chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bowel movement; Sore arm; Gas pain; Tremendous constipation; Bloated; Pain; Making me miserable; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FLATULENCE (Gas pain), CONSTIPATION (Tremendous constipation), ABDOMINAL DISTENSION (Bloated) and PAIN (Pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included ATENOLOL, LISINOPRIL, POTASSIUM, WARFARIN, PRIMIDONE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 07-Feb-2021, 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 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FLATULENCE (Gas pain), CONSTIPATION (Tremendous constipation), ABDOMINAL DISTENSION (Bloated), PAIN (Pain) and FEELING ABNORMAL (Making me miserable). On an unknown date, the patient experienced BOWEL MOVEMENT IRREGULARITY (Bowel movement). At the time of the report, PAIN IN EXTREMITY (Sore arm), FLATULENCE (Gas pain), CONSTIPATION (Tremendous constipation), ABDOMINAL DISTENSION (Bloated), PAIN (Pain), FEELING ABNORMAL (Making me miserable) and BOWEL MOVEMENT IRREGULARITY (Bowel movement) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products also included Thyroid medications No treatment medication included.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up Received on 06-AUG-2021 and no new information was provided and the consent denied for follow-up
Body aches; This is a spontaneous report from a non-contactable consumer. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: SN5318) via an unspecified route of administration, administered in Arm Left on 17Feb2021 as DOSE 2, SINGLE (at the age of 39-year-old) for covid-19 immunisation. The patient received the historical vaccine of bnt162b2. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches on 18Feb2021. The patient did not received any treatment for the event. The outcome of the events was recovered on unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Sore, bump - arm sore and radiated up the neck (the next day). I recommended heat & massage. On the 4th day pain is just localized with a small bump. Doing much better. She has fibromyalgia and only weighs 94lbs. Arms very skinny.
The right side of my face was numb and felt uneven, my throat felt very dry, tingling in my right side of the body. No treatment the symptoms went away within two hours. However, the right side of my face feels tight not numb.
Pt states injection arm is unusually sore and range of motion in arm is decreased and seems to be worse as time progresses.
Information has been received from a 74 year old female with arteriosclerosis, and diabetes and a history of left eye twitching before vaccination who on 11-JUL-2008 was vaccinated with ZOSTAVAX (Merck). On 19-JUL-2008 the patient experienced Bells Palsy. Sporadically her face starts drooping by her mouth and her eye twitches. She has seen an eye doctor and has a future appointment with a neurologist. Magnetic resonance imaging (MRI) was performed, but the result was not reported. At the time of reporting, the patient's Bells Palsy persisted. Upon internal review, Bells Palsy was determined to be an other important medical event. Additional information has been requested.
Information has been received from a consumer concerning her 8 week old son with no pertinent medical history and no drug reaction or allergies on 24-MAR-2011 was vaccinated subcutaneously with a 0.5ml dose of MMR II (Lot# 669200/1346Z, expired date October 2012). There was no concomitant medication. On 24-MAR-2011 the patient experienced fever, a knot in the leg and seemed spaced out. The reporter reported this to the doctor who advised the reporter to give her son TYLENOL and wait. No lab diagnostics studies performed. The reporter stated she was concerned that MMR II was given at a young age. The reporter planned to follow up with her health care provider. At the time of this report, the status of the patient was not known. Additional information has been requested.
Presented with SOB x2 days; CT with bilat PNA; + Covid PNA; Labs: D-dimer 10.16; Ferritin 841; Tx: Maxipime, Decadron, Remdesivir, Zinc, Lovenox, singulair,  supplemental O2 via NC; back to baseline at discharge
This is a spontaneous report received from a noncontactable other HCP (parent). A 7-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced pyrexia (fever), pain in extremity (arm pain), pain (body ache), with outcome of not recovered; and headache, with outcome of unknown. Therapeutic measures were taken as a result of pyrexia, pain in extremity, pain and headache. No follow-up attempts possible. No further information expected.
