chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 35 year old female pharmacist who was also the patient via a company representative referring to the pharmacist herself. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date when she was 35 years old, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date the patient experienced pneumonia. Then a year later she got another dose and a year after that she got another dose and kept getting pneumonia on unspecified date. On unknown dates the patient experienced severe reaction, swelling and her arm was extremely painful. It was unknown after which dose the pharmacist experienced the severe reaction, swelling and arm pain. The outcome of the events was reported as recovered. Upon internal review, pneumonia was considered to be medically significant.
Shivering; Fatigue; Frequent urination; thirst the night of June 1st; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2022, the patient received the 1st dose of Shingrix. On 1st June 2022, less than a day after receiving Shingrix, the patient experienced shivering, fatigue, urinary frequency and thirst. On an unknown date, the outcome of the shivering and fatigue were recovered/resolved and the outcome of the urinary frequency and thirst were not recovered/not resolved.   It was unknown if the reporter considered the shivering, fatigue, urinary frequency and thirst to be related to Shingrix.     Additional Information: GSK receipt date: 02-June-2022 Reporter's comment: The patient-self reported this case. The patient received a dose of Shingrix and experienced shivering, fatigue, frequent urination and thirst in the night of the vaccination day. In June 2022, the shivering and fatigue was resolved. The patient reported that she continued to experience frequent urination and thirst. The reporter did not consent to follow-up.
I received the Moderna Covid-19 Vaccine EUA on January 7th 2021 around 11:15AM. there were no initial side effects.  I started Experiencing the listed side effects from the morning of January 8th, 2021 to the morning of January 9th, 2021. It started with light muscle and joint pain at 8am and progressed to sever muscle and joint pain, chills, nausea, fatigue, headaches and eventually a fever averaging at 100 degrees Fahrenheit by 1-2PM the same day. These side effects were enough to leave me bedridden for most of the 8th. most side effects were gone by the morning of the 9th, the fever eventually broke by 930Am on the 9th.
Patient stated that she had marginal amount of redness and swelling at the injection site. She also had two blisters at the injection site.
Dizziness, loss of motor control, headaches - Dec. '07.  Shooting pains, numbness of feet, legs & arms - Jan. '08.  Diagnosed in Jan. 2008 with Transverse Myelitis through spinal MRI's & spinal tap. 5/22/08-records received for DOS 3/18-3/20/08-DC DX: Transverse myelitis with exacerbation. Admitted with history of increasing weakness on both upper and lower extremities with incoordination more on right than on the left. Difficulty holding objects and ambulation. Hiccups. Admitted in January which showed changes suggestive of transverse myelitis in cervical cord. Treated with IV steroids and responded well. PMH: Hypertension and gastroesophageal reflux disease, sinusitis and pulmonary nodule. C/O severe neuropathic pain. Responded well to steroids and was transferred to tertiary care. 6/9/08-records received for DOS 3/20-3/26/08- DC DX:Transverse myelitis. Diabetes type 2 secondary to steroids, hypertension steroid related, C/O strange sensation in throat on 12/07, weakness and clumsiness. Initially treated on 1/08 and in February was walking with complete resolution of numbness of right side. On 3/11/08 nerve pain on left side including face and shoulder and feet. Numbness and tingling followed which progressed to right side and was more profound than previously.  Follow-up: Loss of muscle control. Continued numbness in limbs; neck and head pain, sensitivity to temperature changes. All the various symptoms related to Transverse Myelitis, including urinary sensation and control. Dates of hospitalization since vaccination: 12/18 - 12/23/07. 01/17 - 01/29/08. 03/18 - 03/26/08. 12/15 - 12/18/08. 04/27 - 05/06/09. 05/10 - present. Doctors are considering plasma exchange therapy as a last option of treatment in this rare case. Plasmaphoresis began on May 12, 2009. Doctor ordered treatments for 5/12, 5/14, 5/16 and 5/18/2009.
The infant had severe body twitch. When he is awake they happen every 3-5 minutes and they last 5-20 minutes. He makes a grunt sound in his throat, he also smacks his lips. Treatment: the neurologist has the patient taking Prelone Syrup, 2 teaspoons a day.
