chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed Covid after Moderna Dose 3; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed Covid after Moderna Dose 3) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included Drug allergy.   On 14-Mar-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Developed Covid after Moderna Dose 3). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 08-May-2022 to 12-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Developed Covid after Moderna Dose 3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter. Patient was not taking other medications/products within 2 weeks of starting COVID-19 treatment. Device Date was reported as 19-May2022.  Company Comment: This spontaneous case concerns a 41-year-old, male patient with past drug history of administration of the second dose of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 6 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed COVID-19, however, no symptoms were reported. He took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 08May2022 to 12May2022. It was reported that the patient developed COVID-19 rebound 7 days after treatment with Paxlovid. No additional details were provided at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old, male patient with past drug history of administration of the second dose of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 6 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed COVID-19, however, no symptoms were reported. He took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 08May2022 to 12May2022. It was reported that the patient developed COVID-19 rebound 7 days after treatment with Paxlovid. No additional details were provided at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Ringing Ears; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 15Apr2021 at 18:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history and no known allergies reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol succinate (METOPROLOL) started on an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the arm left on 25Mar2021 at 18:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021, the patient experienced ringing ears. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing ears was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Rash started Monday 02/21/2005 on abdomin.  20-30 papulovesicular lesions on trunk.
Tetanus vaccination on February 24, 2004. Two days following this, he developed redness and the area was warm to touch. This area was from about the shoulder area down to the elbow. He denies any impairment in mobility or interference with his ADLs. He did not have a fever or any other symptoms. His arm did not itch. He went to medical and was given a steroid taper pack. He reports that this was effective in relieving the symptoms. He denies any prior reaction to vaccines. He does not know if his vaccination was due because his medical record was misplaced in April.
Moderna COVID -19  Two days of high fever (104.1 was highest recorded temp), congestion and difficulty breathing (rescue inhaler was sufficient), racing heart rate, dizziness and weakness, aching bones, pain in joints, acute headache, chills, nausea, extreme fatigue, and swollen lymph nodes (the last symptom continues 5 days later, on same side as injection).
Patient stated felt lightheaded. Lied patient on exam table for 5 minutes and stated feeling better. BP 142/86. Sitting up BP 122/84 and still feeling okay. Standing up BP 125/86 and no feeling of lightheadedness. Walked patient to car.
A hour after the shot 5/25/21 I had a very sore arm no rash no redness it took 4 days till it felt better. Then on 6/14/21 I woke up and my arm is sore I can?t move my arm it?s very painful today is 6/17/21 and it?s not getting any better I?ve iced it use heating pad taking Benadryl ibuprofen tylonal nothing is helping it?s not red or swollen it?s very painful I can?t sleep at night it constantly aches even at resting .
Night of the vaccine: had some pains in my foot, light but sharp shooting pains / cramping sensation on top of feet; had a headache, began having body aches.  Morning after the vaccine: entire body ached, headache, sneezing / runny nose, tired.  Mid-morning after the vaccine: Body aches, chills, fever, dizziness, headache, nauseous, slight congestion and sore throat, numbness in hands, sharp pain on entire right side of head /ear.
No additional adverse event; Caller reports VARIVAX administered IM to a 27yo.; This spontaneous report was received from a nurse and refers to a 27-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 04-AUG-2022, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot # U015688, expiration date: 18-MAY-2023, that was administered intramuscularly for prophylaxis (anatomical location was not provided) (Incorrect route of product administration). No additional adverse events were reported.
Redness at injection site - swelling from injection site, down arm almost to elbow, arm is tender & hot to the touch. Patient advised to seek medical care.
pt recvd vax & devel diffused erythema of scalp, face, upper trunk;
After I got the shot, my arm was just a little sore. I woke up on Monday morning, and I ached for 3 days, every bone in my body ached for 3 days. Then since then, idk if I feel weak or lousy like I am getting the flu or something. I have been in my nightgown all week since Monday morning. I dont have much of an appetite. I don't know if I am coming down with the flu. I am just weak and I don't feel well, and I was getting a bit nausea the other day. I don't know if this is from the shingle shot or what.
Chills lasting for an 1 hr. Feeling overheated for 8 hrs, with no fever. Headache lasting for 36 hrs. Muscle soreness in left arm lasting for 3 days.
Patient reported a bullseye appeared on the vaccine arm approximately 3-4 days after receiving dose. Resolved in approximately 1 week without treatment.
Pinching the inside of arm, pinching and feels as though a movement is in chest, feels weak
On 1/23/21 - 1/24/21: Local injection site pain and soreness.  Resolved after 2 days. On 2/1/21 Developed local urticaria reaction in area where I received the vaccine: Erythema, edema and increased warmth to touch.  Ongoing currently.  No systemic/constitutional symptoms.
