chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 012M20A.) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment information were not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   This case was linked to MOD21-059005 (Patient Link).
The site of injection that was red; The site of injection that was warm; The site of injection that was moist; Scratching the site of injection; A worm like piece with black dot scraped off from skin / Dark brown scab at the middle of the circlet at redness; Injection site blisters; Itching; Broke out in red hives on both of her ankles, right arm and left shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th September 2019, 16 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site discharge, injection site abrasion, injection site scab, injection site blisters, pruritus and erythema urticarial. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site discharge, injection site abrasion, injection site scab, injection site blisters, pruritus and erythema urticarial were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site discharge, injection site abrasion, injection site scab, injection site blisters, pruritus and erythema urticarial to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. Last Sunday, before reporting the patient started itching and broke out in red hives on both of her ankles, right arm and left shoulder. The patient was scratching the site of injection and a worm like piece with black dot scraped off from skin.  She noticed one inch by one inch circle at the site of injection that was red, warm, and moist.  The redness had been now decreased and now there was a dark brown scab at the middle of the circlet at redness. No further details were provided. The reporter consented to follow up.
Pain started after shot. No redness/inflammation. Initial bruise for a few days but pain still persists. Described as more shoulder pain especially w/heavy lifting.
hot and nauseated. patient was evaluated and vitals were taken. all were within normal range. patient stated he has anxiety. patient laid down and was evaluated for the remainder of his 15 min. patient stated he felt find after his 15 min and went home
Information has been received from a male consumer with no past medical history and no allergies who on 08/10/2001 was vaccinated with a dose of varicella vaccine. There was no concomitant medication. On 0/25/2001, the pt began "breaking out with chicken pox all over." It was confirmed by the pt's physician on 08/27/2001 that the pt had chicken pox. The physician told the pt to take Tylenol and Advil. The pt was also prescribed Valtrex. It was noted that the pt was afraid to take Valtrex while he had the chicken pox. Additional info has been requested.
This spontaneous report was received from a Licensed Practical Nurse, referring to an unspecified number of patients of unknown age and gender. The pertinent medical history and concurrent conditions of the patients were not reported. On unspecified dates, the unspecified number of patients were vaccinated with an unspecified number of improperly stored doses of PNEUMOVAX 23 lot # K006681, expiration date 21-OCT-2015 (dose, frequency and route were not reported). No adverse experiences were reported. No product quality complaint. This is one of several cases received from the same reporter. Additional information has been requested.
After first dose patient experienced a very very little fatigue during 48 hours; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (After first dose patient experienced a very very little fatigue during 48 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement (Recent change in status such as improvement or worsening: same). Concurrent medical conditions included Enlarged prostate (Condition was worsening.) since 1990, Blood pressure high (Recent change in status such as improvement or worsening: same) and High cholesterol (Recent change in status such as improvement or worsening: same). Concomitant products included WARFARIN, ATORVASTATIN and HYDROCHLOROTHIAZIDE, LISINOPRIL (ZESTORETIC) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced FATIGUE (After first dose patient experienced a very very little fatigue during 48 hours). On 31-Jan-2021, FATIGUE (After first dose patient experienced a very very little fatigue during 48 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not have any allergies related to medications, food and other products. Patient never tested positive or diagnosed with COVID. After first dose patient experienced a very very little fatigue during 48 hours.   This case was linked to MOD-2022-651167, MOD-2022-651184 (Patient Link).
Distinct sharp pain in shoulder joint on same arm where vaccine was administered. Continues to present day after second dose given on 4/27/2021
insomnia; pain; soreness; redspot; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PAIN (pain), INJECTION SITE PAIN (soreness), ERYTHEMA (redspot) and INSOMNIA (insomnia) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Hypertension, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (pain), INJECTION SITE PAIN (soreness) and ERYTHEMA (redspot). On 09-Feb-2021, the patient experienced INSOMNIA (insomnia). On 13-Jan-2021, PAIN (pain), INJECTION SITE PAIN (soreness) and ERYTHEMA (redspot) had resolved. At the time of the report, INSOMNIA (insomnia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
None will revaccinate in 6 weeks. PCV 13 was expirated when given. No adverse effects. 3/20/13.
