chrisvoncsefalvay/vaers-outcomes huggingface dataset:
we still got sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   The reporter considered the sickness to be probably related to Influenza vaccine.     Additional Information: GSK Receipt Date: 05-JAN-2023 Reporter's comment: This case was reported by the patient's relative via interactive digital media. The reporter stated that his/her grandparents took Influenza vaccine every year in November, they did not like it, because they had still got sick as usual at the time of reporting, so they did not see a point of it. The reporter thought that the event might had been related to product/device. Additional supportive information: This case was one of the three case reported by the same reporter for different patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR001584:Same reporter
this patient was given afluria which is only to be given to 18 and older. no reaction.  I-92579218 and I-92318744
Headache, achy, very tired /took Tylenol every 4 hours / gone within 24 hours
took the vaccine, got the shingles/Suspected vaccination failure; shingles; This serious 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.   The patient's past medical history included shingles (The patient had the shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the vaccine, got the shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-APR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles vaccine and got the shingles again.  The reporter stated that apparently 10 percent of the population still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
fine trembling & staring lasting about 30 secs the same day vax given; felt warm probably low grade fever only;
100.6 onset 8 hours after vaccine, stomach upset first, severe chills, elbow through shoulder ache, joint pain, severe headache, muscle pain, nausea, diarrhea, stomach cramps, can't sleep, fell like may get cold.
Patient had MVA after leaving drs office ? of syncopal episode while driving. Timing not perfectly clear from ED report - seems to be 20 -40 minutes post vaccine administration. Pt had been fine - alert active jocular when left office and throughout procedure before leaving.
Redness surrounding the injection site with a diameter of approximately 6 inches.   Patient said that it has been warm to the touch and has caused discomfort.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient brings this action for personal injuries and damages suffered as a result of being inoculated with the ZOSTAVAX. The patient was inoculated with the ZOSTAVAX for the long-term prevention of shingles. The patient was diagnosed with shingles after being inoculated with the ZOSTAVAX and suffered serious physical, emotional, and economic damages as a result of his shingles and associated injuries. On or about 07-NOV-2011, the patient was inoculated with the ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. On or about 15-SEP-2015, the patient was treated at a medical center, for a vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed prednisone, KEFLEX, and acyclovir for management of his painful symptoms and chronic pain. On or about 04-OCT-2016, the patient sought subsequent treatment and had extensive follow ups at an eye center for a vesicular outbreak, which was diagnosed as herpes zoster ophthalmicus, a varicella-zoster virus infection that involves the eye. The patient was prescribed DUREZOL and MAXITROL eye drops for to ease his painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, herpes zoster ophthalmicus was considered to be medically significant. Additional information has been requested.
swollen eyelid, whites of eye were red;eyes felt scratchy;eyes were annoying;started 9PM 16OCT until Wed time unk; fever, coughing started 20OCT; pt feels fever-saw MD;rt arm very painful-"hit me w/a bat";
persisting headache, 6-8/10 severity, beginning  one day after vaccine x9 days, still unresolved.
had painful, aching quads in both legs and also in the groin area; had painful, aching quads in both legs and also in the groin area; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in left arm on 02Jan2021 14:00 (age at vaccination: 68 years) as dose 1, single for covid-19 immunisation. The patient's medical history included osteomyelitis from ten years ago, blood infection landed in pelvic area. The patient's concomitant medications were not reported. There were no known allergies. The patient did not receive any other vaccine in four weeks or any other medication in 2 weeks. The patient took Advil but it does not give much relief. She constantly massage and apply pressure on certain pressure points and still the pain does not go away. On 02Feb2021, the patient had painful, aching quads in both legs and also in the groin area. The patient on an unknown date had pain assessment at 7 on a scale of 1-10. The patient did not have covid prior vaccination nor was tested positive since vaccination. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Left shoulder discomfort, restricted range-of-motion, possible inflammatory response. Mobic prescribed.
Light headed immediately after injection.  Around 3 hrs after redness and inflammation was noted at the injection site.  Size of area increased from 1/2cm to 3cm.
I experienced a miscarriage that started with bleeding on 3/13 and was confirmed by ongoing hcg level tests starting on 3/17. I passed a lot of blood and blood tissue in an intense event on 3/16. I did not know I was pregnant at the time and was estimated to be around 9-10 weeks (due date around October 2021) based on hcg levels. I was also breastfeeding at the time of my vaccine. I was advised to go to the emergency room if certain conditions occurred including extreme pain -- I opted to go to Urgent Care that evening to get checked out and to get a blood hcg test. Urgent care was unable to do the blood test and they recommended I call my provider the next day or go to the Emergency Department if certain symptoms occurred.
