chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist on 20 August 2015. A 76-year-old female patient, whose concomitant medication was not reported, had received a dose of FLUZONE HD (batch number: UI428AA, expiration date: 18 March 2016, dose and dose number were not reported) intramuscularly in left arm on 17 August 2015. The patient's medical history includes allergic to sulfa, cipro, celestone and gabapentin and also Hypothyroidism. The patient did not have illness at time of vaccination. On 17 August 2015, same day post vaccination, the patient developed pain in injection area and area was the size of a deck of cards which was fading at the time of report. Next day morning, on 18 August 2015 the size of a deck of cards which was fading at the time of report. Next day morning, on 18 August 2015 the patient had injection area redness, and the area on left arm between the injection site and her elbow was black and blue in color. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none.
Pain, swelling, redness, heat at injection site. Swelling and redness is 8 cm by 6 cm on left deltoid.
rash / 3 inches below injection site / down the arm that is slightly itchy.; redness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   On 8th October 2020, the patient received the 2nd dose of Shingrix. On 11th October 2020, 3 days after receiving Shingrix, the patient experienced itchy rash. In October 2020, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving and the outcome of the itchy rash was recovered/resolved.   It was unknown if the reporter considered the injection site erythema and itchy rash to be related to Shingrix.  Additional details were provided as follows: After receiving 2nd dose of Shingrix, patient experienced redness at the injection site and rash about 3 inches below injection site, half way down the arm that is slightly itchy. The redness at the injection site, which was resolving, going away. The reporter consent to follow up.
Pt developed a rash 10 days after her MMR vaccine. It is nonpruritic. She has had low grade fevers up to 99. It gets more red when she gets hot. She had mild URI symptoms following her immunizations. Mom says, "Every time she gets her shots, she cries for 2-3 days." She says that she can not hold her and it is not normal crying but this last time was the worst. On the first 2 days after her immunizations, she would hold her head and cry.
Truncal hives developed approximately 24 hours after administration of vaccine.  No other systemic symptoms.  Treated with 60 mg ZANTAC orally, some resolution in ~1 hour, placed on oral PEDIAPRED x3 days.
Patient experienced rash that ranged from wrist to elbows on both arms which happened within 1 hour of vaccine administration. Patient had vitals within normal limits other than an elevated blood pressure of 160/90. Patient has history of lupus and RA. Patient refused transportation and reports that she felt fine and would go home. Assistance was offered to patient.
Severe chills, vomiting, diarrhea, weakness, muscle & skin aches, swelling of injection site, red, itchy, matted eyes.
Information has been received from a public county health nurse concerning a 26 month old male who on 02-JUN-2006 was vaccinated SQ in the left arm with the first dose of varicella virus vaccine live (Oka/Merck). On 29-MAR-2007 the patient presented with chicken pox rash on his arms, leg and trunk. The patient had less than 50 lesions and had a slight fever. Treatment with Tylenol and oral Benadryl PRN was given. Medical attention was sought. The patient recovered from the fever and chicken pox rash. No additional information is expected.
Nurse 1/28/2021 09:07:30 AM > 0855: Patient c/o blurred vision and dizziness, BP 170/80, P 108, O2 98. Upon assessment patient states she felt like "I'm going to have a seizure", patient completed 15 minute observation and nurse extended observation for additional 10 minutes. 0927: BP 120/78, P78, patient states "feeling much better" and has a doctors appointment tomorrow, nurse suggested that she should visit ER for further observation. Nurse 1/29/2021 08:19:42 AM > Contacted patient for f/u, message left Nurse /29/2021 08:45:01 AM > Spoke with patient, says that her heart rate seemed to be elevated most of the night and that she had to sleep sitting up, concerned about receiving s
Influenza dose given too early. Patient was 4 months old not 6 months. No known adverse events occurred after vaccination.
18 days after shot I am still having arm pain.  It has gotten worse since the onset.  There is pain in arm that is now migrated to my shoulder and neck.  My grip strength is weak due to pain in forearm.  I have  tingling from elbow into my hand.
tested positive for COVID-19 the day after her first dose of the Moderna COVID-19 Vaccine; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19 the day after her first dose of the Moderna COVID-19 Vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8B212A?) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19 the day after her first dose of the Moderna COVID-19 Vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19 the day after her first dose of the Moderna COVID-19 Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
passing out sensation; heart palpitations; sweating; diarrhea; This is a spontaneous report from a contactable consumer (patient's boyfriend). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that symptoms were related to the use of Covid 19 vaccine. The patient received the first dose on 15Jan (as reported) and the day after developed sweating, passing out sensation, heart palpitations and this morning on 11Jan2021 when she woke up she had the same symptoms plus diarrhea. The outcome of the events was unknown.  Information on the lot number/batch number was requested.