This spontaneous report as received from a pharmacist, via company representative, refers to a female patient of unknown age (reported as most likely been over 18 years of age in order to handle the vaccine at all). Reporter informed that there had been e-mail's circulation in pharmacy society that informed that pharmacist should were masks when reconstituting ZOSTAVAX. Reporter informed that she never had read or copied those e-mail. On an unknown date the patient may have developed shingles after working with or reconstituting the ZOSTAVAX. It was not made clear, nor was any of the information confirmed if the pharmacist had ever been administered the vaccine at all or what her specific interaction, with ZOSTAVAX, acutally was. The outcome of shingles was unknown. The reporter did not reported relatedness. Additional information has been requested.
08/08/2005 Mother called advised that child had swollen rash, fever, advised to see doctor.  Mother states had put ice and Tylenol.  On 08/11/2005 called Mother states child was seen at the doctor on 08/08/2005, treated , diagnosed with Cellulitis, on Keflex, doing much better. 09/07/2005 no problems.
Patient noticed swelling and redness around the injection site. She was counseled by the pharmacist that this type of reaction was a possibility; however, after a couple days of the reaction still existing she went to the doctor's office. The doctor found there was an infection at the injection site. The patient was prescribed Cephalexin 500mg 1 capsule by mouth twice daily for 7 days. When picking up antibiotic prescription the patient reported the adverse effect to the pharmacy on duty.
No adverse events.; a patient was administered 1 dose of improperly stored VAQTA and 1 dose of improperly stored GARDASIL 9; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 09-SEP-2019, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) ( lot # S017739 has been verified to be a valid lot number, expiry date 29-AUG-2020) (exact dose and route of administration were not reported) for prophylaxis.  On the same day, the patient also received 1 dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1621934, expiry date 29-JAN-2022) (exact dose and route of administration were not provided) for prophylaxis.  The storage temperature was above 47 Fahrenheit degrees/ 9 Celsius degrees (28 Fahrenheit degrees) for 24 hours. A data logger was not involved. The event was first identified on 10-SEP-2019. No adverse events were reported. The outcome was unknown.
Hives/hive-like rash on thighs/groin/waist area that occurred in patches overnight the day of injection. Saw PCP and started on a MEDROL dose pack. Rash continue to spread to back the day after.
Shingles  outbreak on right side, rash that spread, itching, pain at rash site and under the arm, rash still present 9 days after vaccine
Pt developed hives after being injected with ProQuad approximately 6 yrs.  Hives, urticaria. Had rash on arm prior to ProQuad which she also applied cortisone cream for the first time
Patient had hives, itching, blister-like rashes on her upper arm towards the back on both sides.
NECK SORE TO TOUCH; EXCRUCIATING BACK PAIN; COULD NOT LIE ON BACK AND ON SIDE; MILD BODY ACHES; BACK PAIN RADIATING TO ABDOMEN; CHILLS BECAME WORSE; HEADACHE; MILD TEMPERATURE; CAHRLIE HORSE IN NECK, SHOULDERS. AND LEGS; DIARRHEA; SLEEPY; STOMACH PAIN; LOSS OF APPETITE; FELT TIRED; DRY COUGH; COULD BARELY WALK; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, non-alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced could barely walk. On 2021, the subject experienced dry cough. On 28-MAR-2021, the subject experienced loss of appetite. On 28-MAR-2021, the subject experienced felt tired. On 29-MAR-2021, the subject experienced stomach pain. On 30-MAR-2021, the subject experienced sleepy. On 31-MAR-2021, the subject experienced diarrhea. On 31-MAR-2021, the subject experienced cahrlie horse in neck, shoulders; and legs. On APR-2021, the subject experienced mild body aches. On APR-2021, the subject experienced back pain radiating to abdomen. On APR-2021, the subject experienced chills became worse. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced mild temperature. On 01-APR-2021, the subject experienced excruciating back pain. On 01-APR-2021, the subject experienced could not lie on back and on side. On 02-APR-2021, the subject experienced neck sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excruciating back pain, and could not lie on back and on side on 08-APR-2021, and cahrlie horse in neck, shoulders. and legs on 01-APR-2021, was recovering from diarrhea, loss of appetite, neck sore to touch, and mild temperature, had not recovered from felt tired, sleepy, headache, mild body aches, stomach pain, and chills became worse, and the outcome of dry cough, back pain radiating to abdomen and could barely walk was not reported. This report was non-serious.
