chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9 days after first dose had a PCR test for Covid-19 and she received her positive results; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer. A 93-year-old female patient (consumer's mother) received the first dose of bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. 9 days after first dose the patient had a PCR test for covid-19 and she received her positive results in Jan2021. The outcome of the event was unknown.  Information about Lot/Batch has been requested.
Myalgia, Arthralgia, Fever & NauseaVomiting Narrative:  2230 01/20/2021severe chills and body aches. The severe body aches (muscle pain), joint pain and achiness, fever, fatigue, and nausea lasted all day Thursday 01/21/2021 and all day Friday 01/22/2021
By 10:45 pm the afforementoned affected area was significantly swollen causing some blockage of sight from my right eye; my right lower eyelid beginning to swell; This is a spontaneous report from a contactable other health care professional (Patient). A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810, expiry date not reported), via intramuscular route, administered in Left Arm on 09Feb2021 at 09:45 (age at vaccination: 56 years) as dose 2, single for covid-19 immunisation. The patient medical history was None. There were no concomitant medications. Known allergies were reported as None. Patient did not receive other vaccines in 4 weeks. Patient did not receive other medications in 2 weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982, expiry date not reported), on 19Jan2021 at 9:45 AM via intramuscular route in left arm for covid-19 immunization. The patient reported his right lower eyelid beginning to swell on 09Feb2021 at 22:30 (in the morning), by 10:45 pm the afforementoned affected area was significantly swollen causing some blockage of sight from his right eye on 09Feb2021 at 22:45 . 2 Motrin and Ice Pack placed over right eye was given as treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
PATIENT WAS UPSET HE WAS BEING MANDTATED TO TAKE THE VACCINE. HE TOOK THE VACCINE AND STAYED IN THE STORE FOR 15 MINUTES. RIGHT BEFORE HE WAS ABOUT TO LEAVE , HE FELT WEAK AND FELT LIKE ABOUT TO PASS OUT. PATIENT SAT BY THE WAITING AREA. HE BECAME PALE AND VERY WEAK. PATIENT RESTED FOR A FEW MINUTES AND DRANK WATER, GETORADE AND COCA COLA. HE WAS OK AFTER A FEW  MINUTES.
FLUBLOK given to a 7 year old female patient/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via The Agency (Reference number- 00364189) and transmitted to Sanofi on 18-Nov-2020.  This case involves a 7-years-old female patient who received vaccine once 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (strength: standard, lot number: UJ481AA and expiry date: 17-Apr-2021 via an unknown route and at an unknown administration site) (inappropriate age at vaccine administration) on 18-Nov-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, medication and family history were not provided.  It is unknown if the patient received any concomitant medication and other vaccine.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day)  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
7/6- neck  7/8 - C5-6 corpectomy, C4-7 ACDF 7/9 - C4-7 posterior cervical fusion 7/14 - J&J covid vaccine 7/20 -  numbness and tingling in arms and legs, decreased strength in BLEs 7/21 - MRI spine neg 7/23 - shortness of breath 7/25 - CN VII palsy, MRI spine neg 7/26 - asystolex2 s/p ROSCx2, unresponsive after ROSC, intubated, MRI brain and spine neg 7/27 - patient began following commands and regained strength 3/5 in BUEs and 2/5 strength in BLEs 7/28 - extubated and reintubated for acute respiratory failure 7/30 - repeat MRI neg 8/1 - loss of motor function, now only limited eye movements, started on IVIG, LP showed albuminocytogenic dissociation 8/2 - EMG and NCS demonstrates pattern likely 2/2 guillan barre
The only  symptom following the vaccine was soreness at injection site the next day. Soreness didn?t last long. Several weeks later I noticed my legs were unusually achy,  especially when walking moderate distance or trying to sleep.
Patient presented to health unit on 10.09.19 reporting had Flu vaccine on 10.07.19 and onset of rash and hives 10.08.19. Diffuse rash all over body noted, more concentrated in trunk and abdomen and neck area. Extends to arms and legs but less intense. C/O itching. Denies new medications, or exposure to any other allergic items. Only thing patient thinks that he did different is to get the flu vaccine. Is taking numerous meds and has hx of psoriasis and there are obvious patches of psoriasis but the rash is different in appearance. No sob, difficulty swallowing  or fever reported. APRN did examine patient and prescribe Benadryl otc as directed, and steroid dose pack.
