chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site redness; injection site swelling; discomfort; bumps; and itching; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In December 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site discomfort, injection site rash and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site discomfort, injection site rash and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site discomfort, injection site rash and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received dose  of Shingrix and 2 or 3 days later started feeling discomfort, redness, swelling, itching and bumps as the injection site. The follow up consent was granted.
No reported adverse reaction: Patient received (2) ZOSTAVAX injections 01/11/10 & 6/29/12.
Arm sore; Fever; headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm sore), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Arm sore), PYREXIA (Fever), HEADACHE (headache) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and treatment medications were reported.   Reporter did not allow further contact
BLOOD CLOTS; DIFFICULTY BREATHING; PAIN; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnic origin. 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 (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered 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 was vaccinated with the vaccine and about one month after post injection she had difficulty breathing along with pains and Went to the emergency room and was hospitalized for the weekend and the patient was currently on medications to treat the blood clots and is doing better, number of days hospitalized was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clots, difficulty breathing, and pain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220230343-covid-19 vaccine ad26.cov2.s-blood clots, difficulty breathing, pain. 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). Therefore, this event(s) is considered unassessable.
Information has been received from a female patient who was vaccinated with her first Gardasil and developed a rash on her thigh, hip and stomach. After receiving second dose of Gardasil the patient developed hives and a rash. The patient's outcome was unknown. No further information is available.
her shot; it hurt really bad; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "her shot; it hurt really bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I did my infusion Sunday morning. When it was complete, I had big welts all over both my arms. They were red, swelling, and raised up. They were painful. I contacted my doctor. They gave me a steroid injection. My doctor claimed my infusion medicine and the vaccine  may have caused the antibodies to have clashed - but she wasn't sure.
use by date 1/18/23 admin date 1/20/23, no adverse event reported
Shortly after receiving my second dose of the moderna vaccine I started experiencing joint pain and over the past month have right foot only swelling.
Symptoms: fever of 101, sore injection site, fatigue on Saturday, 03/13/2021. On Sunday morning, 03/14/2021 (less than 48 hours later),  I had a redness and what appeared to be a reaction at the injection site on my left upper arm about 3 inches by 2 inches and a fever of 100.4.  On Monday, 03/15/2021, the fever was gone, but the redness on the upper arm has spread to 5 by 3 inches.
not well for a week; Fatigue and no energy; Feels ill; Feels weak; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feels ill), ASTHENIA (Feels weak), MALAISE (not well for a week) and FATIGUE (Fatigue and no energy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MALAISE (Feels ill), ASTHENIA (Feels weak) and FATIGUE (Fatigue and no energy). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (not well for a week). At the time of the report, MALAISE (Feels ill), ASTHENIA (Feels weak) and FATIGUE (Fatigue and no energy) outcome was unknown and MALAISE (not well for a week) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR - Event and outcome added.
Information has been received from a health professional concerning a female patient with a latex allergy who on 02/13/2004 was vaccinated with a dose of Hepatitis B virus vaccine rHBsAG (yeast).  Concomitant therapy included a Mantoux tuberculosis test.  Late in the evening of 02/13/2004, the patient reported to the emergency room because of a reaction.  The nurse did not yet see or talk to the patient so did not have much information on the reaction but the patient does have a latex allergy.  The nurse knew that the emergency room administered promethazine hydrochloride (Phenergen) 25mg and diphenhydramine hydrochloride (benadryl) 50mg.  As of 02/2004, the nurse did not have any additional information.  There was no product quality complaint involved. Additional information has been requested.
Localized rash, pruritus (L) thigh, papule. Symptoms developed over the course of 4 days. BENADRYL cream applied to area, 25 mg. BENADRYL PO Q 6-8 hrs.
Pt. experienced feeling very dizzy and lightheaded immediately after vaccine. Pt. has a history of this experience after vaccinations. He was responsive the entire time and did not display any other symptoms. I advised pt. to stay seated and calm as possible for a few minutes. After he felt fine, I advised him to wait in the store for 30 minutes and he did not report other symptoms.
3X3 CM INDURATION MEDIAL TO INJ SITE WITH ERYTHEMA AND INDURATION. THE DAY AFTER THE SHOT NOTICED ARM PAIN THAT WAS MORE THAN EXPERIENCED AFTER FLU SHOT. NOTICED SLIGHT PARESTHESIA IN AREA PRIOR TO REMOVING BAND AID AND THEN NOTICED TENDERNESS/INDURATION/ERYTHEMA.
Marked swelling, redness, rash/ring near injection site. Then L forearm red patches, papules, and some vesicles on his palms with redness, papules/plaques on dorsum of feet, calves. R inner thigh with marked red/swollen area. Erythema multiforme-type rash.
The patient received the flublok vaccine, which isn't routinely recommended in children under 18.  It is a higher concentration, and may result in more headaches or arm pain.
13 days after first dose, my period started about 3-5 days early with much more painful cramping than usual.
