chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since my 2nd shot, i have had 3 episodes  that caused me to miss work, go to a medical place and get a covid test, all 3 times i was negative. Point i am trying to make is during my 57 years of life i have been rarely sick. Symptoms have included: fever, headache, nausea, cough, congestion, sore throat, and fatigue.  1st time was in April 2021, 2nd time was Jun 2021. 3rd time was 1-4 Aug 2021.
Necrotizing granuloma; Patient with common variable immunodeficiency used MMR; Literature Report.   Information has been received from the authors in a published literature article entitled as stated above concerning a 46-year-old female patient with a history of Common variable immunodeficiency (CVID) presented with nontender, non-pruritic, enlarging right knee lesions present for over 20 years. She reported a history of trauma of the right knee prior to lesion onset. Physical exam showed violaceous verrucous papules and crusted plaques from the right knee to the distal anterior shin. She reported that occasionally the right knee plaque would ulcerate, for which she self-treated with silver nitrate.   The patient had received two doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R) vaccine in childhood (Contraindicated product administered). In the context of reports emerging in recent years of RuV-associated granulomatous inflammation in patients with inborn errors of immunity (IEI), Vaccine strain rubella virus (RuV) was suspected to be involved in her skin pathology. Fresh tissue from a granulomatous skin lesion, nasopharyngeal (NP) swab, and whole blood were sent to the Centers for Disease Control and Prevention (CDC) for RuV molecular testing, and serum was submitted for rubella serology. Vaccine-derived RuV was detected in the skin biopsy specimen by RT-PCR and viral RNA sequencing. The NP swab and neutrophils isolated from the whole blood were negative for RuV by RT-PCR. Serum was negative for rubella IgM and positive for rubella IgG (ISR = 3.45). Repeat biopsy specimen of one of the small papules showed persistent necrotizing granulomatous (Necrotising granuloma) and neutrophilic inflammation in the same histopathologic pattern as in her prior biopsies.   The outcome of Necrotising granuloma was not reported.  The authors considered that The presence of mmunodeficiency-related vaccine-derived rubella viruses (iVDRVs) in M-type rubella-associated granulomas, the most frequently observed pattern in IEI patients, has been repeatedly confirmed by RT-PCR and sequencing of RNA isolated from these granulomas..  A copy of the published article is attached as further documentation of the patient's experience.
Abnormal serum proteins found on routine serum blood panel (about 9 weeks following the 1st vaccine, and about 6 weeks following the 2nd vaccine). There were no symptoms. A repeat blood panel confirmed the abnormal protein levels. A serum protein electrophoresis was obtained, showing  elevated gammaglobulins and an M-spike.
Shortness of Breath  Difficulty breathing  Fatigue  Muscle or body aches  New loss of taste or smell
about 1 month post 2nd vaccine a suture (ethibond suture) poked out of the back of my neck at the where the head connects to the neck.  They used it to weave thru the tendon to re attach it to the bone when the rods were placed into my neck in 2016. I&D of site done 8/30/21  THIS HAS NOT BEEN FUN....my husband also had plantar facititis that progressed into achiles tentontitis, and he got Phizer vax
Patient's mother described left arm as very tender, swollen, and red. Pt. seen per PMD and instructed to apply warm compress to area started on Bactrim and instructed to call or return to PMD if area becomes worse are child develops a fever.
Myocarditis - chest pain while performing timed military swim test.Admitted over night and discharged. 15/16OCT
Headache, Myalgia,  fatigue, pain and swelling to left arm at injection site Narrative:  Other Relevant History:
At 11:00 am, patient received meningitis vaccine.  At 4:30 pm child had been napping approximately 2 hrs.  Unable to fully wake child, extremely lethargic, unable to open eyes, crying, left leg tremor uncontrollable and hyperventalation. Called and spoke to nurse at Dr's office.  Nurse stated that they had not heard of this reaction to a vaccine and to take patient to ER. Took child to ER shortly after 5 pm.  Facility treated for allergic reaction.  IV fluids, Benadryl and steroid.  Within 45-60 minutes of treatment, symptoms subsided. Facility performed CT Head, EKG, CXR, Blood work and urinalysis which were all normal.  The ER then had her transferred to another Hospital for observation.  At this time, all symptoms had subsided and child was hungry.
