chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with PNEUMOVAX23 (lot # J007786, expiration date: 25-SEP-2014). Route of administration and dose were not reported. Concomitant medications were not reported. On 27-SEP-2013 the patient experienced serious swelling at the injection site and complained of pain. These injection site reactions were larger than the pharmacy has ever seen before. The patient sought for medical attention and treatment was given for the events (not specified). The outcome of the adverse events was reported as recovering. The relationship between PNEUMOVAX23 and the adverse events was not reported. The pharmacist stated there have been 5 or 7 patient who have received this Lot and have not reported any reactions. A lot check was requested by pharmacist. This case is linked to case 1310USA003793 and 1310USA002354 via same reporter link. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 07-OCT-2017, the patient was vaccinated with improperly stored PROQUAD lot # M036295, expiration date 13-FEB-2018, (strength, dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MERCK). The vaccines were exposed to temperature range of 6 degree Fahrenheit (F) to 14 degree F for 1 hour and 20 minutes. This report was because of a digital data logger. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008666: US-009507513-1709USA008861.
Patient called inpatient pharmacy to report that he has been experiencing hives since receiving  the second dose of his COVID-19 vaccine on 09/20/2021. He reports that he has been experiencing hives since 09/23/2021. Told patient to seek medical attention at the nearest ED.
Pt felt light headed and then fainted however, was still responsive. She was breathing normally during the 1-2 minutes then came to normalization within 5 minutes. She stated the inject hurt and that was it. EMT's showed up and an assessment was complete which from what I could tell came back normal.
Right shoulder pain for a couple of weeks now, no injury or trauma. Pain and pressure to the area and with overhead activities. Right shoulder bothers him if he lays down on it. PCM diagnosed with biceps tendinitis.
On day 3 after the second dose, she began to develop a rash on her face and arms around 8 pm. This progressed over the next several hours to the next morning to include swelling of the face and neck, tightness of the throat and chest, and progression of the rash to involve all of the arms, chest, and legs. The rash was a fine maculopapular rash that was itchy. Over the next 3 days the symptoms did not progress further, but they also did not subside. On day 7 after the 2nd dose, she was placed on a Medrol Dose pack. The swelling of the face and sensation of tight throat began to ease by the next day. After completion of the steroid regimen, her skin is dry and flaky with mild tightness in the skin of the face. However, most of the rash has gone and the tightness in the throat is absent.
Vaccine 8/1 to 8/3 noticed erythema and hives at injection site plus hive L cheek and on L arm.
Developed varicella rash about 10 days after receiving his first dose of varicella vaccine. Generalized rash, 102.2 F temperature, and cough. Evaluated at ED on 2/5/2015. Rash onset 2/5/2015.
Patient developed urticarial rash and angioedema involving mouth, tongue and eyes.   Her rash and angioedema worsened over two days and she is currently admitted to the hospital for management.  EDD 8/26/21. Her pregnancy has been uncomplicated previous to this incident.  The also received Moderna COVID-19 vaccine on 3/3/21 and 3/30/21, as well as a previous dose of the Fluzone on 11/3/21.
About a week ago, I experienced palpitations in my heart, and a weak and shaky feeling. I contacted my physician and was sent to do blood work. I am awaiting the results of that. I believe he is checking my thyroid function.
Patient was just short of 18 YO by  6 days. .  Date of vaccination 12/31/2020.  No adverse reactions noted
My face became numb within 10 minutes of the injection. My throat started to close making it somewhat difficult to swallow, but not to the point of having trouble breathing. It has been 12 hours since the injection and my face still feels numb, but swallowing is just starting to get a little easier. The numbness is mostly around my nose, cheeks and forehead.
This spontaneous report as received from a practice manager refers to a patient of unknown age. On 15-FEB-2013 the patient was vaccinated with the first dose of PNEUMOVAX23 (lot#, expiration date, dose, route and indication not reported) and on 15-APR-2013, the patient was vaccinated with the second dose of PNEUMOVAX23 (lot#, expiration date, dose, route and indication not reported). No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
Metallic taste in my mouth, started about 2 hours after receiving vaccine, still continues 12 days later.
