chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe vertigo; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of VERTIGO (Severe vertigo) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 13-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (Severe vertigo) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency.   At the time of the report, VERTIGO (Severe vertigo) and HEADACHE (Headache) outcome was unknown.      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 product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vasovagal-light headedness, dizziness, weakness, nausea, fatigue
patient is fully vaccinated with moderna vaccine, we do not have the lot numbers available at this time patient was exposed to someone with COVID, tested positive on 08/03/21
Can't Sleep; Itches; Huge Rash; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can't Sleep), PRURITUS (Itches) and RASH (Huge Rash) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INSOMNIA (Can't Sleep), PRURITUS (Itches) and RASH (Huge Rash). At the time of the report, INSOMNIA (Can't Sleep), PRURITUS (Itches) and RASH (Huge Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information included Cream
Headache, fatigue begginning several hours after the injection around 6:00 pm lasting until the next morning
Received H1N1 vaccine on 12/21/2010 on 12/23/2010 had extreme starburst effects in eyes that have not gone away. One week later had massive headaches and could not sleep and came down with a cold. Have had 2 MRI in the past week becuase one pupil has dialated larger and have haed stiff neck and eye pain.
Patient states she woke in the middle of the night with her arms feeling like they were asleep. Then in the morning both hands were swollen left more than right. Also states that if she raises her arms up in the air they "go to sleep and become numb". States that last night 11/29/2009 was the first night she was able to sleep through the night and today is the first day she can put her wedding ring back on. States that her hands still swell and arms go numb but is getting a little better.
Patient developed reddened and swollen arm. Given Tylenol for night time relief. Woke on Saturday arm had worsened, more swollen, sore. Taken to the ER. Keflex prescribed and swollen area outlined with instructions to return to the ER if swelling went beyond parameters. Sunday morning more swollen. Returned to the ER Bactrim prescibed. Out of school Monday and Tuesday. On Friday developed itching at site. Treated with Benadryl.
COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028KZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 02-Apr-2022 at 1:15 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2022 at 2:00 AM, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information  Company Comment: This is a spontaneous case concerning a 77-year-old male patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine. No details on the previous vaccinations were given. As reported patient had recurrence of COVID-19 nine days after receiving the treatment Paxlovid. No other clinical or treatment details were given. It was reported that the outcome of the event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 77-year-old male patient with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 1 month after receiving the fourth dose of mRNA-1273 Vaccine. No details on the previous vaccinations were given. As reported patient had recurrence of COVID-19 nine days after receiving the treatment Paxlovid. No other clinical or treatment details were given. It was reported that the outcome of the event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report was received from a medical assistant and refers to a 58-year-old female patient. The patient's pertinent medical history included seasonal allergies and chronic insomnia. The patient's drug reactions or allergies included phenylephrine, nystatin and pseudoephedrine hypersensitivity. On 21-JUN-2018, the patient was vaccinated with PNEUMOVAX 23, 1 dose, 0.5 ml, intramuscularly (lot # N034512, expiration date: 13-SEP-2019) for prophylaxis. Concomitant therapies included levocetirizine dihydrochloride (XYZAL), montelukast sodium (SINGULAIR) and trazodone hydrochloride. On 22-JUN-2018, the patient experienced bruising all over her body, headaches and feeling tired. The patient sought medical attention and on the same date, she was seen by the physician. An unspecified treatment for the events was administered. On 26-JUN-2018, the patient went to the physician for a follow-up visit and the bruising was reported as resolved. The outcome of headaches and feeling tired was reported as recovered on an unknown date in 2018. Relatedness between the events and PNEUMOVAX 23 was not reported.
48 hrs after vaccine administration he experienced headache (Entire head), generalized body aches, upper & lower lip numbness, altered taste, fatigue and generalized muscle weakness.
Information has been received from a physician concerning a 3 & 1/2 month old patient who was vaccinated with the first dose of Rotateq.  The patient did not experience any difficulties.  The physician did administer the second dose ten weeks after the first dose which was not given at the reporting physician's office.  There was no product quality complaint.  Additional information has been requested.
headache; a strange, indescribable taste in her mouth that sort of resembles soap; shakiness; a thick feeling on her tongue with the taste buds feeling indescribable, prominent and dry; is really tired enough to want to lie down and sleep; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 16Feb2021 13:20 as SINGLE DOSE for covid-19 immunisation. Medical history included respiratory tract infection from an unknown date and unknown if ongoing Treated with Mucinex DM, drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took mucinex for respiratory tract infection. On an unspecified date, the patient experienced headache, a strange, indescribable taste in her mouth that sort of resembles soap, shakiness, a thick feeling on her tongue with the taste buds feeling indescribable, prominent and dry , is really tired enough to want to lie down and sleep. The patient underwent lab tests and procedures which included x-ray: respiratory infection. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was unknown.  Information about lot/ batch number has been requested.
