chrisvoncsefalvay/vaers-outcomes huggingface dataset:
- arm tenderness. Initially felt like routine flu vaccine. After 12 hours, arm started to increase in tenderness, more similar to other vaccines such as TdaP or tetanus.  Gradually resolved at 72 hours. - Mild malaise developed at 24 hour mark (1st day post injection).  Checked temperature at 28 hour post injection with 1 degree Fahrenheit higher than normal forehead temperature using Exergen thermometer. Subtle myalgia during the evening.  Symptoms resolved after sleeping, which should be at 40 hours after injection.  Slightly less than normal physical stamina between 40-50 hours post injection (2nd day post injection).  Symptoms have completely resolved after the second night sleep (66 hours post injection or 3rd day post injection). Injection was on Saturday 2:00pm.  Completely symptom free on Tuesday.
Patient reported throat itching and nasal congestion. Pt. denied any difficulty breathing or swallowing. Vital signs initiated at 1354, all within normal limits. Patient was given crackers and water, throat itching and congestion unrelieved, patient was given oral chewable tablets of Benadryl (12.5mg x 2 tablets) at 1355. Patient was monitored for additional observation time of 1 hour total. Vital signs were taken 4 times during that time period, all remained within normal limits.  At 1455 patient reported that throat itching and nasal congestion had subsided, left with friend in no visible sign of physical distress. Last set of vitals: HR 68, RR 14, BP 122/80, O2 Sat 99%.
pt recvd vax & w/in days of inject devel a knot @ the inject site which persisted for several months; No further details were provided;
4/22/2021 6;30/7 pm went to local pharmacy Got shot in left arm 2 hours later felt hot and burning tingling sensation down my back lower back and outer left thigh, woke up with blisters under breasts. i still feel burning pain like I'm getting shingles but there is no visible sign. I'm still burning after 3 weeks. Blisters went away after a few days.
Injections given, pt became faint, pale, resolved after lying down legs elevated, rest, candy given.
Gave MMR vaccine around injection site instantly started to turn red, swollen and a welt formed gave 5cc of Benadryl.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Called and Paramedic assitances arrived on site to evaluate patient
it was rpt pt recv varivax 4/1/97 & 4/10 pt exp massive overall body itch. pt right jaw line started to change p/ itching. tests performed. massive lymph nodes were discovered.
Hives all over body (head to toe) 4 days after 1st dose.  Doctor prescribed (1)Diphenhydramine -25 mg and (2)Methylphednisolone - 4 mg.  Also using OTC Aveeno Anti-Itch Concentrated Lotion.
Caller, calling on behalf of a physician, stated that a patient received Vaxelis at 5 years of age and that the dosing intervals were correct; Male patient born on 16 July 2017, who had not previously received any doses of the vaccines contained in Vaxelis, was administered Vaxelis on a catch-up schedule for three doses on the following dates: 30 Aug 2021, 10 Nov 2021, and 25 Aug 2022.; This non-serious spontaneous safety report, with case Number 2023SA202003 (Inquiry Number 01674630), was received by partner, on 30JUN2023 and forwarded on 03JUL2023 from a healthcare professional.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. "Caller, calling on behalf of a physician, stated that a patient received Vaxelis at 5 years of age and that the dosing intervals were correct and, male patient born on 16 July 2017, who had not previously received any doses of the vaccines contained in Vaxelis, was administered Vaxelis on a catch-up schedule for three doses on the following dates: 30 Aug 2021, 10 Nov 2021, and 25 Aug 2022."  Further information is expected.
Pt began suffering pain in her joints shortly after receiving vax. Dx as arthritis, then connective tissue disorder, then auto immune deficiency. She had trouble breathing, can't walk. The pt died on 4/29/00, no autopsy will be performed. Per the death certificate the pt's cause of death was septic shock and respiratory failure.
I start having lymph nodes under my armpits painful like to small balls; I can feel something like soreness and pain; change the mood; having headache; You have you hit your arm; that you cannot even breath; I start having lymph nodes under my armpits painful like to small balls; I can feel something like soreness and pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that,  A 62-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0171; Expiration Date: 31Aug2021) (at the age of 62 years old), dose 1 via an unspecified route of administration, administered in arm left on 01May2021 as dose 1, single for covid-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing Verbatim: Blood pressure. There were no concomitant medications. It was reported that patient took her first vaccine dose on 01May 2021, on 03May2021 she had lymph nodes under her armpits painful like to small balls, she could feel something like soreness and pain which was coming to her side of her toothbrush and since she was still having the same thing but it was not like constant it went and came back but when it came like the soreness it felt like sometimes it was like, she even had to change the mood, having headache, she hit her arm and started pressing on that arm were she felt that she could not even breath, right like a lump, her second vaccine shot was next day. She took Tylenol and gabapentin as a treatment. The outcome for the events was not recovered.  Follow-up (02Jul2021): Follow-up attempts completed. No further information expected.
