chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first Shingrix dose on 10/29/2019 and a second dose on 2/6/2023.; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29th October 2019).   On 06-FEB-2023, the patient received the 2nd dose of Shingrix. On 06-FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: first Shingrix dose on 10/29/2019 and a second dose on 2/6/2023.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter asked if the patient needed a third dose or if the patient had to restart the series of Shingrix.  The reporter did not provide lot number and expiry date of the 2 doses of Shingrix The reporter consented to follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
30 minutes after injection, face flushed and stayed that way for about 1.5 hours. At about 1 hour, I had numbness on/around left side lip area and slightly on skin around that area. Symptoms left about 2 hours after they started
Two weeks after my vaccine, I had pain in my right leg. I developed a rash about a week later. I was diagnosed with shingles on 12/7. I was given an antiviral medication and gabapentin for pain. I was affected for about a month before it cleared up
Information has been received from a physician and medical assistant concerning a female who was vaccinated with a dose of GARDASIL. The physician reported that the patient was vaccinated with GARDASIL and experienced severe injection site pain, and was unable to go to work. The medical assistant reported that the patient will see a specialist for the event. The patient's outcome was unknown. The medical assistant reported that doesn't believe that the severe injection site pain was related to GARDASIL. Additional information has been requested.
Little reaction to first Shingrix dose but major reaction to second dose. On the day after, intense muscular pain, extreme fatigue, big red blotch on my arm . Muscular pain continued and on 8/14, I experienced severe muscle pain in the injected arm, with leakage, possibly pus, from the injection site. A rash with raised lesions appeared and was very itchy. The muscle pain lasted two days. The itchiness continues even now, although the lesions have crusted over and are diminishing.
Lymph nodes under left arm were significantly swollen; Felt significant pain under left arm; Unable to sleep through the night; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 16:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and known allergy to multiple foods. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient received morphine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP75533) via an unspecified route of administration in the left arm on 27Mar2021 at 17:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 20:30, couple hours after second shot, the patient started to feel significant pain under left arm. The next day the patient noticed that the lymph nodes under her left arm were significantly swollen, and was unable to sleep through the night due to the pain for 4 days, and did not go at physician but was planning to if the pain and swelling didn't start going down by day 5. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of event and included treatment with over the counter (OTC) medicines, paracetamol (TYLENOL), naproxen sodium (MOTRIN), ibuprofen (ALEVE), heat and cold to make the pain tolerable. The clinical outcome of the event felt significant pain under left arm, lymph nodes under left arm significantly swollen and unable to sleep was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
high fever began late afternoon; t105 @ 1AM; seen in ER 20JAN95 given Motrin;
4/19/07 Patient presented to office with hx of rash x 3 days. Vesicles scattered throughout, over 300 lesions. No history of fever. Rx. comfort measures, Aveeno, Benadryl etc. No ASA isolate. 4/26/07 Child rechecked and cleared for school.
On 12/28/21 patient received first dose pfizer shot, after about 5 minutes patient reported losing her voice and throat starting to close up. Patient stated she did not need epipen. She was given dose of benadryl. After approximately 30 minutes, patient stated she was feeling better and comfortable leaving. We advised that she call us next day with an update and she did call us stating she was back to normal and her voice also had returned to normal. Patient called 1/3/22 to let us know she was admitted to hospital on 12/30/21 and just released 1/3/22. She was diagnosed with a blood clot in hospital but not confirmed if it was covid related. On 1/3/22 patient stated she was feeling well and following up with her PCP and a cardiologist
wait until they were vaccinated for Covid before getting their second vaccination; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix over one year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix over one year ago. The patient did not receive the 2nd dose of Shingrix till the time of reporting and was told to wait until he was vaccinated for Covid before getting the second Shingrix vaccination.  The pharmacist reported inappropriate schedule of vaccine and inquired if Shingrix series should be restarted. The patient received the full Covid vaccinations over 14 days before the day of reporting.  The reporter did not know exact dates of Shingrix or Covid immunizations. The reporter did not consent to follow up. This case is linked to case US2021188784 reported by same reporter for another patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021188784:Same reporter
Approx 6:00PM on date of Vaccine began having chills and fever of 101 which reached as high as 103 on Saturday 2/6.  By mid afternoon fever continued to come down.  No other side effects other than chills and fever.
