chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sick to her stomach, not sure if she has vomited, but is upset; Very bad headache/ terrible headache; Fever; She is achy and fatigued/ Extremely fatigue; Hasn't drank much liquid; Doesn't feel too good/Today and last night seems to be ill; Doesn't want to get out of bed/ she still feels awful.; Sore arm right arm injection site; Vivid dreams; Had a back ache; She is achy and fatigued; This is a spontaneous report from a contactable consumer (daughter of patient). A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in Arm Right on 20Mar2021 (at the age of 90-year-old) as dose 2, single for covid-19 immunisation. Medical history included hypothyroidism, alzheimer's from an unknown date and unknown if ongoing. The concomitant medications include thyroid pill. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), administered in Arm Right on 22Feb2021 (at the age of 90-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any vaccines within 4 weeks of getting first COVID19 vaccine. The caller reported that her mother had her second dose of the Pfizer covid vaccine 20Mar2021, today and last night (unspecified date) seemed to be ill. The caller stated that her mother had fever last night (29Mar2021) and vivid dreams. That kind of thing, vivid dreams, were usual when she has a fever. She was extremely fatigue and sick to her stomach and has a terrible headache. This morning (30Mar2021) it was at 98 degrees, sick to her stomach, not sure if she has vomited, but is upset, very bad headache, and she had a backache for a couple of days. Her mother only had the fever last night. It was 97 this (30Mar2021) morning, but she still felt awful. She has no arm pain; she was achy and fatigued. Initial reaction was headache and sore arm right arm injection site. She had not drunk much liquid since last night. She does not want to get out of bed. Does not feel too good. The caller was asking was it too late to be having a reaction to the vaccine. Seriousness of the events was reported as non-serious. The patient underwent lab tests and procedures which included body temperature: 98 on 30Mar2021, body temperature: 97 on 30Mar2021. The outcome of fever, vivid dreams, backache, pain, vaccination site pain was unknown, and fatigue, fluid intake reduced, malaise, feeling abnormal, Stomach upset, headache was not recovered.  No follow-up attempts are needed. No further information is expected.
her facility had vaccine that was pre-drawn into a syringe, stored in the refrigerator for 24-48 hours and then administrated several patients; her facility had vaccine that was pre-drawn into a syringe, stored in the refrigerator for 24-48 hours and then administrated several patients; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), outcome "unknown" and all described as "Caller states she is calling for stability data on the Pfizer Covid Vaccine (grey cap)? Caller states her facility had vaccine that was pre-drawn into a syringe, stored in the refrigerator for 24-48 hours and then administrated several patients".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200531244 same reporter/AE/drug, different patient
I have an IUD in place and haven?t had a menstrual cycle for over a year since it was placed. Similar to my first dose, I experienced a heavy flow period around 24 hours later.
Received flu vaccine yesterday 10/28/2003.  Patient had a "little stomach ache before cause for vaccination."  None since receiving.  Has noticed slight headache, some chilling.  Local redness and warmth noted at site (left deltoid) and slight tenderness today.  Referred to MD (family) per follow up.  To report back to health department.
Pfizer BioNtech Bivalent was given as the very first dose. No adverse event reported from the patient.
Pt called on 08/13/2021 to cancel the @nd dose.  Said she had an anaphylactic reaction and "just got out of the hospital".  Pt did not give any details and did not respond to 3 attempts to contact by phone.
Information has been received from a physician concerning a 2 month old male who was born at 29 weeks gestation, who on approximately 02-FEB-2009 was vaccinated with 2.0 ml of the first dose of ROTATEQ P.O. Concomitant therapy included DTaP and Hib vaccine (unspecified carrier) on approximately 02-FEB-2009. The office is not sure if the full dose was administered because the child did spit some of it out. The child turned blue during administration of the vaccine. On an unspecified date in February 2009 the child recovered from the cyanosis. Additional information has been requested.
Started with muscle aches in legs right after 2nd booster, started getting stiff and having trouble bending over, then pain in knees and upper arms.  Within a couple months was getting very stiff whenever I would stop moving (after standing, sitting, laying down for more than 20 minutes).  It because very difficult to get out of bed at night and in the morning.  Was eventually diagnosed with Polymyalgia Rheumatica.
No signs or symptoms reported; temperature excursion on PROQUAD that was administered to a patient; This spontaneous report was received from a pharmacist and refers to a 4-year-old patient of an unknown gender. The patient's concurrent conditions, pertinent medical history and previous drugs reactions or allergies were not provided. On 09-JUN-2021 the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), 1 time dosage (lot # T027114, expiration date: 07-FEB-2022) (route of administration was not provided) for prophylaxis. No signs or symptoms were reported. According to the reporter, the temperature excursion was 15 degrees Celsius for a time frame of 5 hours, without any previous temperature excursion. Digital data logger was involved.
