chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At about 24 hours after received Pfizer COVID vaccine #1 he started c/o pain along the cephalic vein starting at antecubital fossa and spreading distally. Yesterday mother said she could feel a ropy feel c/w phlebitis. She had him take an aspirin and put heat on it. Today it is a little better. He still has pain along that vein and it hurts to fully extend and flex his arm. Presumptive left UE phlebitis that occured within 24 hours of the first Pfizer COVID vaccine in teh sme arm, possibly reaction to vaccine. Treatment of LUE with heat, compression adn ibuprofen (avoid ASA due to age <18). If worsening pain, swelling, redness or fever; f/u and will consider US.
Pt experienced headache, lightheadedness and nausea 30 minutes post vax.
Pt received his 2nd dose of the Moderna COVID19 vaccine, while sitting in observation he reported feeling itching in his right leg. Pt reported to RN in observation that after his 1st dose when he got home he developed an itchy rash and a sensation of "fullness" in his lips. Pt did not seek medical care or speak with his PCP. Pt also did not mention this to his vaccinator. BP 126/91 HR 95 O2Sat 95%. EMS on site and evaluated the pt. Pt stayed in clinic for over 30 minutes with no progression of symptoms. Pt signed a refusal for transport to the hospital with EMS. ED precautions were given to pt and pt was advised to call his PCP. Pt verbalized understanding.
- Itchy hands and feet (but no visible rash) for about an hour beginning about 9 hours post-injection.  - Jumbling up words when speaking for about 30 minutes (about 9 hours post-injection). - Injection site redness and extreme itching which increased over 48 hours then faded over the next 72 hours. The redness and itchiness returned on day 7 post-injection and remained visible for four weeks before it faded away leaving an indentation that lasted about two more weeks. - Diarrhea, bouts of dizziness, nausea, and vaginal blood spotting on post-injection days 1-3. - Difficulty thinking clearly and concentrating on tasks on post-injection days 1-3. - Hives on neck on post-injection day 7. The hives lasted about an hour. Also minor hives and itchiness on right side of forehead accompanying the more prominent neck hives. - Sharp burning sensation on bicep skin on injection arm on post-injection day 7. The sensation lasted less than a minute. - Bouts of dizziness returned on post-injection day 7.  - Metallic taste in mouth began around 11 pm on post-injection day 9 and lasted for about four weeks. COVID-19 test was negative. - Abnormal vaginal bleeding for five days beginning on post-injection day 13. - Swollen lymph node in neck on side of injection beginning on post-injection day 15 and lasting a few days. - Sudden ringing in left ear (tinnitus) that lasted about a minute (did not record the date but it was within two weeks of injection). - Sensation of throat numbness (similar to dental numbing) that lasted about an hour (did not record the date but it was either evening of vaccination or next day). - Fatigue- minor fatigue lasted for about a week post-injection. - Minor hives on stomach appeared the night of post-injection day 16 and were gone by the next morning. - Trouble sleeping for two weeks beginning on day 14 post-injection. - Frequent urination for one week beginning on day 14 post-injection. - Loss of appetite for two weeks beginning on day 14 post-injection. - Feeling jittery/shaky, even upon waking, for two weeks beginning on day 14 post-injection. - Anxiety for about three to four weeks beginning on about post-injection day 21. Also some symptoms of depression (crying and feelings of hopelessness) during this time.
Initial report received on 05 February 2014 from a healthcare professional. A 16 month old male patient received a second dose of Pediatric FLUZONE 25 mL PFS Quad, batch # U4696EA on 12 December 2013 (route and site of administration were not reported). The first dose was received on 05 November 2013, batch U4696E, (route and site of administration were not reported). The patient's medical history and concomitant medications were not reported. The patient went to the emergency department on 02 January 2014 with a fever for 3 days up to 105 degrees and a mild cough. The patient had a rapid influenza test which was positive for influenza A on 01 February 2014. The patient was seen by a healthcare professional on 04 February 2014 and was feeling much better and no more fevers. The patient outcome is recovering. Documents held by sender: None.
I was extremely sick the next day after the shot.  High fever of 103.8, extreme vomiting, aches that lasted for 30 hours. Then two days later, I experienced an extreme dizziness episode that did not stop for over 6 months. It created extreme ringing in my ears and affected my balance nonstop. It affected my quality of life for over 6 months. I was non-stop dizzy for months with no relief. I went from doctor to doctor to try to find relief for my dizziness with no success. After about 4 months my symptoms started to relieve a little bit but I still struggle with balance and constant ringing in my ears. After consulting with various levels of doctors I finally found a doctor that said they have seen an increase in balance, hearing, and ringing issues since the COVID vaccine.
within 5 days of 2nd dose of MOderna vaccine given, reports "black outs", Orthostatic BP WNL.