The 2-3 days after the shot my mom got a fever (over 100 degrees) and the chills which we were able to control with Tylenol for the most part. However, over the next 4 weeks, my mom gradually lost the ability to control her bladder function, and her ability to transition between sitting, standing and lying down w/o help. She also exhibited even more difficulty with walking than she did before (shuffling). My mother experienced pain all throughout her body, and the pain became as bad as an 8-9 in a range of 1-10. She struggled to raise her arms, reach her arms out, or grasp objects. She lacked energy, she would sleep for 10 hours every night, and she had difficulty concentrating and remembering what she was reading,
I kept a log of the events that occurred. Notes: 25mg amitriptyline taken nightly for the last month, 200mg motrin I?ve never taken pain killers before this, time is in military.   Mar 18  1430 (1 hour 30 mins after my shot) i have a compressing headache toward the back of my head so i take 1 motrin.  1700 i head home, take 1 amitriptyline and head straight to sleep. ( i have no apatite so no dinner ) Mar 19 0100 The pain starts, it?s unbearable. I am sweating heavily and im also shivering cold. i have a high fever I have body aches which turns my shivering into shaking which keeps my wife up all night. In my dreams i feel pain. I talked to my deceased mother, i hold my deceased cat and i relive some of my most regrettable moments.  0700 I wake up, the bed is soaking wet. I take a motrin and get dressed. it takes me an hour longer to get ready for work because, the pain has sapped my energy. My supervisor sends me home seeing how horrible I look. 0900 I take an amitriptyline and lay down. I ask me wife to close to the storm shutters to darken the room. They are normally pretty quiet to close but, this time they are deafeningly loud. I struggled to get 1 hour of sleep.  1500 I wake up due to shaking so bad that i hit my head on the wall. I then take 2 motrin and about 30 mins later i notice theres a tightness in my chest. i take 1 tums. I know that my body is exhausted from the pain and my mind is clouded but i really wanted to do all of the tasks that i was planning on doing this weekend. All of the tasks end up failing. 2100 i try the tasks again and end up failing again.   20 Mar 0100. I eat a pear and 2 cheetos. i do not take a amitriptyline and i lay down. i have no pain or fever. (Dream start) The dream i had is of me watching myself get thrown around by a ghost. The ghost possesses my body for a short time. I grab some kittens (cats are a comfort to me so im guessing that my subconscious trying to reel me back in) I then wake my sleeping wife and tell her theres a ghost and we need to leave. We walk outside and im in an old neighborhood that i grew up in, everything darkens and im in pitch black feeling my way around a room. I open my eyes and im in a hotel. The front desk staff will not let me take the kittens up to my room so i leave them. When i walk into the room, it?s full of kittens (dream end) and i wake up  21 Mar 0900 I wake up and I have a sore throat and tightness in my chest. The soreness prevents me from going back to sleep and the tightness in my chest causing some anxiety. Once I calm myself down and convince myself that im not having a heart attack I take 2 motrin and some tums and the pain goes away from the day. These could be some withdrawals from not taking amitriptyline since 19 mar in the morning. This is still happening as I write this report. (23 March 2021)
Narrative:  patient having a vaccination yesterday, with resultant erythema, his symptoms are likely secondary to local immune reaction. This has been discussed with the patient and his wife. Patient has been offered steroids versus meloxicam in the emergency department for his symptoms. Patient has been informed that steroids may decrease his immune reaction therefore decreasing his immunity to shingles in the future. At this time patient has elected to have steroids emergency department. Patient has received Decadron 10 mg orally in the emergency department for his symptoms. Patient will also be sent with Mobic, 7.5 mg daily for the next 5 days. Patient has been instructed to start this medication tomorrow. Patient has been instructed to not take this medication in addition to other NSAIDs as it can cause GI upset. Patient has been informed that if he needs additional pain relief to take Tylenol. Subjective/Chief Complaint: right arm pain and redness after having shingle vaccine on Monday. Pt. had a sever head ache yesterday that has resolved.
an expired dose of the Moderna COVID-19 bivalent vaccine was administered to a patient; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 bivalent vaccine was administered to a patient) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 bivalent vaccine was administered to a patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 bivalent vaccine was administered to a patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 bivalent vaccine was administered to a patient).    Concomitant products were not reported.  Treatment medications were not reported.   Reporter did not allow further contact
I was having a cough and I was traveling. I made an appointment with an urgent care because I took a COVID-19 home test and it was positive. I was fatigued, decreased appetite and I just did not feel good. I was given PAXLOVID which really did not seem to help my symptoms that I noticed. My spouse did also test positive as well.
STARTED SOB AND DRY COUGH AND RASH WITHIN 15 MINUTES OF VACCINE
8 days post vaccine, I developed erythema ( about 10cmx5cm), pruritis, swelling, and mild tenderness over my injection site.
Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
disoriented; confusion; weak/lack energy; facial and tongue numbness; facial and tongue numbness; dizzy and light headed; This is a spontaneous report from a contactable other HCP. A 63-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 02Apr2021 11:00 (Lot Number: EW0151) as single dose for COVID-19 immunization.  Medical history included hypothyroid (long standing with no new meds), allergies to nkda. Concomitant medication included levothyroxine sodium (SYNTHYROID).  On 02Apr2021 11:15 am, the patient felt disoriented, confusion, weak, facial and tongue numbness, dizzy and light headed, lack energy lasted 10 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse event. The outcome of the events was recovered on 12Apr2021.   No follow-up attempts are needed. No further information is expected.
