chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ringing in the ears; headache; off and on hot flashes; hot sweats; fatigue, off and on fatigue; fevers, off and on fever; body aches, left arm is still sore; chills; joint pain; pain at the injection site, continued into the next day; swelling at the injection site, continued into the next day; redness at the injection site, continued into the next day; stopped menstrual cycle for May2021; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (hot sweats), MENSTRUATION IRREGULAR (stopped menstrual cycle for May2021), HOT FLUSH (off and on hot flashes), TINNITUS (ringing in the ears) and VACCINATION SITE PAIN (pain at the injection site, continued into the next day) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM (KLONOPIN), CEFIXIME (FLEXERIL [CEFIXIME]), DICLOFENAC POTASSIUM (VOLTAREN ACTI), FLUOXETINE HYDROCHLORIDE (PROZAC), IBUPROFEN, MELOXICAM (MOBIC), MULTIVITAMIN [VITAMINS NOS], CALCIUM and FISH OIL, OENOTHERA BIENNIS OIL, TOCOPHERYL ACETATE (OMEGA 3 & 6) for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced MENSTRUATION IRREGULAR (stopped menstrual cycle for May2021). On 19-May-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site, continued into the next day), VACCINATION SITE SWELLING (swelling at the injection site, continued into the next day) and VACCINATION SITE ERYTHEMA (redness at the injection site, continued into the next day). On 20-May-2021, the patient experienced HYPERHIDROSIS (hot sweats), FATIGUE (fatigue, off and on fatigue), PYREXIA (fevers, off and on fever), MYALGIA (body aches, left arm is still sore), CHILLS (chills) and ARTHRALGIA (joint pain). On 02-Jun-2021, the patient experienced HOT FLUSH (off and on hot flashes). On an unknown date, the patient experienced TINNITUS (ringing in the ears) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (hot sweats), MENSTRUATION IRREGULAR (stopped menstrual cycle for May2021), HOT FLUSH (off and on hot flashes), TINNITUS (ringing in the ears), VACCINATION SITE PAIN (pain at the injection site, continued into the next day), VACCINATION SITE SWELLING (swelling at the injection site, continued into the next day), VACCINATION SITE ERYTHEMA (redness at the injection site, continued into the next day), FATIGUE (fatigue, off and on fatigue), MYALGIA (body aches, left arm is still sore), CHILLS (chills) and HEADACHE (headache) 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.
Left arm  injection sight sore, tender,  a little painful Fever  99 to 100.6 Achy bones and muscles.  Headache and fatigue
I was still feeling the long haulers symptoms when I received the 1st shot; Itchy arm; Red arm; Arm being sore; Feeling Queezy; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (I was still feeling the long haulers symptoms when I received the 1st shot), NAUSEA (Feeling Queezy), FATIGUE (Feeling tired), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Red arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Long hauler with additional side effects.) in July 2020. Concomitant products included PROGESTERONE (PROMETRIUM [PROGESTERONE]) and TESTOSTERONE for Hormone level abnormal, VITAMINS NOS, ESTRADIOL and PARACETAMOL (TYLENOL) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced NAUSEA (Feeling Queezy), FATIGUE (Feeling tired) and VACCINATION SITE PAIN (Arm being sore). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POST-ACUTE COVID-19 SYNDROME (I was still feeling the long haulers symptoms when I received the 1st shot), VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (Red arm). At the time of the report, POST-ACUTE COVID-19 SYNDROME (I was still feeling the long haulers symptoms when I received the 1st shot) had not resolved and NAUSEA (Feeling Queezy), FATIGUE (Feeling tired), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Arm being sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included antianxiety drugs.  Unspecified medical tests were done which came back as normal without damage to lungs or heart.  No treatment information was provided.  Company Comment: 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. Further information has been requested   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Added event Covid long haulers; 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. Further information has been requested
This is a cluster of 5 unidentified patients' who experienced similar adverse events following vaccination with FLUZONE. Initial report received from a health care professional on 09 September 2011. A group of 5 unidentified patients' received an intramuscular injection (route and sites not reported) of FLUZONE, sanofi pasteur Inc. lot number UT426AA, on unknown dates. The patients' reported symptoms after the vaccination of 2-3 inches of redness and swelling at the injection site, low grade temperature and body aches. Some of the patient's were bedridden for a few days. The outcomes were reported as recovered. Documents held by sender: None.
Improper preparation for thawed vial; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Improper preparation for thawed vial) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Improper preparation for thawed vial). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Improper preparation for thawed vial) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. No concomitant medication information was provided.  "Follow-up received on 14-Jun-2021 included no new information"   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021 contains no new information.
