. Pt denies fever, chills, chest pain, abdominal pain, back pain, nausea, vomiting, or lower extremity edema. EMS reports that the pt does not normally require supplemental O2 but states that his O2 sat was 75% on 3 L NC home O2. EMS reports that they gave 2 albuterol, 1 Atrovent, and solumedrol. EMS also reports that they placed the pt on 10-15 L NRB and states that his O2 sat was stable at 100%. Pt denies any aggravating factors for his symptoms
Narrative: COVID infection following COVID vaccine series 12/29/2020, Pfizer, dose #1 01/19/2021. Pfizer, dose #2 09/07 COVID swab, result: detected 09/07 SARS-COV-2 Variant Sequencing result: pending 10/16 COVID swab, result: not detected 09/03 pt cc: fever, dyspnea, rhinorrhea, diarrhea, vomiting exposure: unknown
Information has been received from a registered nurse concerning a male who was vaccinated with varicella virus vaccine live. Subsequently the pt developed a fever, nausea, vomiting, diarrhea, rash and lesions (10-15 lesions) 7-14 days after receiving therapy. The pt had a titer drawn about 23 days post vaccination that was negative. Additional info received from the registered nurse indicated that she did not feel that the pt's symptoms were an adverse experience. She felt that the pt's experience was a common side effect. No additional info is expected.
Eight days after 1st injection one inch rash progressing within five days to seven inch rash all with itching and  hot to touch. On 13th day after injection painful to try and lift left arm above head and pain in armpit and neck.
Red, painful rash on left kneecap, lower thigh, with small patches on bilateral abdomen and one on the right back of the thigh. Pain 7/10, some throbbing in time with pulse. Started around 5 hours after shot, got worse throughout the night. I took benadryl at 11pm, woke up with worse pain. Applied hydrocortisone cream at 10:40 pm and the mooring after (today) at 9:10 am.
After receiving my shot, I waited the half an hour. I felt a pinch in my head and tightness in shoulders and neck. Once I reached the parking lot I was belching ridiculously and started feeling like vomiting. Than my chest hurt.  Went back to the clinic and said I don't feel right.  They had me stand in line and wait to be re-admitted.  The nurse starting taking blood pressure and offered me water I could not swallow the tiniest amount.  My neck felt like I was being chocked. My fingers on my left arm started tingling and arm was getting slightly red and arm felt heavy. The nurse said my symptoms were happening internally.  The doctor had me remove my mask and looked at the back of my mouth. Than used a stethoscope on my chest and the back.  Asked  if I had asthma , said no. He Than requested epinephrine shot and a steroid. With in a few seconds I started feeling like I could breathe. He prescribed an epinephrine pen incase I had another episode. Two day later I had another visit online with doctor from about redness on left and right arm. Having another allergic reaction and possible site infection. Now I'm taking 10 days antibiotics and allergy medicine.
Fever of 103.5, severe diarrhea causing immediate diaper rash. Infant Tylenol given, fever reduced in a day
ADMINISTRATION ERROR : Pt. states that was scheduled 06/22/2021 to receive steroid shot (Depamedro) but received a dose of Phizer (3 times the amount) in the left hip. Experiencing nauseating vertigo, fatigue, fever, balance issues, chills, pain radiating through the ears, shortness of breath, and short-term memory loss. Urgent Care visit 06/22/2021 received correct dose of steroid and sent home to rest. 2nd Urgent Care visit 06/26/2021 with reported redness and swelling in the injection site. Sent home with Lidocaine Patch. Previously had received Moderna 1st dose 01/30/2021 (*032L20A) and 2nd 06/02/2021 (*023C11A). Reports that gap between injections due to delayed knee surgery and Positive Covid test (Isolations Dates). Nurse that administered Phizer reportedly terminated.
07jun90 pt vax hepta B. 1hr aft vax pt devel. diffuse flushing, a subjective feeling of her throat closing and tongue swelling, hoarsness of voice and shortness of breath.  pt to er and tx w/ epinephrine, benadryl, and solu-medrol.
I received the flu vaccine at approx 0100 and in an hour I was sneezing, itchy throat, runny nose and red, itchy eyes. Then at approx 0630 I began getting itchy and started developing hives on bilateral arms, stomach and back. Later in the day at approx 2:30 PM my eye lids and face became swollen. I have also had slight swelling of my throat daily since the injection requiring prednisone.