Began having  SOB 3 days post immunization.  worsened over then next 2 days when she was seen in clinic and sent for CT angio where submassive PE was discovered and she was experiencing significant right heart strain which led to hospitalization.  while hospitalized additional DVT was discovered.    received catheter directed TPA.  now on likely lifelong xarelto
Patient received vaccine 12/22 without incident. On 12/26, she developed rapid progression of bilateral LE weakness and numbness, sphincter incontinence, rapidly leading to paraplegia and total sphincter incontinence. Admitted to Hospital where MRI showed e/o diffuse cord signal hyperintensity and edema with patchy enhancement, suggesting transverse myelitis. Lack of clinical improvement with high dose steroids and PLEX x 5 sessions led to repeat imaging, which showed significant increase in associated edema and suggestion of spinal cord infarct in anterior spinal artery distribution, corresponding with her symptoms.
I got my first shot in my left arm and had no reaction. I got my second shot in my right arm and developed a fever 24 hours later. When I woke up the day after I had a red welt on my arm where the injection site was (about the size of a bee sting). It grew through the day to about 3 inches large. It is very warm to the touch and itchy.
Information has been received from a Nurse concerning a child patient of unknown gender and age. Nurse reported that her unspecified co-worker read an unspecified article stating that newly M-M-R II vaccinated child "shed virus vaccination" which infected the unvaccinated children. She reported that article stated "child was shedding vaccine for 5 weeks". The outcome of events was provided. Additoinal information has been requested.
This spontaneous report was received from a nurse practitioner, and refers to an unspecified numbers of patient of unknown age and gender. Medical history and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB lot # K026533; expiration date on 07-AUG-2017(strength, dose, anatomical location and route of administration were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complain involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vomit; Fatigued; Weak; Not feeling well; Lost three pounds; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received the 1st dose of Shingrix. On 8th November 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell. On 9th November 2019, the patient experienced vomiting, fatigue and asthenia. In November 2019, the patient experienced weight loss. On 9th November 2019, the outcome of the vomiting was recovered/resolved. On an unknown date, the outcome of the feeling unwell and weight loss were unknown and the outcome of the fatigue and asthenia were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, vomiting, fatigue, asthenia and weight loss to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she went to bed that night not feeling well, but she did not provide details.  She woke and began to vomit. She continued to vomit. She went to her doctor who gave her a shot to stop the vomiting and told her not to eat anything for 48 hours. She lost three pounds. She still feels fatigued and weak but did go to work. Emergency room visit required. This case linked with US2019AMR206160 and US2019AMR206161, reported by same reporter.
Diagnosed as probable vasovagal episode, but recommend allergy testing prior to next Td.  Pt received routine Tdap immunization.  He indicates that within 5 minutes of receiving immunization, while in the waiting room, he began to feel dizzy, had blurry vision, abdominal pain, and nausea. Went to restroom and had emesis x1.  MGM reports that when he walked out, he appeared pale. Pt reports that he was blowing his nose more (mild rhinorrhea) and had mild throat tightness right before and following emesis.  Pt laid down by clinic staff and administered Epipen Jr and Benadryl.   Transported to ER via EMS where he was monitored without need for further intervention. He has not had any prior vaccine reactions.
it's hot like it's infected - injection site - right arm - from shoulder to almost to the elbow; a little hard injection site - right arm - from shoulder to almost to the elbow; rash at the injection site - right arm - from shoulder to almost to the elbow; red spot at the injection site - right arm - from shoulder to almost to the elbow; a little swollen injection site - right arm - from shoulder to almost to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it's hot like it's infected - injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE INDURATION (a little hard injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE RASH (rash at the injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE ERYTHEMA (red spot at the injection site - right arm - from shoulder to almost to the elbow) and VACCINATION SITE SWELLING (a little swollen injection site - right arm - from shoulder to almost to the elbow) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease, Diabetes and Dementia.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE WARMTH (it's hot like it's infected - injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE INDURATION (a little hard injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE RASH (rash at the injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE ERYTHEMA (red spot at the injection site - right arm - from shoulder to almost to the elbow) and VACCINATION SITE SWELLING (a little swollen injection site - right arm - from shoulder to almost to the elbow). At the time of the report, VACCINATION SITE WARMTH (it's hot like it's infected - injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE INDURATION (a little hard injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE RASH (rash at the injection site - right arm - from shoulder to almost to the elbow), VACCINATION SITE ERYTHEMA (red spot at the injection site - right arm - from shoulder to almost to the elbow) and VACCINATION SITE SWELLING (a little swollen injection site - right arm - from shoulder to almost to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On 06Feb2021, Caller reported to have experienced "severe neck pain" Caller clarified: muscle pain/neck pain that got really, really awful; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 84-year-old female patient received bnt162b2 (BNT162B2, Pfizer-Biontech COVID-19 mRNA Vaccine, Batch/Lot Number: EL9262) via an unspecified route of administration on 22Jan2021, as DOSE 1, SINGLE for covid-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing, arthritis from an unknown date and unknown if ongoing. Concomitant medications included warfarin (WARFARIN) taken for atrial fibrillation, start and stop date were not reported. Patient didnot receive other vaccinations within 4 weeks prior to vaccination. On 06Feb2021, caller reported to have experienced "severe neck pain" clarified muscle pain/neck pain that got really, really awful. Therapeutic measures were taken as a result of on 06feb2021, caller reported to have experienced "severe neck pain" caller clarified: muscle pain/neck pain that got really, really awful Tylenol eight hour-controlled release. Patient stated that the product complaint was Severe neck pain that was ongoing. After she takes Tylenol and moves around it is bearable patient didn't received any physical therapy for the event. Pain was always pretty stabby sample of the product complaint was not returned no information was reported packaging of the seal was intact expiry date and strength of the product was not reported. The outcome of the event neck pain was not recovered.  Follow-up attempts completed. No further information expected.
