chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a health worker refers to a now 22 year old male patient with no pertinent medical history and no known drug reactions or allergies. There was no concomitant medication. The patient was vaccinated with 2 doses of M-M-R II (HSA) for required immunization on 01-JUL-1992 and 18-JUN-1996, respectively and now testing seronegative for measles. The patient sought medical attention by office visit. No treatment was given for the event. At the time of the report, the outcome of the event was reported as not recovered. Additional information has been requested.
Patient came into pharmacy consultation area complaining of flu site reaction from dose 5 days before.  She was 1st concerned shot waas given in wrong place.  She noted it was below deltoid and behind, closer to arm pit.  Area is now warm, raised and bumpy.
Upon awakening experienced dizziness, hot flashes, passed out and unconsciously urinated herself. No known treatment. Full recovery. Dr was made aware according to patient and could still get 2nd vaccine later, but patient says will not get it
12/23/21: Pt admitted to the hospital due to SOB from covid-19 pneumonia with acute respiratory failure. Pt was started on IV decadron, start pulmicort and combivent. Symptoms were >7 days therefore remdesivir was not started. Pt was given O2 by NC, titrating as needed.  12/24: Pt clinically improved. Discharged without O2. Pt was discharged with dexamethasone 6mg tab - 1 tablet once daily for 5 days and albuterol HFA prn.
Information has been downloaded from regulatory authority (US-CHIRONMA-PHHY2013US116901). This spontaneous report was received from a health care professional referring to a 1-year old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 25-JAN-2013, the patient was vaccinated with M-M-R II, 1 dosage form (dosage, strength, lot number, expiration date were not reported) and also with influenza virus vaccine (unspecified) 1 dosage form, both therapies indicated for immunisation. On 25-JAN-2013, the patient experienced fever of 102.4 (units not provided). On 02-APR-2013, the patient experienced a viral rash covering her entire body. On an unknown date, the patient was very irritable, crying, with sleep disorder, runny nose; the patient was a one-year old patient that received influenza therapy. The outcome of crying, viral rash, irritability, sleep disorder, rhinorrhoea and pyrexia was reported as resolved. The causality between the events fever, irritable, crying, sleep disorder, and runny nose with the therapies M-M-R II and influenza virus vaccine was unknown and the causality between the event viral rash and the therapy influenza virus vaccine (unspecified) was reported related. And for the therapy M-M-R II was unknown. The agency considered the all the events to be serious for the following reason: medically significant. Sender's Comments: 483880.
Seconds after vaccination with Varivax to the left deltoid, patient stood and collapsed hitting occipital area of head. Immediately awake and cried. Within ~ 1 minute from vaccination, developed urticaria on left forearm and face. no wheezing, no tongue swelling.
PAIN IN BOTH SHOULDERS OCCURING 5/14/22 AFTER SHINGRIX (FLU LIKE SYMPTOMS), PATIENTS LEFT ARM SORENESS THEN WENT AWAY 2-3 DAYS, 2 WEEKS LATER HAD SHOULDER LIMITATIONS, LEFT ONE MORE SEVERE THAN RIGHT ONE, ALSO SENSITIVITY ON BACK AROUND SHOULDER BLADES, PAIN HAS STAYED THE SAME AFTER ONSET 2 WEEKS AGO, PATIENT HAS NOT TAKEN ANY PAIN MEDICATION TO TREAT PAIN (PAIN LEVEL 4-5) AND CAN LIVE WITH IT. HAD A HX OF OSTEOARTHRITIS FLARE IN KNEES BEFORE, BUT IT FELT DIFFERENT
Busy clinic, late in the day and interpreter needed for adolescent visit for MCV and Tdap vaccines. HPV vaccine series completed previously. Nurse gave HPV vaccine given instead of MCV.
Hearing loss (right ear), ringing in ear,  vertigo, diziness, numbness in my head, pins and needles in my face, arms and legs Diagnosis: Labyrinthitis, Sensorineural hearing loss, BPPV  Recomendations: VRT with physical therapy, steroid treatment
(R) Leg reaction to KINRIX DTAP-POLIO- Friday 4-17-09 child had small knot. Saturday 4-18-09 child had knot 6 inches in diameter, hot to touch.