Information has been received from a registered nurse with no known medical history and drugs allergies, who on 03-May-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck), subcutaneously. Concomitant therapy included ACTIVELLA, Hydrochlorothiazide (manufacturer unknown), Lisinopril (manufacturer unknown) and PROTONIX. On 03-Mar-2009 the patient developed a big, red welt after the ZOSTAVAX (Merck). It was also stated that it had been getting better with each day. No laboratories studies performed. The patient did not seek medical attention. On 09-Mar-2009 the patient had recovered from the big, red welt. Follow up information received on 23-Mar-2009 from the registered nurse stated that she also felt fatigues during the first week after receiving the dose of ZOSTAVAX (Merck). Additional information has been requested.
I had also received a tetanus shot the previous Tuesday, April 2.  The morning after the Shingrix vaccination, I had a bad stomach ache causing a vasovagal syncope reaction and fainted.  I ended up going to the ER.  The only adverse outcome was a black eye from fainting in the bathroom.  Not sure if the two shots days apart were the cause or if this was coincidental.
chills and slight fever. shortness of breath, stuffy nose , severe indigestions. severe fatigue, nausea.  2 days
Pt fainted, was out for 2 minutes then came to was able to verbally express how she felt.  Then fainted 2 more times.  Advised to seek medical attention
Below is a copy of the phone calls that took place between our office and the patient/patient's wife: 10/22/2012  5:56 PM  Signed I spoke with pt's wife.  Pt is much better.  Headache and speech issue have resolved.   Per pt's request, I have added Pneumovax to allergy list with headache as having been a possible side effect.    10/22/2012  3:41 PM  Signed Call and check on him. 10/22/2012  3:38 PM  Signed Pt's wife advised.  Wife verbalizes understanding to call back if there is no improvement, and to call back or seek immediate care if condition worsens or if new symptoms develop. 10/22/2012  3:38 PM  Signed Per Dr:  Pt may take Tylenol 1-2 tabs po q4h prn.  Wife should continue to monitor and should got to ER for worsening symptoms.    10/22/2012 11:49 AM  Signed I spoke with pt's wife.  Pt was here for an appt this morning.  Pt received a pneumonia shot at the appt.  When pt got home, he started having a headache and was also having trouble getting out his words.  I advised wife to be aware of s/s of anaphylaxis, such as tongue/throat swelling, and if that is what is occurring, then they need to call 911 or go directly to ER.  Pt's wife doesn't feel he is experiencing tongue/throat swelling.  Wife said that the pt had similar symptoms once before when pt had a migraine.  At that time, he also seemed to have difficulty expressing himself.  Is there something pt can take for this headache?  Any other recommendations? Call wife at home #. 10/22/2012 11:39 AM  Signed Patient having a reaction to the pneumonia shot.   Patient's wife sent to back line for nurse to advise.
Was prescribed doxycycline for skin infection; This is a spontaneous report from a Pfizer sponsored . A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 11Mar2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported, she had 1st dose of covid vaccine on 11Mar. Yesterday went to see Dermatologist. Was prescribed doxycycline for skin infection. Was reading papers with medication, said you should get vaccine while taking this medication. HCP called in prescription of Cipro and papers say same thing, not to get vaccine while taking medication. Has not started taking medication yet but wants to know if she takes medication, will it impact covid vaccine. Not clarified if appointment with Dermatologist was before or after covid vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Around the hour of 1:42 pm, complained of lightheaded and tingling in her right arm. On assessment, oriented; no sign of respiratory distress was noted. BP 145/97, O2 sat 98%, Pulse 90. She gave a history of hypertension, taking blood pressure medication. She admitted her blood pressure reading runs high. The client was monitored closely. At 2:00, the client remains stable, BP 142/90, O2 sat 99%, Pulse 84. The client verbalized the lightheaded and tingling in her right arm has resolved. The client left the facility at 2:05 with no other complaint.
Approximately 4 minutes after injection, patient stated he could not see and "everything went black".  Patient appeared anxious, pale, and diaphoretic.  Patient denied difficulty breathing, trouble swallowing, and nausea.  He was assisted to a semi-recumbant/supine position.  After approximately 60 seconds, he stated his vision was returning.  Patient received sips of water and ice pack and was monitored for 15 minutes.  Patient stated he felt better and was able to walk out of clinic without assistance.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included colecalciferol, and melatonin. On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm. This report was non-serious.
