chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the second dose past the six month mark; Extreme nausea; Pain involving her local site of injection; Muscle pain; Back pain; Leg pain/finger pain; Her hair, finger all hurt; This case was reported by a nurse via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 7th June 2019, refer case US2020AMR014606).   On 23rd January 2020 03:30, the patient received the 2nd dose of Shingrix. In January 2020, 10 hrs 30 min after receiving Shingrix, the patient experienced nausea, injection site pain, myalgia, back pain, leg pain and general body pain. On 23rd January 2020, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, injection site pain, myalgia, back pain, leg pain, general body pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the nausea, injection site pain, myalgia, back pain, leg pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on 23th January 2020 at around 3:30 pm in her left arm and stated she woke up at around 2 am with extreme nausea, pain involving her local site of injection and, muscle pain, back pain, leg pain. She was stating her hair, finger all hurt. She states she received the second dose past the six month mark, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case linked with US2020AMR014607, reported by same reporter. This case linked with US2020013944, reported by same reporter for the same patient.
This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient was vaccinated subcutaneously with a dose of 0.65 ml (once) ZOSTAVAX (lot number reported as H017447, exp.: 20-DEC-2013) on 06-DEC-2012. No other co-suspects were reported. Concomitant medications included sertraline hydrochloride, metoprolol, torsemide, CRESTOR, EFFIENT, losartan potassium (manufacturer unknown) and NIASPAN. The patient's relevant medical history was unknown. The patient's relevant past drug history was unknown. On 07-DEC-2012 the patient experienced swelling and rash at the injection site and a low-grade fever. Her relevant laboratory data was unknown. No treatment information was reported. It was reported that as of 09-DEC-2012, the patient had discontinued to take ZOSTAVAX and continued to experience swelling and rash at the injection site and a low-grade fever. The relatedness for the events were unknown for ZOSTAVAX. Additional information is not expected.
Upon awakening mother and patient noticed that pt had a rash and his face, arms, chest, neck. At 10:30 AM mom inform writer and requested assessment of pt. Patchy rash-red, raised, no drainage and c/o abd pain. Sent to physician. Mom gave BENADRYL, left to go to physician.
Patient received booster Pfizer COVID vaccine dose #3 on 10/8/21. She experienced rash and body aches all over body that eventually resolved on 10/13/21.  She also experienced lymphadenopathy.
She got her vaccine, had immediate pain in her arm. Had a headache and had nausea. After that initial pain from the injection site went away, that's when she began experiencing her arm going to sleep every 3-6 minutes. She is constant readjusting her arm because of this vibration type feeling. Feels like something is in her arm, moving through her arm. This is at the injection site all the way down to the tips of her fingers, just on the left side. She did not seek immediate attention thinking it went away. She fell and passed out at work 3/30/22, they took her by ambulance to the ER and they did 2 CT scans, one with and without contrast, and found that you had a spontaneous subarachnoid hemorrhage. The hospital wanted her to go to special clinic, she went there and they were going to have a team meeting on Wednesday and she has not heard from anything yet. Not happy and very upset about the vaccine and the reactions, and now she is suffering due to this.
Initial and follow-up information has been received from a registered nurse concerning a college-aged female who in the past was vaccinated with a dose of Gardasil in the gluteal area from another provider and there was less pain.  It was reported that the patient experienced burning pain after receiving the vaccination.  This is one of several reports received from the same source.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007.  Follow-up information was received from the registered nurse.  On an unspecified date the patient requested the injection to be administered at an alternate site due to post-injection pain after the first dose.  The patient was vaccinated with the second dose of GARDASIL 0.5 mL in the gluteal area.  It was reported that the patient experienced burning pain after receiving the vaccination.  At the time of reporting the patient had recovered.  This is one of several reports received from the same source.  Further information is not available.
Periods have been horrible; Very upset; This is a spontaneous report from a contactable consumer. An adult female patient in her 40's (as reported) received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown that patient did receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. On 23Jul2021 at 12:00, reporter was food shopping and a lady came up to the reporter because reporter was wearing her Pfizer Mask and abruptly yelled that on an unknown date, patient's periods had been horrible ever since she received the Pfizer vaccine and patient was very upset and then she stormed off and left the store. The reporter had no information just that patient looked in her 40's and short dark hair. The reporter had no other information to give. It was unknown whether any therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events periods have been horrible and very upset was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Large red inflamed rash around injection site. Hot to touch. Tender to touch. Pain with range of motion, itching. 9 days post moderna vaccine.  Ice and ibuprofen- effective.
