chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like they had the flu; Bedridden; This case was reported by a physician via call center representative and described the occurrence of influenza like illness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza like illness and bedridden. On an unknown date, the outcome of the influenza like illness and bedridden were unknown.   It was unknown if the reporter considered the influenza like illness and bedridden to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The Medical director reported that patients had side effects for a few days and they were in bed after receiving Shingrix.  It was about 2 to 3 patients that had to be in bed for 2 to 3 days because they felt like they had the flu. No additional details were available The reporter consented to follow up.
First day after vaccination - body ache, fever, chills, difficulty with balance; Second day vaccination -  fever and chills resolved, body aches and balance better, new development of rash.  Rash looked like a sun burn over her whole body except face, no bumps, not itchy.
The morning following my vaccine, I was unable to lift my arm. This has been ongoing daily for the last 2 weeks since taking the vaccine. I saw my orthopedic surgeon today 12/21/21, in case my shoulder ?injury? was unrelated to the vaccine. He took X-rays and said there were no impingements and the mechanics of my shoulder were fine & that the vaccine has probably caused inflammation in my shoulder which he can do nothing about.
Redness back of arm and redness at injection site with itching, mom gave Benadryl, cool compresses.
Storage and handling excursion- Patient was given a dose of pfizer vaccine past BUD time of 6 hours- with labeled expiration time of 3:00PM of 8/11/2021 dose was given at 6:33PM . No adverse event reported, no additional required.
Within first minute of shot, my heart rate increased &face felt warm and sensitive. Shortly after my throat started feeling fuzzy, tongue tingly, and lips and nadal area felt weird, but lips did not swell. I waited about 10&11 minutes to see if it would go away, but it got a little worse so I informed pharmacist. He sat down and talked with me, I let him know that my tongue did not feel rigid, but throat was fuzzy and while nasal area and lips felt odd/tingly that it wasn't as bad as my peanut butter allergy and that I could breathe through my nose. He gave me 2 benadryl and after about 30  more minutes, I felt like it was helping a little. I then left and that my face was still feeling a little sensitive, I was glad to get in my car and take mask off. There was a little itching in my ears at 3:43 when I left the parking lot, so then I took a zyrtec&pepcid that I had I'm my purse. It's 9:48p right now and my skin still feels a little sensitive on my face and back- like a slight sunburn or it itches mildly but can't discern between the two so maybe it's both.  I took a long nap and my throat feels much better.
Extreme lethargy, fever.  I was unsafe to drive, could not fully wake up.  Symptoms began at 9pm on Jan 14, exhausted went to sleep 3-4 hours early.  I slept through my alarm and did not wake until 1pm Jan 15.  Throughout Jan 15 I fell asleep several times, including while eating and showering.
Fever, chills, coughing, sore throat, difficulty breathing, nausea, and migraine.
This spontaneous report was received from the office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 06-FEB-2019 the patient was inadvertently administered M-M-R II (rHA) lot number R025335 and expiration date of 06-APR-2020 and lot number R001659 with expiration date of 17-JAN-2020 for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of 60°F for 60 minutes while the sterile water diluent did not undergo a temperature excursion. There was no previous temperature excursion. A "data logger" was involved.; Sender's Comments: US-009507513-1902USA011926: US-009507513-1902USA011925: US-009507513-1902USA007818: US-009507513-1902USA011927: US-009507513-1902USA011923:
Chills; Fever of 100.6; Body Aches; Headache; redness and swelling and soreness below the injection site Lasted about 24 hours No treatment taken
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Muscle tightness and soreness. Started in buttock area and thighs then moved into joints, shoulders and calves. Has lasted nearly 3 months and have been on prednisone for 2 months. They are doing test but haven't figured out what is going on
Information has been received from a a nurse practitioner concerning a male patient with no pertinent medical history or no know drug allergies, who on an unspecified date was subcutaneously vaccinated with 0.5 ml of the second dose of VARIVAX. There was no concomitant medication. At the time of the reporting the patient had titers low. Follow up has been received from the nurse practitioner who stated that the patient did not have illness at the time of vaccination. It was reported that the patient had negative titers after he received the VARIVAX series (lot number and time not reported). No adverse event was reported. Additional information has been requested.
