chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 2017-2018, 2nd not yet, vaccine shortage; This case was reported by a consumer via call center representative and described the occurrence of product supply issue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2017 or 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.   Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: The patient's wife reported that the patient received his first Shingrix dose but had not yet received the second dose. The patient attributes the delay to vaccine shortage.  Nothing else was reported. The reporter declined to provide date of birth. The reporter did not consent to follow up. This is report 2 of 2 linked patients, reported by same reporter. Additional supportive information: The patient did not receive second dose of Shingrix due to vaccine shortage, which led to product supply issue.; Sender's Comments:  US-GSK-US2022163649:Same reporter
10:15 inj lt deltoid;10:30 localized rash @ inj site, DPH;10:45 inc rash, wheels lt arm, DPH;11:00 rash resolving;
She is not that stable today; She has like a chest pain; This is a spontaneous report from a contactable consumer (patient husband). An unspecified age female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown; formulation: solution for injection; expiration date: unknown), via an unspecified route of administration on 16Jun2021 as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the consumer calling for his wife, she had the vaccine yesterday. consumer stated that both had the vaccine (Confirmed as Pfizer Covid 19 vaccine) yesterday, consumer feeling okay, a little fever but he is good, but patient has like chest pain. So, what we should do, should we wait drink some water or go to a like emergency room, is that normal. consumer stated that the patient has like a chest pain in Jun2021, and she was not that stable today on 17Jun2021. consumer stated that they do not think they have expiration date and lot. Yes, they have it, but consumer do not have it here with them. consumer stated that he will call the medical information department. What you think, what should we do, can we go to emergency room better, if we will spend time on phone, we do not know what is going to happen. The outcome of the events was unknown.  Information about batch/lot number has been requested.
103 temp, chills, migraine headache, body aches, nausea,  Beginning 8:30pm on 4/9/21 thru 4/11/21. Extreme symptoms and pain. Took 1000 mg every 4 hours to no avail
Just inferior to injection site, I developed a large, erythematous, indurated, warm, painful rash.
acute hepatitis, asymptomatic, supportive care, resolved (normal LFTs at 4 weeks)
A nerve was hit, I jumped and was stuck again.  I believe I suffered nerve damage with extreme pain in various arm areas, left breast continuing to the present.  I am prescribed gabapentin to ease the continuing pain.  I had no arm pain before this event.
Attendee received dose Johnson and Johnson vaccine at 11:40 in the left arm.  Lot# 205A21A. Attendee was directed to observation area.   Within 30 seconds attendee voiced complaints of lightheadedness, hot/cold feelings, escorted first aid to lie down on the cot. Skin was pale, cool, and clammy, rapid, shallow breathing.   11:43  Alert and oriented, skin now warm and dry. HR:  62   BP:  120/90   RR:   20   O2Sat%:  99      11:48  911 called    11:50 -No voiced complaints- skin warm and dry.   HR:  90   BP:  122/84   RR:   20   O2Sat%: 99   11:55 -No voiced complaints- skin warm and dry.   HR:  72   BP:  120/84   RR:   14   O2Sat%:  100
Starting around 1700 the day I was vaccinated, I started to experience body aches and a sore throat. As the night progressed,  I had a fever of 102F. The fever lasted throughout the night until it broke the next morning. It is currently 2125 the day after vaccination and I still am experiencing body aches and fatigue after sleeping for 18 hours. I have taken Tylenol to help relieve these symptoms.
suddenly passed out; This is a spontaneous report received from a contactable consumer reporting on behalf of the patient. A 30-year-old male (nephew) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter wanted to know if there were reports on patients passing out after not being able to eat after the first shot of the COVID-19 vaccine. The reporter's nephew suddenly passed out after the first shot and was rushed to the hospital on unspecified date. The reporter confirmed that the patient was healthy. The reporter wanted to find out if it is safe for the patient to receive the 2nd shot of the vaccine. Outcome of the event was unknown. The event was assessed as serious (hospitalization).   Information on the lot/batch number has been requested.
The injection day - about 8 pm, I noticed arm tenderness. About 3:00 am< I woke up with chills and couldn't warm up. I took my temp - had 100.2. At 5:30 am, my fever was 103. I took over the counter Tylenol. My arm was swollen, red, painful around the injection site of second dose vaccine and also at the original vaccine site. The fever broke (99) at 10 am. I didn't go to work. Hot and cold on and off. 03:00 pm, was fever at 101. I took Tylenol. At 6:30, I had 98.7 temperature. At 10:00 pm, I was back up to 101.3. I took over the counter Motrin. About 2 am, I woke and was sweaty. No chills, fever was gone. I went to work on Wednesday. I didn't have fever but the injection site was still swollen, fevered injection site. It was hard and raised. Was putting ice packs on at work to reduce swelling. Thursday, knot had gone down and I was just itching. I took the Hydroxocine (prescription for prior vaccine) for itching. Friday I was fine. If I push on it today it's a little tender - like a little bruise.
