chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 56.46.  No concomitant medications were reported.  The excursion time on initial supply was 09:00 AM with temperature 34 degrees Fahrenheit. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
severe allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "severe allergic reaction".  Additional information: Caller was asking for her patient who had a shot of her Pfizer Covid 19 Vaccine for the 1st dose, but experienced a severe allergic reaction because of it. Caller stated that for the patient's 2nd dose she got a shot of the Jansenn vaccine. Caller was asking if they could give Jansenn as her booster.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cancer was discovered in the left breast during a routine mammogram.  Doctor recommended a partial mastectomy.  No Lymph node involvement, no chemo, just radiation.  Cancer was stage 1B.
arm sore; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), described as "arm sore"; HEADACHE (non-serious), outcome "not recovered", described as "headache". Therapeutic measures were taken as a result of headache.  Additional information: Headache that was unrelieved by Extra Strength Tylenol and was asking if she can take Advil. Patient dose 2 was scheduled for 17March2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT SEEN 4/26/2023 AND MOTHER STATES PATIENT RECEIVED HER 16 YEAR OLD IMMUNIZATIONS BUT STATES PATIENT COMPLAINED OF  HEADACHES WHEN SHE ARRIVED AT HER HOUSE. PATIENT WOKE UP TODAY STILL WITH HEADCAHES, RINGING TO HER EARS, AND BLURRY VISION FOR 2-3 MINS. ONLY.
Pfizer 3/23/21, 4/20/21. Positive on 5/26/22
Daughter had Td Booster and meningococcal on left arm at 11 AM Wednesday August 29th. When she came home that evening, still having the BAND-AIDS on from shot site, she complained about pain and not being able to move her left arm. We did cold pack on her arm the first night and when she came home the next day from school she was crying in pain and the site was hot to touch. I'd hoped it would have gotten better but by the third day I knew it was shot site infection. Took her to her doctor's clinic out of normal hours, so emergency/walk in clinic hours. They gave her an antibiotic, Cephalexin, and said she had cellulitis.
Two leg blood clots DVT and also phelbitis same leg..Never had blood clots prior
Information has been received from a registered nurse concerning a 16 year old female patient with asthma and a history of acute sinusitis who on 04-JUN-2010 was vaccinated intramuscularly with a 0.5ml dose of PNEUMOVAX 23 (lot# 662268/1134Y) that had expired on 14-APR-2010. No other vaccines were administered. Concomitant therapy included unnamed nasal spray. On 06-JUN-2010 the patient was seen in the office with possible cellulitis with a localized reaction and temperature to 100.2 F. She was started on AUGMENTIN. On 07-JUN-2010, the patient was seen in the office again. The physician felt that it was a localized reaction. Therapy with AUGMENTIN was continued and added MEDROL and BENADRYL. She would return to the office for follow up tomorrow. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. Additional information has been requested.
Wednesday evening (day of inj) lt arm swollen, red, sore & hot;had chills;2OCT97 noon swelling moved to inner aspect of arm;3OCT97 1130AM saw MD who dx moderate allergic rxn;recommends DPH;
Information has been received from a physician concerning a 3 year old patient who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). The patient received the vaccination at 13 months old and on 14-Aug-2007, at 3 years and 9 months old, the patient had developed chickenpox lesions. Lesions dried after one week (21-AUG-2007). Medical attention was sought. The patient recovered. No product quality complaint was involved. Additional information has been requested.
Patient was given vaccine and 1 hour after her blood pressure increased to 169/74.  After resting and hydrating blood pressure decreased to 154/71.
12/18/2020  ALMOST IMMEDIATLY FELT CHEST TIGHTNESS, RIGHT SIDE OF FACE ITCHY, BACK OF THROAT AND TONGUE WERE ITCHY, LIPS WERE TINGLY; 'FELT LIKE SOMETHING WERE WRONG'. CONTACTED CLINIC AND SPOKE TO PHARMACIST; RECOMMENDED BENADRYL. DID HELP RELIEVE SYMPTOMS. 4-5 HOURS SYMPTOMS CAME BACK, TOOK MORE BENADRYL. AS OF 12/21 SYMPTOMS HAVE NOT COME BACK.  FLU SHOT 10/29/2020
I have had 28 day cycle, and two days of menstruating and have tracked my period for a few years, it's never been irregular. I had severe vaginal bleeding 10 days before my expected period. I had light spotting for 3 days and then on the 22 I had severe bleeding, more than any period I've ever had. From the 22-24 I was bleeding profusely. No other menstrual symptoms. Then today, on Oct 2 I started my period the day I was originally expecting to. The bleeding mid-month was unlike any period I have had it was bright red and extremely heavy. I've never had mid-month spotting or even any bleeding anything like what I had.
