chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11 year old male with right arm localized reaction (redness, swelling) 1 inch of erythema surrounding injection site (+) Induration. No fever, spread of rash, difficulty breathing.
6/19/09 patient felt some pain in her upper left arm and felt a small bump.Seen at this office 6/25/09. She has a 1 cm soft cyst-like nodule which is in the general area of her Gardasil injection. No erythema, induration, heat. It is palpable but not visible.
Left shoulder pain, induration, and redness. Swollen lymph node on axillae. HA for 3 days. Two satellite lesions near vaccination site.
RED ITCHY SPOTS ON LEGS, ARMS, HANDS, BACK.  ER SAID ALLERGIC REACTION.  NO RECENT CHANGE IN FOODS, DETERGENT, SOAP OR ANY THING ELSE.  RECIEVED VACCINE WAS H1N1 SHOT.  HAVE GOTTEN WORSE SINCE ONSET.  2ND DOCTOR WANTS TO SET UP CONSULT WITH IMMUNIZATIONS CLINIC.
Ear ache in both ears immediately following vaccine.  Next day fever , chills, headache, nauseous, aches & pains mostly in back, exhausted, sore throat, oxygen was 87-90 , and heart rate 90. These symptoms lasted all day into the evening.  The next morning 3/21/21 I felt better except for my ears, and throat still hurt, and my mouth had developed soreness and felt inflamed and raw in spots.  Have several spots that are still tender. Mouth ears and throat still not well. Went through whole bottle of Mary?s magic mouthwash. Still no relief.
Pt. reported redness and swelling at site and down to inside of arm starting on day 3 after inj. It worsened from day 3 to day 5 with warmth to touch and then started to resolve. She reports complete resolution at this time. No treatment was required.
Aches all over my body; headache, extremely tired, very hot (but did not take temp).
Severe break out with hives and blisters all over body. Worse on hands and feet. Very itchy, red, inflamed, and affecting quality of life. Has been going on since a few days after covid vaccine. Also happened after the initial doses but I didnt suspect it was the vaccine until I got the booster. The booster confirmed my suspicion. I am highly affected by this rash. My hands are bleeding, I can?t shower, cook or do anything.
Experienced an elongated menstrual cycle going from an average of 28 days to 35 days for next 6 months.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 (Lot number: EL3247, Expiration Date: May2021) as dose 2, single and administered in arm left, administration date 11Mar2021 (Lot number: EL3247, Expiration Date: May2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset May2021, outcome "recovered", described as "Experienced an elongated menstrual cycle going from an average of 28 days to 35 days for next 6 months."  Additional Information: After two doses of Pfizer Covid vaccine in Mar and Apr the patient experienced an elongated menstrual cycle going from an average of 28 days to 35 days for next 6 months. COVID-19 vaccine dose 2 resulted in disruption to menstrual cycle previous menstrual cycle length of 26-28 days for past 12 month and very regular cycle starting may2021 (after 2nd vaccine) menstrual cycle elongated by an extra week May-32 days, June-34 days, July-35, August-34, September-31 days. No other changes to patients lifestyle daily exercise etc. patient is not on any other medications and does not take birth control and does not have an IUD.   No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after 4 vaccines Moderna 3/23/21 Lot# 008B21A;  Moderna 4/20/1 Lot# 002C21A;  Moderna 12/1/21 Lot# 031H21A;  Pfizer 9/15/22 Lot# GH9702
Student developed a rash on his neck, abdomen and back approx. 2.20 pm (per child's mother he developed a rash the day before which quickly subsided).