About 15-16 mins after receiving the shot I experienced a metallic taste which immediately led to my head feeling pressure like it was inflating and my brain feeling like it was short circuiting and doing alot of misfiring or something (hard to explain but it was like a lot of brain activity) which immediately led to my heart pounding and racing (I don't know if the pounding heart and racing was due to feeling panic because of my brain reaction or the vaccine).  The metallic taste and brain issue subsided within a minute (perhaps less) but my heart continued to race for about 3-5 mins and then subsided with a tightness in my chest for nearly 3 hours.
ZOSTAVAX vaccine given around 1:00pm on 10/1/12 pt left and came back approximately 30-45 mins later complaining of injection site itching and she was feeling nauseated. Based on the timing and her complaint, I gave her liquid BENADRYL 50mg & had her sit so I could monitor her. Then we eventually called the ambulance upon patient wanting to go home and not feeling well.
Presents to ED for SOBx3 days. Sypmtoms constant and worse on exertion, and productive cough. HA and generalized myalgias.3-5L home O2,Covid 2-3 weeks ago, was hospitalized.Covid PCR +, Admitted,transfered to ICU,BIPAP pnemonia d/t COVID virus. Treated wih Steroids, Solumefrol. D/C to facility
Itchy, watery, bloodshot eyes, eyelid swelling and hives around eyes, nasal congestion and swelling, some wheezing and coughing
Fever on 105 F, Headache, Pain in the local area of the injection, chest pain, heart over 125 beats for minute, pain in the two livers, breathe difficult, inflammation and pain on the neck ....trouble with swollen and speak , hard abdominal pain, diarrhea, dizziness.
Tachypneic, tachycardic, febrile to 103. Right shoulder swollen and erythematous. Pt given Zosyn, vanc. ID consulted.
Initial information received on 23 October 2006 from the patient's parent. A 20 year old female patient received a first dose of Imovax Rabies, lot number not reported, intramuscularly in the left deltoid on 20 August 2006 following exposure to a bat. Four hours post vaccination, the patient developed redness and swelling at the injection site. She also had a fever of 102 degrees Fahrenheit, headache and nausea. The symptoms at the injection site were treated with ice packs. The patient subsequently received a second dose of Imovax Rabies, lot number reported, administered intramuscualry in the left deltoid on 23 August 2006. She received a third dose of Imovac Rabies, lot number Z0316-2, administered intramuscularly in the right deltoid on 27 August 2006. On 03 September 2006, ,the patient received a fifth dose of Imovax rabies, lot number Z0316-2, administered intramuscularly on 17 September 2006 in the left deltoid. The patient developed the same signs and symptoms after each subsequent dose as she experienced following dose one. The patient recovered from the events. Follow-up information received from the patient's mother on 12 December 2006. In additions to the previously aforementioned vaccines, the patient received a dose of Rabies Immunoglobulin (manufacture and lot number not reported) on 20 August 2006. As per the patient's mother, the patient is "suffering from chronic migraine headaches (daily basis)". The patient's recovery status has been changed to not recovered. No other information was provided at this time. The reported of this case is the same as for case 2006-02768.
ARM PAIN FROM INJECTION SIGHT TO THE WRIST, NO VISIUAL SIGNS OF INJECTION,RASH, INFECTION ETC.
Death Narrative:  Death on 03/22/2021. Patient was a 69 year-old male with history of lung cancer treated with radiation. Recently presented with a right suprahilar lesion Stage III for which he received radiation therapy in 2/2021. He developed a strong cough after radiation treatment and passed from a massive hemoptysis per physician note. He received the 1st dose of vaccine on 03/20/2021 2 days before his death. There is no indication that the event was the result of the vaccine.
