chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is in follow-up to report (s) previously submitted on 5/14/2007. Information has been received from a certified medical assistant concerning a 25 year old female with no pertinent medical history and with penicillin allergy (nausea, vomiting and hives at age 5) who on 28-MAR-2007, was vaccinated with first dose of Gardasil (Lot#655618/0186U). There was no concomitant medication. On 30-MAR-2007, the patient developed widespread body aches, chills and dizziness two days after receiving the vaccine. When she took a deep breath she experienced coughing that lasted a few seconds and some tightness. On 31-MAR-2007, within 24 hours, (at 12:00 noon), the patient recovered from widespread body aches, chills, coughing, tightness and dizziness without treatment. The patient sought unspecified medical attention. Additional information is not expected.
Next day woke up and was hot to touch, red raised and hard bump inside on left arm. Stated it hurt to touch or any pressure applied. Went to Dr. on day 4 and was diagnosed with cellulitis. Was put on KEFLEX PO for 10 days. Once on antibiotic started redness and heat started to go away and decreased.
tiredness; cough; pain in my lungs, in the back and in the chest; pain in my lungs, in the back and in the chest; nausea; This is a spontaneous report from a contactable consumer (patient). The patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). This is the case for dose 2. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on an unspecified date, after the first dose patient had a headache and chest pain, but it went away quickly. Patient received the second dose of the Pfizer COVID 19 vaccine yesterday (19Apr2021). Since then, she's been feeling with a bad headache, tiredness, cough, pain in her lungs, in the back and in the chest and nausea in Apr2021. Patient is wondering whether this has been reported before. Outcome of the events was unknown.   No follow-up attempts are needed; Information related to batch/Lot number could not be obtained.
day p/vax pt exp n/v & diarrhea w/2 lb wt loss;
Pt was in excellent health prior to service entry in May 2009. 13 May 2009 - Pt received multiple vaccines - See Vaccine History. The total number of 5 vaccines administered was divided between injections in both of his arms (2 and 3). He does not recall any significant local reactions at his vaccination sites. 28 May 2009 - Pt reported to Sick call for evaluation of URI symptoms. He was treated with MUCINEX, TYLENOL and SUDAFED. He reports multiple sick contacts with similar URI symptoms. 1 June 2009 - Seen on Sick Call. Diagnosed with Bronchitis and prescribed ZITHROMAX. 2 June 2009 - Pt awoke with tingling, numbness and weakness of his entire body, except for his head and neck. He was seen on sick call for follow up of bronchitis and he was placed on 72 hour quarters. (There was no mention of the numbness or weakness in the clinic note.) 5June 2009 - Pt returned to Sick Call with c/o falling "to his knees...can't feel legs, feet, shins, hands and fingers". (URI symptoms noted to have significantly improved.) No bowel or bladder symptoms or visual changes. Pt was released to duty. 8 June 2009 - Pt seen in the clinic for "body numbness". The following were noted: - Gait "off balance", ataxia, difficulty with balance - Increased concentration required to get dressed as buttons and laces hard to manipulate - Unable to feel when he plants his feet down - Difficulty writing and with fine manipulative tasks - Placed on 48 hour quarters. 10 June 2009 - Pt returned to sick call with c/o body numbness x 10 days and was referred to the ER after PCM consulted with Neurology. 11 June 2009 - Neurologist evaluated patient. HPI noted 10 day hx of numbness of all extremities and entire body, with subsequent generalized weakness, gait difficulty, soreness of calves and thighs. Exam revealed slightly diminished strength of UE and LE (4/5), with 3+/5 strength of distal muscle groups. Also on exam, pt was unable to walk a straight line, with abnormal heel walking and diminished DTRs in UEs and absent DTRs in LEs. Diagnosed with GBS. Treated with IVIGx5 days. Transferred to inpatient rehabilitation facility.  7/27/09 Hospital records received DOS 6/11/09 to 6/16/09. Discharge Diagnosis: Guillaine Barre Syndrome Patient c/o significant numbness in fingers and toes with generalized numbness of body below the neck.  Stumbles when he walks. Arthragias of knees, myalgias in thighs and calves. Easily fatigued, anorexia. URI symptoms such as cough and sore throat, bilateral upper extremity and lower extremity paresthesias, absent DTRs in bilateral lower extremities, decreased DTRs in bilateral upper extremities, weakness of the bilateral upper and lower extremities. Presence of CSF albuminocytologic dissociation (slightly elevated CSF protein with absent pleocytosis).
