chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever up to 99.5, severe headache, severe nausea at times, dizziness, bilateral ear pain, fatigue, muscle aches in thighs, joint pain in hips, knees and hands, some congestion.  Have had symptoms for past 36hrs and continue.  I believe they are starting to lessen.  Have been taking Tylenol, ibuprofen and Mucinex D  around the clock since the day of getting vaccine.
On April 3rd, I woke up with swelling and a ball in my left arm pit. It was warm to the touch and felt really sore. It took 5 days for the swelling and ball in my arm to improve. It is no longer sore. Also, on April 7th, I started to experience lower back soreness which lasted about 24 hours.
BUMPY RASH; This spontaneous case was received from a nurse on 16-May-2019. It describes a male consumer who had bumpy rash, after the administration of Vivotif for an unknown indication.  Case report: A consumer had bumpy rash, after the administration of the first and second dose of Vivotif. Later, the consumer took Benadryl (diphenhydramine) for treatment.  Action taken with Vivotif was unknown.  The consumer had recovered from the event.  Company's Comment: In this case, it was reported that the consumer had bumpy rash, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had bumpy rash, after the administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, rash is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Facial swelling started 8/26/16 approximately 1300 at school. School nurse gave BENADRYL then called parent. Positive eyelid edema. No throat swelling. No difficulty breathing.
Woke up with nausea. Severe body aches and muscle pains. Fever over 100 degrees F.
DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211104021-Covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
I got a positive pregnancy test on 07/22/21. I had my first ultrasound on 8/18/21 everything was good, baby had a heartbeat. At my second visit on 9/13/21 my baby no longer had a heartbeat. I started bleeding on 9/12/21 the process ended on 9/14/21.
20NOV97 evening irritable, no discernable fever noc-fitful sleep;21NOV97 morning irritable-no fever;around noon was breast feeding-began shaking all over-eyes rolled back in head lasted 5-7sec;mom called pt name x3 stopped shaking began fee
A couple hours after the shot I began to talk a lot.  I needed to talk so badly that the words began to be jumbled as I was speaking too fast.  I began texting and talking non-stop.  I was pacing the house and could not sit still.  My pupils did not dilate and my heart rate remained within normal limits. These effects kept me up late and kept me from getting tired.  I have Multiple Sclerosis, so this is unusual.  I finally was able to rest by self-medicating with marijuana at around 10pm that same night.  I still could feel the same effects the next day but much less severe.  This entire reaction was very strange and worrisome.  I realize that injection site soreness is common, but mine was especially severe.  This might be relevant considering the manic side effect that also occurred.  My left arm (at injection site) began to become sore around the same time that the manic effects started.  The pain was so intense that I could not use that arm at all.  It hurt to life the arm whatsoever and the pain radiated down my entire left side.  I even felt it in my left leg as I climbed the stairs.  This pain lessened over the course of the next four days until gone.
Woke up feeling very weak. when I did get up I walked to my kitchen and started feeling very nausea , dizzy and cold sweats. I quickly sat down until the dizziness went away. After this I sat in my chair all day drifting off to sleep many times. I also experienced cold chills thru out the day.
This spontaneous report was received from a Certified Medical Assistant (CMA), referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 13-JUN-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 intramuscularly (strength, dose and dose number were not reported), lot number M037669, expiration date 09-MAY-2018, for prophylaxis. There were not known adverse effects.
patient dxd with herpes zoster on 4/12/2021 visit with Dr  after having symptoms for 2 weeks.   1st Moderna 2/15/2021 2nd Moderna 3/15/2021 she now has post herpetic neuralgia.
