chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In addition to recognized side effects, approximately 24 hours after injection, I experienced sudden-onset severe pain in my right shoulder that traveled through my biceps and into my elbow. On a scale of 1-10, I?d rate the severity as a 10. This lasted approximately 15 minutes.   Over the ensuing 5 days I had noticeable but tolerable intermittent right arm pain. Then beginning on the 10th day following injection, I experienced sudden and severe right shoulder pain that traveled down my biceps into my elbow again. I'd rate the pain at a 9 on the same scale. This time however, the pain started around 11 pm and did not subside. I tried sleeping but couldn?t. I got up and spent the rest of the night holding my arm to immobilize it, however that did nothing to stop the pain. It was about 5 am when I finally took 50 mg diclofenac and in about 2 hours the pain subsided to a tolerable 4 on the same pain scale.   As the day wore on, the pain increased again to a level 9 without medication so I continued with 50 mg diclofenac every 8 hours over the following 4 days and knocked it back to a level 3. This pain has occurred in my right shoulder, biceps, elbow, forearm and even my fingers and intensifies toward evening. I have been able to tolerate the pain without medication at about a level 3 for the past 2 days. However, I take a 50 mg tab of diclofenac an hour or 2 before bed as the pain intensifies toward evening. This has allowed me to sleep through the night.   In addition to the arm pain I developed muscle weakness in my right biceps about 3 days ago and am unable to lift my right arm above my head. The pain is not what prevents the movement. It?s as though my arm is not receiving the nerve impulse to move. Taking all of this together, I?d say that immunization appears to have triggered Parsonage Turner Syndrome. As I understand this immune-mediated syndrome, several events can trigger it, including immunization. I experienced this phenomenon one other time, approximately 2 years ago but did not correlate it to a vaccination at the time. This time it?s too apparent. I wonder how many other reports you?ve received that are like this and whether the vaccines will trigger the same reactions. I also wonder now whether I should receive a Moderna ?booster? if needed in the near to long term. I have no interest in going through this event a
12 JULY 06 (PM) PATIENT NOTED RASH ON BACK, CHEST AND UPPER ARMS 13 JULY 06 (AM) PATIENT PRESENTED TO MEDICAL PROVIDER - AFEBRILE, NON-TOXIC, VESICULAR RASH ON ERYTHEMIC BASE ON CHEST, BACK, AND UPPER ARMS; TREATED WITH NSAID AND ANTIHISTAMINE; PHOTOS TAKEN; REPORTED TO AGENCY  14 JULY 06 (PM) SPECIMEN COLLECTED FOR CULTURE AND PCR 17 JULY 06 (PM) SEEN BY A PROVIDER - RASH IS RESOLVING.
Moderna COVID-19 Vaccine EUA Day 1-4 = shot site soreness, swelling & heat in upper arm area below shot site Day 5 = unusual itching in left hand wrist, thumb & index finger area where arthritis seems to be. Day 8 = upper arm below shot site begins to itch (like a mosquito bite), swells up and tightens with redness Day 9 = Upper arm is itching and swelling again for a period of time.
After about 10 minutes of receiving the 1st Dose of the Pfizer vaccine the patient complained of dizziness and cramping of her hands,  the vaccination nurse took her blood pressure which was very low 97/52. Her feet were elevated and she was given juice, then we called the rapid response team to assess her further.  They took her to the emergency department for observation.
Severe bilateral lower extremity edema. Assoc with pain that makes walking difficult. Also assoc with malaise and fatigue. Occurred both times she was given Hep A vaccines but did not realize relation to vaccine after 1st injection. Sx lasted 10 days each time.
small red bumps all over body; small itcy bumps all over body; bumpy rash; red rash; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2022, the patient received the 2nd dose of Shingrix (intramuscular). In November 2022, less than 2 weeks after receiving Shingrix, the patient experienced local swelling, itchy rash, papular rash and red rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the local swelling, itchy rash, papular rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the local swelling, itchy rash, papular rash and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments:  The patient received second dose of Shingrix.  The days later, the patient experienced small red itchy bumps all over body.  The patient went to healthcare professional who prescribed steroids.  The bumps have not resolved yet.  The education provided per content.  The medical information phone number was provided.  The adverse event was filed. The reporter did not consent to follow up.
