chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Broke out in itchy, swollen, red rash. Began as single spot on right eyelid withing 4 hours of receiving vaccine. Spread over first week, across temple and forehead and chin, later on belly (which spread to cover 1/4 torso below waist on front side), between legs on both sides at top of inner thighs, latter on outer thighs of both legs. Felt like needles pricking skin if fabric touched skin. Lasted three weeks. However, at three weeks I am sill not over the rash. I can now function normally, even though the skin is still red and slightly itchy.  Oddly, the rash was strong on the right side of my body with a fainter mirror image on the left side. I reported all this on the V-SAFE app.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 90-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 06-JUN-2014, the patient was vaccinated by a pharmacist in pharmacy with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) prescribed by a health care provider for the long-term prevention of shingles and zoster-related conditions by healthcare provider. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
I woke up at 3:30 a.m.  lightheaded.  I went to the bathroom and on the way back to the bedroom I fainted.  I regained consciousness and realized that I was on my knees on the bedroom floor.  I felt as though the room was whirling and fainted again.  I woke up to find that I was laying down on the bedroom floor.  At that point, I heard my husband asking me what happened.  I felt him pick me up and put me back in bed.  He didn't sleep the rest of the night listening to me to make sure I was breathing,  I woke up in the morning feeling fine, no more symptoms.  While my episode was going on, I never thought to call for help from my husband.  Very unusual for me not to do that.  I just didn't think about talking, strange for me.
My doctor described it as ?Covid Arm?.  Red, very itchy ?ring? around injection site. Warm to the touch.  Still present and today is exactly 3 weeks post-injection Moderna 1st dose.  Occasional Benadryl and topical steroid, but itchyness & redness persist.  Am  scheduled  for Moderna 2nd dose next Fri, Feb 19.  My doctor said to get 2nd dose in other arm (right arm).
Patient received pneumococcal (PCV7) vaccine on 1/17/06. Received phone call from mother on 1/19/06 to report excessive redness and swelling to site of injection measuring 3" x 4." Larger than expected local reaction.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-DEC-2017, the patient received an expired dose of properly stored VARIVAX injection, 0.5 ml, subcutaneous route, lot # L048466, expiration date 02-DEC-2017, for prophylaxis. It was reported that the VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) lot number M023895, expiration date 18-JAN-2019. No adverse effects reported.
The next day I awoke with a mild sore shoulder, typical to previous vaccinations.  As the day progressed I became increasingly tired to the point of complete fatigue. Around 3 pm I laid down to rest and fell asleep, I did not awale until the next day at 11 am.
neighbors that tested positive on 29Dec2023; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (neighbors that tested positive on 29Dec2023) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Dec-2022, the patient experienced COVID-19 (neighbors that tested positive on 29Dec2023). At the time of the report, COVID-19 (neighbors that tested positive on 29Dec2023) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2022, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient had had less symptoms. Treatment medication was not reported.  This case contains information for the 3rd of 3 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-696687 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-696687: Reporters case
I had a metallic taste in base of my throat and after that I have like burning in my throat; I had a metallic taste in base of my throat and after that I have like burning in my throat; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 65-year-old female patient received bnt162b2 (BNT162B2, Covid Vaccine, lot: EL3247, Expiration Date: 30May2021), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. Consumer stated, "I had the shot (Covid vaccine, Pfizer) a couple of days ago and I experienced the weird side effects. I just wanted to know if that was normal things or if I need to report this? I had a metallic taste in base of my throat and after that I have like burning in my throat. I had another question before you change. I was reading the pamphlets that was given to me at the clinic and it says that it is been in clinic trial an approximately 20,000 individuals have received the vaccine is that all? I had the vaccine on 21Jan2021 and it started immediately afterwards. No, it went away on following day." No treatment received. The outcome of the event was recovered in Jan2021.
