chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VZV aseptic meningitis and zoster; VZV aseptic meningitis and zoster; VZV aseptic meningitis and zoster; This spontaneous report as received from a physician refers to a teenage female patient of unknown age. No information on patient's medical history, concurrent conditions and concomitant medications was provided.      On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot#, expiration date, dose and route of administration were not provided)  for prophylaxis.         On an unknown date, the patient experienced varicella zoster virus (VZV) aseptic meningitis and zoster. The reporter wanted to test her cerebrospinal fluid (CSF) for the vaccine strain. The outcome of the event was not provided. The relatedness between the event and the vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.  Upon internal review, the event of aseptic meningitis was considered to be medically significant.
Hives and red rash developed about 3 half hours after vaccination starting with legs and continuing over entire body.  took Benadryl  & used Ventolin HFA and went to  ER at Hospital .  There treated with more Benadryl, famotidine & prednisone (last dose 8:31 pm).  released.  follow up with primary 2/17/20  continued with hives and rash .  Took Benadryl 5-6 times daily first several days.  Day 13 only needed one.  Also using  still Cortizone 10 Crème .   Day 15 still have red rash and hives starting to go down.
short of breath; greater than 35 days between Covid-19 vaccinations; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (short of breath) and INTENTIONAL PRODUCT USE ISSUE (greater than 35 days between Covid-19 vaccinations) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003T21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (short of breath) and INTENTIONAL PRODUCT USE ISSUE (greater than 35 days between Covid-19 vaccinations). At the time of the report, DYSPNOEA (short of breath) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (greater than 35 days between Covid-19 vaccinations) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Moderna COVID 19 Vaccine EUA The day following the vaccine I had a fever,  headache, significantly higher than normal blood pressure, increased heart rate, chills/sweats intermittent throughout the next 24 hours.  Very much like a severe case of the flu. They subsided somewhat today, but to the loss of being able to sleep pretty weak today.
Mother of child called, stating that child was playing outside with dad. Dad saw wasp swarming near child. Child began crying, but no evidence of sting was found. 45 minutes later, child began to have facial redness, swelling, shortness of breath, and wheezing. Mother questioned whether related to possible wasp sting or vaccine. I instructed her to follow-up with the emergency room immediately. Mom states at the ER, the MD stated symptoms were vaccine related. Treated with Benadryl, Tylenol, and Motrin and symptoms resolved.
Lot of pain in my neck and in my shoulder; Lot of pain in my neck and in my shoulder; This is a Spontaneous report from a Contactable consumer (patient). A 62-years-old female patient received the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: FE3360) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included diabetic. Concomitant medication included Gabapentin, Benazepril, Omeprazole DR and Vitamin D3. Consumer stated, I hope you could help me. I got my vaccine on Thursday, I believe at 3:30 PM. Last night, I started to get a lot of pain in my neck and in my shoulder. Is that a side effect. The patient received treatment with just took Tylenol and Ibuprofen, it was 800 mg of Ibuprofen and Tylenol is only 325 mg. The patient still experiencing events: Consumer stated, Yes, I still have pain but not like the last time. I still have pain in my neck and shoulder. The outcome of the events was recovering.    Follow-up attempts are completed. No further information was expected.
Redness/ large red patch at injection site/ 5 days Swelling/ at injection site/ 8 days Hard lump/ at injection site/ still present after 13 days Fever/ 99.5 -100.2 / 2 days Nausea/ 1 day Severe body aches/ all over body/ 2 days Fatigue/ 3 days
"Moderna Arm"   at injection site arm swollen hard knot about the size of diameter of a baseball, red, itchy and hot.  My arm wasn't sore to raise or anything just the knot  that last for about 5 days and then just red and a little itchy for about 2 weeks. No other side effects.  No fever
Patient had mildly sore arm during the day after receiving the vaccine but approximately 12 hours after several side effects onset. Fever, body aches, chills, headache, joint pain, fatigue, injection site pain, nausea, and generally feeling unwell.
The pt developed an area of redness 2x2cm around the injection site 2nd day after vaccination. Resolving spontaneously during the 3rd day.