Chills; fatigue, could hardly stand; Sore tongue; headache; lips swollen due to the soreness; muscles spasms; Sore mouth; low fever 100.1 F; A spontaneous report was received from a type concerning a 75-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, fatigue, glossodynia (sore tongue), headache, lip swelling (lips swollen due to the soreness), muscle spasms, oral pain (sore mouth) and pyrexia (low fever 100.1 F).  The patient's medical history was not provided. Concomitant medications reported were alpha lipoic acid, atorvastatin 40mg, calcium, flowfe iron supplements,  letrozole 2,5mg, losartan 30mg, melatonin, omeprazole 40mg, sertraline 150mg,  vitamin A, vitamin B, vitamin C, vitamin D3, zinc for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 023M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced headache, muscles spasms, low fever 100.1 F, fatigue, could hardly stand, chills, sore mouth, sore tongue and  lips swollen due to the soreness.  Treatment details included : Tylenol every 5 hours since 4 in the morning on the 20 Feb 2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, fatigue and fever are consistent with the known safety profile of mRNA-1273
9am (jan 14th) noticed bleeding under skin: 2 dark purple dark red areas (1.5" diameter and 2" diameter)  on front of left hand. No pain /itching. Had no physical activity that day or the day before after.  I noticed them because they looked like severe bruising or burn symptoms but had no pain in the areas.  They were very noticeable and my bruises always hurt.  These did not. Saw a telehealth provider and was told it was  purpura  / petechiae.   I'm not sure about the lot number because the  Covid-19 Vaccination card is almost illegible. It is definitely Moderna and  the lot number is definitely "011_ _0A".  The first unknown digit is either 5 or S and the second  unknown is J or 2.  Site number is hard to see. THERE IS NO HOSPITAL OR CLINIC ON THIS ISLAND.  SHOULD I GET THE SECOND DOSE HERE?    I am pro-vaccines but am afraid to get second dose if the first dose is related to a blood clotting reaction.
10 days post vaccination, developed measles-like rash (maculo-papular) that begin on extremities and groin and spread centrally. Rash was pruritic and uncomfortable. No other symptoms.
Next day (less than 24 hours), after vaccination, my tattoo on opposite arm (vaccine administered on left arm, reaction occurred on right arm) welted up slightly with a burning, itchy sensation.  I'm not 100% sure, but I think there was slight oozing of fluid from the reaction site). No treatment administered, aside from taking  two, half-doses of diphenhydramine (half pill each time).
had a similar reaction / swollen armpit up to her collarbone on the side of the vaccine; their doctor drained their lymph node; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "had a similar reaction / swollen armpit up to her collarbone on the side of the vaccine"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "their doctor drained their lymph node".  Additional information: Report 2 of 2 on female that had similar reaction. Caller stated she was calling because she has side effects and when she got it middle of last year, the vaccine, they told her from where she got it to go to a website with the CDC and report her issue, so she has been doing that. Stated that somebody else said to contact Pfizer and see if there was anything else she should be doing, that she may have to go to the doctor. During report caller stated she was talking to someone that had a similar reaction with the vaccine and their doctor drained their lymph node so she didn't know if that was something she needed to do or if Pfizer had doctors she would go see. Caller relays she was not sure which vaccine they had and thinks that she or her doctor made a report about it already. No further details provided.  Follow-up attempts completed. No further information is expected.
She experienced pain & swelling in her right arm around 7PM (approximately 4 hr after the shot). It spread to the elbow & chest. She put ice on it & took a CLARITIN. She could not lift her arm on 9/15. She is doing much better as of 9/16 at 4:00 pm. Saw MD 9/15.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized for COVID-19 pneumonia and bacterial pneumonia. Administered oxygen, steroids, remdesivir, and antibiotics. Discharged medically stable and on follow-up continues to improve.
