chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle ache; Mild fever; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine Lot no: EP6955), via an unspecified route of administration in the left arm on 25Mar2021 at 10:15 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. 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 26Mar2021 at 16:00, the patient experienced muscle ache and mild fever. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events muscle ache and mild fever were recovered at the time of reporting.  No follow-up attempts are possible; information about lot number cannot be obtained.
PSA levels going up after the Pfizer Covid-19 vaccine; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 75-year-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on Jan2021, as 2ND DOSE, SINGLE for COVID-19 immunisation. He reports that he had both doses of the Pfizer Covid-19 vaccine within the month of Jan but could not tell the exact dates. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection) in Jan2021 as historical vaccination as 1st dose, single dose for covid-19 immunisation. The patient's PSA levels going up after the Pfizer Covid-19 vaccine, on an unspecified date. The patient reports that, he continues to see his urologist, but he was "just curious". The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pounding headache for 12+ hours; tried taking Tylenol but it had no effect.
Localized swelling and itchiness at site. Drowsiness and lethargy.
Physician reported that a pt died following the receipt of RotaShield. The baby arrived unresponsive, blue, difficulty in breathing, hypotonic, had vertical nystagmus, had fever, stridor, wheezing, looked cyanotic.
This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unspecified dates since 10-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doss of RECOMBIVAX HB (lot number J013394 and expiration date 25-AUG-2016, lot number K017721 and expiration date 27-AUG-2016, lot number K026666 and expiration date 22-OCT-2016) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. This is one of several reports from the same reporter. Additional information has been requested.
11:30 received H1N1 nasal spray vaccine 1:30 had chills cough - temperature 104.5
large left arm discoloration +  bruising from vaccines in same arm  shingles/Flu. Caused very red large hand sized  bruise on arm and still not right after 1 week. Hot to touch still after 5 days.
Information has been received from a certified nurse midwife concerning a 24 year old female patient with asthma, epilepsy and migraine headaches, no drug reactions/allergies, who on 12-DEC-2008 was vaccinated intramuscularly into the left deltoid with the first 0.5 mL dose of GARDASIL (Lot # 661044/0548X). Concomitant therapy included SYNTHROID, TOPAMAX and asthma inhaler (unspecified). On 18-DEC-2008 the patient experienced dizziness and waves of nausea for four days, the patient stated that, was able to continue A.O.L.. Symptoms decreased after 22-DEC-2008, then went away. The patient had recovered. The patient called to the office on 22-DEC-2008. There were no laboratory or diagnostic tests performed. Additional information is not expected.
Our daughter had long lasting reactions to vaccines every time she was given some.  She would cry and be very irritable for weeks and weeks after each one.  After the initial ones when she was too young to realize what was going on, she became more and more distant after every vaccine session.  After her 1 yr vaccines she just "went away" and lost a lot of previously learned language.  She started living in her own world and did not care much for ours.  Either she was not responding to us when we tried to get her to, or she was tantruming.   She could no longer have a bowel movement without medication.  She was dx as autism spectrum at about 1.5-2 yrs old. This has gone on for years now.  She is better with a lot of treatments, but she may never be the same sweet, smiling, laughing, happy kid that we once knew.   We found out that she should not have been given all of these vaccines when she was on prophylactic antibiotics for ureter reflux.   We are working on finding out the manufacturers and lot numbers.  If this is important, please let us know.  1/6/09 MR received from PCP from June 2004-2007. Normal exams on WCCs 6/29/04 and 9/10/04 with exception of UTI. Vax given 9/10/04. Frequent sick visits.  Asess 3/31/05-Healthy 18 mon old1) hx of vesicoureteral reflux Grade I/V. Intolerant to lactose. Noted to be a picky eater with some behavioral concerns. Temper tantrums noted 9/13/05. Developmental eval 4/24/06 (+) for Sensory Integration Dysfunction. DX of Autism Spectrum  Disorder, PDD 11/12/2007.
around noontime on 1/22 I suddenly felt weak and woozy and started to fall. Had to grab counter to stay from falling. Problem lasted for about a half hour. But a certain amount of weakness persisted and is still with me. Had one other wooziness episode on 1/24 at about the same time. This is new to me and may not be a reaction to the vaccination.