Mild cold-like symptoms developed on 17Dec2021.  Breakthrough COVID case identified on 19Dec2021 (Abbott IDNow). Mild symptoms (runny nose, sore throat, cough) have improved as of 21Dec2021; Mild cold-like symptoms developed on 17Dec2021.  Breakthrough COVID case identified on 19Dec2021 (Abbott IDNow). Mild symptoms (runny nose, sore throat, cough) have improved as of 21Dec2021; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Oct2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single, administered in arm left, administration date 24Mar2021 (Batch/Lot number: EP6955) as dose 2, single and administered in arm left, administration date 03Mar2021 (Batch/Lot number: EL3248) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy: Penicillin" (unspecified if ongoing), notes: Known allergy: Penicilin. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 20Oct2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 17Dec2021, outcome "recovering" and all described as "Mild cold-like symptoms developed on 17Dec2021.  Breakthrough COVID case identified on 19Dec2021 (Abbott IDNow). Mild symptoms (runny nose, sore throat, cough) have improved as of 21Dec2021". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Dec2021) positive, notes: Abbott ID Now. Therapeutic measures were not taken as a result of vaccination failure, COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patient identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023267, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924. A 65 year-old male patient, had received on 19 December 2014 in the morning, an intramuscular left arm injection of FLUZONE QUADRIVALENT, lot number UI205AC with expiration date of June 2015 and 1 day later on 20 December 2014 the patient experienced pneumonia and flu. Illness at the time of vaccination was none, healthy. Concomitant medications and pre-existing conditions were reported as "NA". Laboratory tests were reported as unknown. No further information was provided. Outcome was recovered, date not reported. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
The same afternoon after the 1st dose I noticed sensitivity and tenderness in my areolas. It was so uncomfortable that I had to continually pull at my business attire work shirts to get the material off the areolas throughout the day. There were no changes in diet, exercise, sexual activity, nor laundry products during this time. This side effect lasted up until about the time the 2nd dose was due. For what it's worth, I disclosed this to a male colleague in my office who had previously received the Moderna CoVID-19 offering and he stated he suffered from the same exact side effect but was too embarrassed to disclose it.   The morning after the 2nd dose I began experiencing swelling and pain at the injection site beyond what I remember from the 1st dose and noticed a large purple welt had developed. This welt took about 3 weeks to dissipate. Additionally, I felt body aches, a headache, and nasal congestion. I took 400mg of Advil and proceeded to work as the symptoms seemed tolerable at that time. The headaches dissipated over the course of about 3 days after the dose and the body aches about 5 days after. However, the nasal congestion worsened and I began to cough a lot and dark phlegm with a distinct chemical-like taste began to be excreted whenever I would cough or clear my nasal passages. Over time I noticed traces of blood in both the cough and the nasal discharges and was concerned that I could have contracted SARS CoV-2. I took leave from work and promptly submitted to a free, publicly available PCR test for CoVID-19 and the results came back negative at approximately midnight. I returned to work but could not sustain working under the continual challenges of congestion and shortness of breath so I took leave in an effort to identify the problem and recover. I brought the situation to the attention of my primary care physician whom suspected that I acquired community pneumonia contemporaneously or correlated to the vaccination effects on my immune system and I completed a 7 day 100mg 2 x daily regimen of doxycycline. To date, I continue to have congestion and a distinct chemical-like taste in the discharges, but to a lesser extent.
Member complained of itching at injection site within 5 mins. of administration.  Red rash appeared at 10 mins Benadryl given to member.
no reaction patient administered 2.5ml instead of full dose .5 ml.   patient was called and given the other half of the dose on friday January 20,2023
Sore shoulder for a week after the shot. Also had a lump in my throat for about 2 weeks after. Felt like a sick lymph node, but no adverse affect to me, I didn?t feel sick at all after the shot.