Information has been received from a nurse practitioner concerning a 19 year old female who on 31-AUG-2007 was vaccinated intramuscularly with a 0.5 mL dose of Gardasil (lot 657962/0515U).  There was no concomitant medication.  On 05-SEP-2007 the patient developed hives.  The patient was seen at the student health center and was treated with diphenhydramine HCl.  At the time of this report, the patient was recovering.  Additional information has been requested.
Swelling of the vaccination site the size of a half dollar with redness and soreness. Pt said onset was within 24 hrs of the vaccination but did not report to the pharmacist until 2 days later.
Resp. arrest after exposure to "fog machine" at school dance, then cold air - occurred within 6 hours after immunization. H/O bad asthma.
A few weeks after my second shot, I began experiencing changes in body.  The first change I noted was alcohol intolerance, followed by loss of appetite and changes in the food I usually liked, as well as fatigue and fast heart rate. Over time, the fatigue got so horrible that I could not carry on with my regular activities.  I have experienced post exertonal malaise ( I can no longer work out without worsening of debilitating symptoms) and I seem to have developed orthostatic intolerance.  These symptoms have continued to build since getting my second Covid vaccine, to also include tremors, headaches, nausea, and pins in needles in my hands.  I can no longer engage in daily activities and must severely limit my activity in order to avoid worsening symptoms.  I believe the vaccine may have triggered a form of chronic fatigue syndrome.
c/o cold chills, had brief period of SOB; sx lasted approx 1 1/2hr; Given DPH & IV started of 1000cc of .45 NSS;
No energy after the vaccine, tired and stayed in bed for several days; headaches. Extreme fatigue, no appetite, I got COVID-19 test on June 27th and it was a negative but on the 29th I took another test and it was positive. Both were home tests. I felt bad for 3 days and on July 1st I felt better. On the 30th of June I went to the ER to get the medicine and I felt better.
I previously received the Johnson and Johnson vaccine 3/3/31 and went to a Pharmacy to get a Moderna booster shot.   Two days after injection on 12/25/21 I developed a few hives on the outside my both of my forearms. 50mg of Benadryl seemed to calm the reaction but give never completely faded.   Later that night on the 25th some additional hives developed on my waist and backs of my knees. I took 50mg of Benadryl before bed. The next morning I woke with hives on all parts of both arms, beneath both arms around my crotch and waistline, back, shoulders, chest, neck and some redness on my face. Began prescription of 60mg of Prednisone and took first dose at approximately 12 noon. Benadryl was last taken at about 8pm.   The next morning at 7am I woke with hives covering a significant amount of my body. Took daily dose of prednisone and took 50mg of Benadryl. At appx. 11am I took more Benadryl but reaction was only slightly impacted. Went out to eat lunch from 2-3 and people I was with noted my face and neck increasing in redness over the course of an hour. Took 50mg of Benadryl around 3-3:15. At 3:30 the decision was made to go to a local emergency department. While waiting to be seen by doctor I experienced chest tightness and my throat began to swell, speaking became difficult and my voice was lowered to a very low register. Quick evaluation when checking in to ED showed a 143 bpm heart rate.    Upon seeing the doctor they administered epinephrine and Benadryl via IV and that calmed the reaction for some time but within 10-15 minutes hives retuned around my shoulders, chest, crotch. back, and down my arms. More Benadryl was given after about 30 minutes from original dose via IV. This calmed reaction again but it did not completely subside. Shortly after, I was released. I've continued taking 50mg of Benadryl every 4 hours and have seen a great reduction in symptoms but the hives continue to pop back up in smaller numbers especially with any lapses in taking Benadryl every 4 hours.
Vaccine for Varicella given to patient early in pregnancy. LMP 7/17/14. Vaccine given 8/14/14.
Rash on his back with welts, mild itchiness of the lips and mouth and no SOB.
