chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nearly killed me; severe nerve damage; had two shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included RSV (On an unknown, received first dose).   On an unknown date, the patient received the 2nd dose of RSV vaccine and the 1st dose of RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine and RSV vaccine, the patient experienced near death experience (Verbatim: nearly killed me) (serious criteria GSK medically significant and life threatening), nerve damage (Verbatim: severe nerve damage) and extra dose administered (Verbatim: had two shots). The outcome of the near death experience was not reported and the outcome of the nerve damage was not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the near death experience and nerve damage to be related to RSV vaccine and RSV vaccine.   It was unknown if the company considered the near death experience and nerve damage to be related to RSV vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 10-SEP-2023 This case was reported by a patient via interactive digital media. The patient had two shots and it nearly killed him/her. The patient was still suffering with severe nerve damage and had gone into debt to pay for his/her recovery, but the shot was free. The patient received the second dose of RSV vaccine, which led to extra dose administered.
This case was reported by a healthcare professional and described the occurrence of swollen eyes in a 18-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concomitant medications and no relevant medical history. The subject had not experienced adverse events following previous vaccinations. Concurrent medications included TB skin test. On 6 August 2009 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown route, right arm). On 6 August 2009, 5 minutes after vaccination with BOOSTRIX, the subject experienced swollen eyes. At the time of reporting the event was resolved.
One hour after immunization given, low grade temperature, eyes, face became swollen.  Symptoms subsided by next day.  Refused treatment.
extreme under arm swelling; moderate pain; Second dose : 23 Feb 2021 and Booster dose : 23 Aug 2021; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (extreme under arm swelling), PAIN (moderate pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose : 23 Feb 2021 and Booster dose : 23 Aug 2021) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 037K20A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced SWELLING (extreme under arm swelling), PAIN (moderate pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose : 23 Feb 2021 and Booster dose : 23 Aug 2021). On 23-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose : 23 Feb 2021 and Booster dose : 23 Aug 2021) had resolved. At the time of the report, SWELLING (extreme under arm swelling) and PAIN (moderate pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient uses ice pack to relieve pain.
Fever of 102.6 p/2 doses of APAP; Unable to use arm- pain, hot, red size of baseball, blistery looking; Seen by MD 2JUL;
Vomiting & chills. 4 hours continuous, very intense vomiting from 2am to 6am.  Chills lasted 24 hours.
pt devel an elevated SGPT level following the 2nd dose of Hep B; pt was refused as a blood donor to the Red cross; No further details were provided;
About a minute after the vaccinations were given her whole body broke out in a urticarial rash.
10/16/2022 08:50 pm: Sudden throat tightness, dizziness, lightheadedness, followed by fainting briefly. Nausea, dizziness and lightheadedness lasted for a couple hours after. 10/17/2022 09:15 am: Dizziness and lightheadedness, worsening until I could not stand or sit up around 9:30 am. High heart rate and blood pressure, subsided by 10:00 am. Continued dizziness, lightheadedness, nausea, headaches, joint aches, and chills on and off throughout the rest of the day.
12/14/21  Left arm pain, with immediate onset after injection of Covid vaccine, and has evidence for nerve injury or compression by the vaccine.  Discussed the possibility of pursuing an EMG to further elucidate, but he declines.  Symptoms are improving over time.   12/23/21   Left-sided radiculopathy pain and numbness thought possibly to be early zoster at last office visit, but never manifested rash.  Question now of T4-T5 radiculopathy.  Not worsening over time, but not getting better. Reviewed his literature citation of concern, and given lack of evidence of zoster, and also very rare case reports of zoster after Covid vaccine as an indicator of inflammatory arthritis, overall risks for this appeared to be very low. He is okay monitoring the left-sided dermatomal pain and potentially pursue physical therapy if persistent.  EMG discussed, but declined given the painful nature of the procedure.
Fever (102), Shaking Chills, Headache, Body Aches, Anorexia, Fatigue, Feeling like I was hit by a MAC truck. Lasted for approximately 21 hours. Arm soreness started at same time as above and has persisted from time of injection until now. Redness and swelling started on 12/22 and is still present today.