9-9-08 HPV given in right arm and facial edema started 9-10-08
10NOV94 vax given 11AM; 10NOV94 7PM sz; 1AM sz; hospitalized w/APAP & Phenobarb (1AM);
Large local reaction to the injection site starting day of injection and worsening over 4 days time. Secondary cellulitis developed requiring antibiotic treatment.
Sleeping  1 full day after vaccine tiredness, Back Pain and spasms  for 4 days, Headache for 1 day, Vivid Dreams,  feeling out of it, increased pulse 110, increased blood pressure 160/80 not a hypertensive patient, dizziness and light headedness.  Increase vitals day 2 Back pain started late in the 2nd day and ended on 3/16.
At 9pm, Muscle pain, fatigue, headache and soreness in the arm. Took Tylenol 2x325mg. At 3 am, woke up feeling dizzy and headache. After walking 2 steps I fainted and collapsed on the floor. During the following day, I had fever of 101.5F, extreme headache, dizziness, muscle ache and fatigue.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA
No symptoms or site inflammation for 48 plus hrs Five days after, head congestion began.  Eight days after I had full blown upper respiratory symptoms that lasted 36 hrs. Heavy prolonged cough with foamy white mucous, chills, headache, muscle aches , fatigue, dry scratchy throat. Symptoms are starting to ease, but cough mucous now turning yellow.  I had a delayed reaction to the first pneumonia vaccine in 2018. Systems began 5 days after administering and became systemic and prolonged. I was wondering if this is also a delayed reaction.  I had been self quarantined recently after visiting with family.
Redness mild swelling, mild tenderness at site if injection, spreading to involve most of Right upper extremity.
Beginning around 1900 on 1/27/2021, experienced chills, body aches and lethargy for approx. 24hr
102 fever x 3 days, lethargic with leg weakness bilaterally, within one week of receiving had upper respiratory infection, severy back pain and nausea and vomiting, symptoms are continuing, feels this vaccine compromised her immune system.
LAIV given to 3 year old male who was started on prednisolone by off-base physician one day prior. No adverse reaction/response per father of child.
Left arm 6 inch erythematous area. Occurred/started 8/21/09 and continued to be red & swollen still today 8/24/09 with a measurement of 5.5cm x 6cm. Tsp BENADRYL given at urgent care 8/21/09. 8/24/09 pt started on XYZAL & hydrocortisone cream.
Irritable, epistaxis x 1, headache, nausea, distractible.
The patient's grandmother requested Moderna Covid-19 vaccine and a dose of the Moderna vaccine was administered unintentionally without considering the patient's age.  No adverse events noted.
Prolong headaches (started the day of the shot and I've had one at least twice a week and up to 5 days a week since. I've been very fatigued even though I don't have a lot going on (nothing that should be making me this tired). My arm was sore only a day for the first shot. I was dizzy for about three days during the week of December 9. The second dose was administered 12/27/2018 and the arm soreness lasted close to 4 days. The headaches have continued as before.
2nd dose of HPV vaccine administered to patient, 3 minutes after vaccine- the patient had blurry vision, hypotension (BP 62/40 on L arm and BP 70/46 on R arm, HR 73, RR 18).  No additional medication was given.  Patient returned to "normal (according to patient)" 10 minutes later.  Patient was observed for more than 45 minutes.
Allergic to Neomycin. Told pharmacist he replied that it was not a problem. After he administered the vaccine, he asked her did you say you are allergic to Neomycin. The next day she developed itching throughout the body, wheezing, felt nauseated, light headedness. Patient feels better today, but still sick. Pharmacist prescribed BENADRYL. Patient mentioned pharmacist should be severely reprehended due to this malpractice.
2-5 min after vaccine patient stood up to leave exam room and patient fainted and hit head on exam table. Drop of blood to nose and lip. Patient immediate moan. Rolled patient on side and held c-spine while PCT came BP110/65 HR69. LOC less than 10 seconds
Pt vaccinated with MMR/HIB Grand Mal Seizure approx 12 hrs after the administration of vaccines. Admitted to hosp for 3 days of testing & observation. Placed on phenobarbital and seizure did not recur.
