chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 23Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]; NASONEX; ALBUTEROL [SALBUTAMOL]; PULMICORT. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  Clinical information: It was reported that, female patient who was diagnosed with COVID-19 and had pre-existing conditions called stating that she was put on Paxlovid. Caller stated that she had other medications that she takes. Supplements Herbs or vitamins Nasal spray steroid (Flonase or Nasonex) Inhaler Albuterol Pulmicort (budesonide).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had the shot, still had shingles/Suspected vaccination failure; ShinglesStill had shingles; Pain/may be lessen the pain some; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. 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.     Additional Information: GSK receipt date: 6-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that the shot did not mean that you would not had the shingles. The patient had the shot and still had shingles, might be lessen the pain some. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Dizziness within 10 seconds.  Throat closing, difficulty swallowing, and difficulty breathing within first two minutes.  EpiPen administered by pharmacist.  That reopened the throat. EMT gave benadryl,  IV fluids, ER gave IV steroids, Pepcid, Benadryl and later Tylenol for headache. Sent home with orders to continue steroids, Pepcid and Benadryl.  Follow up with primary care physician in 2 days.
Onset 8/4/02 of 2 "pox" (small reddish blisters) at site of injection. Some fatigue, no known fever. Today 8/5, "pox" dry, mild joint pain in hands, feet, legs. Also notes "tender" armpits. Took Benadryl today.
Rash developed on left arm below vaccination and went across the chest and then 24 hours later hives on face and behind ears and some on shoulders and arms client took Benadryl by pm the face was red without hive and by Sunday the Hives had disappeared.  Monday redness on face and by Tuesday all hives had resolved.  Tuesday still very weak and fatigued and if sits upright HR increases, eating and drinking without interruption.
swelling on a lymph node; This is a spontaneous report from a contactable consumer (Patient) via Pfizer Sponsored Program Pfizer First Connect. A  female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 30Jan2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling on a lymph node on an unspecified date on Friday night. The outcome of the event was unknown.   Information about lot/batch number has been requested.  Follow-up (07MAY2021): Follow-up attempts completed. No further information expected
Prior to my first two Moderna shots my doctor suggested I take Benedryl as I have had adverse reactions to foreign things in my body. After both shots I only had a sore arm.  I had my booster on Tuesday, January 4, 2012 at 9am. That even around 7pm, I got the chills and shook uncontrollably along with severe body aches. I slept very little. The next day the chills were gone but not the headache. I thought I was going to be fine, however, this is day 10 and I am still having symptoms...headache,  nasal drip, tired, on and off chills and hot, and I get nauseous.  I went to the local Clinic Drive thru yesterday and had a Covid test. My test came back today as negative.  I had an appointment with my doctor suggesting maybe it turned into a sinus infection. She doesn't  feel like it is and asked if I would take tylenol,  Flonase,  and Allertec  through the weekend and report back to her. I agreed. About 20 years ago, I was working in the yard when I got some kind of bite.. it swelled and itched and would go away only to wake me every few months being a little smaller but itched like i just got it.. It kept reoccurring  for about 10 years. About 4 years ago I had an eye puncture from a blackberry bush which punctured my eyeball. From that day on, something in my body would swell..my lips, eyes, all over my body. I was sent to many specialists and had a lot of testing only to know nothing.  A year ago I had a shot in the bottom of my foot and when I awoke the next morning my lips were swollen. Now this....
