chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first day after my shot I had the typical symptoms. My body was achy and I was very tired. I felt better by the second day. Two weeks later, I woke up with severe chest tightness. I thought that was strange but I went on with my day. By the next night, I still had the severe chest tightness but I was also  having trouble breathing and I was getting dizzy. I couldn't even read my children a bedtime story without getting winded. I am a very healthy and active person. Before the vaccine, I used to run 3 miles 3-4 times a week without any issues. These symptoms are VERY abnormal for me. They have lasted over 6 weeks now. I've been in and out of hospital and many doctors' offices. I've had numerous tests done on my heart, lungs, blood, etc. Everything keeps coming back normal (thankfully) except for my blood oxygen saturation levels. During a recent stress test, my oxygen level got down to 75% and the nurse had to stop the test. My levels only go down when I'm up and moving around. My doctor tried putting me on a tapered Prednisone pack and that helped my symptoms for about a day and half. My symptoms came back as the dose of medicine was lessened each day. Nothing seems to take these symptoms away completely. I have not been my normal active self for many weeks. My extended family has had to fly in to help my husband and I with the kids because I cannot physically keep up with everything. My life has turned completely upside down. I've never had these symptoms previously and did not ever have Covid before the vaccine. I also tested negative twice since all these symptoms began.
Fine pink papular rash forehead, chest, back, diarrhea 2 days prior to this and recent mild URI symptoms.
Temperature of vial reached to 24 °C; No adverse event; Vial should have been used by 0400 1/25/23 and was therefore used 5.5 hours after beyond use time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial should have been used by 0400 1/25/23 and was therefore used 5.5 hours after beyond use time), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature of vial reached to 24 °C) and NO ADVERSE EVENT (No adverse event) 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)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 25-Jan-2023 at 9:30 AM, 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 25-Jan-2023 at 9:30 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial should have been used by 0400 1/25/23 and was therefore used 5.5 hours after beyond use time). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature of vial reached to 24 °C) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial should have been used by 0400 1/25/23 and was therefore used 5.5 hours after beyond use time), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature of vial reached to 24 °C) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vial should have been used by 0400 1/25/23 and was therefore used 5.5 hours after beyond use time) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature of vial reached to 24 °C).    The vial was pulled out and 1 dose was administered on 24-Jan-2023 at 4 PM. The vial was left out overnight and the next day a dose from same vial was used at 9:30 am, not realizing the vial was past use time. The vial should have been used by 4 AM, 25-Jan-2023 and was therefore used 5.5 hours after beyond use time.  The temperature excursion happened for the first time, the minimum and the maximum temperature reached in this excursion were 2 °C and 24 °C respectively. The duration of the excursion was 18 hours and the 1 vial was affected by the excursion.  The vial is intended to be used in less than 3 days.  No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2023: Significant live follow-up was appended : Event was added and iNarrative supplement was updated.
12 hours post injection - chills, muscle aches, headaches, severe fatigue. Resolved by 24 hours post injection. Treated with ibuprofen. 36 hours post injection - large smooth asymmetrical red rash around injection site. By 48 hours post injection, it wrapped entirely around upper arm down to elbow and around bicep. Hydrocortisone ointment applied starting 72 hours after rash appeared. Began to resolve 6 days post injection (still present).
Vasal vagal response.  Diaphoretic no SOB. Placed pt in Trendelenburg after BP stable patient able to stand and walk around. Wife states this happened before when the pt gave blood. Initial BP 61/43 , BP at D/C 121/60  D/C home stable
Severe fatigue, body ache, sleepiness, cervical and L supraclavicular lymphadenopathy
After receiving the vaccine, patient became dizzy.  Patient is diabetic and did not take her blood sugar this am.  Usually in the 135-145 range.  BP: 182/110, 81 hr and 98% oximeter.  Continued to have elevated blood pressure 182/110, 182/100 by the time she discharged from the recovery area.  She had not taken her blood ressure medicine yet today.  Encouraged to take her meds when she goes home.  She was able to ambulate to her car after consuming water and snack.
woke up for school on 27OCT92 w/red raised, whelps all over body; c/o itching condition not relieved by DPH;
Patient described extreme fatigue after receiving second Shingrix vaccine. She said she was in bed for about a month after the vaccine, that it worsened her POTS.
Fever, diarrhea, ear infection. Tx: amoxicillin x7 days.
not receiving 2nd dose; pregnancy following vaccination; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy following vaccination) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy following vaccination). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose). On 17-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy following vaccination) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This is a case of product exposure during pregnancy and Product dose omission with no associated AEs for this 26-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Child rcvd ADACEL, MENACTRA, FLUZONE, Hep A, VARIVAX, and GARDASIL - just after receiving GARDASIL she stiffened up and eyes rolled back, turned pale, teeth clenched according to mom; BP - 119/79 - HR -~70/min- area no urticaria, lungs CTA, No angioedema- episode lasted approx 5 mins - received O2 via IVC (2 liters).