bad cold; high rise of temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 09Mar2021 (Batch/Lot number: unknown) 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: NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "bad cold"; BODY TEMPERATURE INCREASED (non-serious) with onset Mar2021, outcome "unknown", described as "high rise of temperature". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter was not Healthcare Professional (HCP). The reporter was not  a prescribing HCP. Occupation/Specialty was unknown. The reporter's contact information available to consumer or a sub-contracted party was Unknown. Suspect product(s) Pfizer Covid-19 Vaccine Start Date was 09Mar2021 and Stop Date was 17Mar2021. Patient 2nd dose was rescheduled to 17Mar. He is asking any documents he needs to bring on that day. No any unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected
large red sore spot, @ the area of the shot;red area 35mm round-warm to touch & hardened area under skin
Information has been received from internet concerning a 4 year old male patient with history of peanut allergy with anaphylaxis, who on an unspecified date was vaccinated with a dose of PROQUAD (Merck) (Lot number not reported). Subsequently just minutes after being vaccinated the boy experienced anaphylactic shock. Subsequently allergy tests revealed significant hypersensitivity to porcine gelatin (IgE >20 kU/L). It was unknown if the patient sought medical attention. At the time of the report the patient's status was unknown. The reporter felt that anaphylactic shock was strongly related to gelatin in therapy with PROQUAD (Merck). Upon internal review anaphylactic shock was considered to be other important medical event. This is one of several reports received from the same source. No further information is available.
Injection site swell and pain, and headache, light head, unset stomach subsequent to injection. The following day I noticed a rash, which I never had in my life.  It progressed to blisters and I noticed it was oozing.  I also had a blister underneath my lips .   I went to the doctor 5 days after taking the shot, on 04/22/21.      The doctor I saw was not my regular doctor, and she treated the rash as if it were not associated to the vaccine.  I said I was afraid to take  the second shot, she said:  "don't tell me that you don't want to take the vaccine!"     After treating me as a normal patient with a condition that she said was "shingles", which I never had in my whole life, she said that "nobody can force you to take the vaccine", that's all she said.   I was very upset because there is no doubt it was a reaction to the vaccine.  I had Flu symptoms for 9 days, specially at night with fatigue,  chills, upset stomach, muscle and joint soreness, tiredness.     10 days after the vaccine, I started to feel better and the symptoms started to fade.
Pt developed a fever of 104.6 degrees and had a 10 minute seizure. He was seen at a hospital ER and was diagnosed with otitis media and a febrile seizure. (The ear looked ok to me 11/6). On 11-8 hrs fever stopped. 11/9 he had a rash on his thumb.
Pt. had rashes on hand about 2 hours after vaccine. Took BENADRYL and on 8/16/13 at 10:20 AM said rashes are gone.
Administered the diluent component / without lyophilized powder; Administered the diluent component / without lyophilized powder; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 2EC54, expiry date 11th November 2022) for prophylaxis.   On 8th June 2021, the patient received Shingrix. On 8th June 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only the diluent component of Shingrix without lyophilized powder which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Information has been received from a consumer, concerning her 25 year old female daughter with a history of malaria, who in October 2007 was vaccinated with the first dose of GARDASIL. Concomitant medication included ORTHO TRI - CYCLEN. The patient fainted after getting the first dose of GARDASIL. The patient recovered on an unknown date. The patient has not received the second and third dose yet. The patient sought unspecified medical attention. There was no product quality complaint. No further information is expected.
PENTACEL, PREVNAR and ROTATEQ administered at approximately 1000 on 9/1/09. Mother noted transient mottling flushing, mottling and red hive like areas on face, trunk, extremity approximately 2 PM after napping feverish. TYLENOL given. Arrived in our office at 14:40 with mild pink macular area (L) face x 2. Some mottling of lower extremity alert, no RDS, BENEDRYL given x 1. Transient redness and mottling of extremities @ 1520. Resolved by 1545.
