chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a male, 66 year old consumer with none drug reactions/allergies who was referring to herself. The patient's medical history included vertigo (no dates provided). On 05-NOV-2013 the patient was vaccinated with influenza virus vaccine (manufacturer unknown) injection, one dose (strength not reported) route reported as injection (no further specified). Other suspect therapies included pneumococcal vaccine, polyvalent (manufacturer unknown) administered at the same date on 05-NOV-2013 (dose, strength, route lot number not reported). No concomitant therapies reported. On 09-NOV-2013, the patient experienced inflammation of the eyes, poor vision, double vision and his immune system was "stirred up" (no further specified). The patient was treated with acyclovir, PRED FORTE and cyclopentolate hydrochloride. The patient sought medical attention by doctor visit. None laboratory tests were performed. It was reported that the patient takes multivitamin. The patient was recovering from the events. The reporter did not assess the relationship between the therapy with suspect therapies and the adverse events. Additional information has been requested.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. The patient stated that, Shingles vaccine did not work. The follow-up would not possible as no contact details were available.
DIARRHEA; HEADACHE; MILD ABDOMINAL PAIN AND IT HAS GOTTEN A  WHOLE LOT WORSE; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included steel plate left hip (accident), and concurrent conditions included non-smoker, and non alcohol user, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient was previously treated with gabapentin for steel plate left hip (accident). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A,  expiry: 07-AUG-2021) dose was not reported, administered on 11-JUN-2021 11:00 for prophylactic vaccination. Concomitant medications included atorvastatin for heart condition, and lisinopril for heart condition. On 12-JUN-2021, the subject experienced mild abdominal pain and it has gotten a whole lot worse. On 13-JUN-2021, the subject experienced diarrhea. On 13-JUN-2021, the subject experienced headache. Treatment medications included: paracetamol/methocarbamol. Additional treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 14-JUN-2021, and had not recovered from diarrhea, and mild abdominal pain and it has gotten a whole lot worse. This report was non-serious. This case, involving the same patient is linked to 20210648123.
Felt tingling going up my neck immediately after injection, increased heart rate 100-134 within an hour after. Muscle spasms in whole body started within 24 hours. Body weakness, fatigue and extreme thirst for 2-3 months, too weak to sit up. Spams, heart rate and weakness slowly improved within 3 months, still have the spams in the injection arm and that hand/ fingers. Started having migraines for the first time in my life. They became chronic and frequent, still have them 3-5 times a week. Disabled since the vaccine.
Client reported body aches, weakness, low grade fever, and that he slept for 15 hours. He states that 24 hours after receiving the vaccine he noticed a golf ball sized hard and painful area in his left axilla that lasted 3-4 days.
C/O HA radiating to her jaw, shoulder and neck. Stiffness lower back painful and stiff making it difficult to walk. Went to PMD on Fri 5-8-09. c/o " every joint in her body hurting. Also had fever - Temp. unknown. Stated neck and arms sore til Sunday 5-10-09. PMD
Developed 11x18mm left supraclavicular reactive lymp node.   The node is slightly firm, but not hard or rubbery and is slightly tender
The pt broke out with hives covering both arms approximately 3 hours after given vaccinations. Gave one dose of Benadryl as treatment.
Extreme chills (shaking uncontrollably) for at least half an hour. Freezing cold. This happened twice, about two hours apart, at 11pm and 1am. Low fever of 99.3. The following day I was extremely tired and had a headache all day. Continued to have headache the following day (Monday) and a fever of 99.5 at one point. Continued to have headaches for rest of week on and off (Tues, Weds, Thurs).  Alternated taking tylenol and ibuprofen as needed.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-OCT-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received regarding a case in litigation from a lawyer and a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-DEC-2010, the patient, at 65 years old, was administered the ZOSTAVAX by a healthcare provider at a medical clinic (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician at a medical clinic for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to self, loss of consortium, loss of services and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
I received the vaccine on 04/27/2021. I had a high resting heart rate (100+) with shortness of breath and went to the Emergency Department two days after receiving the vaccine (04/29/2021). They gave me fluids and monitored my heart rate until it came down into the 80s. However, since then, I have continued to have a high resting heart rate with occasional chest tightness and followed up with my primary care doctor who recommended seeing a cardiologist. On 05/09/2021, I also had a skin rash on my face, lips, arms, and hands (I think part of my chest/abdomen as well). I went to the Immediate Care Center and was prescribed hydroxyzine. With the medication, the rash went away within a few days.
I had my first Pfizer Covid Vaccine at Hospital on Monday, March 8th.  I had a sore arm and shoulder for 3-4 days; for a couple of days I felt very jittery and hard to focus, with quite the headache. Today, I still have a bad headache, vision feels off, nausea and chills.  I?m scheduled to get my 2nd vaccine, but I?m worried, I will feel worse then I do now.
