chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initially dizziness, feeling faint, temperature raised. By 9:00pm (6 hours later), severe body aches  and stiffness set in, irritability, nausea. By 12:00am (3 hours later), temperature peak of 100.9, heavy sweating (soaking through clothes and hair), extreme body aches, inability to sleep, diarrhea, lump under skin along with heat and deep redness (unevenly shaped, diameter 2?) at injection site. Temperature and aches/stiffness slowly stabilized by 10pm on 06/05/2021; nausea, diarrhea, lightheadedness and dizziness also gone. Injection site redness and pain still persist as of time writing this report (12:30am 06/07/2021).
injection site throbs and hurts every day.  Intermittant pain but consistantly each day sunce 2nd shot
weakness, dizziness, LOC, loss of balance; unable to stand, sit or lay on lt side; only able on rt side w/eyes closed; has had vax in past;
Bell's Palsy. Left side of face became numb and I couldn't blink, smile or control muscles. I read reports of issues with Zostavax and Bell's Palsy and it left me to believe my Shingrix vaccine administered on March 23, 2020 and May 26, 2020 might be responsible. My physician prescribed Prednisone which I'm currently taking.
March 27, 2021.  Slight redness began. By April 1st, the outer upper arm of the injections was entirely red, hot to the touch and itching.  On April 1st, the throat began itching and swelling inside, which made speech difficult.  Pharmacist recommended OTC antihistamine.  It helped a little, but symptoms are still persisting as of April 4, 2021.  Arm is less red, but the throat is still itchy. The throat feels like the beginning of Shellfish allergy reaction, but not progressing to a worse state.
1 hr post vax MMR/Prohibit pt was choking and had hives;
Hospitalization for UTI, COVID, dehydration. Treated with barcitinib, dexamethasone, Remdesivir.
6 hrs after injection. headache, fever, 12 hours after injection , vomiting for 5 hours and high temp, stomach cramps and gas, belching and farting and unable to drink water without dry heaving. high temp until 36 hours after injection. Finally felt better but dizzy and coughing after 40 hours
Patient came to ED with complaints of worsening shortness of breath and confusion over the past week.  Patient was covid positive 6 weeks prior.  Patient admitted to the hospital with Covid pneumonia and positive covid test.
I received the injection about 9:30 AM on June 26.  About one hour later, as I was driving home, I stopped at the grocery store.  As I got out of the car, I felt dizzy and had trouble focusing my eyes.  I went on into the store and as I was shopping, this feeling would come and go.  After I got home I felt things spinning if I would close my eyes.  I called the doctor who told me to check my blood pressure and pulse and if not in the normal range that I should go to an urgent care clinic.  My husband took my BP and pulse when he got home and, by then, everything was beginning to get back to normal.  After approx. 8 hours the dizziness was pretty much gone.
Suspected vaccination failure; had 4 recent shingles outbreaks; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 4 recent shingles outbreaks). 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 and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 06-SEP-2023 The reporter asked was there any data on redosing Shingrex after someone had gotten 2 doses if they continue to had shingles outbreaks?  The patient who claimed to had gotten 2 doses of the shingles shot in 2019 but was unsure if it was Shingrex or Zostavax.  They have had 4 recent shingles outbreaks. Would additional doses of Shingrex help? All available information had been submitted to safety.  No further information available. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up.
My left palm ( the same side as I received inject Covid19 arm) appear 2 blood spots after I received Covid-19 vaccine 2~3 hours, one of blood spot disappear in 2nd day, remaining blood spot takes  ~10 days to disappear.  I visit my Doctor ( MD) who can' t make right answer but said it's skin rash, but which not skin rash as  exactly blood spots.  I asked to extend expert to review my case, then my Dr contact Infectious Disease specialist, allergy specialist and dermatologist, none of them give me the clear answer why and how to cause the blood spot.
Has not received the second dose; Body ache and pain; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th June 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 30th June 2021, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the general body pain was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: The patient received first dose of Shingrix vaccine and experienced body ache and pain. The patient stated that till this date she had not received the second dose. The patient was unsure if she will get the second dose. The patient gave medical disclaimer. Referred to HCP (Health Care Professional). Spoke per PI(Package insert) and content. The lot number was unavailable. The reporter consented to follow-up. Additional Supportive Information: The patient self-reported this case. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
Focal rash, Left leg by day 3 in definite L3 dermatomal distribution, ie shingles. No clinical history of prior case of varicella disease.