I had my Shingrix vaccine yesterday, May 16, 2022 at 1:00 pm at the Health Department. Around 2:00 am I woke up with chills and shivering. I had that the rest of the night into the morning. When I got up and was in the kitchen I felt like I was going to pass out. The room got dark and it felt like the walls were closing in on me. I sat down and put my head between my knees until the feeling passed. I felt very weak, and ?wobbly? and continued to have chills and shivering. I couldn?t get warm. I also had body aches in every part of my body, joints, muscles, everywhere. I took some ibuprofen and wrapped up in a quilt and stayed on the couch for several hours. Around 12:30 in the afternoon I finally got warm. I?m not chilled anymore but continue to be achy. I do not have a fever. I checked my temperature around 8:00 am and it was 97.5 degrees.
High fever over 102 for 3 days, strange rash to back, cough, runny nose, major fatigue.
Patient states she had headache, diarrhea, tiredness, and sore arm for about 7 days post-vaccination.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 09-SEP-2014 the patient was administered with an expired dose of PNEUMOVAX 23 lot # J009827, expiration date 10-AUG-2014 (dose, dose number, route and anatomical location were unspecified). No adverse effect reported. No concomitant therapies were reported. The outcome of the event was unknown. Additional information has been requested.
Patient received a monovalent dose for their booster dose instead of the bivalent formulation.
Patient developed sinus pressure, drainage, malaise, for several days, followed by 3 days of laryngitis. She then developed a productive cough, chest pain and head pressure with cough, and disruption of sleep. OTC remedies did not help with symptoms, and she presented on day #8 of illness.
Individual states that her left arm was sore the night she received the vaccine and was fine until 3/4/2016 when she experience significant left shoulder pain. States that it is better during day, but can still notice. States that at night it is much worse. Explains that it has affected ROM, ADL, as well as difficulty with sleep. Has not consulted a provider. Has used ibuprofen and heat, with some relief.
itchiness; muscle hardness; discomfort at the site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itchiness), MYALGIA (muscle hardness) and INJECTION SITE DISCOMFORT (discomfort at the site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Multiple myeloma (Was in treatment for three years.). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchiness), MYALGIA (muscle hardness) and INJECTION SITE DISCOMFORT (discomfort at the site). At the time of the report, INJECTION SITE PRURITUS (itchiness), MYALGIA (muscle hardness) and INJECTION SITE DISCOMFORT (discomfort at the site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.
At 3pm i woke up very cold. I started to shiver. I added five blankets, put on a beanie, warm socks, turned on heater in my room and was still freezing. About an hour after that started to get muscle weakness. This was my second shot. Whats weird is that inhad covid in late January but i still had these side effects the second shot. First shot, no symptoms
Strong flu like symptoms.  Mild fever, chills, shivers, hot flashes, sweats, muscle aches, headache, nausea, fatigue,, much increases timitus,. Loss of appetite.  Started about 10 hours after second injection.  Lasted most of night.  Some symptoms, such as loss of appetite, headache, etc continued for 2 to 3 days.   Fatigue lasted 5-7 days.    Greatly increased tinitus partially subsided.  It is still much more than had prior to the second injection.
This is an initial spontaneous report by a contactable nurse via a sales representative. This is first of the six reports.  A patient (race/gender unknown) received a dose of PREVNAR13, administered on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Past product or vaccines given on the same day were unknown. On an unknown date, the patient experienced dark red, hard and raised swelling at the site of injection that did not require an emergency room or doctor visit. Relevant laboratory data was unknown. At the time of the report the clinical outcome of the events was unknown. Follow-up (05AUG2011): Follow-up attempts completed. No further information expected.
4/13/21 in the morning felt ok, afternoon felt both thighs were tight and crampy, later left thigh  feeling  moved to below knee. about 5 pm my legs felt weak and I had a difficult time to bend down/squat to oven, I could not get up unless I held on to something sturdy. I never had this before as day before I was able to bake and bend/squat down with no problem.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-SEP-2014 the patient was vaccinated with a dose of 0.5 ml RECOMBIVAX HB (strength and lot # unknown), injection, intramuscular. Other suspect therapies included PEDIARIX (strength, dose and route unknown) which was manufactured by GlaxoSmithKline, started on 18-SEP-2014. No adverse effected reported. Additional information has been requested.
