chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This pt's left arm from top of should to bottom of elbow was very red and swollen.  No fever, exudate or other symptoms. Pt was moving arm well.
Patient called us 9/28/21 to report that she had developed a lump and bruise at the injection site shortly after administration.  About a week later the bruise went away, but a lump was still present and the lump was painful with sharp shooting pains, so she went to her primary care doctor. She said her doctor instructed her to wait and watch.  She says as of 9/28/2021 she hadn't improved and was messaging her doctor about the situation.
17FEB92 recvd Engerix-B & 28FEB92 devel fatigue, muscle & joint ache, nausea, dec appetite, shaking & chills; 1 wk prior to onset exp flu or flu-like illness; vomiting & diarrhea;
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient was allergic to Codeine. On 21-JAN-2014 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, subcutaneous, lot number reported as J014399 expiry date 20-NOV-2014 in the left arm. Concomitant therapies included an unspecified medication for type 2 diabetes. On an unknown date the patient told the pharmacist that his left arm feels tight, fingers on his left hand feel numb and tingling, feels like he's coming down with something, difficulty using his left arm, and experienced left arm pain that radiate upward and downward from the injection site. The outcome of left arm feels tight, his fingers on his left hand feel numb and tingling, left arm pain that radiates upward and downward from the injection site, feels like he's coming down with something, and difficulty using his left arm was reported as not recovered/not resolved. No treatment was given for the events. The patient sought medical attention by call pharmacist. Additional information has been requested.
headache, stomach pain, fatigue, weak, tired, diarrhea, nausea. all started day after (9/15/21), still having headache and stomach pains (9/20/21).
covid vaccine #1 was given on 12/21  then MMR booster was given on 12/29
Dirraiah; Vomiting; Body aches, sharp pains; Chest pain; Shortness of breath; Ear pain; Running nose; Brain fog; Headaches; Shaking; Chills; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 01May2021 at 14:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications; taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 01May2021 at 16:00, the patient experienced "dirraiah", vomiting, body aches, sharp pains, chest pain, shortness of breath, ear pain, running nose, brain fog, headaches, shaking and chills still going on after 8 days (at the time of this report). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events "dirraiah", vomiting, body aches, sharp pains, chest pain, shortness of breath, ear pain, running nose, brain fog, headaches, shaking and chills was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Noticed pain in (L) arm late evening on 9-24-10. Called office 9-25-10, excruciating pain (L) arm; arm very weak, unable to lift arm or move arm away from body. Has to use (R) arm to lift (L) arm. Took 4 ADVIL without relief. Per Dr. to urgent care/ER: pain med & anti-inflammatory. 9-28-10 F/U care doing much better.
Gvae Pfizer 5-11  BV dose, should have been 5-11 MV
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes (well controlled). Concomitant medication(s) included: CARVEDILOL; L-THYROXINE [LEVOTHYROXINE]; METFORMIN HCL. Vaccination history included: Moderna coviD-19 vaccine (Dose 1), administration date: 09Jan2021, for COVID-19 immunisation; Moderna coviD-19 vaccine (Dose 2), administration date: 06Feb2021, for COVID-19 immunisation; Moderna coviD-19 vaccine (Dose 3), administration date: 23Oct2021, for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Noticed redness and swelling almost immediate. Arm was very itchy. Took BENADRYL with some relief but the redness, swelling has continued to increase in size. Arm is sore. Has FROM of shoulder and elbow. Denies numbness in arm. Slightly tingling. Denies fevers, feeling poorly. Denies difficulty breathing, shortness of breath. Was seen back in office on 04/03/18 and given SOLU-MEDROL injection here as well as a prescription for prednisone.
On 11-2-09 got vaccines and now (11-4-09) thighs are swollen and feels warm more swollen on left side. Did have trouble getting under wear. Mom applied cool compress and gave MOTRIN. Does not act like it is bothering him. Is bruised but was told may bruise d/t move when vaccines given. Dr notified and instructed to use cool compress and RTC if concerned. 11-5-09 swelling down. Still swollen some. 11-6-09 last night looked fine.