Pt recvd Pneumococcal vax on 20NOV91 had sl cough, exacerbating & requiring hospitalization on 8DEC91; pt has hx of bronchial problems; hospitalized w/dx of asthmatic attack; This may be coincidental to immun; pt still confined in hosp;
Narrative: given Cranberry juice monitor 30 minutes @0930: b/p 152/70 P: 90 @P0945: B/P 147/62 P.82 symptom resolved left @ 1000. feeling fine.
pt recvd vax; 6feb95 low grade fever; 7feb95 noted rash on chest;
This spontaneous prospective pregnancy report as received from an unknown type reporter refers to a female patient of unknown age. The patient was vaccinated with M-M-R II (lot number, dose, route, and indication were not reported) on an unspecified date was 8 weeks pregnant at the time of report. The LMP and EDD were not known. The pregnancy outcome was pending. The outcome and action taken were not provided. Additional information is not expected.
Pt given Influenza (preservative free 0.25 ml) lot Um65Ba exp 06/30/2006 inadvertently, received 2 month shots same day, received DTaP and IPV in same thigh. NO reaction (Adverse) 24 hours post.
Onset the evening of influenza vaccine administration, chills, fever, body aches. Duration 3 days
Information has been received from a registered nurse concerning a 26 year old female with sulfonamide allergy who on 08-SEP-2008 was vaccinated IM with the second 0.5ml dose of GARDASIL (lot #: 660555/0279X).  Concomitant therapy included CLARITIN and SEASONALE.  On 08-SEP-2008 the patient fainted and hit her head after she received the second dose of GARDASIL.  The patient was still at the physician's office when she fainted and received unspecified medical attention.  The date of administration and the lot number for the first dose was unspecified.  Magnetic resonance imaging was performed, the result was not reported.  No further information is available.
I experienced high blood pressure in March 2023. I am currently now taking Valsartan medication for my high blood pressure. I also feel tired all the time. I do not know if the vaccine caused my symptoms. I also have received routine lab work. I still continue to have high blood pressure today.
0820: BP 142/92, Sat 98%, HR 82- Patient c/o of nausea, itching and being light headed 0830:response team called 0833: 50mg  Benadryl given and response team called 0837: response team arrives to assess patient. Patient denied ED visit. 0840: BP 145/97, HR 97,  Sats 97% 0846:  Patient starts to c/o itchy throat and slight cough started.  Patient accepted ED admission.
After child received Tdap, IPV, Varicella, Hepatitis B and MMR she fainted in chair, Jerky movements noted for 10 seconds. Transitioned to floor until conscious and stable then transported to cot. Lift clinic 2 hrs later with parents.
pt recvd 3rd dose of vax 1FEB93 & 1/2-1 post vax exp chills & fever & went to ER on 1FEB93, 2FEB93, & 9FEB93 due to fever & chills ea time; addtl on 9FEB93 also had SOB & inc aching;
pt recv vax 17JUN97 & that same day pt devel chills & dizziness;18JUN97 pt was discharged from hosp & devel fever that peaked @ 102.6 & took APAP;pt to ER w/fever of 103 & back & severe joint pain;
15 month old was administered expired DAPTACEL with no adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15-month-old female patient was administered expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no adverse event while receiving vaccine.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR and varicella zoster vaccine (Varicella Vaccine) both for Immunisation.    On 09-Nov-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE at a dose of 0.5 ml once (lot C5774BA, expiry date: 18-Sep-2022) via intramuscular route in right thigh for Immunization.  On 09-Nov-2022 15-month-old was administered expired daptacel with no adverse event (expired product administered, same day latency).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Nurse administered Pentacel to a 2 month old patient without reconstituting it, did not add HIB powder with no adverse event; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case received from a Nurse via call center.  This case involves a 2 months old male patient who administered diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] to a 2 month old patient without reconstituting it, did not add hib powder by a nurse (wrong technique in product usage process), (batch number: UJ160AA and expiration Date: 24-Apr-2021 and batch number: U6395AA and expiration Date: 24-Apr-2021) at a dose of 0.5 ml once via unknown route in left thigh for prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event wrong technique in product usage process (latency: unknown).  At the time of reporting, no adverse event was reported.  Action taken and outcome of the event was not applicable.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt devel an urticarial rxn @ site of inject about 1 wk p/the inject;
Rash on arm and headache day of vaccine. Got BENADRYL OTC and used ice packs. Two days after improvement.
No additional adverse effect reported; ROTATEQ that underwent a temperature excursion was administered.; This spontaneous report was received from a study coordinator referring to patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported.     On 16-JUL-2021, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally as prophylaxis, (lot number:1741375 and expiration date: 5-MAR-2022) (dose, vaccination scheme and frequency, were not reported) which experienced a temperature excursion of 10.3 degrees Celsius for 16 minutes, as recorded by a data logger. There was no adverse effect reported or a previous temperature excursion.
