chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client observed kneeling by chair as diaphoretic. immediately post vaccine.   I asked client if he would lie down  to be assessed.  Client fainted and fell to the floor and hit the back of his head  on the floor.   Called code team with immediate assistance.  Supported head and neck.  Vital signs consistent  with fainting episode  and stabilized within fifteen minutes.  Transferred by EMS to hospital for evaluation of head injury.   Initial assessment showed no immediate neurological deficits and no  superficial  bleeding at head impact location.
had an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on 26Aug2021 (age at vaccination: 56-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After first vaccination on 26Aug2021, immediately the patient had experienced an allergic reaction due to which she was admitted to emergency room. The outcome of the event was unknown.   The Lot number for BNT162b2 was not provided and will be requested during follow up.
Information has been received from an RN concerning a 51 year old male pt "construction worker" who on 10/5/01 was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot 637094/0945K). Two to three days, post vax, the pt called the physician's office because his arm was so sore that he could not work. The nurse reported that the physician recommended that the pt use ibuprofen and ice and that if the arm did not improve, he should come into the office for a visit. It was also reported that the pt developed an "unduly" injection site reaction described as very severe redness, swelling and hard lumps around the injection site. It was noted that these reactions persisted for several weeks. It was also reported that the lumps took several weeks to resolve. The nurse reported that the pt never came into the office and has since recovered. The nurse and a physician reported feeling strongly that the vial was "contaminated". There were no cracks in the vial, the flip-off cap was intact upon the 1st use and the liquid remaining in the vial was clear. The office reported only using 3 doses from this 5 dose vial. The reporter noted that they sent a sample for testing. The records of testing prior to release of this lot have been checked by GMP Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that 2 other pt's were vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent from this same lot (lot 637094/0945K) and experienced similar events (WAES 01113124 and WAES 01113399). No further information is available.
Severe Headache (Migraine) lasting more than 4 days, Body Soreness to injection site area lasting more than 4 days, Fever of 101.3 for more than 8 hours, Large Knot at injection site lasting more than 4 days, Soreness and tenderness to arm after 4 days, Groggy and Cloudy head feeling, nausea with loss of appetite.
Itching, redness and inflammation of right upper around injection site began on day 8. Itching subsided after about 36 hours and inflammation slowly decreased until gone on day 12 after injection.
Awoke 5:30 am 12/30/20  c/o felt like I was freezing. Has had fever up to 101.5
A serious spontaneous report of Bell's Palsy has been received from a Registered Nurse concerning a 52-year-old female subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 05-Oct-2008, the patient received FLUMIST. On 05-Nov-2008, the patient started to experience tingling and numbness. Subsequently, the symptoms became more prominent and a neurologist diagnosed her with BELL's Palsy. The event was ongoing. The sponsor considered the event of BELL's Palsy to be serious (important medical event).
1 of 2 pts vax from the same vial who exp a fever following vax; pt devel a fever of 104.7; no other sx; rx APAP & cool bath; pt recovered;
Warmth at injection site; Swelling at injection site; Discomfort at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOMFORT (Discomfort at injection site), INJECTION SITE WARMTH (Warmth at injection site) and INJECTION SITE SWELLING (Swelling at injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METFORMIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE DISCOMFORT (Discomfort at injection site) and INJECTION SITE SWELLING (Swelling at injection site). On 22-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warmth at injection site). At the time of the report, INJECTION SITE DISCOMFORT (Discomfort at injection site), INJECTION SITE WARMTH (Warmth at injection site) and INJECTION SITE SWELLING (Swelling at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.
Child spiked fever to 105.0 at home, brought into ER for evaluation. Treatment was supportive and Tylenol.
Four hrs. after getting the vaccine.  My face started itching, could feel welts under the skin.  Swelling of the right side of my face started within a few hours later.  Called Drs. , He recommended taking Tylenol.  (Second Day) Next day, felt short of breath, weak, applied ice packs to my face. Third day, felt weak.  By the fourth day, swelling and itching subsided; but skin on my face felt gritty under the skin. Drove me to the doctor's office the third day.  I was short of breath walking from the car to the door to the doctor's office.  I was wearing my mask.  I saw a PA; but, she didn't tell me much of anything.  I don't think she knew what to say.
4 inch circumference area of raised skin with 2 inches of redness, can't raise elbow more than 45 degrees, painful to the touch
pt started running fever next day 104.3 for next 3 days very lethargic-no appetite;was seen by MD on Saturday (10th) pt had a rash & diarrhea;CBC & stool tests were done but all nl;MD could find nothing wrong w/child;
Vaccine given too early. patient had no side affects from being given too early. First dose of Moderna  given 04/13/2021. Second dose 04/29/2021.