This case was reported by a healthcare professional via sales representative and described the occurrence of wrong vaccine administered in a 18-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown given on 27 April 2012; varicella virus vaccine (non-gsk); Merck; unknown; unknown given on 27 April 2012. There were no concurrent medications. On 27 April 2012 at 14:00 the subject received 4th dose of KINRIX (.5 ml, unknown, right thigh) and experienced wrong vaccine administered. The subject was given KINRIX vaccine at 18 months of age instead of DTap and separate IPV. At the time of the report no adverse events were reported. Follow-up information was received on 09 May 2012 via consumer (subject's mother). The subject's medical history included ear tube. The mother reported that the subject developed cranky behavior and couldn't sleep at night about three to four days ago (05 May 2012) and then two days ago (07 May 2012) developed runny nose, drainage (nasal drainage (runny nose)), cough and thirst (like he cannot get enough to drink) so she took him to the physician office yesterday. The subject was prescribed BENADRYL and saline nose spray. At this time the mother was made aware at that the subject received KINRIX instead of a DTaP and Polio vaccine on 27 April 2012. The physician's office stated the subject "hasn't received those vaccines before so they were administered. It is unclear and the mother was not aware of what vaccines the subject had received in the past, but he has received some and she was under the assumption he was up-to date". She stated the subject received one vaccine in one leg and two shots in the other leg on 27 April 2012, but unsure as to which shots went where. At the time of reporting the outcome of the nasal drainage (runny nose), cough, fever and warm were unresolved; cranky behavior, unable to sleep, and thirst were unspecified.
Patient became very lightheaded 5- 10 minutes after receiving the vaccine and when he trued to let us know he fell on the ground. when the paramedics arrived and checked his vitals, his BP was 86/70. Before leaving the paramedics advised the patient  to get a ride home.
After. immunization arm felt a little sore to the touch  Felt fine thru the day  At 1230 am woke up shivering , freezing , burning up Fever  started at 101.6  (temporal thermometer)  Within 2 hours  temp up to 103.6 Vomiting , severe  body aches ,  diarrhea  Very sore at injection site  , unable to lay on left side due to extreme tenderness  Kept high temp  of 102-103.6  thru the day Unable to take Advil /Tylenol due to vomiting  Unable to keep any liquids down , dry heaves  Fever broke  within 24 hours
This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 31-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 744 hours, the lowest recorded temperature was 20 degrees F. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Lymerix injection on 9/11. Achiness particularly in legs within 24 hours. No treatment. By 9/17/01 muscles still just a little tender. Hunter wanted vaccination for prophylaxis.
I was feeling this scratchiness in my throat, and it was really sore. I also had this weird feeling that may be something like postnasal drip, but it had not really started yet. I took a COVID-19 Home Test, and it was negative. The next day I was feeling feverish and then by Friday I was not doing well, and I took another test, and it was positive. I called my healthcare provider, and they advised that I just continue with OTC medications to help with symptoms. I ended up having stuffiness, was blowing my nose and was sneezing and coughing. It was a productive cough, and I had a lot of mucus coming up. I did not lose my taste and smell, but they were muted so to speak. I was so fatigued and tired but I could not sleep. I did end up with a fever of 101.5 for about two days. I started feeling better after about four days but the cough lingered for a few weeks and that did make sleeping a challenge for quite some time.
dry mouth; aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth), PAIN (aches) and HEADACHE (headache) in a 37-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in 2021.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 28-Sep-2023, the patient experienced DRY MOUTH (dry mouth), PAIN (aches) and HEADACHE (headache). The patient was treated with IBUPROFEN (ANADVIL) at an unspecified dose and frequency. At the time of the report, DRY MOUTH (dry mouth), PAIN (aches) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       Concomitant medications were not reported. The patient did not experience any additional symptoms/events. There were no lab data/results available.