Vomiting- onset 35 mins from injection, stopped 1 hour after injection Nausea- onset 35 mins from injection. Lasted about 48 hours from injection.  Fatigue- onset about 12 hours after injection. Lasted about 48 hours from injection Headache, moderate- onset about 12 hours from injection. Was intermittent for 48 hours.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: The patient was seated in the waiting area. Approx 5 minutes after receiving the vaccine, the patient fainted. She woke up on the floor laying on her back after a few seconds. She said she was not hurt and was in no pain. She said she "always" faints or feels like fainting after getting a shot, but she had not reported this before the event occurred. We gave her water and a snack and encounraged her to stay seated for 30 minutes. She refused to let us take vitals, re-stating that she was fine.
sore arm; low-grade fever; vomited; intense malaise; fatigue; This is a spontaneous report from a contactable consumer (patient). A 54-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL8982), via an unspecified route of administration in the left arm on 20Jan2021 at 18:45 (at the age of 54-years-old) as a single dose for COVID-19 immunization. Medical history included seizure, controlled on meds and migraine from an unknown date and unknown if ongoing. Concomitant medication(s) included valproic acid, rizatriptan benzoate (MAXALT) and colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. The patient previously cefuroxime and doxycyclin and experienced drug hypersensitivity. Historical vaccine included first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EH9899), via an unspecified route of administration in the left arm on 30Dec2020 at 18:45 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient stated that ill-effects started 16 hours after injection, sore arm, brief low-grade fever, vomited, intense malaise for 24 hours followed by 2.5 days of fatigue on 21Jan2021 10:00. The patient did not receive any treatment. The clinical outcome for the events was recovered on an unspecified date in 2021 for all events except intense malaise and fatigue which recovered on an unspecified date in Jan2021.  Follow-up attempts completed. No further information expected.
Generalized itching all over her body; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (on an unknown date received 1st dose an experienced injection site pain).   On 5th August 2019, the patient received the 2nd dose of Shingrix. In August 2019, less than 3 weeks after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's ex husband. The reporter stated that the patient after the second dose experienced generalized itching all over her body that has not subsided. The reporter was unable to give consent for follow up but will ask patient to contact GSK to provide more information. This case has been linked with case US2019AMR157393, reported by the same reporter.
Persistent inconsolable crying. DTaP/IPV/HIB/PREVNAR and ROTATEQ given at 9:45 am 6/1/09. Crying began 9:00 pm, stopped 9:00am 6/2/09.
Narrative: Pt reported to the ED on 7/27/2022 with the following signs/symptoms: Weak / Tired, Runny Nose, Chest Congestion, Productive Cough, Short of Breath, Headache, GI symptoms- Stomach Pain, Nausea, Vomiting, Diarrhea, Sore Throat, Body Aches, Change in Taste; Patient has received initial COVID Vaccine series & 2 booster vaccines (4 total vaccinations). Pt reported weeklong history of symptoms (around 7/20/22). Pt is a 76 year old with a PMH notable for renal transplant and chronic renal insufficiency followed by nephrology admitted via ED for acute on chronic renal failure and Covid 19 infection despite 2 vaccination with 2 boosters. Pt admitted to hospital with following diagnosis: Acute Kidney injury (primary diagnosis); Covid-19 injection; gastroenteritis. Patient hospitalized from 7/27/2022 to 8/3/2022. Pt received supportive care and monitoring for COVID infection. Ongoing weakness improved prior to discharge.
