chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Chills; Nausea; Cramping pain all over body; Swollen red large circle around the injection site; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Cramping pain all over body) and VACCINATION SITE SWELLING (Swollen red large circle around the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PYREXIA (Fever). 26-Jan-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Cramping pain all over body) and VACCINATION SITE SWELLING (Swollen red large circle around the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Cramping pain all over body) and VACCINATION SITE SWELLING (Swollen red large circle around the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information which includes a strong  temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  All events are consistent with the established safety profile of mRNA-1273 vaccine.
Day 12 post vaccination: pt developed fussiness, low grade fevers around approximately 100 F. Noted rash over neck and trunk. Few areas on face and arms involved.
Symptom:  Dermatitis, focal Start:  01/2004 Comment:  Tinea capis.  Symptom:  Lymphadenopathy, axillary Start:  09/2004 Comment:  bilat axillary and groin-recurrent.  Symptom:  Fatigue Start:  07/2003 Comment:  Improving.  Symptom:  Joint Pain, multiple joints Start:  07/2003 End: 04/2005 Comment:  fully resolved.
This spontaneous report as received from a medical assistant (M.A.) refers 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 an improperly stored dose of PROQUAD (Merck) (lot# reported as L023111, expiration date 24-SEP-2016, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I didn't feel right but not terrible after the vaccine with achiness and sore arm. I tested positive via a home test for COVID-19 on 08/28/2022. I had a sore throat, coughing, flu like symptoms, fatigue, terrible cough that made my chest hurt. The symptoms lasted for about three days and gradually I started feeling better. I contacted my doctor and had a phone visit and was prescribed Molnupiravir. The doctors office continued to check on me for about five days after the initial conversation. As of today I continue to feel fatigued and cough which makes me need to rest in the afternoon.
first dose: 09Nov2020, did not get the second dose until 03May2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 9Y92A, expiry date 2nd June 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on 9th November 2020, batch number L7574 and expiry date 27th March 2022).   On 3rd May 2022, the patient received the 2nd dose of Shingrix. On 3rd May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's Comments: The pharmacist reported that a patient received second dose of Shingrix on 3rd May 2022. The reporter gave permission for follow up. The reporter consented to follow up. Additional Supportive Information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Fever, chills, headache, fatigue, nausea -- all for about 24 hours before easing
Information has been received from a RN concerning a pt who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647038/0926N). Subsequently the pt developed swelling, pain and redness at injection site. Unspecified medical attention was sought. No product quality complaint involved. It was also reported that others had a similar experience (WAES0408USA01249, 0408USA01759 and 0408USA01760). Additional information has been requested.
Right upper arm red, swollen, and warm to touch. Measures about 7 inches in length. Mom took child see APN. APN is treating area with butt paste, BENADRYL, TYLENOL, and MOTRIN. Mom said arm looks better today than yesterday. APN said no more tetanus.
Felt much like I did when I had COVID virus and after the first short. In bed for almost 2 days. No fever but just felt awful. Did  not eat or do anything. Worst part was the intense pain at injection site in right arm. Pain was excruciating and it took 6 days for it to subside. Sleeping was especially problematic.
Bruised, swollen left eye lid. Whole body aches. Hurting left arm at injection site. Cough, and runny nose. Chest feels sick like a respiratory infection.
Redness and inflammation at the site of injection. Tdap 0.1 mL given in place of PPD.
Pt arm is inflamed from the clavicle to the elbow of the left arm. The arm was tender to touch, red with heat radiating throughout. Mom states that arm was swollen and painful 3/27. Mom states that she doesn't have a doctor here. I advised mom to go to ER for possible treatment of cellulitis.
Tiredness and Fatigue; body aches; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FATIGUE (Tiredness and Fatigue) and PAIN (body aches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced FATIGUE (Tiredness and Fatigue) and PAIN (body aches). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Fatigue, at an unspecified dose and frequency and VITAMINS NOS for Tiredness, at an unspecified dose and frequency. At the time of the report, FATIGUE (Tiredness and Fatigue) and PAIN (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details included Tylenol extra strength and vitamins.
13OCT96 devel rash on face & has advanced to complete body;mom states pt has t102.9 ax;
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Rash (specify: facial area, extremities)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Confusion-Mild.
10 minutes after receiving her vaccination, she started feeling lightheaded. She does have a history of lightheadedness with blood draws. She was taken to a private section of the arena and monitored. Her initial blood pressures were one 170s/110s, then decrease to 150s / 100s. Also reported feeling a headache.
Hives on R side of chest. VS: BP 163/99, 68, SpO2 97%, R 16
Localized swelling, redness and itching night of injection date. Became worse the next day and fluid filled blisters began forming also had fever and muscle aches on 8/13/14. On 8/14/14 14 x 7 cm area of induration and redness around injection site with 2 1/2 - 3 1/2 cm area of fluid filled blisters about 40-50. Site is warm to touch.