Started with severe eye strain; then sneezing and congestion, headache--ongoing; Had same symptoms when I got the seasonal flu and H1N1 flu vaccines.
Fever,  vomiting,  dry-heaving, diarrhea, headache.  My left ear is now bothering me with slight pain.  Swollen lymph node in neck on left side.  This just started 4/18/21.  Took tylenol and ibuprofen combination together
It started in the evening of the vaccination, it was like I was coming down with a cold, I had  fever that started getting higher and higher and a very painful headache, I started having 104 temp and I started taking Advil by the next day 6PM the fever started to go down and everything was getting back to normal. The only thing is that ever since the vaccination I have been having 100.5/100.9 fever everyday since that day. It started to get me nervous so I went to see my doctor, I had chest x-ray and blood work. It has been 30 days and the fever is getting kind of irritating. Every time I get the fever I start with a headache as well. So every day I have to deal with headache and fever. I wasn't given any medication at the time of my visit.
A nurse reported that ten days post vax the pt developed blisters in and on the nose. The pt reported having rec. many doses of influenza virus vax and never having experienced this event.
FEET AND ARMS BURNING; EYES BURNING; SWEATING; COULD NOT EAT; CHILLS; HEAD FELT IT WILL EXPLODE; EXTREME NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 64 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 05-MAY-2021, the subject experienced feet and arms burning. On 05-MAY-2021, the subject experienced eyes burning. On 05-MAY-2021, the subject experienced sweating. On 05-MAY-2021, the subject experienced could not eat. On 05-MAY-2021, the subject experienced chills. On 05-MAY-2021, the subject experienced head felt it will explode. On 05-MAY-2021, the subject experienced extreme nausea. On 05-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, feet and arms burning, head felt it will explode, sweating, extreme nausea, fever, eyes burning, and could not eat. This report was non-serious.
3hrs p/2nd set of immun DTP/OPV/HIB had 3 hrs of shrill screaming x 3 hrs; pt was inconsolable unable to sleep;
This spontaneous report as received from a certified medical assistant who reported that three unspecified patients were vaccinated with VAQTA, lot # L015460, exp. 20-JUL-2017 and three unspecified patients were vaccinated with VAQTA, lot # M011839, exp. 13-SEP-2017 and one unspecified patient received improperly stored RECOMBIVAX, lot # L038018, exp. 13-SEP-2017 (1611USA000313), on unspecified dates. It was reported the vaccines were improperly stored. Temperature was reported as 35 degrees Fahrenheit. Time frame was reported as 15.5 hours. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
I have had spasms in my upper left arm, where i got the vaccine, ever since the first shot. It looks like a heartbeat and is very uncomfortable to have. It has not been every day, but very apparent the past 72 hours.
p/3rd vax lt arm has a big lump-has not gone away as of 7/6/99;pt is c/o muscle cramping/spasms since 6/30/99;inj site erythema, >5cm or SC nodules or pruritus @ site;
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-OCT-2014, the patient was vaccinated with the first dose of expired RECOMBIVAX HB lot # h010965, expiration date 01-JUN-2014, 10 micro-g/ml, route of administration not reported. On 20-JAN-2015, the patient was vaccinated with the second dose of expired RECOMBIVAX HB lot # h010965, expiration date 01-JUN-2014, 10 micro-g/ml, route of administration not reported. No adverse effects reported. Additional information has been requested.
Pt had swelling, redness and itchiness at injection site. Injection site located left rear arm SQ. Pt noticed redness and mild pain on scale 3 on 3/8/08 Redness and swelling mild to moderate from site to elbow.