Second dose was given too soon in series. First dose given 9/19/23 and second dose given 10/12/23 (~23 days later). Patient has only reported redness at injection site, which lasted a few days, and soreness at injection site was reported to last >2 weeks post second injection. Report was recoded with GSK. Patient has been instructed to come back after 12/12/23 for a repeat dose of Shingrix per CDC guidelines.
Next day began heavy vaginal bleeding, abdominal cramping & pain. Was not normal menstrual cycle, occurred nearly 2 weeks prior to anticipated period.
Started with intense soreness in left deltoid progressing to  increased pain in left arm with flu like symptoms
I had my vaccination on 09/18/2022. On 01/25/2023 I started to get a sore on my toe. The anti-fungal cream was not working and the rash spread to both feet and tried an antibiotic which did not work.. I went to the dermatologist who diagnosed me with COVID-19 toes. I had had COVID-19 Positive in 06/2022. I have had weekly migraines with brain fog since this time but lessening over time. I was on Paxlovid during this time.
Chicken pox like rash at or near the injection site. Rash did heal up.
Insomnia, feeling fatigued and lack of energy all of the time, and periodic sickness or nausea to stomach. Cannot sleep more than 2 hours, awake.
Right upper arm was very warm with a moderate blotchy rash and slight itch. Treated with ibuprofen, diphenhydramine, and ice packs. Symptoms were gone after 48 hours.
Mild Headache, Pain in entire left arm (not at injection site), general weakness, mild diarrhea, mild flu like symptoms.  Symptoms began the day after the injection and lasted for 4-7 days.
Patient presented with hypoxia and tested positive for covid post vaccination.  Treatment: dexamethasone, supplemental oxygen
Diagnosed with intussusception 2 weeks ago. Received barium enema, which pushed food out.
1. metallic taste in mouth - 7 days 2. Arm sore at injection site - 4 days 3. Tongue felt swollen-2 days 4. Jaw felt locked--8 days 5. nauseous--20 days 6. diahrreah 2 days a week apart 7. Loose bowels--8 days 8 sharp pain in left ear--4 days 9. vomiting--2 days 10. extremem fatigue--21 days 11. stomach bloated severely--4 days 12. sever headache--8 days, even woke me at 3 am 2 times 13. joints and muscles ache--12 days 14. Chills--4 days; developed a week after the vaccine 15. Extremely stuffy nose and somewhat runny, felt like someone punched me in the face the first 4 days--28 days on and off 16. severe stiff neck--started stared day 14 of vaccine--5 days 17. dizzy and vertigo--started a week after the vaccine, lasted until the Epley Maneuveur done on March 16
Narrative:  It was reported that rash appeared in small area within hours after vaccination and spread slowly that evening. By the next day, rash was all over the entire body including face, back, upper and lower body. Rash reported as red, itchy, raised with rough texture. Rash was treated with diphenhydramine oral tabs and topical cream for 1 week. Rash completely resolved after 1 week of treatment. No additional appearance of rash.
This spontaneous report as received from a licensed practical nurse refers to a 20 year old patient. On 03-AUG-2009, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported) and on 28-MAY-2014, the patient received the second dose of GARDASIL (dose, route and lot # not reported). No adverse symptoms were reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 4 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 01-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
became very lethargic; developed an intense headache; kept taking deep breaths while holding her chest, saying it felt tight.; having a hard time getting a good breath; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Nov2021 09:30 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Connective tissue disease" (unspecified if ongoing); "repaired heart VSD/ASD" (unspecified if ongoing); "repaired heart VSD/ASD" (unspecified if ongoing); "Unruptured brain aneurysm" (unspecified if ongoing); "angioid streaks in right eye" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; FLUARIX QUADRIVALENT, administration date 10Nov2021. The following information was reported: DYSPNOEA (medically significant) with onset 23Nov2021, outcome "recovered" (Nov2021), described as "having a hard time getting a good breath"; LETHARGY (medically significant) with onset 23Nov2021 10:00, outcome "recovered" (Nov2021), described as "became very lethargic"; HEADACHE (medically significant) with onset 23Nov2021 10:00, outcome "recovered" (Nov2021), described as "developed an intense headache"; CHEST DISCOMFORT (medically significant) with onset 23Nov2021 10:00, outcome "recovered" (Nov2021), described as "kept taking deep breaths while holding her chest, saying it felt tight.". The events "having a hard time getting a good breath", "became very lethargic", "developed an intense headache" and "kept taking deep breaths while holding her chest, saying it felt tight" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dyspnoea, lethargy, headache, chest discomfort and included diphenhydramine hcl (BENADRYL). The clinical course was described as follows: The patient waited the 15 minutes required at the hospital after receiving the COVID vaccine. Then left to go shopping at a store within a close distance and within 10 minutes she was having a hard time getting a good breath. She became very lethargic and developed an intense headache. She kept taking deep breaths while holding her chest, saying it felt tight.