"Moderna COVID-19 Vaccine   About 45 minutes after my shot, my left arm started hurting, basically going down from the injection site to my elbow. AT 1:30 am - 4/9/2021 (14 hours after shot), I awoke out of my sleep and was freezing. I got up and layer up on clothing and drank some water. From 1:30 am - 5:45 am- 4/9/2021, I was wide awake, but tired , yawning, freezing, and had a temp of 99.9. My mouth got very dry and I was drink just a little water, but found myself having to run to the restroom once an hours. My temp slowly got down to 99.2 by 5:30am. During this time, I was also nauseous from shaking so much from being cold. I slept for another 15 minutes and then was wide awake from 6:10 am- 7:30  and then fell asleep till 9:30am. As of 12:00pm, - 4-9-2021 I have slept maybe 4 hrs, I have a headache, my arm is throbbing and I am tired. I also feel like I have a bunch of mucus in my throat (but that could be from allergies).
similar but not as intense reaction; This spontaneous case was reported by a consumer and describes the occurrence of SIMILAR REACTION ON PREVIOUS EXPOSURE TO DRUG (similar but not as intense reaction) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced SIMILAR REACTION ON PREVIOUS EXPOSURE TO DRUG (similar but not as intense reaction). At the time of the report, SIMILAR REACTION ON PREVIOUS EXPOSURE TO DRUG (similar but not as intense reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable    This case was linked to MOD-2021-078312 (E2B Linked Report).; Sender's Comments:  MOD-2021-078312:1st dose
Received required flu vaccine at vaccine clinic. Have had severe left upper arm pain, weakness and a numbness/tingling sensation in left hand since receiving flu vaccine. Symptoms began immediately after receiving vaccine and have remained constant and consistent since without any improvement. The nurse administering vaccine administered the vaccine too high on arm - she gave it in shoulder joint, not deltoid muscle. While injecting the flu vaccine, felt a sharp pain spread from the injection site down into arm and had a sharp stinging sensation into fingertips. Have received many flu vaccines before and never have experienced this.
body aches, injection site soreness,  joint stiffness,  nausea, head ache,  flu like symptoms
raised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site; aised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site; aised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site; This non-serious case was reported by a consumer and described the occurrence of rash in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (21 years ago).   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: raised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site), red rash (Verbatim: aised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site) and raised rash (Verbatim: aised slightly burning rash antecubital fossa aproximately 6 cm opposite arm from injection site). The outcome of the rash, red rash and raised rash were resolved (duration 6 days).   It was unknown if the reporter considered the rash, red rash and raised rash to be related to Shingrix.     It was unknown if the company considered the rash, red rash and raised rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2023 The patient received first dose of Shingrix and experienced red, raised slightly burning rash antecubital fossa which was approximately 6 cm opposite arm from injection site. The events were resolved 6 days later. The patient had no lasting issues.
Pt obtained vaccine (ZOSTAVAX) in left arm. She went to ER 2 days later b/c it was red & swollen. Dx with cellulitis treated with KEFLEX 500 BID x 10 days.
could lift left arm >45 degrees;  body aches and malaise; pain awoke her during the night time from sleeping. A few days after that developed sore throat and sinus congestion
About a week after 1st injection an intensely loud ringing in my ears commenced.  The ringing has continued - non-stop - since its onset.  My hearing was considered excellent before the ringing started, as I was a professionally-trained ornithologist who could identify bird species by their vocalization - even very faint or distant calling.   Now, I have to concentrate to discern the identify of singing birds due to confounding din from the tinnitus.  Unfortunately, I did not realize that my recent onset of  tinnitus could be related to the covid-19 vaccine I had a week earlier, and I got my 2nd vaccination shot last Wednesday (4/21).  The ringing has continued unabated, and I am aware of it every waking moment.
Pt developed varicella zoster shingles rash on right lower leg on 02/19/2002-4 months after varivax (14months old).
Severe covid arm.  Half of arm affected.  Rash on neck, chest and itchy all over. Inflamed ear lobes.
See page 2 - all in 1 spot. By the time she sat down in the waiting area after getting the shot, she had a red, rash with hives all over her chest and other areas.  It had minor itching, and she did not report any issues with either her throat or her tongue.   However, the rash kept getting brighter.  So, at 1:24 PM, she was given a 50 mg IM dose of diphenhydramine into her right arm (opposite of the vaccine).   Lot 80014, Exp 8/22 The itching began to calm down, and the hives were not as bright.  She was tired/sleepy as expected, and had her husband come to take her home. Called on 1/15/2020 at 1 pm, she went home last night and crashed for about a 4-hour nap.  When she woke up this morning, the rash is much better.  She has not needed another dose of medicine, and she feels that she is on the right path. She says that she intends to take the 2nd dose of the series when it is due, and she is aware this is likely outcome again.