This is a spontaneous case initially received from other non-health professional on 21-Nov-2018, concerning a pregnant female patient of an unspecified age. On an unspecified date, a 11-week pregnant female patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported] (explicitly coded as vaccine exposure during pregnancy). At the time of this report, the outcome was unknown.
BLURRED VISION; MIGRAINE; HOT FLASHES; PALE; SWEATING; FEVER; MUSCLE ACHES; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included mitral valve prolapse, drug allergies: compazine, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 10:30 for prophylactic vaccination. Concomitant medications included metoprolol tartrate for mitral valve prolapse. On 12-MAR-2021 07:00, the subject experienced blurred vision. On 12-MAR-2021 07:00, the subject experienced migraine. On 12-MAR-2021 07:00, the subject experienced hot flashes. On 12-MAR-2021 07:00, the subject experienced pale. On 12-MAR-2021 07:00, the subject experienced sweating. On 12-MAR-2021 07:00, the subject experienced fever. On 12-MAR-2021 07:00, the subject experienced muscle aches. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 97.9 F, and COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision on 14-MAR-2021, and migraine, and muscle aches on 13-MAR-2021, and had not recovered from fever, hot flashes, pale, and sweating. This report was non-serious.
On 12/4/2021 patient was on an airplane and once she was off plane patient couldn't breath, patient was taken to ER and had Large DVT in right leg and pulmonary emboli, one in each lung.
a little headache; Nausea; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 14Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. He states that he received second Pfizer COVID 19 shot yesterday and he wanted to know if he could take Tylenol for headache or nausea. He also states that he was told to take Tylenol 500mg for any side effects and he wanted to confirm this. He has a little headache and just wanted to take something. The outcome of the events was unknown. Information about lot/batch number has been requested. Additional information has been requested.
Mother of pt called on 10/28/13 to say that child had red, itchy, bumpy area on (L) upper arm and also a mild rash on (R) upper arm in the area where child got vaccines, child is not running a fever or complaining of labored breathing. Parent advised to give dose of TYLENOL or MOTRIN, apply cold or hot compress (to child's comfort) and if signs/symptoms deem necessary contact pediatrician or call 911.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients. In approximately 2015 (reported as since 13-MAR-2015), the patients were vaccinated with doses of GARDASIL lot # K005881, K006960 (expiration dates, dose, route and site of administrations were not reported) that were exposed to temperatures outside of the recommended range. No adverse effects had been observed or reported. Follow up information has been received from the medical assistant on 02-JUL-2015 concerning ap patient of an unknown age and gender who on 10-APR-2015 was vaccinated with a dose of GARDASIL (lot # K006960) (dose and route not reported) that was 24 hours temperature excursion. This is one of several reports received from the same source. Additional information is not expected as all correspondence was received.
Patient's first MMR shot was on Thursday July 27th, 2017. Prior to that, he was fearless, outgoing, and very healthy and active. He took swim classes and gymnastics on a weekly basis. He loved going to the park and swinging as high as we would possibly let him. For his 2nd birthday party in May of 2017, he had it at his gymnastics studio. The instructors at the party commented on how fearless he was, leaping from great heights off of the obstacle courses and tumble mats they had set up. A week after Patient's MMR shot on July 27th, his behavior and personality completely changed overnight. Patient's biological father, is a good dad. He is the shy type with few words. In the two years of Patient's life, father had never brought to me any concerns about Patient's behavior. The first week of August, after Patient had stayed a couple nights with his father, reported to me some serious concerns. Patient suddenly began screaming and screeching and waking all night long. Once in my care, I noticed the same things. Patient became aggressive-- hitting, kicking, screaming, and sobbing. He was having night terrors, screaming and waking up every hour through the night for about a week or two. Me and my now husband, were extremely worried about Patient, mainly about the sudden and extreme behavior and aggression issues. Additionally, we began noticing that Patient was suddenly fearful of everything. Patient was terrified swinging on the swing set (despite not having any injuries or anything else happen in that time). He no longer wanted to participate in his activities and classes. These behaviors peaked in the 7-10 day period after the MMR injection up until one month after injection. His behavior has improved with each passing month since then. It was only this last week (June 2018), that when I took Patient to the park, he was no longer scared to swing high like he once loved. The adverse reactions from the MMR were most noticeable the month of August 2017. There were no other factors in that time period that could have contributed.
Soon after child received shots, patient was seen by a different staff member carrying child to the outside to get air. Child had eyes closed and appeared to have fainted a that time.  By the time this nurse got to child, child was laying down, was very pale and sweating but coherent and responded to questions.  Child was given juice and an ice pack to the back of her neck.  Child remained laying down until color returned to her face.   Child was sat up, given a cracker which she vomited.  Child stayed in clinic until she stated she felt better and left clinic ambulatory with mother.
