chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rebound COVID after taking Paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound COVID after taking Paxlovid) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2022, the patient experienced COVID-19 (Rebound COVID after taking Paxlovid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound COVID after taking Paxlovid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not reported.  The patient reported rebound of COVID-19 after taking Paxlovid.  Company comment: This spontaneous case concerns a 43-years-old female patient, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Rebound COVID after taking Paxlovid) which occurred 6 months 23 days after the third dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment. SARS-CoV-2 test was positive as on 31-May-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 43-years-old female patient, with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Rebound COVID after taking Paxlovid) which occurred 6 months 23 days after the third dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 21-May-2022 for COVID-19 treatment. SARS-CoV-2 test was positive as on 31-May-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Myalgia, Fever, Diarrhea & NauseaVomiting Narrative
Get a little itchy; Little red mark at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Get a little itchy) and VACCINATION SITE ERYTHEMA (Little red mark at the injection site) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 939906, 040B21A and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration and Glaucoma. Concomitant products included BRIMONIDINE TARTRATE, TIMOLOL MALEATE (COMBIGAN), DORZOLAMIDE and LATANOPROST for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Get a little itchy) and VACCINATION SITE ERYTHEMA (Little red mark at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Get a little itchy) and VACCINATION SITE ERYTHEMA (Little red mark at the injection site) outcome was unknown.      No treatment information mentioned.  Patient got a little red mark at the injection site and would get itchy. The mark is still there and itches from time to time.
3/6/21  2:30 am- stiffness in neck, headache, soreness around injection site- Subsided after 1 hours with ibuprofen(400mg ibuprofen) 9:30 am-pain (muscle cramps) down both legs and in arms. Headache- subsided after an 2 hours. I took 400mg of ibuprofen.  12:00pm- dizzy, started to get tunnel vision. I quickly sat down and vision began to come back. I had to sit for around 20 minutes before I know longer felt dizzy. Pain began to come back in both legs. Aching and fatigue. This lasted for around 2-3 hours. I stretched my legs and arms a lot during that time frame.  I began to feel better around 4:30pm.  Still mild aching in legs and arms.   8:00 pm-pain in legs and arms, headache, dizziness (400mg Ibuprofen) I went to bed and when I would up the next morning all my muscle aches and pains were gone. My right arm was still sore for 3 days post vaccine. I noted a half dollar size redness around the injection site. by day 3 the redness was the size of a grape fruit. Day 4 post vaccine the soreness in the arm was gone and redness had began to fade.
Patient called back 45 minutes after getting their second Moderna Booster shot reporting itchy welts on their legs. Patient then reported that they had a similar reaction to the first shot, but did not report it on the informed consent form when they filled it out because they did not attribute it to the shot. It took about 2 weeks for it to go away the first time. I told patient to take Benadryl right now and then every 6 hours. I also told patient to monitor the hives, if it spreads to the face, to seek emergency care. Since there is a possibility, that it can obstruct breathing. The patient reported no breathing problems at this time and did not have any problems after getting shot during the 15 min wait period.  The patient will report their reactions to V-safe from the handouts given during the immunization.
Covid Primary Moderna  Vaccine administered on 9/19/2022, but the use by date is 9/17.
feel feverish; nipples are so sore it's horrible; This is a spontaneous report from a contactable consumer. This 20-year-old female consumer reported that:  A 20-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose at left arm on 06Feb2021 12:30 for COVID-19 immunisation.  Medical history included postural orthostatic tachycardia syndrome (POTS), allergy to nuts. Patient was not pregnant.  The patient had not experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient previously received the 1st dose of bnt162b2 (BNT162B2) on an unknown date for COVID-19 immunisation.   The patient experienced felt feverish and her nipples were so sore, it was horrible on 06Feb2021 16:00. She stated she never had breast pain in her life. Patient received no treatment. COVID was not tested post vaccination. The outcome of events was unknown.    Information on the Lot/Batch Number has been requested.
Pt recvd vax & devel local swelling, induration, itching, erythema @ inject site; sx lasted 2 days; No further details were provided;
Nausea, chills, fever (101.8° F), body aches, head ache
Patient complained of rash the evening of 11/29/22.  Rash covered the majority of torso and extremities.  Noted injection site had a bigger red mark where vaccine was administered.  No shortness of breath.  Patient was taken to local emergency room.  Physician suspected that rash was due to recent completion of a course of cephalexin, however when guardian said that a vaccine had been administered, said that most likely due to vaccine reaction.  Prescribed prednisolone once daily for 5 days and zyrtec nightly.  guardian did not disclose strength.
I had pain in my injection site and it has subsided but literally for 4 months from march until early June I had pain at the injection site. I had an acupuncturist come and massage the injection site. I went to my doctor and she took an MRI and my whole left hand tingles. I still have a slight tingle now.  I had to get a pain killer because I had to take the MRI and I lay on my left shoulder and I could not move but it was painful so I took the pain killer. As the pain has subsided the tingling has increased. What my doctor said is that I was injected in my rotator cuff.
