chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two patients may have gotten booster shots after the 20 punctures in the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 023C21A and 047B21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy.On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021 at 12:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial). On 15-Nov-2021, PRODUCT ADMINISTRATION ERROR (Two patients may have gotten booster shots after the 20 punctures in the vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.It was reported that the patient received vaccine on Deltoid anatomical location. Pharmacist had reported that the vials were stored in normal refrigerator temperatures. No Concomitants and Treatment medication were reported.This case was linked to MOD-2021-390269 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Significant Follow Up Appended- patient initials, Start date of 1st and 2nd dose, batch no and medical history(allergy) updated.
the vaccine exp 8/2019 and the vaccine was given on 9/2019. parent to be notified and vaccine will be re-administered.
COLD FOR LIKE 20 HOURS; LOT OF BODY ACHES; SNOOZE; 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the subject experienced cold for like 20 hours, lot of body aches, and snooze. The action taken with covid-19 vaccine was not applicable. The patient was recovering from cold for like 20 hours, and the outcome of lot of body aches and snooze was not reported. This report was non-serious.
sore arms at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (mild case of shingles in 2008). Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in October 2020, refer case US2021AMR025865).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows:     The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had sore arms at the injection site. The patient commented that patient was glad to receive the dose. This case has been linked with US2021AMR025887 and US2021AMR025893, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025887:same reporter US-GLAXOSMITHKLINE-US2021AMR025893:same reporter US-GLAXOSMITHKLINE-US2021AMR025865:same patient, same reporter, 1st dose
Patient said her back started hurting before she left the store. Eventually her arms and legs had severe pain. She called her doctor. She has always taken the regular flu shot without any problems she said.  This was her first time receiving the High Dose. Her pain lasted two days.
Inadvertent administration of incorrect maker of Covid-19 vaccine #2 with Pfizer. Patient received Moderna Covid-19 vaccine #1 three weeks prior and was due to have Moderna for 2nd dose, not Pfizer.
Jaw infection with facial swelling; Jaw infection with facial swelling; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 51 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 12:00 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included dose 1 via an unspecified route of administration, administered in Arm Left on 22Apr2021 12:00 (Batch/Lot Number: EW0164) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing..Concomitant medication(s) included clonazepam (CLONAZEPAM) taken for an unspecified indication, start and stop date were not reported; venlafaxine (VENLAFAXINE) taken for an unspecified indication, start and stop date were not reported; trazodone (TRAZODONE) taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced jaw infection with facial swelling on 03Jun2021 with outcome of not recovered, Therapeutic measures were taken as a result of jaw infection and facial swelling with 4 courses of various antibiotics required to kill infection.   Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Pain in arm after flu shot. Stabbing pain. Got pneumonia shot 8 days later, same arm. Now experiencing muscle spasms, limited range of motion, weakness and pain. Pain is 5/10 when sleeping, or attempting to use arm. Has gotten worse with time. ALEVE, TYLENOL, ADVIL do nothing for pain.
Patient stated that a couple of days after he received the FLUARIX vaccine his face got bright bright red like a hot flash. This would come and go and lasted for approximately a week before it went away.   Patient stated they had also received a cortisone shot within a few days of receiving FLUARIX. Patient stated they went in to see their doctor and the doctor thought it was most likely due to the flu vaccine.  No treatment needed. Symptoms cleared up completely after approximately a week. Patient stated they had never had a reaction like this to the flu vaccine.
Injection arm, swollen, red, painful shoulder to elbow. Nausea/vomiting, diarrhea.
pt says his left leg started swelling a couple of weeks after taking the vaccine. The swelling is mostly around the ankle and foot area.  Pt states the swelling always stays the same and never goes down.
A few minutes after the injection my arm and fingers felt itchy but went away after a few minutes. Tuesday morning I started to have severe chills and headache with a fever. my muscle's and joints were extremely stiff and very painful my bones hurt to the point I could not move very fast. this went on for several days. by the following Monday I felt much better but I am still experiencing some muscle and joint stiffness.
Noticed that the patient had an imbalance. The patient is taken to the observation and treatment area at 5:05pm to take her vital signs, which were: 98% Saturation, 83 Pulse, 210/100 B/P and 151 Dextrose. The case was consulted with Doctor and she refers that the patient must be transferred and channeled. At 5:18pm the patient is reevaluated and her vital signs remain the same. At 5:35pm the vital signs were taken which were: 180/100 B/P and 63 Pulse. At 5:45pm a final evaluation was made and the vital signs were: 155/98 B/P and 75 Pulse. Patient is discharged and reports feeling well.
I had some redness and pain in my arm at injection site for a couple of days. It disappeared and I thought it was all gone. On the Friday, it started to get painful again and got redness. I was leaving for the weekend but it got worse. It had  hives, and got hard and was red.  I went to Urgent Care - when I came back - I think it was Monday. They gave me antibiotics for cellulitis. I took the whole dose of the antibiotics - after I was on the medicine it was gone in two days.
Swelling and edema with soreness surrounding site. Edema and redness size of a baseball.