Information has been received from a registered nurse concerning a female who on 07-JAN-2008 and 13-MAY-2008 was vaccinated with 05 ml first and second dose of GARDASIL (lot #654741/1208F and 659180/1758U), respectively.  Subsequently the patient experienced a raised rash at the injection site.  The rash was raised and looked like a "bull's eye".  It was also noted that the patient experienced pruritus at the injection site.  The patient was seen at the office.  At the time of this report, the events persisted.  Additional information has been requested.
patient given 0.5ml instead of the correct dose of 0.3ml. Patient experienced severe headache, body aches, fever, nausea and dizziness. She missed 1 shift from work. No medical attention needed.
Headache, Myalgia, Rash, ErythemaMultiform, NauseaVomiting, Chills, Congestion, Fatigue, injection site pain, swelling at injection site Narrative:  Other Relevant History:
Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) 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 HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown.            No Concomitant medication information was reported. No treatment medications were provided.   This case was linked to MOD-2021-301391, MOD-2021-301391 (Patient Link).   Reporter did not allow further contact
After the Vaccination he had developed scabs that are now bleeding; After the vaccination he had developed scabs that are now bleeding; he was scratching; injection site on his right arm and left arm had a wheal; There had been some rashes on his left arm and is now up to his face; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 23Mar2021 as single dose for COVID-19 immunization and  second dose of BNT162B2 via an unspecified route of administration in left arm on 14Apr2021 as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. He consulted with his regular dermatologist on 27Apr2021and the doctor noticed he was scratching and noticed that his injection site on the left arm had a wheal and there had been some rashes on his left arm.He was prescribed with a cream for 2 weeks. As of calling the rashes are still there and is now up to his face. The day before, patient noticed that his injection site on his right arm also had a wheal. They were not healing, and he had developed scabs that are now bleeding. He mentioned that he had no allergies to anything. He was asking for what to do and on what basis should he go to the ER. He has an appointment with his primary doctor but it is a month away. The outcome of the events was not recovered.  Information on the Lot/batch number and expiration date has been requested.
The day of the vaccine patient was well.  The night after the shots were administered, the injection site was extremely hot to the touch but no swelling of the site or fever. 48 hours after the injection patient became very fussy. He cried non stop for over 6 hours. He would not nurse or nap , no rocking or holding him would help. He refused to nurse and both of his arms became partially paralyzed.  He would not move them at all they just hung by his side.
15OCT woke w/rash around waist area spread to chest, arms, legs went to MD was told was allergic reaction & given DPH;
shortness of breath 2 hours after receiving vaccine, admitted to hospital for 2-3 days
Swollen at the injection site. Pain, red rash at site only. Tiredness. Muscle ache.
A physician reported the occurrence of paralytic syndrom in a 14 month old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis during their phase IV study of diphtheria and tetanus toxoids and enhanced pertussis vaccine (Daptacel). The subject's medical history included a seizure with fever secondary to otitis media on 22 Dec 2002. This seizure was described by the emergency medical technician as "primarily right side tonic/clonic activity with gaze deviated to left. Seizure lasted apprx. one to two minutes with apnea period to follow. A second seizure was observed of like duration. The subject received injections of diphtheria and tetanus toxoids and acellular pertussis vaccine on 24 Jan 2002, 26 March 2002, and 23 May 2002. On 16 Jan 2003, the subject received Infanrix for the fourth dose in the DTPa series. Also on 16 Jan 2003, the subject received his first injection of 7-valent pneumococcal conjugate vaccine (Prevnar, Lederle Labs) On 18 Jan 2003, the subject presented to the ER with a fever of 101.7 degrees F, movements in right arm and leg, and gazing to left. His mother reported that the fever had started that day. His right arm then became flaccid. The subject was hospitalized for higher level of care and work up. No seizures occurred while the subject was hospitalized. The subject was discharged from the hospital on 19 Jan 2003. Discharge diagnosis were reported as seizure, febrile and paralytic syndrome NEC. Magnetic resonance imaging scheduled for 20 Jan 2003 was cancelled by either parent or provider. Results of an electronencephalogram performed on 29 Jan 2003 were interpreted as within normal limits. The investigator considered the events to be of moderate severity and possible relate to the vaccines administered on 16 Jan 2003.
Very tired..sleeps more then awake..stares..high fever..very lethargic..not much energy..just generally not acting like her normal self..shaking..and trembling also..
Patient was administered the adult dose of 0.5ml vs the 0.25 for her age
Infected at a large event with some kind of viral infection. Others infected at same event ended up at urgent care with me getting tested for Covid-19. Tested negative three times over the course of treatment. Experienced cough, body aches, fatigue, sinus drainage, fever. Directed to over-the-counter mucinex. Symtoms worsened after week. Prescribed antibiotic, steroid routine, and inhaler with chest Xrays ordered by urgent care. Results of xrays revealed pneumonia in both lungs. It was difficult to lay down and sleep because of congestion in lungs. Lots of coughing, body aches, and severe fatigue. When I met with my doctor,  she changed the steroid routine and the inhaler. Out of work from June 21, 2021 through July 19, 2021. Fully recovered by August 23, 2021
Patient developed rash on arm and pain down arm and hand and also armpit/chest area.  Patient said area was somewhat swollen.