This spontaneous report as received from a registered nurse reported that different facilities might have administered vaccines after vaccines were exposed to temperatures outside of recommended storage range. She stated that she does not have any patient specific information. At the first facility they might have administered VAQTA, RECOMBIVAX HB, and GARDASIL which had been exposed to 33F for 129 hours. No adverse effects reported. The nurse reported that at a second facility they have two sets of vaccines which have both been exposed to temperatures outside of range, and may have been administered to patients. The first set of vaccines were RECOMBIVAX HB, COMVAX, GARDASIL, ROTATEQ which were exposed to 30F for 466 hours, and 47F for 39 hours and may have been administered to an unspecified number of patients. No adverse effects reported. The second set of vaccines for this facility were COMVAX and GARDASIL which were exposed to 30F for 221 hours and 47F for 15 hours and may have been administered to an unspecified number of patients. No adverse effects reported. This is one of the several reports received from the same source. (Same reporter link: 1406USA007003, 1406USA007004, 1406USA007005, 1406USA007006). Additional information has been requested.
pt had fatigue, loss of appetite and was not feeling well and then a couple of days later he started having chest pains and heaviness in the left arm.  He was taken  ER on 7/2/21- they did EKG, Covid test, and lab work.  His test were normal and was told to go home and relax for the next couple of days.  He had a tele visit FU appt w/ Dr. .  Patient no longer has any symptoms.
Headache for approximately 16 hours, fever between 99-100, fatigue   Took Tylenol to limit symptoms
Patient states she developed a fever later that evening.  Said arm was tender and swollen. She took Tylenol for the discomfort. Patent came into pharmacy on 9/9/21 asking for pharmacist to take a look at her arm. Arm was red and hot to the touch with some edema and erythema about 4 inches below injection site. Pharmacist advised patient to try a non steroidal to help with discomfort and perhaps some diphenhydramine along with ice if needed. Patient said she would keep an eye on it and report any changes and check in with pharmacy in a few days.
COVID vaccine given Dec 24th, 2020 and second dose on Jan 16th, 2021.  Conception occurred approx Jan 11th, 2021 pregnancy diagnosed Jan 26th, 2021.   ED Oct 4th, 2021.  US confirmation of pregnancy with gestational sac on Feb 14th, 2021.   Miscarriage/SAB/pregnancy loss occurred spontaneously on Feb 18th, 2021 with bleeding, cramping.  Pregnancy loss confirmed by ultrasound with OBGYN.
Breastfeeding baby developed a rash and hives to my breastmilk.
Very sore and swollen injection site within 2 hours of administration. Fever (102F), dizziness, muscle aches and cramps, headache, stomach ache starting within 24 hours and continuing at this time. Treatment with acetaminophen cool compress, hydration, and rest. Fever reduced with continuing dosing with acetaminophen and cool compress. ***Prior positive Covid test with moderately severe illness lasting 1 month without hospitalization positive PCR 11/03/2020.
Moderna vial was punctured at 8:20 AM on July 26th.  Four doses were pulled out and vial was place back into fridge.  The drawn note did not contain a date, so the pharmacy technician assumed it was punctured today.  The vaccine was left in the vial in the fridge overnight.  The vaccine expired at 8:20 PM but was administered 10:52 AM on July 27th.  Biotech was notified and did not recommend giving more than two doses of Moderna and recommended to use our professional judgement.  We decided not to revaccinate.
no adverse event; a finger flange that is broken into 2 pieces and has broken off of the gardasil 9 syringe; vaccine administered from a syringe with a broken finger flange; This spontaneous report was received from a Registered Nurse referring to a 11 year old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were unknown.      On 13-NOV-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027576 and expiry date 23-JUN-2021 reported, for prophylaxis (strength, dose, route not reported). On 13-NOV-2019, the nurse reported a finger flange that was broken into 2 pieces and had broken off (product quality issue, wrong technique in product usage process) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe. The nurse reported that the vaccine was administered to a patient. No adverse event reported. The outcome of the events was unknown.
At 4:30 P.M. on the day of injection I was suddenly struck with painfulf and watery eyes, throat tightening and white, frothy  sputum, headake, and muscle acke.  Temperature  - 99.1.  Developed sore throat immediately, Symptoms continued for three days. Over- the -counter drugs used to treat.
Contant 102°F fever, body ache, fatigue, severe headache for about 36 hours started 12 hours after the vaccine shot.