Initial soreness in arm resolved by day 2 following the injection, and then on day 8, more soreness developed in my arm, which increased through day 9, when I developed a aches in my shoulders and neck, a headache, and fatigue. Symptoms resolved on day 10.
felt beaten up; heart faster than normal; "Like anxiety attack"; sweatings; nausea; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt beaten up), PALPITATIONS (heart faster than normal), ANXIETY ("Like anxiety attack"), HYPERHIDROSIS (sweatings) and NAUSEA (nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced ASTHENIA (felt beaten up), PALPITATIONS (heart faster than normal), ANXIETY ("Like anxiety attack"), NAUSEA (nausea) and FATIGUE (tiredness). 09-Apr-2021, the patient experienced HYPERHIDROSIS (sweatings). On 10-Apr-2021, NAUSEA (nausea) had resolved. At the time of the report, ASTHENIA (felt beaten up), PALPITATIONS (heart faster than normal), ANXIETY ("Like anxiety attack"), HYPERHIDROSIS (sweatings) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Heart rate: faster heart beats per minute (High) faster.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: NNI FU- No new information
Felt good for 1st 4 hours, then pain in arm that evening which continues. Next morning I woke up with thick bumps near site of injection. That evening produced blisters with pus. Next 24 hours later pus broke and skin raw. I have photos to show.
Pt received vaccine in left arm.  Starting feeling discomfort  in the arm about two hours later.   Pt experienced pain, tenderness and numbing feeling.  Also experienced numbness in left leg.
1023/2006 1:00 pm both pneumonia and flu shot injected in right upper arm (hand lymphedema in left arm).  Arm progressively sorer till evening-slept fitfully.  Couldn't raise arm in am.  To medical doctor -temperature of 101, dizzy, nauseous,  Hot pad all day to upper arm.  No appetite.  Better in 48 hours.
I started getting an unbearable itching sensation on various parts of my body approximately 8 days after my booster shot. If scratched, it would turn red, swell up (demotographia), and stay red and inflamed for aboout an hour after I leave it alone. I've been taking allegra every day to attempt to keep it under control but it only does so much.  The itching and redness has spread now to my entire body including my hands and face.
Information has been received from a physician concerning a male patient with no medical history who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot number not reported) (therapy reason for use was also reported as "sinusitis"). There was no concomitant medication. The patient was not indicated for PNEUMOVAX 23, and received a dose of PNEUMOVAX  23. On an unspecified date the patient's arm swelled and became hot and sensitive. The patient also got a fever. On an unspecified date the patient was admitted to hospital for 3 days. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Presenting to the Emergency Department, via EMS from home, complaining of blood in vomit onset today; incidental COVID-10 finding on pre-procedural testing; asymptomatic.
Two days after receiving second dose of the Pfizer COVID 19 vaccine, I began having blurred vision with irritation and inflammation in both left and right eyes, with the left eye being worse. These symptoms get worse as the day progresses.
On day 1 after vaccination (08/10/2022) fever of up to 102F, which was gone by 08/11/2022. Several days later, 08/15/2022, began to cough and show signs of illness.  By 08/16/2022 at 4:00am, began to have difficulty breathing and was taken to the closest pediatric emergency room.  There, the following were seen: (1) obvious respiratory distress including belly breathing, (2) reduced oxygen saturation (as low as 91%), (3) rapid breathing (measured up to 50/min), (4) increased pulse (up to 150bpm), (5) decreased lung sounds on left side.  Treatment consisted of albuterol nebulizer and prescription for take-home albuterol inhaler. Seen following day (08/17/2022) by primary care, with some residual wheezing but improved vitals and normal appearance/behavior.
Initial case received on 16 February 2010 from a patient. A female patient (age and date of birth not reported) received an injection (route and site not reported) of FLUZONE SV (lot number U210AA-not valid SP lot number) on 16 September 2009. The patient reported she had a bad cold and dizziness for the past 6 months. No further information was provided. Documents held by sender: None.
