chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left wrist pain; This is a spontaneous report from a contactable consumer (patient).   A 31-year-old male patient received second dose of bnt162b2 (BNT162B2), intramuscular, administered in left arm on 24Feb2021 09:39 (Lot Number: EM9809) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included hypertension from 30Sep2020 and ongoing, humerus fracture from 11Jul2017 to 20Sep2019, and humeral fixation with plats. Historical vaccine includes first dose of BNT162B2 received on 03Feb2021 at 09:40 in left arm intramuscular (Lot number: EL9262). Concomitant medication included lisinopril taken for hypertension one tablet a day.  On 26Feb2021, the patient experienced left wrist pain, assessed as medically significant. The event required visit to physician's office.  The patient underwent lab tests and procedures which included Covid-19: negative on 15Jan2021. The outcome of the event was not recovered. Therapeutic measures were taken as a result of left wrist pain which includes Ibuprofen, need orthopedic surgeon examination next.
HPV administered left arm while patient sitting on exam table. Immediately after patient alert/conversant then several minutes later patient fainted, slumped forward and fell off exam table. I was able to break her fall somewhat and she landed on her side/shoulder then side of head touched down, posture stiffened with rigid upper extremities and eyes open in stare. Her legs were quickly elevated and she regained consciousness immediately with significant lip pallor. BP: 110/68 HR: 100 in supine position with legs elevated/juice/snack administered, and color returned to face/lips.   10 minutes later supine: HR: 76 BP: 100/68, PERRLA, alert/oriented x 3. Joints stable with FROM, no pain to shoulders/arms or cervical spine. NO lumps palpable over skull. No obvious injury from fall.   10 minutes later standing: HR: 84 BP 94/60 and able to walk normally. Discharged home with instructions for rest/nutrition/fluids.
17-year-old received the Moderna COVID-19 vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jul-2021 and was forwarded to Moderna on 14-Jul-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna COVID-19 vaccine) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received the Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no treatment drugs included no concomitant drugs included
Left side of face felt numb for about 12 hours after vaccine. Mild tingling still felt in left cheek as of today (03/31/21).
devel  x 5 swelling, inflammation @ site had 6 x 18cm area of redness, heat, swelling including the knee; some limp; onset 5NOV seen 7NOV;
Pt recvd 3 doses of vax p/3rd dose exp purpura on arms, trunk & wrists;
On 3-9-12, at 12:40 pm, Tdap & Hepatitis B vaccines were administered. At 3:13pm, patient experienced a seizure in excess of 6 minutes, (7 min). Our client was transferred to local hospital where he stayed 5 days. He does have a seizure disorder & experienced another seizure on 3-10-12 & one more on 3-11-12. His seizure meds were adjusted & he was released from hospital back to our facility. Our P & T committee reviewed this case as a possible ADR from the vaccines (most probably Tdap).
Muscle weakness to right side of face. Could not close right eye, lift right eyebrow. Smile drooped. Was prescribed  Prednisone, Valacyclovir for 7 days and carboxymethylcellulose drops when needed
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A female patient of an unspecified age received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. Medical history included celiac disease. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 27Jan2021 for Covid-19 immunisation. It was reported symptoms of Bell's Palsy appeared 5 days later on Monday following second dose on 22Feb2021. Patient believes that her neurologist did report the adverse event but has met with resistance in reporting the adverse event. Patient is currently still experiencing symptoms and is taking Gabapentin for the nerve pain. She is willing to talk with someone from Pfizer if you would like additional information and was very pleased that we were reporting her adverse reaction immediately. The outcome of the event was not recovered.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M21A) for COVID-19 vaccination.     The patient's past medical history included Lymph node excision. Concurrent medical conditions included Breast cancer.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 14-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient mentioned that the first dose was administered in her left arm, and as a cancer survivor, she does no receive anything in that arm, she has no lymph nodes on that side. Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter   This case was linked to MOD-2021-289632 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow Up information was received on 18-Aug-2021 and Added DOB/age of patient.
Left arm red and swollen on left anterior portion of arm. Has erythema, no throbbing-"feels think to touch. Has pain-no open area-no drainage. No hx of reaction from other flu shots.
Chills/shivers,  low grade fever, body aches, ringing in ears, stomach ache, and headache.
Flareup to my RSD bilaterally. Backache happened  4 to 5 days after vaccination.
The nurse gave me a double dose of meningococcal vaccine by mistake.  I also received a tetanus vaccination.  I have never had a reaction to a tetanus vaccination, so I believe the reaction was due to the double dose of meningococcal vaccine.  That evening, I felt nauseated.  The next morning, I had a headache, whole body ache, fatigue, hot red face, and I felt sick.  Friday morning, 11/20/2009, I went back to the doctor's office.  The nurse said I had a low fever.  I felt sick all weekend, but gradually less.  On Monday, I felt almost completely better.
I developed excessive fatigue, weakness, palpitations, weight loss, night sweats among other symptoms starting towards the end of October 2021 and lasting until the beginning of December 2021.  This was secondary to acute thyroiditis/thyrotoxicosis.  I was unable to work during this time.
