chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme headache; pain in both ears; fever; chills; nausea; This is a spontaneous report from a contactable consumer.  A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 16Feb2021 at 16:00 (at the age of 53-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included psoriasis. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown) on 26Jan2021 at 16:00 in the right arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included an unspecified low dose blood pressure medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Feb2021 at 07:00, the patient experienced extreme headache, pain in both ears, fever, chills and nausea. The patient did not receive any treatment for the events. The clinical outcomes of the events headache, pain in both ears, fever, chills and nausea were reported as recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
At birth at Hospital patient began with Infamil formula and when perinatal insurance cut me off I was forced to use Similac Advanced, my son took ill with gastrointestinal diarrhea immediately. Health professional & Doctor were fully aware of this. Health professional threatened me she was fully aware of my C.P.S. history & would report me if patient wasn't brought in by 2-18-09 for his shots.
Lymerix booster given 06/25/02. On 06/26/02, the following symptoms begun; Fever, Headaches (several days), Sleepiness (few weeks), Dry mouth, constant sweating (couple of weeks), Dehydration (few weeks), Shakes (few weeks), total loss of balance (few times), dizziness while changing from a low position to a stand (four weeks), Muscle weakness (few weeks), Joint pain in elbows and hips begun about four weeks after (hips seem to be getting progressively worse), short term memory (lack of focus). Medical treatment begun 07/02/02 with the antibiotic Doxycycline.
I had severe COVID and was hospitalized on Dec 7,  I was in hospital (non ICU setting) for 5 days and had O2, remdisiver and dethemethzone IV.  I recovered fully, and have felt very good since mid January.  My reaction after my 1st dose of vaccine on Feb 25  started 20 hours after shot.  Worsened through the day and I got sicker at 24-36 hours, and then stayed in bed another day.  Symptoms were identical to my bout with COVID:  chills (no fever),  nausea, aches in joints and muscles, fatigue.  They were quite significant==I could not be out of bed.  As it went along I also developed the feeling in my chest like COVID--tough to take deep breath, chest hurt---but my O2 readings were fine.   Recovered after 48 hours, People who have had COVID should be aware that they will have a significant response to the vaccine on the 1st does.  I am questioning having a second dose I have not reported this to my doctor
small red bumps appeared on forearms (radius and ulna) were slightly itchy. Bumps not filled with fluid.
pt recvd vax & had acute onset of bilat leg weakness; could not support his own weight; weakness; on exam could not elevate legs against gravity; sxs of weakness;
20 min after vaccine, emp. c/o lightheadedness, tunnel vision, nausea, dizziness, report to supervisor and UWO- instructor who had employee lie down.  EMP. became shaky, clammy, diaphoretic, BP=140/80, P=120 T=98.6.  S/S continued X 4 hrs monitor by OR staff and doctor.  Drove self home later.  Symptoms gone in AM.  Took own BENADRYL.
Localized area on L arm surround injection site 6cm x 8cm raised hive that is warm to touch, raised, and itches.
GOT A BLOOD CLOT IN LEG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height and weight were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency one total, dose, 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 got a blood clot in their leg and our vaccine is not good to compare to mRNA Vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got a blood clot in leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210541027-COVID-19 VACCINE AD26.COV2.S-Got a Blood Clot in Leg. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
2 days after flu shot got joint pain in right elbow, fingers, knee and both sides of hip joint. And right toes.
Patient is a 4 month 12 day old male. Source of information on MD office visit of 9/26/07 was mother. Past medical history reviewed and found to be negative. Physical exam on 9/26/07 office visit was WNL.  12/28/07 Reviewed autopsy report which states COD SIDS.  Sleeping in adult bed, supine position & found unresponsive w/vomitus on face.  Findings at autopsy included: bilateral otitis media (culture neg), slight hepatomegaly & resolved SDH (probable birth trauma).
No tx given by parents. Rt arm at injection site red, tender, and painful to touch.
A couple days later child began with throat irritation on day 2, nausea on day 3, 4, 5, 6.  It is now day 7 and pt. still complains of nausea sensation although it may be subsiding.   On day 3, we took a flight for our family vacation and pt. had a couple of instances of light committing.  I SUSPECT PT. WAS GIVEN 20 MICROGRAMS RATHER THAN 10 MICROGRAMS.  I WILL NEED TO DOUBLE CHECK THE PAPERS WE WERE GIVEN AFTER ADMINISTRATION OF DOSE.  We are currently out of the country on vacation.