This spontaneous report was received from a healthcare worker regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 18-JAN-2016, the patient was vaccinated with expired M-M-R II lot # K000738, expiration date- 16-JAN-2016 (expired product administered). No adverse event was reported. No concomitant medication was reported. No PQC (product quality complaint) was involved. The outcome of the event was unknown. Additional information has been requested.
Rash and soreness at first, seven days later swelling, large round welt and itching
Adult vaccine was unavailable and instead, she was given the contents of two 0.5mL pediatric vaccine vials. The contents of each were drawn up together and given as one shot. She received the shot on 11/13. On 11/15, she noticed burning and redness under her arms. By 11/18, she developed hives to her legs. She was instructed to take Benadryl 50mg PO. She also mentioned she had been using Stacker 3 fat burner dietary supplement and had worn a new pair of jeans without washing them. The reporter recommended she stop the supplement and not wear the jeans. On 11/19, she was seen by the reporter. She was in no acute distress. On exam, her thoracic back had scattered papular eruptions and she described her back as burning. Both axillae demonstrated redness, anterior to both axillae, and including the superior aspects of her breasts. And there was some degree of pre-existing facial acne. Redness, on a scale of 0-10, is deemed a 7. She also described her legs as pruritic. Findings on her legs were rather scant-faint scattered redness. Her lungs were clear. Heart rate and rhythm ok. He suspected an allergic reaction. He administered Kenalog 40mg IM in her deltoid. Since 11/20, she states itching is less. Redness has decreased on the right axilla, abut there was no change in her left axilla. As of today, there was no further changes.  The reporter is arranging for a dermatology consult. The reporter also located a relevant article in a journal. It discussed erythema nodosum skin reactions may occur rarely and may be associated with an immune complex etiology. The reporter could not rule out the Stacker 3 dietary supplement as a suspect, so it is also listed.
This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in left arm on 31Mar2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunization. Medical history included sulfonamide allergy. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3247) via an unspecified route of administration in left arm on 10Mar2021 at 11:15 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination. Since vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 23:00, the patient experienced headache. No therapeutic measures were taken as a result of the event. The adverse event 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 event headache was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
After getting the two shots all was OK. After getting the booster shot, the effects started. 10 days later pain in joints traveled from left hands/elbows/shoulder/hips/knees to the right side. So debilitating in her hands she cannot use them, has no strength and severe joint pain. Fell and found on the floor after 2 days, could not stand. 5 months later developed clots in legs, needed a stent put in to improve blood flow. 9 months after, still have the debilitating joint pain and no use of hands. It has also affected her lungs. She is now on oxygen 24/7. Rheumatoid doctor does not believe she has R.A. and is monitoring for a few months.
Information has been received from a 65 year old male patient with no pertinent medical history and no known drug allergies who on 03-DEC-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 vaccine (lot# not reported).  There was no concomitant medication.  On 04-DEC-2009 the patient woke up with the left side of his face completely paralyzed.  He went to the emergency room on 05-DEC-2009 and was diagnosed with Bell's Palsy.  Since then he had had severe pain around his left ear and cheekbone and as well a dry eye and also had a dull ache at the top of his head.  His physician prescribed VALTREX (manufacturer unspecified) and prednisone (manufacturer unspecified) but the paralysis had not gotten any better.  "Blood work up" was performed but the outcome was not reported.  Follow up information has been received from a physician and medical records concerning a 65 year old male patient with no history of diabetes or facial pain, and "some" hypersensitivity to hearing in left ear who on 03-DEC-2009, at 12:30 PM was vaccinated IM into the right deltoid with a first 0.5ml dose of PNEUMOVAX 23 vaccine (lot# 664653/1337Y).  There was no illness at the time of vaccination.  On 04-DEC-2009, the patient experienced Bell's Palsy which occurred the day after vaccination.  On 07-DEC-2009, the patient was seen by a neurologist.  The neurologist reported that on 04-DEC-2009 (also reported as three days ago), the patient woke up with an odd sensation on the left side of his face and by mid afternoon, he was having difficulty moving the muscles of his left side of his face.  He was subsequently seen in the emergency room where he underwent an evaluation and then placed on prednisone and VALTREX for a period of five days.  It was noted that the day prior to the onset of his Bell's palsy, he had received a PNEUMOVAX 23 vaccine shot.  Otherwise he had not been under any other health issues.  No fevers had been reported.  A detailed neurological examination was performed and there was severe weakness of the muscles on the left side of his face.  However, his neurological examination otherwise did not reveal any other findings.  The neurologist impression stated that the patient had developed a complete Bell's Palsy on the left side of his face.  Subsequently, at the time of the report, the patient recovered on an unspecified date.  Additional information is not expected.
