chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache / after first dose; slept the whole day; muscle aches; fatigue / was so tired; slight fever; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had mild case of shingles in April 2020). Previously administered products included zostavax (received 4 to 5 years ago from reporting date).   On 2nd December 2020, the patient received the 1st dose of Shingrix. On 2nd December 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, fatigue, fever, pain in arm and daytime sleepiness. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the muscle pain, fatigue, fever, pain in arm, headache and daytime sleepiness were recovered/resolved.   It was unknown if the reporter considered the muscle pain, fatigue, fever, pain in arm, headache and daytime sleepiness to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose in the left arm. The reporter stated that within a couple of hours after receiving 1st vaccine the symptoms of muscles aches, fatigue, slight fever and arm soreness were presented. On an unknown date. Less than 3 months after receiving vaccine, the patient experienced headache. The patient was so tired that she slept the whole day after receiving 1st dose of vaccine.  The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR052743.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR052743:same reporter
hives a few days later all over her chest and stomach; This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 12-APR-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 1 dosage form for prophylaxis (dose, strength, route of administration, lot# and expiration date were not reported).  On an unknown date in April 2019 (reported as a few days later) the patient experienced hives all over her chest and stomach.  The outcome of urticaria was reported as recovered approximately 2 weeks after. Causal relationship between  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and urticaria was unknown.
Respiratory difficulty and rash over body.  Administered Benadryl.  Pt appeared to recover.
This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a year after receiving BEXSERO, the patient experienced swelling arm and erythematous rash. On an unknown date, the outcome of the swelling arm and erythematous rash were unknown. It was unknown if the reporter considered the swelling arm and erythematous rash to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. They had a patient with a swollen arm and red raised bump for 5 days.
syncope and vomiting x1 Patient verbalized that he felt okay after vaccination. Family and patient returned to waiting room for 15 min post vaccine waiting period. Pt collapsed and mother caught patient under arms (no injury). Pt regained consciousness immediately and vomited x1. Pt placed supine with legs elevated on exam room table. RN monitored HR, BP and O2 saturation, all WNL for patient baseline. RN provided observation care, apple juice and snacks. Pt remained supine for 10-15 mins and then sat up for 15 minutes. Vital signs remained stable and pt verbalized that he felt much better. After 30 minute observation period, RN helped patient sit to stand and assessed balance. Pt returned home with family. RN left voicemail for patient's guardian today (7/29/22) for follow up.
Severe pain on upper arm No redness/swelling/temp 01/05/2011 call to her PCP due to increasing pain on arm with movement.
p/vax ringing in both ears inc; continue currently; from elbows to tips of fingers numbing & cold feeling; insomnia episode; no sleep;occasional short term memory loss; occasional extreme fatigue;
Information has been received from a consumer concerning a 12 month old son with birth defect where he had "a hole in his heart" and no allergies who on 03-MAR-2009 was vaccinated with a dose of MERUVAX II (lot number not available). Subsequently, the patient developed fever and became lethargic two hours after receiving MERUVAX II on 03-MAR-2009. He was brought to the emergency room on 04-MAR-2009 but was not admitted in the hospital and was sent home the same day. The consumer noted that she and her husband had stomach flu a week prior to the time when the patient got the MERUVAX II. The physician at the hospital thought that it could be the reason of patient's symptoms but the mother did not want to believe that because the patient did not show any demonstration of being affected of the stomach flu prior to him receiving the MERUVAX II. The patient recovered four days after having the symptoms on 07-MAR-2009. The patient sought unspecified medical attention. Additional information has been requested.
Patient had swelling, rash, pain to Rt arm, rash went up to neck. Pt took BENADRYL. Pt was out of town.
dizzy; She is kind of weak; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 14Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer. An 86-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiration date not reported), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history included diabetes from an unknown date. The patient experienced dizzy and she is kind of weak on 14Jan2021. It was further reported that the events started this morning, she was fine yesterday. The patient underwent lab tests and procedures which included blood glucose: 145 on an unspecified date. The patient did not recover from the events.
Has not received vax in last 10 years. Felt strange and fatigue after lunch. Tuesday woke up with flu-like symptoms, chills, aches which remained all week. Bicep (LA) was hot, red, hard. Took MOTRIN which helped somewhat. Went to doctor on Friday. Diagnosed with cellulitis and prescribed amoxicillin. Today, already finished antibiotics, and feels fine.
