chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Vaccination site pain; Headache; This is a solicited report from marketing program based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3862391-00). A contactable 48 year old male consumer (patient) reported for himself that patient started to receive first dose of BNT162B2 (BNT162B2 Solution for injection) on an unknown date via Intramuscular route of administration at SINGLE DOSE for COVID-19 immunisation. On 09Apr2021 patient received 2nd dose Covid-19 Vaccine. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On an unknown date the patient received Adalimumab (HUMIRA) at Citrate Free via Subcutaneous route of administration for Crohn's disease). The patient's medical history and concomitant medications were not reported. On 09Apr2021 the patient experienced Fever Sore arm from Covid Vaccine, Headache resolved and Vaccination site pain. The events were assessed as non-serious. Fever, sore arm from Covid Vaccine and Headache with Humira(Adalimumab). Covid-19 vaccine was also considered suspect for all events. The outcome of the events was recovered.     The reporter's assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On August 1, 2021, exactly 1 month after I received the Janssen vaccine, my menstrual cycle came. It was the lightest period that I ever remember having.  It was unusual for me since my period flow has been very regular my entire life--nearly 28 days and medium flow for 25 years. Then, my period did not come again for 48 days--September 17, 2021. Again, this is extremely unusual my period always comes around the 28 day mark. I have never been this late with my period in my life, except when I was pregnant, of course. My period came again on October 10th any 24 days (slightly early), and this time my flow was extremely heavy. I cannot recall a time in my life when it has been this heavy.
Fever, chill, muscle pain all over, bone (hip) pain 3-4 days. 3rd after immunization redness around injection site spread wide to elbow: red, hot, ache. Primary care MD seen -> cellulitis Dx -> antibiotics (KEFLEX) ordered -> improved.
2 month old baby boy was given an expired PNEUMOVAX 23 instead of PCV 13. Patients mother informed. Instructed to look out for any reactions. Instructed patients mother to take patient to the nearest hospital if any reactions.
ithrombocytopenic purpura blood disorder developed  Severe bruising Worry could have resulted in blood clots and worry could affect future fertility and increases risk of miscarriage
At 5:30 the day following vaccine, I was nauseated and had emesis x 1. I had cold flash throuh my body. Headache, chills, body aches and tired. Temp 99.5
Patient was administered 0.5ml instead of 0.25ml of booster 3rd dosage, patient was called and denies any problems since vaccination. Letter was sent to patient notifying of dosage given
Headache, Myalgia, Diarrhea, NauseaVomiting, Night Sweats, Runny nose, sore throat Narrative:
Seizure, 104.8 temp. Hospitalized for 2 days; test were done, no infections 7 days after MMR. Acting different, falls all the time, can't walk as good. EEG normal. No treatment. Nothing to do but monitored; gave Tylenol and Motrin.
Patient tested positive for COVID-19 on April 21, 2023, patient expired on May 1, 2023.
rash appeared on her face; difficulty breathing; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number G72Z4, expiry date 13th March 2022) for prophylaxis.   On 14th February 2020, the patient received the 1st dose of Shingrix. On 17th February 2020, 3 days after receiving Shingrix, the patient experienced rash and difficulty breathing. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash and difficulty breathing were unknown.   It was unknown if the reporter considered the rash and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced rash appeared on her face and she had difficulty breathing. The patient went to the emergency room and was given oral benadryl and oral steroids for treatment. The reporter consented to follow up. This case seems to be possible duplicate of case US2020031400. However, no further details or confirmation of both cases are for the same patient or not.
Woke up and could not turn head, arm, and shoulder. On the next day scheduled an appointment and saw the doctor 2 days later. Blood test and physical. Not sure what had caused issue but referred to physical therapist. There it was determined that I had a kind of pinched nerve but therapist diagnosed it as a stuck facia. Physical therapy and tools to help exercise to help it. After 6 weeks still working on recovery.
Patient reports a sensation of tingling at the site of his vaccine.  He reported a sensation of swelling, but no swelling was noted on examination.   The symptoms lasted about 15 minutes.