Breakthrough Covid-19 infection occurred 11/18/2022. Note, In my vsafe 3 month check-in, I mistakenly put 12/19 as the infection date which was incorrect. 11/18/2022 is the correct start of symptoms. Symptoms included Headache, Sore Throat, Muscle Aches, Tired, Cough (mixed phlegmy and some dry cough as well) As of 12/30/2022, I still have a very,very minor cough (phelgmy/wet) which is getting better each day. It's almost but not quite gone! I used telemedicine to get Paxlovid from Dr. on 11/19/2022
Noticed that the injection felt to be in the wrong place and hurt more than usual.  Have had pain in left arm, particularly elbow and shoulder, ever since.  Went to physician, who tried a round of prescription strength NSAID, but that did not help.  Physical Therapist diagnosed SIRVA.  Currently undergoing PT, but continue to have pain in left arm.
Fever, sore arm, headache for 2 days then 3 days later started having a chill symptom every evening from around 4 or 5 pm through the evening, feeling dizziness, for 2.5 weeks.  Symptoms stopped just 3 days before I was to take the 2nd doze on 03/25/2021.  Same symptoms started again within 24 hours and worse than after 1 shot.  Blurred vision, lost balance sometimes.  Still having symptoms few days a week.
Case number PHEH2012US019901, is an initial spontaneous report received from a physician on 04 Oct 2012 with a follow up information received on 25 Oct 2012. This report refers to a 75 year old male patient. His current condition included chronic lymphocytic leukemia. His vaccination history included unspecified vaccines which were tolerated well in the past. He was inadvertently vaccinated with MENVEO (batch number: A11064) at a dose of 0.5 ml intramuscularly on 03 Oct 2012. No adverse event was reported following administration error. Follow up information received on 25 Oct 2012: Patient demographics (height and weight), medical history, dose and route of MENVEO updated.
This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 17-APR-2015 the patient was vaccinated with (Merck) VARIVAX INJ, dose 1, subcutaneous (dose and lot # unspecified). On 21-APR-2015 the patient was again vaccinated with (Merck) VARIVAX INJ, dose 2, subcutaneous (dose and lot # unspecified). No medical history and concomitant medications were provided. It was reported that the dose administered on 17-APR-2015 and 21-APR-2015 was an inappropriate schedule of vaccine, as the doses of vaccine was spaced four days apart. No adverse experience was reported. The outcome of inappropriate schedule was unknown. The reporter considered inappropriate schedule of vaccine administered to be not related to the vaccine. Additional information has been requested.
The patient reported that he had an itchy rash on his hands and chest starting about a day after the first vaccine.  It lasted about 3-4 days after the shot.  He also reported having diarrhea.  He reported these reactions when he came for his second vaccine.  He said he did not require any medical care for the side effects.   He used over the counter Cortisone to help with the rash.
DEATH.  My sister took the vaccine on April 28th and DIED on May 3rd.
From telephone call on 08/13/02, it was reported that an 18 month old male patient was vaccinated on 08/09/02 with a Daptacel and a MMR vaccination. On 08/10/02, the patient developed a fever of 102f, along with pain and redness at the injection site (site not specified). Physician prescribed Tylenol and these symptoms resolved. The lot numbers are not available to provide. Case linked with reports U2002-00623 & u2002-00633. Follow up received on 11/14/02, it was reported that the pt did not have any illnesses, pre-existing conditions or allergies at time of vaccination. Pt was not on any other medications at time of vaccination. Pt's birth weight was 3880 grams lot number for MMR is 0528M. Pt's birthday was corrected to 11/1/00. The case is closed.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, concomitant medication and medical history were not reported. On 13-JUL-2018, the patient was vaccinated with improperly stored Oka/Merck VARIVAX)(lot # N034552, expiration date 05-DEC-2019) subcutaneously for prophylaxis (Product storage error), which was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine was exposed to temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This is one of two cases from the same reporter. Sender's comments: US-009507513-1807USA009599.
"Free" flu shot administered by pharmacist in January 2014. Very painful shot. Given very high up on my arm. Being a teacher (retired now) I've received numerous flu shots thru school and have never had any problems. Upper arm/shoulder became very painful when moved. Went to Dr. in March 2014, diagnosed it as "frozen shoulder" and ordered X-rays which did not indicate major concerns. Physical therapy followed from March 18 to June 16, 2014. Still had problems over ensuing months. Went to chiropractor for a couple of weeks. Some relief but still ongoing pain. Decided to try an orthopedic doctor in June 23 of 2015. Cortisone shot given in shoulder - physical therapy ordered from June 24 to August 14, 2015. Found the most relief - however - I now live with shoulder/upper arm pain frequently.