chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; Fever; This case was reported by a nurse via sales rep and described the occurrence of pain in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 mg. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain and fever. On an unknown date, the outcome of the pain and fever were recovered/resolved.   It was unknown if the reporter considered the pain and fever to be related to Shingrix.  Additional information received were as follows: The nurse reported the case for the father. The age at vaccination was not reported. The patient had pain and fever following Shingrix shot. The adverse event disappeared after 2 days. This case has been linked with US2019AMR188737, reported by the same reporter.
After testing negative, symptoms returned and received positive result; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (After testing negative, symptoms returned and received positive result) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     The patient had no known allergies.  Concomitant products included CALCIUM, COLECALCIFEROL (CALCIUM +VIT D) for an unknown indication.    On 12-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (After testing negative, symptoms returned and received positive result). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (After testing negative, symptoms returned and received positive result) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive and negative (Negative) Negative.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient had reported after testing negative, symptoms had returned and patient had received positive result on 04-Jun-2022.  Company Comment: This spontaneous case reported by a patient concerns a 64-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after receiving a fourth dose of mRNA-1273.  She was treated with Nirmatrelvir/Ritonavir (Paxlovid), after which she tested negative for Covid19.  However, around 5 days later the symptoms returned, and she tested positive again.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient concerns a 64-year-old female patient, with no relevant medical history, who experienced unexpected, non-serious AESI Covid19 on an unknown date after receiving a fourth dose of mRNA-1273.  She was treated with Nirmatrelvir/Ritonavir (Paxlovid), after which she tested negative for Covid19.  However, around 5 days later the symptoms returned, and she tested positive again.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Customer said injection site developed a hard knot and later that night became red. The next day she began itching and it swelled up some.
Received Covid vaccine 4/2/21 at 1010 notes that by noon she felt a headache coming on and gradually started to feel worse, with low grade fever of 99.0, wasn't concerned about that, but later around 0130 on 4/3/21 she felt very miserable, temperature 100.9, and felt a hot burning sensation starting slowing from the top of her head, down her face, slowly down both arms, down to tips of fingers, down both legs to her toes. She tried to stand up to go to the bathroom and had trouble walking, mentally knew what her mind needed to do, but visually was unable to see or make out objects, such as the shape of her glasses case.  Her son had helped her to the couch to sit down. This episode had continued on until around 0330-0400 on Saturday morning lasting  up to 2.5 hours. She ended up taking Motrin and the other symptoms of temperature, achiness, and headache slowly went away. No further noted issues to follow.
Information has been received from a physician, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 37 year old female with anaemia and no drug reactions/allergies who on 06-JAN-2012 was vaccinated with VARIVAX (Merck) (Lot#: 670656/0783AA, Exp Date: 24-MAY-2013, route not reported). Concomitant therapy included iron and vitamin D. The physician was reporting that the patient became pregnant after receiving the dose of VARIVAX (Merck). The patient complained of pregnancy symptoms such as dizziness and nausea which happened "several weeks ago". The patient sought unspecified medical attention and the patient's pregnancy had been confirmed by urine pregnancy test. Her Last Menstrual Period (LMP) was on 30-DEC-2011. Expected date of delivery was 05-OCT-2012. Follow up information was received from the physician concerning the female patient who on 06-JAN-2012 was vaccinated with a dose of 0.5 mL VARIVAX (Merck) (Lot#: 670656/0783AA). The patient was tested for varicella antibodies before vaccination with VZV containing vaccine on 24-OCT-2011 with a negative result. The patient's Last Menstrual Period (LMP) was on 30-DEC-2011. Expected date of delivery was 03-OCT-2012 (also calculated as 05-OCT-2012). The patient had 2 previous pregnancies with 2 full-term deliveries. No birth defects occurred in any previous live births. No miscarriage or stillbirth occurred in any previous pregnancy. No local reaction happened at vaccination site. No varicella (chickenpox) symptoms happened post vaccination. No herpes zoster (shingles) symptoms happened post vaccination. Follow-up information was received from the healthcare worker on 10-JUL-2013. Healthcare worker reported that the patient never returned to their office for care. The office did not have any information on the patient's pregnancy outcome or where the patient went for prenatal care. Case was lost to follow-up. Additional information is not expected.
