chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 15-FEB-2010, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 23-SEP-2016, the patient was treated by a physician, for a vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
lip tingling; This is a spontaneous report from a non-contactable nurse (patient). This female patient of unspecified age received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date unspecified) on unspecified date as single dose for COVID-19 immunisation.  Medical history included anxiety, heart was pounding, and palms were sweaty long before the shot.   Concomitant medications were not reported. The patient experienced lip tingling on an unspecified date. Tingling lasted moments not even full minute and went away. Patient is asking if lip tingling with no itchiness and no swelling, is considered anything of concern or in someone without any adverse reactions like anaphylaxis. She already talked to her physician/allergist and was told that event was due to anxiety and panic. She wants to get her second dose of the vaccine but the pharmacist at her employer are reluctant to give it.  Outcome of event lip tingling was recovered.   No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
p/2nd vax pt slept more than usual;3 days prior to death slept almost cont on day died, only took 1 bottle all day;830PM woke up from sleep screaming, had sz, turned blue died in amb approx 15min later;
chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, Heart rate: 130 (High) his heart rate to be 130bpm through 6am. and high (High) couldn't get his heart rate below 110 the rest of the day.         No concomitant medication information was mentioned by reporter  The patient had blood work, an EKG and chest xray and results were unknown.  The patient was put on a beta blocker and referred to a cardiologist.  Company comment: 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.; Sender'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.
Became light headed shortly after waking up, continued on and off most of the morning. Felt achy and very tired, slept on and off ost of the day. Not much appetite. Feeling slightly better now (6:45PM) but still achy.
This spontaneous report was received from a Registered Nurse and refers to a 16 month old female patient. The patient's medical history include scabies. Information regarding drug reactions or allergies and concurrent conditions was not reported. There were no concomitant medications. On 10-NOV-2017, the patient during her follow up visit to the clinic was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot # M034189, intramuscular (strength, dose, expiration date and anatomical location were not provided), pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (dose, route of administration, anatomical location, lot number and expiration date were not reported) and PEDIARIX (dose, route of administration, anatomical location, lot number and expiration date were not reported) all three vaccines for prophylaxis. It was reported that the clinic refrigerator had a temperature excursion on 07-NOV2017 and 08-NOV-2017 between 39 and 48 Fahrenheit degrees (°F) and on 10-NOV-2017 was between 39 and 44 °F, for un unknown period of time, reported as "short lived excursions" and it was possibly as a result of a reading from the Digital Data Logger. However no adverse reaction and no complications were reported. Additionally it was reported that this adverse event was previously reported to the state representative on 22-DEC-2017 and to the manufacturer on 04-JAN-2017.
3/20 (Day 8) returned with lymphaderitis, pain with movement of left arm. Mild erythema @ vaccine site, no streaking, lymphadynpathy axillary X 3 days (Day 6, 7,8) unable to sleep or perform work duties two hours pain. Tequin 400 mg 1 po qd #5 given; recheck on 3/22   3/22 Increased erythema surrounding vaccinate site ,no streaking to axillary. Approximately 4" diameter around site. Positve lymphadinepathy Avelox 400 mg 1 po qd  3/25 cellullitis resolved-allergic Rx to Relafen-hives
Mother brought twins a male and a female on Monday, Sept. 14th to get 1 yr. immunizations. Mother had her cards we given her when we gave then prior vaccines. The CDP that was printed didn't match her card. I looked up past encounters to find out when the history was given to us. The information was not provided by the parent when she had come in for immunizations so i was not sure if it was entered by mistake. I tried look up both child and was unable to access them at the time. I did read the note in CDP by agency that history given by the MD office was entered in CDP on 022609 and they needed one year immunizations. (SMC did give an extra set of immunizations on Mar. 13th when only a Hep B was the only vaccine needed). The immunizations I gave with the current information I had lead me to believe the one year immunizations were due then. Later I was able to pull up information on one twin only and found that another clinic had given her 2,4,6 mos. & 1yr immunizations which is what we had done due to not having the history. Before giving any immunizations on 091409 I asked the mother if any other vaccines had been give to them besides the ones on the card the mother said "No". When i asked about the dates recorded from September she said, "They were done that one time" (when she went to clinic).
Fever, nausea, vomiting, pain to injection site (rigth aram) and entire arm. Numbness to entire arm, left neck and left side of face.
Blood clot in vein in right leg, treatment underway is blood thinner eliquis for next 6 months
Pt states coughing starts, fatigue, headache, and flu-symptoms. She for oversea trip a few days after the vaccination so unable to contact primary physician. She states she still cough and taking promethazine/dm to help with coughing.
