chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 19-May-2023; No adverse event; 3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A), PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 19-May-2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Latex allergy.   On 12-Sep-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-May-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 19-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A), PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 19-May-2023) 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 (3 doses of Bivalent were given past the use date 18-May-2023 - no one reported adverse event. Lot  069H22A) and PRODUCT STORAGE ERROR (The vial was initially stored in referigerator on 18-Apr-2023 and was adminsitered on 19-May-2023).    No concomitant information was reported. The vaccine use by date was reported as 18-May-2023. The administration date of 3 vials was19-May-2023, 21-May-2023, 25-May-2023. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-727682, US-MODERNATX, INC.-MOD-2023-727687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727682:same reporter US-MODERNATX, INC.-MOD-2023-727687:same reporter
After receiving vaccines, patient asked for water. Before receiving water, patient passed out/or fainted.  EMT's called. No physical injury and vitals within normal range. Patient expressed having needle phobia.
This writer witnessed patient having a syncopal event on the chair she was sitting in. With the assist of other health care team, patient was immediately put on the gurney and bed was placed in reverse Trendelenburg so that blood could flow to her brain. Pt immediately became alert and was able to tell us her name. VS were taken and BP was 108/75 and heart rate 76. patient was immediately taken to the emergency room for further care.
pt recv vax 9APR98 10AM lt arm & exp lt arm discomfort & tenderness throughout evening;By 10APR98 swelling, tenderness & redness had inc in lt arm;sx lasted 36hr;still w/sl lump on lt deltoid;
PFIZER COVID VACCINE DOSE #3 GIVE 12/14/21, LOT #FH8027; pt in facility for pneumonia; pt has completed ABX tx; had a positive COVID test on 7/9/22; isolation set up; DNR with comfort measures; family does not want pt sent to hospital; pt passed away 2 days later in the facility
Pt had swelling & hives of his hands and feet on 6/15/11. He was treated at hospital ER with BENADRYL and prednisone.
Headache, Myalgia, Fever, CHILLS, PAIN AT INJECTION SITE
I had the usual side effects from my first dose of the Shingles vaccine. I experienced fatigue, and body aches for about 36 hours.  Several days later (not sure of exact day post vaccine) I developed a small rash on my lower back.  It started with one or two bumps that were itchy and developed into a small patch of about 8-10 small raised lesions that scabbed over. They were located in a small patch in the middle of my lower back.  The rash was itchy. I was concerned that it could have been a side effect from the shingles vaccine so I saw a doctor in urgent care on July 15.  She diagnosed anon specific rash and assured me that it wasn't shingles. The rash eventually cleared up three days later.
On Monday night I tossed and turned, and I gradually realized I felt quite ill. By Tuesday morning I had what I understand to be typical reactions to the second dose: soreness at the injection site, fatigue, muscle aches, chills, overheating, loss of taste, and a touch of nausea. My head was swimming, and putting my hands to my forehead made my head feel a bit better. By midday Wednesday I was gradually improving. But Wednesday evening, at my desk, I noticed my vision seemed blurry. On Thursday morning, I verified that my reading vision (with glasses) was (and is) markedly worse. Now I cannot easily read from my smart phone or computer screen. I plan to see an optometrist as soon as possible.
I had a malaise, lethargy, nasal stuffiness, body ache, chills started 6 hr after vaccination lasted for the next 48 hr. I took OTC Ibuprofen and Acetaminophen, which helped me to recover slowly.
Pt presented with large area of erythema - painful & itching on (R) upper arm.
Information has been received from a registered nurse concerning a 45 year old male who on 31-JUL-2008 was vaccinated SQ with the first dose of MMR (657357/1670U). On 03-AUG-2008 the patient experienced a rash that began on the patient's ankles and moved up his body to his neck. No further information was reported. It was reported that the patient was recovering. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/29/2009.  Information has been received from a registered nurse concerning a 45 year old male who on 31-JUL-2008 was vaccinated with the first 0.5 ml dose of MMR II (lot number 657357/1670U) subcutaneously.  There were no drug reactions, allergies, other medical history and concomitant medication.  On 03-AUG-2008, after receiving the MMR II, the patient experienced a rash, which began on patient's ankles and moved up his body to his neck.  The patient had sought medical attention by calling the practice.  No lab diagnostics study was performed.  At the time of report, the patient was recovering.  Follow-up information received from a registered nurse indicated that on 31-JUL-2008, at 13:00, a male patient was vaccinated with a first dose of MMR II.  The patient recovered on unspecifed date.  No further information is available.