Skin rash and itching since the administration of vaccine on 10-27-2015.
Patient was administered an improperly stored PNEUMOVAX 23; No additional adverse events; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # S029542 with expiration date of 10-JUN-2021 (strength, dose, route, frequency, and anatomical location were not provided) for prophylaxis.          combinationproductreport: Yes; brandname: PNEUMOVAX 23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
URINARY TRACT INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced urinary tract infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of urinary tract infection was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
They gave me the vaccine, an hour after I was feeling extremely dizzy with vertigo. I woke up at 4am the next day and I was very dizzy and hungry. I ate and went to sleep. I had a fever of 103. I had chills. my left side was numb. my fingers on my left hand felt swelled up and I could not bend them. I had a pounding headache. I took Tylenol. I had heat waves over my body. I went to bed that night and my hands and feet were cold. I could not move. I have nausea. I cannot keep anything down. I am still dizzy. I have been in bed for 3 days. I woke up fine today (2/16) but I have a fever of 102 again and I am still dizzy. I feel waves or a radiation of heat across my body. I have no sense of taste. I feel like I have a cotton mouth.  I am very itchy on the injection site. my stomach aches.
Expired PENTACEL was administered to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician and other health care professional via Global Medical Information (GMI) (Reference number- 00682124) and transmitted to Sanofi on 14-Jul-2021.  This case involved 4 month old female patient who administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE [PENTACEL] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); HEPATITIS B VACCINE and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) (reported as ROTOTECK) for prophylactic vaccination.  On 14-Jul-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ341AAA and expiry date: 22-jun-2021) (Frequency: one) (strength: standard) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered)  It was reported that, "RMA (Registered Medical Assistant) stated that she accidentally gave an expired Pentacel injection to a patient today because she looked at the Pentacel wrong. Caller asked what she should do".  It was an actual medication error case (expired vaccine used) (latency same day)  At time of reporting, no adverse event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
rash; fever; This non-serious case was reported by a physician via call center representative and described the occurrence of rash in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced rash (Verbatim: rash) and fever (Verbatim: fever). The outcome of the rash and fever were unknown.   It was unknown if the reporter considered the rash and fever to be related to Shingrix.     It was unknown if the company considered the rash and fever to be related to Shingrix.   Additional Information: GSK receipt date: 7-Aug-2023 and 8-Aug-2023 The physician reported that last year she had a couple of patients that experienced rash and fever after their first dose of Shingrix. The reporter stated that they never came back for the second dose.  No further details were available at the time of reporting.  The representative will call back in if further information was obtained. The Vaccine Administration Facility was the same as Primary Reporter. The representative will call back with any further details and will ask health care professional about permission for follow-up.  If updates received, they will update the safety team via email. The reporter did not consent to follow-up.
Day 1 1p- vaccination 5p- headache, lightheadedness, full body muscle pain, and extreme fatigue start 8p- rigors start  Day 2 -Finally fall asleep around 12am only to wake up from worsening at 1:44am -Fell back asleep around 2:30am and then woke up at 5am, which is approximately 30 minutes before my alarm -Headache, lightheadedness, full body muscle pain, extreme fatigue, and continue all day -Took a nap that lasted approximately an hour in the evening and went to bed around 8pm  Day 3 - Woke up at 7am - All of previous symptoms have resolved when I woke up at 7am; however, I now have lymphadenopathy in my right armpit. It?s very swollen and painful even when my arm is at rest on the side.
Started on his way home, had reddened eyes & trouble swallowing, mom had already given Albuterol when arrived at office. No difficulties swallowing just tingling in throat. We gave BENADRYL Sat was 99%. 15 min after BENADRYL started hives, heavy chest, roof of mouth red. EPI-PEN given & 911 called also gave 60 mg Prednisone - hives gone & patient feeling much better squad TT ED.