Extremely heavy menstrual flow the next cycle after injection #3. At work I was wearing a heavy flow tampon AND an overnight menstrual pad that were saturated  through my clothes in 2 hours. This is exceedingly uncharacteristic for my typical flow. It is also consistent with menstrual flows after the first two injections. Please do not insult my gender by attributing this to anxiety, paying an extraordinary amount of my attention to my body, or any other paltry reason to explain it away. This side effect of the Moderna Covid is genuine, and recipients need to be educated about it. This is a need-to-know side effect because no one at work wants to have menstrual blood soaking their clothes and workspace. Do not disregard it as a "female problem" from oversight or oblivion on my part. Deeper question? Why is this such a common side effect for the Moderna mRNA vaccine and not for the dozens of other vaccines given? Seems to me this is a significant difference. Why?
Moderna COVID-19 Vaccine EUA  029A21A 3/6 upon bed Injection site hurt so bad I could not sleep on left arm, rolled over to sleep on right side and that was so painful I had to get up and sleep in a recliner to find a comfortable spot for right arm.  My muscles in neck, lower back and calves also hurt. At 5:30 am the worst pain in right arm left and I went to bed.  Slept until noon. Temp 101.8 took ibuprofen.  Injection site swollen, painful, face slightly puffy. Day 2 - Site still swollen & painful.  Entire top of left arm swollen. Temp 101.4 took Tylenol.  Right arm not as painful, mostly gone, muscles still sore.  Constipated. Fatigued.  Slept off and on. Day 3 - Temp still 101 but did go down to 99.   Still sore and injection site is still hot to touch and swollen.  Fatigued. Day 4 - Fever broke at 6 am.  98.8.  Injection site still very sore.  Finally was able to go to the bathroom.  Fatigued. Day 5 - Day 8  Injection site still sore and arm just feels funny.  Fatigued and low energy. Day 9 arm feels pretty good today and Day 10 arm is feeling ok.  I am still fatigued and feel like I need to sleep and rest a lot.  I used Tylenol and Ibuprofen.  I noticed just after getting my injection I seemed to have a lot more mucous than is normal.  That seems a bit better now.
Patient received Moderna COVID19 Bivalent Updated Booster 12+ 0.5ml in the right deltoid and Fluarix quad 0.5ml in the left deltoid. The patient then asked for some water and for a receptacle to vomit into. The patient lost color, stated she was feeling unwell and shortly thereafter she her head fell back, her eyes rolled back in her head and she lost consciousness. She came to quickly, but again lost consciousness a second time. She did come to again and asked for the pharmacist and technician to contact her mother who was out waiting in the car. 911 was called immediately after she lost consciousness the first time. EMS arrived and evaluated the patient. The patient and her mother decided to not seek further treatment at the hospital. The patient does have a history of passing out after blood draws, but has never passed out after vaccinations. This information was not disclosed to the pharmacy prior to administration.
I started having heart palpations on site after I received the vaccine, I had an EKG on site. The results from the EKG were normal and I was advised that I would be ok to go. I later that night noticed my left arm, shoulder, and side were swelling. I propped my left arm up due to the swelling and pain. I went back to sleep and the swelling finally went away after 6 hours. Whenever I woke up, I was fine, and the swelling went away. I also had itchy eyeballs for weeks on and off, joint pain, and fatigue.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age. On unspecified dates, the patients were vaccinated with (Oka-Merck) PROQUAD which was exposed to unknown temperatures out of the recommended range for an unknown period of time (dose, route, lot number and expiration date unknown). No adverse effect had been reported. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from a physician and a licensed practical nurse (LPN) regarding a 18 month old (also reported as age 2, units not provided) female patient (child). On 10-JAN-2014 at 4:24 pm, the patient might have been immunized with a dose of (Oka-Merck) PROQUAD lot number J005179, expiration date 03-NOV-2014, in the left thigh (dose number, route and dose were not reported) which was not stored at the appropriate temperature (not further specified). Concomitant medications were not specified. The outcome of the event was reported as unknown. This is one of several reports received from the same source. Additional information is not expected because follow up has been obtained.
Intense and recurring diarrhea, abdominal cramps and bloating.  Also persistent discomfort in left upper quadrant. Symptoms continuing for over 2 months.
On Dec 20, 2021 awoke to Sudden onset of vertigo . Feeling of movement, , inability to walk a straight line (lurching), strong nausea, vomiting.