Pt was scheduled to receive her Pfizer booster on 12/23, however, the medical assistant administering the vaccine administered a pediatric dose of Pfizer instead of the adult booster dose.  Pt was notified of error immediately. Pt reports feeling "mild fatigue and sore arm" after vaccine. Pt was notified of CDC's recommendations to repeat dose and was scheduled for this as appropriate.  Pt will require additional visit to clinic for repeat vaccination, no additional follow up was needed with receiving a lower dose.
Pfizer-BioNTech COVID-19 Vaccine EUA Extreme joint pain, nausea, dizziness, swelling in hands, rapid heart rate, headache, injection site pain, very tired
On 6-28-12 at 9:00, tender nodule at injection site lateral (L) leg, 2 x 3 cm  duration 2 - 3 days, (diarrhea x 1 day) fever from 6/19/12 until 6-23-12, up to 100.0 degrees. Treatment, SEPTRA 40 mg/5 cc, 1 1/4 tsp PO BID x 10 days.
Father was securing pt on lap during vaccine administration when pt freed arm and swatted at needle during shot. Injection was completed but as withdrawing needle pt hit hand near needle causing a scratch at injection site. Immediately made dad aware and show him what had happened and he was aware. Pt showed no adverse reaction during or after shot was given. Cleared to leave.
Information has been received from a consumer concerning her 18 year old old daughter with no pertinent medical history who on 26-JAN-2007 was vaccinated with her first dose of HPV. Concomitant therapy included hormonal contraceptives (unspecified). On 26-JAN-2007 the patient experienced itching at the injection site that developed into full body itching. Medical attention was sought. The patient was treated with Benadryl. There were no laboratory or diagnostic tests performed. At the time of the report, the patient had not recovered. Her second dose was scheduled for 23-MAR-2007. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow-up information has been received from a physician and a consumer concerning her 18 year old daughter with no pertinent medical history who on 26-JAN-2007 was vaccinated intramuscularly, into the left arm, with her first dose of GARDASIL (lot 654540/1161F). Concomitant therapy included YASMIN. On 26-JAN-2007 the patient experienced itching at the injection site that developed into full body itching. Medical attention was sought. The patient was treated with BENADRYL. There were no laboratory or diagnostic tests performed. At the time of the report, the patient had not recovered. Her second dose was scheduled for 23-MAR-2007. Additional information is not expected.
Bowel and bladder dysfunction, aching legs and neck pain. Urinary retention increasing pain to lower extremities. Hospitalized and diagnosed with Transverse Myelitis. Had a course of IV steroids. Worsening pain and noted fatigue and trouble walking. Still have fatigue, pain, neurogenic bladder and am unable to work, treated presently pallatively for symptom relief.
not feeling well; clammy skin; feeling nauseous; This is a spontaneous report from a contactable consumer (reporting on behalf of her husband) received via Pfizer sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration were not reported), via an unspecified route of administration on 30Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that patient was not feeling well after the first dose and wanted to know if this was part of the side effects. Patient was experiencing clammy skin and was feeling nauseous in Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT SAID HE HAD FLU LIKE SYMPTOMS AND PASSED OUT FOR A FEW SECONDS ON THE 3RD DAY AFTER VACCINATION
Information has been received from a nurse practitioner concerning a 30 month old female with no medical history who on 12/12/02 was vaccinated SC in the left arm with the first dose of varicella virus vaccine live (lot # 641155/0793M). Concomitant vaccinations on that same day included the first dose SC in the right arm MMR (lot # 642182/0774M). There was no illness at the time of vaccination. The NP reported that on 6/18/04, the patient developed approximately 11 raised pink lesions on her back, face, and right hand. Unspecified medical attention was sought and a diagnosis of chicken pox was made. The patient was treated with diphenhydramine HCl for the chicken pox and amoxicillin for a concurrent otitis media. Subsequently the patient's chicken pox resolved, however, at the time of this report, the outcome of the otitis media was unknown. Additional information has been requested.
"It hurts"; "Like a swollen vein"; Swelling breast; Swelling under left arm, breast and chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN ("It hurts"), SWELLING ("Like a swollen vein"), BREAST SWELLING (Swelling breast) and LYMPHADENOPATHY (Swelling under left arm, breast and chest) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN ("It hurts"), SWELLING ("Like a swollen vein"), BREAST SWELLING (Swelling breast) and LYMPHADENOPATHY (Swelling under left arm, breast and chest). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of unknown. At the time of the report, PAIN ("It hurts"), SWELLING ("Like a swollen vein"), BREAST SWELLING (Swelling breast) and LYMPHADENOPATHY (Swelling under left arm, breast and chest) outcome was unknown.            No relevant concomitant medications were reported.  Treatment details also include  applied hot compresses on affected areas. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-056054 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up received on 04jun2021 and does not contain any new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Small pox vaccine given 1-25-08, read major reaction 2-1-08.  Noted increased drainage surrounding skin (approx 3").  Became tender, red, warm to touch, partial skin torn off when removing bandage adjacent to pustule.  Diag: cellulitis secondary small pox.  Levaquin 750 mg 1 po qd #5. 2/18/08 cellulitis resolved.