chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fuzzy head; Hives; Rash; Throat swelling; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 05Oct2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously took codeine (MANUFACTURER UNKNOWN), hydrocodone bitartrate/paracetamol (VICODIN) and doxycycline (MANUFACTURER UNKNOWN); all for unknown indications and experienced drug allergy. On 05Oct2021, the patient immediately had fuzzy head, hives, rash, throat swelling, thereafter fatigue and nausea. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of reported events and included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fuzzy head, hives, rash, throat swelling, fatigue and nausea was resolved on an unknown date in Oct2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient became pale and light-headed 3 minutes after vaccination; she sat down and rested about 5 minutes and then went to eat something and was okay.
Patient reports that vaccinator may or may not have received a full dose of 0.3 ml. Per patient, he saw a small amount of vaccine left on the syringe after it has been administered. Patient denies any symptoms.
This case was reported by a consumer via out of hour services and described the occurrence of swelling arm in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. On 13th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th August 2018, 2 hrs after receiving SHINGRIX, the patient experienced swelling arm, pain in arm, erythema of extremities and tenderness. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown and the outcome of the pain in arm was recovering/resolving and the outcome of the tenderness was not recovered/not resolved. It was unknown if the reporter considered the swelling arm, pain in arm, erythema of extremities and tenderness to be related to SHINGRIX. Additional deatils were provided as follows: The patient reported that after vaccination left arm swelled significantly and was red and tender to the touch for at least a week afterwards. Gentle touches to her arm were painful and even after 2 weeks out at the reporting time it was hurting when pressed, but it took a firmer touch. The contact details of the physician was provided.
PATIENT WAS GIVEN A VACCINE WHICH THE MODERNA WAS OUT OF TEMP RANGE. ERROR WAS NOT KNOWN TILL AFTER PATIENT LEFT. PATIENT RETURNED IN AN HOUR TO RECEIVE ANOTHER DOSE OF MODERNA WHICH WAS IN THE CORRECT TEMP RANGE. PATIENT DID NOT HAVE ANY ADVERSE REACTIONS.
COLOR OF THE RASH CHANGED SOMETIMES PINK AND SOMETIMES BEET RED TO; LEGS HAD NO FEELING; LEGS STARTING TO GIVE OUT; SUSPECTED CLINICAL VACCINATION FAILURE; NO MENTAL CONTROL; SUSPECTED COVID-19 INFECTION; BODY RASH ON BOTH SIDES/KNEES/HANDS; This spontaneous report received from a patient concerned a 60year old White, not Hispanic or Latino female. The patient's weight was 200 pounds, and height was not reported. The patient's past medical history included weakness of lower extremities and no mental control, and concurrent conditions included anxiety around 16 years old, schizophrenia around 15 years of age, no-alcohol use, and non-smoker.  The patient had no known allergies. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, 1 total administered to left deltoid on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient started having body rash and it was still present since march. On 15-JUL-2021, the patient experience loss of taste and smell. On 24-JUL-2021, the patient tested positive for covid 19 via nasal swab (suspected covid-19 infection). The incubation period of 28 days has been completed (suspected clinical vaccination failure). The patient then developed a rash on both side of the body on the same exact spot, behind knees and back of hands. The patient stated that it continued to get worse but it doesn't itch and hurt. The patient also stated that the size of body rash varied, some were pinpoint and some were clusters. The color of the rash changed during the day sometimes pink and sometimes beet red. The patient's legs started to give out and had no feeling. The patient also had no mental control. It also happened before the shot and it hasn't happened in couple of months and the patient was not sure whether it was due to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, legs starting to give out, legs had no feeling, and no mental control, had not recovered from body rash on both sides/knees/hands, and color of the rash changed sometimes pink and sometimes beet red to, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000188685.; Sender's Comments: V0: 20210810728-Covid-19 vaccine ad26.cov2.s- Suspected Clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Information has been received from a medical assistant concerning a 17 year old female patient who on an unspecified date was vaccinated with the three doses of GARDASIL (Lot number unspecified). After her first sexual exposure which occurred after she completed the GARDASIL series the patient tested positive for HPV on a PAP smear. At the time of the report the patient had not recovered. The patient sought medical attention by an office visit. Additional information has been requested.
