chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist via a company representative referring to the pharmacist himself, a male patient of unknown age. On an unknown date the patient was vaccinated with unspecified hepatitis vaccine (manufacturer unknown) VAQTA or RECOMBIVAX HB (dose and frequency were not reported). The pharmacist had "titers drawn" on an unspecified date which showed "he had no hepatitis titers". The outcome of the event was unknown. Causality was not reported. Additional information has been requested.
Information has been received from a pharmacist concerning a 80 year old female who on 21-JUL-2008 was vaccinated with ZOSTAVAX (lot # 659672/0294X) SC in the left arm at 1300. There was no illness at time of vaccination. The patient experienced a size of quarter red rash and little bump at the injection site on left arm for a week. The patient said that she usually got a rash with any vaccines but was concerned about the bump. The patient was also feeling nauseated for one week. On approximately 01-AUG-2008, the patient recovered from the rash at the injection site and bump at the injection site. The patient sought medical attention in pharmacy. Additional information is not expected.
After receiving the vaccine, about 10 minutes later minor chest tightness was experienced.  Was given Benadryl and symptoms resolved.   Was instructed to follow up with PCP.
Very shortly after getting the vaccine (within an hour) I developed chest pain on my right side. It was persistent for 22 hours. After 3.5 hours I contacted the provider who gave me the vaccine. She assessed my symptoms over the phone and instructed me to go to an urgent care to have an EKG. I was seen at urgent care promptly after getting off the phone with the provider. At urgent care (arrived at 5:10 pm) I had a physical exam, an EKG and a chest x-ray to rule out other reasons for the chest pain. Both tests were negative for signs or heart issues and for lung infection. During the visit I developed tinnitus. It is still happening at the time if this report- so over 24 hours later. At the end of the visit the provider gave me a ZPAK for a lingering cough. I took the first ZPAK dose before bed that evening. I awoke at 5:00 am too dizzy to sit up. I have never had that reaction to ZPAK ever and I have been on it many times. After a half hour I tried to walk and kept veering left. I got to the bathroom and took a bath. With effort I was able to walk straight. I am intermittently dizzy and feel unwell. Never have felt like this from azithromycin, much less a single dose. This is the vaccine.
Fever 104. Febrile seizure. Hospitalization x 1 day. Blood work, urine, CSF-all  neg. Prophylactic ceftriaxone.
Pt was vaccinated with 1st dose of Pfizer. Pt was waiting in post vaccination observation when at 1500 she stated of itchy hands. Client brought down to floor from bleachers. 1506 Client endorsed itchiness travelling up to forearm and "tingling to mouth. Aid called and arrived to evaluate Pt. 1510 Client care transferred to Aid for additional evaluation and care. 1530. Client to go home per aid. No further symptoms and symptoms decreased. Pt d/c home per EMTs. Client educated on safety and when to call 911 or go to ED.  VS 1503 HR 92 O2 sat 99% on RA  VS 1510  HR 84 O2 sat 98% on RA  VS 1520 HR 77 O2 sat 99% on RA
Received vaccines on 1/7/14, at approximately 2330 on 1/7/14 pt developed fever to 102.5 +, developed shaking on (L) side of body, last approximately 5-10 min per parent report. Taken to local ER had decreased tone on (L) side of body for hours after seizure.
pt recv vax; devel fever of greater than 105 & a rash "w/in the expected length of time";
This spontaneous report was received from a pharmacist referring to a 66 year old female patient. No pertinent medical history, concurrent conditions and concomitant therapies were reported. On 10-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # M020521, expiration date: 17-NOV-2017), 0.5 ml, intramuscularly in an unspecified arm for boil on skin. Dose number was not provided. After vaccination, and within 24 hours, the patient noticed a boil on the opposite side of the same arm of the injection furthermore described as with size of a silver dollar, painful and raised with no redness or head associated with the area. The patient called the pharmacist but no treatment was given for the event. It was not a product quality complaint involved. The outcome of furuncle was reported as not recovered. The causality assessment between the event and the suspect therapy was not reported.
1st dose 4 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date 4 years before date of reporting.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-Feb-2023 Reporter's Comments:  Reporter was the patient, who states that she and her husband received their first dose of Shingrix 4 years ago and had not yet received their second doses.  Did not consent to follow-up.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023029938:Same reporter
Patient called on 12/21/2021 and reported that she developed fever and bodyache on 12/20/2021 after receiving Moderna full dose (dose # 3) yesterday (had J&J vaccine previously), also started vomiting.  Woke up on 12/21/2021 morning, not feeling better. Still feels feverish, profuse sweating, severe bodyache and weakness. No chest pain or SOB but unable to speak in fluid sentences, sounds out of breath.