Muscle aches; Chills; Fatigue; Headache; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 24Oct2021 at 15:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: CL3302) via an unspecified route of administration in the left arm on 11Feb2021 at 11:00 (at the age of 61-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 04Mar2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Oct2021 at 02:30, the patient experienced muscle aches, chills, fatigue and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 28Oct2021, the patient underwent antigen test via nasal swab and the result was negative. The clinical outcome of the events muscle aches, chills, fatigue and headache were resolved on an unknown date in 2021.
10cm urticarial response @ inj site-not itchy-but painful-axillary tenderness;no wheeze, no fever & numbness @ inj site & finger tips;
This case was reported by a healthcare professional and described the occurrence of fever in a 4-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. The subject's medical history included febrile seizure. Concurrent medical conditions included drug allergy to Zithromax. On 26 July 2007 at 16:20, the subject received 5th dose of Infanrix (unknown). On 26 July 2007, immediately after vaccination with Infanrix, the subject experienced mild fever, warm to touch, injection site redness and swelling. Approximately two to three days after the vaccination, the subject also experienced discoloration of skin that was described as looking like the end of a bruise site, or a birth mark but almost black. The discoloration was approximately four inches long and covered the entire deltoid region from the acromion process to the auxiliary crease. An injection site induration with a bulls eye reddened area (injection site) where the injection occurred was also noted. The subject's range of motion was not restricted and his arm and shoulder did not hurt. At the time of reporting the events were unresolved. The nurse reported that she was not aware of any adverse events following previous vaccinations. Follow-up received on 16 October 2007 via the nurse. The subject received Infanrix intramuscularly in the left deltoid. She indicated that the subject was diagnosed with a local reaction post immunization. The onset of earliest signs and symptoms was reported as 25 August 2007. She noted that the events were unresolved as of 09 October 2007, the subject's skin was still discolored. She considered that the events were not serious and possibly related to Infanrix. The subject had not experienced any adverse events following previous vaccinations.
Headache (horrible) Body aches. Joint pain. Tired. Loading voice Swollen joints  Swollen throat  Ear pain
Approximately 18  minutes after administration of Pfizer COVID-19 vaccine IM 1st dose patient c/o having tongue swelling, hives to chin and facial redness. Administered Epi 0.3 mg IM to right deltoid approximately 20 minutes after vaccine administered. Right arm noted to have swelling at site of vaccine administration. IV access obtained and diphenhydramine 50 mg IV administered. NS IV started and approximately 100 ml given prior to EMS arrival. Pt did state he felt better after Epi 0.3 mg IM dose and diphenhydramine 50 mg IV dose provided. Pt alert and able to speak in complete sentences throughout event. Tongue swelling improved after epinephrine and diphenhydramine administered. Pt transported by EMS emergently to local emergency department for further observation and treatment.
Awoke the morning after the injection at 6:30 a.m. with a rapid heartbeat, pulse in excess of 120 bpm.  Blood pressure normal.  Was dizzy and nearly passed out when standing up from a seated position.  Muscle aches (legs and back) and nauseous. Phoned my primary care doctor; she monitored the situation hourly and indicated that if the heartbeat did not slow down by noon, I should go to her office immediately.  By 11:00 a.m. the rapid heartbeat had slowed and returned to normal.  The aches and nausea lasted about 3 days and then gradually subsided.
w/in 1 hrs of vax pt devel "red spots", swelling around eyes, swollen tongue; instructed to see MD; pt recvd DPH;
Patient received the vaccine on 12/3/2018 at 1 pm and started noticing her arm swell up around 4 pm. She stated she had no pain. Around 7-8 pm the same night the swelling started moving down to her elbow. The next day she went to the pharmacy to show the pharmacist her arm and was instructed to go to her doctor.