dizziness; it wasn't a headache but "it felt like tightness in my head"; This is a spontaneous report from a non-contactable consumer (patient). A 55-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included ranitidine hydrochloride (ACID REDUCER [RANITIDINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. On 06Sep2021, the patient experienced dizziness, it wasn't a headache but "it felt like tightness in my head". Caller reported that 4 days after vaccination on Monday he started having dizziness that got progressively worse, had a really bad day, then it got better and now he is clear of it, caller reports that it wasn't a headache but "it felt like tightness in my head" that presented itself on Monday, continued Tuesday, Wednesday it was the worst and Thursday is started getting better. I didn't have an allergic reaction, but dizziness is not a good thing. Caller reported that he read that dizziness occurs in about 17% of patients. He reports that he counts himself pretty fortunate because he didn't experience a fever or anything. Caller wants to know if he will experience dizziness again if he gets the second Covid vaccine dose. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Patient stated that when she received the vaccination, it was very painful and she felt liquid running down her arm. She was told the pneumonia vaccine had "extra liquid" in it and the patient should not be alarmed. That evening her arm swelled up and caused significant pain to her. When she came in on 10/9/19, her arm was still red and swollen. Patient had to take off of work due to the pain in her arm
After about 7 minutes after the vaccine she started having palpitations and generalized feeling unwell. Felt as though she had low blood sugar but did not feel lightheaded or faint. She had this reaction similar prior when she had anxiety surrounding getting TB testing. Felt anxious and did have elevated BP to 144/86. No shortness of breath, rash, nausea, chest pain, dizziness. Resolved with observation, deep breathing, crackers and water.
Difficulty breathing; Weakness; This is a spontaneous report from a contactable consumer (on behalf of his mother).  A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via an unspecified route of administration on 31Dec2020 between 09:00 and 10:00 at single dose on left arm for covid-19 immunisation (works in food staff at a hospital). Medical history and concomitant medications were none. Patient experienced: difficulty breathing and weakness on 01Jan2021. Events were ongoing and had gotten a little worse today (05Jan2021). The action taken in response to the events for bnt162b2 was not applicable. Outcome of the events was not resolved.
Raised, red, itchy inflammation surrounding injection site over 1 week after injection. Treated with cold compress and anti histamines
Slight tingling of the tongue; This is a spontaneous report from the Pfizer-sponsored program from contactable nurse reported for a patient (Husband). A 72-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EM9810, at the age of vaccination 72 years) as dose 1, single for covid-19 immunization.The patient Medical history included diabetes mellitus, hypertension, supraventricular tachycardia. The Concomitant medications included metformin hydrochloride, sitagliptin (JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN]) taken 1 DF, twice aday (1 tablet, twice a day/ 50/1000) for an unspecified indication, start and stop date were not reported; vitamin d nos (VITAMIN D NOS) taken 1000 iU, daily for an unspecified indication, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken 81 mg for an unspecified indication, start and stop date were not reported; glipizide (GLIPIZIDE) taken 10 mg, twice a day for an unspecified indi-cation, start and stop date were not reported; lisinopril (LISINOPRIL) taken 20 mg, daily  for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken 100 ug, daily for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken 25 mg, daily for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken 40 mg, once a day for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken 50 mg once aday for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; atorvastatin (LIPITOR [ATORVASTATIN]) taken 10 mg once a day for an unspecified indication, start and stop date were not reported.  The patient experienced slight tingling of the tongue on 02Feb2021. A nurse reported that her husband got his first Covid vaccine and immediately when he got it, he had slight tingling of the tongue that did go away eventually. He is due for get the second shot and we are wondering if he should get that. Lab work: Nurse stated, he had lab work for his diabetes but that was probably a month ago. No treatment was received. The event outcome was recovered on unspecified date.   No follow up attempts are possible. No further information is expected
Fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.  Treatment medication not reported.
Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). The physician reported that the patient "was administered the shot and then fainted/passed out". Unspecified medical attention was sought. The physician reported that the patient recovered from the event. Additional information has been requested.