The patient was seen by his rheumatologist on 07/18/2001. At this time, his blood pressure was 158/80 mmHg; the heart rate was not noted. The rheumatologist prescribed celecoxib (Celebrex) as need for relief of an unspecified form of knee arthritis. The patient also received, per his request, the 1st injection of Lymerix. The patient was admitted to the hospital on 08/10/01, 23 days post-immunization, with hypotension, fever of 104 F, and 2nd degree atrioventricular block (NOS). An unspecified cardiac pacemaker was inserted. The patient was seen by the rheumatologist on 09/05/01. A Lyme disease ELISA antibody screen and Western Blot were performed. The second injection of Lymerix was administered. Subsequently, the Lyme Disease ELISA showed an index of 4.02; the Western Blot was "negative". On 09/22/01, 17 days following receipt of the 2nd injection of Lymerix, the patient suffered a witnessed sudden death at a service station. An autopsy was performed; results were not available as of 10/03/01. The most recent info received on 01/14/2002 provided the lot number of vaccine administered on 09/05/2001.
Swollen Lt deltoid, hot to the touch, red rash from injection site to elbow. Swelling from injection site to mid forearm. Fever of 101 orally. Pt c/o soreness in left arm.
This spontaneous report was received from a female consumer of unknown age reporting on herself. On 23-JUL-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot number and exp. date were not reported), 0.65 ml/once subcutaneous, for prevention. Concomitant medications were not reported. On 24-JUL-2013, patient experienced redness in area of ZOSTAVAX injection site. Patient reported no "blistering" and that the injection site "seemed to be getting lighter". Patient did not seek medical attention, and did not receive treatment for the adverse events. The outcome of experienced redness in area of ZOSTAVAX injection site and injection site seemed to be getting lighter was reported as recovering/resolving. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
Vertigo: extreme dizziness, room spinning, double vision started the morning after the vaccination. Went to ER. They did a CT and blood tests. Covid-19 test neg. First week extreme vertigo persisted. Saw my primary care physician. He suggested not to get the 2nd dose. 2nd week, some days are better, some days are worse. During bad flares I use a cane and sometimes hold on to another person as well.
Patient reported numbness in left arm/hand that spread to right side of the body over several days.  She also reported mild swelling of her face. She went to her primary care doctor who did not prescribe or provide any treatments but told her to monitor the situation and go to the emergency room if she experiences any difficulty breathing. She reported no issues breathing, and the numbness has lessened.
PREVNAR 13 was administered intramuscularly to right deltoid on 9/13. On 9/21 patient returned to pharmacy to report the adverse event. Course of events: Swelling, pain, erythema localized to injection site starting several hours following injection. Pt said that her arm was "swollen to the size of a grapefruit" by that evening. Also experienced fever and chills. Pt did seek medical attention which improved following a cortisone shot and oral prednisone. Upon presenting to pharmacy on 9/21, symptoms had resolved with the exception of mild erythema on her upper right arm which covered her shoulder and outer bicep. FLUZONE HD was coadministered at the same date/time as PREVNAR. FLUZONE HD was administed in the opposite deltoid relative to PREVNAR. FLUZONE HD was tolerated without incident.
during the administration of vaccine patient developed a wheal at the site on injection.  Pressure and message reduced the wheal.
Information has been received from a physician and a nurse concerning a male who on 26-JUN-2007 was vaccinated with his second SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 656177/0675U). Subsequently the patient developed a nodule and experienced local injection site pain and swelling after vaccination. Medical attention was sought via physician office visit on 10-JUL-2007. Lab diagnostic studies included a TB skin test. The patient was treated with sulfamethoxazole and trimethoprim (SEPTRA) 2 teaspoonfuls BID for 10 days. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Vaccine administered beyond Expiration date. However, per Moderna- all vaccines met viability requirements.  Completing VAERS.
