chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vesicular outbreak, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2013 and 2015, the patient was treated for severe vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Systemic: Patient developed shingles after getting shingrix vaccine-Medium, Additional Details: pt reported he wanted report done.  he got shingles from the shingrix vaccine. told him i would do report so there can be a record of it
Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder pain). At the time of the report, ARTHRALGIA (Shoulder pain) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Localized itching and erythema at the site of injection with onset of hives on the upper arm spreading downward.
Patient was in his usual state of health until 9/25/20, at which time he developed rapid onset weakness and numbness in all extremities limiting his ability to ambulate. He reportedly had received the flu shot several days prior on 9/15/20. The weakness was in an ascending  pattern, with weakness greater in his lower extremities than his upper extremities. His respiratory status worsened on 9/28, requiring intubation.
4/1/08 had slight headache day of vac. 4/2/08 felt well, 4/3/08 awoke w/ red eye and irritation around eye. Appt w/ PCP DX sinus infection-- was given antibiotic oral and oint for eye.  4/6/08 symptoms worse--went to ER w/ DX shingles. ER MD gave Rx Valtrex.  4/7/08 appt w/ ophthalmologist eye OK, but Rx Valtrex.  4/10/08 SX much better, no PHN.
Raised red rash to right thigh.  Low grade fever & soreness to injection site March 1-3; Noticed rash to thigh March 6.
Pt vaccinated w/DTP/OPV 30mins after shot, pt appeared to "pass out". Was limp & unresponsive, no apnea, bradycardia associated, had good peripheral perfusion. Pt recovered within 20-30min.
receiving the second shot after 13 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving the second shot after 13 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving the second shot after 13 days). On 25-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving the second shot after 13 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient reported no adverse events after the dose administration.
Also received Shingrix First Series Left Deltoid IM Lot# 7SK92. Didn't feel good about an hour after immunization.  Felt bad all day and the next morning (09-25-20)   had diarrhea starting around 6:30AM.  Contines to feel week and tired. Told to stay home and symptoms should resolve by Monday (09-28-2020).
Patient came to ED for neck pain from a recent but previous MVA. Patient was tested for COVID while in ED. Not sure why except high incidence in community at this time.
Patient developred right arm pain and swelling within hours after vaccine. She then developed severe headaches, felt warm to the touch, chills, body aches. On 01/13/22 she fell due to loss of conciousness (syncopal episode) lasting approx 15 seconds.
Beginning 7/19/21, had new Fever, cough, sore throat, chills, muscle aches, headache with no known exposure. Tested positive for COVID-19 by PCR on 7/21/21.  Received Pfizer vaccines on 12/23/20, 1/13/21
This spontaneous retrospective pregnancy report as received from a nurse practitioner refers to an approximately 16 year old female patient. No medical history and current conditions were reported. On 03-FEB-2015 patient was given an unspecified pregnancy test which came back negative. On 03-FEB-2015 (reported as on the same visit) the patient was vaccinated with first dose of GARDASIL (lot # J012212, expiry: 18-FEB-2016) (dosing regimen and frequency unknown). It was also reported the product was confirmed as GARDASIL and not GARDASIL 9. No concomitant medications were reported. On 25-FEB-2015, the patient came back to office due to lack of menstrual period and suspicion of pregnancy and the patient underwent another unspecified pregnancy test which came back positive. The nurse reported that at that time it had been 6 weeks since the patient's last menstrual period. The patient became pregnant with Last Menstrual Period of 14-JAN-2015 and Estimated Date of Delivery of 21-OCT-2015. The date of conception was 28-JAN-2015. Nurse practitioner reported that the patient was then seen at an unspecified medical center on 01-APR-2015 due to miscarriage, where an outpatient Uterine dilation and curettage was performed. It was reported that the patient sought medical attention. The action taken with the therapy with GARDASIL was unknown. The outcome of the events was unknown. The reporter causality was not provided. No product quality complaint was involved. Additional information has been requested.