Flu-like symptoms.  High temp, chills, nausea, body aches lasted through the night.
When flulaval was given, patient pulled arm away and needle came out.  Medication could be seen in barrier bandage and a drop one her arm.  The syringe was placed in the sharps container and unable to see how much was still in the syringe.    Per CDC recommendations, vaccine was administered again (flucelvax) on 10/25/2020 in the left arm .
Hand width down from injection site horrible pain in left quad.  Horrible pain with standing and sitting and bearing weight on left leg.  Took Tylenol 1000 mg alternating with Ibuprofen 800 mg every 4 hours.  Site is not red is warm to touch along with pain.
Pt received vaccination, walking to waiting room. Pt states he lost his balance and hit head on door frame. Pt stated he felt dizzy and sick to his stomach. Red area on left forehead. Pt  laid down, legs elevated.
Nonstop vomiting and diarrhea. Went to ER and was told I had very high glucose and lactic acid. I have no history of diabetes.
Pain at injection site; fever; severe malaise; muscle and joint aches; muscle and joint aches; This is a spontaneous report from a non-contactable consumer or other Non-health care professional.   A 54-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route in Arm Left on 28Jan2021 14:00 as 2ND DOSE, SINGLE for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via unspecified route in arm left on 07Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, sleep apnoea syndrome from an unknown date and unknown if ongoing. Concomitant medications included escitalopram oxalate (LEXAPRO), omeprazole (OMEPRAZOLE), zolpidem tartrate (AMBIEN), metoprolol (METOPROLOL XL SANDOZ). The patient previously took amoxil and experienced drug hypersensitivity (Known allergies). It was reported that patient had not received other vaccine in four weeks. Patient had not undergone any covid test prior to vaccination and had not experienced any covid events prior to vaccination. The patient experienced pain at injection site, fever (12 hours later), severe malaise, muscle and joint aches on 29Jan2021 02:00. Patient had not received any treatment for events. Outcome of the events was recovering.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
This case was reported by a healthcare professional (medical assistant) and described the occurrence of blood in stool (guaiac positive) in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DTaP-HepB-IPV; GlaxoSmithKline; unknown; unknown given on 15 October 2013; Hib (non-gsk); Sanofi; unknown; unknown given on 15 October 2013; PCV (non-gsk); Wyeth Labs; unknown; unknown given on 15 October 2013. On 15 October 2013 at 10:10 the subject received 1st dose of ROTARIX (1 ml, oral). By 18 October 2013, "within 3 days" after vaccination with ROTARIX, the subject experienced diarrhea and vomiting. On 21 October 2013, 6 days after vaccination with ROTARIX, the subject experienced blood in stools and guaiac positive stool. On 25 October 2013, 10 days after vaccination with ROTARIX, the subject experienced an elevated white count. This case was assessed as medically serious by GSK. Relevant test results included the following: On 21 October 2013, the subject had a guaiac test with result of positive. On 25 October 2013, the subject had a white cell count that was elevated at 22,000. On 28 October 2013, the subject was evaluated at the office and the guaiac was negative. On 1 November 2013, a repeat white cell count was within normal range. In 2013, per the reporter, "stool studies were also run" and results were "negative (salmonella, shigella, campylobacter)." At the time of reporting the event of diarrhea was improved. The events of blood in stools and guaiac positive stool, vomiting, and elevated white count were resolved. On 28 October 2013, the subject was evaluated and "the diarrhea and stool had been getting better, improved but was still loose." On 1 November 2013, a repeat blood test showed that the white cell count had returned to within normal range. The vaccination course with ROTARIX was discontinued. "The physician had determined that this was probably a reaction specifically to ROTARIX, the series has been discontinued." The healthcare professional considered the events were probably related to vaccination with ROTARIX.