After the 15 minute waiting period, I proceeded to walk to my car which was parked in the farthest corner of the large lot. Although I felt no reaction within the first 15 minutes, by the time I reached my car I could barely stand. I was passing out. Then I began to have severe chest pain. I was throwing up, shaking uncontrollably and felt faint and weak. I did not feel that I could make it back to the medical team on site safely as it was a long walk back. I also did not feel I could safely drive. At that time we were also avoiding the hospitals as they were inundated with Covid patients and considered not safe. I waited on the phone with my boyfriend for approximately 30 minutes while the symptoms seem to get worse then eventually slowed down. I told him if I pass out to call for an ambulance. After 30 minutes the symptoms began to subside although it took several weeks to resolve. I also was sick for the next several weeks with COVID like symptoms.
Patient presented back to clinic one day after receiving a dose of pneumococcal vaccine, complaining of fatigue, body ache, and local swelling in the arm where the dose had been administered. Provider considered differential diagnosis of allergic reaction vs cellulitis and treated for both. Patient received an oral prednisone taper over 5 days, oral diphenhydramine 50mg TID x 1 week, and cephalexin 500mg TID x10 days. Upon followup by phone the next day, patient's symptoms had completely resolved. Patient last previous dose of pneumococcal vaccine had reportedly been given 2005 at another clinic.
Rec'd vaccine on 6.8.11. Experienced slight discomfort at the time of administration which resolved. On 6.21.11, experienced moderate to severe pain in the left upper arm at the site of vaccination. On a scale from 1 -> 10 (least -> most), pain rated a (7) pain experienced with movement, such as raising arm, stretching and specifically noted with piano playing. States that she's unable to play DT the pain. Mother observes slight swelling at site. No redness/warmth.
2 minutes after receiving Covid vaccine- patient felt numbness in his left hand.  About 1 min later he felt numbness in his right hand. About another minute later- his vision started to darken and he felt like he would faint (he was sitting down during this entire experience) and his face started to tingle.  His vision went completely black but he did not lose consciousness.  His eyes were very blood shot during this and he was very pale.  He recovered from all symptoms after about 10 minutes.  He felt very thirsty after this and throat felt dry.
Rapid rise in heart rate (160BPM) at rest, HBP (160/100), speech  slurred, uncontrollable leg spasms for 5-10 minutes, heart palpitations, head tightness/ throbbing of temporal veins in head on both left and right sides. 911 was dialed and an EKG was performed (normal), but advised to visit ER. ER performed EKG which was deemed normal after episode subsided.
Vasovagal syncope with ragged breathing and lingering feeling of nausea and fatigue
Pt called complaining of pain in right arm for past 3-4 months.  Says she has been to PMD and they gave her a steroid injection with no relief.  States she can't use that arm because of the pain.
Information has been received from a registered nurse concerning that her 15 month old niece, who was vaccinated on 19-JUN-2010, with a dose of MMR II (Lot#: not reported). Concomitant therapy included PREVNAR and PENTACEL. On 20-JUN-2010, the patient experienced "rash all over her body" after she was given the MMR II. At the time of the report the patient had not recovered. The patient called the office. Follow-up information has been received from a physician concerning a 15 months old female with no pertinent medical history, drug reactions or allergies reported who on 18-JUN-2010 (previously reported as 19-JUN-2010) was vaccinated with the first dose of MMR II (Lot#: 666511/1777Y), subcutaneously at 10:30 am. Concomitant therapies included PREVNAR (lot n. F260221) and PENTACEL (lot n. C363AA). Physician stated that patient's mom reported that the patient "broke out in mosquito bite like spots". No other symptoms and no new foods were given. BENADRYL was given to the patient and symptoms were resolved on an unknown date. Additional information is not expected.
Develoiped large slightly raised red rah on opposite side of arm from injection site. Rash areas are approx 3-5 inches wide, hot to touch, not itchy.