4am headache, worsening by morning hours, lasting one full week.  For a few days I treated a constant headache along with hives which broke out on my legs, arms and abdomen, worsening and then subsiding. Extremely sore muscles and joints with inflammation, swelling, and joints getting stuck with movement. Specifically both biceps and left knee.  Left knee is currently swollen with limited range of motion. One week after the vaccination I experienced an extreme adverse reaction which I would term a neurological event.  I lost control of my vision and felt my eyes move to the left, and then repeatedly moving, as I saw the room tilt and spin before me.  Notably odd was lack of nausea or dizziness, and I did not faint. The rapid eye movements and vertigo-type experience lasted less than a minute, after which I tried to carry on with my day. I felt strange and was frightened. I went to Emergency Department.  I had the diagnostic tests done, as indicated below, and evidence of TIA or any stroke or irregular heart rhythms was ruled out; however, they did not determine the cause of my extremely frightening event, and at the time, I did not have the headache which the hospital personnel inaccurately referred to in my discharge papers as a current condition.
Had persistent dry mouth after taking the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 07Apr2021 at 15:00 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food, or other products.  Concomitant medications included levothyroxine sodium (SYNTHROID) from unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 13:00, the patient experienced persistent dry mouth after taking the vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event persistent dry mouth after taking the vaccine was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
This case was reported by a physician via call center representative and described the occurrence of rash in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 2 days after receiving SHINGRIX, the patient experienced rash and pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the pruritus was unknown. It was unknown if the reporter considered the rash and pruritus to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient broke out in rash all over her face, chest and armpits after vaccination with SHINGRIX at a pharmacy. She went to the allergist and they recommended BENADRYL. The rash disappeared, but then she started itching in the areas where the rash had been. The physician did not wanted her information to be provided.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown demographics. The patient's medical history was not reported. It was unknown if the patient had any drug reactions/allergies. On an unspecified date, approximately in 2012 (Also reported as five years ago), before the age of 65 (units unspecified), the patient was vaccinated with PNEUMOVAX 23 (Strength, dose, frequency, anatomical location, route, lot/batch # and expiration date were not reported) for prophylaxis. There were no concomitant therapies reported. On an unknown date, the patient experienced swelling in the arm and could not bend the arm for an unknown period of time. It was unknown if the patient received treatment. It was unknown if lab diagnostics/studies performed. The patient did not seek medical attention. There was no product quality complaint involved. The outcome of the events was unknown. The causality assessment was not provided.
Prolonged constipation. Condition improved only  with laxatives.  No other side-effects experienced.
pt devel flu like sx 10 day p/immun aching, fever, swollen glands in neck, rash; devel joint pain in wrists about 12 days later; 2 wks p/immun devel swelling in wrists, stiffness in hands; now has pain & swelling in knees; also has numbness
other zoster-related conditions; shingles; Information has been received regarding a case in litigation from a lawyer and referred to a patient (pt) of unknown age and gender. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. On or about 29-JAN-2008, the pt was administered the zoster vaccine live (ZOSTAVAX) (dose, strength, route, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions by a physician. On an unknown date (reported as subsequently), the pt was treated by physicians, for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions (Ill-defined disorder). The outcome of the events was not provided. The reporter considered the events was related to the suspect vaccine.
Patient received his Pfizer booster. He stood up and his glasses fell to the floor. He bent over to pick up his glasses and fell and hit his head. I did not see him fall, but I was the one who responded to his aid. A bystander stated he fell pretty hard and hit his head. He denied any pain, just that he was dizzy.  We let him lay down for awhile before we moved him to a chair. After about 15 minutes, he felt well enough to go on his way. He denied any medical attention.