03/28/2023 I tested positive.  I had a pin in my ears, I had fever headache, neck, joint and muscle pain and a very dry cough.  I had a fever and the doctor wanted me to stop taking the fever medication and go 24 to 48 hours without any medication. I was then prescribed Prednisone. I took it for five days. Right now, I still got cough, but not as bad. I still having stuffy sinuses, but it's not as bad.  I did lose 10 pounds in 1o days, and still do not want to eat much anymore.  I now have a new medication from my lung doctor because of the cough and I have asthma. I have something going on in my lungs. Also, a steriod inhaler to reduce the cough.
little red area; swelling; lump very hard; itch; lump very hard; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of ERYTHEMA (little red area), SWELLING (swelling), MASS (lump very hard), PRURITUS (itch) and INDURATION (lump very hard) 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 ERYTHEMA (little red area), SWELLING (swelling), MASS (lump very hard), PRURITUS (itch) and INDURATION (lump very hard). At the time of the report, ERYTHEMA (little red area), SWELLING (swelling), MASS (lump very hard), PRURITUS (itch) and INDURATION (lump very hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was included. No treatment drug details was provided.
Caller is having a fever, nausea, and feels weak and wants to know if this is normal and what to do. She has taken Motrin to reduce her fever A. 400. Advised caller injection site pain, fatigue, headache, muscle aches, chills, joint pain, and fever can occur .Swollen lymph nodes and nausea have also been reported. Please seek medical attention if experiencing any shortness of breath, throat swelling, weakness, or diffuse body rash. TR
Approximately the next day after my 2nd booster (Dose 4) I experienced the following symptoms: Headache, Diarrhea, Abdominal Pain, Low grade fever and Chills. I am currently taking Tylenol to help ease my symptoms.
It was reported that a 35 year old male pt received a Rabies Imovax IM vaccination on 8/23/99 and reportedly, the pt experienced moderate to severe knee and leg pain in both lower extremities, starting about 2-3 days after the vaccine was given and increasing with each dose. The pt's doctor prescribed Naprosyn, which is alleviating the condition.
Fainted 10 mins after getting GARDASIL 9. Had pt. lay down for 30 mins given cold soda.
Fibromyalgia; Both COVID vaccines caused pain; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Fibromyalgia) and VACCINATION SITE PAIN (Both COVID vaccines caused pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In May 2021, the patient experienced VACCINATION SITE PAIN (Both COVID vaccines caused pain). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia). In 2021, VACCINATION SITE PAIN (Both COVID vaccines caused pain) had resolved. At the time of the report, FIBROMYALGIA (Fibromyalgia) outcome was unknown.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A 58-year-old female patient, with concurrent medical condition of rheumatoid arthritis, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of fibromyalgia. Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious event of vaccination site pain. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Female gender and concurrent medical condition of rheumatoid arthritis represent risk factors for developing fibromyalgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-623066 (Patient Link).; Sender's Comments: This is a spontaneous case reported by a consumer. A 58-year-old female patient, with concurrent medical condition of rheumatoid arthritis, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of fibromyalgia. Onset date of the event was not provided, latency cannot be assessed. In addition, patient experienced non serious event of vaccination site pain. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Female gender and concurrent medical condition of rheumatoid arthritis represent risk factors for developing fibromyalgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient received shot. Within 1 ½ to 2 hours, his hand muscles contracted and he couldn't move his fingers (on the arm he was vaccinated). They were stiff and curled. This happened after the first shot for 2 days; 2nd shot for 7 days and booster.