Second SHINGRIX immunization w/in 6 months - first was 2/13/18, last one was 6/28/18. I'd noticed weird tingling in my back, across my ribs horizontally and actually had a dermatologist mention it looked like I had a shingles outbreak in a visit some months after the first shot. This last injection seemed fine at first, but later that day, I became achey with chills. The following day, I had a terrible headache, fever, chills and threw up repeatedly...I was in a bed a full 36 hours and a bit shakey after being able to eat, the Saturday following the Thursday immunization. I have heard other people say they have had a rough time following this injection, as well, the tingling continues and it's not painful but weirdly bothersome, to say the least.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received SHINGRIX. On 16th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 16th May 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 17th May 2018, the patient experienced pain, tiredness, fever and sweating. On an unknown date, the outcome of the pain in arm, pain, tiredness, fever and sweating were unknown. It was unknown if the reporter considered the pain in arm, pain, tiredness, fever and sweating to be related to SHINGRIX. Additional details were provided as follows: The patient also reported that in the middle of the night he felt sweaty, tired, achy, and feverish. The patient was taking other medications but the pharmacist did not have access to them.
This spontaneous report refers to a patient who is also a pharmacy student (reporter) unknown age. On 05-NOV-2013, the patient was exposed to ZOSTAVAX vial (dose, lot and expiry date unknown). The pharmacy student informed that some of the ZOSTAVAX might have spilled on her face, and possibly in her mouth, due to the leakage from the syringe. This is 2 of 2 reports from the same reporter. Additional information has been requested.
Symptoms started at noon 4/2/21.  Was very sick with fever 100.8  Noticed red left arm with rash and hot and inflamed below where shot was given, approximately 6 inches in length.  Client went to urgent care 4/3/21 and saw Dr. (Name).  She was prescribed Keflex 500 mg TID for 10 days.  She also took Tylenol 500 mg 4/2/21 for discomfort.  Patient feels that area was not cleaned enough with alcohol swab.  Writer had spoken with client 4/5/21 and she said that are was 75% better with respect to redness and discomfort.  On 4/12/21 she said that arm was much better with slight itchiness.  "Old" area of redness or swelling. Afebrile.  3 more days Keflex left to complete.
Swollen lymph nodes in left armpit; pain and tenderness to touch in left armpit and side of left breast; some tenderness in right armpit when touched  Resolved 7 days after vax
Within 4 days of receiving the vaccine. Respiratory distress and anxiety developed. Dark brown vomit then died the next day.
Pt c/o body aches, joint pain, urinary frequency, weakness, possible fever.
This case was reported by a consumer via call center representative and described the occurrence of leg pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced leg pain and meralgia paresthetica. On an unknown date, the outcome of the leg pain and meralgia paresthetica were unknown. It was unknown if the reporter considered the leg pain and meralgia paresthetica to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was a female from 70 to 74 years old. The patient mentioned having the two shingles shots (assumed to be SHINGRIX). The patient given the 2nd dose of SHINGRIX either at one pharmacy or another pharmacy, she experienced a pain in her leg from 4 inches above her knee to her hip. The patient's physician told her it may not be from the shingles shot but could be due to possible meralgia paresthetica due to the lateral, femoral, cutaneous nerve coming out of the pelvis. This was all the information the caller provided.
Information has been received from a nurse referring to a 15 weeks and 2 days old female patient. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 20-AUG-2018, the patient was inadvertently administered her first dose of ROTATEQ (dose and frequency were not provided, lot # N030175, expiration date 16-JUN-2019) orally for prophylaxis at age 15 weeks and 2 days (drug administered to patient of inappropriate age). No adverse effects were reported.
I was woken up at around 2:40am, after 4.5 days of getting the 1st doze of the Pfizer vaccine, by intense itchiness under the arms. Then, realized that I had rashes all over the body, around the neck, and legs/hands. Raised patches, extremely itchy.  I called my Dr to let her know. She didn't think it was related to the vaccine. However, I did nothing different from every day; no new food, no new circumstances. The itchiness lasted for about 3 days. (I took Benadryl two nights in the row). Today is 9th day, no more itchiness, but the body still has pink areas here and there, indicating that rashes were there. I'm actually worried if I should get the second doze. It its scheduled for April 2nd. I did take pictures of the rashes.
Profound swelling on left arm to elbow. Swelling moved to underarm and left side of chest by second night. Pain is unbearable. Motrin and benedryl taken without relief. Call placed to all support numbers without any further recommendation at that time. To Clinic this am 1/11/2021. Told to be seen in the ER because there is nothing they could recommend at this time and no plan is in place for this reaction to the vaccine.