Rash on arm localized; Swelling; A spontaneous report was received from a consumer concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling, rash on arm localized.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the event(s) swelling. On 28 Feb 2021, the patient experienced the event(s) rash on arm localized.  Treatment details included No HCP consulted.  Action taken with mRNA-1273 in response to the events was not reported.   On 17 Feb 2021 the outcome of event(s), swelling was resolved. On28 Feb 2021 the outcome of event(s), rash on arm localized was resolved.
pt recv vax & inj site became red, hot, tender, itchy & hard;pt has not yet recovered;
received her first shingrix injection 5/2019 / second shingrix injection in 7/2019 / another shingrix vaccination on yesterday; Pain; Headache; injection site is sore; This case was reported by a consumer via call center representative and described the occurrence of pain in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2019) and Shingrix (received 2nd dose in July 2019). Concurrent medical conditions included breast cancer.   On 10th September 2020, the patient received the 3rd dose of Shingrix (intramuscular). On 10th September 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. In September 2020, the patient experienced pain, headache and injection site pain. On an unknown date, the outcome of the pain and headache were not recovered/not resolved and the outcome of the injection site pain and extra dose administered were unknown.   It was unknown if the reporter considered the pain, headache and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that she received her first shingrix injection May 2019.  She then got the second shingrix injection in July 2019.  She said that she got another shingrix vaccination, extra dose.  Less than a week after vaccination patient experienced injection site was sore, pain, and she had a headache. The patient was uncomfortable because she did not get the injections from him.  The patient did not consent to follow-up.
This was a drive through shot clinic held at the parking lot on October 8th. The shot was administered through an open car window at an angle more vertical than horizontal and was given at the very tip of my shoulder. The injection felt unusual immediately. I waited for 10 minutes after the shot and did not mention any pain but I was experiencing a mild discomfort which I didn't think too abnormal. As the day progressed I lost mobility in my arm and within two days could barely move my arm at all. It did start to feel better after several days but I have not regained the ability to move my arm or shoulder to remove clothing, brush teeth, hair, etc.  The pain is significant  when I try to do so.
1 3/4" x 1 3/4" red induration on right post arm, localized heat. Treatment: Benadryl (oral) and Pramosone (hydrocortisone cream)
fever >101 x 3 days;generalized malaise;facial & body rash-red, raised w/itching;
1-2 minutes after administration of both injections she became unresponsive to voice & smelling salts; pale; hypotonic in chair; bradycardic 38 bpm; pulse oximeter 90% - placed on oxygen via rebreather; placed on floor with legs elevated-epinephrine, Benadryl and solumedrol steroid IM-via EMS to hospital.
This spontaneous report as received from a female patient of unknown age refers to herself. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). No co-suspect or concomitant medications were reported. On an unknown date the patient reported experiencing shingles after receiving ZOSTAVAX. The patient did not seek any medical attention. The outcome of shingles was reported as not recovered. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Ten minutes after covid vaccination, patient stood up to get the attention of pharmacy workers at the pharmacy drop off area. He did not make it to the counter. He turned pale and went unconscious. He collapsed and struck his head on the floor. Pharmacist got to him seconds later and he woke up. 911 was called and attended to him. He declined being taken to the hospital.
Patient started not feeling well on 3/24.  She was experiencing dizziness, headache, chills and fever. She contacted her doctor on 3/25 and he thought maybe she had an inner ear infection.  Symptoms continued to worsen and eventually an ambulance was called on 3/27 because patient stated she was having severe SOB and headache along with dizziness and fever.  Patient was transported to Hospital where they tested her for covid and pneumonia.  Both came back negative.  After several tests it was confirmed she had a blood clot in her lung and was also told she had clots in her leg and heart as well.  She was in the hospital for 3 days where she was given heparin and several medications for the headache.  Patient was discharged on lovenox and coumadin and eventually switched to xarelto by pcp who is managing her anticoagulation.  She still has follow up appointments with a cardiologist and neurologist.  She said she is still experiencing some dizziness and SOB but overall doing better
Pt recvd vax in AUg & SEP 1989 & again in FEB90; had neg titer in DEC90; then recvd 3 doses of Engerix-B; titer showed immunity in DEC91 following last dose of Engerix-B in AUG91; titer in JAN92 was neg again;
Vomiting into the second day.; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old non pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: FF8839), via an unspecified route of administration on 27Sep2021 at 16:30(at the age of 69-years-old) administered in Arm Left as a single dose for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medication(s) included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication from 27Sep2021 to 27Sep2021; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient had previously received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies. On 28Sep2021 at 12:00 PM, Vomiting into the second day. This was her booster. She had no special adverse events with her first two doses. No treatment was given for the event. The outcome of the event was not recovered.    Follow-Up (05Oct2021): Follow-up attempts are completed. No further information is expected.
After administration on 8-30-14 redness, swelling, rash and warm to touch. MD prescribed KEFLEX 500mg BID x 5 days.
pt recv vax 9OCT95 & pt devel redness @ the inj site;no tx was necessary;pt recovered;
Pt said she had no use of right arm and leg and some verbal impairment. She said her symptoms are better today. I encouraged her to call her primary md however she said she is between md's. I suggested she call the office and get an appointment to make sure she has no other underlying condition.
