chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle pain on the first day; low grade fever of up to 101.5F; "traumatic" side effects; This is a spontaneous report from a contactable Consumer (patient) via Medical information Team. A (Age: 70; Unit: Unknown) male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, on Jan2021 as a SINGLE DOSE for covid-19 immunisation. Medical history included COVID-19. The patient's concomitant medications were not reported. The patient experienced Muscle pain on the first day (non-serious) on Jan2021, low grade fever of up to 101.5F (non-serious) on Jan2021 and "traumatic" side effects on Jan2021. Call is asking for guidance because he received the 1st dose 2 weeks ago and is experiencing "traumatic" side effects such as Muscle pain on the first day and 2 full days of substantial low grade fever of up to 101.5F. He mentioned that he had "a moderate take of" COVID before and the fever he experienced was almost the same with it being a fever for 2 weeks on and off. The muscle pain was much less than what he experienced with COVID. He is asking if it will be okay for him to take the 2nd dose given the side effects that he experienced and the fact that he had Covid before and might have developed antibodies already. I've heard that the side effects of the 2nd dose would be more egregious than the 1st. Do you have data on that? That's very helpful, you've been great. The patient underwent lab tests and procedures which included Fever: 101.5 F (low grade) on an unspecified date in Jan2021. For events, outcome was unknown.  Information on the lot/batch number has been requested.
24 hours after injection I developed a fever, chills, body soreness, lethargy, headache, and a heavy cough.  It is 3 days later and I am still experiencing these symptoms.  I am starting to feel better now I think, but my cough is getting worse.  I haven't been this sick in many years.  I am really upset that I wasn't warned about how severe the side effects could be.  I have had to miss work this week.
Blood pressure extremely high with high pulse rate. 3 nosebleeds that required 2 visits to ER, because of high BP. Then had nose cauterized. Went to cardiologist to get BP and PR under control. Still trying to get it regulated. No problem prior to vaccine.
Patient complained of difficulty breathing.  Injected self with own epi pen.  EMT called to scene.  Patient refused transport to hospital.
fracture rib; skin disorder; confusion; cat scratch disease; pain in arm; peripheral swelling; This spontaneous case was reported by a physician and describes the occurrence of RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease) and PAIN IN EXTREMITY (pain in arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Macular degeneration (No Medical History was provided) and Arrhythmia.   On 14-May-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease), PAIN IN EXTREMITY (pain in arm) and PERIPHERAL SWELLING (peripheral swelling). At the time of the report, RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), PAIN IN EXTREMITY (pain in arm) and PERIPHERAL SWELLING (peripheral swelling) had not resolved and CAT SCRATCH DISEASE (cat scratch disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (pain in arm) to be possibly related. No further causality assessments were provided for RIB FRACTURE (fracture rib), SKIN DISORDER (skin disorder), CONFUSIONAL STATE (confusion), CAT SCRATCH DISEASE (cat scratch disease) and PERIPHERAL SWELLING (peripheral swelling).    On an unknown date, post vaccination, the patient reported that he experienced symptoms of macular degeneration, oxygen saturation low, white blood cells low and fractured rib. The patient also reported that he experienced symptoms of skin disorder, confusion, cat scratch disease and peripheral swelling.   No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: No new information was received.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except Cat Scratch disease which is unlikely.
12-19-11 received Flu vac 0.25ml 2 hrs later pt had rash to cheeks, all over body after vaccine c/o grinding teeth a lot, itching in throat, scratching all over body, 12-20-11 PRELONE 15/5 1/2 tsp P.O. QD x 3 days, SOLU-MEDROL 20mg IM, returned no improvement 12-22-11 ATARAX 1/4 tsp P.O. Q 6-8 hrs PRN, Dexamethasone 2.5mg IM x 1 today. No fever. No N/V or D.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date, more than 20 years ago, an employee received a RECOMBIVAX HB series (also reported as the name and manufacturer of the hepatitis B vaccine were unknown) (lot number and expiration date were not reported) (dose, frequency and route not reported). No other co suspect or concomitant medications were reported. It was reported that right now the employee had low hepatitis b titers. The outcome of low hepatitis b titers was reported as not recovered. This case is related to MARRS cases 1303USA011314, 1303USA014013. Additional information has been requested.
