chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills/shivers; cold; shaking; could not get out of bed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of chills in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine and postmenopausal symptoms (post-menopausal urticaria).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Chills/shivers), cold (Verbatim: cold), tremor (Verbatim: shaking) and bedridden (Verbatim: could not get out of bed).  The outcome of the chills, cold, tremor and bedridden were resolving.   It was unknown if the reporter considered the chills, cold, tremor and bedridden to be related to Shingrix.     It was unknown if the company considered the chills, cold, tremor and bedridden to be related to Shingrix.   Linked case(s) involving the same patient:  US2023135785   Additional Information: GSK Receipt Date: 03-OCT-2023 The customer reported that she got her 1st dose in October or November 2019. Patient reported that the 1st dose gave her chills, was cold, had shivers and was shaking. The patient could not get out of bed. The symptoms last for about 30 minutes and then subsided. Patient reported she had 10 years of post-menopausal urticaria. The patient reported that she was afraid of taking the Prednisone. Not all information is available. Customer was asked twice for demographic but did not provide during the call. Customer provided consent to follow up with her and her Healthcare professional. Lot and expiration dates of vaccines were unknown. The reporter consented to follow up. This case is linked with US2023135785, same patient 2nd dose.; Sender's Comments:  US-GSK-US2023135785:Same patient, 2nd dose
sore arm (not as sore as the first injection), fatigue, joint pain, headache and "hot flashes".  I was able to control pain and hot flashes with Tylenol.  Duration was less than 48 hours.
Several weeks after the 2nd shot, I experienced an unexpected menstruation.  I have been in menopause for at least 10 years.  This event was typical of past periods in all respects.  It lasted 4 days, with moderate flow and normal characteristics.
Itching all over; Slight headache; Throat felt funny, it was hard to swallow; This is a spontaneous report received from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: ER8732) via unspecified route of administration in the left arm on 24Mar2021 at 12:15 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and hypertension. The patient had allergy to morphine, iodine, latex, most generic medicine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included vitamin d3 (MANUFACTURER UNKNOWN), cetirizine (MANUFACTURER UNKNOWN), enalapril (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN) for unknown indication. On 24Mar2021 at 12:30, the patient experienced itching all over, slight headache and throat felt funny, it was hard to swallow. The patient received benadryl (MANUFACTURER UNKNOWN) as treatment for the events The adverse 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 itching all over, slight headache and dysphagia were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Don't remember any from the first vaccine. But got a wallop from the second. Fever, flu-like symptoms. They passed quickly - within 24 hours or so. Then a  few or more days later I started having aches and tiredness. I didn't associate it with the vaccine. Just thought I was overdoing activities. Rested up. Kept feel worse.  Decided my age had caught up with me. Couldn't stay out of bed. Got so I couldn't put my socks on. Several weeks later I realized something was actually wrong with me beyond aging and I went to doc. She couldn't find anything. I got an appointment with a rheumatologist about a month later. She took a history on me, took blood samples. Believed I might have PMR as a result of the info she gathered. She prescribed 15mg Prednisone daily. I immediately got better. She said I definitely had PMR. That was early October. I'm still taking the Prednisone but she reduced the dosage yesterday to 10mg. I have now been found to have osteopenia.
Delayed onset about 5 days later. Redness, heat, rash that extended to elbow
This spontaneous case reported by a consumer, describes the occurrence of chills (the evening of the same day of the vaccination) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 13, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. On Mar 13, 2021, patient experienced chills (the evening of the same day of the vaccination). At the time of the report, chills (the evening of the same day of the vaccination) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. This case was linked to MOD-2021-043694 (E2B linked report). Sender's comments: MOD-2021-043694: reporter's wife case.
