chrisvoncsefalvay/vaers-outcomes huggingface dataset:
buzzing ears, even more intense since the 2nd dose.; weakness, even more intense since the 2nd dose; headaches, even more intense since the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (buzzing ears, even more intense since the 2nd dose.), ASTHENIA (weakness, even more intense since the 2nd dose) and HEADACHE (headaches, even more intense since the 2nd dose) in a 59-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (buzzing ears, even more intense since the 2nd dose.), ASTHENIA (weakness, even more intense since the 2nd dose) and HEADACHE (headaches, even more intense since the 2nd dose). At the time of the report, TINNITUS (buzzing ears, even more intense since the 2nd dose.), ASTHENIA (weakness, even more intense since the 2nd dose) and HEADACHE (headaches, even more intense since the 2nd dose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   The patient reported some side effects after the Moderna vaccine (both doses) 4 or 6 months ago. She doesn´t remembered exact date. Since the 1st dose she started to feel headaches, buzzing ears and weakness, but even more intense since the 2nd dose.  Treatment information was not reported. This case concerns a 70-year-old, male patient with no relevant medical history, who experienced the unexpected events of Tinnitus, Headache and Asthenia. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since events from the 1st dose had an unknown outcome. The event headache is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-381151 (Patient Link).; Sender's Comments: This case concerns a 70-year-old, male patient with no relevant medical history, who experienced the unexpected events of Tinnitus, Headache and Asthenia. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was unknown since events from the 1st dose had an unknown outcome. The event headache is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
she woke up with a toothache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient woke up with a toothache on 09Feb2021, unrelated to vaccine, for which the dentist put her on clindamycin 150mg dosed 4 times daily. The outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, the reported toothache is likely an intercurrent medical condition and unrelated to BNT162B2.
s/p vaccine c/o lightheadedness,dizziness, sweating, left arm soreness. slightly hypotensive at 104/499 P= 55
Rash, UrticariaPruritus & URTICARIA; PRURITUS; RASH
Patient is a 86 y.o. female admitted to the hospital on 10/11/2022 for generalized weakness and confusion.  She was found to have acute metabolic encephalophy which was thought to be due to dehydration as evidenced by AKI with contribution from memory impairment.  Patient was also found to be positive for COVID, not requiring any O2 supplement.   Patient was medically optimized and was stable at time of discharge.  She was discharged.   Discharge Diagnosis and Associated Hospital Course   COVID-19 infection - Presented 10/11 with: acute encephalopathy, weakness, cough  - Symptom onset: ~10/4 - Positive COVID-19: 10/11 here - CXR: Increased interstitial markings bilaterally, either due to edema or infiltrates, slightly more prominent since the previous - Oxygen status: SaO2 normal on room air - Decadron & remdesivir not indicated - Stable for dc from a respiratory standpoint   Acute metabolic encephalopathy Generalized weakness - May be secondary to dehydration as evidence by AKI compounded on memory impairment (no formal dx of dementia). UA not that impressive for UTI and otherwise asymptomatic. Treated with Ancef in ED but urine culture grew no pathogens - Medically cleared for discharge plans at discharge   AKI (resolved) - Creatinine on admission was 1.28 - Resolved with IV fluid   Essential hypertension  - Continue Norvasc and lisinopril    Uncontrolled DM - HbA1c 8.9%  - Takes metformin at home - Held metformin due to recent AKI   GERD - Asymptomatic - Continue pantoprazole
DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK; DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK; RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of INTERVERTEBRAL DISC DEGENERATION (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK), RADICULOPATHY (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK) and VACCINATION SITE PAIN (RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included INFLUENZA VACCINE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third 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) Citrate free. In 2021, the patient experienced VACCINATION SITE PAIN (RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM). On an unknown date, the patient experienced INTERVERTEBRAL DISC DEGENERATION (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK) and RADICULOPATHY (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK). At the time of the report, INTERVERTEBRAL DISC DEGENERATION (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK) and RADICULOPATHY (DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK) had resolved and VACCINATION SITE PAIN (RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM) outcome was unknown.            NO KNOWN ALLERGIES. No relevant medical history. On an unknown date, the patient experienced DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK. In 2021, the patient experienced RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM. On an unknown date, DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK resolved. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK unknown onset with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of DEGENERATED DISCS IN THIGH CAUSED BY PINCH NERVE IN BACK unknown onset was not provided. The reporter's causality for the event(s) of RECEIVED MODERNA BOOSTER VACCINE, HAD SORE ARM with HUMIRA(ADALIMUMAB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
PT had onset of pain and swelling in left deltoid with some LOM (limitation of motion) left shoulder on day after shot, persisting for at least 16 d. Also had onset rash c/w (consistent with) pityriasis rosea onset 2 days post Td booster - felt unrelated to immunization.