Patient received incorrect vaccine. Patient was observed for the 15minute observation period and had no noticeable reactions.
Around 20 minutes after administration pt stated she felt like she was going to pass out. Pt was sat down, given cold water and monitored. Pt stated she felt "heavy and numb," but was not having any trouble breathing or sensation of tongue or lips swelling. She did not appear to have any shortness of breath and did not appear to have shallow breathing, but did appear to have slowed but steady breathing.  She said she was having trouble speaking and felt very tired. She looked like she was about to fall asleep so we used smelling salts and called 911 and the pt's spouse. Pt continued to be alert but was having increasing difficulty talking or answering questions.
About 15 minutes after shot. Patient reported a tingling down her left arm. Says felt like her arm was going to sleep. Very red and swollen at injection site.
I received my first Moderna vaccine on February 1, 2021. On February 3, 2021, Two days following the vaccine, I was swimming laps (normal activity) and suddenly started having strong tingling at the sight of the injection that went down my arm into my hands. After swimming, the tingling continued until the evening and was present in both hands and feet. Tingling was light. Tingling that week would come and go. I drove back a week later and the tingling continued. I saw a chiropractor and my primary care facility. They gave me a referral to physical therapy since I had also developed upper back pain. After about a month of physical therapy there was no improvement. I was having difficult focusing and working because of the tingling. I went back to Texas for my second Moderna injection which I received on March 1, 2021. The tinging after the injection became worse and much more painful, sometimes feeling like burning. I was not able to work normal hours because of the pain. After my second shot I returned to Texas and went back to my primary doctor who ordered a cervical MRI. The cervical MRI did not reveal any major issues. I changed physical therapists since I was not making any progress. I also made an appointment with UCLA Neurology. The new physical therapist implemented nerve glide exercises, stretching, and trigger point release. At the beginning of April I saw the neurologist who ordered a brain MRI, CK, Aldolase, B12,  tests and EMG/NCS tests. All of these test came back normal. By the beginning of May, with the physical therapy, my symptoms had improved about 50%. I could sit while working more, I had much less painful tingling, although sleeping at night was and still is very impacted. On May 28th I had the EMG/NCS test which also came back normal. The doctor diagnosed me with myofascial pain syndrome, has given me Gabapentin for pain and referred me to acupuncture as well as to continue physical therapy. The back pain is still ongoing although there is much less tingling. The back pain prevents me from doing activities that I was doing before the vaccine including rock climbing and biking. My sleeping continues to be impacted.
I got really sick from the 1st. Fever for a day, unable to eat. For the second, I got a fever, threw up and had a seizure. For both shots, I was weak and ended up sleeping all day. Sore all over unable to move.
Patient developed a 3.5" x 4" red, warm, firm and tender area over lower left deltoid. The patient was prescribed antibiotics for 7 days.
Initial misuse report received from a healthcare professional on 23 May 2013. A patient was administered a booster dose of MENACTRA vaccine as that had expired in January 2013. No information was provided regarding the patient. No adverse event was reported. Documents held by sender: None.
Initial report was received on 02 October 2013 from a consumer which is also the patient's parent. An unborn fetus at 30 weeks gestation had received transplacentally FLUZONE QUADRIVALENT (lot number not reported) on 01 October 2013 and an unspecified amount of time later was found to have an elevated heart rate. The patient's mother had been vaccinated and experienced difficulty breathing, throat feeling dry and coughing (captured in case 2013SA100435). The mother was treated with Prednisone, BENADRYL and Oxygen. No further information was available at the time of this report. Outcome was unknown. Documents held by sender: none. Follow up information received on 06 November 2013. Estimated date of delivery of mother was 07 December 2013. Mother had received treatment for infertility: sperm donor. Mother had previous 3 pregnancies with live birth. The lot number of FLUZONE was U4768AA. The mother had pregnancy complication of abdominal pain. Laboratory investigation included prenatal testing and USD was normal. Follow-up information received from a healthcare professional on 04-APR-2014 through the mother pregnancy report form. According to the form, the date of the last menstrual periods of the mother was on 16-MAR-2013. The mother past obstetric information mentioned 4 previous live births with no congenital abnormalities, no pre-term births, no elective abortions, no spontaneous abortions prior to 20 weeks gestation and no fetal deaths. The patient was born by cesarean delivery after 38 gestation weeks (there were not delivery complications). It was a single male of 53 cm height and 3.969 kg weight. He had no congenital anomalies. His APGAR score was 8 at 1 min and 9 at 5 min. To be noted that after internal review on 04-NOV-2013, it was clarified that the suspect product was not FLUZONE QUADRIVAL Thimerosal free vaccine (manufacturer Sanofi Pasteur SA) as previously coded but FLUZONE QUADRIVAL (manufacturer Sanofi Pasteur Inc.).
