chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received the 2nd dose of SHINGRIX. On 13th February 2019, 1 days after receiving SHINGRIX, the patient experienced chills, general body pain and feeling unwell. On an unknown date, the outcome of the chills, general body pain and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the chills, general body pain and feeling unwell to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. At the time of reporting, the patient experienced pain all over her body and generally did not feel well. The patient disconnected the call, so the representative was unable to ask additional questions. The patient did not consent to follow up.
Was sent home from school 10/23/09 about noon with temp. 100.7. Was not given any medication. Rtn call at 1430 when mother reports child sleeping which is not usual for this time of day. Mother also noted eyes "red with dark circles under eyes" not usual color of eyes as with allergies.
Pt complained of local burning, headache, body aches, stiffness and malaise, post vax.
he has 7 spots/he might have Stage 4 cancer; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration, administered in arm left on 30Sep2021 (Batch/Lot Number: EW0185) (at age 82-years-old) as dose 3 (booster), single for covid-19 immunisation. The patient received the first dose on 30Jan2021 (lot number: EL9262) and the 2nd dose on 10Feb2021 (lot number: EL9266); both at age 81-years-old. The patient medical history was not reported. Concomitant medication(s) included nitric oxide (NITRIC OXIDE) taken for an unspecified indication, start and stop date were not reported.  On Oct2021 (reported as either 10Oct2021 or 11Oct2021), patient developed a bump on his back the left side, everything was on his left side. He saw one on his neck as well as his left knee measuring "16 inches by something". There was something on his upper arm which developed about 3 days ago. They just got back from the hospital where a full body scan done and they said he has 7 spots, but reporter does not know where they all were and they are telling them that he might have Stage 4 cancer. Patient was getting biopsy back on Monday or Tuesday (unspecified date). Reporter was wondering if this could be from the vaccine. Patient did not remember what side he received the vaccine on but he stated usually gets things like that on his left side because he uses his right arm to write so this way if his arm was sore it won't bother him as much. Patient has not had any new bumps developed in the couple of days since then. The event results in hospitalization and emergency room and physician's office visit. Clinical course were reported as: Patient went to the emergency room three times and out after three days there, he was hospitalized from 19Oct-21Oct2021 and thought he had stage IV cancer and he was in pain and all this stuff and these things is the reason for the hospitalization. He went to the ER and it showed his neck and left leg about 9:30pm at night on 12Oct2021 and said his bloodwork was fine and he has fast growing cancer. They then told him to go to the HCP office and get a biopsy; the ER told him to go to the dermatologist on Monday and they went and the dermatologist did the biopsy which said there was malignancy there from the little bump on his shoulder and the one on his neck but did not biopsy the big one. A couple of days later got a bump on his arm and they went to again in the hospital to be admitted and for care and to not let this go on and he had been in the hospital for three days and came home last night. Outcome of the event was unknown.
Localized red area 3" x2" warm and tender to the touch. Generalized body aches starting the day after. Both continue 3 days after receiving the vaccine.
Nerve type pain when making sudden arm movements especially reaching back behind. Has persisted for approximately 3 weeks now and is still on going.
Fever 103.0 F, chills, shaking and body aches approximately 16 hrs after vaccine adminstration.
Received TDAP 2/22/11 in am, a few hours later developed body aches, T 101, headache. Experienced redness/swelling at site of admin. Fever as high as 103 evening of 2/24/11. Started on abx 2/24 to cover for possible cellulitis.
Difficulty with gait/balance. Balance off when walking. Also foot pain, heel, right foot.
Redness, swelling, and warmth to injection site on right deltoid in a 2' circumference around site.
Lump in throat comes and goes; Lump in the throat; Hot neck; throat was also red hot, I mean my neck; Severe chills; This spontaneous case was reported by a physician and describes the occurrence of SENSATION OF FOREIGN BODY (Lump in the throat), FEELING HOT (Hot neck), ERYTHEMA (throat was also red hot, I mean my neck), CHILLS (Severe chills) and SENSATION OF FOREIGN BODY (Lump in throat comes and goes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), METOPROLOL, ATORVASTATIN and MELATONIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced SENSATION OF FOREIGN BODY (Lump in the throat), FEELING HOT (Hot neck), ERYTHEMA (throat was also red hot, I mean my neck) and CHILLS (Severe chills). On an unknown date, the patient experienced SENSATION OF FOREIGN BODY (Lump in throat comes and goes). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) at an unspecified dose and frequency. On 31-Jan-2021, SENSATION OF FOREIGN BODY (Lump in the throat) and CHILLS (Severe chills) had resolved. At the time of the report, FEELING HOT (Hot neck), ERYTHEMA (throat was also red hot, I mean my neck) and SENSATION OF FOREIGN BODY (Lump in throat comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Telephone contact report attached.