Admit for COVID pneumonia. Treated w/ zinc, vit-c, vit-D, steroids, remdesivir. Mild illness not requiring O2. o COVID-19 pneumonia:  Persistent symptoms but improving respiratory symptoms.  The patient was eventually weaned off of oxygen completely.  The patient received full course of remdesivir (last day of the course was on 07/28/2021), IV then p.o. dexamethasone, zinc, vitamin-C, montelukast.  DC Home with HHC
Pt reported 40 min after the covid vaccine, she had tongue and throat tingling and odd sensation like she had to swallow. She took benadryl, with improvement. 2 hours later, she still had symptoms, so she repeated the dose, and then the symptoms went away.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE COAGULOPATHY, UNSPECIFIED TYPE
Sharp, constant and severe pain in right shoulder. per patient pain radiated to hand, upper neck, behind the ear and chin. However, patient did state that pain decreasing everyday.
Patient developed severe chest pain about week after the injection. Found to have elevated troponin consistent with myocarditis. Patient was admitted to the hospital and cardiology consulted.
Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis; This literature-non-study case was reported in a literature article and describes the occurrence of LINEAR IGA DISEASE (Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.       Concomitant products included TERBINAFINE for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LINEAR IGA DISEASE (Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) (seriousness criterion medically significant). At the time of the report, LINEAR IGA DISEASE (Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered LINEAR IGA DISEASE (Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) to be related.    Treatment and concomitant medications were not reported. Company comment: This literature-non-study case concerns an 86-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of LINEAR IGA DISEASE (reported as Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) after the third dose of mRNA-1273 vaccine in the setting of oral terbinafine. Since dates of vaccination and the exact onset date of the event were not reported, latency cannot be assessed. Concomitant terbinafine remains as a confounder for the event. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This literature-non-study case concerns an 86-year-old female patient, with no medical history reported, who experienced the serious (due to medically significant) unexpected event of LINEAR IGA DISEASE (reported as Toxic Epidermal Necrolysis-like Linear IgA Bullous Dermatosis) after the third dose of mRNA-1273 vaccine in the setting of oral terbinafine. Since dates of vaccination and the exact onset date of the event were not reported, latency cannot be assessed. Concomitant terbinafine remains as a confounder for the event. No further clinical information was provided for medical reviewing. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
having persistent rashes on his chest; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (having persistent rashes on his chest) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (having persistent rashes on his chest). At the time of the report, RASH (having persistent rashes on his chest) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient has received his second booster dose of the Moderna Covid-19 vaccine. No concomitant medication was reported. Treatment information include patient talked to his HCP who recommended allergy medications and topical steroids and topical creams which have provided temporary relief.
Five months after the vaccine I was feeling very fatigued after I had experienced flu-like symptoms. I was diagnosed with Thyroiditis one week after the illness. One week later I started to get chest pain and palpitations and after a visit to the ER I was diagnosed with Pericarditis. My heart rate was also elevated at the time. I took steroids for one month and  every time I tried to reduce the dose the chest pain returned. My symptoms continued but I am still taking the  medication and I need to monitor my Thyroid function for a few months. I am also taking a Beta Blockers for the heart problems. It has been five week s ago and it has been six months since my vaccine.
FELL; panctured lung; Broken ribs; small complication; diagnosed with covid19; A spontaneous report received from a Consumer concerning, 95-year-old age female patient who received first dose of the Moderna COVID-19 vaccine and experienced falling, punctured lung, broken ribs and diagnosed with COVID-19 on 05FEB2021.     The patient's medical history was not included. Patient's concomitant was not included.  On 06JAN2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient daughter-in-law stated that the patient received her first Moderna COVID-19 vaccine on 06JAN2021. Patient daughter-in -law stated that the patient fell the next day and punctured her lung, broke her ribs, and had small complication (unspecified). Patient daughter-in-law stated that the patient was moved to a rehab facility after hospitalization. Patient daughter-in-law stated that the patient was diagnosed with COVID-19 on 05FEB2021. Consent was provided for follow up from safety.    Treatment information was not provided/ unknown  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/ not reported.; Reporter's Comments: The events were consistent with increased risk of complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
I started having difficulty breathing and a rapid heartbeat on 9/15/2022.  I was concerned that it was my heart and was taken to the ER on 9/16 transferred me at that time to Hospital. I was admitted overnight for testing. Discharged on 9/17/2022
Pt experienced redness, swelling and warmth at injection site beginning about 3-4 hours post vax. Affected area was about 15 x 10 cm and swelling continued for about 36 hours. Pt applied warm packs to area. Symptoms resolved by 4/21/2000.
Pt. states that after receiving the 1st dose of Phizer 07/27/2021 started experiencing numbness of the left side (visually drooping in the face), left facial cheek swollen. Urgent care recommended.
30 minutes after injection on left arm, pt developed a right forearm 1x2 inch hematoma and swelling  of the right hand subsequently swelling resolving of the hand but turned diffusely ecchymosis on dorsal hand with hematoma slightly improving
Rev'd vaccine Wed 9/2/09 and had soreness at injection site. Thurs next day onset of nausea, diarrhea, fever, itchiness, headache and malaise.