Severe nerve pain, paresthesia, muscle pain, , muscle weakness, muscle spasms, tremor, brain fog
received during the same clinical day a shingrix and varicella shot; This case was reported by a other health professional via call center representative and described the occurrence of off label use in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number mx7ma, expiry date unknown) for prophylaxis.   Co-suspect products included Varicella (Varicella vaccine) for prophylaxis.   On 26th October 2021, the patient received Shingrix and Varicella vaccine. On 26th October 2021, unknown after receiving Shingrix and Varicella vaccine, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The patient received during the same clinical day a Shingrix and a Varicella shot, which led to off label use. It had been considered that having co-administration of the Varicella and the Shingrix vaccine would be a "off label use" as CDC recommended to wait a minimum of 8 weeks after a person received varicella/chickenpox vaccine to give Shingrix. The reporter consent to follow up.
temp rose to 105 on noc of immun; pt given APAP & bathed; fever came down to 102; MD called; no further treatment; high fever lasted 20 mins;
Pt recvd 3rd dose of Hep B vax Feb89; Upon PE in approx JUN89 lab eval revealed SGOT 49 & SGPT 114; On 10JUL89, repeat lab eval SGOT 49 & SGPT 163; 10AUG89 & 12OCT89 SGOT 39 & 26, & SGPT 113 & 67 respectively; On 28DEC89 SGOT 25 & SGPT 68;
a few days p/ recv vax pt devel a fever & diarrhea. pt did not devel lesions
I received two doses of the Pfizer vaccine, the first on 3/06/2021 and the second on 3/26/2021, both at the above hospital.  Sometime in March, a pimple appeared on my left nostril.  It did not resolve.  After several weeks, a second appeared next to it on the same nostril.  Eventual the pimples became sores that would weep, scab over, crust, but never completely heal.  I had to wait two months just to get an appointment, since medical facilities are so backed up.  I went to this facility this past June and was told it was rosacea.  After several weeks of no improvement with the antibiotic gel I was prescribed, I requested another appointment.  On August 10, a biopsy was done, with the diagnosis of basal cell carcinoma.  I had a Moh surgery, including skin graft, on September 10, 2021.    For a supposedly slow-growing type of cancer, this seemed to grow quite quickly.  I believe the surgeon told me the two spots on the left nostril, did not appear connected.
Patient received Johnson and Johnson vaccine at approx 1:30 pm and passed away on 11:03 pm - May 24, 2021.  Was told around 10;20 pm, the patient was experiencing trouble breathing, cold, clammy, non-responsive .
Information has been received from a nurse concerning a female who on 27-FEB-2008 was vaccinated IM with the first dose of GARDASIL. Subsequently the patient experienced swelling around one of her eyes a few days after receiving the vaccination. The patients' outcome was not reported. Additional information has been requested. 07/08/08 This is a follow-up to report(s) previously submitted on 4/7/2008. Information has been received from a nurse concerning a 13 year old female student who on 27-FEB-2008 was vaccinated (2:40PM) IM in her left arm with a first dose of GARDASIL (lot# 655327/1287U). On 03-MAR-2008 (10:00AM) the patient experienced puffy eyes and also had cold symptoms, BENADRYL was recommended. The patient's outcome was not reported. No further complications reported. Patient was not brought to the office. Additional information has been requested.
Initially I had some arm pain and felt ill for 10 hours after receiving the vaccine. Then, within a few days, I developed headaches, disorientation and loss of balance. 3 weeks later I had a stroke. I was hospitalized for 2 days. I have been given a different regimen of medication. Numerous tests have been done to rule out underlying conditions that could have caused the stroke and all came back negative. I am still having some lingering effects from the stroke like loss of memory and general fatigue.
Sugar level jumped to 420; This is a spontaneous case from the United States, initially received from pharmacist via Med Communications (reference number: SEQ19-04655) on 14-Oct-2019, concerning a 31-year-old, female patient.   The patient's current condition included diabetes, while the patient's concomitant medications were not reported.   On 02-Oct-2019, the patient was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5ml, route of administration: intramuscular, anatomical location: deltoid (left or right, as reported), batch number: P100100560, expiry date: May-2020] for an influenza prophylaxis.   On the same date, after vaccination, the patient's blood sugar jumped from 190 to 420 (units were not specified).The patient did not eat anything before receiving the flu shot, and had not taken any steroid shots as well, as reported.   At the time of initial reporting, the outcome of the event of diabetes mellitus aggravated was unknown.  The case was assessed as serious and the reporter did not provide causality assessment.  Company comment: The patient experienced diabetes mellitus aggravated, on the same date after vaccination with the suspect product, Afluria Quad. Chronology is plausible. Reportedly, the patient's blood sugar jumped from 190 to 420 (units were not specified). Causality was confounded by underlying medical history of diabetes mellitus. More information regarding therapy compliance, dietary regimen and physical activity is needed. Based on provided information, causal role of the suspect product is assessed as related.