Lower back pain which says it is severe and interferes with daily activities; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain which says it is severe and interferes with daily activities) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced BACK PAIN (Lower back pain which says it is severe and interferes with daily activities). At the time of the report, BACK PAIN (Lower back pain which says it is severe and interferes with daily activities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medication included pain patch. The patient did not take any treatment medication.  she developed back pain which is severe enough that it interferes with her daily activities. The pain is worse after lying down for long hours and after seating for up to 15 minutes.   Reporter did not allow further contact
Temperature 99.3  F (unusual for the patient even when ill). Sore Arm. Chills, headache,
4:10 pm on 5/22/03, patients mother stated raised red area with itching instructed to apply qwarm compresses.  5/26/03 mother said patient fine
From the second week of the vaccine, I have felt asthmatic symptoms or swollen lymph nodes, confusing symptoms
Significant redness/rash to chest and back with itching, lips numb, dry mouth, itchy hands, "feels like I've been hit by a truck" 2 doses of Benadryl 25 mg IM administered at 11:42 am and at 12:19 pm.   3 hours later, patient still reports feeling like she'd been hit by a truck
2/5/02 onset of sores face scalp limbs. (one pustale) No URI, AGE,  fever ,sores pruritic, initial diagmosis-impetigo (one crusted) and place on Keflux 2/14/02 onset URI symptoms at same time, rash was improving, diagnosis; suspect new onset URI  2/15/02 phone call fever 101 F 2/16/02 office visit: temp 102.9, has new rash with some vesicles(total <50 lesions), new diagnosis: breakthru varicella with fever, URI 2/17/02URI better, no new lesions for two days 2/19/02 phone following: fever resolved, final diagnosis; probably breakthru varicella with new onset febrile URI
Information has been received from a Licensed Practical Nurse concerning an 88 years old female patient with drug allergic to aspirin and AVELOX and a medical history of shingles 48 years ago. The patient was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (lot # 664634/0742Y, Exp Date 23-NOV-2010) on 10-DEC-1999. There was no concomitant medication. On 09-JUL-2012 the patient experienced shingles which were red, swollen and painful in her right eye area. Patient sought medical attention via contacting physician. She was referred to an ophthalmologist for further evaluation. There was no lab diagnostics performed. The patient received treatment of VALTREX and DEPO-MEDROL. At the time of report, the outcome of shingles was reported as not recovered/not resolved. This is one of several reports received from the same source. Additional information is not expected.
itching all over/I am itching/My feet itch, my leg itch, my head itch, my arm itch, and my back itch; feeling like I am itching all over; feels a little sluggish; just getting little anxious; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: ER8730 and expiry date was not reported), via an unspecified route of administration, on 25Mar2021 at 02:00 PM, as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Mar2021 the patient experience itching all over and she feels a little sluggish. It was reported that the patient felt like she was having a bit of allergic reaction or something because she was itching. The patient reported that she did not had any redness at the site or anything, but she woke up last night about at 2 o'clock and even still this morning she felt like she was having a bit of allergic reaction or something because she was itching. Reportedly her feet, leg, head, arm and back itch. The patient reported that she was feeling like she was itching all over. The patient stated that she was just getting little anxious. In response to further probing, the patient queried can you tell me are these side effects from this? The patient did not understand what they were saying. It makes her itch; The patient was just getting little anxious because she can't understand what they were asking her. She needs to know how she should know about the side effects if these are normal or not. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
11/01/21 presents as a "transfer after admission on 10/22/21 for vasovagal syncope. He was also diagnosed with COVID on 10/21" "hx of HTN, DMII, high cholesterol, prostate cancer with radiation treatment"
Incident: Patient was given Monovalent vaccine on 9/28/22 after the CDC update recommendation to the Bivalent Booster dose.
DEATH; This spontaneous report received from consumer via company representative through social media concerned 2 patients of an unspecified age, sex, 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 (dose number series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose and, therapy dates were not reported, 01 total, for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  Reporter stated that, "My daughter knew two people who had the shots and got it and died. I guess if it is time for us to go nothing can stop it. But I did get the booster." On an unspecified date, the patient died from unknown cause. It was unspecified whether autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of event death was reported as fatal. This report was serious (Death).; Sender's Comments: V0: 20211227721-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
The first day I had an itchy throat and by the end of the day I started feeling a bit worse. The next day I woke with a pounding headache and a sore throat. I took Tylenol and DayQuil. The next day I felt a little better, the headache was gone but sore throat remained. The rest of the days following I had cough, mucus, and was achy. A week after having Covid-19 I was having shortness of breath that is sporadic but continuous today. I still have a cough as well that the doctor recently prescribed something for.