On March 23, 2020. Left arm in pain., from shoulder down to hand. Also nerve pain down arm. On March 25 th  red marks showed up on upper arm. On March 27th  went to urgent care and diagnosed with Shingles.  Told to take Medrol dose pack and Acyclovir for 5 days. Pain lasted approx 1 month on the left arm, could not sleep on that arm . Resolved after 5 weeks.
received vaccine midday, woke up from sleep approximately 12 hours later with twitching of right upper lip.  the twitching continues off and on still.  at times can twitch up to 40 min at a time.
pt c/o numbness/tingling in arm & hand on 22JUL95 p/inj; states this cont on & off approx 5-6 times each day until 25JUL95
Approximately 10 days after vaccination I developed pronounced petechiae rash on both lower legs from ankles to just under the knee. Consulted my rheumatologist Dr. which I see on a regular basis for Systemic Lupus, she ordered blood tests. All labs were within my normal limits. Petechiae began to disappear within a few days. Same occurrence happened again after second dose of the vaccine  which I received on January 25th, 2021.
Sudden onset of carpal tunnel eventually leading to discovery of Hashimoto's thyroid disease and low functioning kidneys
Left side of back. Feels numb and/or tingly at times. Not sore like a pulled muscle. Just numb. Comes and goes.
Patient received a second  Afluria for the year instead of the requested Comirnaty shot. Patient states they do not currently feel any side effects from either shot and is feeling fine.
pt with mild erythema and edema at left deltoid region recv vax on 7/16/98; pt exp positive itching, negative drainage or pain
vaccine had an expiration date of 24May2022; The patient in question had a series of this vaccine when younger; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Previously administered products included Havrix (patient in question had a series of this vaccine when younger).   On 31st May 2022, the patient received Havrix. On 31st May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used and extra dose administered. On an unknown date, the outcome of the expired vaccine used and extra dose administered were unknown.    Additional Information: GSK Receipt Date: 01-June-2022 Reporter's Comments: The reporter was now 18 years old. Nurse reported patient was administered a dose of Havrix on 31st May 2022, and after the dose was administered it was noted the vaccine had an expiration date of 24th May 2022. At the time of reporting, dose had not been repeated. The reporter consented to follow up. Additional supportive information: Patient in question had a series of this vaccine when younger and received another dose, which led to extra dose administered which was already expired.
Pneumovax 23 administered on 13-FEB-2009, and 23-SEP-2013; This spontaneous report was received from a health care professional and refers to a 67-year-old male patient. On 13-FEB-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (site and route of administration, lot# and expiration date were not provided) for prophylaxis. On 23-SEP-2013, the patient received another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2105USA003308:
Patient reported being sick due to having a adverse reaction to the fourth Covid-19 vaccine and vagus nerve issues. No further information provided. Patient does not consent to be contacted.
Information has been received from a physician concerning a 47 year old female patient who on an unspecified date was vaccinated with the second dose of PNEUMOVAX 23 (Lot # 665904/0866Z, expiration date on 04-JUL-2011). The physician reported that on an unspecified date, the patient developed severe cellulitis within 12 hours of vaccination. The patient might have been treated with antibiotics. The physician did not provide any information on the duration of cellulitis. At the time of the report, the outcome of the patient was not reported. This is one of several reports from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (665904/0866Z) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from a physician concerning a 47 year old female with asthma, depression and obesity and no illness at time of vaccination who in 2002, was vaccinated with the first dose of PNEUMOVAX 23 and on 17-SEP-2010, was vaccinated with the second dose of PNEUMOVAX 23 intramuscularly in her right deltoid. On 18-SEP-2010, the patient developed significant cellulitis reaction and low grade fever. At the time of the report, the outcomes were unknown. Significant cellulitis with fever was considered to be an other important medical event by the reporter. Additional information has been requested.
Within one week, noted injection site to be bright red with subsequent bruising to area after a few days.  The bruising has decreased, but discoloration remains at site as does an indentation at injection site.  The site has been itchy since vaccine given.  Notes she did receive a covid vaccine at outside pharmacy in same arm in May 2022.  The indentation, discoloration and itching was not evident until after the 9/30/2022 vaccine.  She was seen by PCP this week and ultrasound to site ordered for today.
sleeps all the time; muscle pain in legs and shoulder; tired; bad aches all over the body; This spontaneous case was reported by a patient and describes the occurrence of PAIN (bad aches all over the body), SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs and shoulder) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced PAIN (bad aches all over the body). On an unknown date, the patient experienced SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs and shoulder) and FATIGUE (tired). At the time of the report, PAIN (bad aches all over the body), SOMNOLENCE (sleeps all the time), MYALGIA (muscle pain in legs and shoulder) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: negative (Negative) all tests came back negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.         Concomitant medication of the patient was not reported.  The patient received total 3 doses. The patient went to his primary care physician, all tests came back negative and the cause could not found.  No treatment information was provided by the reporter.
Pt received vaccine on 8/29/12. Pt. reported symptoms to pharmacist on 9/5/12. Pt. states full body rash, itching, severe headache within 30 minutes when she got home. She took 2 BENADRYL 8/29/12. Slight rash still visible. Some swelling in arm (L) deltoid. She is back at work. RPh told pt. to notify her physician.
Pt had an injection site reaction that was the size of half a baseball card. Had a knot in it that was painful to the touch and also was hot to the touch.