rapid heart beat for 15 minutes; Heart rate increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart rate increased) and HEART RATE INCREASED (rapid heart beat for 15 minutes) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included VERAPAMIL, AMIODARONE and FLECAINIDE for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced HEART RATE INCREASED (Heart rate increased). On 22-Mar-2021, the patient experienced HEART RATE INCREASED (rapid heart beat for 15 minutes). On 19-Feb-2021, HEART RATE INCREASED (Heart rate increased) outcome was unknown. On 22-Mar-2021, HEART RATE INCREASED (rapid heart beat for 15 minutes) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included Verapamil.
pt recvd vax; pt had severe pain in left arm starting 20 min after vax; inject site also tender;
Patient says 2, 3 days after vaccination he started to experience a cough that is similar to a whooping cough. It was severe enough that he reported passing out while at a diner for an estimated time of approximately 30 seconds (he was with a friend). He did not seek medical attention for it.
2nd booster was administered at 9:15 AM 4/8.  At 12:30 PM there was noticeable induration in the arm and I had severe chills.  By 3:00 AM I had just under a 103 F temperature and was nauseous and could not drink fluids.   By 7 am I was sweating and fever went down to 99.  (My normal body temp is 97.6).   It remained around 99 up until the afternoon.   I was lethargic for two more days -- the second day being less so. .   By day 4,  my temperature and energy returned to normal.      I may have had COVID-19  in December 2019.   I had similar symptoms but no loss of taste and smell.
shingles since the vaccine/Suspected Vaccination Failure; internal shingles; extreme pain; 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), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-Jul-2022 Reporter's comment: The case was received from the patient via nteractive digital media. The patient have had internal shingles since the vaccine and in extreme pain went to a cardiologist, wanted to put the patient on narcotics. The patient did not want that no one believes the patient, he/she need help where should he/she go and did not do that. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
ABOUT 12 HRS AFTER SHOT GOT A FEVER OF 104 WITH TYENOL WENT DOWN TO 102.5 VERY SORE IN ALL JOINTS BAD HEADACHE FEVER LASTED ABOUT 30 HRS BASICLY WAS INCAPICITATED FOR 3 DAYS STILL FEELING VERY WEAK AT THE MOMENT WHICH IS 86HRS LATER
Upon first Moderna vaccination (12/30/2020), day two rash occurred on chest area, lasted 3 days..  Second Moderna vaccination within nine hours of vaccine,.....headache, leg aches, and body shakes from low grade fever, lethargic, but restless.   Day two rash on chest and lasted 3 days.
Pt was follow up on? spider bite right lower leg. Received DT, left deltoid on 6/14/04. C/o left arm swelling and redness at site. Received DT 6/14/04 follow up on 6/16/2004. Knot? 4cm long x 3 1/2 cm wide also red at site.
This spontaneous report as received from a healthcare worker refers to a 17 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Extreme Fatigue Joint Pain Muscle Weakness Significant Blood Pressure increase  from 112/65 to 170/105.  Required starting of BP medicine.
w/in 24 hrs of 2nd dose had fever (104 degrees fahrenheit) for 3 days, no rash or redness; resolved; treated by MD;
suffered injuries due to the Twinrix Vaccine; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injury in a female patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced injury (Verbatim: suffered injuries due to the Twinrix Vaccine). The outcome of the injury was not reported.   The reporter considered the injury to be related to Twinrix and hepatitis A and hepatitis B vaccine pre-filled syringe device.     The company considered the injury to be related to Twinrix and hepatitis A and hepatitis B vaccine 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 Information: GSK receipt date: 25-SEP-2023  The patient self-reported this case. The patient who was alleging that she suffered injuries due to the Twinrix vaccine administered at pharmacy location.  Through their initial investigation, they have determined the above-referenced that GlaxoSmithKline manufactured the Twinrix vaccine that administered to the patient, resulting in side-effects for the patient.  The follow-up could not be possible as no contact details were available.
This is a spontaneous report from a non-contactable consumer. This consumer reported that a male patient of an unspecified age and ethnicity received PREVNAR, intramuscularly on 10Dec2012. The patient's medical history and concomitant medications were not reported. The patient's left arm hurt for approximately 1 week after receiving the PREVNAR 7 immunization in his left shoulder. Therapeutic measures, if any, taken in response to the vaccination site pain were unknown. The clinical outcome of the event, vaccination site pain was unknown. No follow up attempts possible. No further information expected.
Severe itching in my face. Makes it so I can?t sleep. Feels line sonething crawling under my skin as well. I never have seasonal allergies or any other condition that causes itching.