Extreme muscle pain in upper body; This non-serious case was reported by a consumer and described the occurrence of muscle pain in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included heart disorder (was a heart patient, at present time (at the time of reporting) had no issues at all with heart). Previously administered products included Covid vaccine with an associated reaction of no adverse event (never had any issues with other vaccines), Flu vaccine with an associated reaction of no adverse event, Shingles vaccine with an associated reaction of no adverse event and Pneumonia vaccine with an associated reaction of no adverse event. Concurrent medical conditions included blood pressure high (blood pressure normal with medicines). Concomitant products included labetalol and irbesartan.   On 25-SEP-2023, the patient received RSV vaccine. On 25-SEP-2023, less than a day after receiving RSV vaccine, the patient experienced muscle pain (Verbatim: Extreme muscle pain in upper body). The outcome of the muscle pain was not resolved.   It was unknown if the reporter considered the muscle pain to be related to RSV vaccine.     It was unknown if the company considered the muscle pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 30-SEP-2023 The patient also the reporter. The patient's concomitant products included Labetalol 100 mg once per day and Irbesartan 300 mg once per day. The patient was advised to get vaccine and had extreme muscle pain in upper body. The reporter consented to follow-up.
Immunizations given at 1130 am - screamed till 8:00 pm.
Full fledged flu : fever, chills, body aces and headache lasted the longest but my 2 day nigt, i was almost better.
Information has been received from a nurse concerning a 70 year old male who on 05-NOV-2006 was vaccinated with Pneumovax 23. Concomitant therapy included NORVASC and LEXAPRO. Subsequently the nurse reported that the patient developed redness, swelling and tenderness from shoulder to elbow. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Severe left eye allergic reaction Swollen left eye and cheek Hives in the left side of the face
COUGH, BODY ACHES,  ED to Hosp-Admission Discharged 8/26/2021 - 8/28/2021 (2 days) Hospital COVID-19, Hypoxemia Sepsis   HPI: Patient is a 74 y.o. male with past medical history of type 2 diabetes mellitus, hypertension, hyperlipidemia, obesity, BPH who was admitted to the Hospital with acute respiratory insufficiency with hypoxia secondary to COVID-19 pneumonia.  The patient began to have symptoms last Thursday difficulty breathing, shortness of breath, cough, and dizziness when sitting up and was found to be positive for COVID-19.   Hospital Course:    Acute respiratory insufficiency with Hypoxia secondary to COVID-19 Pneumonia. o He was consented for complete COVID-19 Pneumonia treatment and agreed to treatment with Convalescent Plasma, Dexamethasone, Remdesivir  o He has improved with COVID-19 pneumonia treatment including 3 days of IV Remdesevir.  He did receive 1 unit of convalescent plasma. o His breathing has remained stable off oxygen. o He will not need oxygen on discharge. o No further need to complete IV Remdesevir treatment or dexamethasone treatment.
First vaccine 04/23/21. Starting exactly one week after first dose, I broke out in a hive rash on both thighs which lasted a couple hours.  Subsequent rash outbreaks occurred on 05/07, 05/21, 05/28, 06/03, 06/04, 06/05, 06/06, 06/17, 06/29, 06/30, 07/02.  Second vaccine was received 06/04/2021.    I am currently pregnant and due 10/29/2021.  OBGYN unsure if it?s a pregnancy related symptom, or what the cause is.
Bilateral hand stiffness and pain. It is worst in the morning. I cannot even make a fist. I had some very mild form of this off and on, but this came on quickly and severe. Also had swollen lymph nodes in neck and still do after the second Pfizer vaccine.
This spontaneous report as received from a pharmacist refers to a over 60 year old female patient. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # J004196, Expiration Date: 06-DEC-2014) injection intramuscular. Concomitant medication was unspecified by the reporter. On an unknown date, (reported as one women) who within 24 hours of the vaccination experienced the entire arm from elbow to injection site was red and they felt absolutely terrible on an unspecified date. No treatment was given. Patient sought medical attention reported as went to pharmacy. No Product quality complaint. It was unclear if patient had ever had PNEUMOVAX 23 injection before. Outcome of the reported events was unknown. Causality of the reported event was unknown (not provided). This case related to 1312USA005844 and 1312USA009850 (Same Reporter Link). Additional information has been requested.
