chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; achy; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine two weeks ago on an unspecified date. On an unspecified date, he was achy and tired and was wondering if this was normal. The outcome of the events pain and fatigue was unknown.   Information about Lot/Batch number has been requested.
1/2 hr p/vax pt began crying non stop;crying was high pitched;t99.4 p/APAP; did not stop crying until 9PM;mom was advised to contact MD re:future DTP immun-advised to have pe DT in future;
suspected vaccination failure; she got em.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The reporter was the patient's husband. The age at vaccination was not reported. The reporter reported that the patient got the shingles shot, it worked she got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Shingles lesion on right wrist 6-4-23 and Shingles lesion on right iliac crest on 6-5-23.  Patient is an M.D. and his son-n-law is also an M.D.  His son-n-law diagnosed the lesions as Shingles lesions.
In addition to the common side effects of mild fever and body aches, I experienced facial tightness with mild heat. This caused numbness and swelling to the left-side of my face from my eye all the way down to my jaw. My left eye drooped downward and my eye looked glossy.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No concurrent conditions, medical history and concomitant therapy were reported. No vaccines had been administered. The office manager reported product confusion with PEDVAXHIB and (Oka-Merck) PROQUAD. The cartons the vaccines were packed in had similar blue colors on the outside of the carton, which made it easy for them to get mistaken for the other and stored in the wrong place. No adverse effects were reported. Additional information is not expected as there was no consent for further contact.
From telephone contact with reporting nurse practiitioner it was stated that a 2 month old female patient received a Tripedia, an IPOl,an ACTHIB and a Prevnar vacciunaton on 07/11/01. Within a few hours, the patient experienced a hyporesponsive episode, was sleepy but able to be aroused. Patient was seem in physician's office next day, had a fever of 100.4 degrees F. Patient was doing well. Symptoms resolved
This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Jan 18 began not feeling well and running low grade temp. Jan 19 woke up feeling worse went and tested for flu and COVID-19. Jan 20 symptoms began to resolve. Symptoms resolved quickly with fatigue lasting about a week.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Zoster vaccine diluent administered instead of vaccine on 9/21/2022. Administration on 11/11/2022
Patient received her COVID vaccination in our pharmacy department at about 1:00 PM on Friday 11/10/23.  She has a history of feeling dizzy/lightheaded after vaccinations, so she premedicated with 1 tablet of Metoprolol succinate 50mg about 1 hour before her vaccination.  We had her sit in our waiting area for the required 15 minutes, and by about 1:05 PM patient reported feeling "spacey".  She also felt lightheaded, dizzy, and developed a shaking in her arms.  She was not able to stand up on her own, she did not feel stable enough.  EMS was called for the patient at that time, around 1:05 PM.  An EMT arrived on the scene at about 1:10PM.  Immediately her BP, pulse, and heart rhythm were checked.  All were normal according to the EMT.  She also mentioned to the EMT around 1:11 PM that see felt she was developing a headached.  Patient was taken to Hospital for observation as her reaction was not what the EMT would expect as an allergic reaction to the vaccine.  Upon checking with the patient's mother around 3 PM, patient was given a dose of Ativan at the hospital and was feeling better.  She was discharged later in the evening.  Spoke with patient again around 5/6 PM, and she was feeling much better.
fever of 102 degrees Fahrenheit; nausea; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever of 102 degrees Fahrenheit), NAUSEA (nausea) and MYALGIA (body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Cancer and Penicillin allergy. Concomitant products included DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ), BENAZEPRIL, METOPROLOL, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (fever of 102 degrees Fahrenheit), NAUSEA (nausea) and MYALGIA (body aches). The patient was treated with IBUPROFEN at a dose of every 6 hours as needed. At the time of the report, PYREXIA (fever of 102 degrees Fahrenheit), NAUSEA (nausea) and MYALGIA (body aches) outcome was unknown.            Other concomitant medication included Emergen-C once daily
Patient reporting at doctors office chills, body aches, slight respiratory discomfort, fatigue. Pt was instructed to take TYLENOL.
mild Irritable Bowel Syndrome; A few hours after the first shot I had paresthesia in my legs, arms and back. After the second shot I immediately had paresthesia in my feet which eventually went away; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 13:15 (Lot number: EP7534) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IRRITABLE BOWEL SYNDROME (non-serious) with onset 17Mar2021 17:00, outcome "not recovered", described as "mild Irritable Bowel Syndrome"; PARAESTHESIA (non-serious) with onset 17Mar2021 17:00, outcome "not recovered", described as "A few hours after the first shot I had paresthesia in my legs, arms and back. After the second shot I immediately had paresthesia in my feet which eventually went away". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Mar2021) negative. Therapeutic measures were not taken as a result of irritable bowel syndrome, paraesthesia.  Additional information: A few hours after the first shot had paresthesia in legs, arms, and back. A few days later had mild irritable bowel syndrome that went away after a few weeks. The event was not serious (no death, no life threatening, no caused/prolonged hospitalization, disabling/incapacitating and no congenital anomaly/birth defect). Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.