Patient has received Flu vaccine for last 8-9 years. During home visit, nurse administered vaccine and prescribed patient Clindamycin 300mg for tooth infection.  Patient stopped taking antibiotic after a few days because it made her sickthe product manufacturer was different. After vaccination, symptoms began immediately after; shoulder and neck started hurting.  Pain increased gradually and then it became excruciating. It was painful to move arm. Patient called insurance company the same day and nurse called the next day to provide vaccine information.   Excruciating pain lasted for about 1 week before it started to subside.   Patient called vaccine manufacturer who specified that it had not received a report like hers and given information about vaccine ingredients. Patient is awaiting date to see doctor. Patient has been taking 650mg Tylenol as needed for the pain, is using heat compresses, and using Two Old Goats ointment for pain.  Treatments have helped a little bit.  Patient still cannot move/raise arm even shoulder high or lift anything with left arm.  Pain in shoulder is has decreased a little bit but pain moving arm is not better at all.  The pain is worse with rain/cold weather.  Patient has no use of arm.
concerned about having Covid; runny nose; weak; chills; severe headache; fatigue; bloated; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), ABDOMINAL DISTENSION (bloated), RHINORRHOEA (runny nose), TENSION (concerned about having Covid) and CHILLS (chills) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced ABDOMINAL DISTENSION (bloated). On 27-Mar-2021, the patient experienced CHILLS (chills), HEADACHE (severe headache) and FATIGUE (fatigue). On 28-Mar-2021, the patient experienced ASTHENIA (weak). On 29-Mar-2021, the patient experienced RHINORRHOEA (runny nose). On an unknown date, the patient experienced TENSION (concerned about having Covid). At the time of the report, ASTHENIA (weak), ABDOMINAL DISTENSION (bloated), RHINORRHOEA (runny nose), TENSION (concerned about having Covid), CHILLS (chills), HEADACHE (severe headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Patient came in today stating that she has experienced arm pain and injection site pain since the immunization. She stated that her Doctor had eluded to her that maybe a nerve was punctured during the injection. He also told her that he does not recommend the FLUZONE HD (high dose senior flu shot)  stating that it's too high a dose for some seniors. This was a question she asked her Dr. at a scheduled visit, not a visit just for the arm pain. Patient came in today telling the immunizing pharmacist (me) to be more careful in the future.
This non-serious spontaneous case, was initially received on 18-Oct-2017, from other health professional, concerning a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided for was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However, a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected.
I began experiencing severe anxiety and mood swings within 48 hours of receiving the medication. I have bipolar disorder which has been well-controlled for many years with my existing medication. After receiving the vaccine, I developed extreme symptoms that required immediate attention by my healthcare provider, who prescribed medication to combat the effects. Due to this, I was too afraid to receive the second dose of the vaccine.
Muscles in arm hurting; This is a spontaneous report from a contactable consumer (reporting for herself). A 68-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date: May2021), via an unspecified route of administration in her right arm from 21Dec2020 07:15 to 21Dec2020 07:15 at SINGLE DOSE for COVID-19 immunization. There was no medical history and concomitant medications reported. In Dec2020, the patient experienced that the muscles in her arm started hurting. The outcome of the event was not recovered.
Shingles to T8 distribution:  Patient with very sensitive R sided flank rash that is vesicular and erythematous with mild weeping. patient states that he felt the rash prior to seeing it appear. Pt states that the rash wraps around to his mid abdominal line.
Severe Headache, severe body aches, fever 101.5 F,  severe nausea, vomiting, severe fatigue, severe dizziness and vertigo, severe pain in legs and arms and neck, upset stomach, weakness in legs. These severe adverse events lasted for 40 hours following vaccination.
Patient inadvertently received 2 doses of hepatitis B vaccine within about an hour of each other. No adverse effects noted.
I experienced about 10 min, got a stiff neck, left side and my left arm was in pain, was not able to raise my arm. Very shortly after, one hour after, I had extreme fatigue, mild fever of 101.F for three days. After 4-5 hours after I took Tylenol for pain. After 8 days later, I woke up where I received my vaccine, I had a red rash, skin felt very tight and itchy. I called my allergist and immunologist and I explained my symptoms and did a telemedicine. On 01-31-2021, my rash started to go away. My symptoms were worse on my first vaccine. Today I have eczema on my elbows after my second dose.