Experienced fever, 104, localized pain & induration on both legs & convuls x 1; Also indicated wheezing sx; 7 days f/u indicated still having occasional sz; 30 day f/u indicated sz stopped;
pt  had the COVID vaccine moderna on 4/18. takes allegra every day, and has not had any problems since the injection until 4/25 when she did not take her allegra. pt states on monday 4/26 she got a full body rash at which point she took benadryl. at 2am on 4/27 rash went away except at site of shot to LUE which continues to have a rash and be very itchy. this am 4/27 when she woke up pt reports inside of lips swollen and eyelids swollen at which point she took benadryl which helped with the swelling, pt also resumed taking allegra. today, all symptoms as of right now are resolved aside from the rash at the site of injection.
Patient Recieved Vaccines on 2 Feb 03.  One week later c/o Rt. arm pain, swelling, redness, abdominal pain and headache. Swelling,redness and headaches resolved after 1 month. Symptoms of abdominal pain,nausea, muscle weakness of rt.arm with occ, hand swelling ongoing x 3 months.
42-year-old lady with a history of obesity who was recently admitted to outside hospital with COVID-19 pneumonia and associated complications including acute hypoxemic respiratory failure, ARDS, and AKI.  During the course of her hospitalization, she was treated with dexamethasone, remdesivir, tofacitinib, Plaquenil, and ivermectin.  She required intubation on 9/10 and developed cardiac arrest after a prolonged period of hypoxia on 9/12.  She was transferred for higher level care and treatment with CRRT.  She had a vascular catheter placed on 9/15 initiated dialysis that same night.  She had an echocardiogram on 9/15 that most notably showed RV was mildly dilated with moderately reduced function therefore she was started on therapeutic heparin given the concern for possible PE in the setting of Covid.  Patient underwent dialysis again on 9/17.  Lower extremity Dopplers were negative for DVTs on 9/16. From a respiratory standpoint, she is being treated with flolan and has been continued on zosyn and zyvox since admission. She was started on voriconazole on 9/17 and fungal labs (fungitel, galactomannan, blaso/histo Ag) were ordered for concern of possible underlying fungal infection. CT PE studay showed two RV thrombus. Therapeutic heparin was changed to argatroban to reduce fluid intake.  Unfortunately, despite our best efforts including maximizing ventilator settings and multiple rounds of hemodialysis patient continued to decline without improvement.  After discussion with family on 9/22 decision was made to transition patient to comfort care but to keep her on the ventilator.  On the morning of 9/23 at 0655 patient lost pulse and was pronounced dead.
Soreness and stiffness in arm, redness, heat, swelling, and pain at injection site. Headache and achy feeling, general tiredness.
TOOK FIRST TWO VIVOTIF DOSES WITH ORANGE JUICE; This spontaneous case (PVX2019-1360) was received from a caregiver on 28-May-2019. It describes an 11-year-old female consumer who "took first two Vivotif doses with orange juice". The consumer was receiving Vivotif for typhoid prophylaxis.  Case report: The consumer took the first two doses of Vivotif with orange juice. The doses were taken on 21-May-2019, 23-May-2019, 25-May-2019, and 27-May-2019 respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took first two Vivotif doses with orange juice" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took first two Vivotif doses with orange juice" was considered as not applicable.