Patient is fully vaccinated and boosted on 9/1/2021.  COVID + test on 11/26/2021.  ED visit on 11/29/2021. 74-year-old female history of chronic leukemia. Patient is covid + since 3 days ago. Her symptoms started 5 days ago. She states that her only symptom is persistent nonproductive cough. She is being treated with Mucinex, albuterol inhaler, Tessalon capsules by her PCP. She states that she is concerned that there may be something else going on so she wanted to come to the emergency department. She is not hypoxic on arrival. She is on room air. Denies any fevers, chest pain, nausea, vomiting, diarrhea, body aches, or extremity swelling, history of PE or DVT. BP 148/64  | Pulse 98  | Temp 98.3 °F (36.8 °C) (Oral)  | Resp 16  | LMP  (LMP Unknown)  | SpO2 93% There is no signs of serious bacterial infection, sepsis, meningitis.  The patient is encouraged to use antipyretics, drink plenty of fluids and rest.  She is instructed to follow up with their doctor or outpatient clinic is not improving.  If she has any concerns regarding their condition, or if she feels that they are getting worse, she is to return to the emergency department
After receiving my booster vaccine, I started to have all of the symptoms of COVID 19 - congestion throughout my chest to my head, a slamming headache, brain fog, and notable, loss of taste!
A report has been received from a Study Investigator concerning a 37 year old, female subject, height: 5.7 inches; weight: 106.0 pounds, enrolled in a study. FLUMIST QUADRIVALENT (intranasal) started on 08-Oct-2013. The patient experienced pregnancy which started on 31-Jul-2013. The patient recovered from the event of pregnancy. The outcome of the pregnancy was reported to be a healthy baby born. The report was considered to be non-serious. The investigator considered that there was no causal relationship between pregnancy and FLUMIST QUADRIVALENT.
This spontaneous report was received from a licensed vocational nurse referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions, or concomitant medications. On unspecified dates, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (lot number M036059, expiration date 03-JUN-2019) for prophylaxis (dose and route of administration were not reported). The administered doses of the vaccine experienced a temperature excursion 57 degrees Farenheit for 15 minutes. A previous temperature excursion of 48 degrees Farenheit for 15 minutes was also reported. The temperature excursion were recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports from the same reported (MARRS No. 1704USA001638, 1704USA001639 and 1704USA001640). Additional information has been requested. Sender's Comments: US-009507513-1704USA001638: US-009507513-1704USA001639: US-009507513-1704USA001640.
Pt experienced hives on arms, legs and trunk of body. Extreme itching. Pt first treated with Famotidine 20mg and Methylprednisolone 4mg dose pack on 9/30/13. No relief so therapy changed to Prednisone 20mg and Cetirizine 10mg tablets.
Injected a subtherapeutic dose of 0.3ml instead of 0.5ml.  No other problems or adverse events
24 hours post vax, the pt developed pruritus, swelling, and redness at injection site. 27 hours post vax, the pt developed a rash on chest, lightheaded, and nauseous.
Information has been received from a licensed practical nurse (LPN), concerning a 30 month old female child, who on 17-NOV-1997 was vaccinated with a dose of Pneumovax 23 (Lot #620350/0993E). Concomitant therapy included influenza virus vaccine (manufacturer unspecified). The nurse reported that subsequently (duration onset not specified), the child "became paralyzed and could not walk," and also had a fever (temperature not Specified). the nurse stated the patient recovered from the events in one week. The patient sought unspecified medical attention. Upon internal review, the event of "became paralyzed and could not walk," was considered to be an serious as an other significant medical event. Additional information has been requested.