Breakthrough Case  Patient also received Pfizer booster vaccine on 10/25/2021 Lot FE3590  Pharmacy Store
on 1/16/2021 I started feeling my left upper arm was sore . Injection site had welped up and area around injection site was warm to touch. 1/17/2021 welp on injection site had gone down, injection site was red and there was a big red area right about the size of the palm of a hand ( 4 inches)  that was warm to touch as weel
Two hours after shot: tingling in extremities,  itching around face and neck,  numbness and swelling in the tongue, itching on roof of the mouth, and a metallic taste.   I also developed pain in my left shoulder which is still there after a month of receiving the shot.   I called the pharmacy and they documented my symptoms and told me I was having an anaphylactic reaction and if I had any breathing issues to call emergency number.   I was instructed not to get the second shot.  Although my reaction was unpleasant and concerning, I was not having difficulties breathing and did not feel like I was in need of medical attention.  I took some Benedryl which alleviated the itching.  Tingling and numbness of my extremities and tongue lasted about 5 days.   The metallic taste in my mouth lasted about two weeks.  I still have pain in my shoulder.
Temprature excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 21-DEC-2021, Vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rha) (M-M-R II) with lot # T027936, expiration date:18-AUG-2022 ( dose, frequency, route of administration were not provided) for prophylaxis had temperature excursion (Product storage error). Temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rha) (M-M-R II) was 27.4C, time frame: 52 hours and 30 minutes. There was no previous temperature excursion.
From initial information received on 02/12/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 4 year old male pt received a DAPTACEL vaccination, Lot # C1680AA, administered in the right thigh on 02/11/04.  Later that same day the pt developed local redness and warmth at the site of injection on the right thigh measuring 13x12.5cm.  The pt's recovery status was not provided. From additional information received on 04/17/04 from the initial reporter, it was reported that the pt also received a dose of IPOL, Lot # X0316, administered in the left thigh, a TUBERSOL 5 TU skin test, Lot # C1422AA, administered in the right forearm and a dose of MMR vaccine, Lot # 0819N, administered in the left thigh on 02/11/04.  He did not have a fever and his temperature was reported as 97.4 degrees F.  Upon examination, the pt's thigh measurements were noted to be 18cm for the right thigh and 12.5cm for the left thigh. The right thigh was painful to palpation. Treatment included warm compresses and Motrin. The pt's recovery status was reported as unknown.
Paxlovid  Treatment of COVID-19 on 7-may-22/I had a rebound in symptoms and tested positive after testing negative twice on 5/10 and 5/11; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Paxlovid  Treatment of COVID-19 on 7-may-22/I had a rebound in symptoms and tested positive after testing negative twice on 5/10 and 5/11) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Drug allergy (Allergy was reported as reaction of an unknown historical drug).   In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2022, the patient received dose of NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On 15-May-2022 at 7:00 AM, the patient experienced COVID-19 (Paxlovid  Treatment of COVID-19 on 7-may-22/I had a rebound in symptoms and tested positive after testing negative twice on 5/10 and 5/11). At the time of the report, COVID-19 (Paxlovid  Treatment of COVID-19 on 7-may-22/I had a rebound in symptoms and tested positive after testing negative twice on 5/10 and 5/11) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 11-May-2022, SARS-CoV-2 test: negative (Negative) Negative. In May 2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.  The patient was not taking any other medications/products within two weeks of starting COVID-19 treatment. Patient had a rebound in symptoms on 15-May-2022 07:00. Patient was tested positive after testing negative twice on 10-May-2022 and on 11-May-2022.  Company Comment: This is a spontaneous case concerning  a  39-year-old, male patient with no relevant medical history, who experienced the unexpected AESI non-serious event of Covid-19. The event occurred on May 16, 2022, after the unspecified dose of mRNA-1273 COVID 19 Vaccine. Patient tested negative twice (May 10 and May 11) for SARS-CoV-2 test; Tested positive on May 16, 2022. Patient was treated Nirmatrelvir/ritonavir at an unspecified dose and frequency. The event was reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  39-year-old, male patient with no relevant medical history, who experienced the unexpected AESI non-serious event of Covid-19. The event occurred on May 16, 2022, after the unspecified dose of mRNA-1273 COVID 19 Vaccine. Patient tested negative twice (May 10 and May 11) for SARS-CoV-2 test; Tested positive on May 16, 2022. Patient was treated Nirmatrelvir/ritonavir at an unspecified dose and frequency. The event was reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 78-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had resolved.            Concomitant product use details was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-016974 (Patient Link).
