chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on the abdominal area; This case was reported by a pharmacist and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient had a rash on the abdominal area and not at the injection site. The rash did dissipate. At the time of reporting information of the location of the injection, Lot and Expiration date were not available at the moment of the call. The physician will follow up with additional information. The reporter gave consent to follow up.
shingles; nerve damage; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) and NERVE INJURY (nerve damage) in a  patient of an unknown age and 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles) and NERVE INJURY (nerve damage). At the time of the report, HERPES ZOSTER (shingles) and NERVE INJURY (nerve damage) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  It was reported that these people are in support groups for vaccinated people with symptoms.  No treatment details were reported.   This case was linked to MOD-2021-296653, MOD-2021-296654 (Patient Link).
Missed his second appointment; Anxiety; Depression; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed his second appointment), ANXIETY (Anxiety) and DEPRESSION (Depression) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Mental distress (Patient had anxiety and depression for many years.).    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed his second appointment), ANXIETY (Anxiety) and DEPRESSION (Depression). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed his second appointment) had resolved and ANXIETY (Anxiety) and DEPRESSION (Depression) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported. Treatment not provided.     Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-02-2021 included no new information.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
she was in bed for 3 days; she had chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (she was in bed for 3 days) and CHILLS (she had chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (she was in bed for 3 days) and CHILLS (she had chills). At the time of the report, FATIGUE (she was in bed for 3 days) and CHILLS (she had chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unknown medication for blood pressure and asthma inhaler.   No treatment information was reported.
Information was received on 21-MAR-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. On 06-SEP-2012, the patient received a dose of ZOSTAVAX (lot, expiration, dose, and site not reported) for prevention of shingles. Prior to receiving the ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster or any other ailment collectively referred to as "shingles." On or about 08-JUL-2015, the patient was treated by a health care professional for symptoms of an itchy painful rash that had persisted for 5 days and was worsening in severity. The patient was then diagnosed with herpes zoster, also known as a shingles outbreak. On or about 08-JUL-2015 the patient was prescribed valacyclovir (manufacturer unknown) for the treatment of shingles and shingles-related nerve pain. As a direct result of the vaccine, the patient suffered,  is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result. the patient has sustained severe and permanent injuries. The patient suffered serious, progressive, permanent and incurable injuries as well as significant pain and suffering. mental anguish, emotional distress, loss of enjoyment of life and physical impairment and injury. Herpes zoster and shingles-related nerve pain  and emotional distress were considered disabling. Additional information has been requested.
Pt stated nausea, dizziness shortly followed by shortness of breath and extreme drowsiness.
Night of Injection: Mild arm soreness, lightheaded ("felt drunk"), off-balance, next day developed body wide hives  Seen at Emergency Department 2/15/2021 - Benadryl, discharge home    Continuation of body wide hives on 2/18/2021 Seen at Emergency Department 2/18/2021 - Prednisone, discharge home
Patients nurse called to say the patient reported to PCP and was having "pain related to the vaccination" and needed pain medication. Pt previously had shingles 3 years ago, possibly a flare up, but wanted an ADR reported nonetheless. Vaccination was given on 3/28, patient reported pain on 4/15.
blisters on mygumline; large sores on my gums and inbetween some teeth; painful; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown,) via an unspecified route of administration in the left arm on 08Mar2021 at 08:00 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included carotid artery dissection in 2015. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), aspirin (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); all for unknown indication and from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 09 Mar2021, the patient noticed blisters on the gum line. The blisters continued and got more worse and severe as the weeks passed. On an unknown date in Mar2021, the patient had large sores on the gums and in between some teeth. The gum sores were not painful in the beginning but were very painful and irritating at the time of this report. The patients tongue, under the tongue, inner cheeks, and the roof of the mouth were clear of blisters. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events blisters, sores gum and gum pain were not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen area around the injection site), VACCINATION SITE PAIN (mild pain around the injection site), ARTHRALGIA (mild pain on finger joints in the arm of injection), PYREXIA (Felt feverish) and FATIGUE (Fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jan-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen area around the injection site), VACCINATION SITE PAIN (mild pain around the injection site), ARTHRALGIA (mild pain on finger joints in the arm of injection), PYREXIA (Felt feverish), FATIGUE (Fatigue) and MYALGIA (body aching). On 01-Feb-2021, VACCINATION SITE SWELLING (Swollen area around the injection site), VACCINATION SITE PAIN (mild pain around the injection site) and ARTHRALGIA (mild pain on finger joints in the arm of injection) was resolving, PYREXIA (Felt feverish) and FATIGUE (Fatigue) had resolved. At the time of the report, MYALGIA (body aching) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 100 degree f abnormal. Concomitant medications were not provided. Treatment information was not provided.
Pt reported generalized numbness in entire body after TDap vaccine, evaluated by neurologist on 8-16-13.
Aching muscles & bones, nausea for approximately 24 hours. Sore arm at site of injection for 48+ hours.
