chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VARICELLA-ZOSTER VIRUS MENINGITIS (VESICULAR SKIN LESIONS ON RIGHT LEG, HEADACHE, ACHES AND FEVER); VARICELLA-ZOSTER VIRUS MENINGITIS (VESICULAR SKIN LESIONS ON RIGHT LEG, HEADACHE, ACHES AND FEVER); This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no past medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, and batch number unknown, Expiry Date: UNKNOWN) dose was not reported, once total, administered on unspecified date in MAR-2021 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 in 2021, the patient experienced vesicular skin lesions on right leg and headache with eventual diagnosis of varicella-zoster virus meningitis and it was stated that patient administered vaccine two weeks before and had significant immunological response (fever, aches). On an unspecified date in 2021, the patient had done HIV test and was Ag/Ab Negative and absolute lymphocyte count of the patient was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the varicella-zoster virus meningitis (vesicular skin lesions on right leg, headache, aches and fever) and varicella-zoster virus meningitis (vesicular skin lesions on right leg, headache, aches and fever) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210431759-covid-19 vaccine ad26.cov2.s -varicella-zoster virus meningitis (vesicular skin lesions on right leg, headache, aches and fever) . 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).
11:45: C/O: HEART RACING REALLY FAST.  EMS ON SCENE. VS:  02 SAT R.A.:  97%; P:  72;  BP:  159/90  (FSBS:  257); 12:00 SYMPTOMS IMPROVED- VS: 144/73; P:  68; LEFT FACILITY, NO COMPLAINTS
PATIENT GIVEN A SYRINGE WITH AIR INSTEAD OF VACCINE; VACCINE WAS DRAWN 8 TIMES RATHER THAN 5 TIMES FROM THE VIAL.; PAIN DOWN THE ARM; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-JUN-2021, the subject experienced subject given a syringe with air instead of vaccine. On 07-JUN-2021, the subject experienced vaccine was drawn 8 times rather than 5 times from the vial. On 07-JUN-2021, the subject experienced pain down the arm. The action taken with covid-19 vaccine was not applicable. The outcome of the patient given a syringe with air instead of vaccine, pain down the arm and vaccine was drawn 8 times rather than 5 times from the vial. was not reported. This report was non-serious. This report was associated with product quality complaint: 90000182251.  The suspected product quality complaint has been confirmed to be void:y. it was reported that the nurse drew up 8 doses from the vial, which are 3 doses beyond what a vial should provide. therefore, the nurse might have administered air instead of vaccine into the consumer, who experienced pain on the administered arm. no product quality issue for janssen covid-19 vaccine is identified in this report. confirmed no pqc was identified within the reported complaint reported. based on the PQC evaluation/investigation performed.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications details were reported. Pharmacist reported that they gave 26 doses after the 30-day use by date. Pharmacist would like to know if those doses were viable or not. Number of doses/vials: 26 Date the vial was initially stored in the refrigerator : 14Jan2022  Date(s) of administration of vaccine: 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.Vial did not undergo any temperature excursions.   No treatment information details were reported.
Pt immediately after receiving vaccine developed large hive reaction redness along upper right arm 10 cm x 7 cm. Area slightly warm to touch. Non tender with palp. Moving arm fine. Lungs clear. BENADRYL given.
Peri-orbital edema; more severe on side of injection (right). Mild right facial edema. Pressure in right ear with subsequent swelling and fluid upon assessment by employee health NP. Right facial numbness with hx of Bell's Palsy on that side x 7 years ago. Stinging pain on right face.  I went to employee health for assessment by a medical professional. NP decided to administer 20mg famotadine PO x 1 and 10 mg cetirizine PO x 1. I also contacted my primary physician; he said to take benadryl and if swelling does not improve, to seek help. Medications taken around 11:00 am and right facial swelling began to decrease by 12:00pm but still has not totally resolved at this time 6:00 pm.
I was out of the country. I started to have  nasal congestion, chills, fever. I was extremely fatigued the next day. That progressed to having diarrhea and being unable to eat and became dehydrated. My wife went to the pharmacy and got fluimucil,  Imodium, and dioralyte. I had fever and chills for 3 days. I had diarrhea for 8 days.
Pt vaccinated with Pneumococcal/Influenza developed local erythema& induration at inject site, sensation of tightness in throat; occurred 4 hrs after pt took Benadryl 50mg; tighness relieved; took 2nd dose in AM, size of erythema decreased.
A red patch developed on my right arm (injection arm) about an inch or so above the injection site. The red patch was approximately 2 inches long and 1 inch wide. It felt slightly "funny" (perhaps because the area was slightly raised) but didn't really itch or cause pain. It slowly faded over time and was completely gone after approximately 8-9 days.