Headache; Muscle Aches; This is a spontaneous report from a contactable consumer (the parent). A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 20Feb2021 10:15 (at the age of 24-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: allergies (unspecified), ADD (attention deficit hyperactivity disorder), and allergies sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient had no concomitant medications. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 30Jan2021 (at the age of 24-years-old), as a single dose for COVID-19 immunization. On 21Feb2021 (reported as "at 08:00"), the patient experienced headache and muscle aches. Treatment included ibuprofen. The clinical outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.    Information on the lot number has been requested.
About 27-28 hours after injection felt strong pain in left lung area.  Got progressively worse, especially at night when lying in horizontal position.  The pain became extreme, could hardly breathe (inhalation causing extreme pain) and couldn't really walk on morning of March 6 (about 66 hours after vaccination. Called General Practicioner and he said to go to Emergency Rm.  A catscan showed a small blood clot in each lung.  Given blood thinner injection. Subsequent Ultrasound of legs showed no clots there.  Released 48 hours later, put on Eliquis -- 5mg -- two each time, twice a day for 6 days, then one each time twice a day. for 3 months.
Sore and very itchy Injection Site; Sore and very itchy Injection Site; Itching and Tingling around mouth and eyes; Itching and Tingling around mouth and eyes; feeling pins & Needles and Tingling all over my body; Dizzy; Tired; Sleepy; low-grade temperature; Forehead was warmer than usual; This is a spontaneous report from a contactable pharmacist (patient herself). A 55-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9267), via an unspecified route of administration, administered in left arm on 27Feb2021 13:45 (age at vaccination: 55 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included Hashimoto's, glaucoma and hazelnut allergy. Concomitant medication(s) included levothyroxine sodium tablets and brimonidine tartrate (ALPHAGAN) eye drops. On 27Feb2021 15:45, 2 hours after the vaccination, the patient was dizzy, tired, sleepy, low-grade temperature. On 27Feb2021, the patient's forehead was warmer than usual. On 28Feb2021, the patient was sore and very itchy at injection site, itching and tingling around mouth and eyes, feeling pins and needles and tingling all over her body. The patient received Hydrocortisone 1 percent Cream, Tylenol and Claritine as treatment for the adverse events. The patient did not have any other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination nor was tested since vaccination. The outcome of all the events was unknown.   No follow-up attempts are possible. No further information is expected.
15 minutes p vaccine, began whelps to back. Was given Benadryl decadon, Pepcid and resolved in 30-45 minutes.
Adjuvant not mixed with Antigen; Only adjuvant administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number MY2Y2, expiry date 08-JUL-2024) for prophylaxis.   On 05-APR-2023, the patient received the 1st dose of Shingrix. On 05-APR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant not mixed with Antigen) and inappropriate dose of vaccine administered (Verbatim: Only adjuvant administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-APR-2023 The pharmacist reported that a patient received Shingrix first dose without the lyophilized antigen component. The reporter consented to follow-up by email. The patient received Shingrix without the lyophilized antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Initial report received from pharmacist on 12 Nov 2010: This patient was vaccinated with FLUVIRIN (batch number: 112945P1), intramuscularly on 11 Nov 2010. After 5 minutes of vaccination, the patient was not feeling well and nauseated. The patient also experienced cold sweat, chills, loss appetite and vomiting. The outcome of the events were reported as completely recovered on 12 Nov 2010. Follow up pharmacist report received on 30 Nov 2010: This patient had medical condition of hypothyroidism and was taking levothyroxine concomitantly. The patient received 0.5 ml of FLUVIRIN on 11 Nov 2010 at 15:30 hrs on left deltoid. The patient tolerated vaccine in past. The patient experienced cold sweat, nausea, vomiting, chills and loss of appetite after wards. Next day morning, the patient completely recovered. The reporter assessed the events as medically significant.
Patient waited for observation for more than 15 minutes.  After 15 minutes they went shopping in the store. 30 minutes later the patient came back stating her lips were "puffy" . Patient stated she was not having difficulty breathing or throat or tongue swelling and besides her lips she "felt fine".
9 days after receiving vaccine my arm developed a large red spot about 4 inches by 3inches.  Very itchy and swollen.  Tenderness in my armpit.  First 24 hours the itchy and redness were quite severe.  Gradually it dissipated over about four days.  Occasionally it still itches. I iced it which helped considerably.
Rash develop on arm of injection site, back, buttocks, parts of legs starting the evening after vaccination (Friday September 18, 2019). Patient stated not to have experience any swelling of lips or tongue; no difficulty breathing; no hives. Patient contact pharmacy on Tuesday (September 22, 2019) before heading to work to report rash. Since then has not spread and no symptoms present to suggest shingles. Recommend for patient to use benadryl and calamine lotion. Patient will followup with primary provider if symptoms do no improve by the end of the week.