One week after the shot, incessant headaches, muscle aches, feeling off, head feels off, chills on and off.
After receiving my vaccine, I began to feel fatigue and significant brain fog. I could not drive. My husband drove home. I had a headache. By 1:00PM in the afternoon, I had aching joints and a low fever, by 3:00PM, my fever was 100 degrees and my movement was impaired with global joint pain. I managed with some ibuprofen and had to still take care of my family. By 9:00PM, my fever was 102 degrees and I could not move. Every joint in my body was burning, inflamed and aching. I could feel ever vertebrae in my spine. The headache was significant and if I moved the pain would increase. I called the hotline to try and reach my GP, it was the weekend. The nurse that answered did not know what to do with my position. My neurologist called me around 10:30PM and he didn't think I was in any danger, but seemed a bit helpless to know what to do for me. He encouraged me to continue using ibuprofen and wait it out. I was trying to go to the ER, and the only ER that can handle my health condition is very far away. Plus I didn't have child care. I ended up not going to the ER, but I've learned that I should have gone. I managed with Tylenol, as much as I could, and it took about 16 days for the joint pain and aching to subside. I had a series of tests already scheduled that showed on a deeper lever the reaction that I had. I had to see my neurologist and my rheumatologist. My arthritis had returned after being in remission for at least 6 months. Prior to the vaccine, I had energy, no brain fog, no joint pain and no mast cell reaction. I used to be able to walk 2 miles per day and since the vaccine, I have not been able to do that nor have I been getting better. I had not had headaches before, but now I have them every day, in spite of medication. I cannot exercise or even do basic chores anymore. I am constantly thirsty. My blood work showed dehydration, regardless the amount of fluid intake. POTS went crazy. My blood work with rheumatology came back with a positive ANA and BSNA (double stranded DNA). I had to start taking hydroxychloroquine and get regular IVF infusions. I think that in the grand scheme of things, I have been getting back to stability, in just this last week. I have more tests coming up to see if the inflammation has come down. I won't know until my blood work comes back if I've gone into remission or if I've developed a new condition.
I had raised red whelps over large areas of my body and a itch that was almost unbearable. I took 3 Benadryl to get relief. I had covid arm. That is not the biggest issue as it resolved after the Benadryl. However now anytime my skin comes in contact with hot water (shower washing dishes etc) the same redness and intense itching is where the water touch. I do not mean scalding hot just the typical bath or dish washing temp of water. I have pictures of the red whelped areas and the site of injection as it looked the same as what my body does now once any hot water touches it.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 01:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had been vaccinated a shot of Pfizer yesterday like around noon time in (name) and around 1 o' clock in the morning, when he/she was back from office he/she started getting some diarrhea on 05Feb2021. So, the patient wanted to know that was this the side effect or not. The patient got diarrhea and it started about thirteen hours later and it was there whole night. The outcome of the event was not recovered.  Information about the lot/batch number cannot be obtained. No further information is expected.
Employee given 14 flu vaccine. Shortly after, employee passed out falling backward and appeared to have seizure-like activity. Loss of bladder/urinated. EMS called. Patient regained consciousness. No BLS needed. Patient decided to go home with family. Employee later called and doing ok.
Headache, Fever, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE Narrative:  PCP CONTACTED AND ADVISED TO REST WITH CALL OUT ON 2/10/2021. RTD on 2/11/2021  Other Relevant History:
Rash in area around injection site. Discovered by nurse 3/26/21 when she attempted to administer weekly allergy shots. Canceled the allergy shots. Administered Triamcinolone Acetonide cream twice/day for one week. Benadryl tablet once/day for one week.
