chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cramps on inner thigh; Weakness; Breathing was rapid; Finger tips purple; Light headed; hands pulsating,clammed up; Hands sore; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Cramps on inner thigh), ASTHENIA (Weakness), RESPIRATORY RATE INCREASED (Breathing was rapid), NAIL DISCOLOURATION (Finger tips purple) and DIZZINESS (Light headed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced MUSCLE SPASMS (Cramps on inner thigh), ASTHENIA (Weakness), RESPIRATORY RATE INCREASED (Breathing was rapid), NAIL DISCOLOURATION (Finger tips purple), DIZZINESS (Light headed), MUSCLE TWITCHING (hands pulsating,clammed up) and PAIN IN EXTREMITY (Hands sore). At the time of the report, MUSCLE SPASMS (Cramps on inner thigh), ASTHENIA (Weakness), RESPIRATORY RATE INCREASED (Breathing was rapid), NAIL DISCOLOURATION (Finger tips purple), DIZZINESS (Light headed), MUSCLE TWITCHING (hands pulsating,clammed up) and PAIN IN EXTREMITY (Hands sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient had swelling at site, Redness noted. pain to site, and some mild itching note. The symptoms began in the afternoon of the injections. Patient came in and was seen the following day. The physician instructed for patient to take zrytec as needed for itching, using ice pack for swelling and Tylenol for pain.
received COVID-19 booster, Pfizer, on Friday October 29, 2021 in my left arm. The arm was sore. On Sunday morning 10/31 I noticed an enlarged lymph node in my left axilla that was very sore to move and to touch. I seemed fatigued with a headache as well. I was due to work on Monday 11/1 but stayed home, took ibuprofen and rested. Today the lymph node seems smaller, not as tender.
soreness in left arm and shoulder, fatigue, low grade fever. soreness and fatigue started afternoon of day of injection.  low grade fever and fatigue worsened the next day.
For approximately 24 hours following onset: feeling of ears burning, cold sweats, hot sweats, nausea, vomiting  From onset to present: loss of balance, complete loss of hearing in right ear, partial loss of hearing in left ear 11/9/2009 Hospital records for 10/26-10/27/2009. Patient with c/o's nausea, vomiting, diaphoresis and vertigo. Tx: telemetry, PT eval, IVF, IV Benadryl, Reglan and Zofran. DC DX Vertigo secondary to viral etiology 11/9/2009 ENT eval for 11/2/2009. Patient seen with c/o's sudden hearing loss. Audiogram noted sensorineural hearing loss rt worse than lt, Labyrinthitis rt TX: Prednisone, MRI Brain to be ordered  Labs: CBC, HGB low, Cardiac enzymes norm, Blood glucose high DX studies: CT head and Carotid doppler studies normal 11/9/09 Medical records received from ENT date 11/2/09. DX: sudden hearing loss rt. side. Sensorineural hearing loss, asymmetrical, rt. worse than left. Labyrinthitis. Presenting with c/o sudden hearing loss and vertigo. Pt. states occurred 3 hours after H1N1 vax. Noted a warm sensation in ears then rt. side hearing loss and vertigo. Vomit x1, Assessment: audiology testing performed abnormal results, neck rigid.
the vaccine came out of the syringe while it was being administered to the patient; the vaccine came out of the syringe while it was being administered to the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (the vaccine came out of the syringe while it was being administered to the patient) and DEVICE CONNECTION ISSUE (the vaccine came out of the syringe while it was being administered to the patient) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced UNDERDOSE (the vaccine came out of the syringe while it was being administered to the patient) and DEVICE CONNECTION ISSUE (the vaccine came out of the syringe while it was being administered to the patient). On 23-Mar-2021, UNDERDOSE (the vaccine came out of the syringe while it was being administered to the patient) and DEVICE CONNECTION ISSUE (the vaccine came out of the syringe while it was being administered to the patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not provided.  No treatment information was provided.