soreness in shoulder...cant lift my arm...cant put my arm behind my back...still very sore...
Patient had a synoptic episode approximately 10 minutes after receiving the vaccine.  She fell and quickly regained consciousness. She recovered in a chair in about 15 minutes.  She denied any injuries and did not require any emergency services.
shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2019, the patient received the 1st dose of Shingrix. On 22nd July 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The patient received the diagnosis of shingles. Emergency room visit was required. The reporter stated that the letter from safety could be mailed to his house as he was not sure if he wanted his doctor to receive it. The outcome reported for the event in the structured field is "recovering/ resolving " instead of "not recovered/ not resolved" (outcome uploaded).
Pt received pneumonia vaccine in A.M. 10/21/2010. Pt. states arm swelled by the evening of 10/21. Pt visited local ER 10/23/10, given amox-clar and cetirizine for possible cellulitis or allergic reaction. When pt came to pick up scripts, pt's upper arm was swollen with large red patchy area.
Post vax, the patient developed a "lesion rash". The patient sought unspecified medical attention. Follow up information from the physician indicated that the patient broke out with 2 or 3 lesions about 10 days after vaccination. It was reported that the physician did not consider this to be an adverse experience. No further information is expected.
A nurse reported that a pt received an injection of Pnu-Imune 23 and subsequently, developed cellulitis. The pt was treated with IV antibiotics. This is 1 of 2 pts from this facility who experienced cellulitis following receipt of Pnu-Imune 23 (lot 463748). Additional information received on 6/22/01, indicated that an 11 year old female received Pnu-Imune 23 on 5/10/01 and the next day, developed cellulitis. The pt was hospitalized. She recovered.
32/89 pt failed to maintain adequate titers 27-months post vax w/rabies vax;
Patient stated her arm began to sell and feel feverish in the early morning late evening after the vaccine.  She said she was "out of her head", didn't know where she was and incontinent
elevated D-Dimer, elevated troponin, Left coronary cusp of the aortic valve is thickened. Mild AI. TEE
swelling; had the shringrix shot thurs, and am wondering how long before the redness subside; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were unknown.   It was unknown if the reporter considered the swelling and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced redness and swelling. The patient was inquiring how long would it take to resolve.  The reporter consented to follow up.
Immunization given 3/8/23 but med expired 3/2/23. No adverse effects have been reported so far.
Received 2nd dose of the Pfizer Covid vaccine and woke up with a rash on my chest the next day, then developed a uti and yeast infection, went on to develop blisters on my lips, heart attack like symptoms, Bell?s palsy and they thought I was having a stroke, since then I?ve had non stop tingling all over the body, numbness on right side of body and it hasn?t gone away. I?m horrible pain with heart and nervous system issues.
Pharmacist was giving Moderna Covid-19 Shots. Pt came in to get Shingrix shot. Prepared shot to give and inadvertently gave third dose of Covid-19 shot. Second shot of Covid-19 given on 3/3/21. Pt was about to leave then pharmacist noticed mistake. Apologized to patient, then proceeded to give Shingrix in other arm. Pt was ok with mistake and on follow-up no adverse reactions. Going forward pharmacist will use different color needle tips as to not make future mistake while giving out Covid-19 vaccinations and other vaccinations at same time.
