chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported that he felt dizziness and shortness of breath in addition to itching all over the skin. An oxygen cannula was placed and his vials were taken. Doctor was called, he ordered the administration of .50ml of BENADRYL. The patient was oriented on the medical order and refused the treatment of .50 ml of BENADRYL intramuscularly. Patient reports having BENADRYL PO and that he would wait for the symptoms to pass. The patient was observed for a further 30 min.
4 year old male with right arm swelling, itch and pain after receiving vaccines.  Right arm with 11 x 12 cm redness and induration.  Right arm 1.5cm larger than left.
just a sore arm; headache; Was not bothered much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (just a sore arm), HEADACHE (headache) and ADVERSE EVENT (Was not bothered much) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (just a sore arm), HEADACHE (headache) and ADVERSE EVENT (Was not bothered much). At the time of the report, PAIN IN EXTREMITY (just a sore arm), HEADACHE (headache) and ADVERSE EVENT (Was not bothered much) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: No specific follow-up information recorded.
No additional AE/PQC reported; Improperly Stored PROQUAD was administered to patient.; This spontaneous report has been received from a medical assistant, referring about a patient of unknown gender and age. Information about the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions and allergies was not provided.  On 12-AUG-2020, the patient was vaccinated with an improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), (therapy type: rHA), lot number S021326 with expiration date on 05-JAN-2021, administered for prophylaxis (dose and frequency were unknown by the reporter; strength, route of administration and anatomical location were not provided).  The temperature or the timeframe for the improperly stored vaccine was unknown by the reporter. It was unknown if there was a previous temperature excursion or if the call was due to a Digital Data Loger. No additional AE/PQC reported (no adverse event).
25JUN94 first 2 hrs sleepy, then temp inc even w/APAP to 105 all during noc; To MD next morning who prescribed ATB & APAP; improved w/2nd dose of ATB; irritable noc of 25 & 26AUG;
primary ovarian failure/ irregular mensesand secondary amenorrhea; Information has been received from a lawyer regarding a case in litigation concerning a 14-year-old female patient (pt). No information has been received regarding the pt's past medical history, concurrent conditions, or concomitant medication. Prior vaccination the pt was not suffering from premature ovarian failure.  On 20-OCT-2011 the  pt was inoculated with her first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and on 04-JAN-2012 the second dose, as prophylaxis (exact dose, route of administration, lot number and expiration date were not provided). On 03-JUL-2012, the pt consulted a endocrinologist for irregular menses and secondary amenorrhea. On 06-JUN-2013, in a follow-up (FU) appointment for pt amenorrhea pt labs were consistent with primary ovarian failure. As a direct and proximate result of the vaccine the pt symptoms and diagnoses have resulted in physical limitations not present prior to using the product. As a result of the manufacture, marketing, advertising, promotion, distribution and/ or sale of the vaccine the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt had incurred and will continue to incur medical expenses and other economic harm as a direct result of use of  quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The events has been considered disabling by the reporter.
I was feeling kinda off a little bit. I was having severe headaches and I took my blood pressure. It was very high so I went to Urgent Care.
Patient received varicella (varivax) and varicella from MMRV (proQaud) during office visit.  Follow-up performed and patient had no adverse side effects.  Allergy to varicella confirmed with patient's mother but patient's mother wished to proceed (Pt's mother stated her kid has unconfirmed reaction).
Onset of generalized weakness/ whole body went limp/ febrile/ change of overall color with pallor and stopped breathing/ was given CPR and paramedics were called/ baby was then brought to ER.
pt had chest pains, very cold,legs hurting-pain in legs;pt rushed to hosp;
Headache & NauseaVomitting Narrative: Nausea and Headache caused missed work.
I have sore joints in both hands/fingers, elbows, shoulders, ankles, and toes.  The right side is worse than the left.  I take Advil for pain.  I am uncomfortably sore.  I am walking each day and we are painting our basement so those areas are getting a lot of movement.
Severe nausea and vomiting for approximately 12 hours. Plus headache, chills, fever, body aches. I was mainly fine about 48 hours after the vaccine.
She woke up and was in fever. Temp was 102 at highest point. Top half of arm swelled an remained red and hot to the touch.
nauseous; headache on and off; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and HEADACHE (headache on and off) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced NAUSEA (nauseous) and HEADACHE (headache on and off). At the time of the report, NAUSEA (nauseous) and HEADACHE (headache on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medication provided.
My body temperature dropped to 95F according to a thermal home thermometer. Although cool when I went to bed, I wasn't freezing. However, I woke up in the middle of the night with chills. The thermometer read 96.4F at that time.  I took a hot shower. An hour later. I was still shivering with long johns, two sweatshirts, socks, two blankets, and a cup of hot tea but the thermometer said 95.6F.  After another hour, it dropped to 95F, when I stripped and crawled in bed next to my husband for body warmth. My temperature then started to rise and I was able to go back to sleep. When I awoke, I was "foggy", sore and cold for the whole day but my temperature had normalized. I had a very similar experience with my last Moderna booster (7/19/22) but hadn't thought to take my temperature.