Very high fever, nausea, pounding and rapid heart rate, intense headache, inability to sleep. My arm became swollen, red and sore over an area about the size of my hand. I became very upset when my husband went out to take care of our dogs and didn't come right back. I imagined he had died, and I cried uncontrollably.
Wed. 10/3/2018-approx. 5:30 AM-patient became dizzy, lightheaded, could not stand alone-called "911" for aid. Paramedics took him to hosp, not certain as to what caused this problem. Patient also had "3" very itchy marks on area of right hip, first thought to be "bug bites", however probably "hives" I'm not sure, MDs were not sure, as well. Patient also had "mood change"? He was defiant, rebellious, toward nursing staff. This is not "patient'.
Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine dose/ Was 4 days past the use by date/ Dose administered after 30-day Use By Date/ After manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No Treatment medication was reported.  No vials undergo any temperature excursions.
Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 11-Aug-2022; No adverse event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 12-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 11-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-jul-2022 and was adminstered on 11-Aug-2022).    Concomitant product use was not provided by the reporter. The vial did not undergo temperature excursion. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given. The vial was initially stored in the refrigerator on 08-Jul-2022 and the vaccine was administered from 07-Aug-2022 to 11-Aug-2022. Treatment information was not provided.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with less than a full dose (underdose) of ZOSTAVAX, (Lot number, expiration date, dosage, dose number and route of administration were not reported), due to a needle leak. No other suspect or concomitant therapies were reported. No adverse events were reported. Additional information has been requested.
The biggest reaction I had was a red, painful arm at my injection site that lasted for 3-4 days . I also had fever of 100.3 that lasted about 2 days. I took Tylenol.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Short lived symptoms (approximately 15-20 minutes)
Initial and follow-up information has been received from a nurse for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female with sickle cell trait and no drug allergies who on 13-JUL-2009 or 17-JUL-2009 was vaccinated with the first dose of GARDASIL (LOT# not reported) from another provider. On 26-AUG-2009 the patient went to another clinic office for her first obstetrical visit. No adverse effects were reported. The pregnancy was confirmed by home pregnancy test on an unspecified date. The patient was currently taking prenatal vitamins. The patient's LMP was 13-JUN-2009. Expected date of delivery was 20-MAR-2010. The patient had an appointment with the nurse on 23-SEP-2009. Follow-up information has been received from the nurse. This was the patient's first pregnancy. The nurse stated that the patient during pregnancy experienced anemia, mild oligohydramnios and Maternal Serum Alpha Fetoprotein (MSAFP) positive. She was treated with prenatal vitamins, PO, daily and ferrous sulfate, PO, TID indication for anemia both from 26-AUG-2009 to 15-MAR-2010. The ultrasound was performed on 15-MAR-2010 revealed "oligo", MSAFP was performed on "25-SEP-2010" revealed it was positive. On 15-MAR-2010, the patient delivered a live female infant, weight 6 pounds 12 ounces, Apgar score 9/10, and 39+ weeks from LMP. The infant was healthy. Follow-up information has been received from the nurse. This was the woman's first pregnancy. The nurse stated that the patient during pregnancy experienced Alpha Fetoprotein (AFP) positive, sickle cell trait positive. She was treated with prenatal vitamins, PO, TID for pregnancy and ferrous sulfate, 325 mg, PO, TID indication for pregnancy both from 26-AUG-2009 to 30-MAR-2010. The ultrasound was performed on 06-NOV-2009 revealed within normal limits (WNL) and "UMC". During pregnancy, the patient had Alpha Fetoprotein (AFP) positive and borderline oligohydramnios. On 15-MAR-2010, the patient delivered a live female infant, weight 6 pounds 12 ounces, length 19 inches, Apgar score 9/10, and 40 weeks from LMP. The infant was healthy. No further information is available.
Patient says his arm has been sore, and hurting since the vaccination.  He says it hurts most when he has to raise or lift the left arm.  He says he has not tried anything for the pain.  When showing his arm, it did not appear swollen or discolored.  There were signs of him using cupping, as we were able to see the cupping marks on the upper arm.