Patient fainted after receiving shot. He came too after 1 to 2 minutes. He was pale in the face but was back to normal after waiting for 30 minutes after the episode.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A 13-year-old female patient of an unspecified ethnicity received TRUMENBA via an unspecified route of administration at single dose on an unspecified date for immunisation.  The patient medical history was not reported. The concomitant medications included human papilloma vaccine (HPV) via an unspecified route of administration on an unspecified date for immunization. Approximately 1.5hours post vaccination she presented with headache with outcome of unknown. No follow up attempts are possible. No further information is expected.
After 2nd dose arm was sore. Then that night felt as if I had a fever with night sweats. Overall fatigue and muscle aches along with headache for several days.Felt as though I was coming down with the Flu.Took me a week to regain my normal energy.
pt recvd vax 7DEC92 &  2 to 3 days following vax pt devel severe neck, back & shoulder pain which was so severe that pt was unable to get out of bed; the pain lasted for 4 days; No further details were provided;
Systemic: Confusion-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypertension-Mild, Systemic: Weakness-Mild, Additional Details: After being give his flu shot in left arm, patient asked to receive Moderna bivalent dose in right arm.  As I was disposing of needle in sharps container, patient fainted.  His girlfriend helped me put him in chair-I gave him water, he wanted to lie down so we lay him down and elevated his feet.  He drank some gatorade also as he was very pale.  He seemed to be very tired but his color was coming back.  After 30 minutes he felt well enough to walk home with his girlfriend.
Associate states developed sore throat at 1900 hrs 7/9/08. Associate states on 7/10/08 noticed throat pain with neck swelling at 1900 hrs with swallowing. Notified by associate on 7/11/08 at approx 1345 hrs of neck swelling, stiffness with radiating pain to (L) shoulder, (L) ear and throat. Seen in Emerg Dept for evaluation. On 7/14/08, associate states symptoms nearly all resolved. On 7/17/08 - assoc states all resolved.
Case number PHEH2016US023423, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 48 years old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, into left arm on 09 Mar 2016. On 09 Mar 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion was administered to patient. No adverse event was reported following this medication error (incorrect product storage). The case was assessed as non-serious by the nurse.
Patient given adult dose of Pfizer vaccine. Patient waited for 30 minutes with no adverse effects. Explained nature of incident to patient's mother.  Per policy, patient will return in 21 days for second orange cap (peds) dose. MD updated of adverse event.
03/11/2021 : Low TSH 03/31/21 : Low TSH, + TPO, + TSO 04/23/21: low TSH, + TPO, + TSI 05/03/21: low TSH, +T3, +TSI  Severe FATIGUE, Continuous headache
Thrombosis with thrombocytopenia syndrome (TTS); myocarditis; percarditis; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Thrombosis with thrombocytopenia syndrome (TTS)), MYOCARDITIS (myocarditis) and PERICARDITIS (percarditis) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (Thrombosis with thrombocytopenia syndrome (TTS)) (seriousness criteria death and medically significant), MYOCARDITIS (myocarditis) (seriousness criterion medically significant) and PERICARDITIS (percarditis) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was Thrombosis with thrombocytopenia syndrome. It is unknown if an autopsy was performed. At the time of death, MYOCARDITIS (myocarditis) and PERICARDITIS (percarditis) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. Thrombosis with thrombocytopenia syndrome (TTS) moderna and 9 deaths were reported and so far 3 confirmed cases associated with Moderna. No treatment details reported.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact; Reported Cause(s) of Death: Thrombosis with thrombocytopenia syndrome
excessive diarrhea; tender to touch; Hard like knot; swelling at the injection site; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (excessive diarrhea), VACCINATION SITE WARMTH (tender to touch), VACCINATION SITE MASS (Hard like knot), VACCINATION SITE SWELLING (swelling at the injection site) and CHILLS (severe chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Asthma. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and TIOTROPIUM BROMIDE (SPIRIVA RESPIMAT) for Asthma.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (excessive diarrhea), VACCINATION SITE WARMTH (tender to touch), VACCINATION SITE MASS (Hard like knot), VACCINATION SITE SWELLING (swelling at the injection site) and CHILLS (severe chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of UNK dosage form. On 13-Mar-2021, DIARRHOEA (excessive diarrhea), VACCINATION SITE WARMTH (tender to touch), VACCINATION SITE MASS (Hard like knot), VACCINATION SITE SWELLING (swelling at the injection site) and CHILLS (severe chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
rash and ringing in the ear treated with benadryl 50mg . the treatment was for couple of days and helped improve symptoms of rash but for ringing in ear only slightly improved
Pt recv vax in 11/97; on 12/12/97 pt exp HTLV-2 positive; in 2/98 pt exp HTLV-2 negative
Nonstop inconsolable crying for 4 hrs beginning about 3 hrs after immunizations. Crying stopped. Treated with ibuprofen and tylenol.
