chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Enlarged heart; Arm soreness; arm tenderness; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMEGALY (Enlarged heart), PAIN IN EXTREMITY (Arm soreness) and TENDERNESS (arm tenderness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010 ( illegible digit/letter) 21A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (Triple bypass performed two years ago.). Concurrent medical conditions included Osteoporosis (Osteoporosis in left knee). Concomitant products included PARACETAMOL (TYLENOL) for Osteoporosis, CLOPIDOGREL, PAROXETINE, ATORVASTATIN, BUPROPION, LOSARTAN, AMLODIPINE BESYLATE, VITAMIN D2 and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and TENDERNESS (arm tenderness). On an unknown date, the patient experienced CARDIOMEGALY (Enlarged heart). On 04-Mar-2021, PAIN IN EXTREMITY (Arm soreness) and TENDERNESS (arm tenderness) had resolved. At the time of the report, CARDIOMEGALY (Enlarged heart) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: heart was slightly enlarged (abnormal) Heart was slightly enlarged.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2021-239268 (Patient Link).
10-7-09 client's parent called and stated her infant received MMR, PCV7, HEP A, and VARICELLA on 10/7/09. Infant was taken to ER with generalized rash over her body. Parent stated symptoms had started appearing 6 hours after immunizations, but got worse the next day. Parent stated she was called from daycare, because the infant was not eating, and a little restless. Parent tool infant to hospital ER, and infant was treated with injection of BENADRYL, and dx was generalized hives R/T MMR. Parent stated ER physician stated allergic reaction was due to MMR
Information has been received from a doctor of pharmacy concerning a 64 year old female who in January 2009 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (lot number not reported). Subsequently the patient experienced itching, redness, burning, pain and a rash about 3 inches in diameter at the injection site. It lasted for about 2 weeks. As of 05-MAY-2009, there was a scar about 2 inches in diameter on the patient's arm. The patient had sought unspecified medical attention. At the time of reporting, the patient was recovering. Additional information has been requested.
Fever & chills & aches and pain all through my body and chest discomfort. I Idk if it is from my acid reflux .
Has continued L upper arm pain and numbness down to elbow, cannot raise L arm above 90 degrees. States vaccine caused these symptoms. Has seen her personal physician twice and is currently referred to a shoulder specialist
1 week after receiving the vaccine my arm swelled up and got itchy and painful. I felt unwell the day after, and had pain in my arm for 4 days after, but the swelling and itching didn't start until 1 week after.
Community event attended by staff offering Moderna and Janssen COVID vaccines to public. Client filled out consent and listed DOB. Client signed consent. Fact sheet offered, screening questions discusses with RN prior to vaccination. Client verbalized and agreed to receive vaccine. Client received 1 full dose of Moderna COVID Vaccine without any issues. Client was observed for 15 minutes by vaccinating RN without any observable or stated adverse reaction by client. Client ambulated from vaccination station in stable condition with a friend after observation time completed.  When entering information into system, client DOB was listed incorrectly. Called client and confirmed correct DOB. Client was 16 yrs of age and received full dose of Moderna COVID vaccine.  Writer called parent listed in system as responsible adult at # listed for follow up. Left 2 messages on 6/28/21 and 6/29/21 with voice mail to return call to writers desk #. No return calls received as of 6/30/21.
Joint ache in right elbow, same arm as injection. No other signs. First day of injections. Has resolved after 2 days.  Stabbing pain in webbing of left foot and hand. On hand between index and middle finger, on foot between big toe and next toe. Started on the morning of 3/25/2021 about 3 days and 20 hours after first dose. Issue is ongoing and the catalyst for this report.
16JAN91 chills, increased T achy - 103-102- 17JAN developed fine red rash 18JAN temp 99 - w/rash.