Left arm swelled, became warm to touch.  The swelling and red spread across my whole arm. 4/9 was diagnosed with an infection at the injection site. Was put on antibiotics- Cephalex 500mg ever 12 hours for 10 days.
pt recv vax 242PM c/o itching @ 246PM;redness & rash developed @ affected limb (lt upper arm) @ 250PM;area extended 2 inches above the site & 3 inches below;no other systems involved;parents refused IM DPH & recv DPH PO;
A few days after receiving the Janssen COVID19 vaccine, a palpable area on right side of neck developed.  A nodule on the Thyroid. Right lobe Hypervascular Heterogeneous nodule. No prior history of thyroid disease.  Ultrasound June 10, 2021 with 3.5 cm solid isoechoic nodule in the mid right thyroid.  Also with 1.4 cm predominantly solid isoechoic nodule in the inferior left thyroid. At the time of the ultrasound, the 3.5 cm right-sided nodule underwent fine-needle aspiration biopsy with cytology of follicular lesion of undetermined significance (FLUS).  It then underwent Afirma genomic sequencing classifier which classify the nodule was benign.
tenderness in her left arm; mild pain in the arm; This is a spontaneous report from a contactable consumer or other non health care professional. A 77-years-old female patient received bnt162b2 (BNT162B2PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200, Expiration Date: Jun2021), dose 1 via an unspecified route of administration, in Arm Left on 23Feb2021 (at the age of 77-years-old) as 1 ST DOSE, SINGLE (0.3MCG/0.3m) for Covid-19 immunisation. The patient medical history included seasonal allergy. The patient concomitant medications were not reported. It was reported that, the patient received the 1st dose of the vaccine on 23Feb2021 and experienced nothing more than a little tenderness in her left arm where she gets the shot. She stopped taking her daily Claritin for her seasonal allergies to Tree pollen a day before getting the vaccine until now because she has read on an article and hear on the news that it was not recommended to take antihistamines during Covid19 vaccination. She is due for her 2nd shot on 16Mar2021. She had her first dose but having a minor allergy and tenderness on her arm. she stopped taking the generic Claritin, loratadine 10mg a 24hr antihistamine, takes for allergy to tree pollen that is picking up and affects her year-round, has never had a serious reaction to anything. The patient is asking when she can resume her Claritin and it was reported that if taking the Loratadine 10 mg tablet for her preexisting allergy which she last took on a day before she got her first dose of Covid-19 vaccine on 23Feb2021 can affect the efficacy of the vaccine. Patient also said that she felt mild pain in the arm after she got the first dose of the vaccine which according to her is nothing much serious. The outcome of the events was unknown.  Follow-up(02Mar2021): New information received from a contactable consumer. Which includes: The event (she felt mild pain in the arm) was updated and clinical information added.  No follow-up attempt is possible. No further information is expected.
altered taste; Fever; chills; muscle aches; migraine; exhaustion; pain at injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 15:00 (Lot number: FH8028) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sulfa drugs, reaction(s): "allergy"; Neosporin, reaction(s): "allergy"; Penicillin, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 05Mar2021, when the patient was 60 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7533, Location of injection: Arm Left), administration date: 27Mar2021, when the patient was 60 years old, for COVID-19 Immunization; Tetanus, reaction(s): "allergy". The following information was reported: TASTE DISORDER (non-serious) with onset 31Oct2021, outcome "recovering", described as "altered taste"; PYREXIA (non-serious) with onset 31Oct2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 31Oct2021, outcome "recovering", described as "chills"; MYALGIA (non-serious) with onset 31Oct2021, outcome "recovering", described as "muscle aches"; MIGRAINE (non-serious) with onset 31Oct2021, outcome "recovering", described as "migraine"; FATIGUE (non-serious) with onset 31Oct2021, outcome "recovering", described as "exhaustion"; VACCINATION SITE PAIN (non-serious) with onset 31Oct2021, outcome "recovering", described as "pain at injection site". Therapeutic measures were not taken as a result of taste disorder, pyrexia, chills, myalgia, migraine, fatigue, vaccination site pain.  Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
1st dose, 12:10 pm pt c/o feeling flushed, rapid pulse, cold legs and body, funny taste in mouth, light headed, and nauseous. BP 140/80 HT 84  O2Sat 99% , Repeat VS 140/80 HR 72 O2sat 98%. Pt reports history of allergy to Augmentin, with hives. Denies anaphylaxis.  12:15 PM pt reported feeling a little better. Pt declined EMS evaluated that was offered. Pt signed Chesprocott refusal form and was given ED precautions. Pt was advised to contact her PCP this afternoon. Pt?s husband who was present the entire time will drive the pt home.