runny nose with thin mucous; muscle pain in right arm; muscle pain in right arm; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) solution for injection, via an unspecified route of administration in right arm on 22Jan2021 11:00 at a single dose for Covid-19 immunization. Medical history included diabetes and chronic kidney disease. Concomitant medications included calcitriol, fluoxetine hydrochloride (PROZAC), and labetalol. The patient experienced runny nose with thin mucous and muscle pain in right arm on 23Jan2021. Patient did not received any treatment for the events. Outcome of the events was recovering.  No follow-up activities are needed. No further information is expected.
short of breath; nausea; throwing up; temperature was varying 97-99; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), NAUSEA (nausea), VOMITING (throwing up) and PYREXIA (temperature was varying 97-99) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (short of breath), NAUSEA (nausea), VOMITING (throwing up) and PYREXIA (temperature was varying 97-99). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (short of breath), NAUSEA (nausea), VOMITING (throwing up) and PYREXIA (temperature was varying 97-99) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Vaccine that expired on 2/12/22 was administered to the patient on 2/17/22.
Injection site pain and selling starting within a few hours of injection and continuing for about 3 days. The day after the injection, the patient experienced fatigue, nausea, and malaise which lasted about 24 hours.
Patient was 17yo when he received Moderne Covid 19 vaccine. Patient experienced no side effects other than a sore arm and fatigue
Severe diarrhea and weight loss lasting several months and leading to Crohn's Disease diagnosis
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine maintenance and for the prevention of shingles. After receiving ZOSTAVAX the patient began to experience severe pain in her right eye and headaches. Shortly thereafter; she broke out in a rash on her forehead, right side of her head, right eye, and down her neck. In response to these complaints, the patient presented to her primary care physician and was diagnosed as suffering from herpes zoster and followed up with a specialist regarding issues with her right eye. Upon internal review ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
Dizziness, Headache, Myalgia, Diarrhea,  "I felt like my blood sugar dropped immediately." Narrative:
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 76-year-old male patient who received SHINGRIX. Concomitant products included BENICAR, CRESTOR, Vitamin D3, Levothyroxine, Magnesium, COQ10 and fish oil. On 19th February 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular). In February 2018, less than a week after receiving SHINGRIX, the patient experienced injected limb mobility decreased. On 19th February 2018, the patient experienced weakness, sweating, sleeplessness, fever, heartbeats irregular, injection site pain and injection site lump. On 19th February 2018 18:00, the patient experienced shivering. The patient was treated with Acetaminophen and (NOS) BENADRYL. On an unknown date, the outcome of the shivering, weakness, sweating, sleeplessness, fever, heartbeats irregular and injection site lump were recovering/resolving and the outcome of the injection site pain was not recovered/not resolved and the outcome of the injected limb mobility decreased was unknown. The reporter considered the shivering, weakness, sweating, sleeplessness, fever, heartbeats irregular, injection site pain and injection site lump to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The reporter stated that, on 19th February 2018, he got SHINGRIX at noon on an by 6 PM he started shivering uncontrollably and spent the next day and a half on a heating pad. On the same day, the patient had a low grade fever, around 100 to 100.5 and all other adverse events, the patient stated that, he never had symptoms like this following a vaccination. The patients arm also hurts where he got the injection such that it effects his ability to move his arm, and he had a lump at the injection site. After the symptoms started he began taking acetaminophen and BENADRYL every 4 to 6 hours, but the patient did not think they helped. This case has been linked with case US2018029340, reported by the same reporter.
Patient had a syncopal episode 5 minutes after shot was administered.  Patient stated severe nausea, dizziness, and "not feeling right".  Bp dropped from 104/58 to 80/6o, Pulse increased to 100.  patient was places supine with q5minute VS until VSS 40 minutes post-injection. Patient discharged from clinic with instructions to present to ER/call 911 any recurrence of s/s.
pt had cellulitus and went to the hospital.  Is ok now and called to report.  Pt mentioned she will be contacting her prescriber tomorrow when they are open
I've had skin rashes on hands and fingers (similar to a form of contact dermatitis in appearance) since April 11th.  I've had what appears to be angular cheilitis since June.  I've had irritation, itchiness, and skin peeling around both eyes since June.
multiple erytremius macular hive-like rash areas bilateral groin, inner thigh, bilateral arm pits, Right crease elbow, Left ankle area.Hives started 5-2-08  Hep B given 4-30-08. Took benadryl.  Medrol 4 mg dose pack given and Triamcinolone 0.1% cream to affected skin areas.
