chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site swelling; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
The patient said she had breathing issues for 5 mins after getting the Pfizer shot; she used an albuterol inhaler and an half benadryl and said she felt fine. No issues afterwards.
spongiotic dermatitis; red eruption on her legs; rash spreading to her arm and torso/eruption on legs; itchy eruption on her legs; scaly eruption on her legs; This case was reported by a physician via call center representative and described the occurrence of subacute spongiotic dermatitis in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced subacute spongiotic dermatitis, erythematous eruption, generalized rash, itchy rash and rash scaly. On an unknown date, the outcome of the subacute spongiotic dermatitis, erythematous eruption, generalized rash, itchy rash and rash scaly were unknown.   It was unknown if the reporter considered the subacute spongiotic dermatitis, erythematous eruption, generalized rash, itchy rash and rash scaly to be related to Shingrix.  Additional details were reported as follows: This case was received from live chat. The physician reporting a patient experienced a red itchy scaly eruption on her legs within 1 week of receiving Shingrix vaccination.  The physician stated the rash had been present since October and was now spreading to her arms and torso.  A skin biopsy showed spongiotic dermatitis.  The physician also noted this might not be related to the shot.      Lab Comments: lab test were performed on an unknown date
Vertigo onset, required dr care and referral to neurologist as well as mri referral
10-29-13 - Vaccine on 10-25-13, onset evening of 10-27-13 c/o deep pain to (L) arm 9 - 10 on pain scale with some pain in (R) arm as well relieved with hot water bottles. Next day 'light pain' worsened last night 10-28-13. Came into clinic 10-29-13. Has appt with PMD in "3-4 days". Called and reported to PCP. Spoke with someone in office who offered pt appt today. He declined instead to call us if change in status care. 11-12-13 F/U with pt stated pain persisted 8 days and resolved did see MD for scheduled visit.
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose, route, lot number and expiration date were not reported). No adverse experiences reported. This is one of several reports from the same source. Additional information has been requested.
1) Burning sensation dorsum of hands; 2) Redness of face, neck, chest, ear; 3) Lightheadedness; (Accidentally took PCN tab - not took same pill again and had anaphylactic reaction)
Patient lethargic, hard to arouse, low oxygenation (88%) requiring new order for oxygen, diaphoretic, no appetite, no voiding during shift
Swollen lump above collar bone where shot was administered. Light-headedness. Sick to stomach. Overly sore arm.
chills, 101 fever, could not move arm very painful, armpits are swollen, pain going up neck and side of her head, pain in stomach
she took some more Benadryl for her symptoms which made her sleepy; sleepy with heat on side of face when sleeping; arm hurt at the area of the injection site during dose administration; red itching rash all over the body, described as arms, legs, torso, and face; left arm felt sore and hurt to lift for the first couple of days after the dose; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she took some more Benadryl for her symptoms which made her sleepy), RASH PRURITIC (red itching rash all over the body, described as arms, legs, torso, and face), PAIN IN EXTREMITY (left arm felt sore and hurt to lift for the first couple of days after the dose), FEELING HOT (sleepy with heat on side of face when sleeping) and VACCINATION SITE PAIN (arm hurt at the area of the injection site during dose administration) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Feeling unwell, Headache aggravated, Fever, Weakness generalised and Shaking. Previously administered products included for an unreported indication: MENINGOCOCCAL VACCINE B. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 11-Mar-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced RASH PRURITIC (red itching rash all over the body, described as arms, legs, torso, and face), PAIN IN EXTREMITY (left arm felt sore and hurt to lift for the first couple of days after the dose) and VACCINATION SITE PAIN (arm hurt at the area of the injection site during dose administration). On 13-Mar-2021, the patient experienced FEELING HOT (sleepy with heat on side of face when sleeping). On an unknown date, the patient experienced SOMNOLENCE (she took some more Benadryl for her symptoms which made her sleepy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (she took some more Benadryl for her symptoms which made her sleepy) outcome was unknown and RASH PRURITIC (red itching rash all over the body, described as arms, legs, torso, and face), PAIN IN EXTREMITY (left arm felt sore and hurt to lift for the first couple of days after the dose), FEELING HOT (sleepy with heat on side of face when sleeping) and VACCINATION SITE PAIN (arm hurt at the area of the injection site during dose administration) had resolved.        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.   Treatment medication include the moisturizer to treat the symptoms related to drug administration
light sensivity. Light hurts my eyes almost like migraine; migraine; This is a spontaneous report from a contactable consumer reported that a 70-year-old female patient (consumer) (non-pregnant) received BNT162B2 (Solution for injection, lot number: El3249) on 27Jan2021 at 11: 00 AM in single dose for Left arm, dose number: 2, for covid-19 immunization. Patient medical history included Controlled BP, cholesterol, thyroid, known allergies: sulfa drugs. Patient previously took cimetidine sodium alginate (TAGAMET) and had Tagamet allergy, tetracycline and had tetracycline allergy, Iodine and had Iodine allergy. Historical vaccine included BNT162B2 on 06Jan2021 at 11:00AM (lot number=EK9231, vaccine location=Left arm, dose number=1) for covid-19 immunization. Concomitant medications were not reported. On 28Jan2021, at 08:00AM, patient had light sensitivity and Light hurts my eyes almost like migraine. If this was still like this Monday she will go to doctor. No treatment was received for adverse event. It was unknown, whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. No seriousness criteria reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was not recovered.