Now at 48 hours /Symptoms began at 12 hours after shot. Reported/visited doctor. No treatment. Swollen lips/hives on hands, knees, ankles. Itch at these sites and also feet. Pain at vaccine site. Symptoms continue. Administered Benadryl. NOTE: Patient has known sulfa allergy. Drug (ADACEL) processed with products that could cause reaction/not known at initial visit...researched after visit.
I am a 68 year old male. For the second year in a row I had a flu shot about the first of October. This year I had the Fluad 20-21 Quad 0.5 ML IJG SEQI (Info from the pharmacy receipt) injection. Last year when I got the shot I was very sick with flu like symptoms in the day immediately following the injection and again approximately three weeks later. I also had the usual expected symptoms of soreness at the injection site and general tiredness. Last year the symptoms were bad enough that I had to curtail regular activities for three to four days. This year the same thing happened to both me and my wife (66 year old female). Neither of us were real sick after the shot but we were very sick for three or four days about three weeks out from the shot. I had the shot on October 5th and I have not felt well since that time. I'm concerned about either of us getting the flu shot next given the severity of the symptoms the last two year. I looked on line regarding issue but couldn't find any credible information regarding these kinds of side effects. Last year I suppose we could have just picked up a cold but this year we have been mostly limiting interactions and wearing masks so I am really concerned that this could be something to do with the vaccine. Can you provide some guidance?
Pt had ZOSTAVAX vaccine about 9:30 P.M. Tuesday, 2-23-2010 with her husband. On Thursday morning she said injection site was red "warm" and swollen. She went to a doctor and she was treated. Friday all symptoms were gone.  Doctor thought it was a "fluke."
pt recv vax 8APR98 & approx 1hr later arm began to hurt & hurt x 4 days then on Monday 13APR arm began to swell @ site & began to burn & sting;pt took APAP 8APR98 & 16APR98;
Day 1 AEs: Diarrhea, headache, slight fever (99.2°, which is a fever for me). Symptoms subsided by Day 3 and did not reappear with subsequent doses.
Information has been received from a nurse concerning a 74 year old female patient with asthma and no drug reactions or allergies who on 08-DEC-2010, was vaccinated IM with a 0.5 ml dose of PNEUMOVAX 23 (Lot# 667914/1067Z). Concomitant therapy included NEXIUM, albuterol, ADVAIR and montelukast sodium (MSD). It was reported that within a couple of days after the vaccine was given, the patient developed cellulitis and had to go to the emergency room. There were no lab diagnostics studies performed. At the time of the report, the patient was recovering. Information was received from a nurse and medical records concerning a 74 year old female (5'2", 152 lbs.) with no known drug allergies, asthma and a history of contact dermatitis who on 08-DEC-2010 at 3:00 pm. was vaccinated intramuscularly (left deltoid) with PNEUMOVAX 23 (Lot# 667914/1067Z). On 11-DEC-2010, the patient was seen by a physician for myalgias, fever, and spot where injection was given had gotten redder, hotter, and more painful. The patient was diagnosed with cellulitis and was started on dicloxacillin. The patient was admitted to the emergency room 12-DEC-2010 for worsening cellulitis and was placed on intravenous antibiotics. It was reported that the patient has recovered (date of recovery was not provided). This is one of two reports from the same source. Additional information is not expected. All available medical records will be provided upon request.
Temp 102, chills lasting 12 hrs, muscle and joint pain throughout body lasting 24 hrs. Very painful. Numbness around mouth. Took total of 2 grams Tylenol and Benadryl 25mg.
muscle aches; Joint pain; headache; dizziness; fatigue; This is a spontaneous report from a contactable consumer. A 48-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9810, Expiration date was not reported) via an unspecified route of administration, administered in arm left on 03Mar2021 08:30 as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, Expiration date was not reported) via an unspecified route of administration, on 10Feb2021 10:00 as 1st dose, single dose for COVID-19 immunization. 36 hours after injection, on 03Mar2021 4 hours after vaccine application the patient experienced fatigue, muscle aches, joint pain, headache and dizziness. No treatment was given for adverse events. Patient not tested prior or after vaccination. The patient had no history of allergies. The outcome of the events was recovered on an unspecified date.  No follow up attempts are possible. No further information is expected.