No adverse effect; Administered Improperly stored vaccine; This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 02-APR-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R024265,expiry date: 26-AUG-2020) via subcutaneous route for prophylaxis. Concomitant drugs included sterile diluent. The vaccine administered was not properly stored and was administered after reconstituting with properly stored sterile diluent. The temperature at the time of administration was 11.8 Fahrenheit with time frame of 2 hours and 20 minutes. The vaccine had previous temperature excursion at 6.8 Fahrenheit for 2 hours 40 minutes. No adverse effects reported. No product quality complaint involved in this case. Digital data logger was involved.
Immediately upon receiving 0.5 ml IM Janssen lot # 042A21A exp. 9/19/21, patient reported feeling like he will pass out.  He was immediately helped into a chair that he could lay  back in and was assessed.  His initial vital signs at 6:39 pm were 96/55, and heart rate 49.  He did not lose consciousness and was alert and orientated throughout the observation time.  Patient was monitored until vital signs recovered and symptoms resolved.  At 7:33 pm vital signs were 95/73, hear rate 65 and O2 Sat 98%.  Patient had steady gate, was alert and orientated and denied any symptoms or complaints and left facility without assistance.  He received education to follow up with a primary physician and ER precautions.
On July 5, 2022, feeling extremely tired, on July 6, 2022, woke up still feeling extremely tired with a little scratchy throat, took  a rapid antigen home covid test and it was positive.  Contacted my doctor immediately and was prescribed paxlovid due to my asthma and having a stroke on 1/31/22..
My son fainted within 5-10 minutes after being given the first dose of Gardasil.  He was standing at the nurses counter and fell down hitting his head on the floor.  His body went stiff, and he was knocked out for a few seconds.  He was extremely pale.  He was dizzy and nauseous the rest of the day and had a bad headache and sore neck.  He was still a little dizzy and sore the next day.
Got flu vaccine at 14 weeks of age. Mom requested flu and age was not checked prior to vaccination. Mom informed will need at 6 MOS.
Fever 99.8, nausea, tiredness, feeling unwell. Slept and rested. Symptoms gone by 3-24-2021 at 11:00 AM
COVID 19 Treatment.; COVID 19 Treatment.; interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; bnt162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 24Oct2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 24Sep2023 to 29Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322656 Same patient/same product, different dose/event;US-PFIZER INC-202300322528 Same patient, different product, different dose/event;
Elevated heart rate; Elevated heart rate; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 08:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 11May2021 at 17:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis, anxiety and formaldehyde allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received cefprozil (CEFZIL), ibuprofen (MANUFACTURER UNKNOWN) and bupropion hydrochloride (WELLBUTRIN) and experienced drug allergy. Concomitant medications included ketorolac (MANUFACTURER UNKNOWN), hyoscyamine (MANUFACTURER UNKNOWN), diazepam (VALIUM), paracetamol (TYLENOL), diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL), etc; all for unknown indications, from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Apr2021 at 23:30, and on 12May2021, the patient experienced elevated heart rate after both the first and second shots. The patient reported her resting heart rate was usually between 60 and 80. About 12-15 hours after the shots, it shot up to 90-130. The first time she got the shot, it went away within a few days. The patient underwent lab test and procedures which included test for heart rate on unknown date and the result was between 60 - 80 (UNSPECIFIED UNITS) and again underwent test for heart rate after the vaccinations, on an unknown date in 2021, and the result was 90-130 (UNSPECIFIED UNITS). Since the vaccination, the patient had not been tested for COVID-19. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event elevated heart rate, after the first dose, was recovered on an unknown date in 2021 after the duration of few days and the clinical outcome of the event elevated heart rate, after the second dose, was recovered on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected
inappropriate schedule of vaccine administered; OFF LABEL DOSING; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced inappropriate schedule of vaccine administered, and off label dosing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious.