I sustained a punctate right occipital stroke in a cortical location confirmed by MRI on brain. I suffered Left side numbness and left eye blindness for around 2 hrs and continued partial loss of left eyesight for several days.
Vasovagal syncope ~20 hours post vaccination. Happened after a short 5 minute walk.
Pt developed stroke like sx the morning after second COVID vaccine including weakness and numbness of R extremities. PCP ordered MRI the following Monday that showed an acute lacunar infart of the L periventricular white matter between the caudate nucleus and thalamus, likely embolic from untreated afib and CHADS-VASC 4.
RN inadvertently administered Pfizer Bivalent, client had not had primary series. During questioning client understood to have had primary series, though difficult to understand, on re-review of paperwork RN noted client checked box stating had not had any covid-19 vaccine, at which point RN noted error.
Post vax, the pt appeared flushed and had a fever that fluctuated between 100.1 to 104.8. The pt ran high fever for more than 3 days, also had spotted rash on trunk, arm, and legs; and had swollen glands in pelvic area/groin. Fever would spike and drop over 3 days. Pt was treated with tepid baths, clear liquids and water, and Tylenol.
Headache, sore arm at injection, leg cramps - evening of injection  >>> Blood pressure spike to 150/100 on second evening after injection, felt funny, bad sleep <<<
This spontaneous report was received from a healthcare worker and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 23-DEC-2015, the patient was vaccinated with an improperly stored M-M-R II (lot # K021151, expiry date 02-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
arm soreness; headache; This is a spontaneous report from a contactable consumer. A 59 year old female patient had received bnt162b2 (Pfizer-biontech COVID-19 vaccine, Solution for injection, Batch/lot number: EL1283 was reported) via an unspecified route of administration on 26Jan2021 as DOSE 1, SINGLE for COVID-19 immunization(at age of 59 years). The patient medical history had included type 2 diabetes and concomitant medications was Metformin hydrochloride, Sitagliptin(JANUMET,500-100mg , take two tablets once a day).The patient did not take any vaccination within 4 weeks prior to vaccination. On 27 Jan 2021 the patient had experienced arm soreness and a slight headache. On Jan 2021 the clinical outcome of the event was recovered.  Follow-up (28May2021): Follow-up attempts completed. No further information expected.
Congestion, lots of nasal fluid and cough, fatigue have been pretty mild. The doctor did a rapid and PCR test were given yesterday 9/19/22. She prescribed me FLONASE and MUCINEX but I'm not feeling that bad so haven't taken anything.
Flu like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6206) via an unspecified route of administration on 10Mar2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Mar2021, the patient experienced flu like symptoms. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event flu like symptoms was resolved on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Encounter for lap cholecystectomy; incidental finding of COVID+ on preprocedure swab; asymptomatic
c/o (R) arm "very sore" from her ear to her hand", pain level 0-10 scale at "7" also c/o "pink tonsil, sputum when she coughs. Has "red spots of blood in it too. Sx stared evening after Pneumonia shot. Cough comes intermittently about 5 times since 10/08/08. Can't take Ibuprofen or TYLENOL since Kidney transplant (not antihistamine suppressants)
Swelling of Lymph on the left side of bottom of neck within a half hour. Then in evening of that day, swelling of face, eye lids, lips with tingling, hands, feet, tiredness, headache, muscle pain, neck pain real bad on the left side more, joint pain, feeling unwell, brain fog, dizziness, weakness, difficulty breathing at times. This lasted for 3 days, and after 15 days I now have Pink eye, swelling in hands yet and breathing is short at times.
A non-serious spontaneous report of administration of expired product was received from a clinic administrator concerning a 12-year-old female subsequent to the administration of FLUMIST. The patient's medical history and concomitant medications were not reported. On 22-Feb-2010, the patient was administered FLUMIST. There was no adverse event associated with this vaccination error; therefore treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. No late occurring adverse events were reported. Additional information was received on 13-May-2010 and incorporated into the narrative: information on late occurring adverse events.
Three days post DTaP, the pt developed red rash at injection site. Five days post vaccination, he developed systemic urticarial rash.