I?m still black and blue & tender at the injection site of 1st dose, just had 2nd dose & had to be done in my other arm
Pt states arm hurting real bad went to  clinic-red swollen w/pimple type area @ inject site & red streaks; MD dx cellulitis issued Augmentin & tavist;
MUSCLE TWITCH IN BOTH ARMS; This spontaneous report received from a parent concerned a 25 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: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced muscle twitch in both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle twitch in both arms on 2021. This report was non-serious.
itchy at injection site; injection site sicolored; reactions to product; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 26th September 2019, less than a day after receiving Shingrix, the patient experienced injection site itching, injection site discoloration and reaction to drug excipient. The patient was treated with benadryl (nos) (Benadryl Cream). On an unknown date, the outcome of the injection site itching, injection site discoloration and reaction to drug excipient were not recovered/not resolved.   The reporter considered the injection site itching, injection site discoloration and reaction to drug excipient to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The patient was talking to a pharmacist about ingredients and had to leave. The patient received Shingrix 8 days ago, the patient had swatch about 3 inches by 6 inches on the arm. The patient's arm was still itches below the injection site and still discolored. The patient putting Benadryl cream on it twice daily. It seems the diluent as it tried to absorb downward on the arm by gravity caused the reaction. The reported that the vaccine had Polysorbate in it and that is a Sorbitol derivative. The patient was concerned if it would be worse with the second one and if the patient get any other vaccines this year with that ingredient.
I was administered influenza vaccine by my colleague on 10/19/07 evening.  I proceeded to go to exercise class then.  On Saturday morning, I woke up with a headache and a neck ache.  I took aleve and the headache improved, but the neck ache persisted.  On 10/22/07, I woke up with a very stiff neck, much worse than Saturday.  No further exercise was done after the initial 10/19/07 class.
Complained about severe pain in (R) arm with redness/swelling. Pain went into armpit and glands. Had sharp pain in legs, hands that night. Stay awake all night with extreme salivating. Unable to walk or call for help (confused).
Itchiness in arm and hives; Itchiness in arm and hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness in arm and hives) and URTICARIA (Itchiness in arm and hives) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRURITUS (Itchiness in arm and hives) and URTICARIA (Itchiness in arm and hives). On 15-Feb-2021, PRURITUS (Itchiness in arm and hives) and URTICARIA (Itchiness in arm and hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details are also not provided.   Reporter did not allow further contact
Soreness in left shoulder & arm, nausea, vomiting, headache Initial soreness lasted 3-4 days then savaged. Currently, pain soreness & swelling in left hand & wrist. This has persisted for past 3-4 days.
Varicella vaccine given 5/22/13 and 0n 5/23/13 noticed swollen and red in PM and by noon on 5/24/13 it had extended to her elbow and around her arm and was red, swollen and warm. Saw PMD and was started on AUGMENTIN and improved each day with minimal redness by 5/28.
Cellulitis-right arm, 4.5cm width right upper arm with erythema/heat.
Fever, Chills, redness, local injection site reaction (approximately 6 inches in diameter), pain and itching at injection site.
Information was received from a dentist regarding several patients. On an unknown date, patients were vaccinated with ZOSTAVAX. It was reported that several patients had developed shingles after vaccination with ZOSTAVAX. No further information was provided. Additional information is not expected.
At 4:30 PM pt c/o stinging, redness, and edema on left arm.  Mother contacted facility and pt was assessed by staff at 4:50.  BP 100/60, HR 98, RR 16, noted 15 x 15 cm redness and denied c/o shortness of breath.  Applied ice pack to left arm. Dr. in to assess pt. Orders given to take OTC Benadryl prn and to call 911 with shortness of breath.  Per mother s/s were gone by the afternoon on 5/4/10.
Entire arm was very painful.  The site of the injection was very hot.  The pain went all the way down to the hand. Felt sick to the stomach.  Felt faint.  Took an over the counter Aleve which took a long time to work.   Had chills in the middle of the night after the shot.  Then midday the following day, had another episode of chills.
Patient fainted 10 minutes after injection of Gardasil and Varivax. Blood pressure low at SBP of 88.
Discharge Physician:  DO Primary Care Physician:  MD  Date of Admission: 4/18/2023 Discharge Date: 4/19/2023   PRESENTING PROBLEM: Generalized weakness  COVID-19    HOSPITAL COURSE: Patient is an 82 year old female with history hypothyroidism, GERD, anxiety, and essential tremors who presented with fatigue and loss of appetite. Her symptoms began on 4/16 and she was noted to become progressively more weak, her husband brought her to the ED as he was unable to care for her with her weakness. In the ED, she tested positive for COVID and was also found to have an AKI, her vital signs remained stable and she required no supplemental oxygen. The hospitalist team was consulted for admission as the patient was too weak to go home. The patient was admitted, she did have two episodes of vomiting but was also tolerating a diet. She worked with therapy and did well as was felt to be safe for discharge home with continued PT/OT. Overall, she stated that she felt much improved and was found to be medically stable for discharge to home. Due to her intermittent nausea and vomiting, she was given a small supply of Zofran.   Electrolytes were monitored and repleted PRN throughout the admission. Patient clinically improved and hemodynamically stable for discharge.  Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days. Patient voiced understanding was agreeable with plan of care discharge.