pt was vaccinated, stated he felt like he was "going to pass out," stumped over in his chair & was lowered to the floor in a sitting position by vaccinator & another staff. Patient exhibited symptoms- clammy/ pale skin, sweating, & some shaking of body.    B/P 60/30 HR 38.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 19-OCT-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (lot # L009214, expiration 17-MAR-2017, dose and route were not reported) (incorrect product storage). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
Within 5 minutes of vaccines patient became pale, sweaty, dizzy and felt like he was going to pass out and throw up. BP 80/50. HR 98. Alert, oriented, articulate. With cold rag to neck, rest, pedal exercises and popsicle patient felt fine and color returned and vs WNL within 10 minutes, left office in well condition.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 02-JUL-2018, the patient was vaccinated with a improperly stored dose of ROTATEQ orally, lot # N030175, expiration date 16-JUN-2019 (strength and vaccination site were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion at or above 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 84 hours. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA010993: US-009507513-1807USA010995: US-009507513-1807USA010304.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX (batch number 37KL2, expiry date 12th February 2021) for prophylaxis. On 18th July 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced swelling arm and intramuscular formulation administered by other route. The patient was treated with BENADRYL and Ice Pack (Nos). On an unknown date, the outcome of the swelling arm and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the swelling arm to be related to SHINGRIX. Additional details were reported as follows: The reporter was a pharmacist calling on behalf of the patient. The reporter stated that the patient received SHINGRIX subcutaneously on left arm, which led to incorrect route of administration. The reporter also reported that the patient had a swollen arm after the SHINGRIX dose. The patient used BENADRYL and ice on the swollen arm. The reporter stated that she would also be filling out a VAERS report for this event.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 11:00 as dose number unknown (booster), single (Lot number: gh9694), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Dec2022) Positive; (08Dec2022) Positive; (09Dec2022) Positive; (10Dec2022) Positive; (11Dec2022) Positive; (12Dec2022) Positive; (13Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received vaccine and Other medication in 2 weeks. Other medication details: Other medication in 2 weeks product: Alka Seltzer Plus Cold Medicine. Other medication in 2 weeks brand: Alka Seltzer, Other medication in 2 weeks start date: 01Dec2022, Other medication in 2 weeks stop date: 10Dec2022. Covid symptoms of cough, runny nose, sore throat, fever and congestion returned 07Dec and tested positive. Covid symptoms and positive test results continued through 13Dec.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 20-JUL-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K023432, expiration date 18-JUN-2016, dose, route and dose number were not provided). Excursion temperature and time: -0.6 degrees Celsius for 1 hour and 53 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
TINGLING PRICKLY FEELING IN HANDS; SHIVERS; DIDN'T FEEL TOO WELL; FEVER OF 39 DEGREES; WEAK; This spontaneous report received from a consumer 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 was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced weak. On 10-AUG-2021, the patient experienced tingling prickly feeling in hands. On 10-AUG-2021, the patient experienced shivers. On 10-AUG-2021, the patient experienced didn't feel too well. On 10-AUG-2021, the patient experienced fever of 39 degrees. Laboratory data included: Body temperature (NR: not provided) 39 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weak, and the outcome of tingling prickly feeling in hands, fever of 39 degrees, shivers and didn't feel too well was not reported. This report was non-serious. This case, from the same reporter is linked to 20210850476.
Itchy and burning; Hives; big blotchy and red raised welts; Itchy and burning; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Itchy and burning), URTICARIA (Hives), RASH ERYTHEMATOUS (big blotchy and red raised welts) and PRURITUS (Itchy and burning) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Itchy and burning), URTICARIA (Hives), RASH ERYTHEMATOUS (big blotchy and red raised welts) and PRURITUS (Itchy and burning). At the time of the report, SKIN BURNING SENSATION (Itchy and burning), URTICARIA (Hives), RASH ERYTHEMATOUS (big blotchy and red raised welts) and PRURITUS (Itchy and burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.   This case was linked to MOD21-085375 (E2B Linked Report).; Sender's Comments:  MOD21-085375:
Red flat rash on trunk, neck, back groin. I first noticed about 36 hours after second dose. It could have been there sooner, I was just so sick from fever/body aches, I would t have noticed. It progressively got worse by  the end of the day so I finally took Benadryl before bed. The nurse told me to try not to take anything, but the night before my fever wouldn?t let up and I felt really bad so took Advil. The rash kept getting worse so I ended up taking Benadryl and it helped clear it up. It looked very drug allergy to me. Not raised, just red
Symptom Onset 3/12/21  4:30pm - 4am  Fever of 101.9,  muscle pain, joint pain, numbness in fingers, muscle weakness, difficult to move on my own, skin pain, migraine-like headache . 3/13/21  9 am - muscle fatigue, muscle pain, headache, sensitive skin, joint pain, brain fog.