1wk post vax gen varicella-like rash to entire body-approx # of lesion 50-70;med given, calamine lotion, oatmeal baths;DPH given;
Since getting the second dose, I have developed tinnitus, brain  fog /difficulty focusing and fatigue.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm, sickness, shooting pain, erythema of extremities and itchy upper limbs. On an unknown date, the outcome of the swelling arm, sickness, shooting pain, erythema of extremities and itchy upper limbs were unknown. It was unknown if the reporter considered the swelling arm, sickness, shooting pain, erythema of extremities and itchy upper limbs to be related to SHINGRIX. Additional details was reported as follows: From the date of reporting, last Saturday the patient received vaccine and had a reaction to the shot on her arm where it was swollen and red and very itchy. The patient was in bed all the day Sunday after the vaccination on Saturday sick with shooting pains clear through to her feet. The patient inquired as to how long the swelling and redness of arm will last longer. The patient was referred to her health care professional (HCP) before the call ended. It was unknown if the reporter gave permission to contact. No further details were provided or able to be clarified beyond what was documented above. The reporter declined to answer any form questions.
The pt experienced pain at the injection site, starting 30 minutes, post vax. Pain has lasted nearly 2 months. Pain is not continuous. Pt has no other symptoms. Pt stated she had pain after dose #2 on 7/25/01, lasting approx. 2 1/2 months. Vaccine administrator was not aware until after injection was given.
63 year old vaccinated female was admitted for Covid-19 pneumonia and treated with Remdesivir. She also reveived empiric antibiotic. She will be discharged home today in stable condition.
From what I recollect, I was super tired, lethargic and unable to get out of bed for a couple of days. I did not seek any medical help, I just rested.
pt recv vax;devel mild,fine,itchy rash on extremities & then on posterior and anterior areas of trunk;approx 1 1/2 wk later,to MD who stated rash looked like  a faint prickly heat;
pain at injection site started within 24 hours; Chills; sore throat; This is a spontaneous report from a contactable consumer (Patient, Self-reported). A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: and expiry date was not provided), first dose via an unspecified route of administration, in Arm Left, on 17Feb2021, 01:45 PM as a single dose for COVID-19 immunisation at Workplace clinic. Patient medical history included like elevated cholesterol, blood Pressure, Generalized Anxiety Disorder (GAD). No allergies reported. Concomitant medications were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that patient had experienced pain at injection site(within 24 hours), Chills(within 24 hours), Sore throat(within 24 hours) on 18Feb2021, 08:00 AM. The events are subsided within the next 24 hours. No treatment received for the events. Outcome of the events were recovered on an unspecified Feb2021.  Information about lot/ batch number has been requested.
Started with soarness in the injection arm becoming pain in mid back by that night which got progressively worse causing difficulty breathing and/or laughing.By Sunday bedridden painful to move/breath went to hospital that night. Still feeling pain today.
Hives in different part of body/hives in back area which crawl back to chin area; Itchy in armpit; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives in different part of body/hives in back area which crawl back to chin area) and PRURITUS (Itchy in armpit) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives in different part of body/hives in back area which crawl back to chin area) and PRURITUS (Itchy in armpit). At the time of the report, URTICARIA (Hives in different part of body/hives in back area which crawl back to chin area) and PRURITUS (Itchy in armpit) had not resolved.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-439650 (Patient Link).
Information was received on 23-OCT-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported) subcutaneous on or about 01-JAN-2014, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-NOV-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Rash on arm; This is a spontaneous report from a contactable consumer (patient). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the left arm, on 03Feb2021 11:30 (also reported as 02Mar2021 11:30, pending clarification) (Batch/lot number: EN6198), at age 17 years old, as dose 1, single, for COVID-19 immunisation, at a clinic. Relevant medical history included hypertrophic cardiomyopathy from an unknown date, not reported if ongoing or not. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included atenolol and an unspecified vitamin both taken for unknown indications, start and stop dates were not reported. The patient did not receive any other vaccines in four weeks. On 03Feb2021 (also reported as 03Feb2021 03:30 and 02Mar2021 03:30, pending clarification), the patient had rash on arm which resulted to physician's office visit. It was unknown if the patient received treatment for the event. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Inflammation, redness and tenderness to left shoulder area measuring 5cm by 5cm. Pt treated oral Antibiotics.
I had Vertigo. Every time I would turn my head, it felt like my head was spinning. I went to visit the ENT and they repositioned the crystals in my ears. It took about a month to start feeling a little better.
vaccine administered, patient left immunization room and was asked if she had any signs or symtoms related to vaccine replied "No" steped into hallway with family and started to feel faint. Patient was taken back to room elvated feet, Bp taken, given Juice and Crackers, patient facial skin was pale and sweating. She was not released to go home until all symptoms subsided and able to walk with out assistance.