Fever, body aches and fatigue within 12 hours lasting for approximately 12 hours. Within 48 hours, developed moderate tinnitus which progressed to severe tinnitus within . I have experienced tinnitus in the past but it was mild and tolerable. This was much worse and become unbearable. I couldn't concentrate and had difficulty sleeping. I scheduled an appointment with the doctor, an ear, nose and throat specialist who prescribed antidepressants and suggested hearing aids.  I met with an audiologist and am now wearing hearing aids which help mask the tinnitus. It has not subsided.
Redness in skin near injection site if any pressure is applied in area. Redness faded after 2 hours.; Fatigue; pounding headache; arm soreness; This is a spontaneous report from a healthcare professional. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 13:45 at single dose for COVID-19 immunization. Medical history included allergies gluten intolerant, mildly allergic to cow's milk and autoimmune atrophic gastritis from an unknown date and unknown if ongoing. Concomitant medication included cyanocobalamin (VITAMIN B12). The facility where the most recent COVID-19 vaccine administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 24Dec2020, the patient experienced fatigue, pounding headache, arm soreness for next 24 hours and redness in skin near injection site if any pressure is applied in area. Redness faded after 2 hours. No treatment was given to the patient for the events. The outcome of the events was recovered in Dec2020. The events were considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Ten minutes after receiving Flu vaccine, began to cough, copious amounts of mucous, tightness in her throat.
On the evening of Oct. 12th, very cold with chills. Throughout the night did not ache but had severe hurt/pain in bones and muscles all over.  Every time I moved it was very painful.
"severe fever" (but patient did not check the actual temp), and generalized achiness that started about 30 minutes after the injections and lasted a couple of days
COVID-19 Infection Narrative: Patient received 2 dose series of Pfizer COVID-19 Vaccine at outside location on 1/1/21 and 1/25/21. On 2/6/21 the patient reported to the ED with shortness of breath and hypoxia. Patient required admission to an intermediate care unit and an increase in baseline supplemental oxygen. Patient completed course of dexamethasone and remdesivir. Discharged home on 2/24/21.
Patient administered expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder on Modernatx.com the expiration date was 14 Aug 2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14 Oct 2022. The vial did not undergo any temperature excursions. No treatment drugs were reported.
Left upper arm (where shot was administered is  red, swollen, warm, hard, hurts and is itchy.  Started 24 hours after injection and has gotten worse over the past 5 days.
Site: Pain at Injection Site-Medium, Additional Details: patient still reporting pain in the arm where vaccine was administered after more than 7 days. pharmacist Informed patient to use analgesic to relieve pain and monitor for improvement, if not improved should consult primary care.
received Shingrix second dose SC instead of IM; Shingrix first dose was given SC too; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 7434N, expiry date 24th April 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7434N, expiry date 24th April 2022) for prophylaxis.   On 30th October 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 1st April 2021, the patient received the 2nd dose of Shingrix (subcutaneous). On 30th October 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 1st April 2021, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route and intramuscular formulation administered by other route were unknown.  Additional details were provided as follows: This case was reported by nurse on behalf of patient. The patient said to nurse that Shingrix 1st dose was given subcutaneously, which led to intramuscular formulation administered by other route, so the nurse gives 2nd dose of Shingrix at an ambulatory clinic, subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route.  The nurse was looking for safety information for this situation and stated that she needed to follow up with patient. The reporter consented to follow up at her private cellphone.
I had a mild COVID-19 infection in January, 2021. My symptoms were mild congestion and slight body ache. I did not lose any sense of smell or taste, nor were those senses altered in any way during my infection. I waited 3 months for my COVID-19 vaccine. About 10 days after I received my first shot of the Pfizer COVID vaccine I started to experience weird tastes and smells with certain foods such as eggs, corn chips and popcorn, and strawberries. I did not lose my sense of smell or taste, but they have been altered. When I eat these foods I have a bad taste and smell. The sensation seems to have dissipated a bit but is still with me 3 months after the first dose.
Had the vaccine on Wed and then Thursday and Friday had 101.0 temp.  By Saturday feeling better.  Saturday evening began feeling itchy and painful nerve pain throughout my body.  Finally went to ER on Sunday evening and kept as inpatient until Tuesday 2/16.  I was also on an antibiotic for an infection and Dr.  feels that this was the primary source of my reaction, but not sure if it was compounded by the vaccination.  It?s been a rough couple of days, but feeling better now.
Received vaccine on 1/26/2021. 1/27/21 at 7:30 pm developed diarrhea. GI symptoms continued on 1/28/21 in the morning. At approximately 1:20pm on thursday. employee had a syncopal episode. Pale and diaphoretic.  Then had episode of vomiting. Treated for dehydration with IV fluids. Given script for zofran. Treated as outpatient.
Approximately 2 months after my 2nd dose I experienced the following symptoms: Hypertension, Fatigue. I consulted with my doctor and was prescribed with Eliquis, Carvedilol, Valsartan and I have developed high cholesterol as well over the course of time and was prescribed with Rosuvastatin.
I had a headache that lasted for a day or two.  I then started to have swelling in my fingers and toe.  Then 2 weeks later, I started having serve joint pain.  I could hardly stand up or move. I could not even sleep through the night.  It was from my neck down to my toes.  I contacted my doctor.  They prescribed me steroid medicine for 10 days.