Pt seen on 3/11/2021 for left facial paralysis, increased tearing. and periaricular pain for 4 days. Pt diagnosed with Bells Palsy
Flair of Trigeminal Neuralgia, now getting ready to have to have surgery due to the inflammation on the cranial nerves from having the COVID-19 vaccines. Facial pain, Headaches, Ear Pain, Trouble Chewing, Trouble Sleeping, Fatigue, Eye Pain, Dizziness, Have been getting treated with medications, and can't get the pain and inflammation back under control. Have seen a neurosurgeon and was told it was now too complicated for the Gamma knife, I have to have open Brain surgery to get fixed, due to now having multi-cranial nerve involvement.
The evening of my vaccination I felt very light headed.  Also my joints were very achey and I was nauseous.  The next day I was not able to be out of bed for very long due to the same symptoms.  The symptoms eventually got better, but they have recurred every few days or so since that time.  I am still experiencing light headedness and joint aches on a regular basis to this day.
Non itching rash began on left wrist and went to shoulder, within a day rash was also on left arm, wrist to shoulder.
Client given booster at age 13. Clinician made aware of mistake and follow-up done.
Pt started coughing 10 minutes after receiving 1st dose of Pfizer Covid vaccine.  Pt was sitting down and started coughing.  She informed us she has an anaphylaxis reaction to penicillin.  We gave her 50mg of Diphenhydramine and gave her some water.  She was alert and communication with us. After 30 minutes her coughing subsided and she said she felt better.  She contacted her husband to dive her home.
On June 23, 2022, I started having a itchy throat and it sort of felt like allergies. On the June 24, 2022, in the morning I tested positive for COVID-19. I contacted Dr. on June 24th, 2022 at about 6 pm and she prescribe me Paxlovid.
5-6 pts (2-5 yrs) devel inject site react following vax from same vial ot DTP; react consisted of 1 or more of following sx: erythema, swelling 1-2 in, & mild low grade fever; several pts seen by MD; presumed recovery;
bruises in her mouth and on her stomach; Suspect platelet disorder; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 23Feb2021 at 18:30 (at the age of 65-years-old) as dose 1, single for COVID-19 immunisation. Medical history included overweight, antibiotic and latex allergy, implant done for her tooth, gastrointestinal upset (She is having an implant done for her tooth and was put on an antibiotic. She only took it for one day because she started to have gastrointestinal upset) and arthritis in both feet (Recently she has had two people die in her family. She attributes it to being upset. Recently she has arthritis in both feet that popped up out of nowhere. It is more in the left foot. She saw a Podiatrist and the orthotics are helping already), all from an unknown date. There were no concomitant medications. The patient previously took iodine and steroids and experienced allergies. The patient experienced bruises in her mouth and on her stomach on 25Feb2021 at 08:30. The clinical course was as follows: Patient wanted to know if bruises in her mouth and stomach area are side effects of the PFIZER-BIONTECH COVID-19 vaccine - She had the 1st dose last 23Feb2021 then symptoms came out today 25Feb2021. She got the shot on the twenty third at 6:30pm. She didn't have any kind of reaction at all, but this morning it's been a day and a half. She has bruises in her mouth and on her stomach. She looked it up and sees all the platelet problems. She is concerned about that. Is what she is experiencing a side effect? It says there have only been 36 people that have platelet issue. The bruise on her mouth is getting darker and bigger. It is on the corner of the lip going into the mouth. It is the edge of her lip. It is more of a purple color now. She has not had anything at this time, but she thinks she may go to get a blood test. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt noticed that there was a raised bloody scab at the site which started to bleed.  I examined the site and there was a raised area in the area that we would vaccinate with a scab on it.  It did not look infected but she received the vaccine almost 2 months ago.  Pt is unaware of any other injury to this area.  This is the first time she received the high dose flu vaccine.  I recommended that she receive the regular flu shot in the future.
Body chills; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 53-year-old non pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 25Mar2021 at 14:45 (at the age of 53-years-old), as single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, diabetes, compromised immune system and COVID-19, which was diagnosed prior to the vaccination. Concomitant medication was not reported. The patient previously took morphine (MANUFACTURER UNKNOWN) for unspecified indication and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 04:15, the patient experienced body chills and body aches. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body chills and body aches was resolving at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was screened appropriately, indicated she had no reason to think she was pregnant. Urine HCG just prior to vaccination was negative. Patient reported UTI symptoms 22 Jan 2019, routine labs drawn, which included a serum HCG (positive). Serum HCG qual and quant drawn on 30 Jan 2019: results positive and 8509.0 mIU/mL. Patient referred to OB and Regulatory Authority, is being enrolled in their Pregnancy Registry.
