chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe shoulder pain; Reduced mobility; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing. On 09Apr2021, the patient experienced severe shoulder pain and reduced mobility. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe shoulder pain and reduced mobility were not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient came to pharmacy complaining that after receiving vaccine by 8 hrs pt had the chills, fever and headache took 2 ADVIL then symptoms improved. Also arm swelling at site of injection after 4 hrs also improved.
Initial report received from a healthcare professional on 09 April 2013. A 41-year-old female patient had received first intramuscular dose of ADACEL, (batch number: U4567AA) on right deltoid on 04 April 2013. The patient had no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient concomitant medication was not reported. On 06 April 2013, i.e. 2 days after vaccination, the patient developed asymptomatic erythematous macular rash (not C-W hives) on her upper body and was most notable after the shower. Lab investigations and corrective treatments were not reported. On an unspecified date, the patient had recovered from the event. Documents held by sender: None.
On 5/11/2022, patient reported that on 1/14/2021 when he received his first COVID-19 vaccine, he developed pain in his left shoulder and neck.  When receiving his 2nd shot, he requested it be given in his right arm and the pain returned after injection to his left shoulder and neck.
pt recv vax & devel an unspecified rxn;this is 1 of 3pt from this site to report adverse rxn to lot#431965
Urticaria reaction; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
No additional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine. The patient received only one dose; This spontaneous report was received from a healthcare worker and refers to a 2-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-AUG-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection for prophylaxis (strength, frequency, route of administration and anatomical location were not reported) lot number W003118 with expiration date on 13-JUL-2023 or W015191 with expiration date on 27-JUL-2023 (incorrect product storage), however the reporter did not specify which actual lot received the patient.  The hepatitis a vaccine, inactivated (VAQTA) underwent a temperature excursion of 11.3 degrees Celsius (C) for a time frame of 34 minutes and there was no previous temperature excursion. No additional adverse events were reported.
Local reaction at injection site.  Arm swollen, red, hot rash extended to entire upper arm.  Itchy red swollen and rash for 9 days.
4-2-07 AM leg pain and soreness and swelling in both knees. Lasted 3 days. After 3 days above symptoms moved up to right arm lasted 3 days. Symptoms subsided, moved to left arm same symptoms, lasted 3 days and subsided. 4-5-07 rash developed anterior neck. Saw oncologist 4-13-07 for stated symptoms. Pt was assessed. No treatment given.
Fainted twice! Causing massive head trauma & wounds. It happened 35 hours after the vaccination & I was given no warning that this could happen.
No Adverse Event; Patient was administered the Bivalent Moderna COVID-19 Vaccine. He requested a booster/Wrong vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered the Bivalent Moderna COVID-19 Vaccine. He requested a booster/Wrong vaccine administered) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered the Bivalent Moderna COVID-19 Vaccine. He requested a booster/Wrong vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered the Bivalent Moderna COVID-19 Vaccine. He requested a booster/Wrong vaccine administered) 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 WRONG PRODUCT ADMINISTERED (Patient was administered the Bivalent Moderna COVID-19 Vaccine. He requested a booster/Wrong vaccine administered).    Concomitant medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Dec-2022: Significant Live Follow up received contains event start date and narrative updated.
This spontaneous report as received from a registered nurse referring to two patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with inappropriately stored doses of VARIVAX (Merck) lot # K016132 (expiration date 29-SEP-2016) (route, dose, dose number and frequency were not provided). Concomitant medications were not reported. The reporter stated that these doses of VARIVAX (Merck) were stored at 15 degrees Fahrenheit for 15 hours. No adverse events were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sore Joints; Sore Joints and Muscles; welt at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Aug2021 at 13:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included duloxetine (MANUFACTURER UNKNOWN) 60 mg from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Jul2021 at 12:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. On 07Aug2021, the patient experienced sore joints and muscles and welt at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with aspirin. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events sore joints and muscles and welt at injection site was recovering at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Pt c/o itching all over on 17APR94, lightheaded & nauseated on 18APR94 & sick 19APR94; pt seen by MD on 19APR94; advised that had a virus; pt reports husband also had some virus a few days later;
Sudden onset severe headache; fever; rash, swelling at injection site; rash of head and neck, shortness of breath, feeling of throat closing.
Patient experienced insomnia the night following the vaccine starting at 8 hours post vaccination. She lost her voice entirely 4 days later.
This was the vaccine recipient's 2nd vaccination. They had no issues with the 1st vaccination. Vaccine recipient reported that after 10 minutes of receiving the 2nd vaccine they developed a headache that felt like a migraine. The vaccine recipient took Advil, then a few minutes later started sweating, felt clammy, and hot. The symptoms started to pass 15 minutes later. That night they reported that their chest felt tight but it went away before bedtime. This morning 1/7/2021, vaccine recipient reported feeling tired and mind felt foggy. They were able to continue to go to work.