Upon review, booster given at 4.5 months instead of the approved 6 month interval. Pt tolerated booster well and left after 15 minutes.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an expired dose of ZOSTAVAX 19500 PFU (dose, lot number and route were not reported) (expiration date: January 2013). Concomitant medications were not provided. Additional information has been requested.
Increased redness at flu vaccine injection site. F/U vaccine given x 2 days ago. Hurts when you push on it and states hurts to walk on L. leg. Skin normal except 4" round, erythema flat slightly warm to touch localized inflammatory reaction.
Patient rec'd vaccine in clinic office. As we were leaving tx room, pt told mother she did not feel well. We sat down in pt waiting area. Mother then witnessed pt turned pale & fall over side of chair (passed out). Pt recovered (woke up) w/in 60 sec & complained she could "not think" felt like bubbles in her head & vision was "black". Mother called for assistance. Pt was pale, clammy, sweaty. Pt did not really remember where she was or what had happened corpsman then helped mother transport pt back to clinic tx area where pt was placed in recliner chair and Pulse ox & BP were monitored. Initial O2 sats mid 90's BP OK, HR increased. Continued to monitor pt for next 45 minutes. Color returned w/in 15 min of incident. Pt was released to mothers call 45 min after vaccination - all vitals were normal. Pt continued to be very "foggy" in her head all day - she was profoundly tired & complained of ringing in ears. Pt was fully recovered the following day.
headache; fever; chills; muscle soreness; weakness; This is a spontaneous report from a contactable nurse (patient) response for herself in HCP letter sent. A 52-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9261, Expiry date: May2021) via intramuscular route in right arm on 26Jan2021 at 11:30 as single dose for covid-19 immunization. Family medical history included all 4 household family members positive covid 18Dec2020 to 20Dec2020. The patients ,medical history included positive covid test. Historical vaccine included dose 1 of BNT162B2 (COMIRNATY) vaccine. On 26Jan2021 at 22:00 (approximately 11 hours after vaccination), the patient experienced headache, fever, chills, muscle soreness, weakness. The patient did not receive any treatment for the events. The adverse events did not require a visit to emergency room or physicians office. The clinical outcome of the events headache, fever, chills, muscle soreness, weakness was recovered. The patient reported that there was a causal relationship between the events and the suspect.
pt comes to ED and states he was diagnosed positive for COVID 2 days ago; presents to ED with increasing SOB, fever, chills, hypoxic, placed on 3 L O2 via NC; COVID test is positive; pt is hyperglycemic; received insulin, steroids, antibiotics, remdisivir, thromboembolic prophylaxis; eventually switched to BiPAP; mental status worsened; MRI of brain shows widespread, extensive acute infarctions; his condition worsened and he eventually passed away in the hospital
This spontaneous report was received from a Nurse Practitioner regarding a patient of unknown age. There was no information about concurrent condition and historical medication. On 15-AUG-2016, 16-AUG-2016, 17-AUG-2016, 18-AUG-2016, and 19-AUG-2016, the patient was vaccinated with improperly stored VARIVAX, lot# L048464, expiration date - 02-DEC-2016, lot# L035129, expiration date - 14-SEP-2017, lot no. M040181, expiration date - 01-MAR-2018 (incorrect product storage). No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was developed. This is one of several reports received from the same reporter. Additional information has been requested.
Full body rash that was very itchy; Fever; Chills; Headache; Body ache; Nausea; Loss of appetite; Severe pain in left arm at injection site, causing inability to raise arm for 2 days; Severe pain in left arm at injection site, causing inability to raise arm for 2 days; This is a spontaneous report from a non-contactable consumer, the patient. A 63-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to non-steroidal anti-inflammatory drugs (NSAIDs).  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration on 23Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient also previously received amoxicillin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 13Apr2021 (reported as 4 to 48 hours post vaccine), the patient experienced fever, chills, headache, body ache, nausea and loss of appetite. The patient also experienced severe pain in left arm at injection site, causing inability to raise arm for 2 days. On 15Apr2021, 2 days post vaccine, the patient experienced full body rash that was very itchy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events full body rash that was very itchy, fever, chills, headache, body ache, nausea, loss of appetite and severe pain in left arm at injection site, causing inability to raise arm for 2 days was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.