Information has been received from a physician concerning a 9 week old white male who was vaccinated PO with the second dose of ROTATEQ. Subsequently the patient experienced constipation, a "hard stomach," and appeared to be in pain for about 4 weeks. The patient was seen for a physician office visit and was referred to a gastrointestinal specialist. Subsequently, the patient's symptoms have resolved. Follow-up information has been received from a physician concerning this 14 week white male infant with gastrooesophageal reflux disease, allergic colitis, milk and niacin allergies and a history of minor feeding problems and blood in the stool (30-OCT-2006). It was noted that the patient was seen by a of doctor and started on nutramigen (prior to vaccination). After the nutramigen was started. It was noted that the patient's constipation (previously reported) had improved and there was no blood in his stool. On 02-NOV-2006 the patient had a KUB, which was normal and his hemoccult test was negative. The patient was vaccinated with a first (lot # 654663/0942F). Second (lot # 653581/0411P) and third (lot # 656102/1165p) dose of ROTATEQ. On 12-DEC-2006. 10-FEB-2007, and 12-APR-2007 respectively. Subsquently, on 03-JAN-2007 the patient developed vomiting and was crying. On 19-JAN-2007 the patient developed diarrhea. On 12-FEB-2007 the patient was seen by a GI doctor. It was noted that the patient's gastrooesophageal reflux disease continued. There were no medications given. On 04-APR-2007 the patient developed vomiting and diarrhea. On 05-DEC-2007 the patient developed diarrhea. It was noted that the patient was placed on amoxicillin (AMOXIL) at that time. At the time of the report, the patient recovered on an unspecified date. Additional information is not expected. This is on of the several reports from the ssame source. There was no product quality complaint.
Started hearing ringing in ears that would come and go from October through December. Since the beginning of the year the ringing (Tinnitus) has been a constant high pitch ring
Patient had no adverse reactions; administered a dose of PROQUAD on 5/3/23 instead of the MMR and Varicella separately; This spontaneous report was received from a nurse referring to a 15-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.  On 03-MAY-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter (mL) injection (0.5 mL (also reported as 1 dose), lot#, expiration date, and anatomical location were unknown) subcutaneously (SQ), instead of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacture unknown) injection and varicella virus vaccine live (oka/merck) (manufacture unknown) injection separately (all for prophylaxis) (wrong product administered). The patient had no adverse reactions (no adverse event). No other information was provided or known by reporter. No PQC was reported.
Itchiness on neck and chest along with redness, blotchiness on arms 45 minutes after vaccine being administered.  Administered 25mg oral diphenhydramine and symptoms resolved.
Shingles; crusts 1x1 inches; colored pink; due to supply issues he could not get the second dose; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, crust, erythema and product supply issue. The patient was treated with cortisone (non-proprietary) (Cortisone 10). On an unknown date, the outcome of the shingles, crust and erythema were recovering/resolving and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the shingles, crust and erythema to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's spouse. The reporter stated that the patient received the first Shingrix vaccine in 2018 but due to supply issues he could not get the second dose. The nurse reported that male patient till the time of reporting due to out of stock of the vaccine second dose has been not yet receive which led to product supply issue. The patient received first dose of Shingrix in 2018 and developed shingles describes as crusts 1 by 1 inches, colored pink, no pustules. The patient administered corticoids and applied bandages every day reduced the symptoms after a week.  No other information was provided as patient identifiers, no lot number nor expiration date. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021157381:Same reporter, FU, deleted from database US-GLAXOSMITHKLINE-US2021157377:FU2 deleted
Is a male who seems to have a history of a pacemaker as well as high blood pressure and BPH based on his medications who presents here to the emergency department febrile confused and weak for change in mental status.  He apparently lives with family at home last saw him getting on the toilet around 130 however had came back to find him as he had not returned from the bathroom for couple hours later brown 330 to find the patient weak and confused.  Patient is denying any pain at this time.  He denied any problems breathing.  He did state his name and that he was 87 years old.  There is no known trauma.  Patient is a very poor story and no family is here yet at this time. Associated Symptoms: confusion, fatigue, fever, weakness
The flu vaccine gave me bruises on my right arm. There's still significant bruising 8 days after receiving the vaccine.