headache; feeling unwell; received the first dose on 18Dec2020 injection in left arm at 07:00am/ second dose on 11Jan2021 at 15:30; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, in the left arm on 11Jan2021 at 15:30, at a single dose, for COVID-19 immunisation (prevent COVID). Relevant medical history included seizures diagnosed in 2014. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) injection on 18Dec2020 at 07:00 A.M. in the left arm for COVID-19 immunisation (prevent COVID). She was ok on 19Dec2020. After mid-day around noon she did not feel well, and it was hard for her to work on the 19th. She missed two days of work. On 20Dec2020, she could not get up from the bed. Concomitant medications included topiramate for seizures and levetiracetam (KEPPRA). The patient did not receive other vaccines within four weeks prior to and on the same day of COVID vaccination. The vaccine was administered in the hospital. The patient received the COVID vaccine yesterday (11Jan2021). She missed work today (12Jan2021) since she was feeling unwell and having a headache. She works in housekeeping. She started feeling unwell and her headache started after 3 in the morning. She wanted to stay home. Last night she was quite unwell, but she was better after taking second dose of Tylenol. She may need to take more medicine in 2 hours. The events did not require emergency room or physician visit. She does not have lot, NDC, or expiration date to provide for either dose. Outcome of the events headache and feeling unwell was recovering.  Information about lot/batch number has been requested.
Rash started 6 hours after immunizations given on the left arm where DTAP and Polio injections were given. Mom states patient was sluggish the next morning and at approximately 2:10 p.m. on 7/3/08 patient had fever of 101F, with rash of 2-1/2" around front of arm and a hard lump on the top side of arm. Mom gave child tylenol at approximately 2:10 p.m. Mom put ice pack on patient's arm and then child had trouble breathing. Patient has controlled asthma with Flovent daily. Patient has seasonal allergies. Patient was taken to ER at approx. 4:00 p.m. and given Cephalexin 5ml four times a day for 7 days, benadryl (mom unsure how much given, thinks it was tsp), and a breathing treatment. Patient felt better after ER visit but arm still hurt. ER told her to call physician office immmediately if rash got to elbow, which it did the next morning on 7/4/08. Mom took patient to urgent care to make sure she was not dehydrated or constipated, and child checked out ok. Child was tired rest of 7/4/08 and felt better next day, on 7/5/08.
Flu like symptoms; Low fever; soreness at the injection arm; swollenness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PAIN (soreness at the injection arm), INJECTION SITE SWELLING (swollenness at the injection site) and PYREXIA (Low fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 6381C20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Hypothyroidism and Radical nephrectomy (One kidney removed). Concomitant products included SERTRALINE for Anxious depression, EVOLOCUMAB (REPATHA) for High cholesterol, AMLODIPINE and RAMIPRIL for Kidney disorder, LEVOTHYROXINE for Thyroid disorder.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (soreness at the injection arm) and INJECTION SITE SWELLING (swollenness at the injection site). On 10-Mar-2021, the patient experienced PYREXIA (Low fever). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 11-Mar-2021, INJECTION SITE PAIN (soreness at the injection arm), INJECTION SITE SWELLING (swollenness at the injection site) and PYREXIA (Low fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved.            No treatment medication were provided.   This case was linked to MOD-2021-020272 (Patient Link).
Information has been received from a pediatrician for the unborn child concerning a female who on an unspecified date was vaccinated with her third dose of 10 mcg/ml RECOMBIVAXHB (lot # not reported) (manufacturer unknown) while pregnant. The patient was still pregnant and a recent hepatitis B titer was positive for hepatitis B. The physician did not know if this was surface or core antibodies. The patient had not recovered from hepatitis B titer positive for hepatitis B. The patient sought unspecified medical attention. Additional information has been requested.
Rash on upper and lower extremities, fever of 102. Treatment: TYLENOL as needed for fever/discomfort.