tingle in left hand; felt hot; her face was flushed; her lip started to swell with a little bit of redness above the right side of her lip; her arm was sore too; touched her lip and it felt numb; This is a spontaneous report from a contactable consumer or other non hcp. A 49-year-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration in Arm Left on 07Mar2021 16:30 as dose 1, single for covid-19 immunisation (at hospital). patient didn't received other mediations within 4 weeks prior to vaccination patient didn't had any illness prior to vaccination. Medical history included food allergy shellfish allergy from an unknown date and unknown if ongoing. The concomitant medications were not reported. On 07Mar2021 the patient experienced tingle in left hand, felt hot, her face was flushed, her lip started to swell with a little bit of redness above the right side of her lip, her arm was sore too, touched her lip and it felt numb. Therapeutic measures were taken for the events Benadryl was prescribed by physician. She would be planning to receive her second dose on26MAR2021 No relevant tests were reported. The outcome of the events paraesthesia, feeling hot, flushing, lip swelling, pain in extremity, hypoaesthesia oral was recovered.  No follow-up attempts are possible. No further information is expected.
pt had "obvious signs of COVID" on 3/16 not tested at that time. Now tested pre procedure and has a positive test but is completely asymptomatic
Less than 24 hours after the vaccine, I had hives all over my body. Face, neck, stomach, back and legs. They have lasted for 48 hours and have not gone away.
Resident was hospitalized for confusion, and hypotension and increased weakness; resident proceeded to have a NSTEMI and died on 5th day in hospital on 1/31/2021.
Hot flash with intense sweating for about 30 min at 11:00pm Intense right temple headache, sharp stabbing and throbbing for an hour. Went away after taking two Advil
Information has been received from a physician's assistant concerning a male patient in his 70's, who in the March time frame of 2011, was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). The physician's assistant reported that 2 months later vaccination in May 2011, the patient got pneumococcal meningitis. The patient was hospitalized for two weeks. At the time of the report, the patient had recovered. Pneumococcal meningitis was considered to be immediately life-threatening by physician assistant. Additional information has been requested.
The nurse gave my daughter a injection in her outer right thigh intramuscular of Hib-Prp-omp on 5/8/17 at 11:00am. She put gloves on but did not wash her hands. The next morning at 5:30am my daughter had a fever of 102.4, and that one injection site turned bright red overnight (she woke up at 5:30am crying) I took a pen and outlined the redness to monitor the site. Also the site was swollen, raised and hard. I called the nurse at the clinic that morning at 7:30am, left a message and the nurse who administered the shot had the appointment desk call me back to notify me that this was a normal reaction, I insisted on speaking to the nurse directly as I felt is was not normal (I have two other children and have not seen this kind of reaction with them) nurse insisted it was normal, I told her I would feel better if the Doctor and nurses looked at it and felt it. She agreed and I took my daughter in so they could look at the site and feel it. Two nurses and a Doctor looked at my daughters swollen, red, hot, raised hard injection site on her right thigh) they all said it was Normal. But to follow up if she had a high fever, she got worse, the site opened up into pus on 5/14/17 6:00pm during her bath, I rushed her to the ER, They did blood work, and told us the CBC was not elevated and to follow up with the pediatrician on 5/15/17 am, I called in the morning 7:30am to get in for appointment, they got us in at 9:30am with the doctor who was able to squeeze out a large amount of pus.
11/3/15: headache and tiredness. onset: upon waking, lasted all day. 11/4/15: headache, cough, tiredness upon waking, swelling under arm. onset: upon waking, lasted all day. slept entire day. 11/5/15: loss of use of left arm onset: upon waking, lasted all day. Severe swelling and pain. unable to sleep due to pain. 11/6/15: no use of left arm, severe pain, fatigue, tiredness all onset upon waking lasted all day. 11/7/15: tiredness, increased but limited movement of arm, pain in left side of chest. Lasted all day. 11/8/15: decreased swelling, pain with arm movement (onset upon waking and lasted all day). 11/9/15: moderate swelling, mild pain. onset upon waking, lasted all day. 11/10/15: mild to moderate swelling.