This case was reported by a consumer via call center representative and described the occurrence of ministroke in a 56-year-old male patient who received HAVRIX (batch number 5354D, expiry date 17th November 2018). Concomitant products included CRESTOR. On 5th June 2017, the patient received HAVRIX (intramuscular) 1 ml. On 5th June 2017, 6 hrs after receiving HAVRIX, the patient experienced ministroke (serious criteria GSK medically significant), mobility decreased (serious criteria GSK medically significant), cerebral disorder, disorientation and vertigo positional. On an unknown date, the outcome of the ministroke, cerebral disorder and vertigo positional were recovering/resolving and the outcome of the mobility decreased and disorientation were unknown. The reporter considered the ministroke, mobility decreased, cerebral disorder, disorientation and vertigo positional to be possibly related to HAVRIX. Additional details were reported as follows: At 12:00, the patient received HAVRIX on left arm and stated that experienced serious cerebral event. The patient required emergency room visit and was diagnosed with positional vertigo, but required no overnight hospitalization. The patient felt like he was having a mini stroke and was not able to move for a 2 hours period and was also completely disoriented during that time.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients. The patients were vaccinated with unspecified dose of M-M-R II (Lot#, dose and route not reported), date unspecified. "Later" on unspecified date the patients had low or negative titers to one of more components of the vaccine. It was not known if the patients sought for medical attention. At the time of this report the patients' statuses were unknown. This is one of several reports received from a same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided all available.
Received Hepatitis A vaccine 2/23/06. Started oral typhoid vaccine on 2/24/06. Afternoon of  2/26/06 developed slightly tender hive like rash on face. No other symptoms. Called to clinic (telephone help line) 2/26/06. Told to hold oral typhoid vaccine, increase fluids, benadryl or claritan over the counter as needed.
29 weeks, still born delivery, Estimate date of delivery 06/14/2021 and Birth weight at delivery 2 lbs.  03/24/2021  vaccination then on 03/27/201 was not able to feel the baby movement, had an appointment 04/01/2021 and not heartbeat and delivered. on and Delivered at the hospital. Spoke with the doctor that she got the vaccination.
Pt was seen 1/19/00 for local reaction on L/thigh, L/L swollen (2x/size). Recheck on 1/21/00, continues w/swelling of 11 3/4". Moving leg well, not hot to touch.
MMR gave. Red, raised area surrounding the shot on the left thigh, immediately after BENADRYL 125mg to be given by parent if injection still red tonight. BENADRYL may be repeated in the am on 9/19 if still red.
Looks like I have a golf ball under my skin at the site of injection due to extreme swelling, which has still not gone away 7 days later. Was very red at the site, but that has since pretty much fully gone away.
3 days after I received the vaccine, the muscle on top of my forearm near the elbow (approximately where the "funny bone" is located) has been very sore and still is as of this writing. It hurts to straighten my arm out. It hurts to bring my fist to my shoulder. It hurts to clench my fist tight. It's affecting my capabilites at work. I delayed reporting it because I thought it was just from getting a shot and would pass.
This case involves male patient of unknown age who experienced got the flu shot and got the flu while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency, route, lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious event "got the flu shot and got the flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got the flu shot and got the flu). At time of reporting, the outcome was Unknown for the event got the flu shot and got the flu.
Pt received annual Anthrax booster on 1/14/03 at approx. 13:00 and developed rash about 6 hours later 19:00. Pt also had headache and nausea. Pt was treated in ER on 1/19/03 for nausea. No other treatment. Is ongoing.
This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date: not reported), via an unspecified route of administration, on Mar 6, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date in Mar 2021, patient experienced neck and shoulder pain. Caller wanted to know if the patient could take prednisone for their neck and shoulder pain (after the first dose of the Pfizer COVID-19 vaccine and while the patient gets second dose). Patient will be having the 2nd dose Mar 27, 2021. Outcome of the event: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Shot given around 1125 am.  Pt and pt's mother went to sit in front of pharmacy.  At around 1135, pt fell out of chair, sounded/looked like he may have hit his head on blood pressure machine that he was sitting near.  We thought he had fainted.  Pt woke within 10 or so seconds after fall and was confused.  Said his head didn't hurt.  His skin did lose it's color and he was looking "white as a sheet".  We had pt lie on floor and elevated his feet.  After a few minutes he was feeling better and was able to sit in a chair.   Pt and his mom left the pharmacy area about 15-20 minutes after pt fainted.  Upon looking at video of the event,  it appears that before the patient fell out of his chair that his right arm raises up and his elbow is bent in a very stiff way.  A split second later his whole body appears to stiffen and bend to the left, then he falls out of the chair and is lying on the floor.  When on the floor, his legs appear to be fairly stiff as well.  This whole episode seems to last about 10 seconds or less.  The video makes it look more like a seizure than a case of syncope.