Started at 8 pm, difficulty breathing like having an asthma attack, wheezing, fast heart beat and at the same time my arm was aching so I looked at the vaccine sight and was red, swelled up and warm to the touch and it itched.
This dose was administered in the wrong location. Resulted in redness, swelling, tenderness and swollen lymph nodes under arm.
Patient received  an undiluted dose of pediatric pfizer Covid vaccine. No side effects to report at this time.
Pt had raised area of 1 1/2 inches below injection area and a 1 inch lateral from another injection. She complained of area itching, and area slightly warm. Child does not have a temperature.
Child lost consciousness, fainted and fell to the floor within 10 seconds of receiving first vaccine dose.  He regained consciousness within a few seconds.  Paramedics were called as the nurses monitored his vital signs.  He stabilized within 30 minutes or so and was cleared to go home.
heart palpitations; sore arm; blood rushing; it is kind of an electrical feel through her whole body//it is an energy force going through her body; have a heart condition; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EU6208) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Coronary artery disease" (unspecified if ongoing), notes: Verbatim: Coronary artery disease. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Mar2021, outcome "not recovered", described as "sore arm"; SENSATION OF BLOOD FLOW (non-serious) with onset Mar2021, outcome "unknown", described as "blood rushing"; PALPITATIONS (non-serious) with onset 15Mar2021, outcome "not recovered", described as "heart palpitations"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "it is kind of an electrical feel through her whole body//it is an energy force going through her body"; CARDIAC DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "have a heart condition". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient had her Pfizer first dose on Saturday 13Mar2021 and she is getting heart palpitations, states it is kind of an electrical feel through her whole body, states she does have a heart condition, states it is a weird thing, she is reaching out to Cardiologist later today, caller is wondering what it is, or what to do about it, it is an energy force going through her body. Wondering, she did blood work, they said you may have a reaction if you have high antibodies to the zoster virus, just have that tested, and it is super high, states this is prior to the vaccine.  No follow-up attempts are possible. No further information is expected.
Information has been received on 09-FEB-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 11-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-FEB-2016, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster with neuropathic pain. The patient has been prescribed valacyclovir and gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Pt requested Moderna Vaccine.  As per company protocol, when patient received the vaccine she waited in pharmacy 15 minutes.  She was not feeling any symptoms or side effects so she left.  However after she left it was discovered that she had been inadvertently administered Janssen vaccine instead of the Moderna Vaccine.
48 hours after second vaccination, got a 3 by 3 inch rash under the vaccination spot, just about where you would imagine gravity would take the medication
No symptoms at time of vaccine injection.  1 week later pt had hive like rash at injection site after a shower.  Solid induration, warm and red, the size of palm of her hand. Pt put some neosporin on it but it?s still present.
irritation; breakage; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (irritation), SKIN DISORDER (breakage) and HYPERSENSITIVITY (allergic reaction) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 045B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN IRRITATION (irritation), SKIN DISORDER (breakage) and HYPERSENSITIVITY (allergic reaction). At the time of the report, SKIN IRRITATION (irritation), SKIN DISORDER (breakage) and HYPERSENSITIVITY (allergic reaction) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2022-456314, MOD-2022-456311 (Patient Link).
Flu like symptoms; Mild reaction; Cold; Body is weak/ She does not want to go anywhere; Mild fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Mild reaction), NASOPHARYNGITIS (Cold), ASTHENIA (Body is weak/ She does not want to go anywhere) and PYREXIA (Mild fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Mild reaction), NASOPHARYNGITIS (Cold), ASTHENIA (Body is weak/ She does not want to go anywhere), PYREXIA (Mild fever) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION COMPLICATION (Mild reaction), NASOPHARYNGITIS (Cold), ASTHENIA (Body is weak/ She does not want to go anywhere), PYREXIA (Mild fever) and FATIGUE (Tired) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
A report has been received from a health professional concerning a 5 year old, male patient. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient started receiving treatment with nasal FLUMIST Quadrivalent. A child received FLUMIST on Monday, Oct 27, 2014 and then tested positive for influenza B on 10/29/14. Reporter stated child returned to office not feeling well, did not know exact symptoms. Action taken with FLUMIST Quadrivalent was unknown. The patient recovered from the event of influenza on an unspecified date. The report was considered to be non-serious by reporter.