1day after 2nd dose, exhaustion, joint aches and stiffness  Ongoing symptoms, as of 6/6/21- extreme joint aches, knees, hands, elbows sometimes severe, sometimes milder
SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT.  Initial report received on 18 January 2008 from a patient.  A 46-year-old female patient, with a medical history of seasonal allergies, had received a right deltoid, intramuscular injection of Fluzone SV 2007-2008, lot number U 2491AA, on 23 October 2007 in the a.m.  At 6:00 p.m. on the same day, the patient developed hives on her face, lips, and ears.  She was examined by a physician twice and treated with Benadryl and prednisone.  The symptoms resolved but returned when the patient was no longer taking the prednisone.  The patient indicated that egg products may possibly cause similar symptoms.  The patient had unspecified blood testing for allergies, but results were not provided.  At the time of this report, the patient had not recovered.
Information has been received from a nurse concerning a 21 month old patient who on an unspecified date was vaccinated with at least one dose of VARIVAX (Merck) (Lot # and route no reported). The nurse reported that the patient on an unspecified date came down with chickenpox. At the time of the report, the patient outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient reported tingling and numbness to one side of face and spreading down her neck.  Patient transferred to E.D. for observation.
Hasn't received a second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose over year ago).   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 Information: GSK receipt date: 13-Feb-2023 Reporter's comment: The pharmacist reported that the patient received first dose of Shingrix over a year ago and had not received a second dose. The reporter consented to follow up. Additional supportive information: Till the time of reporting the patient did not received the 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Information has been received from a healthcare professional concerning her 17 month old son who in 5/1999, was vaccinated with MMR. In May, 1999, the pt experienced local reaction at injection site "about 8cm hard and red with bruises all around it." The pt was vaccinated with a 25 gauge, 5/8" needle. The pt sought unspecified medical treatment. The pt's local reaction at injection site persisted. Additional information has been requested.
Thursday and Friday night i had heart palpitations.  Thursday night I had body aches all over and night sweats.  Also night sweats Friday and Saturday night.  Friday I broke out in a rash on the insides of both thighs and under my arm pits.
I had sore throat, cough, if I had a fever it wasn't very high, and I was feeling flu'ish. The symptoms were not very severe but enough that I did get a PCR test because I was traveling overseas and didn't want to infect anyone. Also I knew I was exposed by my granddaughter.  I went and got tested at a walk-in site. I believe the strain was the strain.
p/vax pt exp flu-like sx; swollen hands; inc blood sugar (250); pain in wrists; hands; feet & ankles;dx:polymyalgia rheumatica; tx: acetylsalicylic acid & advil; sed rate-nl;
HAD DINNER AROUND 6:30 PM, SUBSEQUENTLY ABOUT 7:30 P.M. WENT TO THE BATHROOM AND THREW UP EVERYTHING I HAD EATEN, I TRIED TO CLEAN UP THE MESS I HAD CREATED AND FOUND I WAS DIZZY AND COULDN'T STAND UP EASILY. I KEPT FALLING TO MY RIGHT SIDE. I DECIDED TO GO TO BED AND WOKE UP THE NEXT MORNING CONSTANTLY FALLING TOWARD MY RIGHT. I HAD SOMEONE TAKE ME TO THE EMERGENCY AT THE HOSITAL WHERE I WAS ADMITTED AND WAS TESTED.
Initially with burning sensation at injection site similar burning sensation now migrating in other location. At first arm of injection site-deltoid for 1 week ipsilateral thigh then contralateral thigh then (R) forearm. Currently (R) eye. One month duration.
Seizure reported to this RN the morning after clinic. Seizure happened after clinic ended and this RN did not witness event.