No other AE; Caller is a nurse who reports that PROQUAD and VARIVAX may have been given after a temperature excursion that occurred in April 2022. Vaccines were then sent back so she does not have time/temperature data and does not know whether any vac; This spontaneous report was received from a nurse and refers to an unknown number of patients of an unknown age and gender.  The patient's medical history, concurrent conditions. concomitant therapies and previous drugs reactions or allergies were not reported.  On an unknown date in 2022, the patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot #W004694, expiration date: 08-AUG-2023, and lot # U019289 expiration date 15-DEC-2022 (vaccination scheme, dose description and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) lot #U030162, expiration date: 28-SEP-2023, administered for prophylaxis (vaccination scheme, dose description and route of administration were not provided) following a temperature excursion that occurred on an unknown date in April 2022 (product storage error), it was mentioned that there was not previous temperature excursion. No additional adverse event was reported.  This is a non-valid case due ot lack o f patient's identifiers.  Follow-up information has been received from a registered nurse on 07-SEP-2022 and patients' identifiers have been provided. The patient was a 4-year-old female. On 11-FEB-2022, the freezer temperature on the temperature tracker was noted to be out of range and on 21-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U019289 subcutaneously in the left thigh for prophylaxis. There were no previous doses reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA003332: US-009507513-2209USA003333: US-009507513-2209USA003334: US-009507513-2209USA003333: US-009507513-2209USA003332:
patient was administered expired ActHIB with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old female patient was administered expired HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and POLIO VACCINE INACT (IPV) for Immunisation.  On 04-Nov-2022, the patient received a  third dose 0.5 ml of suspect HIB (PRP/T) VACCINE once  (lot UJ574AA; expiry date: 24-SEP-2022) via intramuscular route in the right thigh for prophylactic vaccination.   On 04-NOV-2022 the patient reported a non-serious event  patient was administered expired HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event (expired product administered).    Action taken:not applicable.   At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and fever. This report was non-serious.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 5-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004992: US-009507513-2005USA004993:
Started feeling sciatic nerve pain in left side of body, mainly with arm and foot.  Episodes were intermittant.
Feverish. Body aches. Throat hurt. A lot of pain in the opposite arm from which the flu shot was given (pain in right arm)  Chest area felt like she pulled a muscle  2 days later still fatigued. Still has pain in opposite arm
This spontaneous report was received from a registered pharmacist concerning to a 37 years old female patient. On 08-NOV-2012, the patient was vaccinated with lot # (H010661, Exp. date: 02-FEB-2014), with 0.5 ml PNEUMOVAX23 (route not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient felt hot and flushed within 15 min of receiving PNEUMOVAX23. Pharmacist observed the patient for 45 minutes afterwards and patient flushing improved. No treatment information was reported. No labs were performed. Additional information has been requested.
presents to the ED with respiratory issues. Patient reports 4 days of subjective fevers, cough, SOB, and fatigue. States it has been worsening. Patient reports using inhalers with minimal relief.  Denies any other alleviating or aggravating factors
No adverse effects; VARIVAX was administered following temperature excursion; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 15-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # U020244, expiration date 28-JUN-2023, 0.5 ml (route of administration and exact anatomical location were not reported) for prophylaxis (Product storage error). Administered dose of vaccine experienced a temperature excursion of 6 degrees Fahrenheit for 7 minutes. There were no previous excursions or additional adverse events reported.
Patient was given FluMist nasal spray today at age 18 mos (Vaccine is recommended starting at age 24 mos).
It was reported to us approx a week later, that one day post vaccination with moderna booster, Patient has severe lymph node swelling in neck area. Sought care at primary care MD and prescribed steroids.
Had diminished hearing loss for 1 day, and sense of smell was affected, smelled vomit all day. This was the day after the vaccine. On Friday, I was back to normal. Thank God! No treatment needed.
Chills; Weakness; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, weakness and dizziness. On an unknown date, the outcome of the chills, weakness and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the chills, weakness and dizziness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient received 2nd dose of Shingrix and he experienced chills, weakness and dizziness, which had not resolved. No other information was provided concerning this event. The reporter declined to answer any questions related to the patient and his adverse event. The reporter declined to provide health care professional information. The reporter did not consent to follow-up.
I have had some pain in my shoulder and a pain shooting down my arm to my finger tips. First we are trying anti-inflammatory medicine.
CHILD RECEIVED KINRIX  AND MMRV TODAY BUT HAD ALREADY RECEIVED THEM A YEAR AGO.  NO TREATMENT REQUIRED.
Within five minutes of shot, started to feel pins and needles and slight numbness in left hand.  Five minutes later also started to feel pins and needles and slight numbness on left side of face.  Within the next 40 minutes, when I was able to take off my thick coat and boots, also felt these symptoms from shoulder down to fingers and calf down to toe (all still only on left side of body). One week later also felt same effects in left breast. When using these body parts such as hand or leg, it would get tired a lot faster then the right side, but still had full mobility and function.   Symptoms are still ongoing and it is now 2 weeks later.
Varicella and Gardasil vaccine given - on her way to the car, turned pale and was dizzy.  BP 105/65, HR 84.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had reaction (unspecified adverse event) to SHINGRIX. This is one of the 5 cases reported by the same reporter.