Arm swollen and bruised, joint ached. No treatment, waiting to see if alleviates. Still bruised on Sept. 22, 2016, not sure if CLL is reason for prolonged bruising.
pt recvd vax; 3days after vax, pt exp dizziness & devel fever;
After an adverse reaction to the Covid 19 Vaccine, the emergency room Doctor suggested I contact you for a follow-up visit.   Dateline and symptoms:  03/01 Received first Moderna Covid Vaccination at 3:45 p.m... 03/02 No symptoms until 6 p.m. When blood pressure started to go up from my normal level of 116/68 to 179/82 by 10 p.m..  During this time I had what felt like mild electric currents from the left side of my chest down my left arm and into my hand.  These systems subsided around 11 p.m. and by midnight my blood pressure was almost back to normal. 03/03 Felt sluggish all day but no blood pressure problems. 03/04 Felt great all day then around 6 p.m. my blood pressure started to rise, by 9:30 p.m. it was 190/90.  At this time I started to feel like my body was shutting down, my face felt flush, and experiencing long distant vision problems, so I had my wife take me to the emergency room. At 10:00 p.m. I went to the emergency room  EKG  showed no heart problems, the blood test showed no heart problems, and after 11:30 p.m. my blood pressure started going down and I was released at 1:30 a.m..  Blood test did show high levels of Blood Urea Nitrogen 26.0, Bun/Creatinine Ratio 33.0, Aspartate Amino Tranf (AST/SGOT) 43, Alanine Aminotransferase (ALT/SGPT) 59 and Alkaline Phosphatase 189, all of which are higher than my last blood test on 10/22/20. 03/05  As of 10:30 a.m. my blood pressure is 126/62.  I feel fine except I'm very tired from not much sleep last night.  1p.m. Starting to feel some more chest and arm symptoms as described before, blood pressure now 146/66. Events happened twice, 2 days apart.
The patient experienced unilateral lymphadenopathy of the chest on the same side the injection was administered.; This is a spontaneous report from a non-contactable consumer. An adult female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, first and second dose both on an unknown date as single doses for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if patient was pregnant during vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced unilateral lymphadenopathy of the chest on the same side the injection was administered. The clinical outcome of the event lymphadenopathy was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: updated primary reporter additional qualification as none of the above,  first dose of bnt162b2 was removed from historical vaccine and added to suspect dose, vaccine date and event onset date were removed.
Patient had 1st COVID vaccination on 4/9/2021.  After 4 days, developed left sided tinnitus and ear pain.  Recommended to use flonase for 1 week.  On 4/12 he had started nortriptyline prescribed by neurology for headache,  so stopped this due to side effect of tinnitis. He does feel the hearing is decreased.  Subjectively states ringing got better after stopping nortriptyline and starting flonase. On 5/7/21 patient had 2nd covid vaccine.   On 5/29/21 audiology shows left side with mild-moderate sensorineural hearing loss from 250-500Hz, 6000-8000 Hz patient reports 2 months of constant left side hissing tinnitus after vaccine. 5/21/21  patient prescribed prednisone oral titrating doses for 14 days.
Patient with known allergies to PEG. Had a slight reaction of hives following 1st dose. Patient consulted with her PCP and oncologist and her oncologist was adamant that she was to receive her 2nd dose, not an option to not receive despite documented PEG allergy. After receiving 2nd dose approx 5-10 min later in monitoring area reported to EMS RN feeling dizzy, flush, and eye flutter. EMS evaluated, vitals HR 104, RR 21, BP 137/98, PulseOx 97%. RN noted patient was very anxious and this contributed to the patients symptoms. However, the patient did begin developing mild flushing and small red patches on arms, legs, trunk. Hives and flushing resolved within 30 minutes. Approx 45 minutes post reaction symptoms, patient reports feeling better, flushing resolved. Denied wanted further workup or transfer to ER and left with her mother.
pt to hospital with c/o dyspnea x 2 days; placed on NRB with O2 saturation on NRB 84%; found to be positive for COVID; started on steroids, ABX and fluids; septic shock; required intubation; pneumonia; AHRF; hypotension; AKI; no improvements; pt's condition worsened; family decided on palliative extubation; pt passed away in the hospital
This infant had erythematous papular rash, some confluence, over the right deltoid lateral thigh only.