Headache about day 3, got worse as day went on. Nausea and indigestion has become much worse with severe stomach and torso pain all night, really nauseous and feel like throwing up. Can't eat at all, has been four days now and only tried a tiny bit of oatmeal today, this too didn't set well. No fever. The bad headache that started on day 3 got better some today on the 8th. Still have really bad nausea and stomach/back pain from it. Have had trouble trying to drink water without gaging. Still ill today.
Pt with fever, tachycardia, headache, severe myalgias for 36 hours +
Patient came to the pharmacy 4 days after the administration and the arm appeared swollen, painful  and a rash was present. Pt unable to move the arm above the shoulder. I verified that the ADR was localized to the arm. Patient instructed to apply ice and take ibuprofen for the pain/swelling. Patient instructed to take BENADRYL for the rash. Patient instructed to follow up with an urgent care if the reaction worsens over the weekend. Patient instructed to follow up with the PCP if the reaction is not better by Monday (12/17/18).
On the day of vaccination, I had a question about the contact solution question. I was advised Benadryl would help with anything. I knew It was good for all to get vaccinated and I was satisfied with the advice.  At vaccination, I felt pain within a few minutes, as expected. Within 30 minutes I felt numbing around my face and mouth and this went away within the hour. I was tired for the rest of the day. Experienced a sore arm for 3 days.   Day 5 I broke out in hives on my arms. Self-treated with cool water and rubbing alcohol. I figured it was some sort of contact irritation.  Day 8 Grew increasingly lethargic. Pain underarms became unbearable took nap around 5 pm.  By 5:45 pm I woke up with a huge lump. I mean lump in my arm and redness and itching around the injection site. Took Benadryl that night hoping to ride it out and thinking it was just my immune response to the vaccine.   Next day the arm pain was more moderate and the redness was worse and spreading in circumference by the hour. Itching. swelling all over body, and pressure on the red areas increased.
PA from hospital called store and told Rph that pt admitted w/Guillain Barre to fill out VAERS. PA complied.
Patient reported, erythema, prurtitis, swelling, and warmth around injection site with a 3in radius.
This spontaneous report as received from a physician regarding a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 19-JUN-2015, the patient received improperly stored PROQUAD (Merck) (lot# L002419, expiry date: 23-JUL-2016, dosing details were not specified) which was stored at 23 Fahrenheit for 27:00 hours. There was no concomitant medication reported. No adverse effects was reported and no product quality complaint involved. This is one of several reprots received from the same reporter. Additional information has been requested.
Local immunization reaction. Treated with PO abx-Cephalexin 250/5ml+ tsp po tidx10days
18AUG98 11PM started getting a fine rash on rt arm also on chin w/itching-no fever - slept all night & most of the day today;woke up w/welts on chin & cheeks;erythematous, pruritic rash;face swollen;probable contact dermatitis;
Bloody stools/diarrhea 24 hours after Rotateq administered. Treatment: Hydration with Pedialyte.
Medication administration error: Pt received 0.3mL instead of 0.5mL. No known adverse reaction
I have a horrible sinus infection; Painful sore throat (puss in throat red it's gross); Painful sore throat (puss in throat red it's gross); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 19-year-old female patient received bnt162b2 (PFIZER BIONTIC COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 02Jul2021 at 10:30AM (at age of 19-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There was no medical history, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol / norgestrel (ELINEST). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 on 02Jun2021 at 10:30AM (at age of 19-year-old) for covid-19 immunisation. The patient had been dealing with a painful sore throat (puss in throat red it's gross) and she had a horrible sinus infection on 05Jul2021 at 01:15 PM. No treatment was received for the event. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Pt admin vaccine on 11/19/10. Mom reported to us on 11/29/10 pt had fever and vomiting on 11/26/10. Pt seen in our office on 11/30/10.
Approximately 2 days post vaccine (given in (L) hip) the patient noticed a painful enlarged lymph node in her (L) groin 48 hrs later. Started KEFLEX 11/28 (500 QID) x 28 doses through 12/5. As of 12/6, lymph node is now normal size, non-tender, no further adenopathy.
herpes zoster viral infection of face and ear nerves; shingles; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around 27-NOV-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered chronic herpes zoster outbreaks and diagnosed with herpes zoster viral infection of face and ear nerves, shingles, and postherpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The 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), the patient sustained severe and permanent personal injuries. Further, the 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 zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of all events was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered all events to be disability.  Upon internal review, the event of herpes zoster oticus was determined to be medically significant.