Pt came in for second dose, and when pt came back for him to fill out card we noticed he got dose early 12 days after the first.
Fever not as high as 101; Chills; Hard, red injection site; Fatigue x 36 hr; Drenching night sweats - continue through today - no sign of stopping. Hair loss worse than ever before - alopecia areata onset age 6. 1 month after SHINGRIX: Patient developed croupy cough Feb 5, 2019. Drenching night sweats got much worse on 2/9/19. (Home scale) weight loss 2/10 - 2/17 and hunger - stabilized at 127 # (Down from 130 # on 2/9/19). 2/8/19, BP 111/68, P 69, O2 sat 99%, lungs clear, heart S1, S2, RRR. HT 169.0 cm; WT 59.4 kg dressed. PCP prescribed fluticasone nasal spray - used it for a days until nose was too dry 2/6/19 - 2/10/19. Hair loss patient stated dramatically worse after 2nd SHINGRIX dose. Alopecia areata ophiasic pattern since childhood. Scalp corticosteroid injections were stopped in 2018. Last dose 10/12/18. Lack of benefit and scalp atrophy were reasons for stopping q 4-6 injections. Onycholysis with intermittent paronychial  swelling and pain since summer 2018; did have episode in late Dec (telephone call documented in medical record at dermatology practice) visit on 1/24/19, loose nail remnants were removed of nails beds left 1st and 3rd. She also started topical triamcinolone 0.1% ointment, KENALOG injection were performed by PA-C at dermatology. Patient was also using tea tree oil in December stopped. Patient has been seeing physical therapist for thoracic back pain and left greater than right functional instability of upper quarters (scapular motion pattern). Previous C-Reactive Protein levels were all under reference lower limits; from 2008-2014. Hgb A1C was 5.8 - 6.0% on 2/14/19.
Within 1 hour after vaccine administration, the patient had sudden onset of severe vomiting, pallor and lethargy. The patient was clammy. He was observed in the office and received oral hydration for 5 hours.
Prolonged excessive crying. Severe swelling and redness of the entire thigh where injection took place. Administered Infant Tylenol (0.4ml) once before bedtime.
hand feeling like it was numb; Tingling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Mar2021 11:00 (Lot number: ER2613) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid" (ongoing); "Rosacea" (ongoing); "cholesterol" (ongoing); "may-thurner" (ongoing); "gall bladder removed" (ongoing), notes: gall bladder removed. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder (ongoing); ASPIRIN (E.C.) (ongoing); DOXYCYCLINE taken for rosacea (ongoing); ATORVASTATIN taken for blood cholesterol abnormal (ongoing); VITAMIN D3 (ongoing); CALCIUM (ongoing). Vaccination history included: Bnt162b2 (1st dose, Time: Noon, Anotomical site of injection: left arm, Route of Administration: Intramuscular, Batch/Lot number: EN6202), administration date: 24Feb2021, when the patient was 72 years old, for Covid-19 immunization.  The following information was reported: HYPOAESTHESIA (non-serious), outcome "recovered", described as "hand feeling like it was numb"; PARAESTHESIA (non-serious), outcome "recovered", described as "Tingling".  No follow-up attempts are possible. No further information is expected.
The night of the vaccine she developed fever and chills. 3/17 she had bowel and urine incontinence and her daughter told her to rest and then she insisted on getting into the shower because she was upset about the incontinence 9:15 am she had gotten in the shower and her other daughter was close by when she had bowel and urine incontinence again and then lost consciousness and then she came to and had bowel and urine incontinence for a 3rd time. The bowel movements were massive diarrhea. Reporter believes she had a TIA event (Mini stroke). She was cared for at home by her daughter who is a nurse. In the past, when she has high fever and chills she tends to have TIA events.
Large black and blue mark about 4" wide and 1" - 2" high.  And, a red mark below it.  Some swelling, warmness, and itching at the site. A little fatigue.  A little nausea.
Pain; Chills; Body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Pain), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Fatigue). At the time of the report, PAIN (Pain), CHILLS (Chills), MYALGIA (Body aches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. No treatment was reported.   This case was linked to MOD-2021-183220 (Patient Link).
Vesicular rash at site of PEDIARIX injection (DTaP/HBV/Polio).