She feels like the "vaccination made it worse" (her arthritis); Swelling in feet and hands; severe pain in her hands, knees and feet; This is a spontaneous report from a contactable consumer. A 91-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 intramuscular, administered in Arm Left on 08Feb2021 11:00 (Lot Number: EL3247; Expiration Date: Aug2021 at the age of 91-years-old) as single dose for covid-19 immunisation, prophylaxis. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 14Jan2021 (EL3249 Expiration Aug2021) as single dose for covid-19 immunisation. Medical history included ongoing osteoarthritis and rheumatoid arthritis (both genetic), ongoing blood pressure abnormal (she also takes blood pressure medicine), road traffic accident on 31Oct2017 (she was in a mess). Her both wrist were broken and she had surgery in hands before receiving the vaccines, cataract on an unknown date. She had cataracts removed and this was before the vaccine. Family medical history was none. Concomitant medications included losartan (strength: 100 mg, formulation: Tablet) taken for blood pressure abnormal at a dose of 100 mg daily, metoprolol (strength: 25 mg, formulation: Tablet) taken for blood pressure abnormal at a dose of 0.5 DF twice daily, cyanocobalamin (VITAMIN B-12) taken for an unspecified indication at an unknown dose and frequency. Pain with arthritis and it has gotten so bad after the second dose of the COVID vaccine that she was doubled over with pain in wrist and knee caps where engine burnt both knees. She had severe pain in her hands, knees and feet. She noticed 2 months ago that she felt her fingers were hurting. She had swelling in feet and hands. It was easing up. The pain was noticeable on 11Feb2021, and worsened by 14Feb2021, and started improving by 16Feb2021. She had them switch her blood pressure medication and got the new type and the swelling started improving right away. When reading the bottle of medication, she stated she could hardly hold it. Her hands did not swell this bad before the second dose of the vaccine. The outcome of the events was recovering.
After the 4th shoot ( 2nd booster) I started experiencing chest pains on my left side. I had high fever, chill, no appetite slept about 36-40 hours. Then on the following Thursday as the pains were intermittent during the week they became constant. I called my DR.  who advised I go the ER as they thought I was having a heart attack.  My  pain was constant and my blood  pressure was 157/ 75 high.
extreme itching; pimple like lesion within the area of his nose; cannot sleep at night; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (extreme itching), DERMATITIS ACNEIFORM (pimple like lesion within the area of his nose) and POOR QUALITY SLEEP (cannot sleep at night) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On an unknown date, the patient experienced PRURITUS (extreme itching), DERMATITIS ACNEIFORM (pimple like lesion within the area of his nose) and POOR QUALITY SLEEP (cannot sleep at night). At the time of the report, PRURITUS (extreme itching) and DERMATITIS ACNEIFORM (pimple like lesion within the area of his nose) had not resolved and POOR QUALITY SLEEP (cannot sleep at night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR, primary physicians contact details were provided.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported,1 total administered on 25-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 24-JAN-2022, the patient experienced symptoms of fever, cough, sore throat and are still ongoing (suspected covid19 infection). On 26-JAN-2022, Laboratory data included: COVID-19 antigen test (NR: not provided) Positive (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number was requested.; Sender's Comments: V0: 20220151060-JANSSEN COVID-19 VACCINE Ad26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ELDERBERRY EXTRACT, start date: 01Mar2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Other medication in 2weeks: Yes. Antiviral details: Product: COVID 19 Treatment, Brand: Pfizer, treatment start date: 12Jul2022, Treatment stop date: 16Jul2022, Lot number: GA8849, Indication=Treatment of COVID-19. Other medication details: Multivitamin (Centrum) start date: 01Jan2021, Nutrafol Women's Balance (Nutrafol) start date: 10Jun2022, Elderberry with Zinc and Vitamin C (Bioschwartz Natural) start date: 01Mar2020, Magnesium, (Nature Made) start date: 01Jun2022. Adverse event: On day 1 of taking paxlovid experienced an odd taste in my mouth within an hour of the first dose. Over the next five days the taste was constant but would ebb and flow in its strength. On day 2 experienced extreme backache and stomachache as well as diarrhea. All of these symptoms persisted for Days 2 through 5. I would take my morning dose at 9am and the pain would start within 90 minutes and then last on and off for the next 14 hours. It never asted more than 2 hours after the evening dose at 9pm and would stay away until about 10:30 the next morning. The pain was equivalent to extreme period cramping that could last hours at a time before subsiding and then coming back on in another wave 30 mins later. I tried taking the meds with food and it made no difference. Adverse event start date: 12Jul2022, Adverse event start time: 10:30 AM, AE resulted in: None of the above, If patient recovered: Recovering, If treatment AE: No, Known allergies: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 27MAY95 & 15JUN95 pt devel a rash w/red papules;30JUN95 pt presented w/vesicular rash & dx w/impetigo;pt recovered;