Pt states the day after receiving the Influenza & Pneumococcal vaciines his Rt shoulder started to hurt with stiffness & the pain/stiffness started to progress down into his hips & knees.  He has difficulty opening his Lt hand when he wakes up in the morning.  He states he has a little arthritis in the Lt shoulder & "spurs" here & there" but his physician is not able to find the cause of the joint problems.
18 y.o. was vaccinated with SPV, AVA and typhoid on 8/17/11. On 8/25 he reported with c/o fever (102), H&V, lethargy. Treated with MOTRIN and Phenergan. Temp spiked to 103.4 and he returned for IV fluid and more Phenergan. Spinal tap was done at this time. Early on 8/26 he was transferred to ED with temp of 104. Diagnosed with vial syndrome and discharged after treatment. Later the same day he was sent to a different ED for further work up and evaluation. He was admitted to r/o encephalitis vs meningitis. Admitted 8/26 with h/o of high fevers, vertigo, N&V, fatigue and more recent symptoms of HA and stiff neck. Received DECADRON and ROCEPHIN in ED prior to admission. Spinal tap was done as well. Labs and diagnostics included MRI, HSV, CMV, enterovirus, Epstein, adenovirus, smallpox PCR, Lyme, HIV and syphillis. Was on Acyclovir and Ceftriaxone while awaiting test results. Some nuchal rigidity especially to R, Kernig's and Brudzinski's elicited minimal pain, neuro exam otherwise negative. Symptoms greatly improved. Pt. d/c'd on 8/29/11 on Doxycycline. D/C diagnosis: lymphocytic meningitis.
Left arm edema and induration at site. Tx: Ibuprofen, Benadryl, and hot pads.
got the shot,/got the worst case of shingles/suspected vaccination failure; worst case of shingles/ little pox popping up; Nerve damage; little pox popping up; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, nerve damage and vesicular rash. On an unknown date, the outcome of the vaccination failure, shingles and vesicular rash were unknown and the outcome of the nerve damage was not recovered/not resolved.  It was unknown if the reporter considered the vaccination failure, shingles, nerve damage and vesicular rash to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the wife for his husband. The age at vaccination was not reported. Two years after vaccination, the patient got the worst case of shingles ever, now he had nerve damage. The patient after years still had little pox popping up on him. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were not provided.
Minutes after- Itching throat, felt like swelling, sneezing, increased blood pressure 1.5 hours after-  sweating and shaking, swollen arm, red and hot Next day- headache and nausea   Arm swelling, redness and hot, kept moving down and around my arm as days went on
This is in follow-up report(s) previously submitted on 5/14/2004. Information has been received through the manufacturer's pregnancy registry from a physician and a 27 year old female with no medical history and no known drug allergies who on 06/24/03, and 07/24/03 was vaccinated SC in the left thigh with a first and second dose of varicella virus vaccine live (Lot # 0726M and 643120/0505M) respectively. There was no concomitant medication. There were no varicella or herpes zoster symptoms post vaccination.  The pt was not vaccinated for immigration purposes. Subsequently, the pt developed a swollen area where the shot was given. It was also reported that on 07/29/03 the pt had a positive pregnancy test. The physician believes that the pt was about 4 weeks pregnant.  On 05/9/03 the pt was tested for varicella antibodies before vaccination and the results were negative. The pt's LMP was 06/20/03 and the EDD is  03/27/04.  Unspecified medical attention was sought. Until week 8, approximately 08/17/03 the pt took venlafaxine hydrochloride. No product quality complaint was involved. On 19-May-2004 it was reported that the patient was last seen in July 2003. She had moved out of state in late August 2003 and it was recommended that she schedule an initial pregnancy visit with an obstetrician before moving. No further information is expected.