Next morning, pain at injection site with redness and swelling. Symptoms remitted over the course of 2-3 weeks, A hard knot remains at the injection site under the skin.
pt presents with worsening dyspnea x 2-3 days; hx of COPD, on 5 L O2 via NC @ home; hx of MS, A Fib,CHF; positive for COVID; O2 sats 70s on BiPAP in EMS; c/o fever, diarrhea, myalgias, nausea; pt is septic; required intubation  and mechanical ventilation during her hospital stay; extubated and on BiPAP; condition worsened and she died in the hospital
Patient admitted  for dizziness, nausea and vomiting. Patient reports ear ringing
Weakness, diarrhea, headache, nausea/vomiting, body aches, sore arm. All happening for two days now.
(R) upper arm - Red and swollen measures 3 1/2" X 3".
Entire muscles weakness over 5 days, severe watery diarrhea for 6 days, headache, 101 deg F temperature for 3 days, constant feeling of vomiting, nausea, stomach cramps,
presented with syncope and covid, had no acute pulmonary findings, pts cardiac symptoms monitored and d/c home
She got her vaccine, she had a circle on her left cheek, it turned dark and inside was like little pimples.  She put on Neosporin on it, the skin kind of lifted and she picked at it, peeled away that portion of the skin/darkened spot.  Last week about a week ago had a lot of pimples near the hairline across her forehead like pin-drop pimples, down the side of her face, down the bridge of her nose, and were itching a bit this morning.   As she scratched the ones on her nose black scabbing stuff came off.  Her sister had the vaccine with similar pimples that had pus in them.  She put alcohol on it, some other kind of ointment to help it, but nothing has helped it.  She does have an appointment with her doctor unrelated to this but will mention it.  The skin feels rough.  Her mother also has similar reactions to her daughter that is reporting this.  They also have turned dark on the side of her face. She tried to do what she was supposed to do by getting the vaccine and bothers her that all of these pimples are in her face.
Brain fog; Swollen right side; fatigue; severe pain; A spontaneous report was received from a consumer, concerning a female patient of  age 60 years, who received Moderna's COVID-19 vaccine and experienced brain fog, swelling, fatigue and pain.   The patient reported having medical history of fibromyalgia and arthritis. Concomitant product use was not provided by the reporter.  On 17-JAN-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 039K20A) via unknown route for COVID-19 infection prophylaxis.   On 17-JAN-2021, after first dose of vaccine, the patient experienced brain fog, swelling, fatigue and pain. Patient  reported undergoing medication.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events, brain fog, swelling, fatigue and pain  was considered to be unknown at the time of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 28th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 28th July 2018, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left arm. The patient reported that the pain at the injection site lasted for approximately one month till 28th July 2018. The patient planned to follow up with her physician on an unknown date.
Client reported back to clinic with red swollen area on Lt. arm. States that she had shots yesterday and just wanted someone to check area. Arm warm to touch, red, denies any SOB or any other reactions. Informed client to seek medical help for any SOB or if.
Mother called clinic after 5 hours, post vax. Mother said child's face has some moderate rashes and was red all over face. Mother said no temperature and no other symptoms or reactions.
17days p/vax pt exp mild varicella w/approx 20 lesions, only 2 blistered.
Patient reported feeling dizzy, lightheaded, migraine like headache, numbness on the left side of the mouth, and mental fog, 10 min after receiving  the vaccine.  BP 145/100. Monitored patient for another 10min. Patient reported that the symptoms subsided prior to leaving. Patient was taken home by spouse.  Advised patient to report any other symptoms to primary health provider or report to ER if experienced any life-threatening symptoms.
My wife and I were in group event, she tested positive for COVID-19. I tested when I started to feel a little off with a home COVID-19, it came back positive. I went to the local corner "doctor", I started feeling better in a couple of days. I was testing negative then I got rebound COVID-19. I finally tested negative, it did take a long time for me to not be tired or congested in my chest.