Mother states patient cried 4 hours after vaccine administered on 8/4/15 patient had swelling of (R) deltoid, arm, and hand with alterations of warm/cold to touch. Patient complained her throat felt tight and she couldn't breathe. Patient also said "felt like something was sitting on her chest". Then mom noticed patient seemed lethargic and confused. Today patient is having headache and neck pain.
Patient presented to the ED on 4/4/21 with viral illness and left sided chest pain. Patient presented to the ED on 4/14/21 with chest pain and was subsequently hospitalized for NSTEMI. These visits are within 6 weeks of receiving first COVID vaccination dose.
Extreme non stop itching on the soles of my feet without presentation of rash, bumps or redness. 24 hours after second dose, duration of at least 48 hours.
Stiffness and swelling in lymph nodes around the neck. Painful swelling  in the armpit . I was told to manage with ibuprofen and allergy meds.
A 2-YEAR-OLD WAS GIVEN AN ADULT DOSE OF PFIZER. THERE WAS NO ADVERSE REACTION NOTED
Currently can?t get warm with body chills/shakes but probably have a fever. Headache and nausea. Took 2 ibuprofen 200mg/ea at 0130
This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-2022 at 10:07 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   On 15 Jun 2022, the vial was initially stored in the refrigerator. On 23 Jun 2022, at 10:10 A. M. the vial was first punctured. Total amount of time the vial was exposed to room temperature range was (8 degree to 25 degree C-46 degree C to 77 degree F): less than 24 hours.
My arm started swelling & getting a short time after the shot. Called the pharmacy & was told this was normal. The next day arm was getting worse and I was running a fever. Called doctors office and was unable to get an appointment. The next day I went to ER. Still wasn't getting better went to doctor for stronger medication.
1 day after receiving the 2nd vaccine, my mother began to have chest pain/uncomfortable feeling in her chest. 7/18/2021, my mother had TWO heart attacks. Ambulance took my mother to Hospital. She was transferred to a different hospital a few days later. Heart attacks damaged heart to 40% function. Right leg bypass performed 9/21 (right leg) failed due to heart attacks. 12/30/2021 my mother contracted COVID. 2/7/2022 my mother was admitted to cardiac ICU at Medical Center with only 5-10 percent heart function. 2/10/2022 my mother started having seizures resulting in brain damage. 2/13/2022 my mother passed away. THE CDC SHOULD HAVE NEVER RECOMMENDED THE COVID VACCINE TO PEOPLE WHO HAVE CARDIOVASCULAR DISEASE.  SHAME ON THE CDC. SHE HAS 2 HEART ATTACKS DUE TO THE 2ND VACCINE, WAS FULLY VACCINATED BUT WITH NOW 40% HEART FUNCTION, AND DIES FROM POST COVID HEART INFLAMMATION / COMPLICATIONS. AND THE CDC/ VACCINE MANUFACTURERS ARE NOT SUPPOSED TO BE HELD NOT LIABLE FOR PUSHING THE VACCINE WITHOUT WARNINGS FOR PEOPLE LIKE MY MOTHER? ABSOLUTELY DEVASTATING!
I had a moderate reaction. I was slightly dizzy. I was weak. I had a low grade fever for a few days. I had a headache for a few days. I had "covid arm". It was red, sore, it had some swelling, and intense itching. I am still tired. I have diarrhea as well.
No adverse event reported yet, but patient was given 4th dose closer than recommended to the third dose accidentally.
Patient received her Covid19 Vaccine and had and began to feel lightheaded approximately 5 minutes after vaccine administration. Paramedic assisted the patient to the bed where the patient sat down. Vital and patient history was obtained. Paramedic contacted Dr. and was instructed to monitor the patient for any changes in patient condition. The patient was continuously monitored and stated that she began to feel much better. Paramedic obtained three sets of vitals which were all within normal limits. The patient relayed that she was no longer feeling her symptoms. The patient was walked to the front door. BP 187/121 HR 98 RR18  /  BP 84/112 HR 100 RR18  /  BP 168/109 HR 87 RR 16
patient mistakenly gave consent and received a dose of pfizer for a second dose after receiving moderna as her first dose manufacturer. no adverse outcomes observed. Patient was counseled regarding CDC adverse event guidelines for receiving a mixed manufacturer dose.