Pt developed rash and hives from ZOSTAVAX injection. Also had heaviness of lips within 20 minutes of injection.
muscle in her body was constricting; Thought was suffering aneurism and was going to die; shivering; no energy; no appetite; sweating; Awoke at 2am, at 5:30am; arm was sore at the injection site; Couldnt put hand on bed, feet on floor it was so bad; This non-serious 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 Herpes zoster (Shingrix) for prophylaxis.   On 14-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 14-MAR-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: arm was sore at the injection site). On 15-MAR-2023, the patient experienced muscle contracture (Verbatim: muscle in her body was constricting), impending doom (Verbatim: Thought was suffering aneurism and was going to die), shivering (Verbatim: shivering), loss of energy (Verbatim: no energy), appetite absent (Verbatim: no appetite), sweating (Verbatim: sweating) and sleep disorder (Verbatim: Awoke at 2am, at 5:30am). In MAR-2023, the patient experienced mobility decreased (Verbatim: Couldnt put hand on bed, feet on floor it was so bad). On 15-MAR-2023, the outcome of the muscle contracture was recovered/resolved (duration 2 hrs). The outcome of the injection site pain, shivering, loss of energy, appetite absent and sweating were recovered/resolved and the outcome of the impending doom, sleep disorder and mobility decreased were not reported.   It was unknown if the reporter considered the injection site pain, muscle contracture, impending doom, shivering, loss of energy, appetite absent, sweating, sleep disorder and mobility decreased to be related to Shingrix.     It was unknown if the company considered the injection site pain, muscle contracture, impending doom, shivering, loss of energy, appetite absent, sweating, sleep disorder and mobility decreased to be related to Shingrix.   Additional Information: GSK receipt date: 16-Mar-2023 The patient had received her second Shingrix vaccine and reported that her arm was sore at the injection site right after she received the Shingrix vaccine.  The patient went to bed that night a awoke at 2 am and reported every muscle in her body was constricting for about 2 hours.  During that time, the patient thought she was suffering and aneurism and was going to die.  The patient reported that she could not even put her hand on the bed or feet on the floor it was so bad and went back to sleep and got up at 5:30 am to use the bathroom and she noticed she was shivering and went back to bed.  The shivering resolved that morning, but she had no energy to do anything.  The patient also reported that no appetite, but she did drink water all day.  On day before the reporting, last night, she again awoke at 2 am and her sheets, nightgown and especially her pillows were really wet from her sweating.  The patient did not gave permission to contact her health care professional since she did not contact her.  The patient would be glad to answer any questions on her experiences, email provided. The reporter did not consent to follow-up.
30 minutes after the shot he woke up from his nap with the high pitch screaming, he would not let me console him, his lips were pale and it lasted for more than an hour.
Arm swelled at injection site, felt numb and patient was dizzy and not feeling well.
Throat swelling; Difficulty swallowing; Nausea; Dizzy; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration on 06Mar2021 (at an age of 39-years-old) as single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of known allergies (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within 2 weeks of vaccination. On 06Mar2021, the patient had experienced throat swelling, difficulty swallowing, nausea and dizzy. The patient did not receive any treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events throat swelling, difficulty swallowing, nausea and dizzy were resolved on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
Chest pain, from time to time difficulty breathing , from time to time pain the heart area every 30 sec.
Flu vaccine 11/19/11 - 11/26/11 hives on buttocks - resolved in 2d. History: 11/17/04 flu -> 11/22/05 hives. 10/9/07 flu -> 10/16/07 hives. 10/17/08 flu - 10/24/08 hives.
Information has been received from a registered nurse concerning a 12 week old female with a history of diarrhea the morning prior to vaccination (patient's mother mentioned) who on 25-JAN-2008 was vaccinated PO with her first dose of Rotateq. On that same day, the patient experienced diarrhea. The patient was brought in for a check-up on 31-JAN-2008 and still had diarrhea (about 10 times per day) and on 03-FEB-2008 the diarrhea was down to about 4 times a day. The office had not seen the baby since her last visit. The nurse also mentioned that the patient did not have any fever, blood in the stool or vomiting. There was no product quality complaint. Additional information has been requested.