0935 - Vaccination time 1003 - Arrived to medical response area reporting itchiness, visible hives/redness/rash to right arm and abdomen, and diaphoretic.  Benadryl 50MG PO given. 1003 - BP 170/106, HR 98, RR 20, SpO2 96% 1007 - BP 155/83, SpO2 98% 1012 - BP 130/73, HR 78, RR 16, SpO2 95% 1019 - BP 151/82, HR 91, RR 16, SpO2 94% 1028 - BP 140/78, HR 88, HR 16, Sp02 94% 1043 - Abdominal and right arm rashes almost totally resolved. No more itching. Still diaphoretic. D/ced home w/ husband to provide transport.  Advised by to discharge with post-Benadryl instructions, husband to provide transportation, and the following:  "Please follow-up with your PCP before your second vaccine dose. You might need to follow up with an allergist prior to receiving your second vaccination."
Itching around RUE under shoulder with mild rash and fatigue. Flu like symptoms w/o sore throat.
The Pfizer COVID-19 vaccine was diluted incorrectly: 0.8mL of diluent was used instead of the 1.8mL that is required. The patient still received a 0.3mL volume dose however that dose was more concentrated due to the incorrect dilution. The patient was made aware of this incident and was not experiencing any adverse side effects from the vaccine when contacted.
I have had radiating pain from my hip to knee causing throbbed pain and instability in my right leg since an hour after my vaccine
Bexsero given instead of Menveo; indicated of age group but given out of recommended time frame
This non-serious medically confirmed spontaneous report (initial receipt 30-SEP-2014) concerns a 53-year-old male patient. On 30-SEP-2014, the patient received AFLURIA (batch number T50507) less than 0.5 ml once intramuscularly. AFLURIA had been stored correctly,. On 30-SEP-2014, during the vaccination, the plunger was depressed completely as the vaccine entered into the patient's arm. After removing the syringe from the patient's arm, the reporter noticed that there was still vaccine in the syringe despite the plunger was depressed completely. The plunger of the pre-filled syringe could not be manipulated further to expel the remaining vaccine. This resulted the patient not receiving a full 0.5 ml dose of the vaccine. The patient did not experience any adverse reactions due to administration. Outcome was reported as recovered on 30-SEP-2014. Reporter's comments: The reporter assessed the case as non-serious.
Lightheaded,  dizzy, clammy skin. Immediately after vaccine (Yellow Fever, Influenza). Pt placed in recumbent position and placed cold pack to back of neck. Pt. monitored for additional 20 minutes. Pt. state that she use to faint with shots when she was a young child.
Photo was emailed to director showing a 2.5" area in diameter of redness just below the puncture site which was clear on the picture.  A bandaid residue was also noted around the puncture site.  In the picture it appears the injection was given distal and slightly medial to the deltoid muscle into the biceps brachii muscle.
Headache, fever, felt like I had the flue, swollen and red circle around injection site, and very painful, joints all over painful, weakness, no appetite, stayed in bed for 4 days. Did NOT loose taste or smell.
Information has been received from a nurse concerning a 13 month old patient who on 27-APR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot# 670169/1574AA). The nurse mentioned that on 04-JUN-2012 the patient had outbreak of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of several reports from the same source. A lot check has been initiated. This is one of the same reporter link. The F/U information has been received from a physician refers to a 13 months old male patient with a weight 24 lbs and height 30 in, no sibling information reported, no pre-existing allergies, birthday defects and medical conditions were reported. The patient was subcutaneously vaccinated with lot # (670169/1574AA) dose 1 VARIVAX (merck) at right leg on 27-APR-2012. On 04-JUN-2012 the patient "to clinic with a rash described as'across upper back and upper chest are multiple erythematous areas with small clear vesicles, some died lesions are noted on the upper extremities". Diagnosed with Chickenpox, no testing was done, no illness at the time of vaccination. The outcome of patient had outbreaks of varicella was reported as recover/resolved, on 28-Jun-2012 as"no rash noted". Additional information is not expected.
Received 2 shots on 2/18/03 and on 2/25/03. I had a 3" X 3" red, raised, itchy rash form for 4 days. On 3/5/03, I received shot #3 and on 3/5/03, I had a 5" X 3" raised, red, itchy rash formed right below the shot site (about 1/4" below; the rash from the 2nd shot was the same X (1" below shot site). With the 2nd rash, my arm hurt at the rash site (felt like pain down to the bone) and I had numbness down to my hand on 3/8/03 and bump that looked like a mosquito bite formed on the rash. On 3/11/03, the rash and bump went away.