pt recv 18AUG97 & 21AUG97 pt devel warmth, sl swelling & itching @ the inj site;past vax booster hx was reported as unk;MD feels that this is vaccine related;
This spontaneous report as received from a medical assistant refers to an unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown date in 2015 (reported as "between 01-MAY-2015-09-SEP-2015"), the patients were vaccinated with doses of improperly stored M-M-R II (dose and route were not reported) lot # K024824, expiration date 02-DEC-2016 and lot # K007107 expiration date 16-JUN-2016. On an unknown date in 2015 (reported as "between 01-MAY-2015-09-SEP-2015"), the patients experienced redness at the injection site. There was no treatment given for adverse event. The outcome of redness at the injection site was unknown. The relatedness between redness at the injection site and suspected therapy was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Next day after injection, she had redness, some swelling and warm to touch area. Following days redness seemed to spread and area turned black and blue. Pt stated said had similar rx last year, not as severe.
suspected vaccination failure; he came down with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: he came down with shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient's wife via interactive digital media. The reporter stated that please beware of shingles vaccine. The patient had shingles vaccine, he came down with shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2023AMR061462, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR061462:reporter´s case
Developed very large local reaction upper left arm, generalized pruritis. Treated with epinephrine, Claritin, Prednisone and Motrin. Symptoms peaked at about 4 hours after injection was given.
diffuse shaking (?rigors) (non epileptiform), no fever w/in 2hrs of vax;
Headache, Myalgia & Fever Narrative:  Pt reported headache, body ache, fever day after receiving covid vaccine dose #2. Pt self treated with tylenol.   Other Relevant History:
Fever 100 degrees Chills severe Body aches mostly legs Mild soreness in injection area (nothing more than a typical shot)
SEIZURE; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: seizure, and virus. The patient received covid-19 vaccine ad26.cov2.s (vaccination dose series was 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) 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. The reporter stated that " grandson had a virus over 1 year ago so immune system and incepilitious caused the seizure was in hospital for 2 months on meds and got the vaccine this year and had the seizure" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211213078-COVID-19 VACCINE AD26.COV2.S-Seizure. This event is considered unassessable. The event 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.
Patient presented with itchy rash all over her whole body that started the night prior. Mildly pruritic.  Appetite low and some fatigue.  no fever.  No cough, coryza, or conjunctivitis.   She had one lesion in right oral mucosa suspicious for a koplick spot.
Info regarding Prevnar vaccine was received from a healthcare professional regarding a 2 month old male pt who experienced injection site redness and injection site lump. At 2 months of age, the pt received a dose on 7/20/05. Pt had no relevant medical history. Indication for Prevnar was immunization. Product was administered on 7/20/05. Dose regimen was 1 dose, IM. Pt was not taking concomitant therapy. EVENT DETAILS: On 7/20/05, the pt received 1 dose of Prevnar. The very next day, pt experienced a red lump at the injection site. Pt was treated with ice, diphenhydramine and Tylenol for the discomfort. No further info was provided. Added note: Caller stated that 2 pts experienced the same event.
Severe eye pain, was diagnosed with uveitis by healthcare provider. Prescribed a steroid eyedrop.
arm swelled up/almost like a baseball/It was humongous; arm was red; arm was inflamed; arm was hot; couldn't get up and walk; when she got up, she got dizzy; had sores on her face; her eye was almost shut because of the swelling; shingles in the left side of her face and left eye and it hurt; whole body started aching; More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot) and GAIT DISTURBANCE (couldn't get up and walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker. Concomitant products included IBUPROFEN and FEXOFENADINE HYDROCHLORIDE (CHILDREN'S ALLEGRA ALLERGY) for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot), GAIT DISTURBANCE (couldn't get up and walk), DIZZINESS (when she got up, she got dizzy), FACIAL PAIN (had sores on her face), SWELLING OF EYELID (her eye was almost shut because of the swelling), HERPES ZOSTER (shingles in the left side of her face and left eye and it hurt), MYALGIA (whole body started aching) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot), GAIT DISTURBANCE (couldn't get up and walk), DIZZINESS (when she got up, she got dizzy), FACIAL PAIN (had sores on her face), SWELLING OF EYELID (her eye was almost shut because of the swelling) and MYALGIA (whole body started aching) outcome was unknown and HERPES ZOSTER (shingles in the left side of her face and left eye and it hurt) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Inhaler..
Patient states she has a raised red hard area 3"x3" on her upper left arm where the ZOSTAVAX was given. It stayed that way for 3 days. Today s he states it is not as hard or as large.
throat numbness and tightening, was given IM diphenhydramine and observed for 30 minutes. Arm had red painful oval shape for a week
Child has had a high fever of 104 throughout the night with shaking & dry heaves. Today is limp, unable to keep eyes open, drinking liquids poorly.  Motrin given every 4-6 hrs. Dr. appt. this aft. Last temp. 102.7. mother reports older sibling had similiar reaction.