Loss of strength, bad all over. Went to Dr 4 times. He said what I had was polymyalgia rheumatica. Tripped by the flu shot. I am still weak.
This spontaneous report as received from a physician via a company representative refers to a 63 year old female patient with a pertinent medical history of high blood pressure. Drug reactions or allergies and concomitant medications were not specified. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration and lot number were not reported) to prevent shingles. The patient received the vaccine from an unspecified pharmacy. A week later, the patient developed shingles. The patient sought medical attention via a doctor visit. The outcome of herpes zoster was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Redness, warmth, tenderness, pain, swelling at the injection site that eventually moved down the arm and lasted 3 to 4 days. Patient iced the swelling on day 1 and took Acetaminophen.
Approximately 90 minutes after the injection, patient had an urgently to have a bowel movement. This urgency continued until approximately 10 PM that same same day.  Anus was very raw and stool very watery.  This urgency continued for 7 days after eating food  and drinking water.  The urgency lessened  daily with the drinking of water but with the intake of solid food, the need for an urgent bowl moment continues after 7 dayds.
Bad muscle aches, fever, chills, fatigue, joint pain and nerve pain in various body locations. This lasted for 36 hours. Worst reaction I have ever had to a vaccine.
Syncopal episode, unresponsive. Able to arouse but slow, garbled speech. Transferred from chair to cot. BP 128/68, HR 95. Lethargic, oriented x3/3. Called EMS. Blood glucose 49, glucagon, juice and crackers given. Refused transfer to ED. Boxed lunch provided. Emergency contact called. Refused ride home. Observed for total of 1hr15minutes. Awake, A&O x3/3, steady gait when sent home.
hives; This is a spontaneous report from a contactable consumer (Patient's daughter), based on information received by Pfizer (manufacturer control number: EC-2021-087951), for BNT162B2 (COMIRNATY). A female patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA, Batch/Lot number was not reported), via an unspecified route of administration from 05Feb2021 to Mar2021, at 14 mg, daily for Endometrial Carcinoma; pembrolizumab (KEYTRUDA, batch/lot number was not reported), route of administration, start and stop date, and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced hives on 07Apr2021 and treated with prednisone. It was reported that the patient diagnosis was endometrial carcinoma, Prescribed Lenvima 14mg daily, start 05Feb2021, stop Mar2021. Patient has stopped all treatments and therapies (stopped Lenvima in Mar2021). Patient's daughter, stated the patient had hives on 07Apr2021 which was due to her receiving the Pfizer COVID vaccination a day before her Keytruda infusion, and there was a reaction of hives. Patient had taken prednisone to treat, which she was no longer taking. The action taken in response to the event for lenvatinib mesilate was permanently withdrawn on Mar2021, for pembrolizumab was unknown. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
the patient got terribly sick; Initial information was received on 30-Sep-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer (under reference number: US-SA-SAC20211006000280).  This case is linked to cluster cases 2021SA330955 and 2021SA330912.  This case involves an adult male patient who experienced non serious event "the patient got terribly sick" (illness) while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE  produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious the patient got terribly sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "The reporter's husband for 26 years was forced to take a flu shot and every year he got terribly sick. Her mother-in-law took one last year and shortly after had a stroke. This shot was as dangerous as the COVID shot. Her dad got Guillain barre syndrome from a flu shot."  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  On an unknown date, at time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
p/vax states could "feel it" when recv vax then pain devel about 5 days p/vax;now whenever uses arm knows it's there; actually hurts when raises lt arm or does something unusual w/lt arm;vax site has no swelling or redness
Patient was given 2nd Pfizer dose one week too early. Received first dose on 08/24/2021 and second dose on 09/07/2021. No adverse events were reported by the patient.
Patient was in post vaccination monitoring area when she proceeded to pass out.  She was unconscious for less then a minute and stated she was fine when she regained consciousness.  She stated she has history of syncope with vaccine administration and stated she passed out from the pain of the injection and having a fear of needles.    She waited for several more minutes and left on her own accord.
Sudden onset of fever, dizziness, nausea, vomiting, fatigue. Lasted just about 24 hours.  Unable to keep anything (even water) in stomach for 24 hours
I had my vaccination on 06/13/2022. I started to experience fever achiness cough on 10/02/2022. I tested COVID-19 positive on 10/03/2022. I was prescribed PAXLOVID and I currently feel fine on 01/09/2023.