Approximately 10 minutes after vaccine administration, patient became lethargic and unresponsive. Ambulance was called and arrived within 5 minutes. By that time he was alert and was transported to hospital.
Tiredness; atrial fibrillation; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-115049).   A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 27Sep2021 (at the age of 79-years-old) as dose 2, single for COVID-19 immunisation.  Medical history included ongoing hypothyroidism, ongoing hypertension, Goiter, radiotherapy (20 years ago), macular degeneration (she was receiving unspecified shots for 3 years), ongoing back arthritis, cyst removal from 2021 to an unknown date (in private area - this past summer), cyst (in private area), swollen arm (arm got real red), feverish, chest pain, ongoing eye bleeding and eyeglasses wearer. Concomitant medications included unspecified shots for macular degeneration. The patient experienced atrial fibrillation on Oct2021 and tiredness on an unspecified date.  It was reported that patient received 2 doses of the COVID vaccine with the 2nd dose administered on 27Sep2021 and stated she had a reaction to the 2nd dose. Patient was wandering if it could have caused her atrial fibrillation. Patient slept for a week. Patient got hurt in her chest and got short winded and told her husband to take her to ER and that was when they diagnosed her with atrial fibrillation (AFIB). Patient went to the ER on 24Oct2021. The consumer reported that she had an echocardiogram of her heart while she was in the hospital and they told her that heart was strong, no damage and her lungs were clear. The consumer reported that she got shots in her eyes for macular degeneration and received a shot in her eye today (29Oct2021). She reported that she had bleeding in her eye so bad. The outcome of events was unknown.
legs from the knees down especially kept patient awake at night from itching; Patient got it in the upper left arm in the muscle it was not hurt when it went in but it was kind of hurting now; Reaction on both legs they covered in red spots and at knees it was especially bad/it's more like a color; kept patient awake at night from itching/it woke patient up; red spot over the injection site; also there was a swelling just that gone bad; it was more like a discoloration in skin; Hurting so bad like a waxing kind of stinging and burning; Hurting so bad like a waxing kind of stinging and burning; skin it felt very warm; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK92321), via an unspecified route of administration on 06Jan2021 at single dose at left arm for covid-19 immunization. Medical history included arthritis and lost a couple of inches from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had the Covid-19 shot on 06Jan2021 and had reaction on both legs. They were covered in red spots and at knees it was especially bad, it wasn't like bumps, it wasn't like rash it's more like a color and skin it felt very warm and legs from the knees down especially kept patient awake at night from itching and the itching started on 07Jan2021 night into 08Jan2021 and it woke patient up and patient was just calling at knees. So patient got up and went into bathroom and patient put some anti-itch that's what patient husband had for his allergies. Patient said the spots on knees, the red spots are basically gone but they were still there and the left knees was specially bad and you can feel through pants even that it's warm on these places but when rubbing hands on it you can't feel rash or anything, it was more like a discoloration in skin, there was also a red spot over the injection site, patient would say about the size of a tennis ball and also there was a swelling just that gone bad but and it was okay really but it was there, patient had at a place on belly and it was gone, so let do something else but the discoloration on leg the splotches, patient guess they called splotches not a rash like a pimply rash but just there and they itch something there but it was getting better now. Patient was about 5'4' or maybe 5'4.5', and patient weighed a 141. Patient had 2 Covid test that were negative. Patient got the vaccine at the College. Patient got it in the upper left arm in the muscle it was not hurt when it went in but it was kind of hurting now, but it was okay. Patient put some kind of cream as treatment. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient was going to because it was hurting so bad like a waxing kind of stinging and burning but then patient just put more cream on it and it would stop, it was going to the doctor on 09Jan2021 morning but it was so much less and now patient didn't think she feel any ill effects. Outcome of all events was recovering.