Patient got vaccine and went to restroom once given despite being told to wiat 15mins before going. After 10mins of being vaccinated patient stated not feeling well. His face became pale and bacame shaky and sweaty. We laid him on the ground and elevated his ffet and called 911. Patient felt batter and was sitting in chair when parmedics arrived. Once the paramedics arrived patient had another episode as previouse and threw up. After a while patient states he had 2 beers before coming for the  vaccine and had it on an empty stomach. Pstient was taken by paramedic to hospital for evaluation.
Lethargic; No energy; Cannot put one foot in front of the other; in bed for two weeks; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: was not reported) via an unspecified route of administration, administered anatomical location not reported, on an unspecified date, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced lethargic, no energy, cannot put one foot in front of the other and in bed for two weeks. It was reported patient called to report on the COVID 19 shot clarified calling about the Pfizer BioNTech COVID 19 Vaccine.  While providing details about himself he mentioned he knows a young lady's whose father Pfizer COVID Shot. He got their second shot and have been lethargic, no energy, cannot put one foot in front of the other He has been in bed for two weeks. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
App 2-3 weeks post vaccine, I noted increased in ectopy. I have a history of occasional pvc?s and with my PCP we increased my beta blocker. Over ensuing weeks ectopy became more frequent. I saw a cardiologist almost two weeks ago , have been on an event monitor , and got a cardiac MRI that shows myocarditis.
Patient presented due to a  painful boil of the proximal inner right thigh with drainage associated with fever, chills and generalized malaise.  He was admitted to the observation unit and started on intravenous doxycycline (cephalosporin allergy).  The patient did test positive for COVID-19 and was placed in appropriate isolation.
This spontaneous report was received from a 89 year old female patient with diabetes mellitus, hypertension and drug hypersensitivity. The patient's medial history included cerebrovascular accident. On an unspecified date in April 2015, the patient was vaccinated with ZOSTAVAX (dose, route and concentration were not provided). Concomitant therapies included glipizide, PLAVIX and losartan potassium (manufacturer unknown) and unspecified "water pills". Two days after receiving ZOSTAVAX, the patient experienced psoriasis all over her body. On an unspecified date the patient sought medical attention with an unspecified physician and a "skin biopsy" was taken which confirmed the reaction was psoriasis. The consumer stated that the physician has prescribed her numerous unspecified "creams" as treatment but "nothing has helped". There was no product quality complaint (PQC) reported. The outcome of psoriasis was reported as not recovered. Additional information has been requested.
Patient came in on 7/19/2018 c/o new skin rash over lump at left triceps area after vaccination on 7/18/2018. Patient stated she has sore throat, fever (98.1F, explained to pt that fever is 100.4 F or higher), fatigue and 1-dollar coin size lump  and pain in injection site.
9 days post injection: pain at injection site with heat and induration 6 inches above and below site. Pain extended down to wrist at one point. Pain and inflammation relieved with ASA Q 6-14 days post inj. 90% resolved.
Moderna COVID-19 vaccine EUA Apthous ulcers in mouth on buccal membrane of lower lip
Pt received Zostavax in left arm on 9/29 around 12:30 PM, Pt called pharmacy on 10/1 around 6:30 PM stating that injection site is "red, itchy, and size of an orange" but denies temperature, pain, or swelling in other parts of body. States feels fine but has watch site grow swollen over past 2 days. Did not recommend hi-antagonist due to medication interaction. Suggested cool dressing and to notify primary care in AM. Pt did not want visit to ER.
Sharp chest pain came on suddenly about 27 hours after second vaccine does. Sharp pain caused shortness of breath due to discomfort. Unable to sit/stand up straight due to discomfort.  Continued for 3 hours until laid down to rest/go to bed.  Symptoms returned shortly after waking up around 8:30am the next day (4/8) and continued all day long until bed around 10pm.