Associate felt dizzy and weak after vaccination, BP was elevated. clammy skin. HR elevated. Monitored closely for 60 minutes. Associate felt better after about 48 minutes post vaccine. Closely monitored. Did not drive home after vaccine.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Flu like symptoms; pain all over; felt like fever; next day Asthma, short of breath; feeling unwell
Information has been received from a health professional concerning a female who on 14-MAR-2007 was vaccinated with the first dose of Gardasil, IM in the right deltoid (lot# 655503/0012U). Concomitant therapy included Mircette and vitamins (unspecified) (One-A-Day Essential Vitamins). Subsequently, immediately following the vaccination the patient experienced pain in the injection site arm. The patient recovered from the pain in "a day or two" but it returned on approximately 18-MAR-2007. This pain was described as a shooting pain in the injection site arm "down to the elbow" that occurred when the arm was moved. There was no pain on touch. It was reported that the pain was worst at the end of the day and immediately upon arising. The patient was treated with Advil which was reported to have helped the pain. The patient was examined at her physician's office on 26-MAR-2007 and was prescribed Tylenol with codeine. Subsequently, the patient called into the office on 09-APR-2007 and reported that the pain in the arm was still present and had worsened. The patient was referred to her primary care physician for further evaluation. Additional information has been requested.
pox itch; pox all over her body; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (pox itch), RASH (pox all over her body), CHILLS (chills) and FATIGUE (fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and ALPRAZOLAM for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced CHILLS (chills). On 05-May-2021, the patient experienced FATIGUE (fatigue). On 17-May-2021, the patient experienced RASH (pox all over her body). On an unknown date, the patient experienced RASH PRURITIC (pox itch). At the time of the report, RASH PRURITIC (pox itch), RASH (pox all over her body), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.        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 treatment details were provided.
My son started limping right after immunizations. Reaction was noticed the next morning at 2 a.m. with 101 degree fever. When he woke up later that morning, left leg was very swollen and covered with rash. Taken to walk-in clinic. Given Children's Benadryl Allergy and Cephalexin to take for 1 week (3 x per day).
Pain in left elbow and arm.  Pain when lifting, gripping, apply weight.  Same in right knee.
Felt heat and it radiated down my arm and in my chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, 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: MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Felt heat and it radiated down my arm and in my chest".  Additional information: The patient stated that she took the vaccine Mar2021 and after felt heat and it radiated down my arm and in my chest, but she thought that was normal reaction.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe chills, Fever, lower Back-ache and lethargy (symptoms lasted about 16-18 hours)
Patient said that it just hurt badly from inside but it is not swollen or red. He couldn't move his arm or it hurts when he does. He took ADVIL.
Symptoms of depression, bouts of crying, feeling sad and down, not wanting to do anything but lay down
Day 2 post vaccine: patient complains of chest pain.  Pt states: "feels like swelling inside" and has some relief if laying in prone position. Day 4 post vaccine: patient reports feeling better and has had no problems since.  Patient has history of mitrovalve prolapse.
This case was reported by a nurse via call center representative and described the occurrence of hives in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 20th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: This case was reported via click to chat. The patient just received a SHINGRIX vaccine on last Thursday, from the date of reporting. After receiving SHINGRIX, the patient was broke out with hives and wanted to know how long she needs to wait to receive a steroid injection. The reporter just wanted to see if there were suggestions on that. The reporter did not have the lot number. No additional information was provided.