2 1/2 x 3 1/4 length area w/erythema @ site lt deltoid, area warm to touch;t96.9;
In the PM on the day of the vaccination, the patient developed an area of redness around the injection site on the left thigh. On 12/19/2000 the patient was seen in the office, with redness at the site, approximately 3 cm area. Doctor believes reaction is from DTaP
Arm (injection site) was a little bumpy and sore; Arm (injection site) was a little bumpy and sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Arm (injection site) was a little bumpy and sore) and INJECTION SITE PAIN (Arm (injection site) was a little bumpy and sore) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE SWELLING (Arm (injection site) was a little bumpy and sore) and INJECTION SITE PAIN (Arm (injection site) was a little bumpy and sore). At the time of the report, INJECTION SITE SWELLING (Arm (injection site) was a little bumpy and sore) and INJECTION SITE PAIN (Arm (injection site) was a little bumpy and sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
headaches; woke up with severe Charlie horses in legs; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Apr2021 16:30 (Batch/Lot Number: EW0150) at single dose in arm left (at 64-yaer-old) for COVID-19 immunisation. The second dose Pfizer COVID vaccine was scheduled for 23Apr2021 (this Friday). The patient's medical history and concomitant medications were not reported. No medical history (including any illness at time of vaccination), no family medical history relevant to AE. Back in 2009 she had the swine flu shot and that was because caller had new grand daughter baby and really bad if babies get it. Caller got the swine flu shot and had some pain in the kidney can not tell which side because does not remember. Reports it was momentarily did not go to doctor. Caller did report it to the Doctor. Doctor said the vaccine does not cause that. The pain in kidney was just there and done. The day of the first dose Pfizer COVID vaccine (02Apr2021) patient woke up in the middle of the night with severe Charlie horses in legs. The patient said she did not normally have Charlie horses but had had them before. She can not say if this was due to the Pfizer COVID vaccine but did have the Charlie horses the first night after receiving the first dose Pfizer COVID Vaccine. The day after receiving the first dose Pfizer COVID vaccine (03Apr2021) caller started having headaches, it off and on every day usually right in the temples and kind of moves up. It's mild and patient did not take anything for it. It's not normal for the patient. The next day started with that mild headache. Pain in her honestly quite concerned about taking the second dose Pfizer COVID vaccine. She did not know what was in Pfizer COVID vaccine or what it's doing to her. Patient was positive within self this has to do with the vaccine, did not get headaches and had one. No relevant test. The outcome of event headaches was not resolved, of event charlie horses in legs was resolved completely with no issue on 02Apr2021.   Referred to doctor. The caller was provided with phone number of :(Withheld) option 3 prior to attempted warm transfer. Unable to warm transfer due to high call volume.  No follow-up attempts are needed. No further information is expected.
Patient stated today (3-16-21) that her arm has been sore since receiving Shingrix in September. When patient was asked to provide more details, she stated that every once in a while she has trouble moving her arm up above a certain point and she will have a shooting pain down her arm, but that it occurs only once in a while. Patient was directed to follow up with her PCP.
11:00pm Slight fever over-night (gone by morning), 11:00pm Chills over-night (gone by morning) 10:00pm Slight Headache increasing in intensity throughout the night and next day. Went to work and took some ibuprofen in the morning,  by 2pm the 12th the headache returned as the ibuprofen wore off. Took Tylenol. By the time that wore off headache was gone.
Not receiving the second dose of Shingrix within 6 months after dose one; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. The patient reported that she had not received the 2nd dose of Shingrix within 6 months after dose one and till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up. No more information was available.
Case number PHEH2014US003961 is an initial spontaneous report received from a pharmacist on 24 FEB 2014 with a follow-up received on 01 APR 2014. This report refers to a 16-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with 0.5 ml of FLUCELVAX (batch number: 004011A, expiry date: JUN 2014) intramuscularly into left deltoid on 08 JAN 2014 at 5 PM. No adverse event was reported following this administration error (inappropriate age at vaccine administration).    Follow-up received from a pharmacist on 01 APR 2014: Site and time of vaccination updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 01 APR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Fever after 2nd shot; Shivering  and chills after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after 2nd shot) and CHILLS (Shivering  and chills after 2nd shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had COVID disease & positive PCR 6 months ago, prior to vaccination.), Heart disorder (Patient has heart problems and has a couple of stents in her heart.) and Stent insertion NOS.   On 04-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced PYREXIA (Fever after 2nd shot) and CHILLS (Shivering  and chills after 2nd shot). At the time of the report, PYREXIA (Fever after 2nd shot) and CHILLS (Shivering  and chills after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Polymerase chain reaction: positive (Positive) positive PCR 6 months ago, prior to vaccination..         No concomitant medication reported. No treatment information was provided It was reported that reporter mother did not complain of any heart symptoms so far, and she does not had medical history of Pericarditis and Myocarditis that he knows of.
I experienced menstrual bleeding just 1.5 weeks after my normal period. To date (5/25) I have gotten my period every 1.5 weeks since getting the second dose.