a joint transplant in my toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYTIGA, start date: Mar2021. The following information was reported: LIMB INJURY (medically significant), outcome "unknown", described as "a joint transplant in my toe". Therapeutic measures were taken as a result of limb injury.  Clinical course: Is the reporter's contact information available to you or a sub-contracted party reported as yes. Patient reported "I recently had a joint transplant in my toe. I have a titanium rod put in". Covid vaccine: Pfizer 2 shots & booster- Fall 2021. Patient did not provide any further details about the joint transplant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HIB vaccine outdated.  Exp 6/2008. Follow-up Information 15-OCT-2008: None/Vaccine was outdated/will repeat
4/28/2021   The patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  feels " swimmy - headed".   Assessment : Time of assessment 1421. Alert and oriented.   Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN. VS at 0221, BP- 127/79, P- 77, O2- 97%, water given,       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.       Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/28/2021  1:59 PM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8736   NDC: 59267-1000-2          Electronically signed by RN at 4/28/2021  2:40 PM  Immunization on 4/28/2021   Detailed Report  Note shared with patient
Initial report received from a health care professional in the USA on 03-August-2005. A 5 year old, female patient developed injection site inflammation after receiving Daptacel, lot number C2243AA, in the left thigh on 01-August-2005 (route of administration not reported). The patient also received IPOL, lot number Y0424-2 in the right thigh on the same day. At the left thigh site of the Daptacel injection, she had "golf ball sized redness, warmth, swelling and knot on the evening of vaccination." The reporter states that the office "routinely uses needles size 25 g 5/8." At the time of reporting, the patient did not recover. The case has the same reporting facility as cases 2005-01488; 2005-01497 and 2005-01498.
severe pain in the right foot; This severely affected their mobility; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm left, administration date 29Apr2021 10:00 (Lot number: EW0171) at the age of 36 years as dose 2, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was the pharmacy/drug store. The patient had no relevant medical history; the patient had no known allergies. There were no concomitant medications; the patient had not received any other medications within 2 weeks of vaccination. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (dose 1, single; Batch/Lot number: ER8731, location of injection: left arm), administration date: 08Apr2021, when the patient was 36 years old, for COVID-19 immunization, reaction: "left wrist then fingers, then entire left arm tingling, that moved to neck/jaw area, then entire right arm (lasted for about 2 hours after the shot in full affect)/tingled in face (still tingled in face some around 24 hours later on and off)." The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The following information was reported: PAIN IN EXTREMITY (disability) with onset 01Jun2021, outcome "not recovered," described as "severe pain in the right foot"; MOBILITY DECREASED (disability) with onset 01Jun2021, outcome "not recovered," described as "This severely affected their mobility." It was further reported that there was no immediate reaction. After about a month or 2, the patient developed severe pain in his right foot, especially when standing or walking on it; he still have this at the time of the report. That alone might not be interesting, but his wife developed the same thing about a month or 2 after her 2nd dose as well and still had that pain today. This severely affected their mobility and was very annoying to deal with. The patient had yet to move on his 3rd dose as he was worried it could make it worse than it already was or he would get pain in another area. The patient had not seen a doctor about this as he had not had the time to go and he was hoping it would just go away. The adverse event resulted in disability or permanent damage. Therapeutic measures were not taken as a result of pain in extremity, mobility decreased.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200157496 same reporter, product, and event; different patient
Fever, fussy, loss of appetite, just didn't act right, ears seemed to be bothering her 9/18/08-records received-office visit 3/11/05-C/O fever, evening prior. Fussy, decreased appetite. Right ear erythema. Right otitis media. Office visit 7/15/05-fever, viral exanthem. Office visit 3/25/06-ears pierced few days prior now C/O ears looking red and puff no pain. 1/26/2010 In my opinon, she has not. I've still got to take her every year or two, to see if her hearing loss is progressing. She still breaks out when eating certain processed foods, her eyes still get red with it occassionally.