10:20 AM pt received Hep B injection. Was told to wait in room. At 10:30 AM pt complained of "scratchy throat". Benadryl given PO. At 10:30 AM pt states she is not feeling well, complained of slight tightness with breathing. Skin warm to touch, color good, no cyanosis. Administered Epipen 0.3 mg called 911. Paramedics arrived at 10:42 AM. Administered oxygen and transported to hospital, alert and awake for observation.
8/1/2021: patient admitted. Apparently, he has been ill for a few days.  He was given antibiotic as outpatient basis - including oral ivermectin.  He was diagnosed with COVID at outside facility.  He failed outpatient treatment.  His oxygen has been going down.  He presented to the emergency department with shortness of breath as well as chest pain.    Diagnosed with Covid pneumonitis, hypoxic resp failure Note: patient previously vaccinated with Covid-19 vaccine: First dose: 01/02/21 Lot Number E110140;Second dose: 01/23/21 Lot Number EL3248 8/7/2021: patent Died
Temperature Excursion Product Administered; Initial Report Received on 07-Apr-2022  An administrative manager from a Hospital reported that a 66 year-old female (race and ethnicity not provided) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization involved in a temperature excursion.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 07-Apr-2022, the patient received the first dose of HEPLISAV-B (Lot # 937233, expiration date 11-Mar-2023, NDC # 43528-003-05 and serial number 659541770826) intramuscularly in the left deltoid from a licensed practical nurse. The patient received the vaccine that was involved in a temperature excursion, which was 0.8 degrees Celsius for 31 hours and 12 minutes from 30-Mar-2022 through 04-Apr-2022.  No additional information was reported. It was reported that the patient did not experience adverse reactions.  Company Comment:
Information has been received from a consumer concerning her 6 year old son with no medical history or allergies, who on 5/14/99 was vaccinated with a dose of hepatitis B virus vaccine. There was no concomitant medication. In approximately 2002, when he was 2.5 years old, the patient developed autism. Unspecified medical attention was sought. Laboratory diagnostic tests included a Denver screen. At the time of this report, the patient had not recovered. No product quality complaint was involved. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information is not expected.
pt has history of anxiety w needles.  felt hot shortly after receiving vaccine.  gave cold compress.  We began to walk toward bench area to have patient lay down. She felt nausea and did vomit, then felt much better. gave bottle of water. she rested w her husband after and felt good before leaving.  symptoms attributed to anxiety about needles, not the vaccine itself.
The pt experienced localized erythema and swelling. Treated with antibiotics. diagnosis-- cellulitis
1/26/21 nausea, dizzy, 1/29 back pain, nauseous continuing
muscle spasm by the injection site, it's like a twitching sensation under the muscle; Feels like she has a bug on her legs, but she doesn't; had bumps at the injection site; Twitching is all over her body; Achiness in her joints especially her wrist; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (muscle spasm by the injection site, it's like a twitching sensation under the muscle), FEELING ABNORMAL (Feels like she has a bug on her legs, but she doesn't), VACCINATION SITE MASS (had bumps at the injection site), MUSCLE TWITCHING (Twitching is all over her body) and ARTHRALGIA (Achiness in her joints especially her wrist) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasm by the injection site, it's like a twitching sensation under the muscle), FEELING ABNORMAL (Feels like she has a bug on her legs, but she doesn't), VACCINATION SITE MASS (had bumps at the injection site), MUSCLE TWITCHING (Twitching is all over her body) and ARTHRALGIA (Achiness in her joints especially her wrist). At the time of the report, MUSCLE SPASMS (muscle spasm by the injection site, it's like a twitching sensation under the muscle), FEELING ABNORMAL (Feels like she has a bug on her legs, but she doesn't), VACCINATION SITE MASS (had bumps at the injection site), MUSCLE TWITCHING (Twitching is all over her body) and ARTHRALGIA (Achiness in her joints especially her wrist) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
A physician reported that a 3 year old boy received FluMist vaccine by mistake on Oct 25 2005. No adverse event occurred at the time of report. The reporter causality is not provided.
Fever, chills, and headache beginning around 5:00pm; took ibuprofen around 7:00pm: symptoms had resolved by 6:00am
Pt came in on 10/22/11. Stated his side was broke out in a shingles-type rash. Recommended continue his acetaminophen & cold compress & to f/u with his PCP.
Cellulitis at injection site; This case was reported by a other health professional via sales rep and described the occurrence of injection site cellulitis in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB57AA, expiry date 31st August 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th October 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 18th October 2021, 3 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis was not recovered/not resolved.   It was unknown if the reporter considered the injection site cellulitis to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was a vaccine representative calling on behalf of the customer. The reporter reported that the patient received dose of Bexsero vaccine Friday (15th October 2021) in left arm and today (day of reporting) came back to HCP office and was diagnosed with cellulitis at injection site. The vaccine was given by an experienced MA, spoke per content. The reporter consented to follow up. This is one of the 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021215513:Same reporter. Pt 1 of 2
Moderna was the second injection in the series. First injection in the series was Pfizer in January of 2021.