Patient went to lab to draw blood and while was sitting in the chair started to feel faint, and looked pale and was slipping out of lab chair. Pt was raised into chair. BP had dropped and FS 88. Eyes were open and he was responsive and was given fluids, apple juice and allowed to lie down. Pt was observed for over 1 hour and recovered and was discharged home. On f/u call 12/28/16 to see how patient is, mother reports child is still not himself, had a headache, sore throat, and slight temperature for past few days. So mother was recommended to bring child to ER now for further evaluation.
This is a spontaneous report from Pfizer sales representative on behalf of an other healthcare professional (the receptionist who was calling on behalf of physician) for a patient. The is the second of three reports. A patient of an unspecified age, gender and ethnicity received TRUMENBA single dose, on an unknown date. Relevant medical history and concomitant medications were unknown. The patient experienced headache, fatigue, and chills on an unspecified date. Clinical outcome of the events was unknown.
pt recvd vax 29OCT93 & exp sore throat, nose running, eyes watery, coughing;
Rash, Benadryl 12.5mg PRN, pt had already at home.
Minor muscle aches, slight fever, lethargy, diarrhea. All of these symptoms resolved after 24 - 36 hours.
09/22/22 reports to ED for "shortness of breath". PMHx of "HTN, dementia, DM"
Information has been received from a company representative reported that she read about a teen in a High School new article.  The article talks about a 23 year old female who went into a coma after receiving GARDASIL (Lot # was not available) and was paralyzed.  Upon internal review, paralysis and coma determined to be other important medical events.  This is one of several reports from the same source.  Attempts are being made to verify the existence of an identifiable patient and reporter.
After the vaccine on Jan 16, 2021, I had a sore arm with minor inflammation for 3 days.  This subsided without any over the counter medications.  Yesterday at about 5 pm, my arm started to itch slightly at the site of the shot.  Upon waking up this morning, my upper arm has a red circle and is inflamed and it hurts again.  I applied prescription cortisone and will continue to apply throughout the day.   The soreness seems about the same pain level as the first 3 days after receiving the shot.  There is no evidence of bug bite and it would be very strange if I got bit in the exact same location as the shot.
It was very hot; 100.1 temp the entire time; still exhausted; "arm had swelled up to the size of the palm of my hand"; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING ("arm had swelled up to the size of the palm of my hand"), FEELING HOT (It was very hot), PYREXIA (100.1 temp the entire time) and FATIGUE (still exhausted) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021 at 1:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021 at 8:00 PM, the patient experienced PERIPHERAL SWELLING ("arm had swelled up to the size of the palm of my hand"). On an unknown date, the patient experienced FEELING HOT (It was very hot), PYREXIA (100.1 temp the entire time) and FATIGUE (still exhausted). At the time of the report, PERIPHERAL SWELLING ("arm had swelled up to the size of the palm of my hand"), FEELING HOT (It was very hot), PYREXIA (100.1 temp the entire time) and FATIGUE (still exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) Fever.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
This spontaneous report as received from a physician refers to a 12 month old male patient with no pertinent medical history or drug reactions/allergies. On 27-JUN-2011 the patient was vaccinated with (oka/merck) VARIVAX (lot # 669098/1567Z, EXP date 11-NOV-2012, route not reported), MMR II (rHa, lot # 666684/0741Z, EXP date 19-MAY-2012, route not reported) and VAQTA (lot # 670282/0125AA, EXP date 06-DEC-2013 route not reported). Concomitant therapies included PREVNAR (lot # and route not reported, vaccinated on 27-JUN-2011). On 27-JUN-2011, one hour after the administration of vaccine, the patient experienced bad, widespread generalized hives further described as hives on face, arms and a little bit on chest. On an unknown date the patient experienced facial swelling. Patient sought medical attention. The patient was treated in the emergency room on 28-JUN-2011 with BENADRYL (route unspecified) and discharged on 28-JUN-2011. On 29-JUN-2011, patient was treated in another emergency room with BENADRYL administered intramuscularly and systemic steroids. Patient was discharged from this emergency room on 29-JUN-2011. Patient recovered on an unspecified date. The adverse event of bad, widespread generalized hives further described as hives on face, arms and a little bit on chest and facial swelling was reported as medically significant and life threatening. Additional information has been requested.
Severe swelling of upper arm with redness and itching.  Lasted 36 hours.
Developed itching, redness, tenderness at site of injection about 8 days after injection.  Also noted swollen lymph node under ipsilateral side as well as tenderness along the clavicle.  Feels tired and achy.  No fever or hives.  No SOB or other swelling. No hives.
She  has developed a cellulitis to the left arm near the elbow. site is very swollen and painful and warm to touch.  She is also developing some pain, warmth  and swelling near the right elbow.  she has been started on doxycycline.   She saw her PCP and was informed that they have seen this in another individual after receipt of the J and J vaccine.