Expired Engerix administered; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a neonate patient who received HBV (Engerix B) (batch number LH3RJ, expiry date unknown) for prophylaxis.   On 2nd November 2018, the patient received Engerix B. On 2nd November 2018, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-JAN-2023 Reporter's Comments: A patient received a birth dose of a GlaxoSmithKline (GSK) Hepatitis B vaccine and was documented as expired.  No outcomes information available as this information was provided by a school to the reporter. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Engerix-B, which led to expired vaccine used. In order to reflect age group as vaccination and event onset date was same.
Redness, pain, swelling at injection site 12 hours after injection then developed fever, chills, T102.5 symptoms resolving on day 3 after vaccine.
Starting around 1:00 AM I was feeling hot and sweaty, cold sweats and a headache. No fever! at 6am I went to bed the 25th. .  I woke up around the10 am  the 25th.the next day. I had a migraine that wouldn't go away. I was feeling nauseous and still had a light sensitive headache. I took Migraine medication, and eventually mid afternoon the symptoms went away. Less than 24 hours later I was back to normal. March 4th I was using Gold Bond Ultimate Mens lotion and had an adverse reaction. My hand swelled up, and got red.  I took Benadryl and it went away. March 5th I used Curel lotion and the same thing happened. Did not take Benadryl.
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 4LP5Y, expiry date 27th February 2021) for prophylaxis. On 15th November 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 16th November 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the patient experienced chapped skin. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved and the outcome of the chapped skin was unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and chapped skin to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The patient experienced redness and heat at the injection site that started the next day after receiving the vaccine. These symptoms have resolved but now there was a chapped ring around the injection site where the redness and heat were previously. The reporter provided the lot number and expiration date she had on file but she did not know if this was for the first dose or the second dose. She only had lot number and expiry date information for one dose.
This is a spontaneous report from a contactable physician received via a Pfizer sales representative. This physician reported similar events for two patients. This is the first of two reports. A 68-year-old female patient of an unspecified ethnicity received a single dose of PREVNAR 13 (Lot Number: J67645), via an unspecified route of administration on 18Dec2014. No other vaccinations were given at this time. The patient's medical history and concomitant medications were not reported. On an unknown date in Dec2014 within 24 hours after receiving the vaccination, the patient started to experience intense pain, then progressed to arm numbness radiating down the arm and through fingertips, and intense pain radiating up the neck, into the jawbone and cheek. The patient went to the emergency room and it was unknown if the patient was admitted. Lab tests were unknown. Therapeutic measures were taken in response to the events and included treatment with steroids. The events were not recovered.
Uterine bleeding started couple weeks after 2nd dose giving on 1/6/2021
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 75 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2007, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
The patient presented via telemedicine on 1/29/2022 for a hospital follow up from 1/16/2022 for dizziness, headache, shortness of breath, and other symptoms. She reports a low blood pressure of 70/60 mmHg, an elevated and irregular heart rate, and hyperglycemia (297) in the ambulance and ER. Both an x-ray and CT were done and reportedly unremarkable. She states she was diagnosed with COVID-19 on 12/24/21. She also notes she had the second dose of Pfizer on 12/20/21 in her left deltoid and within 24 hours she developed headache, fever, and and chills. She has had various ongoing symptoms since then including Bells Palsy, left ear tinnitus, heart racing, and dizziness. She reports all of her concerning symptoms are occurring on her left side and it is in her left deltoid where she received the vaccine. She wonders if she is experiencing an adverse reaction to the vaccination or to COVID-19.  She notes she is severely limited in daily activities such as driving, standing and walking. She states she is still experiencing dizziness with sudden flushing and heart racing while going about her daily activities. She is scheduled with an ENT and a neurologist in the upcoming weeks. She denies personal history of diabetes or gestational diabetes.
CLIENT RECEIVED MODERNA VACCINE 1/21/2021.  THEN RECEIVED PFIZER VACCINE ON 2/8/2021 AND SECOND PFIZER DOSE PREMATURLY ON 2/24/2021, ONLY 16 DAYS APART.
Little swelling at injection site, warm to touch; itching; mild rash. Advise patient to take diphenhydramine 25 mg x 2 STAT and monitor closely.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) 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 medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Internal review on 19 Jul 2021 resulted in updating the event verbatim and outcome and pregnancy information (birth type and fetal outcome).
I experienced being paralyzed for over two hours about 20 minutes after Moderna , my blood pressure shot up to 188/77 I was rushed from the vaccine clinic to the ER I experienced trimmers that I couldn?t stop , temporarily not being able to speak at times all of this happened in such a short period after Moderna booster .. please everyone if you gonna vaccinate make sure the drs care because when I had my reaction they left me to sit in the waiting room .. I received both shots without this reaction
Chills/ hot flashes 2 days Metallic taste in mouth 3 weeks Muscle cramps  ongoing since 4/14 Muscle burning  ongoing since 4/14  Headaches 2 weeks Dizziness ongoing since 4/14 Numbness in left hand ongoing since 4/14 Fatigue ongoing  since 4/14 Muscle weakness ongoing since 4/14 Back pain ongoing since 4/14 Pain in left arm / shoulder started last night  Unable to sleep. Ongoing since 4/14 Nausea 2 days  Pain in calves 1 day Cough 1 week
Employee describes: chills, shaking, body aches, headache for about five or six hours.