I administered 2 vaccines to patient. I could tell she was nervous and slightly shaking. I administered BOOSTRIX in the right arm and meningitis in left. The patient passed out and fell our of chair about 5 minutes after administered. I asked if she had eaten anything and she said yes. I think it was her nervousness.
temp 103.8; severe chills; muscle aches; nausea; diarrhea; sinus congestion; mouth/tongue sores; mouth/tongue sores; sore throat; headache; This is a spontaneous report from a contactable other hcp. A 57-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EN5318), dose 2 intramuscular, administered in Arm Right on 28Jan2021 12:00 as SINGLE DOSE for covid-19 immunisation. Medical history included narcolepsy from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing HTN, thyroid disorder from an unknown date and unknown if ongoing thyroid disease, obesity from an unknown date and unknown if ongoing. Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; modafinil (MODAFINIL) taken for an unspecified indication, start and stop date were not reported; pitolisant hydrochloride (WAKIX) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported; pramipexole dihydrochloride (MIRAPEX) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (VITAMIN C) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B) taken for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken for an unspecified indication, start and stop date were not reported; tocopherol (VITAMIN E) taken for an unspecified indication, start and stop date were not reported. On 29Jan2021 02:00, the patient experienced temp 103.8, severe chills, muscle aches, nausea, diarrhea, sinus congestion, mouth/tongue sores, mouth/tongue sores, sore throat, headache. The patient underwent lab tests and procedures which included body temperature: 103.8 on 29Jan2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was recovering.
Information has been received from a medical assistant (M.A.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored ROTATEQ (lot # L035510, expiration date 13-MAY-2017, oral). GARDASIL 9 was supported in prescribing information. No adverse effects were reported. Additional information has been requested.
Sore throat/Cough on day 1.  Treated symptoms as if it was a cold. Sore throat, dry cough, fever on day 2. Symptoms worsening in severity. Sore throat, dry cough, fever, headache, fatigue on day 3. Symptoms worsening., continued to treat with OTC cold meds.  Called Dr. Was given an appt for Covid-19 test on day 4. Symptoms continued to worsen, was diagnosed positive for Covid-19 on day 5. Symptoms lasted approximately 8 days. Was cleared from isolation on day 10. Continued to isolate for 2 more days, as a precaution to returning to work.  Felt tired at the end of each day for approximately another 10 days-2 weeks. No lasting effects.
PT WAS BEING OBSERVED BECAUSE SHE STATED THAT SHE HAD A HISTORY OF FAINTING DURING A FLU VACCINATION. WITHIN 10 MINS OF DOSE, PATIENT STATED THAT SHE WAS FEELING DIZZY, RESPS INCREASED AND HEART RATE INCREASEDTO 151. PATIENT STARTED TO EXPERIENCE A SEIZURE. 911 WAS CALLED.  MD AND CODE TEAM CALLED. EMS ARRIVED. PATIENT TAKEN TO HOSPTAL ED BY EMS.
This spontaneous report was received from a licensed practical nurse concerning an approximately a 68 year old patient of unknown gender. On 08-OCT-2013, the patient was vaccinated with an improperly stored dose of 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J001007 and 24-APR-2014 respectively), subcutaneously in the left arm. Concomitant therapies included a dose of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified) administered on 08-OCT-2013 in the right deltoid and a dose of FLUVIRIN (lot number, expiry date, dose and route unspecified) administered on 08-OCT-2013 in the right arm. No adverse effects were reported at the time of report. Additional information has been requested.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 50-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). On 5th February 2018, the patient received the 1st dose of SHINGRIX. On 5th February 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In February 2018, the outcome of the injection site pain was recovered/resolved. The reporter considered the injection site pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. Pain at the injection site lasted for 3 days. For tolerability after receiving 2nd dose of SHINGRIX, refer case US2018GSK081832.
About 30 days after my second vaccine I noticed my short term memory deteriorating. I was terrified I was getting Alzheimer?s at 47 yo and was talking at work and found that 4 of my coworkers that got the same vaccines were having the same issues. One of the girls recently had a CT scan  I will pick up my phone or go to my email and cannot remember for what. I cannot remember if I have taken my medications. I?ll call someone and cannot remember why.
The worst abdominal cramps I've ever experienced to the point where I could not walk over the course of about 8 hours
Information has been received from a physician concerning a 7 year old male who on 4/13/1999 was vaccinated SC in the leg with a first dose of varicella virus vaccine live. Concomitant therapy that day included a first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) administered SC in the leg. On 6/6/2005, the patient developed breakthrough, described as mild case of chickenpox with less than 50 lesions. The outcome was resolved without medication on 6/10/2005. No further information was available. Unspecified medical attention was sought. There was no product quality complaint. No additional information was available.