Arm began a dull ache and sore under the biceo]p area .  Elbow and arm ached and fingers tingling  Still has almost constant dull ache and heavinessin left arm.
Elevated heart rate (110-120)  beginning about 9 hours after vaccine and lasting about 12 hours. Fever (101 degrees F) beginning about 9 hours after vaccine and lasting about 36 hours. Body aches and joint pain beginning about 9 hours after the vaccine and lasting about 36 hours. Fatigue beginning about 9 hours after the vaccine and lasting about 36 hours.  Treated with acetaminophen and ibuprofen. Headache beginning about 9 hours after the vaccine and still continues currently (3.5 days after vaccine) now in an occipital neuralgia, intermittent shooting pain on one side of scalp. Treating with massage, heat, rest, acetaminophen and ibuprofen.
Pt developed signs/symptoms of cold/flu 1 day post vax. Pt also developed swollen feet and SOB. Others who received the Pneumococcal vax developed similar effects; however, the vaccines were supplied by 2 different drug manufacturers. Pt treated with po Promethazine & Guaifenesin/Dextromethorophan.
From one of the nurse vaccinators: the man who had a laryngectomy who gave me a hard time about an id when we first started..I was so happy to see his name on my list this morning. I saw that no one could contact him..I got into the building ..no answer at the door ..phone disconnected ..found the super..he died 3 weeks ago..he didn?t know cause..just emergent situation to hospital and passed.
Booster dose; Felt tired; Patient indicated had diarrhea; This is a spontaneous report from a non-contactable consumer. A non-pregnant female patient of unknown age received third booster 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. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if patient received any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included umbralisib (UKONIQ) for unknown indication from an unknown date and was unknown if ongoing. The patient previously received first dose and and second dose covid-19 vaccine on an unknown date for COVID-19 immunisation, primary Immunization series complete but unknown manufacturer. On 08Oct2021, followed by receiving the COVID-19 booster shot, the patient had diarrhea. The patient believed the shot was the cause of the sudden onset of diarrhea, and on 11Oct2021, as of the current day (of reporting), the patient felt tired and patient believed this was also due to the covid vaccine booster shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the event the patient indicated had diarrhea and felt tired 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.
As of 9/5/07, pt has had no adverse effects from administration of Hepatitis A on 8/30/07.
Arm soreness; headache; fatigue; myalgias; arthralgias; undetectable antibodies; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#EK9231) for the first dose via intramuscular in the left arm on 22Dec2020 12:00 for COVID-19 immunization. Medical history included post viral syndrome (COVID) or long COVID from Mar2020. The patient had undetectable antibodies in Apr2020. Concomitant medications included curcuma longa rhizome, piper nigrum fruit (TURMERIC +), colecalciferol (VITAMIN D), cobamamide (VITAMIN B12), bifidobacterium lactis (PROBIOTIC). The patient was diagnosed with COVID-19 prior to vaccination. The patient had no known allergies (NKA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested for COVID-19 since the vaccination. The patient had arm soreness 3 days, 1 headache, fatigue starting from night of injection increasing to requiring 1 hour nap on day 6 and 7, myalgias and arthralgias day 6 and 7; events onset date reported as 22Dec2020. Blood drawn 1 week after injection and the patient had undetectable antibodies in Dec2020, no movement in her CD4 or CD8 in T lymphocyte panel. The events resulted in doctor or other healthcare professional office/clinic visit. Events were reported as non-serious. No treatment was received for the events. The outcome of the events was recovering.