Pt was admitted to Antepartum Unit on 8/9/122 for DCDA twins, Newly Dx IUGR both twins,  Pre Eclampsia w/o SF, Thrombocytopenia. Pt also had Dx of Bell's Palsy, Pyogenic granuloma, Dx with Asy positive Covid on admission  Pt developed Pre Eclampsia with SF on 8/13/22.  Primary LT C-Section done.  S/P Postpartum Hemorrhage S/P Magnesium Sulfate 24 hour postpartum. Started on Labetalol 200mg BID Discharge from hospital on 8/17/22.
Moderna vaccine #1 administered on 1/18/21 Adverse event observed 1/24/21 @ 1am:  soft tissue swelling eyelids, cheeks, lips. No swelling of gums, tongue or throat. Severity: Moderate. No airway obstruction. Severe itching of eyelids, face. Interference with speech due to swelling. treated with OTC diphenhydramine 25 mg oral every 6 hours.  Adverse event lasted 72 hours. Moderna vaccine #2 administered 2/22/21 Adverse event observed 3/2/21 @  1am:  severe edema peri-orbital tissue, intense redness peri-orbital tissue; intense itching of eyelids. Skin changes over few days to "lizard skin". Chronic redness, itching, swelling, texture changes;  Scheduled for dermatologist tomorrow, 4/7/21.  Approximate length of time adverse reaction has existed > 30 days.
fever, redness & swelling @ site of vax lt arm area; rx APAP & warm compress;
101 fever,; Muscle pain; body aches; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, reporting for herself. A 28-year-old non-pregnant female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: ER2613), via an unspecified route of administration in the left arm on 24Mar2021 at 04:45 at a single dose for covid-19 immunisation. Medical history included obesity. There were no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (Lot Number: EN6205) on 03Mar2021 at 3:30PM in the left arm at 28 years of age for covid-10 immunization. There were no other vaccines administered 4 weeks prior to bnt162b2. On 25Mar2021 at 10:30, the patient experienced 101 fever, muscle pain, body aches, and swollen lymph nodes. No therapeutic measures were taken as a result of the event. Lab data included body temperature: 101 on 25Mar2021. There was no covid prior to or post bnt162b2. The clinical outcome of the events was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
20 minutes post vax the pt developed swelling at the site, shortness of breath, tingling of arm, hand, fingers, tightness in throat and chest felt heavy. Was immediately brought to ER. Possible medicine reaction.
This spontaneous report as received from a consumer refers to a 71 year old (currently 78 year old) female patient refers to herself. The patient's concurrent condition included hypertension. On 05-MAR-2007, the patient was vaccinated with ZOSTAVAX, 1 injection, subcutaneous (lot # and expired date were not reported). Concomitant therapies included TOPROL XL tablets, metoprolol, and LIPITOR. The patient had continuously been getting breakouts of shingles, somewhere around 2 months (approximately in May 2007) after receiving the ZOSTAVAX injection of 05-MAR-2007 she was administered with the vaccine by Nurse (now retired). She was experiencing pain, burning and itching and it was always on the left side above where her knee bends, all the way up to the buttocks. Her primary physician diagnosed her first rash as shingles after he received her lab work back "about 2 months" (calculated on 05-MAR-2007) after the ZOSTAVAX vaccine was received. Lab diagnostics study was performed: lipid and cholesterol (result not provided). She said that that week she had experienced 29 instances of shingles. She always knew when she would have another episode of shingles because she felt fatigue, and very sleepy before an outbreak. The patient sought medical attention. The patient was treated with VALTREX. When she weared pants during a shingles outbreak, her pants felt like sandpaper against her skin. She said the shingles outbreaks were affecting her lifestyle. The outcome of adverse event was reported as not recovered/no resolved. Additional information has been requested.
Red area about 3? in diameter. Hot and painful. Not there until 10 days after vaccination
Severe fatigue: Started 03/14/2021 the facility that gave the vaccine, and was advised to call the COVID-19 Hotline.
Information has been received from a pharmacist concerning a 40 year old female patient, with multiple sclerosis, who on 12-JUN-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#, dose and route did not reported). Concomitant therapy included REBIF. No adverse effects reported. Follow-up information has been received from the pharmacist via a vaccine adverse experience report concerning the patient. The patient was vaccinated on 12-JUN-2012 4:30 PM (lot #: 1659AA, SQ, 1 dose). The patient experienced redness, swelling, or burning sensation at injection site starting day after vaccination lasting 3 to 4 days, she states rash measured 4 inches wide by 10-12 inches long, Rash healed but dry spot still at site, 07-JUL-2012. At time of the report, the patient had recovered. It was reported that the patient didn't require emergency room/doctor visit. Additional information is not expected.