inadvertently administered both Pentacel and Pediarix instead of the ACT-HIB and Pediarix; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of accidental overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included PENTACEL (batch number UJ844AB, expiry date 02-MAR-2024) for prophylaxis.   On 07-JUL-2023, the patient received Pediarix .5 ml and PENTACEL (intramuscular, right thigh). On 07-JUL-2023, an unknown time after receiving Pediarix, the patient experienced accidental overdose (Verbatim: inadvertently administered both Pentacel and Pediarix instead of the ACT-HIB and Pediarix). The outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-AUG-2023 The unsolicited valid non-serious case received from a Other Health Professional.  This case involved a patient who was inadvertently administered both Pentacel and Pediarix instead of the ACT-HIB and Pediarix with no reported adverse event and patient inadvertently received an extra dose of the dtap and ipv antigens with no reported adverse event.  The patient's past medical history, medical treatment, vaccination and family history were not provided.  The patient received 0.5 mL dose of suspect diphtheria/tetanus /5 hybrid AC vaccine via intramuscular route in the right thigh and unknown dose of suspect Pediarix not produced by Sanofi Pasteur (batch number, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination, inadvertently instead of the Acthib and Pediarix and received an extra dose of the dtap and ipv antigens with no reported adverse event (latency same day).  This suspected adverse reaction report was 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 2001183/EC and Module VI of the Good Pharmacovigilance Practices.  The classification as a medical error was 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 was to be held liable for the occurrence of this medication error,  The suspect Pentacel, dose, batch number and expiry date added and text updated accordingly. The patient received inadvertently Pentacel and Pediarix instead of the ACT-HIB and Pediarix, which led to accidental overdose.
pt was seen by well baby clinic; no URI; pt was started on Amoxicillin; @ the same time vax for pt were administered; on AM 26APR94 pt was brought to ER unresponsive; CPR unsuccessful
Information regarding Prevnar was received from a pediatrician, regarding a female pt, who is now 28 months old. The child received her first dose of Prevnar on 12/11/01 and at 7 months, received a second dose on 5/19/02. The child developed bacterial pneumococcal pneumonia with empyema and pneumococcal sepsis on 2/11/04. It was reported by a pediatrician that a 28 month old female pt, having received two doses of Prevnar on 12/11/01 and 5/19/02 respectively, was hospitalized on 2/11/04. The child was diagnosed with sepsis, pneumoniccal pneumonia with empyema, which had to be drained. On 2/11/04, a blood culture was obtained, which was positive for streptococcus pneumoniae. A bacterial culture was also obtained, which was positive for pneumococcal bacteria. The physician stated that the child, "is not a high risk pt and has no relevant previous medical history." As of 2/17/04, the pt remains hospitalized, and is being treated with cefuroxime with moderate improvement. Follow up on 03/22/04 states: "It has been determined that HQWYE151419FEB04 is a duplicate report of HQWYE150119FEB04. Therefore, the reports are being consolidated into HQWYE150119FEB04, which will remain the official case of record. No additional information was available at the time of this report."
Janssen Covid-19 Vaccine EUA.  Severe headache, muscle ache, fever, chills
June 1, 2022 , I tested positive for COVID-19 after fighting with congestion and other cold symptoms. I then isolated for 12-14 days as I continued to test myself. I treated myself with over-the-counter medications. I was very sick, but I never felt the need to go to the ER.
Patient came into the Pharmacy on 10/19/19 and said that her arm was still hurting after receiving the Prevnar on 9/30/19.  She stated that her right arm was very sore after 2 weeks and that it was painful to lift her arm.  She could move her arm around but that it was very sore and had been sore since receiving the Prevnar.  She also stated that it was getting better but wondered how much longer it would last.
Child had 6 month shots at 11:00am. There was no food given besides formula after shots. At 18:30 rapid rash developed over the baby. Starting on he lower back moving to the head and then down to the chest. No treatment was given per doctors on call order that night. 13 days later rash is still present.
She has had intermittent fatigue since receiving the vaccine, which is slowly improving. She had significant pain after receiving the vaccine which resolved in a day or two. She was unable to move the arm the evening after receiving the vaccine (feeling completely asleep), but has gained full strength. She continues to have paresthesias (like the arm feeling asleep or bugs crawling) to the forearm and her entire hand. She did take diphenhdyramine and isn't certain if it improved the paresthesias, but it did make her fall asleep. Two to three days ago (about 6 days after receiving the vaccine), she developed a cellulitis about 5 cm distal to the vaccine site without systemic symptoms for clinically apparent abscess.