My son took the first dose of the Pfizer Vaccine. About 4 days later contracted Covid; My son took the first dose of the Pfizer Vaccine. About 4 days later contracted Covid; This is a spontaneous report from a non-contactable consumer. A male patient (reporter's son) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown, NDC number: Unknown, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated, "My son took the first dose of the Pfizer vaccine. About 4 days later contracted COVID. My question was should he get his follow up shot, this Friday." The outcome of the events was unknown.    No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
On Monday morning  I had a rash on my left arm then went down to my elbow, by Thursday it has spread to neck, chest, back and stomach
5 MINUTES AFTER INJECTION WHILE IN THE CAR, I FELT HOT, NAUSEUS THEN FOLLOWED A STRONG SURGE OF DIZZINESS. IT HAPPENED TWICE WITHIN 15 MINUTES.  12 HOURS LATER, I WOKE UP WITH HEAVY LEGS AND SLIGHTLY FEVERISH. MILD FATIGUE PERSISTED THROUGHOUT THE DAY EVENTUALLY GOING AWAY AFTER A DAY OF REST.
BURNING SENSATION UNDER ARMPIT; TINGLING OF THE ARM - FELT LIKE SLEEPING ARM WRIST TO HAND; WIGGLING THE NEEDLE WHILE INJECTED IN THE ARM; SNEEZING; PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included lymphoma, socially consumed alcohol, and non smoker. The patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 05:42 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced sneezing. On MAR-2021, the subject experienced pain. On 09-MAR-2021 05:42, the subject experienced wiggling the needle while injected in the arm. On 16-MAR-2021, the subject experienced burning sensation under armpit. On 16-MAR-2021, the subject experienced tingling of the arm - felt like sleeping arm wrist to hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation under armpit, and tingling of the arm - felt like sleeping arm wrist to hand, and the outcome of sneezing, pain and wiggling the needle while injected in the arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Patient received 1st dose of Pfizer COVID vaccine. Upon administration, patient reported she felt as though she was having an anxiety attack. She then fainted and started falling forward in her chair. The pharmacist and technician caught the patient as she fell forward and as they were leaning her back in the chair she began seizing in their arms for approximately 5-10 seconds (no more than 20-30 seconds). At this point, the patient spoke and stated that was weird and said she felt lethargic. Another technician was on the phone with 911 at this time. We gave her a bottle of water and kept the patient seated in the immunization room until EMS arrived. She was complaining of being very hot and lethargic. EMS arrived and checked her vitals and recommended the patient go with them to the hospital due to B/P and pulse being very low (exact vitals were not communicated to us). She agreed to go to the hospital and we will be following up with the patient tomorrow.
pt cried uncontrollably x 16 hr-resolved next AM; no tx x/warm compresses @ inj site;
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 24 years and 8 months old. No concomitant medication information was provided. On 10-Jun-2022, medical was notified about an audit that was done and they were then made aware of vaccines that were administered beyond use date after the thaw process. Patient got Moderna with vaccine Ndc code. Reporter stated that there was no patient that had any adverse reactions and there were no reports of any reactions after the administration of vaccines. No treatment medication were provided.
Heart rate 197 bpm and heart palpitations which subsided as of 12/20/22
Pt C/o arm at injection site being warm to touch, swollen and somewhat painful. Pt seen in office on 12/14/2005 redness almost gone. No further treatment per Dr.
Patient was seated in waiting area post vaccination. communicated to technician he felt dizzy. Pharmacist came to patient's side. Patient slowly went unconscious, folding forward in chair for about 30 seconds. Pharmacist kept patient in chair and called for technician to call 911. patient regained consciousness and pharmacist talked patient down to the ground for safety and rested against wall with head by knees. patient stayed conscious until paramedics arrived. they tested vitals and patient's blood pressure was very low. patient loaded onto a gurney and taken to unknown hospital.
a vaccine was administered while undergoing a temperature excursion; This spontaneous report was received from an office manager (customer) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 31-OCT-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, albumin status recombinant Human albumin (rHA)) (PROQUAD) (0.5 mL, lot # W023868, expiration date: 24-JAN-2024; strength, route and anatomical location was not provided) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions of minus 10 degree Celsius (C) up to 8 C for 35 hours 0 minutes 0 seconds and 9 C to 25 C (21.1 C) for 52 hours 0 minutes 0 (product storage error). The patient had no previous temperature excursion.
Rec'd vaccine - felt sluggish about 1 hour post vaccine, chills. Took a nap, then went to Health Center. Currently being tx for reaction to medication/BP.
Patient stated that her arm got red &  painful the day after she received the shot. Patient received shot on 9/11/20. Dr sent her for Xray on 9/22/20 because she was still having pain
feeling heaviness in his chest; vaccine made him feel tired all the time.; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (feeling heaviness in his chest) and FATIGUE (vaccine made him feel tired all the time.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical information provided.  Concomitant products included CLOPIDOGREL, PANTOPRAZOLE and VITAMIN D3 for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced CHEST DISCOMFORT (feeling heaviness in his chest) and FATIGUE (vaccine made him feel tired all the time.). At the time of the report, CHEST DISCOMFORT (feeling heaviness in his chest) and FATIGUE (vaccine made him feel tired all the time.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: normal (normal) NORMAL.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       breathing test was done on 14-APR-2021 and the results were normal.  No treatment medication provided.  Patient had received second dose on 28Feb2021 and batch no. was 011A21A. Second shot was in left non dominant deltoid.   This case was linked to MOD-2021-293596 (Patient Link).