Adverse Events: chronic inflammatory demyelinating polyneuropathy (CIPD); Guillain-barré syndrome (GBS); lupus flare -- since May 2021 to present January 2022; symptoms include(d): paralysis in legs, numbness and tingling in hands and feet, back pain; inability to sleep; loss of appetite; -40lbs rapid weight loss; swollen testicle; loss of strength; depression; anxiety; acne; hand tremors; freezing limbs  Treatments: Immunoglobulin therapy (IVIg) Plasmapheresis Duloxetine Pregabalin Gabapentin Topical lidocaine for hands and feet
I got a swelling on my elbow; It is like a spongy node, it is like a ball of water; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 01Feb2021 at 16:00 at a single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. Consumer stated, "I got my Covid 19 vaccination yesterday, the first one and I was reading all these side effects and the only thing that I had a question for is that I got the vaccination at approximately 4 O'clock in the afternoon and at 10 O'clock at night, on the arm that I got the shot, I got a swelling on my elbow. It is like a spongy node, it is like a ball of water and it is not at the injection site. It is on my elbow it just showed up. So, it is a side effect that I am reporting. I called the health department and they told me to call my physician. I called my physician, he told me to call my health department. You know, I got frustrated. I saw this number, I am calling you guys to report the side effect. It does not hurt and no pain. It is just a blob on my elbow." The patient did not receive treatment for the event. The outcome of the event was unknown.
Shot 1: no reaction  Shot 2: sore arm reaction at injection site and itchy hands Shot 3: sore arm reaction at injection site and itchy red raised welt rash on both sides of neck about a week after shot which persists
G40.901 STATUS EPILEPTICUS 4/21/2022 CYSTITIS I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 5/15/2022 CYSTITIS G40.901 STATUS EPILEPTICUS 4/21/2022 DM 2 W RENAL MANIFESTATION I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 5/15/2022 DM 2 W RENAL MANIFESTATION G40.901 STATUS EPILEPTICUS 4/21/2022 CKD STAGE 3A (GFR 45-59) I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 5/15/2022 CKD STAGE 3A (GFR 45-59) G40.901 STATUS EPILEPTICUS 4/21/2022 ACUTE STROKE DUE TO OCCLUSION OF RIGHT POSTERIOR COMMUNICATING ARTERY I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 5/15/2022 ACUTE STROKE DUE TO OCCLUSION OF RIGHT POSTERIOR COMMUNICATING ARTERY
Loss of feeling in left side of face, headache, difficulty swallowing, mouth ulcers, arm pain - all symptoms localized to left side of body. Symptoms started approximately 30 minutes after vaccination. Symptoms have persisted for approximately 8 days now. Ibuprofen being administered as needed for symptoms.
About 4 hours after his vaccine, the injection site starting hurting, but not bad.  He could not sleep on it at night as he felt like he was sleeping on a red hot pocker.  On Saturday he was extremely tired in the afternoon.  Had to come in from yard work as he could not function.  He also had pain in his neck and shoulders.  On Sunday he the feelings were going away, but his muscles started aching.  On Monday he felt really strange, felt like he was in a fog, and his muscles ached.  He could not get relaxed, did his normal Monday chores, laundry and house cleaning.  He then tried to relax but his muscles and nerves were very tense.  He went to bed around 9:30 on Monday, fell asleep and awoke at 2:00 AM and could not go back to sleep his muscles in his arms and legs were in spasm and his arm would jump like a shock reaction and jump off of the mattress, as well as his leg.  It was worse on the left side than the right arm.  This went on every 10-15 minutes for about 3-4 hours.  Around 4:00 AM this morning it eased off to sleep and woke up at 10 and felt better today.  He hasn't had any more of the seizure type feelings in his arms or legs.  He did speak with Moderna who told him that he was the 4th one with this reaction and to report this to us.