Immediately after injection patient stated sharp pain and lightheaded. Was laid back on table and patient fainted and had jerking movements in arms/legs lasting about a minute. Patient came to and didn't know what had happened. Told to stay laying down and ice pack placed behind neck. After 15 minutes sat up slowly and given water after 5 minutes helped to standing, patient stated feeling better. Slight dizziness remained for around 15 minutes. Normal arm soreness also reported.
Patient tested postive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested postive for COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031G20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced COVID-19 (Patient tested postive for COVID-19). At the time of the report, COVID-19 (Patient tested postive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were provided. Patient was scheduled to receive the second dose on 12-MAR-2021.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non-Significant followup appended
I received the vaccine at approximately 1 p.m. on October 22, 2008.  At 5p.m., I was feeling tired, but decided to attend my regular exercise class anyway.  Class ended at 6:30, and on the way home I suddenly developed a cough that was painful in my chest.  The painful cough persisted, and I lost my voice and was having slight trouble breathing.  I took a quick dissolve Benadryl and used an old Albuterol inhaler that I had from a previous bout with bronchitis, and I went to bed.  The next day the cough was gone. I have never had an adverse reaction before, and I have been getting flu vaccine for many years.   I'm hoping this doesn't mean that I can never get a flu vaccination again.
got the vaccine years ago, got Shingles this summer/suspected vaccination failure; Shingles / not bad; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)) and dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got got the vaccine for Shingles 3 or 4 years ago, but he/she got a case of the shingles this summer (2022).  The patient stated that it was not a bad case and his/her physician cured them quickly with antibiotics and a pharma (Rx) cream. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Time to onset was captured as more than 2 years as shingles was occurred this summer (in 2022) after 3 or 4 years.
Despair/Hopelessness; Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues; Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced NEUROPATHY PERIPHERAL (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) (seriousness criterion medically significant) and ORAL DISCOMFORT (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues). On an unknown date, the patient experienced FEELING OF DESPAIR (Despair/Hopelessness). At the time of the report, NEUROPATHY PERIPHERAL (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) and ORAL DISCOMFORT (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) had not resolved and FEELING OF DESPAIR (Despair/Hopelessness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NEUROPATHY PERIPHERAL (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) and ORAL DISCOMFORT (Burning mouth/ neuropathy triggered by Moderna 7 weeks ago continues) to be related. No further causality assessment was provided for FEELING OF DESPAIR (Despair/Hopelessness).    Concomitant medications were not provided.  The patient had received the fourth COVID-19 vaccine, 1st Moderna.  Treatment medication were not provided.  Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral on an unknown date after receiving mRNA-1273 vaccine given as 4th dose in the COVID-19 vaccination series.  Latency between vaccine and event cannot be established. Patient also presented with burning mouth which could either be peripheral and/or a central neuropathic disorder.  No information was provided on any other COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of Neuropathy peripheral on an unknown date after receiving mRNA-1273 vaccine given as 4th dose in the COVID-19 vaccination series.  Latency between vaccine and event cannot be established. Patient also presented with burning mouth which could either be peripheral and/or a central neuropathic disorder.  No information was provided on any other COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Chills, mild fever (approx 100 degrees), nausea, aches, mild dizziness
Had first Pfizer vaccine in right arm on 3/22/2021, no problems, absolutely no side effects.  Received second Pfizer on 4/22/2021 in left arm.  A few hours later, had severe soreness in right arm (first injection site), no redness or outside indication of any problem.  No other symptoms.  I am still having severe pain in the right arm months later.  Contacted my PCP, who advised that I see ortho.  Just returned from ortho visit, xray of arm is normal, was told they could do nothing but recommend stretching exercise and prescribe NSAIDs.
administration error: pt received moderna instead of flu shot pt ran a fever, chills all night, constantly urinating, loss of appetite, bloated stomach, abdominal pain, colon infection, UTI
Around June 2021- I was having a pain in my lower right abdomen that lasted a few weeks. It would occasionally come back but not bad enough for me to see a doctor. In August, I had a cyst rupture. I was at work crying because I did not know what was going on. I had to drive to the Emergency Room Medical to see what was going on. I found out it was a ruptured cyst they gave me fluid and medication for nausea. I was throwing up from the pain. I went to my GYN. She wrote me off work for the rest of the week that following Monday. Recently, I am now having continuous problems. I had a cyst rupture on Tuesday, 11/16/2021, and was unable to walk from the pain. I had ovarian cyst when I was 15 years old. Back in 2019 I had a laparoscopic surgery they justified everything was clean. I had a clean bill of health. Now at 24 years old, after the vaccine, they appeared again. 11/18/2021- I have not recovered from the adverse event or ovarian cyst. I am still in pain but I am just able to walk with it now. I am not curled up in a corner anymore.