1/27/2021 - Arm pain the first 30 hours, then all okay. On Feb 4, N/A8 days later,  felt like a knot in location of shot, red , warm to the touch, itchy and pain.
severe reaction following the 2nd dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient for self. The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The patient reported having a severe reaction following vaccination. The reporter did not consent to follow up.
MMR, VAR and KINRIX given to pt who was anxious. Within seconds broke out in hives and complete rash head to toe. Pt checked no SOB or other sx given BENADRYL 2 Tsp and within seconds rash disappearing. Called and checked on afternoon mom said rash gone site areas also fine.
Rash on face and low fever, lasted several hours (was gone the next morning), treated with dose of Benadryl per Dr.'s orders. Rash/fever returned every day at the same time for 6 days. Treated with Benadryl each time successfully.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX (batch number CX5BG, expiry date 18th May 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (received 1st dose on 30th September 2018, for tolerance refer case: US2019GSK026941). On 30th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st February 2019, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, mobility decreased, injection site burning and injection site itching. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site erythema, mobility decreased, injection site burning and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, mobility decreased, injection site burning and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced injection site burning and had difficulty in lifting arm. The pharmacist reported that, the patient planned to follow-up with her physician on an unknown date.
Reaction to shot 3 1/2 cm x 2 1/2 cm - treat with Advil as needed, left leg.
Headaches, body aches, joint aches, fatigue, shortness of breath, fever, chills.
dizzinesss, loose/inflammed  joints, swollen/hot/red injection site and surrounding areas.
Lethargy and mental fog appeared on 2 February 2021. Taken to by paramedics to Hospital where she was admitted.  Diagnosis: Fever, pneumonia, and chest x-ray showed  left lung pleural effusion.  Underwent thoracentesis on 4 February 2021.  About 1000ml fluid removed.  Heart meds were adjusted to 100mg metoprolol succinate twice per day.  IV antibiotics given every 8 hours. Eventually discharged from hospital. Continued need for thoracentesis:  Incontinence began with greater frequency the week of 17 August 2020 Left lung pleural effusion so need a thoracentesis Thoracentesis 4 February 2021 Removed 1 liter fluid normal Thoracentesis 11 March 2021 Removed 1 liter fluid normal Thoracentesis   8 April 2021  Removed 1 liter fluid normal Thoracentesis 7 May 2021  Removed 1 liter fluid normal Thoracentesis 15 June 2021  Removed 750ml fluid normal Thoracentesis 16 July 2021  Removed 550ml fluid normal Thoracentesis 31 August 2021 Removed 500ml fluid Thoracentesis 11 November 2021 Removed 500ml fluid
1st dose 11/2021. Second dose not yet administered.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2021).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 02-SEP-2022 Reporter's Comment:  The reporter stated that the patient did not received second dose of Shingrix vaccine yet. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Rash and itching all over body, patient took BENADRYL oral 50mg and improved.
Red itchy rash at injection site on left arm, no treatment, still ongoing on day 2 so unsure of outcome
"Significant rash" per provider dictation. Rectal temp 100.0 degrees F.
While sleeping, rolling over in bed, severe dizzy spell, probably vertigo, lasted about 15 seconds. Since then, light dizziness throughout the day. But still today, in bed, laying down or rolling over creates that vertigo like dizziness.
Information has been received from a pharmacist concerning a male who was vaccinated with a dose of Varivax. Subsequently the patient developed a generalized mild rash 10 days after vaccination. No other symptoms were noted. No additional information was available. Unspecified medical attention was sought. There was no product complaint. Additional information has been requested.
pt recvd vax 15NOV95 & 16NOV95 called & stated became ill in PM of 15NOV95 & MD said pt had adverse vax event;pt stated had light h/a, nausea,sl shooting pain, even down to little toes;hx arthritis;exp hives
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml) (lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for each time were 40, 34 and R; 256, 33 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.