Arm is red about 3 inches round, surrounding the shore site. Also hard and hot to the touch.
I received my second dose of the COVID vaccine on 1/11/2021 at 9:30am. That evening, I developed severe body aches. No fever was ever noted, but I felt hot through most of the next day. The body aches impaired my ability to work on 1/12/2021 and as a result I called out sick. These symptoms resolved the morning of 1/13/2021 and I have felt fine since.
I kept the bandaid on but noticed the area surrounding it became red, hot, and a little swollen like a rash. The next day I took off the bandaid and it was very red and a little blister or bubble that was clear but yellowish in color appeared.  The area was still extremely warm especially the little bubble. The next day I began having a strong itching sensation at the rash and bubble. I had been touching it quite a bit but nothing more than putting my hand over it to temporarily relieve the itching sensation. The bubble has gone down a little bit and is a little wrinkly now but still very warm. I took an allergy pill today but I think it?s just been an allergic reaction that I had to this booster specifically. I had a sore arm and a little bit of red last booster but nothing like this bubble
Initial report received from a health care professional, office manager on 10 Mar 2010: This patient was vaccinated with expired dose of FLUVIRIN (Batch No. 10103265P), 0.5 ml, intramuscularly, QD, sometime between 01 Mar 2010 and 09 Mar 2010 (on an unspecified date). The outcome of the event was not reported.
patient reports receiving a Shingrix vaccine at pharmacy on 6/21/21- per the database this would be her third Shingrix, as she received the first two on 10/29/19, and 1/10/20. No side effects, reactions at this time. Patient feeling well.
pt recvd vax & 2 days later had swelling of glands; glands are still swollen;
Pt had SPV on 3/6/09 and AVA on 3/11/09. On 3/17/09 pt describes feeling fatigued, he had non positional left sided chest pain (1-2/10), cp worse with exertion and inspiration, + vomiting, no SOB or palpitations. On 3/18/09 the chest pain with dull (2/10) constant, increased with inspiration, not affected by position, no vomiting; on 3/20/09 the pain worsened to 6/10 and was sharp with inspiration, nonpositional. Pt went to the ER for evaluation. 4/13/09records received for D0S 3/19-3/20/09-DC DX: myopericarditis likely secondary to small pox vaccine.  Presented with 3 days of CP, some itching on left arm around small pox vaccination site. Devloped acute nausea and vomiting. 5/14/09 records received-beginning on 3/17/09 C/O fatigue and constant low grade left sided chest pain, vomiting and pain increasing with inspiration.
LUPUS SYNDROME; SICKNESS; This spontaneous report received from a patient via another manufacturer concerned a 6 decade old female unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported,1 total, administered on 25-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. On an unknown date, patient had rash from Humira shot on stomach (injection site rash). The patient was recovering from injection site rash. No concomitant medications were reported.  On an unspecified date in 2021, patient had sickness and on an unspecified date patient had lupus syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from sickness and the outcome of lupus syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220401951- covid-19 vaccine ad26.cov2.s-Lupus Syndrome. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
POSSIBLE VAX ADMINISTRATION ERROR: Patient feels that her vaccine was given incorrectly, has had arm pain since 09/14/2021. Arm is very sensitive and patient is unable to lay down on right side.
This vaccine caused an autoimmunity flare up.   My autoimmunity was pretty stable, but I did eat foods I was allergic to that day (which could have caused an immune response on it's own). I have had graves disease in the past, have treated it and now take hormone replacement. I haven't had a autoimmunity flare up in years. But my first dose of Pfizer caused a flare up. I understand that research regarding autoimmune disease and this vaccination is limited, i knew there were risks and hypothetical adverse reaction possibilities.   It's been 3 weeks since my first shot and I'm still nursing autoimmunity. I do not believe I will be stable enough to get the 2nd shot out of fear of a total immunity "freak-out"  Please note that this vaccine caused an autoimmune flareup in a patient of stable health.
Pt states she had extreme joint and muscle pain.  Constant headache.  Aches, fatigue, nausea, and vomiting.
Left anterior thigh - 8 cm x 4 cm erythema mild warmth and induration over the injection site. Dx: cellulitis and abscess of leg except foot.
Second dose. Fever of 99, whole body aches, skin everywhere feels rashy, chills, fatigue, eyes feel puffy and stingy. I?m on day 2 of side effects.
Case number PHEH2012US016122 is an initial spontaneous report received from a nurse on 10 Aug 2012. This case refers to 24-year-old male patient. He was given only with MenCYW-135 liquid conjugate component of MENVEO (batch number: X11051) intramuscularly on 10 Aug 2012. He did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following this administration error.
Patient's mother, advised that patient had received first dose of Moderna COVID-19 vaccine at about 4pm on 8/15/21; patient started to have an itchy rash on her entire back and her body felt weird. PT Mother advised that, in the middle of the night, patient complained that she did not feel well. At about 9am on 8/16/21, patient got out of bed and was sitting down when patient fainted and had a seizure. Patient was transported to the ER, but was not able to be admitted due to availability issue. Patient was later discharged and is now feeling better.