Developed cellulitis at injection site; Developed / at injection site / warm; Pt refused 2nd dose (1st dose given 7/15/20); Developed / at injection site / Pain since injection; This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 97C2S, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 15th July 2020, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the patient experienced injection site cellulitis, injection site warmth and incomplete course of vaccination. The patient was treated with cephalexin (Keflex). On an unknown date, the outcome of the injection site cellulitis, injection site pain and injection site warmth were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix and less than a week after receiving Shingrix, developed cellulitis at injection site. On 22nd July 2020, the nurse called, the patient stated pain since injection, warm and treated for cellulitis with Keflex for 10 days. The nurse stated that the infection (adverse events) resolved. The patient refused the 2nd dose and till the time of reporting, did not received it, which led to incomplete course of vaccination.
Golf ball size swelling of lymph nodes above clavical on side where shot was administered two days after.  Pain radiating through arm and breast.  Swollen lymph nodes in breast after three days.  Physician does not think there is a connection with vaccination, ordered biopsy and mamogram.
Felt feverish and achy with chills and extreme fatigue beginning at 10:30 pm  on 3/12 and lasting all day Saturday 3/13.     Treated by alternating ibuprofen/aspirin  every 3-4 hours.    Fever was gone by Sunday morning, although extreme fatigue and head fog lasted the entire day.    Felt completely fine by Monday morning - 3/15.
I was 13 weeks pregnant when receiving my dose of J&J Covid vaccine. I informed the facility that I have a history of allergic reactions and they told me I shouldn?t worry, that if it was severe I should go to a hospital. Otherwise, no other advise was given.   2 days following the injection, I developed a rash along a section of my right back, towards the center. As days progressed, the rash got larger. They almost appeared as raised, red bumps. They resembled a cross between a hive and a pimple. I did not change any topical products I use in my household, nor have I changed anything else with my daily events. The rash progressively spread throughout my entire back from top to bottom as well as along my both shoulders and upper arms. I applied a prescription allergy cream which my allergist has prescribed me recently when I went for a routine allergy test this past June. The cream provided some relief in the sense that new marks didn?t appear as often, but the rash has not went away completely and it?s been nearly 2 weeks.  Most recently, I developed a patch of severely itchy skin  on my right elbow a few days ago. The allergy cream is not providing any relief. It almost appears as a hive patch, but difficult to tell since it?s on the crease of my elbow.
Information has been received as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, the patient's son experienced toxic neurological effects of mercury poisoning, considered serious. Onset date was unknown. Relevant history and concomitant medications were not provided. The outcome of the event was unknown. Toxic neurological effects of mercury poisoning was determined to be an other important medical event (OMIC). No further information is available. This report was received from the manufacturer's legal department on 12/13/04.
On 5/14/01, pt had onset of swelling to hands (bilaterally), knees and ankles. Went to PCP. Off work X 5 days for arthritis symptoms.
Headache, low grade fever, body aches. Did not have any side effects with the first or second dose I received from Pfizer vaccine in Jan. 2021 and February 2021, Only the 3rd shot. Symptoms' lasted approx. 24 hrs.
DTAP given left deltoid. Developed cellulitis at the site, resolved on antibiotics.