patient was sitting after the shot in the waiting area for 15 min after the shot and one of his college who is sitting near by called me and said he passed out twice but when I went with the nurse he was ok and he said he did not. but his friend said no he did. we kept watch him closely for one hour. no symptoms observed. no sob , we offer him epipen or bendryl but he refused. I asked to call his family dr of pcp he said he does not have one. I called the patient on his sell phone after 6 hr of incident and he said he had no issue after that
About four weeks ago, around the 29th, started getting scratchy throat and started coughing. Progressed to heavy coughing fits. It went on for 2 weeks. I went to Hospital Urgent Center - doctor prescribed an antibiotic (2 pills a day for 7 days) for sinus infection and said to take Flonase and do a sinus flush periodically and take Claritin. I feel like I have postnasal drip constantly and get a buildup of phlegm. For the most part it's done - I'm not coughing uncontrollably still but just occasionally.  Immediately after the vaccine, I felt a little flu-ish for one day and then it was done.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 51-year-old female patient who received FLUARIX Quadrivalent. Concomitant products included sertraline. On 18th October 2017, the patient received FLUARIX Quadrivalent. In November 2017, less than a year after receiving FLUARIX Quadrivalent, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were not recovered/not resolved. The reporter considered the pain in arm and mobility decreased to be related to FLUARIX Quadrivalent. Additional details were provided as follows: The patient received concomitant medication Multi vitamin. At first, the patient's arm felt fine but then she experienced severe pain in her left upper arm. Now she was having trouble getting her shirt on an off and the pain had gotten worse. She was also having trouble lifting things. She could not confirm the name of the flu vaccine but her pharmacist referred her to GlaxoSmithKline and Seqirus as the manufacturer based on the date of her vaccination.
Redness, heat, itching, right 5th PIP swelling and redness.
Dizziness; Fatigue; Headache; Fever; resistant wounds in front of crease of armpit and shoulder/inflamed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever) and INFLAMMATION OF WOUND (resistant wounds in front of crease of armpit and shoulder/inflamed) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) Solution for injection in pre-filled pen, Citrate free. On an unknown date, the patient experienced DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever) and INFLAMMATION OF WOUND (resistant wounds in front of crease of armpit and shoulder/inflamed). At the time of the report, DIZZINESS (Dizziness), FATIGUE (Fatigue), HEADACHE (Headache) and PYREXIA (Fever) had resolved and INFLAMMATION OF WOUND (resistant wounds in front of crease of armpit and shoulder/inflamed) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Action taken was reported as unknown for  co-suspect ADALIMUMAB (HUMIRA) with respect to all the events.  Treatment information was not provided.  The reporter's causality for the event of resistant wounds in front of crease of armpit and shoulder/inflamed with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the events of fatigue, dizziness, headache and fever with HUMIRA(ADALIMUMAB) was no reasonable possibility.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Sore arm; extreme fatigue; achy; flu like symptoms which lasted for 30 hours.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: El1283), in left arm, on 22Feb2021 as dose 2, single (Lot number: En6201), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obese" (unspecified if ongoing), notes: Obese; "sleep apnea" (unspecified if ongoing); "Eustachian tube dysfunction" (unspecified if ongoing), notes: Eustachian tube disfunction; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish; "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex. Concomitant medication(s) included: CELEBREX, start date: 26Jul2021, stop date: 06Jun2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) Negative, notes: Tested COVID negative on 12Jun2022 & 13Jun2022; (13Jun2022) Negative, notes: Tested COVID negative on 12Jun2022 & 13Jun2022; (15Jun2022) positive, notes: COVID symptoms returned on 15Jun2022 & tested positive on 15Jun2022. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Tested COVID negative on 12Jun2022 & 13Jun2022 after Paxlovid course ended on 10Jun2022. COVID symptoms returned on 15Jun2022 & tested positive on 15Jun2022. Antiviral product included Paxlovid started on 05Jun2022 for Treatment of COVID-19 and stopped on 10Jun2022. Other medication in 2weeks product details: Celecoxib, Celebrex started on 26Jul2021 and stopped on 06Jun2022, Emergen-C, started on 04Jun2022 and stopped on 10Jun2022, Sambucol, started on 05Jun2022 and stopped on 12Jun2022, Ayurveda Tea Elderberries Echinacea, Herbal Cup Tea started on 05Jun2022 and stopped on 15Jun2022, D3 50 mcg, Nature Made started on 05Jun2022 and stopped on 10Jun2022 (lot number 2434964), Zinc 50 mg, NOW foods started on 05Jun2022 and stopped on 10Jun2022 (lot number 3184716).  No follow-up attempts are possible. No further information is expected.
chills; muscle soreness in my legs; fatigue; mild headache; This is a spontaneous report from a contactable consumer (patient). A 30-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3248), via an unspecified route of administration, in left arm on 04Feb2021 15:30 (at 30-years age) as 2nd dose single for COVID-19 immunisation and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number:EL3248), via an unspecified route of administration, administered in left arm on 14Jan2021 16:00 (at 30-years age) as a 1st dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not allergic to medications, food, or other products. Facility where COVID-19 vaccine was administered was at a workplace clinic. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 05Feb2021 at 3 a.m. the following morning patient experienced chills, muscle soreness in his legs, fatigue, and a mild headache. These symptoms continued intermittently throughout the day ending around 4 p.m. The patient was not tested for COVID-19 since the vaccination. No treatment was received for the events. The outcome of the events was recovered.   No follow-up attempts are possible. No further information is expected.
08/2021 Had health appointment and my doctor said my blood pressure was really high. I had a follow up and it was still high. Now I'm on medications for my blood pressure. I have never had high blood pressure in my life.