4/5/21 Started feeling tired and run down 4/6/21 Feelings of exhaustion, body aches, headache, fever of 102.7 degrees, chills, slight nausea 4/7/21 Still feeling run down, headache, fever of 100.1 degrees
At approximately 10 am on 8/2/19 MA gave HPV & Menveo in R arm.  Then, she gave Tdap in L arm.  Patient began becoming stiff, glassy eyes and unresponsive to name, & started drooling after receiving Tdap . MA laid patient down & then gave ammonia inhalant & then patient began responding.  I was called to the room after this.  Patient was  sitting up on table and answering basic questions with mom and MA at her side. Pt laid down for 10 minutes & then mini neuro exam done: CN 2-12 intact, FTN intact, EOMI intact, 2 + patellar reflexes, able to walk on toes and heels, min mental status exam done- pt knew name, age, and could answer basic questions such as favorite shows that mom watches, what she likes to do- anime & drawing, what happened yesterday (grandfathers 2 year death anniversary). Pt had difficulty with spelling world backwards and counting backwards from 100 by 7 (answered 92 first, then 91).  Pt given water & left after 30 minutes.
Syncope a few seconds after administration.  Syncope lasted 30 seconds.  Resolved on its own.  No treatment warranted.
Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 77 years old male patient who experienced arm has severely bruised around injection site and is red at needle insertion point. Large area of purple, around that was light pink and a white dot at center with what looked like pus in it, while he received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any concomitant medication. On an unknown date, the patient received a 0.5ml dose from pre-filled syringe of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine, lot UJ024AC, expiry date 29-Apr-2029 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious arm has severely bruised around injection site and is red at needle insertion point. Large area of purple, around that was light pink and a white dot at center with what looked like pus in it (vaccination site bruising) with unknown latency following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. Lab data was not provided. Final diagnosis was arm has severely bruised around injection site and is red at needle insertion point. Large area of purple, around that was light pink and a white dot at center with what looked like pus in it. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for arm has severely bruised around injection site and is red at needle insertion point. Large area of purple, around that was light pink and a white dot at center with what looked like pus in it. The patient told by pharmacist to seek medical advice from his HCP right away for evaluation and treatment. List of documents held by sender- none.
This spontaneous report received from a nurse referred to patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that the patient was vaccinated with an improperly stored PROQUAD (dose, route was not reported) (Lot number: M021427; expiry date: 29-OCT-2017) on 21-NOV-2016. The vaccine was stored at 72.6 F for 69 hours. There was no previous temperature excursion. No adverse symptoms reported. Additional information has been requested.
touched the back of her ear, it was tender and very sore; feeling very tender on the gland; Lymphatic glands, those were the ones that got swollen; Headache; Neck was hurting; swollen; Neck was hurting; swollen; dryness, felt it on lips; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on14Jan2021 at a single dose for COVID-19 immunization. Medical history included arthritis on clavicle, thorax and lumbar. The patient had concomitant medications (unspecified). The patient wanted to report the reactions occurred on 14Jan2021 for the vaccine she got; she got a headache, couple of hours later, her neck was hurting. So, she asked somebody that was with her to check and told her that it was swollen. She also had dryness, felt it on lips. The patient touched her neck and it hurts. It did hurt and it was swollen, the neck. They gave her Tylenol and Benadryl. So, it does help her sleep but the next day, she was not so much hurting. Just had headache. On 17Jan2021, when she touched the back of her ear, it was tender and very sore. It was not as bad as it was. The first day (14Jan2021), she was feeling very tender on the gland. Those were not swollen. Lymphatic glands, those were the ones that got swollen on 14Jan2021. She would like you to know the main cause, they looked and told her it is normal for the lymphatic glands to get swollen after the vaccine. So, the patient guessed that is what she got but she still had a lot of soreness in the back of her neck. Outcome of the event events headache and neck pain was not recovered while unknown for other events.  Information on the Lot/Batch number has been requested.
Unprovoked DVT/PE Narrative:  April 6th patient reported right lower extremity numbness and pallor with discomfort. Went to emergency room where he was diagnosed with acute onset peripheral vascular disease. Hospital follow-up next day patient revealed during discussion that he was having right-sided chest pain. Sent back to emergency room where he was diagnosed with large right lower extremity popliteal DVT and to clots on his right lung. TPA initiated with resolution of clots however patient expecting to be medically retired from service as he is in a specific occupation.