Provider note states positive test on 12/21/22. No positive lab in chart. Currently hospitalized for sepsis and probable pneumonia. Tested again on 1/5/23 for COVID and found positive. Provider unsure why patient re-tested but not felt to have current positive COVID infection.
0950 Patient arrived for Covid-19 vaccine/1st dose. 1013 Covid-19 vaccine was administer to patient. 1024 Patient states "I'm having a hard time swallowing". Medical alert called. Medical alert team arrived at 1026. 1029 BP 165/90, HR 80, SaO2 100%. 1030 Patient was transfer to ED by nurse via wheelchair for further evaluation.
soreness at injection site, swelling, intense itching at site, itching spread all over my body, felt like it was under my skin every where it would spread from place to place, in my eyes etc ...
Information has been received from a 32-year-old female certified medical assistant (C.M.A) who on 02-MAR-2007, while vaccinating a client with a dose of Zostavax, was inadvertantly exposed to a small amount of Zostavax. It was reported that "while aspirating a small amount of the vaccine came out and got on her right hand". There was no concomitant medication. Within 24 hours of the exposure, on approximately 03-MAR-2007, the C.M.A. stated that she developed shingles on her right hip. Medical attention was sought and she was treated with an antiviral. As of 13-MAR-2007, she stated that she was improving and is feeling better; she has no pain and the rash on the right hip is almost gone. The C.M.A. was not interested in the VZV Identification program. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The reporter stated that, on an unspecified date, and unknown number of doses of LIQUID PEDVAXHIB (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported. Follow up information has been received on 22-JUL-2014 from a receptionist. The reporter stated there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share with Merck. Follow-up information from the registered nurse who provided patients details. This report refers to a 6 month old infant patient of unknown gender. On 25-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported, lot# J014512, expiration date 12-AUG-2016) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected.
37 minutes after getting the Flu Vaccine in the (L) deltoid, I began to get hives on the (L) arm, (L) rib region, (L) side of face and (L) thigh. My lips became tingly and itching to head & ears. (L) ear was red & warmth to the touch. I took oral Benadryl, used my inhaler (proair) took singulair and followed up with Dr. (allergist) prescribed prednisone.
Severe pain on left side of torso and neck.  Inability to turn neck to the left or lift left arm.
Hives, itching - began approximately 1 1/2 hrs after vaccine given. BENADRYL given and sent to pediatrician.
She thinks she passed out / dizzy, lightheaded, sweaty when she attempted to get up to go to the bathroom on 9/9 in the early morning, woke up on the bathroom floor, no injury.   Dizziness.
This case is 1 of a cluster of 2 patients who experienced similar adverse events following vaccination with H1N1. The event for the second patient was captured in case number 2010-02464. Initial report received from a consumer on 26 April 2010. A 41-year-old male patient, with a medical history of a sulfonamide allergy, had received a left arm injection of H1N1 on 10 April 2010 and 2 days later, he developed a fever, phlegm, ear infection, and sore throat which persisted at the time of the report. The patient stated that he had a sore arm and was not able to lift the arm. He also complained of swollen arm joints. The patient's concomitant medications included XANAX and "merrinol". The events were reported as not recovered. Follow-up information received from a health care professional on 24 May 2010 clarified that according to the immunization program records the patient received an intramuscular H1N1, lot number UP100AA, on 30 March 2010 (previously reported by the consumer as 10 April 2010). The patient's facts were inconsistent with the truth and he had no illness at the time of vaccination. The patient did not have any cultures taken during his emergency room visit to positively diagnose his illness. The patient's information of being unable to lift his arm was inconsistent with the recent fishing stories he told while having his prescriptions filled. The patient concomitant medications included XANAX, MARINOL, OXYCONTIN, and LYRICA. Documents held by sender none.
Injection site pain Tiredness Headache Muscle Pain Chills Nausea Vomiting Feeling unwell
8:50am Swelling of face, eyes, tongue, lips. 9:00 tingling in lips and tongue.. 9:05 numbness in lips and tongue. Then difficulty swallowing. Benadryl 9:05am 11:00am Benadryl. Epipen on standby. Numbness in top lip and slight swelling lasted until 4/10/2021 around 2:00pm
Pt expressed sweating and dizziness a couple minutes after receiving the flu vaccine. An MA got a BP of 94/56. An NP helped assess the pt and advised it could be a possible vasovagal reaction. Pt reported that she had never had an adverse reaction to the flu and that she hadn't eaten anything this morning. Pt reported that she usually does eat in the morning. Pt reported this reaction happening only once before when she got her blood drawn. RN got water and crackers for pt, took vitals, and took blood glucose. Blood glucose was 71 and BP went back up 110/76 after 15 minutes. Pt still felt dizzy and RN encouraged pt to stay seated and eat more crackers and drink more water. RN retook vitals again after 15 minutes and BP was 109/80. Pt reported feeling better and was able to stand and walk. Pt was given ER precautions that if she began to feel dizzy, faint, or sweating profusely again to call 911 and go to the emergency room.