Red rash at injection site; 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 INJECTION SITE RASH (Red rash at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 INJECTION SITE RASH (Red rash at injection site). At the time of the report, INJECTION SITE RASH (Red rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
There has not been an adverse effects as of yet. Patient has not had any symptoms.  Patient is 24 weeks pregnant.  EDD is 6/22/2022.
Narrative:  COVID infection following completion of COVID vaccine series 01/07/21 COVID vaccine dose #1 01/28/21 COVID vaccine dose #2 07/26/21 Pt presents to clinic reporting chills, cough, fever, runny nose, shortness of breath that started 07/19; states he tested COVID POSITIVE 07/25; rx given acetaminophen, DM/guaifenesin, albuterol, vitamin C, vitamin D, zinc; presents to community ED with complaint of worsening SOB; CXR patchy interstitial opacities and alveolar consolidations suggestive of infectious/inflammatory etiology; admitted to community hospital and treated with azithromycin, ceftriaxone, dexamethasone, and remdesivir 08/04/21 Pt discharged from community hospital with home oxygen; reports fatigue and declines daily COVID calls
After both the first and second vaccines, I ran a fever and didn't feel well from about 16 hrs post-vaccine to about 36 hours post-vaccine. Not a big deal, but it did slow me down. After the first vaccine, my arm got sore but I expected that. After the second vaccine, the same things happened which I was ready for this time, but in addition, I developed a large red welt on my shoulder, AND the reason for this report, is that I developed a severe rash. It looked like sun poisoning (which I have never gotten before). I noticed it a little less than 48 hours after the vaccine and it got worse over the next couple days. It covered my neck, chest and upper arms. It was inflamed, itchy and after about a week my skin felt like course sandpaper. Just to be clear, I was not sunburned even though the response fit the description of sun poisoning to some extent. I treated it with cortisone cream, kept covered up from the sun and slathered on sunblock for weeks. All the skin on my neck peeled after about 10 days. It has been about 6 weeks and I still get several red, itchy welts after working outside on hot weekends.  It doesn't matter if I stay covered or use sunblock. Maybe the form in response to the heat and sweat?  The response seems to lessen every week so I  believe my skin's sensitivity will eventually return to a normal state, but the experience makes me wonder if that vaccine just over sensitizes the immune system to uv radiation or heat or sweat. I haven't read any reports of that side effect, but I can't help but believe this is vaccine induced. The timing was right in line with an immune response to the vaccine and my work outside was not at all out of the ordinary for me. I have been doing the same for years.  I did take a picture or two and I told my Doctor though I did not visit him or ask him for any meds as it seems to be resolving with time and over the counter cream.
PATIENT EXPERIENCED A RED RASH AROUND ARMPIT AREA THAT SPANNED ABOUT 2 INCHES, THAT BEGAN 4 DAYS AFTER VACCINATION.  DOES NOT REPORT ITCHING OR PAIN, JUST REDNESS.
Bulging fontanelle in well appearing infant and fever within 18 hours of recieveing 4 month immunizations. She was sent to the ED and had a lumbar puncture which did not show signs of meningitis. She had a cranial ultrasound which was normal. She was observed in the hospital overnight. Notably, she also had a respiratory viral panel which was positive for RSV and Human Rhino-Enterovirus.