Weakness, flu-like symptoms, night sweats and fever (2 nights), large bi-lateral rash covering most of torso and extending to back (I have photos.)
Information regarding PREVNAR 13 was received from a healthcare professional regarding a male patient who experienced rash and hives. The patient received a dose on 07-May-2010. The patient experienced rash and hives on 10-May-2010, three days after receiving PREVNAR 13. The patient visited the physician. Treatment was not reported. The outcome was unknown. See related case(s): US-WYE-H15212810 (adverse event, non-expedited) and US-WYE-H15212910 (adverse event, non-expedited). No additional information is available.
Extremely unusual pain at injection site, (compared to any other past injections)  generally achey, headache,  occasional waves of nausea, fever 100.4, fatigue (stayed in bed most of the day).   There was one occasion where my left hand had a strange involuntary "twitch".  I only mention that because on Saturday (1/23/21) i had a few episodes of  speech difficulty (words "not coming out right")
Approximately 5 minutes after receiving vaccine, patient became unconscious. Patient's wife yelled for help from their car (we were doing the vaccines outside in patient vehicles).  Dr and medical assistants called 911 and stayed with patient until he woke up. He was transported to the hospital and it was determined to be a vasovagal response.
Son fainted a couple minutes after getting the Pfizer vaccine. He is complaining of a headache and bad tummy ache.
had vax 230PM & 6PM started crying hysterically-unconsolable-fell asleep for 1/2 hrs then started crying for another hr;
In late 2010 I found I had some severe injuries in my left shoulder, upper arm areas. I hadn't been in an accident and we never knew what caused the injuries. I did respond well to Physical Therapy and cortisone shots and only felt a twinge now and again. In late 2014 the same set of injuries occurred in the right shoulder areas and, again, there was not an obvious cause. Treatment was Physical Therapy and cortisone shots and I experienced some stiffness and twinges but by mid 2016 there was no painful evidence at all of either of those two injuries. On November 14, 2016 I had an appointment with my Primary Care Physician. She recommended that I receive the flu and pneumonia shots, which I had never had before. I have had severe pain issues in both shoulders and up and down through the mid arm muscle areas and outer elbow pain ever since those shots. These effects did not decrease appreciably and I had an appointment with Dr. on January 14, 2017 and she ordered repeat X-rays and referred me to an osteo physician. Again I had the osteo cortisone shots this time with lidocaine. This helped for a short period of time but I was referred to a pain Doctor too. I saw the pain Doctor on February 20, 2017 and he prescribed Physical Therapy and a return visit to his office in three month's time. I saw his NP yesterday, May 15th, and, since the pains were again re-invasive I received the osteo cortisone with lidocaine shots in both shoulders again. I hope they do better this time!!! I am sending this information to FDA because I have heard from Physical Therapists about three other people who seem to have this problem right after taking the flu and pneumonia shots just in this past year. I am a retired Medical Technologist and my mind goes along the lines of "This pain from the past return after the vaccinations could be coincidence, but if there is a medical problem that might be connected with that recent procedure it should be reported and tracked."
This case was reported by a nurse via sales rep and described the occurrence of leg pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced leg pain. On an unknown date, the outcome of the leg pain was unknown. It was unknown if the reporter considered the leg pain to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the nurse who herself was patient. The patient's date of birth was unknown. The age at vaccination was not reported. The nurse agreed to be followed up.
Headache, some severe, severe joint pain, muscle pain, cough, lung pain, dizziness, pain in joints not felt prior to the vaccine, trouble with temperature regulation, soreness at injection site which started 2 days after injection. Still having issues with all of these now, one week and 3 days after the vaccine, some just started 2 days ago.
Uncomplicated pregnancy. Baby born at 39 weeks 6 days, 7 lbs 10 oz. uncomplicated delivery. Baby diagnosed with laryngomalacia
Excessive sweating, respiratory distress, heart murmur, jaundice  Was in NICU for two weeks