51 year old M with h/o O2 dependent COPD, Severe pulmonary fibrosis became increasingly hypoxic around 1800hours 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he decompensated further, and after discussing with family and palliative care, He was changed to comfort care. He expired on 1/12/2021@2325 at medical center.
felt like she could not move it and then she felt like paralyzed for less than three second; right arm little bit hurting/pain in her hand like she couldn't grab something; pain in her hand like she couldn't grab something, and it's twitching; felt short breath/felt like she need to grab air to breathe, she can't breathe/it was hard to breathe; chest kept hurting/short pain in chest; felt like she could not move it; body felt super tired; Chills; little fever; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18May2021 (at the age of 36 years old; Lot Number: EW0182, unknown expiration) as 1st dose, single for COVID-19 immunisation.  Medical history and concomitant medications reported as none. The patient reported that she received her first shot on 18May2021. She came home with her right arm little bit hurting, felt pain in her hand like she couldn't grab something, and it's twitching. As soon as she received the vaccine, she felt short breath, she called the place where she received the vaccine, she was there for 20 minutes. In her aid, she walked out as she needed air and her chest kept hurting and hurting on 18May2021. Every time she breathes, she felt like she need to grab air to breathe, she can't breathe/it was hard to breathe. Since 18May2021 to today, she felt short pain in chest and right hand and in the morning it was like twitch, she felt like she could not move it and then she felt like paralyzed for less than three second and then the shortening went to exactly to her chest and felt like she was losing air. She mentioned she need air to breathe and her body felt super tired on 18May2021. She is a very active person; she feels so tired. She also experienced chills, little fever, and her chest was hurting more on 18May2021. Due date of second shot is on 08Jun2021. The patient did not receive treatment for the events. The patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected.
I started getting symptoms of itchiness on the tops and bottom of my feet. That continued to my legs and arms. It was extreme itching and I couldn't sit still. Nothing was visible on my skin. It was like the same reaction as I have to sulfa drugs. I have went to my doctor and was advised to go to an allergist which is scheduled for the future. I was prescribed a methylprednisolone steroid medication and I also take an Aller-Tec allergy pill everyday. This is still ongoing to this day that is always present.
This spontaneous report as received from a pharmacist via a company representative refers to an approximately 50 year old male patient with shingles. There were no drug reactions or allergies. On 30-OCT-2013, the patient was vaccinated with ZOSTAVAC vial 19400 PFU lot # H022152 exp date 18-MAR-2014, 0.65 ml, subcutaneous for routine vaccination. There was no concomitant medication. In 2013, the patient experienced rash at an unspecified site of his body. On 11-NOV-2013, the patient sought for medical attention at the physician's office and was prescribed Valtrex as treatment for the rash. The outcome of rash was not reported. This is one of several reports from the same source. Additional information has been requested.
I developed Bell's Palsy. The right side of my face went completely limp. My eye would not close. I went to the ER at first, and they ruled out a stroke. My doctor put me on medication and eye drops to help my eye with closing. My mouth was drooping and I had problems with eating. My face looks like I had a face lift. My mouth is not exactly even, but I don't notice any other lingering issues. I would say that it took about 2 weeks for my eye to close. Getting my face back to normal was closer to 4 weeks time.
Symptoms started 24 hours later.  Lasted 36 hours.  Took Tylenol. 1 - fever, chills 2 - joint stiffness 3 - extreme tenderness 4 - left upper arm showed hot, reddened area -   approx. 4"x5"
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Lot number: gh9694) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booter), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound COVID occurred after negative test; Positive, notes: positive test 3 days post negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2, BNT162B2 OMI BA.4-5 in this patient cannot be completely excluded.
2 hours later pain in arm approximately 4-5 inches. Was not able to utilize left arm on yesterday. last night experienced muscle aches and chills. Taken Tylenol and rested.  This morning experienced a really bad headache.
30mins p/vax devel burning ears, tingling tongue, swollen eyes, 4 hrs p/vax devel cough rx antihistamine
Vomiting; Sickness; Diarrhea; Tummy is going wild; Stomach is ill; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Tummy is going wild; Stomach is ill), CHILLS (Chills) and VOMITING (Vomiting) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), Centrum, POTASSIUM, DIPYRIDAMOLE (PERSANTINE), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CITALOPRAM, LOXAPINE, ALPRAZOLAM, CITALOPRAM and Others for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 08-Apr-2021, the patient experienced ILLNESS (Sickness), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Tummy is going wild; Stomach is ill) and CHILLS (Chills). On 10-Apr-2021, the patient experienced VOMITING (Vomiting). At the time of the report, ILLNESS (Sickness), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Tummy is going wild; Stomach is ill), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.
This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis. On 8th December 2021, the patient received Shingrix. On 8th December 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional details were provided are as follows: The age at vaccination was not reported. The patient received an expired dose of Shingrix. The reporter consented to follow-up.
Patient was still within the 15 minute observation period. Patient starting saying she was hot. Bottle of water given to patient. Patient then passed out, attempted to talk to patient and performed sternal rub. Patient was lowered to floor with assistance to flat surface, rolled to side. Patient become alert. Rapid Response was called and patient was then taken to the Emergency Department.