METALLIC TASTE; This spontaneous report received from a patient concerned a 30 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, anxiety, alcohol use occasionally once per month or once every 3 months, and smoke marijuana twice daily for anxiety, and other pre-existing medical conditions included no known allergies and no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for hypertension.  On 10-APR-2021, the subject experienced metallic taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste on 10-APR-2021. This report was non-serious.
Patient received pneumonia vaccine on 9/30/19 at 18:53 in left deltoid.  On 10/1/19 at 15:30 pt complained of swelling, tenderness, warmth and pain in the left arm which he stated the previous night. Ice applied. MD notified. Keflex 500mg po QID started. Vitals signs 99.4-72-18 129/74.  Swelling, redness, and pain increased that evening  and due to his hx of DVT was sent to the local hospital ED for evaluation at 21:00.  Pt later returned with no new orders. Continued on Keflex.  Seen by MD in rounds 10/02/19 at about 9:00-10:00.  Afebrile. Tenderness, erythema and warmth noted. Area about 10cm in diameter.  Elevate arm and continue with ice packs and Keflex.  On 10/03/19 pt was seen by the nurse practitioner in rounds. Vital signs stable. Afebrile. Erythema and edema improving.  Pt routinely discharged.
Same day of vaccine around 3:30pm I started to shiver I showed a fever of 99 by 4:00pm I had incontrollable shaking with a fever  104.2 fever and sever headache. I had muscle pain on my back and neck. I had violent vomiting multiple times. I felt asleep and about 2 hours later I woke up and I had an SVT episode where my heart rate was beating was up to 200 by then the fever had gone down to 99. I called the nurse line.. they told me to call an ambulance. I called the ambulance they took me in they immediately put fluids they monitored me for 7 hours and they sent me home afterwards. I slept for 24 hours. Then on 4/27/2021 I had another SVT episode where my heart rate went up to 176 beats per minute. This lasted for 2.5 hours but I did not have to go to the the ER.
Around three hours post-vaccination, I developed a headache and arm pain at the injection site. As the afternoon progressed, the headache intensified and I became more tired and lethargic, and just not feeling well. Around 9 PM I laid down to try and go to sleep but the severe pain in my arm made it difficult. The pain radiated down to my elbow, up into my armpit, and across my chest. I experienced some chest tightness. The headache remained. All of my joints ached and were painful. I took an epsom salt bath and soaked. I took Tylenol and Bendryl to try and help me sleep. The next day, I feel drained, weak, lethargic, and tired. I still have a headache and don't feel well. It has been over 24 hours since my injection and I still don't feel like myself.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-364296 (Patient Link).
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment was provided by the reporter.
No adverse event; 4 patients received 0.5 ml the Moderna booster as opposed to the bivalent; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Oct-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 06-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (4 patients received 0.5 ml the Moderna booster as opposed to the bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients received 0.5 ml the Moderna booster as opposed to the bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (4 patients received 0.5 ml the Moderna booster as opposed to the bivalent).    No concomitant medications were reported.  No treatment information was provided.
Vaccine given 6/17/23. On 6/18/23 pt developed red, itchy rash in the middle of the night. She took benadryl around the clock with no improvement. Came back to clinic on 6/19/23. Rash has improved today 6/19/23 & prescribed Triamcinolone cream.
Swollen Lymph Gland Under Jaw; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen Lymph Gland Under Jaw) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced LYMPHADENOPATHY (Swollen Lymph Gland Under Jaw). At the time of the report, LYMPHADENOPATHY (Swollen Lymph Gland Under Jaw) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
No soreness or issue at first dose, no symptoms at all including no soreness at injection site, no swelling or bruising. 2nd dose resulted in extreme pain in arm for approximately 7 days with pain throughout arm to fingers. Unable to use left hand with confidence for this period. Patient was not yet in menopause confirming regular periods every 28 days for 3 to 4 days in length. No heat flashes, no symptoms of pre menopause. Following second dose patient did not menstruate again. Patient has not experience any  pre or premeno symptoms and is now in menopause.
Varicella vaccine given 4/30 at approx 930 am. Noticed pain that same afternoon. Redness and swelling noted 5/1/14.