Eleven year old was assessed by the check-in staff and Nurse to need TD, Hep B, Polio, MMR, Meningococcal, and his first HPV.  History taken given via questionnaire provided by father.  After nurse administered each vaccine, the client was asked to sit in the chair outside the administration room for observation as procedure and wait 15 minutes. Before the 15 minutes of time elapsed (approx 11:40am), client was observed by Nurse as she came down the hall toward him to slouch over toward the floor from the chair.  Client landed on side and rolled over supine.  Hitting of head not observed but a sound as he hit the floor was heard.  Client seemed to contract both arms upward with eyes open looking straight ahead. Seemed dazed momentarily (10 sec), and then sat up with assistance.  Nurse assisted him to cot as other nurse proceded to take vital signs.  First set of vital signs 100/60; p-76 ; r-18 at 11:45am.  Client was oriented to name and day of week when asked by nurse. No swelling, redness or knots palpated on head. He stated to interpreter that his head did not hurt.  EMS activated by RN at that time.  Second set of vital signs 100/70  p-68;  r-18. Paramedics arrived at approx 11:50am. Staff member assisted with interpretation the whole time.   Father gave no contraindicated history for administration of vaccines.  Client was assessed by paramedics and determined to need precautionary evaluation at hospital. Client was walked from clinic by paramedics accompanied by father and siblings.
This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732) at the age of 59-years-old, via an unspecified route of administration in left arm on 22Mar2021 at 15:00 at single dose for COVID-19 immunisation. The patient's medical history was reported as none. He has no known allergies and has COVID prior to vaccination. Concomitant medications included metoprolol, rosuvastatin, oxybutynin, and tamsulosin. There were no other vaccines in four weeks and no additional vaccines administered on the same date of the COVID-19 vaccine. The patient reported that he was having some wild effects from the vaccine and did not know what to do. On 26Mar2021 at 15:00, he was having neuropathy like effects. His hands, arms, legs, and feet were experiencing pain and burning sensations, they were burning like nerve damage; he also has a little burning sensation in his nose and cheeks. He has never had this before. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. He was also having some weird sensations in his calf muscles, these sensations started within the past week and a half (Apr2021) which prompted physician office visit. The physician placed him on gabapentin 100 mg to start from 12Apr2021, but it was not enough, it was titrated up to 300 mg, three times a day and he is scheduled to see specialist soon. The patient mentioned that this vaccine has ruined his health. He also went to an urgent care center because his leg was bothering him, it was swelling on an unspecified date in 2021; he thought he had a blood clot; they did some kind of test where they looked at the leg and did not find anything. He didn't have a particular question. He would just like to talk to someone to see if this was going on with anyone else, if it will go away, or if this was permanent problem he will have. The patient was not tested for COVID post vaccination. He received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration in left arm on 13Apr2021 at 15:00 at single dose for COVID-19 immunisation. The outcome of the events was not recovered.
I went in for my regular Diabetes blood test, and that is when they told me I had Anemia. And then I went in to the doctor that and it was iron related. They stated my hemoglobin (red blood cells) were low. I had another blood test, and still the anemia was low. Last Thursday I went into the hematologist they did blood test and he told me that my iron was low and my hemoglobin was low and that he thought I was low iron that was effecting this. And he stated that their could be other facts but he was pretty well in feeling that the iron was the man cause. I was feelin fatigued for 2 months or so.
18:10 Pt. reports to observation nurse throbbing (R) eye stabbing pain, (R) sided headache. 10 minutes post vaccine. EMS evaluation. B/P 125/71, HR 88, 99% Sat O2, 2 hours post prandial BG 149. (R) sided headache and (R) sided eye pain worsens, pt. agree to transport to local area hospital.
3 days after receiving the vaccine the pt came in with the bandaids still on the skin. There was redness around the bandaids and below towards the elbow. patient states it wasn't irriated at all, he just noticed the redness in the mirror.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 12-JAN-2018, the patient was vaccinated with an expired dose of VARIVAX injection, lot # M000998 with expiration date on 07-JAN-2018 (dose and route of administration were not reported). No adverse symptoms were reported.
Fatigue began appx 24 hours after 1st vaccination.  Cold like symptoms (runny nose, post-nasal drip, sore throat) began appx 3 days after vaccination.  No fever, no body aches or shortness of breath.
Rash-red, bumpy, itchy blotches all over body, real bad headache, nausea, and vomiting. Lasted x3 days. Did not seek medical care.