Arm redness swelling itching Nausea  Vomiting Diarrhea  Fever of >104  Body aches Chills Joint pain
Sore arm; Rash that started on ankles and wrists and the moved to arms and legs in clusters; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash that started on ankles and wrists and the moved to arms and legs in clusters) and PAIN IN EXTREMITY (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CELECOXIB (CELEXA [CELECOXIB]), LEVOTHYROXINE SODIUM (SYNTHROID) and LEVETIRACETAM (KEPPRA) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced RASH (Rash that started on ankles and wrists and the moved to arms and legs in clusters). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, RASH (Rash that started on ankles and wrists and the moved to arms and legs in clusters) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications like Benadryl (Diphenhydramine) was included.
light swelling; redness; bruise; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE SWELLING (light swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (bruise) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE SWELLING (light swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (bruise). On 16-Jan-2021, INJECTION SITE SWELLING (light swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (bruise) had resolved.        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 reported by investigator No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before + after. DOH determine the vaccine to be at risk + advised reporting and Revaccination Child had no ill effects thus far
Headache, Fever, NauseaVomiting, chills and fatigue. nausea started 1/25 and other symptoms progressed the next day Narrative:  missed work
Mom states had projectile vomiting approx 4 hrs after rec vaccines, became somewhat listless, somewhat unresponsive at times. Red splotches on face, neck and abd. Seen in ER. No fever, no resp problems.
pt recv vax OCT97 & 5 to 7 days p/vax pt exp rash w/approx 100 lesions & was seen by NP;pt recovered;
Acute onset neck pain while sleeping began on date reported.  Remained severe for ~5 days.  Since then, waxing and waning pain.  Significant improvement by June 2021 but not resolution.
I received shot approx. 2 pm on July 9th, 2021. I woke up at midnight the following day with severe convulsions and tensing of all muscles of my body. My teeth were badly chattering though I was not cold nor had a fever, and in conjunction with my body being tensed it was very painful. I did not have anyone else with me, and did not feel safe in driving to the emergency room, or I would have. This lasted for 4 hours. All I could do is just lay in bed and have whole body spasms. Since then, I find myself exhausted by normal daily activities that did not tire me before, I have body ache constantly, nor do I sleep as well. I am gaining weight where I had been the same weight for over 10 years and exercise is not effecting that trend though my diet is balanced and healthy. I recently (within the last two weeks) got a tattoo. I had multiple previously before I received the vaccine. However, my reaction to this tattoo was completely out of the ordinary. None of my previous tattoos had swollen, turned red, itched, or had any other adverse effects to my body. However, the one I received after my vaccine did all that. The area I got the tattoo on ballooned and turned red enough to concern me and the only reason I can think of is how the vaccine has changed my body and it's chemistry. I received the vaccine to comply with a job offer, but frankly I don't think it was worth it now.
BECAME PALE, PASSED OUT, ARMS BECAME STIFF AND FLEXED IN A SPASM FOR ABOUT 20- 30 SECONDS. BREATHING WAS HEAVY. AFTER THIS TIME SHE BREATHED NORMALLY, BECAME LIGHT HEADED AND AWARE, AND REMAINED WHITE AS A SHEET. SHE WAS PLACED SUPINE WITH HER FEET ELEVATED WITH A COOL MOIST CLOTH OVER HER FOREHEAD. SHE BECAME MORE AWARE AND COHERENT OVER THE MINUTES AND IN ABOUT 10 MINUTES STARTED TO HAVE SOME COLOR IN HER CHEEKS. SHE REMAINED IN THE ROOM FOR ABOUT 20-30 MINUTES AND THEN WAS ABLE TO WALK OUT WITH NORMAL VITAL SIGNS
Information has been received from an administrator concerning her nephew who on 22-JAN-2010 was vaccinated with a dose of RECOMBIVAX HB (lot# not reported). On 31-JAN-2010 the patient died. At the time of death, in approximately 31-JAN-2010 the patient had a bloody nose. The cause of death was unknown. Additional information has been requested.
The lymph glands in my armpit became swollen and painful. Then on 10/25/2014 about 1:00 PM my arm started tingling, hurting and going numb. It is 10:53 PM now, same day, and the symptoms are just now easing up.
in July2021, I went to the doctor on July2021 and went through the test and it was vertigo and had to exercise
arm red & hot, c/o itching since day of shot; recommended use warm compresses to see MD if no improvement;
Started with headache and dizziness.  Was seen in ER and discharged home.  Headache, dizziness and now Nausea and vomiting.  Eyes tracking to one side continued.  Returned and head CT was read as negative.  Transferred to  Hospital  MRI showed two cerebral infarcts. She remains in ICU.  Her speech and one side of her body was affected.  She is scheduled to be moved to rehab this week.