No adverse effect; patients who received improperly stored GARDASIL 9 since 8/13/2019; This spontaneous report as received from a phlebotomist refers to a 13-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.     On an unknown date in 2019 (reported as since 13-AUG-2019), the patient was vaccinated with incorrect stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1602281, expiration date 21-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The temperature excursion occurred on 13-AUG-2019. The vaccine was stored in temperature 30.60 degrees Fahrenheit for 41 minutes and in temperature 56.80 degrees Fahrenheit for 4 hours 30 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1909USA004622:
all symptoms came on suddenly, body aches, exhaustion, nausea, headache, uncontrollable body shivers, sore arm (MUCH more sore than first dose of vaccine)
can't get out of bed; really cold; arms sore; back of neck is sore; can't breathe well; chest pain; bad headache; might have fever; whole-body hurts; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (can't get out of bed), FEELING COLD (really cold), PAIN IN EXTREMITY (arms sore), NECK PAIN (back of neck is sore) and DYSPNOEA (can't breathe well) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in May 2020.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced MOBILITY DECREASED (can't get out of bed), FEELING COLD (really cold), PAIN IN EXTREMITY (arms sore), NECK PAIN (back of neck is sore), DYSPNOEA (can't breathe well), CHEST PAIN (chest pain), HEADACHE (bad headache), PYREXIA (might have fever) and MYALGIA (whole-body hurts). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (can't get out of bed), FEELING COLD (really cold), PAIN IN EXTREMITY (arms sore), NECK PAIN (back of neck is sore), DYSPNOEA (can't breathe well), CHEST PAIN (chest pain), HEADACHE (bad headache), PYREXIA (might have fever) and MYALGIA (whole-body hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.
Vaccine site became very red extending out across back of arm about the size of an orange. It was very swollen and hot to the touch with complaints of itching and pain.
diarrhoea; itchiness all over her body that lasted for a week; sore arm that lasted for about 2-3 weeks.; shooting head pain all over her brain; joint pain; body aches; fatigue; fever of 99.9 F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhoea), PRURITUS (itchiness all over her body that lasted for a week), PAIN IN EXTREMITY (sore arm that lasted for about 2-3 weeks.), HEADACHE (shooting head pain all over her brain) and ARTHRALGIA (joint pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (diarrhoea), PRURITUS (itchiness all over her body that lasted for a week), PAIN IN EXTREMITY (sore arm that lasted for about 2-3 weeks.), HEADACHE (shooting head pain all over her brain), ARTHRALGIA (joint pain), MYALGIA (body aches), FATIGUE (fatigue) and PYREXIA (fever of 99.9 F). At the time of the report, DIARRHOEA (diarrhoea), PRURITUS (itchiness all over her body that lasted for a week), PAIN IN EXTREMITY (sore arm that lasted for about 2-3 weeks.), HEADACHE (shooting head pain all over her brain), ARTHRALGIA (joint pain), MYALGIA (body aches) and PYREXIA (fever of 99.9 F) outcome was unknown and FATIGUE (fatigue) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 99.9 (Inconclusive) fever of 99.9 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant Medications were reported. No Treatment Information Provided.   This case was linked to MOD-2021-116746 (Patient Link).
Red, bumpy, itchy rash on underside of left arm (same arm that received vaccine). From wrist to elbow.  Cleared up within 3 days, required no medical treatment.
Pre-term delivery. Pregnancy with di/di twins, no complications noted throughout pregnancy. Water broke and labor started day after vaccine given. Was set to deliver 38w2d on November 21 2023. Delivered at 34w0d. Baby A birth weight 4lb 7oz Baby B birth weight 4lb 14oz
pt recvd vax & 1hr later started temp that afternoon started w/numbness of hands, progressed to both arm;hands turned red & hurt when touched things returned to school today;now has intermittent numbness & tingling; nausea
Rash covering 90% of body and 102 degree fever. Possible egg allergy - doing testing.
Syringe and needle separated after vaccine was injected.  Full dose given.  No AE.
pt devel fever, rash on exterior body + internally on mouth + on throat, could not eat; still has rash on exterior body
LUMP AT THE VACCINATION SITE; 2 INCHES BELOW THE INJECTION SITE ARM SORE/SLIGHTLY SORE WHEN LIFITING ARM UP; PAINFUL BURNING AT THE VACCINATION SITE; This spontaneous report received from a patient via an unspecified company representative concerned a male 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, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced lump at the vaccination site. On 08-APR-2021, the subject experienced 2 inches below the injection site arm sore/slightly sore when lifiting arm up. On 08-APR-2021, the subject experienced painful burning at the vaccination site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lump at the vaccination site, and painful burning at the vaccination site on 08-APR-2021, and was recovering from 2 inches below the injection site arm sore/slightly sore when lifiting arm up. This report was non-serious.