This case was reported by a consumer via interactive digital media and described the occurrence of adverse event in a female patient who received Flu unspecified (Influenza vaccine) for an unknown indication. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced adverse event (serious criteria life threatening). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to Influenza vaccine. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. The reporter posted on social media that others were taking big chance getting one of these flu shots and advised them to do research on what was in the Flu shot. The mother further stated that she never had flu shot and never had the flu since 1983. However, her daughter got the flu shot and was almost died.
same red bumps/pimples started to form across my forehead and face; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1; Lot number: ER8732, EW0158; Administrator route: Intramuscular, Administration date and time: 02Apr2021and 09:30 AM; vaccine location: Left arm), administration date: 02Apr2021, when the patient was 30 years old, for COVID-19 immunisation, reaction(s): "break out on my forehead. Small red bumps/pimples". The following information was reported: ACNE (non-serious), outcome "recovering", described as "same red bumps/pimples started to form across my forehead and face". Therapeutic measures were not taken as a result of acne.  Additional information: Patient did not experience COVID prior vaccination. Patient didn't test COVID post vaccination. Patient didn't experience any known allergies. Patient did not take other vaccine in four weeks and other medications in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, 100 degrees; Pain, right shoulder and arm; Bruising at injection site.
Anxiety, sleepless, angry, aggressive, loss of mind. Bone and muscular pains.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information on the patient's pertinent medical history, concurrent conditions, concomitant medications drug reactions or allergies was provided. On 05-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 injection, lot # M043987, expiry date: 14-OCT-2017 (strength, dose, frequency, route of administration were not reported) for prophylaxis. The temperature excursion and the time frames were unknown by the reporter. No previous temperature excursion was noted, data logger was not involved. No adverse effects reported. Product quality complaint (PQC) was not involved. This is one of 2 reports from the same reporter. Sender's Comments: US-009507513-1710USA007815.
She got her vaccine yesterday, no problems initially, then today 4/9/21 started having chills, loss of appetite, fever, headaches and eyes hurting as well, and aching joints.  Chills to the point that she has turned her heater on but it's in the 80s outside.  She has not taken anything for her symptoms.
I experienced aura headache next day and 2 days later sudden vision loss in both eyes. I was diagnosed with macular puckers.
Patient reports low grade fever and flu-like symptoms starting Saturday 07/13/19 the day after vaccine administration. Rash developed on the back of the neck at hairline going up behind ear and across forehead late Sunday night into Monday morning, unsure of exact time. Rash was red and itchy (patient provided pictures). Called the pharmacy Monday evening 07/15/19 after no relief and was advised by on duty pharmacist  to take Benadryl which did relieve itchiness and redness. When patient presented on 07/16/19, rash was no longer visible and patient reports no itching of area.
Pt apparently had his first shot for influenza at Dr's office on 10/14/03 in the morning at 11 am up to 12 noon. That evening of 10/14/03 had sore throat. Became more ill upon awakening on 10/15/03 Wednesday. Sore throat, cough and fever, ached all over, not eating, intense headache. Did attempt to go to work but felt worse and went home at 3:30pm. Shaky, uncontrolled chills, and his temp was 103. Cough somewhat productive, not colored. He tried taking ibuprofen and Day Quil but his fever progressed up to 105. Admitted to hospital on 10/16/03-indication: chills, fever, pneumonia, cough and congestion, headache, muscular aches and pains. X-ray indicated no radiographic evidence of acute cardiopulmonary disease. Pt was hospitalized until 10/19/03. Discharge 10/19/03 with instructions to follow up with his physician in 7-10 days. Wellbutrin 150mg take twice a day. Continue any other home meds.