Amenorrhea. Normally progressing puberty beginning age 9.  MD expected menstruation to begin at age 12.  Still no period at age 13.  Experienced one abnormally long (30 days) period at age 13.5, then no further menstruation as of age 13 years 10.5 months.
tested positive after first dose/ I tested positive for Covid; She was still kind of under the weather a little bit; This is a spontaneous report received from a contactable consumer (patient) via medical information team and Pfizer sponsored program.  The 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: ER8731 and Expiration date: Jul2021), dose 1 via an unspecified route of administration, administered in arm right on 21Apr2021 at 12:50 (at the age of 47-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history and family medical history was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Apr2021, the patient was tested COVID positive after first dose and she did quarantine to the previous weekend. She was not showing any severe symptoms like fever or anything like that. She was still kind of under the weather a little bit. The patient wanted to know if she could proceed with second dose which was scheduled for 12May2021 or need to wait any longer to get her second dose. The patient was mostly recovered, but she was still feeling a little under the weather but had no more fever. On 28Apr2021, the patient underwent lab tests and procedures which included COVID-19 Rapid Test: positive. The outcome of the event tested positive after first dose/ I tested positive for COVID was recovering and she was still kind of under the weather a little bit was unknown.  No follow-up attempts are needed. No further information is expected.
Within hours of receiving my first shot, I became very tired. I took a nap and when I woke up my hips, particularly my right hip, was starting to hurt. The next morning the pain became more severe and within 2 days of that it was so bad, especially after being still for any length of time, that I couldn?t get out of bed. I was also having trouble with my eyesight at the same time and it also seemed to cause my heart to start throwing PVC?s much more than is normal for me. Basically it felt like every joint was inflamed, with the worst of it concentrated in my lower back and hips. I am not exaggerating when I say this was a severe reaction, it was. The worst of it lasted almost a week and it was over a month before I felt like I was back to normal.
Break through COVID . Pcr test given prior to  angioplasty. Positive test. Cold like symptoms and pneumonia
pt recv vax & exp hives;no med tx was administered & pt was reported to have recovered from this exp;past med hx reveals a healthy pt who's birth weight was 7pounds 13oz;
Low grade fever, severe body aches, severe headache and fatigue between 2-24 hours post-vaccination.  6 days post-vaccination, supraclavicular lymph node on the same side as injection site mildly painful swelling, has swollen to the size of a grape. On day 7, the node feels as if it has doubled in size over 24 hour period.
3 inch red, swollen, firm welt at injection site. It's itchy and hurts to touch. I thought it was a sunburn last night but this morning it felt very firm.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Within 5 minutes of receiving first dose of Moderna vaccine, patient felt lightheaded. Upon checking, BP was <70/50, with noticeable change in color and presence of sweating. Patient was given water and protein bar immediately, and patient began to feel better. Patient remained seated for another 10 minutes and BP was rechecked; BP was 99/70. Patient states that her BP typically runs low but she is feeling much better. Patient stayed seated for another 5 minutes before leaving pharmacy.
Last night I felt discomfort in my body so I took a Tylenol, since I woke up in the morning I felt discomfort in my head, I felt chills until the end of the day around 6:00 pm the discomfort went away
Developed systemic hives/urticaria starting 9 days after Moderna booster and still continues. Taking one Zyrtec a day which helps alleviate the itching but does not stop hives from forming.
Herpes simplex; Infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES SIMPLEX (Herpes simplex) and INFECTION (Infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Herpes simplex (She stated that over the years she had this medication once and has a history of herpes simplex 1.5 - 2 years ago).   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-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 HERPES SIMPLEX (Herpes simplex) and INFECTION (Infection). At the time of the report, HERPES SIMPLEX (Herpes simplex) and INFECTION (Infection) outcome was unknown.            Description of Event or Problem: The patient stated that she has been prescribed antibiotic in July for Valacyclovir (Valtrex) which is an anti-viral medication for herpes simplex outbreak per the patient. The patient has not yet taken antibiotic yet.
This case was reported by a healthcare professional and described the occurrence of elevated alanine aminotransferase in a 27-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject's medical history was unknown. It was unknown if the subject had any concomitant medications or if she had any adverse events following previous vaccinations. Social history included a monogamous relationship. The subject denied intravenous drug use. On 25 March 2008, the subject received 1st dose of TWINRIX (1 ml, unknown, left arm). No other vaccinations were given on 25 March 2008. On 26 March 2008, 1 day after vaccination with TWINRIX, the subject had routine lab work done that showed elevated alanine aminotransferase and elevated aspartate aminotransferase. It was reported that the alanine aminotransferase was extremely high, but no specific numbers were provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with TWINRIX.
Patient says he suffers from anxiety, but has not had a panic attack in years.  Suffered a panic attack the evening following the vaccination and feels it could be related
Mother states that child "was out for one half hour" after an apparent seizure.  She did not witness this activity.  She was told this by another family member.
Fatigue, heart palpitations, weakness in the legs, dizziness when standing/walking, & mild sweating at times. Duration has been since the shot. FYI: I was experience stress and lethargy prior to getting vaccine. I got a Covid-19 test on 1/14/20 suspecting possible Covid-19. The test was Negative. After receiving the vaccination, the symptoms I was experiencing previously worsened.