Pt was given a DTaP vaccination in his right deltoid.  When the patient arrived home his right upper arm was hot, hard, red and swollen.  On 3/8/08 his mother took him the ER (because it was a Saturday) to be checked because the swelling and redness was not subsiding.  ER provided no treatment on their visit stating it was a normal reaction to a vaccine.  I phoned the mother on 3/10/08 to follow up and was told that his arm was still swollen and uncomfortable.  We recommended hot packs to the arm to help encourage absorption of fluid in his arm.  He was seen today 3/14/08 in our office.  His arm is still somewhat red and warm.  Pt complains of itchiness and slight tenderness.  There were no systemic reactions reported.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 02-NOV-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
Medical Provider Note on 11/21/2022:  rash on his legs starting mid calf to thigh and on upper arms, no lesions have been on his face and his neck, but a little on upper chest, the only place that itches is his right lower leg, they have not bled and seem to have stopped bleeding.  NAD, calm and cooperative - Seen Medical Student, no lesions on palmar surfaces, no lestions in mouth.  Clustered rash raised along the calf and upper thigh, no excoriations present, areas of confluence and raised.   Medical Provider Note on 12/06/2022 for date 11/22/2022 at 0950:  consulted with Dermatology for patient's non-blanching rash distributed mid-shins, upper arms, and chest.  (Continued) Onset 3 days prior that has slowly been worsening in rubor, w/o evidence of cellulitis.  Dr. agreed rash was consistent with Henoch Shonlein Purpura (HSP).  Youth recently received an influenza vaccine on 11/17/2022 and had no prior respiratory infections that might have contributed to the event.   NSAIDs for abdominal pain Admit to unit to monitor for conjunctivitis and any hemorrhagic changes U/A to monitor for protein and need to be repeated after 1 week (+/- blood or protein) due to delayed responses If protein and blood persist, patient will need referral to Dermatology Dr. in agreement with labs ordered in case of rheumatologic component and ANA and labs negative   [from RN note]  On 11/03/2022 at approximately 1530, patient was assessed in unit for a reported rash.  Patient had scattered rubor on the trunk of his body and forearms with pruritis reported.  No weeping or swelling noted.  Lung sounds present and clear in all fields, no wheeze auscultated, youth denies SOB.  Patient states the rash has been occurring each night after showering and usually resolves by morning.  Patient administered 25 mg. of PO diphenhydramine for itching, calamine lotion was applied to the patient's trunk and upper extremeties, and placed on the provider's schedule for further evaluation.
5 year old patient received the adult (30 mcg) dose of the Pfizer COVID-19 vaccine rather than the pediatric (10 mcg) dose. Patient did not experience any immediate side effects.
Patient has a history of epilepsy. She has not had a seizure since age 13 and is not currently medicated. She received her first dose of Pfizer Covid 19 vaccine into her LEFT DELTOID on 4/5/21 at 8:40 am. Patient left a message on voicemail on 4/11/21 reporting a seizure on 4/10/21 and COVID 19 symptoms (fever, chills, body aches, etc.) The seizure was minimal compared her prior seizure history (she did not lose consciousness and did not require medical intervention).  Patient wanted us to be aware of this issue and see if we recommended proceeding with her second Pfizer Covid 19 shot when due. I spoke to the patient and she told me she had had Covid 19 in February 2020.  We have seen clinical reports of more pronounced reactions to 1st dose vaccines in patients who had the Covid 19 virus and explained that to the patient. I spoke to the patient on 4/14/21 and she was feeling much better.  I recommended to patient that she delay getting her second dose indefinitely.
Increased temp 103 - decreased to 101 with Ibuprofen - (L) arm swelling red - warm measuring 3 X 3 1/2 inches on 10/28/10 tender to touch. Some n/v. Saw Dr. today & gave antibiotic.
Friday migraine within 30 minutes took migraine otc pills. Saturday morning noticed swelling and redness at injection site. Muscle pain, felt tired and weak and felt nauseous all day. Sunday the  same as Saturday.  Monday will call my doctor.
Narrative:  Physician reports that patient became hypotensive and had seizure subsequently after receiving the COVID-19 vaccine
No side effects reported; Vaccines administered experienced a temperature excursion; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 21-JUN-2023, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (lot number: W026137, which was determined to be valid, with an expiration date on 05-FEB-2024) and diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) Injection, as prophylaxis (lot number: U7374BA, which was determined to be valid, with an expiration date on 06-MAY-2025) (strengths, doses, schemes, routes of administration were not reported) (Product storage error).  The administered doses underwent a temperature excursion of 8.74 degrees Celsius for 35 minutes. No previous temperature excursion was reported.   No additional adverse event was provided.  This case is one of several reports from the same reporter.
Rolled over in bed and left arm was painful. Notice small area of redness and some itching. Late that day injection site became warm to touch and area of redness was larger.