"Woozy" feeling; Headache; Some diarrhea; Chills; Some nausea but not throwing up; Extreme fatigue; This is a spontaneous report received from a contactable consumer or other non hcp. A 68-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9269) via an unspecified route of administration in Arm Left on 10Feb2021 14:15 (age at vaccination 68years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had a historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL8982) via an unspecified route of administration in Arm Left on 20Jan2021 14:15 (age at vaccination 68years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 11Feb2021 13:00 the patient experienced "woozy" feeling, headache, some diarrhoea, chills, some nausea but not throwing up, extreme fatigue. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist via a company representative refers to a patient of unknown age and gender. No medical history was reported. On 19-APR-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # 0363AE, expiry: 16-MAR-2013) that was also improperly stored prior to administration. No concomitant medications were reported. No adverse event reported. Additional information has been requested.
Fever. 101.4. Headache. Very sore arm.   Hives on arm  very tired   Tylenol. Benadryl
vomiting and diarrhea 4+ hours in duration fever of 99.7 extreme weakness and fatigue 16+ hours, (patient is still experiencing extreme weakness and fatigue at the time of this submission).
kaleidoscope scotoma for approx 25 minutes followed by migraine headache lasting about 2 hours.  First time this has occurred in my life
dizzyness; aches; tenderness; swollen left breast; slept 19hrs/slept 16hrs; fever; chills; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gerd" (ongoing); "Asthma" (ongoing). Concomitant medication(s) included: DEXILANT taken for gastrooesophageal reflux disease (ongoing); ALBUTEROL [SALBUTAMOL] taken for asthma. Vaccination history included: Bnt162b2 (1st Dose, Date: 02-MMM-2021, Anatomical site of injection: left ram), administration date: 2021, when the patient was 32 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzyness"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "aches"; TENDERNESS (non-serious) with onset 2021, outcome "unknown", described as "tenderness"; BREAST SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swollen left breast"; HYPERSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "slept 19hrs/slept 16hrs"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information: Dose 2: It knocked her out for 2.5 weeks. Day1- fever, slept 19hrs, chills, dizziness. Day 2-fever, Chills, aches, fatigue, headache, swollen left breast (2x size) slept 16hrs, tenderness, dizziness. Day 3 3-7 headache, ache, fatigue, dizziness. Day 8- 21 fatigue and random headaches. Prior vaccinations were reported as none. Date and time of second dose: 03-MMM-2021, time: 15:45.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
covid pfizer grey top vaccine given 2 days after an email notice was sent out not to give the primary series vaccines. staff was not aware of the recent change  pt did not have any adverse reaction while at the clinic
Noticeable decline after 2nd Moderna vaccine, patient could no longer get out of bed, stopped eating and was unable to communicate verbally
had 5 small seizures; felt very dizzy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 09:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included pre-diabetes and depression. Patient was not pregnant. The patient's concomitant medications were not reported. There were no other vaccine in four weeks. The patient previously took antibiotics and antidepressants and experienced allergies. 5 minutes after getting the vaccine, patient felt very dizzy. She had 5 small seizures on 14Apr2021 10:45 which resulted in emergency room/ urgent care. Treatment was received for the events. Outcome was recovering. Patient had covid prior to vaccination on an unspecified date and had not been tested post vaccination.
This spontaneous report was received from a pharmacy student, regarding an adult patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB one dose (strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. However, no adverse events were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1710USA011207.
febrile seizure & became shaky, apnea;no vomiting  diarrhea;
a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Benign Prostatic enlargement" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number: 4, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 3, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Unknown manufacturer), for COVID-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2022, outcome "unknown", described as "a cold".  Additional information: Seriousness criteria-Results in death/Seriousness criteria-Life threatening/Seriousness criteria-Caused/prolonged hospitalization/Seriousness criteria-Disabling/Incapacitating/Seriousness criteria-Congenital anomaly/birth defect all were reported as no. The patient did not received any other medications the patient received within 2 weeks of vaccination. Patient had a cold before catching Covid, so the symptoms have been confusing as to which was which.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201400118 same patient, different dose and event;
Diffuse macular rash over entire body.  prescribed methylprednisone 4mg  dose pack .