pounding headache    ears ringing          threw up friday pm  3x,  fever,   tired.  achy, dizzy, no appetite. until monday.  11/15/2021.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: hives on inside of both arms, back of knees and up through thigh and lower back lasting from 3am to 6am.  No medical attention was seeked by the patient
Ringing in ears 2-3 times a day Each incident lasts about 3-5 seconds
An apparent sz, shook head side to side & had some tonic-clonic movement of upper extremities x 15-20sec; then post-ictal (sleepy) & subsequently fine, no problems;
EE stated she began felling light headed after exiting the observation rm and it became progressively worse when in elevator.  Became pale and diaphoretic, was lowered to the floor by other CW employees.  Assisted to wheelchair transported to observation rm. 1627 BP 88/43 pale diaph  1630 BP 70/38 HR 62 POX 96 pale diaph.  EE was lowered to supine position with legs elevated. 1631 BP96/55 HR 62 POX 100 Color improving 1633 BP101/63 HR 68 1635 BP 108/73 HR 66 RR 16 1636 BP 114/68 HR 62 RR 16 able sit up continues to "feel better" drank apple juice/H2O 1639 BP 107/83 HR 72 POX 100 1640 Up to w/c color improved, "feeling better" tolerated transition well 1642 BP108/59 HR 79 POX 99 1643 BP105/55 HR56 POX 100
lost hearing in right ear; This case was reported by a other health professional via other manufacturer and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingrix) (batch number LD3NH, expiry date 11th December 2021) for prophylaxis.   On 23rd July 2020, the patient received Shingrix (intramuscular) .5 ml. On 27th July 2020, 4 days after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was not recovered/not resolved.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported as patient lost hearing in her right ear 4 days after receiving the Shingrix Vaccine.  The reporter consented to follow up. The case has been linked with case US2020159610, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159610:same reporter
Muscle aches (day after vaccination 12/29/2020), sore arm (start 12/29/2020), injection site redness, itching, warmth & swelling (start 12/29/2020), injection site redness and swelling tripled in original size (as of 1/6/2021, still current), nausea (start 1/4/2021, still current), GI upset (start 1/4/2020, still current)
mom states pt rt arm is swollen approx size of hard ball;swelling began 9MAY96 early evening;swelling noted to be approx size of half dollar @ that time;no fever noted;mom stated pt is not as active as usually is;
At approximately 11:30PM on 12/25/20,  pain in my left axilla  woke me from deep sleep.  There was (is) a palpable, painfull swollen  lymph node .  It remains painful at the time of reporting (12/27/20 12noon).  The pain is temporarily relieved with NSAID.  Other than pain, there are no other associated symptoms. I had mild pain at injection site on day 2 but no other notable events  following vaccination on 12/19/20. I will send a message to Dr ,  (my PCP) but do not think a visit will be necessary.   I am scheduled for my second vaccination on 01/08/21 and intend to get it - in my right arm.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) 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 VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No treatment medications were provided.
Hives and rash all over body that appeared about a week after vaccine. Rash comes and goes and still to this day is appearing on my body. Dr prescribed prednisone and Zyrtec and Benedryl.
Nurse calling to report at temperature excursion involving PROQUAD / the PROQUAD was administered to one patient this morning; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported.  On 27-JAN-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 0.5 milliliter (ml) (strength, number of administered dose, vaccination scheme, frequency, anatomical site of vaccination and route of administration were not reported; lot number T028139, which has been verified as valid, expiration date reported and validated as 15-FEB-2022) as prophylaxis, that experienced a temperature excursion (product storage error).  The vaccine underwent a temperature excursion of minus 13.8 degrees Celsius (C) for 12 minutes, as recorded by a data logger. There was no previous temperature excursion.
In the 1-2 days after vaccine, patient had mild shoulder pain and malaise, self resolved. Two weeks after, however, developed severe unrelenting pain in the left shoulder girdle. After about one additional week, grip strength became weak and dexterity for manipulating small objects became impaired. Focused examination showed MRC grade (R/L as appropriate): trapezius 5/5, shoulder external rotation 5/5, deltoid 5/5, biceps 5/5, triceps 5/5, wrist extension 5/5, wrist flexion 5/5, finger extension 5/5-, APB 5/5-, APL 5/4-, FDI 5/4+, ADM 5/4+, FDP IV/V 5/3-, FDP II/III 5/5. Pinprick and temperature sensation were normal. Left biceps reflex was 1+; all other UE reflexes were 2+. EMG/NCS done and consistent with mild lower trunk brachial plexopathy. MRI done and shows enhancement in the scalene muscle just adjacent to lower brachial plexus. Presentation felt consistent with Parsonage Turner syndrome, brachial neuritis. He was treated with a one week prednisone taper. Over the next 3 months, he has had gradual improvement in strength and sensation. Only minimal deficits remain.