Headache and vomiting  beginning night of vaccination on 12/24/2020 and continuing to 12/26/2020 accompanied by extreme lethargy. Patient states she was unable to do anything and stayed in bed for days. When I spoke with her today 12/28/2020 she stated she had a headache and was very fatigued still.
TDAP given 10-22-10, was painful began with arm edema/redness, started 10-23-10 - itchy, hard lump - no dyspnea or fever pt took BENADRYL 25mg 3 x once yesterday. On exam pt has a 5-7 cm mass with areas of erythema - no streaks mass tender - pt to use ice/TID/ start cephalexin 500mg po q 8 hours x 7 days. Use BENADRYL prn.
According to the order on Nov/7/2017 noted there was a list of vaccinations recommended by Dr which were not clear and after communication with Dr, he advised the patient get following vaccines, the Hep B, MMR, HIB, PSV 23, IPV, varicella and polio. Verified with another nurse the vaccines. After the vaccines given noticed that instead of varicella SHINGRIX vaccine was given. Notified the DR and he stated that the vaccine is no danger to patient. The patient had No contraindications to the vaccine. Dr said he will call the patient and I reported this to my supervisor. The pt was fine and no adverse effect.
Approx 2-3 hrs following vax w/DTP/OPV/HIB pt exp afebrile sz which mom described as stiffening of pts body, rolling of eyes, appearnce of blank gaze;
grogginess; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 02Apr2021 at 16:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, type 2 diabetes mellitus from an unspecified date. Concomitant medications included sertraline hydrochloride (ZOLOFT), bupropion hydrochloride (WELLBUTRIN), insulin glargine (BASAGLAR), dulaglutide (TRULICITY) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 11Mar2021 at 16:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 the patient experienced 4 weeks after 2nd dose, experienced continuous grogginess and fatigue. Lasting all day and was making it extremely difficult to work and be productive. The clinical outcome of the events groggy, fatigue was unknown.  No follow-up attempts are needed. No further information is expected.
Very heavy period; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced very heavy period. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event very heavy period was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt devel an inj site rxn characterized by induration & redness p/vax;
approx. 12 hrs after vaccine I started shaking uncontrollablly, and was extremely cold, I could not warm up. Temp. was 98.6. Put 8 heavy blankets on me and still could not warm up, my heart was racing. after about 3 hrs of that then I got hot, very hot (I think from all of the blankets on me) my temp was then 101. Heart still racing. I slowly tried to cool down, but of course when taking blankets off I was still cold and shaking. I could not sleep and my heart was still racing, I finally fell asleep and got about 4 hrs of sleep, woke up and felt better, still a little weak and tired from not sleeping and from shaking, but felt fine over all. DUring all this, I did consider going to the ER, due to the uncontrollable shaking and heart racing, but just stayed home.
Excruciating pain. My left arm where I got the shot  is swollen and feels like my arm is dead. My hand is also swollen. The lymph nodes in my left armpit are swollen and sore and so sensitive to touch that just barely grazing them causes me more pain than I?ve ever known. The pain was mostly On my left side, in my arm and breast. It was non stop the day after the shot and the worst pain of my life. The lymph nodes in my head are also swollen and sore. I started to feel a little better on day 2?the pain went from a 10 down to a 7? I felt like I even had a little more energy. But then I would get shooting pains in my armpit or my neck/chin where the lymph nodes are, and then I would get really dizzy, really nauseous and so week I couldn?t hold my head up. It would last for 20-30 minutes . I have never known a pain like this in my life. It doesn?t relent and no amount of over-the-counter medication I take helps. Today I still have soreness in my left arm and the lymph nodes in my left armpit are still swollen and sore. The pain is at a 4 today.
Patient had syncopal episode that lasted less than 5 seconds. Upon awakening, he was aware of surroundings and location.  He had a slight laceration with bleeding to his left shoulder just above the Band-Aids from injection site as well as a small area of ecchymosis directly underneath chin.  Patient was able to move jaw and talk without pain or discomfort.  He was able to drink apple juice without difficulty.  After approximately 15 min, patient was back to baseline and mother felt comfortable taking home.  Reviewed symptoms that would warrant immediate re-evaluation.