Swelling in both armpits, soreness and slight burning sensation. Has continued to get worse over past six months. Burning has spread to cover upper body, head, neck, and face. Have taken antibiotics started on 11/29/2016. Have seen PC Physician on 11/29/16, 1/11/17, and 5/16/17. Visited the ER on 1/7/17 due to increased pain and burning. Have seen a neurologist on 1/12/17, 1/25/17, 2/20/17, and 4/12/17. Seen an allergist on 3/7/17. Had a chest xray, chest CT, MRI, and numerous blood tests. Have been taking Gabapentin and Prednisone.
Initial information received on 07-Jun-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a five months old patient (gender not reported) who was vaccinated with QUADRACEL instead of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to Wrong vaccine administered as five months old pt. inadvertently received QUADRACEL instead of PENTACEL. No adverse event was reported. 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. Documents held by sender: none.
Possible cellulitis around injection site, redness, chills, HA 4 hours after injection and 24 after. Keflex 500 BID x 10.
no adverse reactions; didn't realized it was MMR-11 and varicella combined; accidently gave a 4 year old patient an expired dose of VARlVAX.; It was also reported that the staff member gave PROQUAD but meant to give MMR-II and didn't realized it was MMR-II; both VARlVAX and PROQUAD were given intramuscularly rather than subcutaneously; Information has been received from a medical assistant, referring to a 4 year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-JUN-2021, the patient was vaccinated by accident with an expire dose of varicella virus vaccine live (oka/merck)(VARIVAX), (lot number and expiration date were not reported) intramuscularly for prophylaxis. It was also reported that the patient was also vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot number and expiration date were not reported) instead of measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II). n addition, the reported confirmed that both vaccines (varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD)) were given intramuscularly rather than subcutaneously. Per reporter, the patient did not have any adverse reactions.
Feel week; Everything in body hurts feel so tired; This is a spontaneous report from a contactable other healthcare professional (reporting herself). A 35 year old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not available), via an unspecified route of administration in left arm on 04Feb2021 at 14:45 (age at the time of vaccination was 35 years) as a single dose for COVID-19 immunization. The patient's medical history included anaemic. The patient's concomitant medication was not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication with in 2 weeks of COVID vaccination. The patient did not diagnose with COVID-19 prior to the vaccination. The patient did not test for COVID since the vaccination. On 04Feb2021 at 14:45, the patient experienced felt week, everything in body hurts felt so tired. The patient did not receive any treatment medication. The outcome of the events was not resolved.  Information on the lot/batch number has been requested.
titer for MMR II and the titer result came back "low"; This spontaneous report was received from a patient's mother and refers to a 29-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown dates (reported as "at recommended age"), the patient received two doses of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) administered intramuscularly (dose, anatomical location, lot # and expiration date were not reported) as immunization for prevention of measles, mumps and rubella. On an unknown date, the patient's healthcare professional (HPC) took a titer for measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) and the titer result came back "low" (viral titre decreased). The patient's HCP recommended a third dose of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II). The outcome of the event was unknown.  Causality assessment was not provided.
lightheaded and dizzy, extremely tired which started 5 days after the injection. on January 9th noticed a large red area on the left arm below the injection site.
Pt recvd 3 doses of Engerix-B vax & following 3rd dose exp hives in area of tight clothing;
1. Swollen Lymph nodes on upper chest near shoulder (Left thoracic duct area) and left arm pit large enough to feel by hand, lasting approx 8 hours.  2. Stomach bloating accompanied by stomach discomfort / pain and  severe diarrhea for 48+ hours.  3. Intermittent Dizziness and headaches lasting approx 24 hours.  4. left arm and finger joint stiffness, lasting approx 48 hours.
The evening of the vaccination about 8:00pm, I began to feel body aches all over and my fever spiked to over 100 degrees. My heart rhythm became a bit erratic  per an ECG I took with my wearable device although still sinus rhytum.  I took the Tylenol as directed and went to bed. That night was the worst sickness in over a decade. My entire body was in pain, and the fever was up to 102 despite taking Tylenol every 4 hours. I was drenched in sweat, with fever and chills. My heart was palpitating. The illness continued for 5 days, with fever and fatigue, until it subsided.  I took Tylenol the whole time. Around May 28, I fell ill again with almost the same symptoms. Fever, chills, fatigue, aches, and this time my tongue swelled and turned white.  I had a rash on my back and chest. This continued for 2 weeks until subsiding. I tested negative for Covid.  I did not seek medical care at this time. I have not had a fever in over 10 years from any illness. I now am suffering from what appears to be Graves Disease.
Shingles after vaccine/ Suspected vaccination failure; Shingles, still suffering through process; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated anyone could get shingles after the vaccine and the patient was still suffering through this process. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient reports swelling of hands, feet, and face evening of injection, also extreme pain in head, neck, and shoulder, she took BENADRYL.
GASTROINTESTINAL SYMPTOMS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced gastrointestinal symptoms, and fever. The action taken with covid-19 vaccine was not applicable. The outcome of the fever and gastrointestinal symptoms was not reported. This report was non-serious.
permanent hearing loss; Information has been received from lawyers referring to a male patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not reported.  In or around 2013, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   On an unknown date, the patient experienced permanent hearing loss. The patient did not recover from the event. As per the reporter, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The event was disabling.   The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the event was determined to be medically significant.