17NOV92 stated t103 oral & sore arm 6PM, nausea, no vomiting; 19NOV92 taking sips of juice no solid food, diarrhea;
I was engaged in moderate physical activity for about 2 hours when I suddenly became very weak. I stopped working and took a shower. Within an hour I started having severe cramping around my chest and torso that last about 24 hours. Since the second day, I haven?t been able to  be active without starting to sweat and suddenly feeling weak and having to sit down. Even repotting a plant this morning started symptoms in minutes. I also have been experiencing dehydration since the day of the injection.
vaccine for shingles, After the covid vaccine I got Shingles/suspected vaccination failure; I got Shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   The patient's past medical history included chickenpox (had in 3rd grade).   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got Shingles and after the covid vaccine, the patient got the shingles. On an unknown date, unknown after receiving Covid 19 vaccine, the patient experienced shingles.  It was unknown if the reporter considered the shingles to be related to Covid 19 vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Information has been received from a consumer concerning a potential varicella outbreak in her 8 year old niece who, on an undisclosed date was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). The patient had a total of 37 itchy pimples that turned to blisters, starting on her face and spreading to her trunk and arms. The patient also developed a fever of 102, nausea and a sore throat. The illness was considered mild and treated with Advil and Tylenol for mild fever. The events all resolved in 7 days. The pediatrician of the child asked that the child not be brought into the office, since they felt that she was contagious. The original source of illness was thought to be a woman in her nieces neighborhood who had a bad case of shingles and did not restrict her contact with others, but the physician informed her that several cases were seen in the school system prior to summer break. The product quality complaint unit was not involved. Additional information has been requested. The consumer also provided information regarding other patients' experiences while on treatment with varicella virus vaccine live (WAES #0706USA03851, 0706USA04141, 0709USA00017).
This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 24Feb2021 (at the age of 58-years-old) (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medication included levothyroxine. On 25Feb2021, the patient experienced having little itching on my arm and have like a little rash; little rash on both of my arms. Events were treated with Neosporin cream. The outcome of the events was not recovered/not resolved. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
swelling around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling around injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 VACCINATION SITE SWELLING (swelling around injection site). At the time of the report, VACCINATION SITE SWELLING (swelling around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications are provided .  No concomitant medications are provided .
Edema of neck, face, shortness of breath, and anxiety ER visits 01/03/2021, 01/09/2021, 01/12/2021, & 01/17/2021. Treatment with prednisone, hydroxyzine, alprazolam, diazepam, benedryl, buspar, fluoxetine Labs:  cbc, cmp, tsh, ekg, cardiac enzyme labs PCP visits 01/05/2021, 01/11/2021, 01/20/2021, 01/28/2021 Psychiatrist: 01/25/2021, 01/28/2021, 02/02/2021; treating anxiety with fluoxetine Imaging: ultrasound neck Referral:  Allergy Specialist
Patient's wife came in to the pharmacy and showed pictures of patient's arm which showed a large bruise from shoulder to elbow. Patient's wife is worried that it is a blood clot or an infection. Patient's wife states patient went to immediate care a few days ago and they did not do anything for treatment, and then the following day patient went to primary care physician and they did not do anything for treatment there as well. Both the photographs and the response from the doctor's office is that the reaction is likely a bruise from the blood thinners a patient is taking (warfarin and clopidogrel) and the bruise will likely heal on its own and no treatment is necessary.
new onset of joint pain that's mild-mod intensity; symptom onset after receiving 2nd dose of COVID
Itching about 3 inches either way, grew at the bottom, like it was running down my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching about 3 inches either way, grew at the bottom, like it was running down my arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching about 3 inches either way, grew at the bottom, like it was running down my arm). At the time of the report, VACCINATION SITE PRURITUS (Itching about 3 inches either way, grew at the bottom, like it was running down my arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
I get sick every time I get the flu vaccine; Initial information received on 20-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced i get sick every time i get the flu vaccine while receiving vaccine INFLUENZA VACCINE (MONOVALENT).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE (MONOVALENT) produced by (unknown manufacturer lot number, strength and expiry date)  via unknown route in unknown administration site.In the context of COVID19 crisis, the batch number and expiration date were requested.  On an unknown date the patient developed a non-serious event "i get sick every time i get the flu vaccine "(illness) (unknown latency) following the administration of INFLUENZA VACCINE (MONOVALENT).  Action taken with INFLUENZA VACCINE MONOVALENT (INFLUENZA VACCINE (MONOVALENT)) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I get sick every time I get the flu vaccine).  At time of reporting, the outcome was Unknown for the event i get sick every time i get the flu vaccine.
11:00 pm  on day of vaccine had fever, chills, headache, dizziness    Next morning had temperature of 102