Facial swelling and hives covering body; no breathing or swallowing difficulty. Redness/swelling of right thigh at injection site. Seen in ER--Benadryl; steroids.
mom noted hives @ inject site, lt elbow, & across the back; pt woke up in morning 14APR94 w/t103 also vomiting; states took pt to ER MD then to see pvt MD; MD prescribed DPH & APAP; mom states sx subsided on 15APR94 & pt recovered;
Fever of up to 102.8, chills, body aches, headache. Alternated Tylenol and Ibuprofen q4h starting the morning of 1/19. Lasted 2 days. Felt much better by 1/21/2021.
Severe muscle spasms in leg and chest; May have pricked a capillary; Bleeding at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hemorrhage in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number XG7RF, expiry date 21-MAY-2024) for prophylaxis.   The patient's past medical history included surgery (multiple back surgeries including interbody fusion involving L4 + L5 and C3, C4, C5 and C6). Previously experienced adverse reactions included reaction to excipient (unable to tolerate "statin" medications, which are used to treat high cholesterol, due to muscle spasms/pain) and reaction to excipient (unable to tolerate injectable cholesterol lowering medications, such as Praluent). Concurrent medical conditions included cholesterol (the patient went to cardiologist due to (high) cholesterol) and spinal stenosis. Concomitant products included paracetamol (Tylenol).   On 22-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 22-MAR-2023, less than a day after receiving Shingrix, the patient experienced injection site hemorrhage (Verbatim: Bleeding at injection site) and wrong injection technique (Verbatim: May have pricked a capillary). On 23-MAR-2023 02:00, the patient experienced muscle spasm (Verbatim: Severe muscle spasms in leg and chest). The outcome of the injection site hemorrhage and muscle spasm were recovered/resolved and the outcome of the wrong injection technique was unknown.   It was unknown if the reporter considered the injection site hemorrhage and muscle spasm to be related to Shingrix.     It was unknown if the company considered the injection site hemorrhage and muscle spasm to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAR-2023 The patient reported this case. On Wednesday 22nd March 2023 the patient received 1st dose of Shingrix. The patient noticed bleeding at the injection site and felt as though a capillary had been pierced by a needle. On Thursday 23rd March 2023 the patient experienced muscle spasms in the leg and chest. The patient experienced very severe muscles spasms and scared of might having a heart attack. The patient had received concomitant drugs Tylenol and Claritin. The spams resolved. The reporter consented to follow up.
The patient reported to the pharmacy on 06/02/2014 that when she awoke on the morning of 5/28 her arm was significantly swollen, hot to the touch and there was a hardened circular area of skin surrounding the injection site. Upon inspection within the pharmacy the hardened skin was approximately 7cm in diameter. Her skin was still swollen but was lessening according to the patient. The edges of the swollen area were warm to the touch. This patient was referred to her physician.
Tongue and eye lids and surrounding tissue swelling, difficulty swallowing.  Two days after the event, the tissue under my tongue and throat are sore.
This spontaneous report was received from a physician referring to a 5 months old patient of unknown gender. No information about the patient's medical history, concurrent conditions and conocmitant medications was reported. On 05-SEP-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N014945, expiry date 31-AUG-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt did not have breakfast before her shot at 11am. She got the shot and sit down. Mom came over and said her daughter passed out. Rph and techs rushed over. We laid her down to the floor and call emergency number. After a few minutes, she wake up and feel better. Mom said thank you and took her to eat.
Body pains; mild head ache; tiredness; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 25Feb2021 at 01:00 PM (age at vaccination: 48 years), as Dose 2, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 04Feb2021 at 01:00 PM (age at vaccination: 48 years), as Dose 1, single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Feb2021 morning, since she woke up i.e. 6 AM, she had the symptoms. The patient experienced body pains, mild head ache and tiredness and took advil at 9:30 AM. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
1 week after receiving the shot the patient was diagnosed with clots and prescribed Eliquis.
pt recv vax 6JAN96 & 7JAN96 pt exp diarrhea, achiness, fatigue & rhinitis;
This spontaneous report as received from a Certified Medical Assistant refers to a 25 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On an unknown date of 2010 (at age 23 years old), patient received the first dose of GARDASIL 0.5 ml, intramuscular (lot number and expiration date were not reported. On an unknown date of 2012 (at age 25 years old), the patient was vaccinated with second dose of GARDASIL 0.5 ml, intramuscular (lot number and expiration date were not reported). Medical assistant stated that patient received first dose of GARDASIL near the 23.5 year old (approximately in 2010), then the second dose of GARDASIL at 25 years old and the patient wanted to complete GARDASIL series and now she was 27 years old. No adverse effects reported. Additional information has been requested.