Fever within 12 hours, sore and ach within 24-36 hours.
Information has been received from a physician via company representative concerning a 12 month old male patient, with no past medical history or allergies, who on March 7, 2003 at 09:00 was vaccinated with a first dose of MMR II (lot # 63963/1201M) SC into the left arm. Concomitant therapy included varicella virus vaccine live (lot #643822/0866M), a third dose of Streptococcus pneumonia vaccine (Prevnar) (lot # 485-985) IM into the left thigh and fourth dose of HIB conjugate vaccine (ActHIB) (lot # UB431AB) IM into the right thigh. There was no reported illness at the time of vaccination. On approximately Mar 07, 2003 the patient broke out in a rash all over his body and was suffering from a fever. Unspecified medical attention was sought. Follow up information has been received from a physician which indicated that the patient developed a macular papular rash on the chest, face, and back and also developed occipital adenopathy. There were no diagnostic teste performed. The reported indicated that the patient recovered on Mar 22, 2003. Additional information is not expected. It was reported that "five other children" had similar experiences.
Woke up with headache, left arm very painful to move-swollen, red, hot to touch, lump, itchy rash which grew in size to next day to about 5 inch diameter  fever 101.8 severe body aches upset stomach back kidney pains, kidney stone pains tarted 2 days after vaccine as of today, 3/1/21 kidney pain is gone and arm rash is much smaller and not as itchy
I experienced extreme joint pain, and fatigue for 2 days following the vaccine before I recovered. One month later I noticed a ringing in my ears that did not abate. I have seen my doctor and am being monitored, but not diagnosis or treatment has been recommended. It's most noticeable when I lay down. The ringing in my ears is still lingering, which has affected my health anxiety.
Dizziness, headache, nausea, muscle aches, shivering, weakness, leg shaking while standing, possible fever. Did not take temperature do to weakness.
Pfizer-BioNTech COVID-19 Vaccine EUA lethargy, pain at the injection site (began several hours after injection), congestion
9pm hives, general allergy, cough progressing to difficulty breathing. To E.R.-IV Benadryl and steroids. D.C with Prednisone decreasing dose pack.
High fever, weakness, chills, nauseous. Started at 10am. Was hyperventilating trying to vomit but couldn't took Pepto-Bismol.  Fell asleep about 3pm woke up at 630pm soaked from fever breaking. took temperature then was 101.7. Still have fever of 100.7 at 10am 3.7.21
Covid rebound/Treatment of COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid rebound/Treatment of COVID-19) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: keflex and Penicillin. Past adverse reactions to the above products included Allergy with Penicillin and keflex. Concurrent medical conditions included Ventricular tachycardia, Prediabetes and Obesity.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022, the patient experienced COVID-19 (Covid rebound/Treatment of COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid rebound/Treatment of COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient's historical drug mentioned as sulfas, had reaction of allergy with sulfas.  No concomitant medications were reported.  It was reported that patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The event reported was Covid rebound with Device Date as 26-May-2022.  Company Comment: This is a Spontaneous case concerning a 44-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 2 months after a dose of mRNA-1273 vaccine. Patient completed 5 days treatment with nirmatrelvir, ritonavir (Paxlovid) for COVID-19. 5 days after treatment finished, COVID-19 started again. No information about diagnostic tests was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 44-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 2 months after a dose of mRNA-1273 vaccine. Patient completed 5 days treatment with nirmatrelvir, ritonavir (Paxlovid) for COVID-19. 5 days after treatment finished, COVID-19 started again. No information about diagnostic tests was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Initial report received from a health care professional on 03 Dec 2009: This 3 year old patient was vaccinated with FLUVIRIN (batch no.: 102136P1) on 03 Dec 2009 inadvertently. No adverse event was reported.