pt received 1st dose of Pfizer Covid vaccine at 0710; began complaining of feeling HOT only and was fanning self; writer offered  a bottle of water  and began talking to pt at 0715  at 0720 pt stated that HER throat was becoming ITCHY and began gagging;  vitals bp 144/92, HR 105, 02 sat 99% on RA. 0721 pt received STAT EPI in Left thigh;  stat call made. Repeat vitals 02 sat 100 % hr 93. Pt began feeling better stating  THROAT itching was better, however she had trouble speaking as voice was raspy and weak and she kept clearing her throat; almost sounded like slight audible wheeze which didn't progress any further.  Stat team arrived; when pt stood up she had felt dizzy and mentioned she had some shakiness  but was able to ambulate to WC on own.  vitals 0723 bp 132/88 HR 96 02sat 99%.  Pt was taken to ED via WC   0725  for further evaluation.
Initial report received on 03 February 2010 from a health care professional. A 5-month-old male patient, had received an intramuscular right thigh injection of PENTACEL (Lot number C3427AA); an intramuscular left thigh injection of PREVNAR (lot number D57303, manufacturer Wyeth); and an oral dose of ROTATEQ (lot number 0175Y, manufacturer Merck) on 23 September 2009. The patient was screaming throughout the exam. The nurse then administered the above-mentioned vaccines, and the parent picked the patient up, and the patient went limp in the parent's arm. The patient's color was fine, eyes were closed, and breathing was fine. The episode lasted 1 minute and the patient recovered. It was noted the patient had two prior, but similar episodes that occurred after vomiting. One time the vomiting occurred prior to receiving vaccines and the other time the vomiting occurred after receiving vaccination. The date and vaccines associated with these episodes were not reported. Documents held by sender:  none.
bad taste in mouth during inj;lightheadedness;chest tightness pulse, resp & BP reexamined stable during 2hr observation;shakes, nausea, vomiting-immed;emesis;erythema, swelling & pain @ site of inj;
8APR mom called pt had sz 7APR between 230 & 4PM; no fever seen by MD; MD does not feel vax related to sz;
menquadfi to a patient under 2 years of age with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 20 months old female patient who was under 2 years of age was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history included Cancer with patient who had cancer and was successfully treated and cleared and Acute myeloid leukaemia in remission. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A) and Hepatitis B Vaccine (Hepatitis B Vaccine) in the left leg for Prophylactic vaccination.  On 24-May-2023, the patient received a dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection (lot: U7576AD) with unknown strength & expiry date via intramuscular route into the right quadriceps muscle for Immunization with no reported adverse event (product use issue) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
At 3pm client started to vomit every 15 mins until 6:30pm.  Mom gave child Tylenol at 1:30 for discomfort from the DTaP vaccine.  Mom gave infant Pedialyte at 11pm when she woke up, but she vomited the Pedialyte up in 15 mins.  When child woke up at 8:30am she was better, no more vomiting.
This case was reported by a other health professional and described the occurrence of lethargy in a female patient who received Influenza vaccine. In November 2017, the patient received Influenza vaccine. In November 2017, less than a week after receiving Influenza vaccine, the patient experienced lethargy, muscle pain and joint pain. On an unknown date, the outcome of the lethargy, muscle pain and joint pain were unknown. It was unknown if the reporter considered the lethargy, muscle pain and joint pain to be related to Influenza vaccine. Additional details were provided as follows: The age at the vaccination was not reported. The patient had been feeling extremely lethargic and achy in her muscles joints. The reporter asked was it possible that now she could feel the effects of the vaccine. The reporting health care professional was not willing to provide other personal information. The reporter stated that she was a retired nutritionist who still worked part-time at a nursing home.
Pt came into store 1/9/11 will cellulitis at injection site. She will see MD tomorrow and let us know outcome. Spoke w/MD & received course of KEFLEX, which she has been on since Sunday. Area feels & looks much better, pt says should resolve in a few days.
Left once then returned w/diff breathing. Pt then denied w/secondary question. 112/65 P100 R Home w/mom.