chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold; She now has a larger red area around the injection site but it is not raised; Headache; She initially had a red spot around the injection site that was raised and then cleared up; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (She initially had a red spot around the injection site that was raised and then cleared up), VACCINATION SITE ERYTHEMA (She now has a larger red area around the injection site but it is not raised), HEADACHE (Headache) and NASOPHARYNGITIS (Cold) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE SWELLING (She initially had a red spot around the injection site that was raised and then cleared up). On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (She now has a larger red area around the injection site but it is not raised), HEADACHE (Headache) and NASOPHARYNGITIS (Cold). At the time of the report, VACCINATION SITE SWELLING (She initially had a red spot around the injection site that was raised and then cleared up) had resolved and VACCINATION SITE ERYTHEMA (She now has a larger red area around the injection site but it is not raised), HEADACHE (Headache) and NASOPHARYNGITIS (Cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported Treatment medications were not provided
Rash appeared on 10th day.  Rash is red, swollen, itchy and warm to touch
sore muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient). The consumer reported similar events for two patients, this is the first of two reports. This 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6200) via an unspecified route of administration in the right arm on 07Mar2021 at 16:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (BP) from an unknown date and unknown if ongoing, and cholesterol from an unknown date and unknown if ongoing. The patient had no allergies to medications, food or other products, and was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included losartan from an unknown date for an unknown indication; atorvastatin from an unknown date for an unknown indication; and fish oil from an unknown date for an unknown indication. The patient had not received any other vaccines in the 4 weeks prior to vaccination. The patient experienced sore muscle pain and dizziness on 08Mar2021 at 8:00. The patient reported she knew that sore muscle pain was normal but three days after vaccination and dizziness continue. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The outcomes of the events were not recovered. It was also reported that since vaccination the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021285640 same reporter/drug/event, different patients
every time the patient tried to stand up, the patient will see yellow spots and felt as if the patient would pass out; retching; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left, at the age of 68-year-old, on 06Apr2021 08:15, as SINGLE DOSE for covid-19 immunisation.  Medical history included sulfonamide allergy. There were no concomitant medications. The patient did not receive any other vaccine in the last four weeks nor other medications in the last two weeks. The patient was not diagnosed with COVID before vaccination and was not tested after vaccination. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) single dose on 17Mar2021 08:30 at left arm at the age of 68-year-old, for covid-19 immunisation. On 06Apr2021 at 23:30, the patient began retching. After that for about an hour, every time the patient tried to stand up, the patient will see yellow spots and felt as if the patient would pass out. The patient was not dehydrated and had to lie down for a while and then it passed. The patient was still not on top of the world (3 days later) but much better. The patient did not receive any treatment in response to the events. Outcome of the events was recovered in Apr2021.
Patient with 2 weeks of redness and swelling at site of injection. Patient was already on antibiotics for a different condition.
This case was reported by a physician via sales rep and described the occurrence of arthralgia in a female patient who received SHINGRIX for prophylaxis. On 12th May 2018, the patient received SHINGRIX. In June 2018, 42 days after receiving SHINGRIX, the patient experienced arthralgia, leg pain and general body pain. On an unknown date, the outcome of the arthralgia, leg pain and general body pain were not recovered/not resolved. It was unknown if the reporter considered the arthralgia, leg pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The physician stated that the patient still had pain down her legs and lower body 6 to 8 weeks after the vaccine. The sales representative was not provided with any other information about the patient. The sales representative was not aware that adverse event reports must be filed within 24 hours of acknowledgement.
no adverse event; PROQUAD was given to a 21-year-old female; This spontaneous report was received from a medical assistant and refers to a 21-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.     On 06-APR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 time dose for prophylaxis (exact dose, route of administration, lot# and expiration date were not reported). The reporter asked if that could be considered a valid dose. No additional adverse events were reported.