Diverticulitis onset (pain, fever). Constipation) It Was treated outpatient with 4 antibiotics. Symptoms continued for several months .. This episode followed  by 2 more episodes during 1 year.  Same symptoms , treated with antibiotics.
This is a spontaneous report from a contactable consumer. A 64-year-old female patient received PREVNAR 13 (NDC number 0005-1971-01; lot M16258; Expiry Date 30Apr2020), on 14Dec2015 at noon on left arm at 0.5 ml. Medical history included ongoing asthma (diagnosed years before), ongoing respiratory problems (diagnosed years before, when she got a cold, she used inhaler once a year), ongoing seasonal allergy to dust, mildew, ash and elm tree pollen, reflux, joints disorder, blood cholesterol. In Sep2015 she had flu vaccine (unspecified trade name) on Right arm and right after the injection her arm was sore and she could not lift her arm up for 24 hours, event subsided after twenty four hours; at the end of Oct2015 she received shingles vaccine. Concomitant medication included CRESTOR ongoing at 10 mg 1x/day for blood cholesterol, ESTRATEST half strength, started 15 years before and ongoing as hormone therapy, SINGULAIR for about a year and ongoing for allergy, PREVACID ongoing for reflux at 15 mg 1x/day, ZYRTEC ongoing for allergies, Vitamin C taking for years and ongoing at 200 mg 1x/day for routine health maintenance, multivitamins for seniors taking for years, Primrose oil 1x/day taking for years and ongoing for skin and hair, biotin taking for years and ongoing for skin and hair, Vitamin D ongoing for bones at 1000 mg, 1x/day (2x 500 mg), Calcium + D ongoing for bones at 1000 mg, 1x/day, fish oil with krill ongoing for routine health maintenance at 1500 mg, 1x/day and glucosamine ongoing for joints 1x/day. On 15Dec2015 patient started to get sore throat, itchy throat and ears and at 8:00 am she had headache, which woke her up; she also had respiratory distress, described as labored breathing when she was walking, she felt like she had congestion. On 17Dec2015 at 6:00 AM she noticed a rash under her breast, it was inflamed and sore. Patient stated her side effects were not improving. Itchy throat and ears, respiratory distress, labored breathing, congestion and rash under her breast not recovered; sore throat not recovered and worsened; headache recovered on 16Dec2015.
Headache, runny nose, sore arm and swelling/bump (injection site), dizziness, muscle aches, joint pain, chills, left eye pain on occasion, low grade fever 99.8° My head feels very heavy; too heavy for my shoulders to carry.
I believe my vaccination was administered incorrectly and administered subcutaneously instead of the required intramuscular  route as I have shooting tingling pains going down my arm since immediately after vaccination. The pain has slowly been getting worse and worse and after some research I am quite confident my vaccine was administered incorrectly based on the video I just watched on the CDC's websites showing how to administer Subcutaenous vaccines versus Intramuscular ones. The pharmacist exactly followed the video to administer my Pfizer Covid-19 Vaccine via the subcutaneous route and she squeezed my upper arm fat and injected me at a 45 degree angle. At the time, I remember thinking it was strange she did that as hsitorically I always had doctors vaccinate me and they NEVER squeezed my arm fat and always vaccinated me at 90 degress rather than 45 degrees. I am at a loss at what to do as I am confident the vaccine was NOT administered correctly and  my fingers tingle uncontrollably and I also have weird bruising all over my hand and arm. Aside from the pain, was the vaccination even effective? Or am I suffering now for no reasons.
Post vax, the pt died from Hib disease. Additional information from the reporting physician confirmed that a representative from another company told him that she had heard of a Hib disease death in a child after receiving Hib vax. The physician could not and would not provide further details.