Pt recvd booster dose of MMR on 31JUL90; On 02AUG90 pt devel urticaria; Rash progressively worsened, w/assoc pruritus, & covered entire body; The next day, to MD office tx Epi;
PT CAME IN FOR SHINGRIX VACCINATION. HER SHINGRIX WAS RECONSTITUTED WITH A DIFFERENT DILUENT THAN ONE PROVIDED IN BOX WITH VACCINATION. AS A RESULT PATIENT DID NOT RECEIVE FULL POTENCY OF VACCINE. CONTACTED PATIENT AND EXPLAINED THAT BECAUSE OF ABOVE ERROR WILL WE REVACCINATE HER USING CORRECT DILUENT SO SHE RECEIVES FULL POTENCY AND PROTECTION.
Patient was with her father. She was receiving Pfizer bivalent vaccine and fluarix and her father was  receiving Shingrix. She was in given Shingrix by the pharmacy intern at 4:20 pm. She was monitored for signs/ symptoms for 20 minutes without incident.
EXPIRED VACCINE ADMINISTERED (EXP 6/30/2022). NO ADVERSE REACTIONS REPORTED.
Vaccine expired on 08-Nov-2021 and moved to refrigeration on 25-Nov-2021 and administered on 26-Nov-2021; Vaccine expired on 08-Nov-2021 and was administered on 26-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine expired on 08-Nov-2021 and moved to refrigeration on 25-Nov-2021 and administered on 26-Nov-2021) and EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 26-Nov-2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 26-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 08-Nov-2021 and moved to refrigeration on 25-Nov-2021 and administered on 26-Nov-2021). At the time of the report, PRODUCT STORAGE ERROR (Vaccine expired on 08-Nov-2021 and moved to refrigeration on 25-Nov-2021 and administered on 26-Nov-2021) and EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 08-Nov-2021 and was administered on 26-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided. Vaccine expired on 08-Nov-2021 and moved to refrigeration on 25-Nov-2021 and administered on 26-Nov-2021   This case was linked to MOD-2022-570635, MOD-2022-570643 (Patient Link).
Developed severe leg cramps, worse at night and some leg weakness today.  Legs feel fatigued, like they are going to give out on her.
On the day of the shot, the injection site had minamal swelling; however the following starting occurring the day after the shot, Severe swelling of lymph node along the collar bone (egg size), hives on face, neck and hands, swelling from the injection site up to the face on left side of body, labored breathing, constant low grade fever, fatigue, thick tongue, havev felt very weak, also very sore throat (bloody red), headache, extremely hot swollen injection site. Visited a doctor on 5/15 due to continuous inlargement of lypmh node on collar bone, fever, etc. . . was told to continue on Benedryl & Motrin and to go to emergency room if fever started going up, lymph nodes continued to get bigger or if I continued to have breathing difficulties. Today, the 6th day after the shot I still have a fever (100.1) but the swelling has gone done some.
She got her vaccine,  was fine.  The next day she was exhausted, but nothing unusual.  Then about 4/6/21, a month later she started slowly loosing her vision, and got her vision back for about 2 weeks, and then she slowly started loosing it again.   She went to her primary care who told her nothing, and told her to go to the ER.  She went to two walk in clinics, the ER, an ophthalmologist, a neuro-ophthalmologist.  She has been to a retina specialists, two other neuro-ophthalmologists, and a neurologist who do not know what is wrong with her.  They tell her that her eyes look healthy and good but she cannot see.  Her left eye she may have about 5% of her vision and 15-20% in the right eye.  She was given dry eye drops by one of the earlier physicians.  She has had some follow ups, and the neurologist told her to drink water eat low carbs.  So, she is frustrated at this point that nobody knows what to do and treat her eyes and is depressed.  She lives alone and is not able to see to read her credit card info to order food or to see what she has to eat.  She was also given Xanax, which she has not taken yet.