This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. Medical history and drug allergies were not reported. On 22-OCT-2013, the patient was vaccinated with RECOMBIVAX HB lot # H012250, expiration date 06-FEB-2015 (concentration, dose and indication were not reported) that was exposed to three low temperature excursions of 28F for 24 hours, 31F for 24 hours and 30F for 96 hours. No adverse effect has been observed or reported. This is one of several reports from the same source. Additional information is not expected.
hypotonic, hyporesponsive 10-15 mins p/shot; stimulated & responsive p/; no apnea, HR nl, no fever; adm to ICU;
Itchy rash/welts on same arm vaccinated, otherwise fine.  Gave 25 mg liquid Benadryl.  Slightly better 20min later and so pt went home.
Diagnosed with Bell?s Palsey. Right side of face drooped and right eyelid was unable to close with blurred vision. Speech  was also slurred. A speech pathologist prescribed facial muscle stretches. An optometrist prescribed eye ointments, goggles, eyelid cleaners, and eye lubricants.  As of October he has regained facial muscle movement and is able to close the affected eye although not at 100%.
Fatigue, whole body muscle weakness, dizziness, nausea, chills, sweats, tinnitus
Extreme (not mild) muscular aching; Headache; Nausea; Fever (101-102)
TEMP 105 F, (axillary), episode where eyes keep moving side to side for approx. 10 min. Pt alert during this. Temp in the office 101.6 F 1 day post vaccination
medication error due to administering DAPTACEL twice in two consecutive days with no reported adverse event; Initial information received on 13-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old male patient who experienced medication error due to administering daptacel twice in two consecutive days with no reported adverse event while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 07-Apr-2022, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5774CA, C5829BA via intramuscular route in unknown administration site for Immunisation.  On 08-APR-2022 the patient developed a non-serious medication error due to administering daptacel twice in two consecutive days with no reported adverse event (vaccination error) 1 day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (medication error due to administering DAPTACEL twice in two consecutive days with no reported adverse event).  At time of reporting, the outcome was Unknown for the event (medication error due to administering daptacel twice in two consecutive days with no reported 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.
Pt recvd 1st dose of Hep B vax w/no noted problem; Pt recvd 2nd dose of vax 18AUG92 & w/in an hr following vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; no further details were provided;
After second shot, congestion and wheezing (2-3 weeks after). After 4th shot uncontrolled screaming for hours, eyesight seemed off, legs would turn purple and puffy, development delay started, stopped using left hand. After 6th shot started infantile spasms and seizures. A follow up report received 11/30/2001 adds: After the 4-month vaccinations on 3/12/1996, the pt's mother first noted the developmental delays (poor eye focus, left arm weakness, loss of use of left hand). She states there is a note in her daughter's medical record that the doctor's office noted developmental delays between 3-4 months of age, but these delays are not specified. At the time of the 6-month vaccinations, the child was being treated with antibiotics for otitis media. After these vaccinations, the child began to exhibit almost constant "jerking" movements. These continued for about 2 months. They were later diagnosed as infantile spasms. By 1 year of age, the child began experiencing "grand mal" seizures for which she was hospitalized and medicated with Ativan. The seizure episodes were 2-4 hours in duration. Mother describes child as "turning blue" prior to these seizures. After the 18-month vaccinations, including DPT, the child's seizures again became very difficult to control and several different anti-epileptics were tried in various doses. At age 1 1/2, child had normal vocabulary, but by age 3, she stopped using speech to communicate. In Oct 2000, the child underwent right brain surgery. Portions of the brain were excised and a stimulator was placed in the brain. Pre-op EEG showed all lobes of brain demonstrated "focal seizures". Currently, seizures are generally well controlled, but the child has exacerbations whenever she is ill with an infection such as chronic sinusitis. Child continues to become cyanotic at onset of seizures. At one point sinus surgery was performed, but the effects were temporary. All allergy tests have been negative to date. Pt's eyesight is so poor that she is classified as legally blind.
Continuous itching & rash from neck to stomach  Could not sleep whole night.  Also itching & rashes other parts of body.  Going to see my doctor in the afternoon.