Diarrhea; fatigue; nausea; flu like symptoms; jittery; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING JITTERY (jittery), DIARRHOEA (Diarrhea), FATIGUE (fatigue) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029a21a and 041L20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRBESARTAN for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING JITTERY (jittery), FATIGUE (fatigue) and NAUSEA (nausea). On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 08-Mar-2021 for Flu like symptoms, at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING JITTERY (jittery), DIARRHOEA (Diarrhea), FATIGUE (fatigue) and NAUSEA (nausea) had not resolved.            After internal review it was decided to keep the patient's date of birth unknown until follow-up information was available.
When patient was 13 yo she received one HPV vaccine. Her mother feels her ongoing symptoms of anxiety, depression, abdominal pain, kidney pain & blood in urine and due to HPV. Ongoing appts to treat anxiety depression.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 11th September 2018. Please refer the case US2019GSK022654). On 30th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 30th November 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, malaise and fatigue. On an unknown date, the patient experienced injection site erythema. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, injection site erythema, malaise and fatigue were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, malaise and fatigue to be related to SHINGRIX. Additional details were provided as follows: Within a few hours of receiving the 2nd dose of the SHINGRIX vaccine, she developed pain at the injection site that lasted for 2 to 3 days and then resolved.  Within 24 hours of receiving the vaccination she began to experience malaise and fatigue. These resolved after 24 hours. She also developed a thin, red, horizontal line running across the bicep just under the injection site on her left arm. This lasted for approximately one week and then resolved. The reporter gave permission for her physician to be contacted. The reporter gave consent to follow up. This case has been linked with case US2019GSK022654, reported by the same reporter.
On 6/11/2021 after my 2nd injection, I received muscular pains in my left arm. After applying pressure to it, it felt much worse. On 6/13 I went to a walk-in clinic to have it checked out. The NP prescribed 7 days of Naproxen 500mg and to use hot/cold treatment as needed. At the time of this form being filled out, I have a tingling sensation in my left hand and forearm, due to the Naproxen after doing research. The condition has not worsened.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 21-AUG-2020 (conflicting information, also reported as 03-SEP-2030), the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml as prophylaxis (lot # S036821 with expiration date 21-APR-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
BUE with redness, warmth at injection sits. Pt reports tenderness to palpation almost a 2 inch diameter. AUGMENTIN 875 mg one PO BID x 10 days on 12/28/16.
HEAVY BREATHING; DIARRHEA; SEVERE STOMACH PAIN; THROWING UP; This spontaneous case report was received from a consumer (PVX2019-522) on 26-Feb-2019. The report described a 24-year-old female consumer who had heavy breathing, diarrhea, severe stomach pain, and throwing up following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer took the first dose of Vivotif last night at around 10:00 PM on an empty stomach. On 26-Feb-2019, she had breakfast and drank water, then right after breakfast she started throwing up and experienced severe stomach pain and diarrhea. She was also having heavy breathing. She stated that the adverse events were coming in waves. She clarified that about every 5 minutes, she will need to throw up and her stomach will cramp up really bad and then it will go away and then start again. She stated that it was ongoing since it started and did not resolve.   She stated that she did not take any treatment for the adverse events. She did not have exposure to any unhygienic food or water recently and was doing the normal daily routine. She ate a bagel for breakfast and that she eats the same thing every single day.  The action taken with Vivotif with respect to the events heavy breathing, diarrhea, severe stomach pain, and throwing up and was unknown.  The clinical outcome of the events heavy breathing, diarrhea, severe stomach pain, and throwing up was not resolved.  Company's Comment: In this case, it was reported that the consumer experienced "heavy breathing, diarrhea, severe stomach pain and throwing up" after intake of Vivotif. There is temporal association between the intake of the vaccine and the events. Also, the events "diarrhea, severe stomach pain and throwing up" are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced "heavy breathing, diarrhea, severe stomach pain and throwing up" after intake of Vivotif. There is temporal association between the intake of the vaccine and the events. Also, the events "diarrhea, severe stomach pain and throwing up" are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.