rash, warm to touch, welps, lightheaded, dizzy, headache, felt like something was stuck in throat
Information has been received from a 72 year old female consumer with a penicillin allergy, depression, hypertension and Lennox-Gastaut syndrome who on 26-SEP-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck). Concomitant therapy included sertraline HCl (ZOLOFT), lamotrigine (LAMICTAL) and verapamil. On 30-SEP-2007 the patient developed a raised macular papular rash. Unspecified medical attention was sought. No lab studies were performed. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Follow up information from the physician on 08-OCT-2007 indicated that the patient was not vaccinated at his office. Follow up information received on 09-OCT-2007 from a certified medical assistant indicated that the patient was seen in the office for her rash which was described as an erythematous, pruritic rash on the extremities. The patient was treated with cetirizine hydrochloride (ZYRTEC). No further information was provided. The medical assistant considered treatment with cetirizine hydrochloride (ZYRTEC) to be an intervention to prevent serious criteria (OME). Additional information has been requested.
Pt was a non-responder p/3 doses of vax; p/1 booster dose still did not convert;
Injection site tenderness, pain, and bleeding; headache, sweating, chills, full-body muscle and joint aches, lethargy, malaise, runny/stuffy nose. Started a couple hours after the dose and continued for two days after.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 23-OCT-2014, the patient was vaccinated with the first dose of GARDASIL (lot #, route and expiration date were not reported). On 11-SEP-2015, the patient received the second dose and, on 26-OCT-2015, received the third dose of GARDASIL lot # K016966, expiration date 10-MAY-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Itch and brief pain to left shoulder for < 2 min followed by nausea and stomach ache
Rash from neck to trunk, splotchy w/individual dots - red @ inject site. Fever started same day of inject 100.3 under arm cried for more than 3 hrs/unusual high pitched cry.
pt had tingling in the left arm pain at the injection site and a rash on the lower part of the injection site arm
Had shots and still had light case of shingles/ suspected Vaccination failure; Had shots and still had light case of 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In November 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. In May 2022, between 5 and 7 months after receiving Shingles vaccine and 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 and Shingles vaccine.     Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The patient self-reported the case via interactive  digital media and described the occurrence of suspected vaccination failure. The patient received last shot of Shingles vaccine in first week of November 2021. After receiving Shingles vaccines, the patient still had light case of shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting. The follow up would not be possible as no contact details were available
Product Storage Error; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 3K9LY, expiry date 30th June 2022) and (batch number 3P3TY, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent 2021-2022 season. On an unknown date, the dose was an unknown dose. On an unknown date, the patient started Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   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 applicable for this report. The vaccine coordinator requested stability data for Flulaval as the needle was placed on the PFS and was not discarded at the end of the day, but was used for 4 days after, which led to incorrect product storage. About 15 patients received the vaccines with most receiving them on 22nd November 2021.  The reporter prefers follow up be made for patient demographics, she did not wish to provide at this time. The reporter consented to follow up via post
01/31/2019: patient woke up with muscle aches, joint pain, facial pressure, fever 101 F. Seen in clinic 02/01/2019 and tested negative for Influenza. Provided rehydration solution, and instructed to take Ibuprofen as needed. 02/04/2019 Seen in clinic for diarrhea (6 x/day) for one day on 02/02/2019, with fever up to 101. On 02/04/2019, patient stated diarrhea only lasted one day, no other symptoms except fatigue and fever of 101 1 day ago. Feels much better today. Exam WNL. Provided Azithromycin 500 mg x 1 for diarrhea.
Pt was given MMR and VZV on left arm two days ago (6/11/10). Mom noticed erythema on left arm today which has worsened since. Erythema 19 cm in length from shoulder to above elbow and circumferential all the way around. Normal ROM shoulder, elbow. Mild tenderness on palpation.