(R) arm redness, swelling and itching. States she noticed it when she got home and it was that way all weekend. She took TYLENOL Friday. Her NP put cold pack and gave BENADRYL topically.
Initial report received from a healthcare professional on 23 September 2013. A female patient whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (Route, dose number, batch number and anatomical side of vaccination was not reported) in arm on 19 September 2013. On an unspecified date, the patient had pain in arm. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the event was not reported. List of documents held by the sender none.
Right leg shingles/zoster (L4 dermatome with rash and sensory symptoms), sensory symptoms alone extending from L4-T8 dermatomes on right.
SUPRACLAVICULAR ADENOPATHY - SWOLLEN, TENDER LEFT SHOULDER, NECK, EARACHE, TOOTHACHE
Diagnosed with upper respiratory infection 5 days post vaccination. Sore throat, cough, fever, chills, sinus pressure, fatigue, muscle aches,
I started with swelling in my lymph nodes in my armpit. Now on day 11 of receiving the vaccine, there is a lump the size of a baseball in my armpit. I also have developed a rash at the injection site. That has developed in Day 11.
10:14 Pt notified staff of heeling ?light headed and legs feeling heavy?.  1st Pfizer vaccine received @9:55a in Left Deltoid.  BP 100/50, HR 76 and regular.  Pt reports this BP being ?a little low for her?.  Pt ate breakfast and then had a snack before coming to clinic.  She has a distant history of ?getting very sick with the flu vaccine?.  Within a few hours of the dose 15 years ago or so, she developed a fever of 103 and had flu symptoms of aching everywhere.  The next year they gave her a pediatric dose and she had a similar response and has not had another flu shot since then.  She has received allergy shots for more than 10 years and takes OTC allergy meds daily.  She took her Zyrtec this am. She spoke with her allergist and received the recommendation to get the Covid vaccine.  Her next allergy shots are due next week.   She reports feeling fine before and during the injection and then the light-headedness started 5-6 minutes after sitting in the obs area.  Site director and pharmacist aware of events. 10:22a Pt drinking water and reports ?feeling strange with swallowing and jaw feels tight?. Pharmacist to pt side and decision made to give 12.5mg of liquid Benadryl.  Pt states, ?I wonder how much of this is me being anxious?.  8 oz water consumed and tolerated well. Pt reports ?tongue feels thick? with drinking Benadryl  10:24 pt reports legs feel less weak.  10:29 HR 76, BP 110/70.  Husband arrived.  Pt reports still feeling the same level of dizzy and throat feeling ?less tight?.   10:38 No change is s/s.  Consult with pharmacist-advised giving additional 12.5 mg oral Benadryl.   10:41 Benadryl given and tolerated well.  ?I don?t feel great?.  Finished second 8 oz bottle of water and third given.  Pt reports still feeling the same level of dizzy but has some increased thickness in throat.  Improves with drinking cold water.   10:46 Pt reports although throat feels better with water, that her airway still ?feels smaller?. When describing her throat and airway, ?it?s not 100% normal, but better?.   10:50 HR 64, BP 104/64. Pt reports ?dizziness unchanged throughout, legs still feel weak, jaw and tongue feel back to normal, but back of throat still feels tight, but cold water helps but when swallowing, it still feels harder to do?.   Reviewed case with pharmacist and site director, recommendation to take pt to ER for further obs.  Pt agrees to go.   10:59 Pt transferred safely to wheelchair and escorted to ER.  ER RN given report after pt checked in with husband beside her.  Recommended to pt that she notify her PCP and Allergist of today?s event and recommended they get a recommendation for receiving the second dose.
pt recvd 2nd dose of vax & pt exp fatigue, abdominal pain, nausea, vomiting, diarrhea, a headache, & severe lower back pain;
Severe pain in shoulder and arm weakness and limited use of shoulder and arm that has lasted +2 months. (Hot flushes/fever experienced)
Dizziness 24/7, nausea, can't focus, neck and back pain, swollen lymph nodes, vomiting, light headed, headaches, chest pressure, heart palpitations, confusion, fatigue, severe allergic reaction on face and body.