immeidate metalic taste, emotional feeling,pain in right side of neck, right arm, clamy, nausea.After 40 minutes feeling headache, extremem fatigue, strange feeling in my neck, abit of a burning sensation there, stiffness in my jaw, burning eye.  I feel not at all right.
GBS peak in approx 19 days:fatigue, foot numbness, diff breathing,  numbness-waist down, needs walking cane, food/drink w/ unusual taste, no reflexes, unable to eat solids, speech slurred, can't close eyelids, rapid HR, unable to feed self Per HCP follow up report-This patient had not been in over 1 year. Her phone has been disconnected. I have sent a letter to patient still waiting for response.
Arm felt itchy, painful and warm. Red at injection site. Pt react to the PNEUMOVAX vaccine.
bad knees; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (bad knees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (bad knees). At the time of the report, ARTHRALGIA (bad knees) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Reporter did not allow further contact
FEELING UNWELL; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced feeling unwell. On 2021, the subject experienced nausea. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, headache and feeling unwell was not reported. This report was non-serious.
Felt minor pain in arm at first, but it went away. Felt fine for at least two weeks. It's nearly time for my 2nd shot (coming up this Saturday) and for the past two or three days, my arm has been hurting at the injection site.  Pain was getting severe so I stretched (followed a 5 minute routine from a video), and now it is _very_ painful. Seems to have made it worse. I did the same routine in my other arm, but it feels fine.  The pain is very weird - I have no idea what muscle has the problem. I can lift my left arm above my head without any pain, and I can point it straight in front of me without any pain. I can carry something quite heavy without any pain at all. However, if I lean forward, there is some of the worst pain I have ever felt in my life at my upper forearm where I think I was injected. It has gotten worse the past day, and woke me up from sleep. It's uncomfortable / nearly impossible for me to lean over to pick something up, even from a table.  I have no bruises nor lumps or bumps from the vaccine though. Honestly I'm really not sure if this is from the vaccine or from something else, but I have not lifted anything heavy (except grocery bags, yesterday), and have not stressed my arm in any weird way that the other arm hasn't been stressed (from stretching).  Am not sure if I should get the second shot at this point; am considering seeing my doctor, but so far have not contacted him about this. I'm hoping it just goes away on its own.  Must stress that the pain I feel when leaning forward is some of the most intense pain I have ever felt - and I have had both eardrums rupture at once and passed out before. Must also again say that I still am not sure this is from the vaccine and it confuses me if it is because it has been 3 weeks (almost 4?) now since the 1st injection.
Nausea  Vomiting  Diarrhea  Headache Chills Rash, Pain, Swelling, Redness at site area
dural venous sinus thrombosis involving the mid and posterior aspects of the superior asagittal sinus, extending into the transverse and sigmoid sinuses.  The dural venous sinus thrombosis extends into the upper 1/3 of the jugular vein on the left and to the jugular bulb on the right.  She also has subarachnoid hemorrhage in the left inferior temporal lobe and bilateral occipital lobes.  The event that led to hospitalization and finding the thrombosis was a syncopal  episode on 7/7/21
The symptoms started 2am that same day. I woke with a headache and muscle pain starting at my waist and encompassing my lower extremities.  This has continues since the shot and has now migrated up both flanks to just below my Armpits.  I have also been experiencing on and of left chest pain with nothing seeming to cause it, such as activity, and nothing makes it better or worse. Its not reproducible and doesn't radiate anywhere else. Without Nsaid and muscle relaxers I get woken up several times a night from muscle  pain and unable to work as a nurse without them.  Pain is constant at an 8/10 without previously mentioned meds
Pain, redness, swelling, itching  in Left arm 06/06-06/12/2019 06/07/2019- general malaise 06/08 thru 06/10/2019 stomach pain, severe nausea, diarrhea, shivering, muscle aches, weak. 06/11/2019 thru 06/12/2019- malaise,