I had flu-like sx starting 12 hrs after the 2nd dose, a large red rash grew around the injection site, and took a few days to start decreasing.  Just under 2 weeks after my 2nd shot, the rash is returning and there are 2 smaller circles, it's somewhat itchy and bumpy, it's gotten larger over the last few days and I'm not sure if this will continue.
Employee states she is experiencing significant pain radiating to her shoulder and upper arm with impaired range of motion.
A serious spontaneous report of exertional rhabdomyolysis has been received from a non health professional concerning a 29-year-old female, subsequent to FLUMIST and H1N1 vaccine. The patient has no past medical history. She does not smoke, she drink alcohol occasionally and performs eccentric exercise. Family history was significant for an older sister who passed away one month prior from H1N1 complications. Concomitant medications included oral contraceptives. The patient received FLUMIST three weeks prior to the first episode of exertional rhabdomyolysis and H1N1 vaccine three weeks prior to the second episode. The patient was a soldier who presented with two day history of diffuse muscle pain associated with dark urine following a workout two days prior. The patient reported a typical workout consisting of squats, push-ups, sit-ups and shoulder press. The following morning she noted increasing diffuse muscle pain with severe upper arm and leg pain exacerbated by movement. She denied any recent heat exposure, medications or supplements. She recently completed a half Ironman triathlon and did weight training three times weekly. The patient was admitted for exertional rhabdomyolysis without renal complications. After CK peaked, the patient was discharged home with aggressive oral hydration & recommended physical rest. Two months later, after resuming low-impact exercise, the patient developed symptoms again. This time, she reported that she had received the H1N1 vaccine three weeks prior. Due to the recurrence of symptoms, an exercise intolerance mutation panel was done. Physical exam was significant for diffusely tender muscles and pain on passive ROM. The differential diagnosis was exertional rhabdomyolysis. The following lab tests were done: first episode: CK= 66,000; BUN 8; Cr 0.8; AST 441; ALT 220, UA 1.006, small blood, no RBCs. Second episode: CK 1,300; BUN 8; Cr 0.8; AST 99; ALT 40; UA 1.001, small blood, no RBCs. The exercise intolerance mutation panel showed no mutations for myophysphorylase deficiency, carnitine palmitoyltransferase II deficiency, or myoadenylate deaminase deficiency, muscle biopsy was negative. Per the reporters, this patient was used to eccentric exercise, it seemed rare that she would develop unprecipitated symptoms of rhabdomyolysis without a predisposing factor. Given the timeline of live-virus influenza vaccines three weeks prior to each episode of symptoms, as well as a negative genetic work-up, it is hypothesized that the live influenza virus vaccine in combination with eccentric exercise caused rhabdomyolysis. The outcome of the event was unknown. The reported assessed the event of exertional rhabdomyolysis as related to FLUMIST and H1N1 Vaccine.
Information has been received from a physician and an Alaska native female (age 62 at time of reporting), with allergies to unspecified "pain killers," asthma with increasing problems over the past year, chronic obstructive pulmonary disease, allergic rhinitis, hypertension, gastrooesophageal reflux disease, degenerative bone disease and a history of extreme swelling of her legs, extreme joint pain and shortness of breath while on therapy with amlodipine positive skin tests to aero-allergans, headaches, itching and breathing problems (not further specified) while on therapy with morphine and codeine, breathing problems (not further specified) while on therapy with trifluoperazine hydrochloride (STELAZINE) and unspecified reactions while on therapy with aspirin (+) butalbital (+) caffiene (FIORINAL), pentazocine lactate (TALWIN) and sulfa, who on an unspecified date was vaccinated with a dose of pneumococcal vaccine 23 polyvalent.  Subsequently the patient experienced a reaction (not further specified).  The outcome was not reported.  Follow up information from the physician indicated that there was no information in their records regarding the patient having received a dose of pneumococcal vaccine 23 polyvalent.  No further information is expected.  On 02/20/2003, the physician and patient also reported the experience of the patient while on therapy with montelukast sodium (WAES # 0302USA02296).
Pt recvd 3 doses of Engerix-B on 9MAY90, 6JUN90, & 26NOV90 & was found to be a non-responder;
Possible brain aneurysm. 12/15/2008 MR received for DOS 11/25-12/03/2008 with Dx:  Subarachnoid hemorrhage.  Abnormal electrocardiogram probably related to intracranial abnormalities. . Pt presented with 7 day hx of severe h/a which began following flu shot with stiff neck. Seen at local facility where CT scan was concerning for R temporal and R parietal subarachnoid hemorrhage. Transferred to current facility for mgmt. PE (+) for disconjugate gaze. Pt spent several days in ICU then regylar floor with slow resolution of h/a and no further development of any other sx. D/C to care of family  and for outpt f/u.
pt recv vax 4MAR96 & seen again same day-screaming since inj given;
client stated he felt dizzy, after receiving moderna booster vaccine, patient lost consciousness for four seconds. 911 was called. after few seconds client was awake, alert, oriented to person place and time,  and verbally responsive. client refused medical treatment and insisted on going home. After thirty minutes of extensive 1 on 1 monitoring the patient stated he was fine and good to go home.