First dose given at office 8/28/01. Second dose 9/27/01. I started having hives after the second dose on 10/5/01. I treated myself with Benadryl until my gynecologist gave me a prescription for Zyrtec because it would not make me feel washed out like Benadryl. My medical doctor ran all tests to check for any possible reason for hives and could not find any medical reason. I called him when I was suppose to get my last Hep B shot and due to hives being listed as one of the unusual conditions, such as a serious allergic reaction, he told me not to get the shot. It will be two years in October and I still have hives if I do not take the Zyrtec and they also come through even on the Zyrtec, but to date I have only had to take an additional Zyrtec the same day due to hives making me too uncomfortable.
Rash developed approx. 13 days after getting shots. Client states rash is on arms, knees, and lower back and is red and raised. Denies other symptoms.
RIGHT DELTOID, EDEMA ERYTHEMA (70MM) WARM TO TOUCH.
Vaccine given Monday,11-6. Awoke 11-7 with right arm swollen, red & painful. Thursday 11-9; arm still swollen, felt achy all over "like I had the flu".  Saw Dr in clinic at 3pm. Took oral Benadryl pms, & Claritin ams, ice to swollen area. Ice relieved a lot of the pain. Better when contacted 11-12.
Narrative: Exact documentation from administering nurse is as follows: Writer was given verbal order by neighborhood NP to give resident covid booster vaccine NP stated that this was supposed to be performed days ago but resident refused until speaking with NP again and said resident agreed this morning.NP informed writer that NO ORDERS were needed to give booster. Writer verified twice with NP, resident name and order for COVID booster vaccination, as well as to where to obtain vaccine. NP repeated said resident and covid vaccine and where to pick up to booster vaccine. However, NP informer writer that the booster was not for this particular resident after booster had been given. Resident assessed at this time. No s/s/ of adverse effects. Charge nurse and med nurse made aware to observe resident closely. Resident is on 1:1 currently. Will continue to monitor and observe resident.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient was inoculated with ZOSTAVAX on or about 29-JUL-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about the dates of 12-MAR-2014; 23-MAY-2014; 10-JUL-2014; 17-SEP-2014; 04-AUG-2015; and 11-NOV-2015, the patient was treated by a physician for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles, which had spread to the eyes. The patient received ongoing care from the physician for repeated severe outbreaks and glaucoma and ocular inflammation secondary to herpes zoster. On or about 24-APR-2017 the patient was diagnosed by the physician as having herpes zoster anterior uveitis OD, a serious condition caused by worsening shingles that had persisted despite aggressive treatment with antivirals. The patient was prescribed VALTREX, COMBIGAN, AZOPT eye drops and DUREZOL eye drops management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review herpes zoster anterior uveitis OD and glaucoma were considered to be a medically significant event. Additional information has been requested.
Chronic Spontaneous Urticaria (Hives)  10 days after the booster injection, I began experiencing hives all over my body. Today is day 13 of continuous symptoms.  I am concerned this will be an ongoing adverse effect.
This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown age and gender. The patients' concomitant medications included sterile diluent (MERCK) (lot # and expiration date were not provided). The patients' medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. On an unspecified date, unspecified number of patients were vaccinated with improperly stored doses of PROQUAD, M-M-R II, PNEUMOVAX 23, PEDVAXHIB, ROTATEQ and VARIVAX, all for prophylaxis (dose number, route, anatomical location, lot # and expiration date were not provided). The administered doses of the vaccines experienced a temperature excursion in the range between 47°F to 77°F (49.1) (°F degree Fahrenheit) during 1 hour and 20 minutes as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Upon receipt of follow-up information it was determined that this case is now valid because patient identifiers were provided. Follow up information received on 13-JUN-2018: This spontaneous report was received from a nurse regarding a 12 months old patient of unknown gender. On 01-MAR-2018, patient was vaccinated with improperly stored doses of VARIVAX, lot # N017395 (dose number, route, anatomical location and expiration date were not provided). This is one of two reports received from the same reporter (1803USA002638).
SWELLING and redness oF Right arm, initially at The injection site with progression to Below Elbow. Not Streaking, Doubt cellulitis Not a systemic allergic reaction
crackling in right ear,  slight hollow  type sound when moving jaw, slight muffling, noticeable on and off... has not subsided as yet, have not ever had this type of issue with hearing..