I received the shot on the 1st of April and on the 6 th of April out of the blue not under any stress I had a heart flutter . It lasted a couple of seconds around 2:25 pm. The rest of the day heart palpitations off and on . I did end up going to the Hospital around 6:30 pm to find out what was going on . Test were done and I was released at 1:00 am Wednesday
chills; headache; This is a spontaneous report from a non-contactable consumer from a Pfizer-sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and headache on an unspecified date. The outcome for the events were unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
This case was reported by a consumer and described the occurrence of joint pain in a 62-year-old female patient who received SHINGRIX (batch number JC92P, expiry date 22nd November 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of cough (For the tolerability of 1st dose, refer case US2018GSK167643 reported for same patient). On 15th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 15th August 2018, less than a day after receiving SHINGRIX, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was recovering/resolving. The reporter considered the joint pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced joint pain. It was unclear that if the patient experienced cough, fever, general body pain, muscle pain, headache, lethargy, cold sores lip and palpitation after 2nd dose of SHINGRIX as well hence only 1st dose of SHINGRIX is considered as an suspect for this events.
a patient received Hib component of the Pentacel vaccine was reconstituted with the same diluent they use for the MMR vaccine/ No AE; Initial information received on 03-Aug-2020 regarding an unsolicited valid non-serious case from a nurse manager.  This case involves a six-month-old male patient who was vaccinated with hib component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine (Lot number on the Pentacel carton was UJ227AAA expiration date: 23-Apr-2021. Lot number on the powder component of the vaccine is UJ227AA expiration date: 23-Apr-2021. Lot number on the liquid component of the Pentacel vaccine was UJ314AA, expiration date: 23-Apr-2021) that was reconstituted with the same diluent they use for the MMR (mumps, measles and rubella) vaccine and the liquid component of the pentacel vaccine was not administered to the patient, vaccination was indicated for prophylactic vaccination on 30-Jul-2020.   Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX-B) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination on 30-Jul-2020.  It was a case of an actual medication error case due to wrong solution used in drug reconstitution (PT: product preparation issue).  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Myositis of left triceps beginning on 11/8 ~ 11 days after vaccine given.  Appears to be a delayed hypersensitivity reaction
Events:  Mild body aches, stuffy/runny nose, mild fever,  heavy fatigue, light cough, irritated throat, sore right arm, mild swelling of upper right arm, cold sweats.  Treatment:  2 maximum strength Tylenol every 12 hours (for 48 hours), 1 Sudafed every 12 hours (for 48 hours), lots of water/hydration, mostly bed rest for first 24 hours starting 8 hours after vaccination (booster) Outcome:  2.5 days later, still have a subtle cough & stuffy nose, but it?s getting better.
Increase tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Increase tinnitus) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced TINNITUS (Increase tinnitus). At the time of the report, TINNITUS (Increase tinnitus) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Saturday, 04/03/2021: the day after shot; low grade fever (99.6°F - 100.6°F).  Headache as well. Took Tylenol (500g) to relieve symptoms. Sunday, 04/04/2021: two days after shot; had sinus headache that went away by noon (had runny nose; blew nose and sinus headache went away). Noticed swollen arm at injection area (bicep area); it?s sore and feels hard. Also, there?s a pink patch around the shot area (about 3/4? x 1.5? in size).  Monday, 04/05/2021: 3 days after shot; Swollen arm and pink patch still present.  Overall, arm was sore but gradually lessened in pain as the days go by; still sore but not that prevalent. Pain/soreness is felt when lifting arm or pressed on.
Day of vaccine: extreme muscle weakness and tenderness at injection site 24 hours later: chills, fever of 100 degrees, body aches, extreme fatigue 48 hours later: low grade fever, normal menstruation turned into extremely painful menstruation, swollen lymph nodes, sweating like breaking a fever
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 29-JAN-2019, the patient was vaccinated with improperly stored PEDVAXHIB (1 injection, via intramuscular, lot # reported as: R0123571, expiration date reported as: 19-MAR-2021; strength and anatomical location were not reported) for prophylaxis. No adverse effect was reported. The PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006925: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950.
Janssen Covid-19 vaccine EUA. Approximately 10 hours after the dose I started developing severe chills and sweating. I checked my Temperature and it was 99.7 Degrees F. this has continued all last night and through today up to the time of submission of this report.
Swollen upper left arm, hot with vesicles at site of shot. No systemic problems.
Because of the covid situation they didn't received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 29-APR-2022 Reporter's Comments: The pharmacist reported that employees of the facility were late for the second dose of Shingrix, because of the COVID situation they did not receive the second dose of Shingrix.  No information provided because this happened 2 years ago. No adverse event was reported.  The reporter did not know how many employees were missing the second dose. No patient's identifiers provided. No LOT number and expiration date provided and no vaccination date provided. The reporter consented to follow up.  Additional Supportive Information: The pharmacist reported that employees of the facility were late for the second dose of Shingrix, because of the COVID situation they did not receive the second dose of Shingrix, which led to social problem. The Vaccine Administration Facility is the same as primary reporter. VAERS details were reported for the 1st dose of Shingrix.
Swollen, painful, red rash on 3 separate sites on arm. Rash on leg & feet.