Pt vaccinated with Fluzone became light headed legs & ears started to ache by the afternoon also headache. Felt a little funny soon after the vaccine. Rest, Tylenol, Fluids advised.
Shot well tolerated, no discomfort. After 30-60 minutes noticed her arm becoming sore at site and radiating down to elbow. Described as severe. Hx similar pain with fibromyalgia years ago, but has had flu shots since then without incident. By next day pain is resolving without treatment. Level 4 or 5 on scale of 10.
Shingles -- onset began with headache on 3/19, blister outbreak on 3/20, nerve tingling and numbness on 3/23. Diagnosed per Dr.  on 3/23 with shingles and prescribed VALACYCLOVIR HCL (1GM) and PREDNISONE (30MG) for symptoms.
Onset pulmonary fibrosis with persistent cough since 2nd Shingrex See provider note from 12-4-19 Pt recieved Shingrex vaccine.  1. CREST syndrome, had been clinically stable 2. Recent shingles vaccination, 2nd dose, with significant reaction 3. Acute onset shortness of breath with apparently normal pulmonary function studies and normal chest CT scan 4. Cough. One of her major symptoms
Patient was first administered Moderna Vaccine  on 8/16/21 and  an   incorrect MRNA  COVID -19  vaccine (Pfizer) FF8839 administered for second dose  in 2 -dose series on 9/12/2021
Headache starting approx. 10:00 PM. Fever/chills starting approx. 11:30 PM Nausea starting around 1:00 AM, 1/15/2022. Vomiting occurred at around 1:30 AM, 1/15/2022. Nausea continued Vomiting of gastric juices at approx. 9:00 AM, 1/15/2022, coinciding with bowel movement. Nausea continued. Vomiting has not continued.
had to get one back in the 60s at work and got the flu a week or 2 later, have not had one since then and have not had the flu; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 08-Dec-2020.  This case is linked to case 2020SA355663.  This case involved a male patient who had to get one back in the 60s at work and got the flu a week or 2 later, have not had one since then and have not had the flu (influenza), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had to get one back in the 60s at work and got the flu a week or 2 later, have not had one since then and have not had the flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  It was reported that patient might be immune to it. Patient also did not got poison ivy even thought patient had been in touch with it many times.  Relevant laboratory test was not reported.  Final diagnosis was influenza.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
pt recvd vax 11FEB95 & myalgia, arthralgia, malaise, & weakness exacerbated;sxs con't
Localized swelling, redness, induration at site of DTAP shot on LL
lymph node under the Right arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node under the Right arm swollen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced LYMPHADENOPATHY (lymph node under the Right arm swollen). At the time of the report, LYMPHADENOPATHY (lymph node under the Right arm swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment information was provided.  Reportedly, her lymph node under her right arm is swollen, not painful but is uncomfortable. She says she usually gets the same swelling with a flu shot that occurs the first day after the shot then will go away in about a day, does not last long. She has not iced or taken a pill like Tylenol.
Diarrhea, abdominal cramps, lack of appetite (typically later in the day)
Case number PHEH2016US023619, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a male patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 1516501) at a dose of 0.5 ml intramuscularly on 13 Sep 2016. It was reported that, 2 employees were administered FLUVIRIN vaccine that expired in Jun 2016. No adverse event was reported following this administration error. The case was assessed as non serious by the nurse.
Last year I had 3 shots of Shingrix - do I need another booster this year?; This non-serious case was reported by a consumer and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2022 the patient received 1st dose) and Shingrix (In 2022 the patient received 2nd dose).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Last year I had 3 shots of Shingrix - do I need another booster this year?). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 13-JUL-2023 The patient received three shots of Shingrix last year (2022). The patient wanted to know if he/she need another booster this year. The patient received 3rd shot of Shingrix which led to extra dose of vaccine administered.