Information has been received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On unknown dates the patients were vaccinated with doses of improperly stored ZOSTAVAX (dose, dose #, lot #, route and application site were not reported). Concomitant therapy was not reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
On approximately 03/02/2001 the patient developed a fever of 101F and a chicken pox-type rash. The patient did not recall being exposed to wild type virus. Additional information has been requested. Per F/U 6/18/02: Info has been received from a health professional concerning a 38 year old male with no past medical history who on 2/13/01 was vaccinated SC in the left arm with a 1st dose of varicella virus vaccine live (lot 635208/0076K). There was no illness at the time of vaccination. On 3/1/01, the pt developed a fever of 102F (also reported as 101F) and "broke out with a chicken pox-type rash all over his body". Subsequently, the pt recovered.
Ten minutes after vaccine was given, Patient complained of his chest feeling heavy, hard to breath, and that his tongue felt funny and there was a lump in his throat. Patient was monitored with blood pressure, pulse, oxygen and lungs for approximately 30 minutes by RNs at the vaccine clinic. He was released when on a scale of 1-10, he was back to a 1, indicating that he felt normal. We followed up with Dr. on 16 Nov.
Patient received both TWINRIX & TYPHOID before collapsing on the chair.  Immidiately patient started to cease.  Patient was moved to the floor and feet were elevated. Vitals were taken.  Shortly after EMS arrived on the scene and took the patient to the ER.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with "three doses" of GARDASIL (Lot# unknown), 0.5mL, IM. The physician reported that the patient was using GARDASIL and on an unspecified date experienced syncope. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
After 24 hrs, developed fever.  Hyperactive and irritable, unable to sleep at night (usually an exceptionally sound sleeper).
Induration 11 days post-vaccination - warm, hard, and red - about 4cm in diameter, non-painful and non-itchy.
Increased swelling and slight pain in left underarm lymph node about 2 days after 3rd dose. Pain subsided about 1 week after; however, swelling has stayed.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 08-DEC-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L023385, expiration date: 25-JUN-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
approximate 3 inch x 3 inch erythematous, warm, slightly raised, urticaric appearing irritation
pt recv vax 13JUN96 & immed devel a 2cm area of swelling & erythema @ inj site prior to the needle being withdrawn;tx w/DPH;15JUN96 pt recovered;
Received Influenza vaccine 9-30-09 at 7:30 pm on 10-1-09 at 5 pm child c/o to mom arm was sore mom noticed orange size erythema on upper arm.  Seen 10-2-09 Left upper arm with vesicles, large area of erythema and edema up to left shoulder and spreading down with streak toward left elbow, few scratch marks but unable to identify vaccine administration site.  Tender on palpation.
Initial misuse report receive from a healthcare professional (nurse) on 24 January 2014 and the case was received on 21 March 2014 at the agency. This case is linked to case 2014SA046378 (same reporter and same product). A 2-year-old patient (gender was not reported) had received first dose of 0.5 ml of FLUZONE (batch number, route and site of administration was not reported) on an unspecified date. It was reported that he adult dose was administered to a child. No adverse event was reported. List of documents held by sender: none.
Left Knee joint effusion, subsequently drained on 11/25/09 by ortho sample sent for analysis was negative for crystals and infection. Within 1.5wks effusion returned and left lower extremeity edema developed.  The lower extremity edema resolved after about 1 week but knee effusion persisted. MRI of left knee was obtained which did not reveal any clear cause of the recurrent effusion per orthopedic.  Currently starting 1 month trial of Naproxen.
After patient's bath at she started shaking uncontrollably. Her lips turned blue and I scooped her out of the tub and tried to warm her up quickly and get clothes on her. I laid her on her changing table and she kept shaking but was talking kept saying "are you ok, I'm ok" and had a terrified look on her face. She would not bend her legs for me to get clothes on her so I scooped her up and called her father to come home from work asap. Her temperature was 102.2 and she felt very hot. Later, at 1am, she threw up everywhere in her crib. She carried a fever the whole next day until about 2pm.