Hives at injection site 8 days after vaccine was administered. Redness and slight irritation remained at site for an additional week before clearing up.
Pt and family reported small bruises around the vaccine injection site (L deltoid) within 24 hours of receiving the Pt's first COVID-19 Vaccine.  Within the next few days Pt noticed multiple other bruises on both arms, shoulders, hands, and thighs.
Expired varicella vaccine administered and was noted immediately.  Patient was recalled and non expired dose of varicella was administered the same day. When patient was seen in follow up three days later, she was asymptomatic with no evidence of an adverse outcome
Headache, CoughWheeze, post nasal drip, stuffy nose Employee stated after receiving 2nd vaccine she had a severe headache last night, this morning she has post nasal drip, stuffy nose, intermittent cough.
syncope reaction (dizzy near fainting, lost vision and hearing) without any physical injury.  Occurred 2-3 minutes post vaccination while she was in observation area.  She was immediately moved to floor after mentioning symptoms to avoid injury.  She recovered fully after 5 minutes of ice pack on forehead, elevating legs.  Patient left under he own power after 30 minutes of observation and she was fully recovered and did not want any further medical treatment.
Patient received vaccine on  Wednesday 05/18/2022. On Friday 05/20/2022 patient states her right arm became sore and painful. On Tuesday 05/24/2022 patient states she noticed a raised nickel size lump with redness at injection site ( right deltoid). Patient states she has been taking advil to help soreness. Patient was advised to also try Tylenol or Ibuprofen to help with pain and swelling at injection site. Patient was also advised to go to local urgent care or emergency room if worsening of symptoms or if any further complications occur.
Had rashes and hives all over my body a week after receiving the booster.  4 days after getting hives, my hands and feet swelled up to the point where it was tough to move my hands and feet without pain. These rashes still come and go, not as often now, but it has been 5 months. They normally are on my hands, and if anything barely scrapes me my skin becomes red and raised.
Dull pain and pressure in the head at least once daily.  Pain/pressure moves from one area of head to another in a few seconds and occurs randomly regardless of body position or activity.  The symptoms lasts 5-10 seconds to 1-2 minutes.
Narrative: Patient reports injection site reaction with redness and itchiness after vaccination. Symptoms ongoing but has improved since yesterday.  Other Relevant Hx:: Symptoms:  & injection site reaction Treatment:
caused a permanent and significant jump in my blood pressure!; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure abnormal" (unspecified if ongoing), notes: Had been stable for decades!. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, Lot number and expiration date not provided.), for COVID-19 immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "caused a permanent and significant jump in my blood pressure!". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blood pressure increased.  Additional Information: It was reported that "your" (as reported) first damned booster caused a permanent and significant jump in my blood pressure! Had been stable for decades!  Had to double one of my two meds!  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I feel there is an association of my post-menopausal diagnosis of endometriosis with the receiving mRNA COVID shots/boosters.  After a dozen years of menopause, I began having a period and cramping on 12.22.21.  I had a uterine biopsy and no cancer was found, but much bleeding was present. The cramping and exhaustion from the symptoms became worse over the months following, and I had diagnostic sonograms and exams by a GYN.  I had laparoscopic surgery on 5/31/22 and was diagnosed with endometriosis at age 65 and 9 months.  I noticed the initiation of this uterine abnormal reactivity was after my first booster shot (Pfizer 11.4.21).  The doctor removed endometriosis from my bladder, ovaries, and fallopian tubes and performed uterine curettage. I recovered from this surgery, and --reluctantly-obtained my 2nd booster (Moderna 6.23.22).  About two weeks later, on 7/9/22 I started bleeding and cramping again!  I couldn't believe it and this time the association really clicked. This pain (and associated fatigue) continued for 3 months.  I had a complete hysterectomy on 10/11/22.  Even after the laparascopic surgery and D/C, there was endometriosis present and my uterus was 2x normal size with hyper-proliferative lining.