After vaccination patient felt intense pain in left arm, about an hour so after. Pain continues, limited mobility, seen by Doctor in August, and is currently in physical therapy which begin in September.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) lasted 24-48 hrs.         No treatment and concomitant medications were reported   This case was linked to MOD-2021-113560 (Patient Link).
Red, swollen and itchy arm at vaccination site. It started as pale pink and has gotten darker and bigger. The site is now about ten inches long and  four inches wide at its widest point.
difficulty inhaling on occasion, like trying to breath through a straw. discussed with Pulmonologist who only stated it should go away.
Day of injection patient only had symptom of sore arm, following morning patient woke up at 0330 with chest tightness and increased arm soreness. At 0555 pt woke  to take acetaminophen and ibuprofen for muscle and joint aches pains, while standing at counter patient significant other witnessed patient syncope resulting in head hitting floor. Prior to syncope pt had episode of flush feeling with instance of nausea, does not remember falling. Pt continued to have episodes of dizziness when ambulatory, fever, chills. Pt significant other took her to the emergency department for assessment as bruise of face began to show and headache increased after fall.  Pt had drank adequate fluids and eaten dinner the night before, dehydration was not a factor.
Received a 3rd dose while not being immunocompromised; The 3rd dose was from another company; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received a 3rd dose while not being immunocompromised) and INTERCHANGE OF VACCINE PRODUCTS (The 3rd dose was from another company) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Received a 3rd dose while not being immunocompromised) and INTERCHANGE OF VACCINE PRODUCTS (The 3rd dose was from another company). At the time of the report, OFF LABEL USE (Received a 3rd dose while not being immunocompromised) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (The 3rd dose was from another company) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.  The patient was fully vaccinated and she went to get a 3rd dose. She went to the pharmacy to get a 3rd dose and they did gave her Pfizer. She says that she is not immunocompromised (no cancer treatment, no organ transplant, etc.)
Patient within seconds of administration fainted/small seizure-like which lasted less than 20 seconds. She was able to sit in vaccination chair within 40 seconds of episode. She stated she had ringing in ears. She recovered in less than 20 minutes that I requested she sit and rest. Signs/symptoms appeared to be resolved and she was able to leave on her own power.
Left shoulder pain with handball size rash warm to touch, pain to touch, afebrile, c/o medial left arm shooting pain from armpit to elbow and left fingers 2-5 with tingling, and left arm weakness. Antibiotics through personal MD given. Outcome not yet determined.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter considered EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) to be not applicable.    No Treatment medication was reported. No concomitant medication was reported.   Reporter did not allow further contact
I experienced flu type body aches, chest tightness, low energy, upset stomach and mild fever.
Pt developed wheal around Prevnar site and then developed papular rash all over body. He had no GI or respiratory symptoms.
The patient stated on Thursday 3/8/18, that she had bad muscle pain, weakness, and fatigue that lasted about 2 to 3 weeks after her flu shot. She specifically kept referring to the flu shot and not the other shots for some reason. She has fully recovered. I do not know if there was medical treatment for this.
Rash, hives, and swelling of both tongue and mouth started approximately 3 days after receiving vaccine. Patient admitted at the hospital and now doing better
administered a dose from a vial left out at room temperature "greater than 24 hours"past expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial left out at room temperature "greater than 24 hours"past expiration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial left out at room temperature "greater than 24 hours"past expiration). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial left out at room temperature "greater than 24 hours"past expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The reporter declined being aware if the patient experienced any side effects   Reporter did not allow further contact
Local rxn to rt thigh. Erythema, induration, 10.5 cm x 7 cm.
Two hours after I had Palpitations. My heart rate was elevates for24 hours. The next morning I had a fever and joint pains. I had a doctor appt an hour ago and still had a fever of 100, my highest yesterday was 101.9. I also got tested for Covid and it was negative.
Pt received pneumococcal vaccine, developed reaction, swelling at the site, pain and induration.
59YO female who was admitted to hospital on January 13th with a hgb of 6.9 and elevated indirect bilirubin and LDH consistent with autoimmune hemolytic anemia as Coomb's test was positive for a warm IgG auto-antibody and haptoglobin was undetectable.  Her reticulocyte count was not elevated though she did not have any prodromal viral symptoms. However, she did receive the H1N1 vaccine just about four weeks before the development of the autoimmune hemolytic anemia.  Parvovirus IgM was low.  ANA was negative.  Pt started on steroids and remains on prednisone and dose was slowly tapered off.  She is tolerating therapy well.