Tinnitus; Lightheaded; This is a spontaneous report received from a contactable consumer, the patient. A 51-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in left arm on 22Mar2021, 12:30 PM, (at the age of 51-years-old) as a single dose, for COVID-19 immunisation. Medical history of the patient included hypothyroidism and obesity. The patient was allergic to medicine - too many to list. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and azelastine hydrochloride (MANUFACTURER UNKNOWN) since from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 13:00, the patient experienced tinnitus (much louder than normal all of the time since the night of the vaccine) and at 12:40 (about 10 minutes after the shot), lightheaded (a few times that evening and the following day). Events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for events. The clinical outcome of events tinnitus and lightheaded was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 10-JUN-2014, the patient was vaccinated with VARIVAX lot # J012210, expiration date 28-SEP-2015. No concomitant medication reported. The reporter stated that VARIVAX was exposed to improperly stored temperatures outside the product insert. No adverse effects were reported. Causality was not reported. This case has been linked to 1406USA006736, 1406USA013598, 1406USA006998 and 1407USA000740. Additional information has been requested.
Arm swollen like an egg; localized feeling of hot; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen like an egg), FEELING HOT (localized feeling of hot) and PRURITUS (Itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 01120A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen like an egg), FEELING HOT (localized feeling of hot) and PRURITUS (Itchy). On 31-Jan-2021, PERIPHERAL SWELLING (Arm swollen like an egg), FEELING HOT (localized feeling of hot) and PRURITUS (Itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment included an antihistamine, not otherwise specified.   Reporter did not allow further contact
After leaving the office patient ate lunch, exercised on a exercise bike then developed shivering, chills, muscle aches and fever.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; EXPOSED TO COVID-19; This spontaneous report received from a patient via a other company (Pfizer, Inc) concerned a 75 year old male. Initial information processed with additional information received on 11-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy (unspecified). The patient had previously received 2 doses of covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 1) (form of admin, route of admin and batch number were not reported, expiry: Unknown) dose and start therapy date were not reported, administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with 2 doses of covid-19 vaccine (Unspecified manufacturer) (Dose number in series: 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin was not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 in total administered in left arm on an unspecified date in FEB-2022 at 12:00 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 75 years old. Concomitant medications included lovastatin, and metoprolol. On an unspecified date in 2022, following vaccination with covid-19 vaccine ad26.cov2.s, the patient exposed to covid-19 (Dose number in series: 2). On 20-JUL-2022, Laboratory data included: COVID-19 virus test Negative. The patient was quarantined from 20-JUL-2022 to till present. On 22-JUL-2022, the patient tested positive which was confirmed covid-19 infection and confirmed clinical vaccination failure (Dose number in series: 2). Laboratory data included: COVID-19 virus test Positive. On 23-JUL-2022, the patient received non-company co suspect drug Paxlovid (form of admin, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, for treatment of COVID-19. Paxlovid last administration date was 27-JUL-2022. On 29-JUL-2022, the patient still tested positive. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with Paxlovid was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure and exposed to covid-19 was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000246040.; Sender's Comments: V0: 20220820808- covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
had a problem with reaching, with lifting things; the muscles behind my things, same thing. It hurts; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (reporters girlfriends daughter) that:   A 5-decade-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER BIOTECH OVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on unspecified date for COVID-19 immunization and patient experienced she could not lift her arm. It was reported patient received both doses of the vaccine. She said she has talked with a pharmacist who recommended calling Pfizer and that she has experienced her symptoms for five months. The caller stated that after the first vaccine she felt like she could not lift her arm. After the second shot, she felt like she had a problem with reaching, with lifting things. she felt the muscles behind her things, same thing. It hurts. she was given Mobic, took that for six days then my blood pressure went up and caller started getting headaches and then right hand went numb and burns off and on. She has been to physical therapy, but is unsure if that is helping, and was told to see a rheumatologist and a neurologist. The caller reports also that she hasn't "slept for nights", that she is a side sleeper and keeps turning from one side to the other. Caller is wanted to ask if her symptoms have been reported and wanted to know length of time of the symptoms and what she should do. also shared her girlfriend's daughter is much younger, in her forties, but is having the same things. Her daughter told her to ride it out for six months and was also told that skinny people had a harder time after the vaccine. Caller said she had never heard of such a thing and asked if weight affected symptoms. The outcome for the event was reported as unknown at the time of his report.  Information about lot/batch number has been requested.  Follow-up (28JUL2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.