Then 3 days later anxiety; Then 3 days later anxiety & panicattacks.; Instant tingling all over; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6703) via an unspecified route of administration in the arm left on 15Mar2021 at 15:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included fluticasone propionate, salmeterol xinafoate (WIXELA INHALER) and salbutamol (ALBUTEROL) both for unknown indication and started on an unknown date. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6703) via an unspecified route of administration in the arm left on 22Feb2021 at 15:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021, the patient experienced instant tingling all over for an hour. On 18Mar2021 at 13:00, the patient experienced anxiety and panic attack. It was reported that 2 months later the patient still had events. The events resulted in a visit to doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were not taken as a result of these events. On 26Mar2021, the patient underwent nasal swab COVID-19 test and the result was negative. The clinical outcome of the event instant tingling all over, anxiety and panic attack was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a physician, concerning a 23 year old female who was vaccinated on an unspecified date at another facility, with the first dose of Gardasil (Lot # not provided). Ten days after the vaccine was administered, the patient developed redness and swelling at the injection site. She also developed general malaise and dizziness (onset timeframe not specified), and 17 days after the vaccine administration, she developed bilateral lymphadenopathy. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. No further information is available.
Pt developed macular rash on trunk and proximal parts of upper and lower extremities, 4 months old.
migraine- type headache, neck pain and stiffness on right side, eventually arm pain also on right side (Pain was different from regular pain), extreme fatigue
Had dose 4 on 04/20/2022, started feeling feverish the middle of June and tested positive on 06/20/2022 with a home COVID test. Called Dr. and was prescribed PAXLOVID.
Sterile water was used as the diluent with the Covid Vaccine (Phizer)instead of normal saline.
Rash started within 72 hours of the injection on tops of both feet around ankles behind knees then spread to back torso and genital area
ongoing symptoms day 2 with HA, muscle aches and pains, dizzy and feeling faint x3 today.
Within 10 minutes patient experienced facial flushing/hotness, patient notified RN vitals checked within normal limits. Evaluated by MD as well. Facial flushing/hotness lasted into day 2 with added chills. Patient was instructed by MD to take Tylenol which seemed to resolve symptoms within 1-2 hours.
9:28AM Developed local urticaria at varicella imm sight right away. Cold compresses and 3.4mL Benadryl given. No generalized rash, cough or wheezing. Lungs clear and pulse ox 100%. Observed in MD office. 9:57AM: Pt playing/walking. Hive at site smaller in size. 10:15AM: site of IM minimally erthematous appx 1 cm. No other SX. No other reactions.
pain in arm; jaw pain; lymphadenopathy; Joint pain; Fever; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (pain in arm), PAIN IN JAW (jaw pain), LYMPHADENOPATHY (lymphadenopathy), PAIN IN EXTREMITY (Joint pain) and PYREXIA (Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), PAIN IN JAW (jaw pain), LYMPHADENOPATHY (lymphadenopathy), PAIN IN EXTREMITY (Joint pain) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (pain in arm), PAIN IN JAW (jaw pain), LYMPHADENOPATHY (lymphadenopathy), PAIN IN EXTREMITY (Joint pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-015015, MOD-2021-015015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Feb-2021: No specific follow-up information recorded.
Fatigued/ tired; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the right arm on 29Aug2021 at 11:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Aug2021 at 10:00, the patient was fatigued/ tired. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event fatigued/ tired was resolved on an unknown date in Aug2021.
Patient did not contact pharmacy to report event until Tues 11/24/20.  Stated that about 30 minutes after vaccination she had redness on face, neck, and chest.  Redness turned to itching.  She appied calamine lotion to soothe itching, did not seek medical treatment.  Patient said symptoms were improved, gone by next morning.
I developed a headache, sore throat, cough, fatigue, absolutely no energy, I used a home COVID-19 test, that did come back positive. I called my doctor's office to have a telehealth visit to discuss my positive test result and symptoms. I was prescribed the Paxlovid and was able to start it on April 6, 2023. I started feeling better after taking the full five-day regimen.  I do still have a cough and some phlegm in my throat, I am testing negative though. I am not completely over this but I am feeling better.
About 24hrs after the shot was given, there was swelling, redness and hardness of the muscle in the upper deltoid of the left arm. The size of the redness was about the size of an avocado. 48 hrs later  the redness grew to be as large as almost her whole upper arm, but the hardness had lessened. 56 hrs later, the patient was vomitting, but the redness decreased, hardness decreased and only a little bruising and rash like red dots were visible.
Breakthrough case admission after 4 vaccines Moderna 2/28/21 Lot# 010A21A;  Moderna 3/28/21 Lot# 018B21A;  Moderna 11/11/21 Lot# 051F21A;  Moderna 10/6/22 NO LOT #  INFORMATION NOT AVAILABLE IN LOCAL DATABASE
4wk post vax pt devel a sense of distrubance & a clinical course of chronic inflammatory demyelinating polyneuropathy;electrostudies supported both axonal & demyelinating polyneuropath & paraspinal fluid protein elevated;devel pseudotumor