Swelling, itching, pain at site of injection  Feeling of difficulty swallowing  Sunburn looking rash on forearms
awake middle of noc w/itching in face, neck behind ears upper chest; has lot of periorbital edema; NO SOB;
1. Right hand rash started with blisters and spreading. Involves area between fingers with lumps and flaking skin. Ongoing. 2. Muscular aches from upper thighs down leg to ankles, both kegs.
Information has been received from an RN concerning a 15 month old Asian female with no known allergies and a history of otitis media who on 6/29/00 was vaccinated with a 1st dose of MMR in the left buttocks (lot 633095/0254K). Concomitant therapy included the 2nd dose, in the right buttock, of Act-Hib (lot UA509AA). It was reported that there were no illnesses at the time of vaccination. On 6/30/00, the pt developed a fever that had elevated as high as 103F. On 7/1/00, the pt vomited 1 time and on 7/3/00 had diarrhea 1 time. It was reported that her appetite had been diminished but that she had been taking fluids well. Additionally, she was less active than usual. She also had a cough and runny nose. On 7/3/00, the pt was seen in the ER. At the time of the visit, her temperature was 103F (rectum). Her vital signs were stable. The physical and neurological exams were benign except for the following: the left tympanic membrane was red, dull and bulging, but still transparent. The right tympanic membrane was normal except for a slight tinge of red. Her pharynx was diffusely erythematous. There was questionable exudate on the right tonsil. The physician's dx was acute febrile illness, acute pharyngitis and acute left otitis media. The pt was started on amoxicillin and advised to follow-up with her PCP on 7/4/00. Upon internal review, the pt's fever was determined to be an "Other Medical Event". The pt was discharged from the ER in stable condition on 7/3/00. On 7/10/00, the pt developed a rash and on 7/12/00, the pt experienced a fever of 104.6F. The pt's mother gave her Tylenol and lukewarm baths. She was seen in the physician's office on 7/12/00, at which time she was alert. It was noted that she had still been taking the amoxicillin prescribed in the ER for bilateral otitis media. The physician suspected a possible viral infection and she was started on Cedax 9mg po qd for 10 days. On 7/13/00, the physician's office was notified by the pt's mother that the rash had increased and that the fever persisted at 105F. The physician's impression following the phone call was a possible viral fever and amoxicillin rash. On 7/14/00, the pt's fever was "still off/on". The rash was noted to be "morbilliform" and all over her body. Her tympanic membranes were less red. There were no Koplik's spots. The physician's impression was a possible measles rash due to the MMRII. Two additional pts (WAES 00071118 & 00071119) had a similar experience. The reporter expressed concern with the lot number. Follow-up information from an RN reported that on 7/21/00, the pt was seen by a physician and noted to be "feeling better". The pt was finished her medications as per the reporter. The pt is recovered. No further information is available.
Baby woke up 3 more times in the early morning total of 5 times, saying ouch, ouch, ouch. I checked for temperature, there was no fever. Sleeping in and out by 6:50am baby was in so much pain and could barley stand up, lethargic and only wanted me to hold him. I called the dr. they said give him a bath to ease the pain and some TYLENOL this was on Friday at now 8:30am. I did what they said, within the hour he was feeling a little better so I took him to childcare at 11:00am, when I picked him up he had a rash, hives up and down his face and was lethargic again. I knew something was wrong. Went home spoke to husband, I called the Dr. they were on lunch, I said if they don't answer within the hour we are going to emergency. we laid him down because he started fading in and out, it was very unlike him but we thought from the meds he was tired. 20 mins later our nanny ran down and said the baby is having a seizure! We didn't know how long within the 20mins, he was in seizure we called ambulance, he had been seizing at that time 7-10mins and begin to lose consciousness. The paramedics said his breath was slowing down after they gave him VERSED to stop the seizure. by the time he got to the hospital they needed to incubate him. The welts looked like burns. (hives). MRI and Cat scan were done. We now know he has a preexisting condition and will not take to the vaccines.
Information was received from a certified nurse assistant regarding a 14 year old male patient who was administered GARDASIL (lot # J008423) injection intramuscular 0.5ml in right deltoid on 02JUL2014. The GARDASIL was involved in a temperature excursion. No adverse event was reported. Please see additional information for other cases reported by same provider. Additional information is not expected.