On approximately 6/25/99, the pt received her first dose of Lymerix. Three hours later on 6/25/99, the pt experienced headache, disorientation, sore joints and she almost passed out. Her joints were sore for 1 1/2 weeks. She rested and took Tylenol.  The most recent information received on 7/26/99 reports the condition of the pt is recovered.
So after my second dose of the Moderna vaccine, my period came at 22 days. In June, I had two periods and in July and August it continued this way. This is uncommon for me, and in September it continued again as well. I have never had a history of menstrual cycles this way. I went to my OBGYN and told him that my periods were off and he told me he expected it would last a couple months and then it would balance out, but it has been about 6 months and it has continued. So I will go back soon and get tested, my hormones and all that to make sure I am okay.
Extreme fatigue and high fever (greater than 101) for more than 24 hours.
Pt. returned to clinic, 1 1/2 hr. after vax, c/o feeling "detached and unable to concentrate". Color pink, skin warm, dry. B/P 112/70, pulse 72. Resp. 18, lungs clear. No sob, trouble swallowing, itching or weakness. Rested, now feels fine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the improperly stored dose of ZOSTAVAX (lot # M019646, expiration date 18-JUL-2017, subcutaneously; dose was not reported). No adverse effects were reported. The vaccine was stored in 10F for 48 hours and on the other date, in 10F for 24 hours. The call was made because of the data logger. This is one of several reports received from the same source. Additional information has been requested.
1 day after Varivax was administered, child developed redness, pain and swelling at injection site. 2 days after, the area of erythema and induration measured 2x3 inches. Child c/o pain an itchiness. Pt was afebrile no local reactions with the other vaccines.
No other adverse event (AE); HBP calling to report the administration of an expired dose of a PNEUMOVAX 23 SYRINGE to a patient on 10/20/2023.  Caller confirmed no previous temperature excursions for this product and no symptoms or further details reported.  Caller requested if; This spontaneous report was received from other health professional and refers to a patient with an unknown age of gender.  The patient's pertinent medical history, concomitant medications, drug reaction and allergies were not reported.  On an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (lot number W019533has been confirmed to be valid for pembrolizumab (KEYTRUDA), expiration date not reported but upon internal reviewed established as 30-SEP-2023) (strength, route of administration, and indication were not provided).  On 20-OCT-2023, the patient received an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (expired vaccine used). No previous temperature excursions for this product and no symptoms or further details reported. No addicional adverse (AE) event was provided.
2:35 ITCHING @ SITE OF MMR (SQ OVER R TRICEP) & VARICELLA (SQ OVER L TRICEP) VACCINES. 2:40 C/O CONFUSION; PLACED IN RECUMBENT POSITION. 2:45 C/O PALPITATIONS; CALLED 911; BP 157/99; P 66. 3:00 EMTs ARRIVE; 12 LEAD EKG UNREMARKABLE. 3:10 CLIENT C/O CHEST PAIN; EMTs TRANSPORT.
I had the flu vaccine around 1:30 pm yesterday, Nov. 10. I woke up a little before 5 am this morning, Nov. 11, with painful and watering eyes and a bad headache. I got up and found that both eyes are red, swollen nearly half shut, painful, dry/scratchy and so constantly watering (which leads to constantly blowing my nose). I had so much trouble trying to read the morning newspaper that I had to give up. It is now going on 8 am and after taking ibuprofen my eyes are watering less, although still dry and red, and my headache is less, although both head and eyes still hurt. I am recently retired from decades of working in a hospital, I've always had a flu shot at work and never once had an adverse reaction from a flu vaccine given at the hospital. That being said, about 4 or 5 years ago I did have a flu vaccine at pharmacy and had the same reactions that I am having today. I would love to know if pharmacies use a different (as in lesser quality) flu shot then hospitals. It makes no sense to have these dramatic side effects only twice - both times after using a pharmacy for the vaccine while having zero side effects for thirty years of hospital provided vaccine. Last time the symptoms went away in about 24 hours. So I will seek no medical treatment to see if this also goes away within 24 hours or so.