Rash; This case was reported by a other health professional via call center representative and described the occurrence of widespread rash in a 5-year-old male patient who received HAV (Havrix) (batch number PA99T, expiry date 7th June 2021) for prophylaxis.   On 6th August 2019, the patient received Havrix. On 6th August 2019, immediately after receiving Havrix, the patient experienced widespread rash. The patient was treated with prednisone and ibuprofen (Motrin). On 6th August 2019, the outcome of the widespread rash was recovered/resolved.   It was unknown if the reporter considered the widespread rash to be related to Havrix.  Additional information received were as follows: The office administrator reported that the patient experienced a rash immediately following a dose of Havrix. The rash was described as spreading from left shoulder across the entire chest.  The healthcare professional noted that the patient was immediately treated with Prednisone and Motrin.   The rash completely resolved within approximately ten minutes. The reporter consented to follow up.
This 18 month old female received her fourth dose of vax on 09/27/99. In the evening of the same day, she experienced a local reaction at the injection site with redness, swelling, and tenderness. The following the site was less hot, but the event continued. Ice and ibuprofen were used to treat the reaction. The most recent information received on 09/29, reports the condition of the pt as ongoing.
Pregnancy still birth, 34 weeks, 3 days. Baby delivered at 5 lbs 3.8 ounces, 18 inches. Placental abruption
Thirty-six hours after receiving the Covid (Moderna Booster) vaccine, patient stated that she could not raise her left arm above her head while at yoga class. Her arm was stiff, and her muscle was hard as a rock. Then her left arm was swollen all the way down to just below her elbow. The swelling did go down, but it is still swollen as of 11/07/22. Then at one point her arm felt like it was filled with fluid and was very itchy. (She is on an allergy medication, Allegra, which helped her).
Information has been received from a registered nurse regarding an unknown age and gender patient. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 12.75 hours. On 22-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 5 hours. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 C for an estimated total time out of range of 14-25 hours. On 29-JAN-2013, the patient was administered an out of range dose of ZOSTAVAX (dose and route were not reported) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Pale, hives, dizziness, weak, some difficulty breathing and a fast heart rate.
a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy; arm was sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and RASH PRURITIC (a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 04-Feb-2021, the patient experienced RASH PRURITIC (a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown and RASH PRURITIC (a rash on their upper arm, not exactly on the site of the injection, of around 2x3 inches, and it is a little itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
diarrhea              low gas pain              chills / sweating             dry mouth             sleepy no apatite           cough with phlegm             dizzy             loss of bladder control blood clots in nose mucus
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not provided. In July 2015, unspecified number of patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ, oral, lot # K016261 expiration date 23-JUN-2016 and lot # K016263 and expiration date 26-JUN-2016 (doses were not provided). There was no concomitant medication reported. The reporter referred that the vaccines were administrated by an unspecified physician and no adverse experiences had been reported. This is one of several reports received from the same reporter. Follow up information has been received on 25-SEP-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Information has been received from a registered nurse concerning a 15 year old female who on 18-OCT-2007, was vaccinated with a dose of GARDASIL (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007. No problems were reported. It was unknown whether medical attention was sought. There was no product quality complaint. This is one of several reports from the same source.
No additional AE; Improperly stored VARIVAX administered to patient; This spontaneous report was received from a nurse referring to a 1-year-old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 11-MAR-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T022312, expiration date 30-JUN-2022; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature excursion was -12 degree Celsius for 6 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse event was reported.      This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA004887: US-009507513-2103USA004186: US-009507513-2103USA004233:
Acute onset edema, erythema, and tenderness of L hand, arm, and shoulder on side where vaccine administered.
Headache; Body Aches; Slight Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Body Aches) and PYREXIA (Slight Fever) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (Headache), MYALGIA (Body Aches) and PYREXIA (Slight Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), MYALGIA (Body Aches) and PYREXIA (Slight Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided.   This case was linked to MOD-2021-271852 (Patient Link).
This spontaneous report as received from a nurse refers to a child of unknown age. On 06-AUG-2013 the patient was vaccinated with COMVAX (route, dose, Lot # and expiration date were not provided). The patient was vaccinated with improperly stored vaccine. The patient experienced no adverse effects. It was reported that revaccination will be scheduled. This case is linked by same reported to case # 1308USA014806 of a child who received improperly stored GARDASIL vaccine and case # 1309USA006536 of a child who received improperly stored ROTATEQ vaccine. Additional information has been requested.
After 4 days, I started having chills and broke out in hives. A day later, I had severe diarrhea for a month, lost 20 pounds, have hives and itchiness all over my body. Hands would get really red and itchy. Severe brain fog. Blood pressure issues. Stomach cramps. Heart palpitations and tachycardia. Joint and mobility issues. Burnings sensations on thighs Cold hands and feet. Inflammation on injection arm.
Mom reports that pt complained of tenderness at site on Friday. Sat. night 2 areas, hive-like, were at the site about 1 inch by 2 inches; these merged to a hot, red, raised area, on Sunday. ER was called but no visit made. child was given Benadryl on Sunday night. On Monday the area was palm-sized, but not as red or hot. Benadryl given again X 1.