Severe back, neck, and shoulder pain. Lightheaded and tired for 3 days now. Swollen, red, hard area above injection site  Chills
Patient receive 1st dose of Twinrix and experiences fatigue, muscle aches, and diarrhea more than 30mins after receiving vaccine. Patient stated SE was tolerable and did not report until came in for the second dose. patient was monitored for 15 mins after both doses to which he had no reactions. Advise patient to call immediate after onset of SX occurs with second dose.
patient developed a hemorrhagic stroke within one week of receiving the vaccine patient started having symptoms within a few days of the vaccine
experienced intense pain in shoulder,  pain became sharp upon using arm to reach up - started at approximately midnight shoulder and arm were extremely sensitive to touch (even fabric) woke up around 3am with shivering/chills at that time his arm was extremely painful lasted about 5 1/2 hours at 5am shoulder and arm were sore but movable without intense pain does have a history of arthritis in shoulder
Three chicken pox around injection site that became infected with staph. Was treated with oral antibiotics and topical antibiotics responded to treatment well.
3 weeks after the second vaccine, my right trigeminal nerve started progressive numbness from the lower jaw to the upper scalp.  After 6 weeks, the condition is now intense and the entire trigeminal nerve on the right side is engaged and numb.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2015, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
A few days after the vaccination, I noticed a small hard lump in her left thigh at the site of the injection.
4/9/2021   Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  diaphorectic, light headed..pale.   Assessment : Time of assessment 1105, pale, diaphoretic, light headed. Sitting on floor, transferred to wheelchair   Actions taken:  Vitals sign taken  VAERS form completed 1105- BP - 79/33, P- 51, O2- 100%, 1110: BP- 84/44, P- 52, O2- 100%, Jiuce and granola bar given, at 1118- Bp- 97/60, P- 57, O2-97%, 1141: BP-97/60 , P- 56, O2- 99%     Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the system.      Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/9/2021 11:00 AM
45min p/vax c/o chills, fever, h/a on 18MAR98;c/o pain lt upper extremities;reports still c/o chills, h/a today;reports T100 on 18MAR98 p/vax;
Menstruation change; Depression; ADHD; Chronic fatigue/Tired all the time; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Menstruation change), DEPRESSION (Depression), ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD), FATIGUE (Chronic fatigue/Tired all the time) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676 and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (allergic to banana), Drug allergy (bioxin), Depression and ADHD. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE), ESCITALOPRAM and BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.   On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jul-2021, 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 experienced MENSTRUATION IRREGULAR (Menstruation change), DEPRESSION (Depression), ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD), FATIGUE (Chronic fatigue/Tired all the time), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, MENSTRUATION IRREGULAR (Menstruation change), DEPRESSION (Depression) and ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) outcome was unknown, FATIGUE (Chronic fatigue/Tired all the time) was resolving and HEADACHE (Headache) and MYALGIA (Muscle pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were not provided.
Worsening Asthma; Sore throat; Injection site itches; rash was at the injection site and on her forearms/ Bilateral raised itchy rash on my forearms; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHMA (Worsening Asthma), OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE PRURITUS (Injection site itches) and VACCINATION SITE RASH (rash was at the injection site and on her forearms/ Bilateral raised itchy rash on my forearms) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Smoker. Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL SULFATE (VENTOLIN ACCUHALER) and ALBUTEROL SULFATE for Asthma, FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), PREDNISONE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced ASTHMA (Worsening Asthma), OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE PRURITUS (Injection site itches) and VACCINATION SITE RASH (rash was at the injection site and on her forearms/ Bilateral raised itchy rash on my forearms). At the time of the report, ASTHMA (Worsening Asthma), OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE PRURITUS (Injection site itches) and VACCINATION SITE RASH (rash was at the injection site and on her forearms/ Bilateral raised itchy rash on my forearms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant included Claritin. No treatment was provided. Action taken with Moderna covid-19 vaccine was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded.
not sure if related. having acute swelling near left knee. after reading side effects include joint swelling decided to report. planning to see a doctor tomorrow to see what they think.
Swelling around her eyes, lips, and cheeks; Swelling around her eyes, lips, and cheeks; Swelling at the injection site; Itchiness at the injection site; Facial swelling; Rash developed around the injection site; A spontaneous report was received from a healthcare professional, concerning a 58-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial swelling, rash developed around the injection site, swelling around her eyes, lips, and cheeks, swelling at the injection site and itchiness at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced facial swelling and rash developed around the injection site. On an unknown date, the patient experienced swelling around her eyes, lips, and cheeks, swelling at the injection site and itchiness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   At the time of this report, the outcome of the event facial swelling was resolved and the outcome of events rash developed around the injection site, swelling around her eyes, lips, and cheeks, swelling at the injection site and itchiness at the injection site were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Reporter stated that Doctor injected an office worker w/40mcg of Hep B vax (Recomb) instead of 10mcg; @ the time of the report there was no adverse rxn; No further details were provided;