closing up of throat; shortness of breath; Trouble breathing; This is a spontaneous report from a contactable consumer (patient herself).  A 24-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 29Mar2021 15:00 as Dose 1, single for COVID-19 immunization and administered at hospital. Medical history included bipolar disorder, fast heart rate, urinary problems, insomnia; all from an unknown date and unknown if ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination and since the vaccination, the patient not diagnosed with COVID-19. The patient received other medications (concomitant medications) within 2 weeks of vaccination. The patient previously took bactrim and cephalexine; experienced Drug allergy. On 29Mar2021 19:00, the patient experienced closing up of throat, shortness of breath and trouble breathing. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
slightly injured left knee while working out; This spontaneous case was reported by a patient and describes the occurrence of JOINT INJURY (slightly injured left knee while working out) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 016C21A and 016B21A) for COVID-19 vaccination.     Its unknown if the patient ever been diagnosed with/ tested positive for COVID-19.  The patient's past medical history included Nail fungal infection NOS on 18-Dec-2007 and Subluxation patella (Last major injury was in 1987.) on 01-Jun-1987. Concurrent medical conditions included Allergy to antibiotic (Neomycin), Latex allergy, Allergy to antibiotic (Cephalexin), Arthritis (After 4th Moderna shot, left knee worsened - knee swelling) since April 2014, Osteoporosis (Ongoing bone decay) since 03-Dec-2010, Osteopenia (Ongoing bone decay) since 03-Dec-2012 and Pre-diabetes. Concomitant products included VITAMIN B COMPLEX (VIT B COMPLEX) from 2007 to 15-Mar-2022 for Anxiety, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]) from 2014 to an unknown date and DOCOSAHEXAENOIC ACID, EICOSAPENTAENOIC ACID (OMEGA 3 FATTY ACID) from 2019 to an unknown date for Arthritis, L-LYSINE [LYSINE] from 15-Apr-2016 to an unknown date and VALACYCLOVIR [VALACICLOVIR] from 15-Apr-2016 to an unknown date for HSV infection, ASCORBIC ACID from 2000 to an unknown date for Immune imbalance, ZINC PICOLINATE from 2000 to an unknown date for Injury NOS, FERROUS BISGLYCINATE (IRON BISGLYCINATE) from 2002 to an unknown date for Iron low and Dizziness, VITAMIN D [VITAMIN D NOS] from 2010 to an unknown date, VITAMIN K NOS from 2010 to an unknown date, CALCIUM from 2010 to an unknown date and MAGNESIUM for Osteoporosis, VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced JOINT INJURY (slightly injured left knee while working out). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 23-May-2022, JOINT INJURY (slightly injured left knee while working out) had resolved with sequelae.            On 11 Apr, patient had a minor injury that didn't require much attention. Patient have not dealt with patellar subluxation since 1987 when right kneecap popped out due to a ballet dance injury. Since then, patient's knees have been in fairly good shape, with very minor subluxation that eventually corrects itself within a day. Zoster vaccine recomb adjuvanted (Shingrix).   This case was linked to MOD-2022-549599 (Patient Link).
Pt recvd 3rd dose of vax on 24AUG92 & devel a sore arm @ the inject site; No further details were provided
Information has been received from a physician concerning a male adolescent who on an unspecified date was vaccinated with a 0.5 ml dose of GARDASIL. Subsequently, on approximately 01-SEP-2010 (reported as "in the last week or 2), the patient started feeling faint but never fully passed out. The patient sought unspecified medical attention. The patient recovered after stopping the therapy (same day as the adverse event). No further information is available.
7mm x 5mm lump in arm that is painful, red but not hot.  Fever, joint pain, headache, fatigue, sore throat and shortness of breath started 24 hours after vaccine but resolved after 24 hours.
passed out after the first COVID vaccination; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jul2021 13:30 (Lot number: EM0179) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Sinusitis" (unspecified if ongoing). Concomitant medication included: ADVAIR. Past drug history included: Augmentin, reaction: "Allergy". The patient has not had other vaccine in four weeks.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "recovering", described as "passed out after the first COVID vaccination".   No follow-up attempts are possible. No further information is expected.
Had a heart attack the next day after this vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 29-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Had a heart attack the next day after this vaccine". Clinical course: Reporter stated that he knew a 29 year old person who had a heart attack the next day after this vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352878 Same product, different event /patient;
Pt recvd 3 doses of Engerix-B on 23JAN91, 20FEB91, & 16JUL91; 22OCT91 post HBSAB was 1.4RU which is interpreted as neg (no immunity);
Fever 100 Chills / sweats Nausea Headache  Fatigue
Left arm turned red then black and blue and swelling.Pt also had 3 intense headaches.
Client had rash on arms, stomach, palms and soles of feet. Took Benadryl 10/23/07 and relieved symptoms. Woke up on 10/24/07 with rash again. Taking Benadryl as needed. Rash slowly going away.
Swelling and tenderness to left lateral deltoid.  Tenderness to left supraclavicular.
patient has redness, soreness and itchiness on skin below the deltoid where the flu shot was administered. Patient has had the vaccine multiple times before but believes this side effect has been caused by the vaccine.
Case number PHEH2015US021579, is an initial spontaneous report from a nurse received on 21 Oct 2015. This report refers to a 47-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 1517401) intramuscularly at a dose of 1 ml in error on 21 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
This is a spontaneous report from a contactable reporter (consumer or other nonHCP). A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 05Dec2021 at 02:15 (Lot number: FF8839) at the age of 48 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None" (unspecified if ongoing), notes: Not applicable. Concomitant medications included: ADVIL and ATHLETIC GREENS supplement. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP6955, Anatomical site: Left Arm, Route of administration: Intramuscular), administration date: 18Mar2021, when the patient was 47 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP6955, Anatomical site: Left Arm, Route of administration: Intramuscular), administration date: 08Apr2021, when the patient was 47 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021 at 02:15, outcome "unknown", described as "Dose received: 3"; AXILLARY MASS (non-serious) with onset 07Dec2021 at 08:30, outcome "unknown", described as "Lump under left armpit since morning of 12/07"; LYMPHADENOPATHY (non-serious) with onset 07Dec2021 at 08:30, outcome "unknown", described as "seems like swelling lymph nodes (as described in some web reports)".  Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary mass and lymphadenopathy.Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had a recent (<3 months) negative mammography. The events resulted in doctor or other healthcare professional office/ clinic visit.