Staff of facility experiences light headiness and extreme dizziness.  Patient explained that her legs felt heavy and were very tingly. Monitored BP and remained within normal rages. Gave Benadryl at 11:35am. Patient also drank water and ate some food. After sitting for 45 minutes patient felt better
Intense shivers; Fever; Arm tenderness; This is a spontaneous report received from a contactable 42-year female consumer (patient) reported for herself that who received the Pfizer vaccine, bnt162b2 (BNT162B2) Solution for injection, unknown dose (Lot number and expiry date was not reported) via an unspecified route of administration on 02Apr2021 as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. She was having some side effects. She received the vaccine on Friday. Saturday, she had arm tenderness (on 03Apr2021), yesterday she was fine. At 3am she woke up with intense shivers and a fever. Friends say they got their side effect in the 48 hours. Should I be concerned?. On Sunday she didn't have anything and then this morning she had a fever and chills (on 04Apr2021). She was wanting to know if that was all normal. Provided PMI number and tried to transfer to  but there were calls holding. Cold transferred to PMI due to wait times. Fax to . Transferring agent stated, have a consumer on the line, she received the Pfizer COVID 19 Vaccine this past Friday, on Saturday she has some arm tenderness and then at 3 am this morning she woke up with shivers and fever. Consumer was informed about the role of Pfizer Drug Safety and requested to probe. No further probing could be don as the consumer hung up the call abruptly. Hence limited information available over the call. Outcome of the events was unknown.   No follow up attempts are possible, no further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021377881 same reporter/drug, different patient/AE
pain, redness, swelling of 2 inch by 3 inch area around injection site of arm that received Boostrix + Menactra with warmth
Approximately 6 hours after the injection I noticed body aching, specifically in lower back.  The following 8 hours after the first symptoms appeared, I had extreme chills followed by profuse sweating, fever, headache, tiredness, inability to sleep. I was able to help the symptoms with ibuprofen. The hot flashes and headache, continued sporadically 2 days following the injection.
I developed a moderate sinus headache the day of my vaccine. It persisted for 72 hours and was bad enough that I took Advil 48 hours later, which I rarely take. The headache has not completely gone away, although it has gotten milder, over 3 weeks later; it?s distinct because besides the pain, my sinuses feel very dried out. I noticed it right away as an odd sensation and unlike any other headache I could remember. I have tested negative with rapid tests several times since, have not had a confirmed exposure and have developed no other symptoms, so I don?t believe this could be a case of Omicron.
Severe headache 4 hours after shot, generalized muscle weakness all over 12-15 hours after shot (felt paralyzed), fever (100.5) 12-15 hours after shot, nausea and moderate abdominal cramping morning after shot, extreme fatigue for 1 week following shot
Daughter vomited violently right when I got her home from day care.  She had complained of a stomach ache during the afternoon.  She threw up again about one hour later.  She has felt a little warm but not too feverish.  She has not eaten anything since.  It is now 8:22 PM.  I will watch her closely during the night.
Upon awakening the next day, I began to have extremely painful deep chest spasms starting in outer right side ribs and quickly radiating under breast and up into nipple. Happened in a succession of maybe 2-3 spasms then stopped. Occurred maybe 6 times over the course of about 5 hours, then totally stopped around the 24 hour mark of the injection.
Chills; Did not feel good; Body aches; Fever; Whole time I felt that I was in a fog; Lethargic; Diarrhea; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6206 and expiry date: Jun2021), via an unspecified route of administration (at the age of 55-year-old), on 03Mar2021, as dose 1, single for COVID-19 immunization. The patient medical history included liver issue. Concomitant medication was not reported. The patient stated that he had received a Covid Vaccine shot on 03Mar2021. He still experiencing problems from the shot. He can go through the list of things that happened to him from 03Mar2021. On 03Mar2021, that evening he went through the chills, did not feel good, body aches. Went to work on Thursday, the 4th, did not feel good all day, came home that night from work and went to sleep, on Friday, did not feel good. I felt normal on Saturday 6th, felt good normal. He went up the chills and body aches and then he had a fever approximately for four days and whole time he felt that he was in a fog and had been lethargic the whole time, body ache, diarrhoea, you name every symptom he could have. When paraphrased the concern patient confirmed the same and stated, it has been two weeks and he was not feeling good and Right from the day one and he still have the problems. The patient stated that he had a Liver issue that is one of the reasons that he was eligible to take the shot. The patient went to two doctors. One he went to get a COVID test to make sure that he did not have Covid. Then he went to his regular primary Doctor because of all those symptoms. He did not run any lab or blood work or anything. The patient received treatment for the event fever with Tylenol and did not receive any treatment for other events. The patient underwent lab test and procedure include SARS-CoV-2 test with the result of negative on an unspecified date. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse via sales rep and described the occurrence of syncope in a 12-year-old male patient who received FLULAVAL QUADRIVALENT (batch number GC32K, expiry date unknown). On 15th November 2017, the patient received FLULAVAL QUADRIVALENT. In November 2017, less than  a week after receiving FLULAVAL QUADRIVALENT, the patient experienced syncope. On an unknown date, the outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: GSK representative called to report Adverse Event had very limited information.