Received HEP A adult c/o large amt. of pain in room at site spent few mins. with her she was OK I walked out of room patient felt dizzy sat on table fell off about 3ft. landed on head wrong and had seizure. Sent to ER via ambulance.
no adverse event reported; Administration of VARIVAX and MMR II (Stored in Freezer) that underwent a temperature excursion to a patient; This spontaneous report was received from a licensed vocational nurse and refers to a 1 year old male patient.  The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.   On 20-MAY-2021, the patient was vaccinated with an incorrect storage dose of  varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously, 0.5 ml, lot # T027305, expiration date 12-AUG-2022 for prophylaxis. On the same date, the patient also received an incorrect storage dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II). subcutaneously, 0.5 ml, lot # S037497, expiration date 20-NOV-2021 for prophylaxis. The vaccines were exposed at 19.3 Fahrenheit (F) for 1 hour and 31 minutes. There was no previous temperature excursion. The call was made due to "data logger". No other adverse events were reported.
pt received pfizer dose for 12 year old and up instead of the pfizer dose 5-11 year old
Patient came to the RX to get the vaccine as 17 years with her mom. We gave patient the vaccine after confirming her information and her form with allergies, medications history. Pt was ok and not allergic to anything per mom. After got the vaccine, she was sitting 15 mins to see if pt is having the reaction to covid and she passed out 5 mins later. pt was unconscious for 10 second, after I lay her on a flat surface,  elevated her feet and get her blood flow, she was ok with her bp is 85/65. paramedic came to take her.
Nausea and vomiting within 2 hr of vaccine administration. Increase in wheezing, relieved by albuterol (known asthmatic). Given ZOFRAN in ER.
Patient was sent to the nurses station to receive a Gardasil, Menactra, and Tetanus shot.  She received all three, and was asked if she felt okay, replied yes.  She found her mom and her mom asked her again if she felt okay, again she stated yes.  They made it to the car and the patient started complaining of nausea.  As they started driving towards home, they made it about 1/2 block and the mother states that pt started seizing.  She explains that she did not pass out, but did have tonic/clonic like seizure and did become incontinent.  Mother drove the patient back to our clinic where she was seen again by ARNP.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB (lot # M006708 with expiration date 02-JUN-2018, lot # L048848 with expiration date 09-AUG-2018 and lot # reported as M020926 with expiration date 11-AUG-2018; dose and route were not reported). The vaccines were stored in 50.3F for 45 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chest started hurting really bad like a stabbing pain; Getting worse to the point she couldn't breath; Double pneumonia; Ear infection; Back pain; A spontaneous report was received on 08 Mar 2021 from a consumer, who was a 56-year-old,  female patient,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced double pneumonia, ear infection, back pain, chest started hurting really bad like a stabbing pain/ chest pain, and getting worse to the point she couldn't breathe/ dyspnea.  The patient's medical history was not provided. Concomitant product used, included hydrochlorothiazide (HCTZ) 25 milligrams, rosuvastatin, losartan 50 milligrams, acetylsalicylic acid, benzonatate, ezetimibe 10 milligrams and dulaglutide.  On 03 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number: 043L20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 03 Mar 2021, prior to the onset of the events, the patient received her second of two planned doses of mRNA-1273 (Lot number: 022M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   On 03 Mar 2021, on the night of the same day of receiving the vaccine, the patient felt severely sick. The patient also felt like she got hit by a truck, she had back pain, extremely cold and felt like flu like symptoms. The next two days patient went to work. On Thursday of 04 Mar 2021, the patient's chest started to really hurt bad like a stabbing pain and kept getting worse to the point where she could not breath. On Saturday of 06 Mar 2021, patient had been to the urgent care and was diagnosed with double pneumonia and an ear infection. The patient was given an antibiotic shot in her hip and oral antibiotics doxycycline. The patient was quarantined till 09 Mar 2021.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, double pneumonia/ pneumonia, ear infection, back pain, chest started hurting really bad like a stabbing pain/ chest pain and getting worse to the point she couldn't breathe/ dyspnea, were 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 events, a causal relationship cannot be excluded
Pt received flu inj. Felt dizzy. Sat down. Unconscious. Fell to floor. Conscious again. Layed down until paramedics arrived. Pt fine after 15 minutes.
Patient received Men B vaccine in her RA and was suppose to received MENVEO.  I adv mom or error on 11/18/2016. I reported error to the manufacturer. Mom said her arm was very sore at the time and I spoke with mom again today 11/25/2016 and she said she is still extremely sore.