pt recv vax; rash and urticaria starting 12 hr p/ vax; rash mostly on arms, legs, back and upper chest; managed sx w/ dph; rash lasted approx 6 days;
pain; can't even walk or write; can't even walk or write; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine ((DOSE 1, SINGLE), UNKNOWN MANUFACTURER), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown"; GAIT INABILITY (non-serious), DYSGRAPHIA (non-serious), outcome "unknown" and all described as "can't even walk or write". The events "pain" and "can't even walk or write" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient has been in different doctors and different studies and all the results are fine (reported as find) and normal. The pain was awful. Now because of the pain, patient can't even walk or write. What the company is doing to help people like the patient with side effects. Patient can't even be with the daughter because of the pain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine administered 1912 111820 PT passed out 1914 111820  Family of 3 comes in for flu shots, administer daughters vaccine at 19:12. Administer 2 brothers shots before mother asks "whats happening to her" at 19:13:51. Mother catches daughter and lays her down on the floor. Mother stated pt urinated and was unable to move. Went to check on epi injection in case of allergic rxn. Pt alert and oriented according to mother with regular breathing. Confirmed with mother that pt needed ambulance and called immediately. Waited with mother/pt until ambulance arrived pt laid on the floor. After ambulance arrival, waited to answer any questions from the paramedics before going back to the pharmacy
Feverish; chills; pain; felt really weak; painful swollen lymphnode in under arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), CHILLS (chills), PAIN (pain), ASTHENIA (felt really weak) and VACCINATION SITE LYMPHADENOPATHY (painful swollen lymphnode in under arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PYREXIA (Feverish), CHILLS (chills), PAIN (pain), ASTHENIA (felt really weak) and VACCINATION SITE LYMPHADENOPATHY (painful swollen lymphnode in under arm). At the time of the report, PYREXIA (Feverish), CHILLS (chills), PAIN (pain), ASTHENIA (felt really weak) and VACCINATION SITE LYMPHADENOPATHY (painful swollen lymphnode in under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received and contains updated AE Contact information.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. The reporter stated that the diluent vial was completely empty(PQC filed) and they could not reconstitute a dose of with ZOSTAVAX for the patient. The patient did not receive their dose of ZOSTAVAX and the patient will have to come back at another time to receive with ZOSTAVAX. No adverse effects reported. Additional information is not expected.
Could not lift arm on injection side for days, resolved top of neck all the way down spine hurt starting morning after injection sore muscles all over starting night of vaccine admin.
I received the vaccine at 8:30 am, felt fine before and afterward, until about 4:30pm. I started having chills, then joint pain and headache, my skin hurt to touch it, an overall feeling of blah. about 6:30pm I started running a low grade temp of 100. I took 2 extra strength Tylenol and went to bed. At 10pm my temp was 101,  I took 600mg of Ibuprofen. I woke up at 12.35am and could tell that my fever was down, but my body still ached and I still had a headache. I went back to sleep, woke up about 6:30am and my fever was 100.2 with chills, skin pain, joint pain, and headache. I have taken 2 more Tylenol extra strength.
Headache x3 weeks treated with OTC Tylenol 1,000mg BID, Fatigue x5 days, Irregular menses x 3 periods with heavy bleeding x1 period (7 days) starting  11/18/2022 to 11/25/2022, second episode  12/2/102022, and third episode 12/23/2022 treated with rest, intermittent chest pain episodes lasting 3-14 hours at rest 11/18/2022 to present 1/13/2022 treated with baby aspirin x3 doses and rest.
after five minutes that I pull vaccine Moderna my face left side numb and my battle lip I put my vaccine 2:30 pm I feel my symptoms at 2:35pm they can't control it so they transfer me and ambulance to the hospital
Patient is experiencing pain, swelling, and redness on inner elbow of left arm. The pain and swelling can extend up into the upper medial side of arm.  She states that at times her blood vessel specifically seems swollen and stands out.  This is continuing to this day.  I advised her to seek medical attention to confirm or exclude a blood clot.
