chrisvoncsefalvay/vaers-outcomes huggingface dataset:
other zoster related injuries; shingles; vaccinated at 56-years-old; Information was received from a lawyer regarding a case in litigation concerning a 56-year-old patient of unspecified gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On or about 01-DEC-2010, the patient was inoculated with zoster vaccine live (ZOSTAVAX), administered by a healthcare provider at a pharmacy, for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date (Reported as "subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a physician and other healthcare providers, at a family practice for shingles and other zoster-related conditions (Ill-defined disorder). The outcome of events was not provided. Causality was related.
Headache began 4/3/21 and got progressively worse to be a serve headache with nausea and vomiting by 4/6/21. On 4/8/21 I visited my PCP and received a phenergan shot and toradol shot.
Severe headache; Pain in neck; Burning and pain; Sore arm; Bruised at injection site; Back ache; Leg ache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 30-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207) via unknown route in the right arm on 19Mar2021 at 11:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included NEXPLANON implanted birth control, ibuprofen (MANUFACTURER UNKNOWN). The patient did not report any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient had allergy to penicillin and any medications based, flagyl. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested positive for COVID-19 since having the vaccine. On 19Mar2021 at 11:15, the patient experienced burning and pain in the injected arm, shooting sharp pain down to wrist, sore and bruised injection site, severe headache, other body aches; both arms, neck, back and legs. The patient reported burning and pain in the injected arm during injection and up to 45 mins after until 800mg of ibuprofen (MANUFACTURER UNKNOWN) was administered. The patient also reported shooting sharp pain down to wrist in the injected arm which lasted for 15 mins. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome burning and pain in the injected arm, shooting sharp pain down to wrist, sore and bruised injection site, severe headache, other body aches; both arms, neck, back and legs was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
PT RECEIVED PNEUMOVAX 23 OM 1-9-20 AND ON 1-10-20 HAVE SLIGHT ITCHING REDNESS ON WHOLE ARM AND  SWOLLEN AND SORENESS AND VERY LOW GRADE FEVER, SHE WENT TO MD AND THEY GAVE HER CEPHALEXIN
I had side effects beginning the morning after that lasted 7 full days. they seemed to be the normal side effects; sore arm (injection arm) nausea, headache, body ache, extreme exhaustion, diarrhea, heart palpitations, loss of appetite, upset stomach, brain fog, pain and sensitivity in face and glands. these side effects happened through the 7 days, ending by the evening of the 15th. they were all consistent except the pain in my face and glands only happened a couple times through that week and only lasted a short time each event. HIGH ALERT SIDE EFFECT: on the evening of 4/13 at 11:20 PM. I had been asleep for about 90 minutes, I woke up suddenly with a super rapid heartbeat and acid reflux. my left arm (injection arm) was totally numb, my fingers were tingling and ice cold. I was unable to grasp a phone of hold anything. I tried to shake it off for about 30-45 minutes.  I began to panic so I connected to a teledoc via phone. he indicated it COULD be a side effect of the vaccine and to try and get sleep and see if it was still there in the morning. I went to bed again about 2:30AM and woke up at 5:00AM and the sensation was gone and it I was back to normal.
13 SEP 03 FEW HOURS AFTER IMMUNIZATION RECEIVED PATIENT HAD UPSET STOMACH THEN RETURENED HOME AND SPLEPT FOR AN EXTENDED PERIOD OF TIME. SUNDAY NIGHT NOTICED EXESSIVE SWELLING AND PAIN IN RIGHT ARM AT THE VACCINATIONS SITE.
Almost immediately after the final dose was administered patient looked very pale and started to lean over. Her eyes rolled back and there was saliva bubbling from her lips.  The nurse laid her back on the table.  At that point patient's arms tightened against her chest and were shaking.  Within a few seconds her eyes opened and she tried to sit up.  We were trying to get her to lie back down but she was insistent that she had just fallen asleep and was okay to sit up.  We got her to lie back down and with 30 seconds she started to regain her color. Another nurse came in and checked her BP and pulse.  The Doctor then came in and checked her pulse. We had her lay on the table for about 10 minutes.  She was then able to get up without problem.