two days(8-4-07) after recieving Dtap(given on 8-02-07), Pateint retruned to clinic.  Pateint had about a sowllen, hot to the touch, red wheel on her right arm where the Dtap was admin.
A few hours after the vaccine my arm swelled. The following day I had a headache, chills and  fever that lasted about 18 hours along with a very swollen, lumpy injection site with a red bullseye mark. Now five days later, the injection site is swollen, itchy and still a bit painful. On Sunday, March 7, I woke up with a patch of shingles on the right side of my chest. Very painful and still hasn't gone away. I believe it is connected to the vaccine (speculation, I know). I don't feel well.
This non-serious spontaneous case, initially received from other health professional (nurse) on 19-Oct-2018, concerns a 60-year-old, adult, female patient. The patient had no relevant medical history and did not take any concomitant medications at the time of vaccination. On 09-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 1.5 ml instead of 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252235, expiry date: 30-Jun-2019]. At the time of this report, no adverse events were reported. This case 201804677 was linked to the source case 201804657 due to the same reporter.
hand is still restricted, can not use the arm; Pain that did not go away/pain in her arm; shoulder injury related to vaccine administration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (hand is still restricted, can not use the arm), SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (shoulder injury related to vaccine administration) and PAIN IN EXTREMITY (Pain that did not go away/pain in her arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (shoulder injury related to vaccine administration). On 22-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain that did not go away/pain in her arm). On an unknown date, the patient experienced HYPOKINESIA (hand is still restricted, can not use the arm). At the time of the report, HYPOKINESIA (hand is still restricted, can not use the arm), SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (shoulder injury related to vaccine administration) and PAIN IN EXTREMITY (Pain that did not go away/pain in her arm) outcome was unknown.            Concomitant medications were not provided. The patient's doctor did prescribe methylprednisolone, but she was not able to finish it as it upset her stomach. She had seen several doctors. She had all types of tests including an MRI.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Date of birth, events updated.
This spontaneous report as received from a pharmacist refers to a 3 patients of unknown age and gender. The pharmacist reported that on an unknown date the patients were vaccinated with ZOSTAVAX (lot # and expiration date unspecified) 0.65 ml, once, subcutaneous injection (anatomical location unspecified). Pharmacist reported that he had 3 patients over the past four months (approximately in 2013) reporting a mild case of the shingles after receiving ZOSTAVAX. Patients did not seek medical attention. At the time of the report the outcome of patients was unknown. Additional information is not expected.
Pt is reporting of arm pain and after stating that symptom is common pt reported having some numbness in leg. Informed patient to contact their healthcare provider  for exam
8 hours after shot extreme nausea. In one instant, extreme  feeling of an instant blow to the head, extreme ringing in ears, unable to hear, disoriented, unable to speak, incoherent, rapid fever that quickly reduced. Symptoms disappeared quickly and were gone within an hour.  Afterwards mild headache, fatigue, nausea persisted for 2-3 days.
This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 20-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Pt was having chest pain, itching on injection site, redness, shortness of breath, chills, increased B/P, anxiety.
Patient was admitted to Medical Center 8-29-21. Previously diagnosed with right upper lobe pneumonia and was started on Levaquin. Was tested for COVID with admission, test result is positive. 8-30 patient compensated quickly and did pass away.  Pt was vaccinated with the Moderna Vaccine 02-03-2021 and 03-03-2021.
'Measles-like' rash to trunk of body, arms and legs.  Presentation of symptoms 16 days after administration of MMR vaccine, resulting in doctor visit at MTF.
I just got dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (I just got dizzy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (I just got dizzy). At the time of the report, DIZZINESS (I just got dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided. Treatment medication not provided.
Pt. had this vaccine on 11/10 - on day 2, her arm was bright red, warm below site, 10cm x 8cm, appearing to resemble cellulitis. This is the 4th person with this reaction.