Right arm the first and second time/she had a sore right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 79-year-old female patient received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EP6955) at the age of 79 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Right arm the first and second time/she had a sore right arm".  Additional information: Anatomical Location of Administration of Pfizer vaccine considered as suspect: right arm the first and second time, and then wanted to remember not to do that again because she had a sore right arm, may have gotten the booster in her left arm as well as the second he was not sure which one she got it in.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201152145 same patient, same event, different dose;
Rash appeared on left leg 09/16/2005 spread to forehead, face, stomach, back, arms, hands, legs, feet 09/17/2005. The rash looks like big goose bumps and most bumps are flesh colored while some are red. Some are in patches and some are spread out. The rash itches. The child has experience no fever, no difficulty breathing, decreased appetite but maintains a normal energy lever. No treatment at this time.
Patient reported the adverse events that she experienced just after the immunization with SHINGRIX were rash, warm area, low grade fever and muscle ache. She mentioned that she was in the bed for couple of days, ADEs resolved after 3 days.
Rash / Urticaria appears 2 days after completion of oral typhoid vaccine. Patient started oral vaccine or at home on 8/1/09.
Per chart, pt received the PNEUMOVAX injection Friday AM, 9/21. He reports that by 1400-1500 that same day, he had the following sx which lasted 3 days: Lightheaded and dizzy, severe H/A, Left arm very painful with limited ROM, injection site red and warm, chills/fever. Denies having throat swelling, difficulty breathing. No tx used, just tried to remain hydrated. Today, 9/24, pt states he can use his arm and all other sx have resolved except as below: Observed his left deltoid is red and warm. Diphenhydramine mg PRN, acetaminophen mg PRN.
No adverse event; Patient received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but later realized that patient already received a previous bivalent booster on Sep-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but later realized that patient already received a previous bivalent booster on Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (bivalent booster) in September 2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5).    On 20-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Jan-2023, the patient experienced EXTRA DOSE ADMINISTERED (Patient received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but later realized that patient already received a previous bivalent booster on Sep-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but later realized that patient already received a previous bivalent booster on Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Patient received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but later realized that patient already received a previous bivalent booster on Sep-2022).    No concomitant product was reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was stated by HCP that 3 patients received 1 COVID-19 Vaccine Bivalent booster on 20-Jan-2023 but then realized that patients already received a previous bivalent booster on Sep-2022.  No treatment information was reported.  This case contains information for the 2nd of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-705945, US-MODERNATX, INC.-MOD-2023-705243 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-705945:Patient 3 US-MODERNATX, INC.-MOD-2023-705243:Patient 1
On the 3rd day after vaccination, the patient developed mild malaise. As the day progressed, there was increasing difficulty moving and talking.  That night the patient began hallucinating,.  Later at night the patient awoke and couldn't move at all.   By the morning, things were better and patient could get out of bed and eat.   Ity sounds like a dopamine reaction which the aptient has previosuly expeicned, however, there was no irregularity in L-dopa dosing.
Patient developed a 1/2 inch wide rash starting at injection site and going down arm about 3 inches. It resembled a scratch or scrape, but patient insists he did not scrape his arm on anything.
Shot administered at 3:50, patient said he felt lightheaded then he laid on floor & complained that he was hot then complained of difficulty breathing. Call 911 & gave EPIPEN shot at 3:55. A few minutes later & he said he was breathing OK & had him lay there for awhile then sat up & EMS arrived. He refused to go to ER.
had little bit sore; This is a spontaneous report from a contactable female consumer via Pfizer-sponsored program. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on unknown date at single dose for covid-19 immunisation. Medical history included high level of potassium. Concomitant medication was not provided. The patient stated that she received her first dose of the Covid-19 vaccine last Tuesday and had little sore and had no other reactions. The patient inquired what ingredients were in the injection as she was concern if there was potassium content in the vaccine. The outcome of event "had little sore" was unknown.  The lot number/expiration date for the vaccine, BNT162B2, was not provided and will be requested during follow up.
PATIENTS STATES THAT SHE INITIALLY HAS HIVES AND PAIN IN THE EAR AND A LUMP ON THE FOREHEAD THAT LATER SPREAD DOWN TO THE  EYEBROW.  SHE ALSO  HAVE A SECOND LUMP BEHIND THE EAR.  SHE WAS TAKEN TO THE HOSPITAL WHERE SHE WAS GIVEN INTRAVENOUS ANTI-HISTAMINE  AND LATER DISCHARGED SAME DAY WITH SOME ANTI HISTAMINE TABLET.