Diarrhea; Cramping; Fever/Fever: started between 8:00PM and 9:00PM. Highest temperature reached was 100.2 degrees. Think it subsided. Temperature this morning was 99.1 degrees; Headache; This is a spontaneous report from a Contactable consumer (patient). A 54-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no. EL8982, expiry date 31May2021) via unspecified route of administration in right arm on 27Jan2021 at 12:40 as single dose for COVID-19 immunisation. Medical history included diabetes. Family history included diabetes runs in both side of family. Both parents passed away and had diabetes. Concomitant medication included pioglitazone 15mg tablet once in the morning and vitamins given by her nutritionist. No other vaccine in four weeks. Previously patient took metformin (but no longer) for diabetes. Patient experienced fever, headache on 27Jan2021, diarrhea and cramping on 28Jan2021. It was stated that, she received the Pfizer Covid 19 vaccine yesterday at university. She reports the following side effects: fever and headache yesterday and really bad diarrhea and cramping this morning. Is the diarrhea a side effect? she received a copy of the Fact Sheet for Recipients and caregivers and did not see it listed there. She states she ate breakfast and took her vitamins this morning and the symptoms have subsided. She wants to report a side effect. Got the injection at (Hospital name). Did get a little fever, which was normal, correct? Woke up this morning with diarrhea and wanted to report that. Would diarrhea be a side effect also. Clarified product as: Pfizer BioNTech COVID-19 Vaccine. Fever was last night. Diarrhea this morning as she woke. Noticed listing of side effects doesn't have diarrhea. Statue diarrhea was one of the ones from COVID so she could get a form of diarrhea after the COVID-19 Vaccine. Is assuming that's what it was. Her family members too also had a little diarrhea. Confirmed she had no NDC/Lot/Exp for either family member's COVID-19 Vaccine. Stated her family members live somewhere else. Patient received COVID-19 Vaccine on 27Jan2021 at a little after 12:40PM. Goes back to hospital on 17Feb2021 for the second dose. Fever started between 8:00PM and 9:00PM. Highest temperature reached was 100.2 degrees. Think it subsided. Temperature this morning was 99.1 degrees. Diarrhea is ongoing as of right now. Just ate breakfast but didn't want to. Hasn't had to go to the restroom yet. This morning she had to go to the restroom a couple times, and it was like water. Had been drinking water and noticed afterwards she had to go right away. She stated is a pastor from a church. Had a press release from main pastor. Had a press conference. Wants to get her community willing to be vaccinated. No COVID prior vaccination. Seriousness reported as non-serious. The outcome of event diarrhea was not recovered, whereas other events were recovered on 28Jan2021.  Follow-up attempts are completed. No further information is expected.
Felt hot and cold; 2 inch circle rash; Dark pink in color; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), VACCINATION SITE RASH (2 inch circle rash) and VACCINATION SITE ERYTHEMA (Dark pink in color) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Seasonal allergy. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), VACCINATION SITE RASH (2 inch circle rash) and VACCINATION SITE ERYTHEMA (Dark pink in color). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), VACCINATION SITE RASH (2 inch circle rash) and VACCINATION SITE ERYTHEMA (Dark pink in color) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Body aches; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2019, an unknown time after receiving Shingrix, the patient experienced general body pain and injection site pain. On an unknown date, the outcome of the general body pain and injection site pain were recovered/resolved.   It was unknown if the reporter considered the general body pain and injection site pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR007267  Additional details were reported as follows: The reporter was patient's husband.  The patient received a dose of Shingrix and 12 hours later experienced injection site pain and body aches which resolved 2 days later. The patient received first dose on 18th November 2019 and second dose on 24th September 2021. The reporter wanted to know if his wife should restart the series. Consent to follow up was denied. For tolerance of 2nd dose of Shingrix, refer case US2022AMR007267; Sender's Comments:  US-GLAXOSMITHKLINE-US2022006699:Same reporter. US-GLAXOSMITHKLINE-US2022AMR007267:Same reporter.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "History of hodgkins lymphoma" (unspecified if ongoing). Concomitant medication(s) included: VIT D [COLECALCIFEROL], start date: 04Nov2019; VIT C; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; NEXIUM [ESOMEPRAZOLE SODIUM]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Stabbing stomach pain, low fever, chills, fatigue, body aches, severe arm pain