Painless swelling of R axilla that started Thursday, stopped on Friday. On Monday she noticed swelling, redness, and increased temperature of R upper arm aprox. 4 inches in diameter. Currently has no fever. Experienced some itching the day of vaccination but unable to recall is she had scratched area.
Injection site pain/ soreness  4/21 11:00pm Headache 4/22 2:00pm Fever 4/22 9:00pm Increased heart rate 4/22 9:00 pm
Patient complained of fever 1one day past immunization along with general malaise, dizziness, and weakness. Two days past immunization, patient noticed redness, swelling, and whelps at injection site. States she self treated with BENADRYL and pain relievers.
In late December 2022, she was nauseous and vomiting.  She had terrible head congestion and coughed so much her chest hurt.  She thought she had broken a rib.  She visited the urgent care on December 31, 2022, and received Paxlovid and took half doses as prescribed.  She felt better.  It took her an additional two weeks to completely recover.  She was extremely fatigued.
That evening I started having difficulty walking because my venous insufficiency in my left leg. I started having stiffness in my ankle area in the evening. In the morning, I wasn't able to put weight on it. It was really painful, stiff. I had vascular burning. It was only located in foot area originally but it started disseminating throughout and I felt it all the way to pelvic area. The biggest problem was the walking. That was affected by the pain. I had an appt with primary care physician on the week after (15th). On the 22nd, I had blood drawn and the results came in. Official diagnosis - Klippel Trenaunay Syndrome, (for my venous insufficiency). Dr. recommended I do not get the 2nd vaccine because not enough data at that point. The 28th of January or 29th is when the symptoms disappeared. So for three weeks: I kept having the  pain when I was walking and the burning inside the blood vessels rising from ankle all the way to the pelvic area. They were nothing like I've ever experienced with in my life. I was still working every day but it was really difficulty. After 29th, it was gone. In my support group for my chronic diagnosis people were experiencing similar symptoms after receiving the vaccine.
Delayed cutaneous hypersensitivity reaction-  7 days after injection, pruritic, erythematous rash at side with upper extremity swelling
Pt recv vax on 11/6/98; immediately post vax pt exp nausea, seeing stars, swollen arm
Initial case received from a health care professional on 30 October 2013. A child (gender and age were unknown) patient, received, received an dose of FLUZONE on an unspecified date (Route, site, dose and batch number were not reported). It was reported that on an unspecified date patient developed swelling and redness at injection site and low grade fever. Corrective treatment and concomitant medication were not reported. At the time of report the outcome of event was unknown.
Fever; chills; injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Prior to 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 4 weeks prior to the COVID vaccine. On 25Mar2021, the patient experienced fever, chills and injection site pain (vaccination site pain). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fever, chills, and injection site pain were recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
had the vaccine and still got the shingles/suspected vaccination failure; shingles; 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-APR-2022 Reporter's Comments: The patient self-reported the case. The patient received Shingles vaccine and still got the shingles. Additional Supportive Information: This case was reported via interactive digital media and described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
has no appetite; feels nauseas; This case was reported by a consumer via interactive digital media and described the occurrence of appetite absent in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 2 months after receiving Bexsero and an unknown time after starting Bexsero Pre-Filled Syringe Device, the patient experienced appetite absent and nausea. On an unknown date, the outcome of the appetite absent and nausea were not recovered/not resolved.   It was unknown if the reporter considered the appetite absent and nausea to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's parent. The patient received first dose of Bexsero and since then she had no appetite and felt nauseas on daily basis. The reporter wanted to know if this was a long term side effect of the vaccine. The follow-up would not be possible as no contact details were available.
Pt developed fever on 08/07/17 and then a generalized rash to face and legs and progressed to body.
This case was reported by a physician via call center representative and described the occurrence of fatigue in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was recovered/resolved. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccination about 2 to 3 months before the reporting date. For a day or two afterward, the patient felt fatigue, something which he never felt after vaccinations, even after vaccination with the earlier formulation. On the reporting day, the patient received his second dose of SHINGRIX. The patient was asking, could he expect the same reaction. For the answer, the patient was transferred to the Medical Information Scientist who worked with SHINGRIX closely.
NOSEBLEEDS; DIZZY SPELLS; BODY ACHE; HEADACHE; This spontaneous report received from a consumer concerned an adult male. The patient's weight was 190 pounds, and height was 74 inches. The patient's past medical history included: smoker, and concurrent conditions included: high blood pressure, and non alcoholic, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced nosebleeds. On MAY-2021, the patient experienced dizzy spells. On MAY-2021, the patient experienced body ache. On MAY-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nosebleeds, dizzy spells, and body ache. This report was non-serious.