Pt came to ER c/o SOB on excertion onset the last couple of days.
asthma; Asking if there is an interaction between Ivermectin and Covid 19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single for covid-19 immunisation; ivermectin (IVERMECTIN) (ongoing) (Batch/Lot number: unknown) at 15 mg 1x/day for covid-19. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Caller clarifies that she had Covid before the first two vaccines, not after. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "asthma"; POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "Asking if there is an interaction between Ivermectin and Covid 19 Vaccine".  Additional information: Dosages regimen for concomitant: 15mg once a day for 6 days straight and now taking it once a week for 3 more weeks for a total of 45 tablets Reporter states she just started Ivermectin 2 weeks ago and she was not taking it when she received the first two doses. Reporter states she was taking Ivermectin for long haul Covid symptoms also clarifies that she had Covid before the first two vaccines, not after. She takes Ivermectin 15mg once a week and she took 15mg once a day for 6 days straight and now she is only taking it once a week for 3 more weeks for a total of 45 tablets.  The lot number for bnt162b2 was not provided and will be requested during follow up.
On June 28, I woke up feeling nauseated, chilled and very tired and sluggish as described in CDC information vaccine sheet. Went to dental appointment between 9:00 and 11:00 for initial crown repair on two teeth and was only given NOVOCAIN. At noon, I walked with friends over the noon hour, but did not feel well and did not feel like climbing stairs or going up hills. When I returned to office, I felt as though I was going to pass out in elevator and felt very claustrophobic. After getting off elevator and getting back to my office in another building, I placed my head down on desk for a few minutes because I was not feeling well and 10 minutes later, called a family member to pick me up and take me home. When I arrived home, I slept for approximately 4 hours, woke up and ate dinner. After dinner, I measured my temperature which was 99.6 and took TYLENOL. I also noticed that my lymph nodes under my right arm ached. I returned to bed. Felt better than the prior day on Friday, but still had ache in right armpit lymph node area and also noted a slight pain in my upper spinal cord area. I decided to go to work and walked with friends at lunch and did fine with that. I did still feel chilled; however, on Friday. I did not report this to my PCP, Dr., but will next week.
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (her friend experienced negative effects following vaccination) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Sep 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 23, 2021, patient experienced vaccination complication (her friend experienced negative effects following vaccination). At the time of the report, vaccination complication (her friend experienced negative effects following vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Patient's arm swelled up to twice its normal size, became very warm to the touch, and is reddish/bluish as if bruised. It spans a large diameter of approx 3.5" and is rock hard to the touch.
About 7 mins after the first covid vaccine was administered in my left deltoid my mouth became numb. I was advised to stay in the pharmacy for 20 mins after administration then I was able to go and I did not need to report back to the administering nurse. As soon as my tongue and back of my mouth became numb I noted the time. I continued to walk around the pharmacy monitoring my symptoms and closely monitored my breathing. After the 20 minutes was up I left the pharmacy and went home. Around 547pm that same night I grew curious as to why my mouth was still numb, I went to the mirror to look in my mouth. That's when I noticed my taste buds/ tongue were swollen. I also had become itchy on my neck and chest, red spots presented and were noted as well. I took picture documentation of visible reaction. The next morning I woke up and the numbness in my mouth/tongue had subsided as well as the red itchy spots. This has created a fear in me that getting the second shot in the series will cause me to have a greater reaction if not anaphylaxis.
PT reported feeling normal immediately after vaccine was administered. According to PT, they began feeling extremely lightheaded approximately 5 minutes post-injection. Approximately 8 minutes post-injection, I observed the patient rise from her seat and begin to stumble towards me. The patient was exceptionally pale, and reported to me that she was feeling light headed. I promptly directed the patient to sit down, but before she was able to reach a chair, she collapsed entirely. She fully regained consciousness within a few seconds and was alert to presence, place, and time. PT was able to seat herself at this point.  Her blood pressure registered 82/51 mmHg immediately after the episode. PT was visually slowed and confused, but was otherwise fully present. PT was given water and allowed to recover in a seated position.  Blood pressure registered at 117/71 mmHg 15 minutes later, and PT reported feeling much better. PT was visually much more alert and cognitively present. After 15 minutes of no change in condition, patient was allowed to leave facility with the accompaniment of her mother. No epinephrine or antihistamines were administered.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 29-FEB-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K012472, expiration date 11-JUN-2016, exact dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 62 degree Fahrenheit for 165 hours before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for follow-up.
Got the vaccine, and he got home and his whole body was like he was freezing with chills, could not walk, could not talk, had a headache, could not eat, felt like he was dying.  Really bad.  The arm is swollen up like a balloon, black and blue from the injection.  Took aspirin, and still having the chills and he can hardly move his arm.
Pt called pharmacy 4/25/2017 stating that she had pain and redness "a little larger than a 50 cent piece".  She also complained it was hot to the touch.  She also stated that is was improving a lot today.
rash; itching on arms, hands and legs; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Mar2021 at 15:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. The patient was allergic to tetracycline (MANUFACTURER UNKNOWN). Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN); all for unknown indication and unknown start date. 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 COVID vaccine. On 02Apr2021, the patient experienced rash and severe itching on arms, hands and legs. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event rash and itching were not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.