Soreness at injection site, temporary/brief abdominal muscle pain, joint aches (neck, shoulders, elbows, hands, fingers, leg/hip joint, thigh muscle ache, mild headache, tired
the injection site.  The area also began to hurt; Red area described as looking like a pimple, presented at the injection site; arm became weaker than normal/hand is weaker; hand is weaker and gets numb; Pain in her shoulder above the injection site; Injection site pimple; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received HBV (Engerix B adult) for prophylaxis.   On 17th August 2020, the patient received the 1st dose of Engerix B adult (intramuscular). In August 2020, 1 week after receiving Engerix B adult, the patient experienced injection site pain, injection site erythema, weakness in extremity, numbness in hand, shoulder pain and pimples. On an unknown date, the outcome of the injection site pain, injection site erythema, weakness in extremity, numbness in hand, shoulder pain and pimples were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, weakness in extremity, numbness in hand, shoulder pain and pimples to be related to Engerix B adult.  Additional details were provided as follows: The age at vaccination was not reported. A week following the vaccination, a red area described as looking like a pimple, presented at the injection site. The area also began to hurt and the arm became weaker than normal. It hurts when pressure was applied and the hand was weaker and get numb after a while when hold a cell phone in her hand. There was pain in her shoulder above the injection site. All symptoms presented a week after vaccination and have not resolved. The reporter consented to follow up.
Approx. 2 days after inj pt was seen in ER for rash that was felt to be eczema. Follow-up Information received 12-JUN-2009: Mom reports to us that rash started about a day or two after injection.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age with warts on her hands. On an unknown date, approximately in 2009 (also reported as 5-6 years ago) the nurse practitioner administered the full series of GARDASIL (intramuscularly, dose, frequency and lot # not reported) to a female patient who was older than recommended age but who had warts on her hands. The nurse practitioner noted that the patient's warts resolved after the second dose of GARDASIL. The outcome of the event and relatedness between the event and GARDASIK were not reported. Additional information has been requested.
Information has been received from a 72 year old female consumer with no pertinent medical history, no drug reactions/allergies, who on 14-NOV-2010 was vaccinated with a "1 time" dose of ZOSTAVAX (Merck) (Lot # not reported). Concomitant therapy included LIPITOR, PREMARIN and BENADRYL. Consumer stated that on 21-NOV-2010 she experienced itchiness in the eyes and head and asked if these symptoms could indicate shingles. A blood test was performed (results not provided). Consumer sought unspecified medical attention. At the time of the report the outcome of the patient was unknown. No further information is available.
Cutaneous wheal and erythemtous streaking around injection site (deltoid) and down adjacent bicep
LUMP AN INCH IN SIZE AND REDENED ARE ABOUT 4 INCHES AND PAIN AT THE SITE
Initial report received from a healthcare professional on 17 September 2014. A female patient, whose medical history and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE QIV, (batch number: UI158AA, expiry date: not reported), in unspecified site on 15-Sep-2014. On 16-Sep-2014, patient experienced congestion, felt achy and slight fever. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none. Follow-up information received from healthcare professional on 12 November 2014. Age of the female is reported as 30-year-old. It was reported that patient had fever for 24 hours with the chills. She had congestion in her nose and body ache for a couple of day. Other medication, Illness at the time of vaccination and pre-existing diagnosed allergies and medical condition was reported as No. At the time of this report, the outcome of the event was reported as recovered. List of documents held by sender: none.
with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad; 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 76-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad".  Additional information: Patient stated that she states she has had 4 covid vaccines in the past, all Pfizer and with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad. The 1st and 2nd hurt really bad at injection site, but she noticed it was when nurse pinched up skin to give injection. The 3rd and 4th she asked them not to do that and it didn't hurt. Her husband had the same experience. She thinks that's why her arm was so sore and thought she would pass it on if it would help. It just came up in the conversation because she remembers how her whole arm hurt.    The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309739 same patient, different dose, different event;
patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines; patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines) and CHILLS (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Left ventricular dysfunction (on medications) and Left bundle branch block.    On 04-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines) and CHILLS (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines). At the time of the report, MALAISE (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines) and CHILLS (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included left ventricular dysfunction medicines (not specified).  On 05-Mar-2021, patient received first dose of Moderna vaccine with lot number 032M20A. On 02-Apr-2021, patient received second dose of Moderna vaccine with lot number 045A21A. On 10-Nov-2021, patient received second dose of Moderna vaccine with lot number 039F21A.  A caller stated, she had the usual chills and was not feeling well which, she also got after getting her previous COVID-19 vaccines.  No treatment information was provided.   This case was linked to MOD-2023-748940, MOD-2023-748946 (Patient Link).
Continuous high pitched, screaming & crying for 6 hrs, started within the 1st 30 min after injections. Would not nurse.
Severe muscle aches, and fever of 101..8, headache  and extreme pain at injection site  24 hours.
Fatigue, aches 3/12. Large red, hot, swollen painful vaccination site (Moderna) 3/13 & 3/14.
rash and red cicle at vaccination site, warm, hard knot and tender to the touch.
fast heartbeat; This spontaneous case was reported by a patient and describes the occurrence of TACHYCARDIA (fast heartbeat) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TACHYCARDIA (fast heartbeat). On 17-Mar-2021, TACHYCARDIA (fast heartbeat) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
pain developing in left axilla radiating to left breast.  Very painful to touch , cannot wear a bra due to pain