Information has been received from a nurse concerning a 25 month old patient who on 16-MAY-2011 was vaccinated with a dose of VARIVAX (Merck) (lot# 667234/1378Z). The nurse mentioned that on 21-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. A lot check has been initiated. Follow-up information has been received from the registered nurse via a completed B-form provided information that female patient with wheezing, Tinea Pedis and Onychomycosis, who at 3:30PM on 16-MAY-2011 was vaccinated with the first dose of VARIVAX (Merck) SC in the left leg, came to clinic on 21-MAY-2012 with a rash described as "moderate, generalized vesicules and pustules on face, scalp, upper/lower extremities", diagnosed as varicella. Lab diagnostic test were not performed. None illness at time of vaccination. Follow up visit on 26-JUN-2012 indicated that there were no rash and the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Patient reported experiencing dizziness, headache, and cough as of 3:00 PM day after getting flu shot.
Patient called day after receiving second Shingrix shot complaining of fatigue, nausea/vomiting, flushing, and chills.
Lower back pain and weakness and eventual dx of Guillain Barre Syndrome. In coma like state for 2 1/2 mo, ventilator assistance for 8 mo. In ICU for 6 mo. treated with Plasmapheresis and IVIG (inpatient rehab) for 1.5 mo and continued rehab as outpatient to current.
I had a typical reaction with my first dose. The second dose seem typical for the first 24hrs. After that joint pain increased all over and I started having muscle spasms. The fever went away by Sunday but them my arm started to turn red, heat up and swell at the injection site. It started out about the size of a quarter and grew to the size of my palm by Monday afternoon. My shoulder started to hurt at that point and still hurts today. The pain is from the front all the way around to the  shoulder blade and the headache that started on day 2 is still here.
Mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Mild sore arm). At the time of the report, PAIN IN EXTREMITY (Mild sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reporter.
Patient 1st noticed when she went to take a bath morning following vaccination. Redness and dark red dots extending from deltiod injection site diagonally towards inner arm -  approximately 4 inch wide red striation from deltoid to axillary region is swollen. Patient says it is tender entire arm from elbow to shoulder is warm to the touch. Muscle spasms in the bicep area. She had the PREVNAR vaccine 2 years ago, flu shot every year and has never had such a reaction similar to this which is why she decided to report this denies pain, denies itching, denies shortness of breath.
This spontaneous report as received from a pharmacist via company representative refers to a 68 year old female patient. On 21-AUG-2014 the patient was vaccinated with ZOSTAVAX lot no. K003601 (expiry 19-MAR-2014) 1 single shot injection. No concomitant medication was reported. In approximately August 2014 the patient experienced redness and swelling the size of a dollar bill down the back of her arm. On 22-AUG-2014, the patient called the pharmacy and then on 23-AUG-2014, visited pharmacy to show redness and swelling the size of a dollar bill down back of her arm. No itchiness was indicated. Lab diagnostics were not performed. The patient seeked medical attention in the pharmacy. Product quality complaint was not filed. The outcome of event was unknown. The causality of events with ZOSTAVAX was unknown. Additional information has been requested.
Pt c/o itching and tingling at site of injection.  Upon inspection RN observed redness, swelling, and irritation where pt had been scratching the site.  Offered to give pt benadryl on site, but pt refused because it "knocks her out" for 13 hours.  Advised to take a non-drowsy antihistamine when able, use cold compress, and stop scratching the site.  Pt was asked if she was having any other issues at that time, which she denied.  Telephone call made to patient at 4:18pm to follow up.  Pt stated she started to have an itchy throat and throat swelling and went to the hospital.  There she was offered Benadryl but declined.  She was given a steroid injection because she was having "difficulty breathing".  Pt states ER doctor recommended a non-drowsy OTC antihistamine, and was unable to tell her if the difficulty breathing was an allergic reaction or due to anxiety.  Recommended following up with 2nd dose in 4 weeks but to see her PCP before that time to discuss.  Pt does not have PCP, so I recommended that she establish care and have an appt prior to her 2nd dose