On 6/9/2021 developed severe shortness of breath, directed the ED and was found to be in 2nd degree heart block requiring a dual chamber pacemaker placed on 6/11/2021
The symptoms started immediately as drinking a lot of water and going to bathroom and we went to her doctor after she was tired and losing her energy; so when diagnosed her ; found her blood sugar more than 500 and she asked us to send our daughter to emergency to correct her blood sugar and to know how to deal with her condition, now she is living on insulin shots and this very horrible addition to her autistic condition...
Patient reported experiencing dizziness and blurry vision to both eyes the day after receiving the vaccine.
Received vaccine 01/06/2021. No adverse reactions until 01/14/2021 and a local reaction at site noted with itching, warm to touch and redness.  Applied cold pack to arm with improvement shown 01/15/2021.
26 year old nonverbal with known refractory intractable epilepsy, spastic quadriparesis cerebral palsy, developmental delay, presented to ED with the concerns of seizures by the mom. Patient was recently seen in the urgent care for UTIs. Her current AED include: Clobazam 5 mg BID, Oxcarbazepine 600 mg BID and Lorazepam 1mg qhs. Patient is being followed by Dr. in the epilepsy clinic. Patient is being admitted to neurology service due to concern for new type of seizure witnessed at home characterized by smiling and staring. Similar events captured during the evening of 4/30 are without electrographic correlate. In the setting of bowel regimen that was held due to endoscopy and worsened bowel gas pattern seen on KUB at time of admission. these new events were initially have EEG correlated abundant bursts and runs of high amplitude 5-6 Hz theta with occasional bifrontal sharp waves; multiple pushbutton events (predominantly smiling and staring) without definitive epileptiform discharge or seizure. She was initially loaded with Keppra 600 mg (20mg/kg) in the ER, and after the concerns of the EEG we Loaded with lacosamide 60mg with scheduled lacosamide 30mg BID liquid and increased Clobazam to 10mg while continuing Oxcarbazepine 600 mg BID and home Lorazepam 1 mg qhs. on 5/2/2021 no more EEG concerns of dischrges. will be discharged home and cont to follow with Dr on 5/4/2021
Information has been received from a lawyer regarding a case in litigation concerning an approximately 66 year old female patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 07-NOV-2011, at age 64, the patient was administered the ZOSTAVAX by a healthcare provider. On an unknown date in 2012, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claims damages as a result of: injury to herself and economic losses. Additional information has been requested.
Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On an unspecified date in 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for long term prevention of shingles and zoster related conditions. On an unknown date, the patient experienced herpes zoster. It was reported that the patient was treated by a physician for the herpes zoster. The outcome of the herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested
Shingles rash on left shoulder blade; Rash on left shoulder blade; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies and allergy to sulfa drugs. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) from an unknown start date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On 26Mar2021, the patient underwent Sars-CoV-2 test and the result was negative. On 31Mar2021, the patient experienced shingles rash on left shoulder blade. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the events shingles rash on left shoulder blade was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Per mom that Patient had 2 episodes of "leg spasms" on 6/9/20. She states she was otherwise doing well and for first occurrence was eating and smiling when she noticed that her left leg was shaking. Denies any jerking or rhythmic movements. Mom had her hand there and felt it shaking but did not try to stop it. This lasted approximately 5 seconds and resolved. Then 2 hours later she had a similar episode where again she was smiling throughout. Per mom she remained engaged and alert throughout both episodes and is otherwise acting normally. Denies any fevers, chills, swelling or redness at injection site.  She otherwise has been doing well since vaccines on 6/4/20.  offered office visit to evaluate, mom declined as she felt Patient was doing better and would call back if sx recurred.
I had a stroke July 13th in the morning I was in restroom putting on my slacks and I fell over and that last I remember. I had 2 clots one went to my brain and one went to my heart.
Information has been received from a female patient of unknown age with rheumatoid arthritis referring to herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, lot#, dosage and route unspecified). Additional information is not expected because there was no available contact information.