Severe body aches, chills, low grade temperature 100.1 degrees, headache, and pressure around eyes.
pt recvd typhoid shot 10 mins later had chills & aches; 2 hrs later was brought into acute care clinic w/fever & vomiting (t104.4);
Approximately 24-36 hours after receiving my second dose of the Pfizer COVID-19 vaccine I started having three noticeable side effects: pronounced exhaustion, occasional mild headaches, and a transient heart arrhythmia usually lasting 5-15 seconds.  These symptoms have not subsided and the arrhythmia became persistent enough last night that it required a trip to the local ER. The first doctor I spoke to, informed me that he had been out of work for a week following his second dose of the Pfizer vaccine due to transient, but consistent, heart palpitations, which ultimately brought him into the ER to take his own EKG. He advised me that a number of other patients with identical complaints had come to the ER over the last 4-5 weeks. Ultimately he referred me to a local cardiologist and told me not to worry about the arrhythmia, that it would clear up in a few days. I?m curious why this isn?t listed as a common side effect of the vaccine, had it been, I would not have been so concerned about it.
Info has been received from a health professional concerning a 6 year old white male with no known medical history or allergies who on 7/14/00 (previously reported as 7/15/00) was vaccinated, IM in his right thigh, with 0.5 mL, "standard dose for child", of varicella virus vaccine live (lot 632371/1464J). Concomitant vaccinations that day included a 1st dose of MMRII (lot 631639/0109K) in the left thigh and 4th dose of Hib-Titer (lot 581313A) in the left thigh. There was no illness at the time of vaccination. On 12/29/05, the pt developed a case of breakthrough. On 12/29/05, the child began to feel itchy and run a fever. On 12/30/05, he developed about 50 lesions on his trunk, arms and legs. Unspecified medical attention was sought. The doctor prescribed acyclovir to treat the symptoms. No labs or diagnostic tests were performed. At the time of the report the pt had not yet recovered. No product quality complaint was involved. Follow-up info was received from the health professional that indicated that on 12/29/05, the pt's parent noticed a red bump on the pt's trunk then more the morning of 12/30/05. He had a fever of 100l.2F, the morning of 12/30/05. The pt was examined in the office 12/30/05. He was dx'd with varicella and given a prescription for acyclovir, 400mg 5 times a day for 5 days. Additional info is not expected.
Patient was given vaccine and Nurse did not know that patient received bivalent vaccine already in September. Patient did not disclose that they already had this vaccine. No documentation provided about it
Patient returned to clinic 6/17/2011 1 1/2 inch circular erythematous swelling (R) lateral upper arm.
I received the shot Friday and early Saturday am around 3. I woke up with the chills, was warm etc.. Through out the next day all day and night , i was in bed, with muscles pain, chills and nausea and was so tired. The fever would come and go. I took Tylenol for treatment. I had no appetite until , i woke up Sunday morning around 9. Got up , ate and later Sunday felt much better. Monday, back to feeling my old self but  i noticed a large swollen lump under my left armpit when i showered. In the left arm i was injected. Today ,  the large lump, its still there rather large.
Patient developed chest pain and tachycardia. Diagnosed with pericarditis.  Symptoms started 11/24, hospitalized 11/30.  Discharged 12/1 and improving 12/2 with scheduled NSAIDs.
Numbness and tingling in left ulnar nerve starting 2 min after injection into left deltoid. 6h after injection began the flu like symptoms: fever 101, systematic joint ache, fatigue, diarrhea, loss of appetite, and sweats. Symptoms lasting for ~38h.   Treatment:  Tues: nyquil  Wednesday:  dayquil, advil, and nyquil  Thursday by 1030a, 44h after injection did symptoms subsided suddenly.
Fully vaccinated with moderna x2. Tested positive for Covid 01/25/2022. Admitted to hospital on 02/07/2022. Expired on 02/10/2022 while still hospitalized.
A couple day after vaccination I started experiencing vertigo. I felt as if the room was spinning. The intensity came and went. It was continuous through February 2nd-3rd. Dr. Put me on me sea-sickness meds that I took a couple time was not helpful.