Redness, swelling, warmth, pain at injection site x 2 days.  Muscle aches x 3+ days, chills x 3 days, headaches x 3 days, moderate fatigue 3+ days, stomach pain x 2-3 days, upset stomach x 3 days, Day 2-3 onset of non-descript rash that very typically appears on patient with presence of a virus.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 25th March 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm, injection site wheal, injection site redness and injected limb mobility decreased. On 26th March 2019, the patient experienced generalized muscle aches. On 27th March 2019, the patient experienced itching eyes and itchy legs. On 26th March 2019, the outcome of the generalized muscle aches was recovered/resolved. On an unknown date, the outcome of the pain in arm, injection site wheal, injection site redness and injected limb mobility decreased were unknown and the outcome of the itching eyes was recovering/resolving and the outcome of the itchy legs was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, injection site wheal, injection site redness, injected limb mobility decreased, generalized muscle aches, itching eyes and itchy legs to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for herself. The patient received the SHINGRIX vaccine into the left arm. A few hours after receiving the vaccine, the patient's arm was very sore and there was a large, red, welt at the injection site. The patient could barely move her arm. The next morning, she had muscle aches all over her body. The aches lasted about 12 hours. It was severe for about 8 hours and then better for the last 4 hours. The morning after that (27th March 2019), the patient developed itching that started in her eyes and traveled to arms and legs. It was less severe but the itching was present at the time of reporting. The reporter provided the consent to follow up.
Information was received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 20-AUG-2015 the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (dose number, dose and route unknown, lot # L007225, expiration date: 03-MAR-2017). There was no information about concomitant therapy. No adverse event was reported. Additional information has been requested.
administered the reconstituted liquid adjuvant; administered the reconstituted liquid adjuvant; This case was reported by a physician via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows:  The age at vaccination was not reported. The family doctor reported that one medical assistant administered the reconstituted liquid adjuvant of Shingrix to a patient, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. No more information was available.  The reporter did not consent nor decline to follow up.
PATIENT HAD TINGELING IN VACCINATED ARM, THEN HE LOST CONSCIOUSNESS BRIEFLY, BLOOD PRESSURE WAS ELEVATED BRIEFLY  , SWEATING,  PALE , 911 WAS CALLED AND HE WAS TAKEN VIA AMBULENCE TO ER FOR EVALUATION
Sore vaccination site, started to get brain fog which lead to a headache, fatigue, extreme urge to cough, aches muscles, inability to regulate temperature (back and forth chills and hot waves),  nausea, and sharp pains in my bones.   Treatment: drinking water  Started around 3 and has gotten progressively worse
pt recvd 3 doses of Hep B vax 13NOV91, 14DEC91 & 20MAY92 & lab testing in AUG92 showed HBs antibody 0.7; pt discontinued hemodialysis in DEC93 & died of renal failure on 06DEC93;
I noticed the spot where I received the shots; the rash is very itchy; There is now a rash around the site where I received the shot and the rnsh is very itchy; There is now a rash around the site where I received the shot and the rnsh is very itchy; the spot where I received the shots hurt; can't sleep on that side; my right arm is in so much pain; I noticed a big lump; a blister on the lump and then a few days later it scarred over; a blister on the lump and then a few days later it scarred over; there is a hole in the same place; This spontaneous report was received from a 76-year-old female patient and refers to herself. Concurrent conditions included diabetes and high blood pressure. Concomitant therapies included metformin and enalapril. The patient had an allergy to perfumes, kiwi, strawberry and pineapple.   On 06-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in the right arm (dose, route of administration, lot# and expiration date were not provided) and with flu shot (dose, route of administration, anatomical location, lot# and expiration date were not provided), both for prophylaxis. On the same day, the patient notice the spot where she received the shots hurt and on an unknown date in October 2019 (reported as a few days later) she noticed a big lump, a blister on the lump and on an unknown date in October 2019 (reported as a few days later) it scarred over. The scar had fallen off but at the time of the report there was a hole in the same place. There was a rash around the site where the patient received the shot and the rash was very itchy. Her right arm was in so much pain that the patient could not sleep on that side and she was a side sleeper. The patient applied neosporin and wash with peroxide. The patient also went to a pharmacist then she went to the doctor. There was no lab diagnostics or studies performed. Pt wanted to know how many people experienced a big lump, blister, scar and itchiness after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the flu shot. Pt also asked if her reactions were from pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) or the flu shot and how long her reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) would last.  The outcome of scarring over was reported as recovering. The outcome of the rest of the events was not recovered. The relatedness between the events and suspect therapies was not provided.
Redness and swelling and heat in in the area within ~3 inches of the injection site.