received the complete Pfizer vaccination series "3 weeks ago," and were inadvertently administered a first dose of Moderna today (18Feb2021); received the complete Pfizer vaccination series "3 weeks ago," and were inadvertently administered a first dose of Moderna today (18Feb2021); A spontaneous report was received on 18 Feb 2021 from a pharmacist concerning unknown age male patient who received the complete Pfizer vaccination series 3 weeks ago and were inadvertently administered a first dose of Moderna's COVID-19 vaccine. (Interchange of vaccine products) and (Extra dose administered).  The patient medical history provided was dementia. No relevant concomitant medications were reported.  On 18 Feb 2021, patient received their first of two planned doses of Moderna's mRNA-1273 (Lot number: unknown), for the prophylaxis of COVID-19 infection. The patient received the complete Pfizer vaccine series, 3 weeks prior to the Moderna's vaccine.   Treatment for the event was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event received the complete Pfizer vaccination series 3 weeks ago and were inadvertently administered a first dose of Moderna's COVID-19 vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of interchange of vaccine products and extra dose administered for mRNA-1273 (lot # unknown) with no associated AEs reported.
within 30 minutes of the injection, my mouth and tongue started tingling and feeling numb at the same time. It felt like there was swelling but I did not see swelling when looking in the mirror at the back of my throat, so the numbness may have just made it feel swollen, I'm not sure.  The best way to describe it is that my mouth, tongue, and throat felt like I had just received a numbing injection at the dentist or gargled with lidocaine. My throat also got very itchy and it was slightly difficult to swallow. I took 50 mg of Benadryl upon arriving home after the vaccination. The numbness and tingling lasted about 7 hours. I did not see a doctor, as my breathing was fine. The next morning, my throat is still itchy but numbness and tingling are gone.
Patient complains of numbness and tingling in fingers and toes. Patient states he can bite his fingers and not feel it
Information has been received from a physician via a literature article, concerning a pregnant female who on an unknown date was vaccinated with the first dose of GARDASIL. The patient had a spontaneous abortion which occurred 47 days after vaccination with the first dose of GARDASIL. This report was part of a post-marketing surveillance program. The primary investigator felt that spontaneous abortion was possible related to the study therapy. Upon internal review spontaneous abortion was considered to be an other important medical event. This is one of several reports from the same source. No further information is available. A copy of the published article is attached as further documentation of the patient's experience.
The morning after the first injection I woke up w/a severe headache that lasted about 36 hours.  The night of the second injection extreme fatigue, chills. I woke up the morning after second injection w/fever, headache, entire body muscle/joint pain, fatigue and nausea and lasted 24 hours.  The morning of the second day post injection left arm nymph node extremely swollen and painful, severe headache , body ache, nausea and intermittent fever.
Diarrhea until about 3:00 AM, stumbling walk, felt off balance.  Had sore stomach entire next day and felt bloated.
Rash all over body x 2 days (10 days post MMR) erythematous - blanching of skin coalescent at places, no itchiness, macular, no papules or vesicles.
On 5 July 2016, at approximately 2:10 pm, and several minutes after the patient received her last vaccination (a HPV9 vaccination) she leaned forward in her chair, fell out of the chair, and bumped her head on the floor. Patient was laid flat on the floor. Patient felt nauseous and sat up to try and vomit, but was unsuccessful. Patient was laid back down on mat with her legs elevated. A call was placed to 911 at approximately 2:20. Patient recovered and was evaluated by the paramedics. As a precautionary follow-up the patient was transported to hospital.
t103.4 w/ c/o hot flashes & chills, mild nausea & extremity tingling;rx rest, APAP;
Got 0.25 mL instead of 0.50 mL as a first dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Got 0.25 mL instead of 0.50 mL as a first dose) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (Got 0.25 mL instead of 0.50 mL as a first dose). On 24-Jan-2022, ACCIDENTAL UNDERDOSE (Got 0.25 mL instead of 0.50 mL as a first dose) had resolved.            No concomitant medication information was provided. No treatment medication were provided.
-Blurred vision, Stiff Legs, Physically shaky, Dizziness, Fatigue, Muscle Pain (Legs), Stiff Joints (Legs and hands)   no dx or tx was performed.  Dr is the PCP and the reporting pharmacist called to inform the MD of the patient's side effects.   Immunizing Pharmacist was Pharm D  Patient was advised to call primary care physician.  He declined due to leaving for vacation.
emesis onset 845PM 15SEP92; t99 ax; fussy; refuses to walk; falls down;