Rash, UrticariaPruritus, pain at site of injections x 3 days
Patient received the covid19 vaccine(moderna bivalent)  on 4/26/23.  patient presented today to the pharmacy may 8,23 with complaint of itchy rash on his torso from below the neck to waist area.  pt stated this allergic reaction started the day he received the covid19 vaccine.    pt already tried using benadryl capsules with no relief of itch.   I recommend to use hydrocortisone cream for the itch, instead.
Received her second dose of vaccine on 1/12/21 and 2.5 hours later felt shaky, dizzy, nauseated, pale and diaphoretic.  Seen in the ED and was given fluids and monitored a couple hours and released.  On 1/21/20 she continued to feel poorly with dizziness and ringing in her ears.  She was seen by her physician and given a steroid injection and a meclizine prescription.  Physician believes her symptoms are a continued reaction to the vaccine.
Felt tired with muscle aches all over for about 3 days.  My primary concern is that ever since receiving the vaccine, I have experienced the following symptoms in my left knee (constantly) and my left calf and thigh (sporadically throughout the day) - soreness, stiffness, numbness, tingling, burning, pain when bending the knee, pain when sitting, pain when standing, pain when using the stairs.  The above symptoms are concentrated in the left knee, but they come and go throughout the entire left leg.  The discomfort is constant, meaning every day, all day.  It has made walking difficult, and I have to limp a lot.  It's very concerning because it's not getting better after a month.
Information has been received from a pharmacist referring to a 61 year old female patient. The patient had no concomitant medication, pertinent medical history or drug allergies/reactions. The pharmacist reported that the patient always had sensitive skin and was "sensitive to all vaccines." On 04-SEP-2015 the patient was administered ZOSTAVAX (lot # L006392, expiry date 25-MAY-2016, dose, route and dose number were unspecified). The patient immediately started itching above the injection site when she got ZOSTAVAX. No treatment was given for the adverse event and no lab diagnostics study was performed. The outcome of the event was reported as recovering. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (many side effects) and PRODUCT DOSE OMISSION ISSUE (I never did my second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (many side effects) and PRODUCT DOSE OMISSION ISSUE (I never did my second dose). At the time of the report, VACCINATION COMPLICATION (many side effects) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I never did my second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided.
with the 2nd dose she had an anaphylactic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202101758384 (Pfizer).  A 21-year-old female patient received BNT162B2 (COMIRNATY, solution for injection) (Batch/Lot number: unknown) as dose 2 , single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose: 1), for Covid-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (hospitalization, medically significant), outcome "unknown", described as "with the 2nd dose she had an anaphylactic reaction".  The lot number for bnt162b2 was not provided and will be requested during follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: Er87376031), in right arm, on 23Apr2021 as dose 2, single (Lot number: H2ew0171), in right arm and on 04Jan2022 at 10:45 as dose 3 (booster), single (Lot number: 33036BD) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Known allergies: Flaxseed" (unspecified if ongoing), notes: Known allergies: Flaxseed. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient was not pregnant at the time of vaccination. No other medications reported in 2 weeks. It was reported that, about 4 days after finished Paxlovid, the patient got feverish again and got all COVID symptoms again and was even sicker the second time. Therapeutic measures included Anti-viral details, Product: COVID 19 Treatment, Brand: Paxlovid, Treatment started on 12Nov2022 and stopped on 17Nov2022, Indication: Treatment of COVID-19.
Crying around 145-2PM & cried /c screaming cry until 730-8PM. MD was contacted by phone around 4PM. Complete recovery.
* First 48 hours: Fever to 101 degrees, headache, excruciating muscular pain, joint pain, nerve pain (sensitive to touch), extreme fatigue, stomach discomfort, inflammation of injection site and left underarm * Every day after the first 48 hours: All Mild but lingering symptoms of fatigue, lack of energy (not feeling like my normal self), headache, joint pain, brain fog (memory, concentration, sleep problems), few occasions of fast pounding heartbeat lasting for few minutes, dizziness when I stand up or move quickly. Fatigue, brain fog and dizziness get worse even after mild activities (physical, mental such as studying). All symptoms got better now than the first 7 days but still lingering.