My arm pain at injection site was worse than any other vaccine & lasted several days. I did not have any other side effects while at the health facility that administered the vaccine other than being a bit lightheaded. Within a week or two, I started feeling toxic - as if something was attacking my entire body. I started having increased joint/muscle pain & inflammation that is ongoing. I developed high blood pressure, which I have never had. I don't want to blame anything on the vaccine, but these are the symptoms that developed after the bivalent shot. I thought I was having a heart attack one weekend and had to seek help from my primary provider (I brought my log of blood pressure readings). I also sought help at the end of October with my Rheumatologist regarding all of my pain.
Vaccine given halfway down her arm; she has a large red mark around the vaccine site; A spontaneous report was received from a consumer concerning a 72-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history, as provided by the reporter, included autoimmune condition (Polymyalgia Rheumatica) and a pulmonary condition (Pulmonary Fibrosis). Concomitant medication included prednisone.   On 31 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 039K2CA) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 010A21A) subcutaneously for prophylaxis of COVID-19 infection.   On an unspecified day in Mar-2021, after receiving the second dose  the patient noticed a large red mark around the vaccine site and she believe the vaccine was given halfway down her arm. There was no treatment information provided.  Action taken with mRNA-1273 in response to the events is not applicable.  The outcome of the event vaccination site erythema was unknown.  .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Day of: fatigue 2 hours after  Day 2: fatigue, headache, chest pain/burning in left side  Day 3: fatigue, continued chest pain  Day 7: chest pain subsides
pain in arm from point of injection and shooting up the arm-shoulder-collarbone-neck to my ear, which continued for periodically throughout the day mostly from the collarbone  up my neck to my ear until May 2021 at which time just dull pains and sometimes sharp pains
Rash and fussy 20 days after administration of vaccines. Rash on face, chest, back and arms. Erythematous macular/papular rash with areas where pinpoints and areas of consolidation esp on trunk. No vesicles.
rash on his arms; kinda itchy; little red rash in his elbow; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored Program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced rash on his arms, little red rash in his elbow and kind of itchy on an unspecified date. The outcome of the events was unknown.    Follow-up (23Mar2021/24Mar2021): new information received from same contactable consumer includes: New event details (little red rash in his elbow and kind of itchy).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My wife had tested positive for COVID-19 on 18DEC2022. On the evening of 21DEC2022 I experienced a runny nose and started to feel a sickly tiredness, I did two COVID-19 test and both were positive. I called urgent care the morning of 22DEC2022 and I asked for PAXLOVID and received it and started it that evening. The symptoms then were chills, a light cough, congestion and body aches, I had no sore throat or shortness of breath I did have a fever of 99.7 never above 100 and my pulse OX was never below 94, no loss of taste. I received the lower dosage of PAXLOVID due to potential early kidney disease. I had three nights of intense nasal congestion. I tested negative on 28DEC2022.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult female patient who received SHINGRIX for prophylaxis. On 25th July 2018 15:00, the patient received SHINGRIX. On 25th July 2018 21:00, 6 hrs after receiving SHINGRIX, the patient experienced muscle pain, joint pain, chills and fever. On an unknown date, the outcome of the muscle pain, joint pain, chills and fever were unknown. It was unknown if the reporter considered the muscle pain, joint pain, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 9:00 pm in the evening, the patient started to experience muscle and joint pain around along with fever and chills. The patient's body temperature was registered at 102 degrees. The patient did not wish to provide additional information.
suspected vaccination failure; shingles; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. The patient paid 150 dollars for the Shingles vaccine. After receiving Shingles vaccine, the patient got shingles. The patient stated that, it was very very painful. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Mother called and said her daughter stated that at 12 AM, she was not feeling well. Then at 3 AM, with a temp. 100 and was throwing up. At 5 AM, she had a severe HA and stopped throwing up. This morning, 845 am, temp was 101. Mother was waiting for doctors office to open this am to call him,  She is also waiting for someone to bring her some Tylenol for her daughter. Client also c/o back hurting, Left arm being very sore. and warm to touch at injection site.
Pt recvd vax & exp flu-like sx; No further details are available; This case is considered to be invalid;
Forty minutes after vaccination, stayed there for 20 minutes. heart racing for about five minutes. Went home, tiredness, weakness, arm pain up into shoulder blade and neck. The next day still tired. Today the injections site is hot, red and swollen.
Received only the liquid adjuvant portion of Shingrix; Received only the liquid adjuvant portion of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient might had received only the liquid adjuvant portion of the Shingrix vaccine without it being reconstituted with the powder component. The reporter stated that this could had been 1 or 2 doses of adjuvant only for these patients, the reporter was unsure at this time, the review of the medical records to confirm was pending. The reporter did not had the dates of administration, lot number, expiration date and any patient information at the time of the reporting. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information:  The reporter gave by error Shingrix adjuvant diluent portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR159620:same report, other patient US-GSK-US2022159157:same report, other patient
Discomfort, pain, and dime size discolor at injection site. Soreness has not improved and getting worse.