Pt received J&J vaccine at 4:15p (no allergies/no previous reaction to vaccine) She felt dizzy shortly after; water was provided. Within 5 minutes patient become limp, unconscious and was not responding. 911 was called to respond; within 20 seconds, she became conscious again and was alert and responding (she knew her name and where she was at). Police, then fire department arrived to take patient's vitals. Everything was normal and she signed off to refuse additional medical attention. Patient felt fine when she left the pharmacy.
Right arm swelling with pain felt like sunburn, took 3-4 days to resolve.
1) Mild pain at injection site (still present, but decreased) 2) Moderate pain in left armpit, probably swollen lymph node (still very uncomfortable) 3) Achiness and generally feeling unwell, mild joint pain in knees, hips, and lower back (still present)
Pretty bad, tinnitus in both ears with other reactions; This case was reported by a consumer via interactive digital media and described the occurrence of tinnitus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of adverse reaction (had the first shot on an unknown date with not much reaction).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, several hours after receiving Shingles vaccine, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingles vaccine.     Additional details reported were as follows: The age at vaccination was not reported. The patient's second shot was pretty bad. Hours after receiving 2nd dose of Shingles vaccine, the patient experienced tinnitus in both ears along with other reactions and never went away.  The reporter knew several other people that also had this reaction. This case was linked with case US2022AMR051452, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR051408:Same reporter. 1st dose. US-GLAXOSMITHKLINE-US2022AMR051452:Same reporter. Hearsay
On December 14th, I was sick for two weeks, I had mucus in my eyes, ears, back of my throat& running nose, congestion, on Dec 13, I had a home COVID-19 test and it was positive, next I went to the nurse; she did a complete physical exam, nurse gave me antivirus (molnupiravir) to treat COVID-19. I took it for 5 days. Gave me medicine for my ears and eyes.
Patient moved arm while RN administering vaccine. Patient complained of pain. Small abrasion observed at injection site. Patient given an ice pack.
mom described the child as having joint pain, low grade fever & swollen glands;described as looking like a chipmunk;child taken to pvt MD;
Diffuse papular erythematous rash on face and body, itchy. No fever.
Dose was given / to a 10 year old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old male patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The reporter requested information regarding the administration of a dose of Kinrix.  The 10 year old patient received dose of a kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This is 1 of 3 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097954:same reporter US-GLAXOSMITHKLINE-US2021AMR097825:same reporter
very tired woke up several times Saturday leg pain. gave Tylenol Sunday and it seemed to help. he did his sleep study Sunday and did great.
c/o fever & fussy p/vax; hardness to lt leg; still fussy 14JUL92 came into office-afebrile-hardness to lt leg approx 1 1/2" diameter; rx APAP;
No aditional AE; The nurse called to evalauate an administered expired dose of GARDASIL 9.  The GARDASIL 9 expired on 2/26/2022 and was administered to a patient on 4/15/2022.  No adiitional AE's and no PQc's were reported.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.  On 15-APR-2022, the patient was vaccinated with an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe formulation administered as prophylaxis (expire dose reported as 26-FEB-2022) (strength, dose, vaccination scheme, route of administration and anatomical location, and lot number were not provided) (expired product administered). No additional adverse event (AE) (no adverse event).
rash on chest and back; rash on chest and back that is tender when wearing clothes; very sensitive of clothes; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than 2 weeks after receiving Shingrix, the patient experienced rash, tenderness and increased skin sensitivity. On an unknown date, the outcome of the rash, tenderness and increased skin sensitivity were unknown.   It was unknown if the reporter considered the rash, tenderness and increased skin sensitivity to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient has had rash on chest and back for 5 days that was tender when wearing clothes and was very sensitive of clothes. The reporter would write back after physician's diagnoses.
no other side effects; a patient was given an expired MMR II on 8/12/2021; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.      On 12-AUG-2021 the patient was vaccinated with an expired of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # S023656, expiration date 30-JUL-2021; dose and route were not reported) for prophylaxis (expired product administered). No other side effects were reported at time of call.
Multiple red, raised and itching hives covering upper body. Took Benadryl 25mg every 4 hours with relief by following day.
Large local reaction on left upper arm. Erythema, swelling, and warmth. Fever of 100.5
At 11:45 pt. c/o light headedness, nausea and tingling in left arm . v/s included 90/60, HR=80, RR=18bpm, T=97.4 degrees F.  A&O X4. Pt. was put into a supine position with legs elevated. One minute later pt. reported that symptoms had subsided.  Room temperature water was offered in an upright position. At 11:50 v/s were 100/72, 60bpm, 16bpm, @100%RA. T=97.8. No reported symptoms. At 1200, v/s included 108/70, 64bpm, 16bpm, @100% RA. T=97.4. Pt was d/c soon after 3rd v/s. there was no falls , injury or trauma to the pt. while at the clinic.