itching; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR036652   Additional Information: GSK Receipt Date: 27-Feb-2023 Reporter's Comments: The reporter reported the case via interactive digital media. The patient had shingles they were bad took. One vaccine fifty dollars Later got second vaccine 150 dollars said this was better insurance did not pay. The patient had itching every now and then. Note: it was unknown whether itching was after 1st dose or 2nd dose or after both doses. Therefore, conservatively captured for both doses; Sender's Comments:  US-GSK-US2023AMR036652:
arm soreness for 36hrs; oral temp of 99.7 deg F.; malaise; chills; nausea; indigestion leading to small amounts bile rising into mouth when burping; indigestion leading to small amounts bile rising into mouth when burping; short of breath on usual activities; headache; sore throat; frequent dry cough; This is a spontaneous report from a non-contactable nurse (patient).  A 35-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) in the hospital, via intramuscular route on 15Jan2021 at a single dose for COVID-19 immunization. Medical history includes allergy to sulfa. The patient's concomitant medications were not reported. The patient did not have COVID-19 prior to vaccination. The patient had a COVID PCR nasal swab in 15Apr2020, 29Sep2020 and in 04Dec2020 all with a negative result. The patient had a COVID antibodies blood test on 09Dec2020 with a negative result. The patient had a COVID test saliva on 23Dec2020 with a negative result. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) via intramuscular route on 28Dec2020 for COVID-19 immunization. The patient did not have other vaccines in four weeks. The patient experienced arm soreness for 36hrs, obtained oral temp of 99.7 deg F, malaise, chills, nausea, indigestion leading to small amounts bile rising into mouth when burping, short of breath on usual activities, headache,  sore throat and frequent dry cough all on 16Jan2021. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
When the pt came back to our pharmacy to get her flu vaccine on 11/12/21, she stated that she had a reaction to the J&J vaccine.  She stated that she had blurry vision and she continues to have problems with her eye sight.  Our pharmacist told her to call her physician.  I called her for a F/U.  She explained that hours after the injection she was sleepy; she explained that she had blurry vision and "could not see".  She could not read the numbers on her CC, she stated they were cloudy and fuzzy.  She said that lasted for several days and that it is better, but still not good.  She stated that now she is having headaches everyday in the same spot near her temple and behind her left eye.  She said that her headaches start at the same time each day (mid-morning).  I asked if she thought they were from her eye strain at work and she said no.  She then told me that about 3 weeks after her shot she had pain in both legs.  She said it was like when she was on a medication and her physician thought she may have had blood clots in the past.  She said it was the same kind of pain.  I asked if she notified her physician and she said, "no".  I asked if she has been to her eye doctor and she said, no.  I emphasized that she needs to see her physician or go to an urgent care.  She stated that she will call her physician.
Saturday (1/16/21) I woke up with a small red patch on my cheek. As I have eczema, I assumed that was an eczema patch. It was neither painful nor itchy. Sunday (1/17/21) the same patch was there; it had started expanding a little and was becoming quite itchy. I took a Benadryl dose at ~2pm after noticing it spread all the way from near my nose out to my ear. Sunday evening around 5:30pm I went for a walk with a medical mask on. When I returned from my ~1 mile walk, my face was a little itchy and hot. Within 5 minutes, I had started breaking out in itchy hives all over my cheek. Had to continue with Benadryl regiment for the rest of the evening (max dosage allowed on the instructions). On Monday, I started prednisone in addition to Benadryl, and had to continue on that regiment for 8 days.
One week after my first vaccine (and 9 days prior to my regular period), I started spotting bright red blood. I spotted  until my period started. Heaviness was less than a period but more than I think a pantyliner could have handled. Additionally, I had excruciating cramps the day my period did start. I realize the increased pain may have been psychological, but the bleeding was not. I am 39 and I have NEVER had anything like the bleeding I had after my vaccine.
Patient received Vaxelis and Engerix-B on the same date; This non-serious spontaneous safety report, with reference number 2022SA439355/ Inquiry# 01337995 was received by the partner on 25-OCT-2022 and forwarded on 27-OCT-2022 from another health professional.   Due to the nature of the event, the causality between the event "Giving an extra dose of HEPTITIS B to a 6-month-old patient. The patient received several other vaccines the same day including VAXELIS." and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 28-OCT-2022 and forwarded on 02-NOV-2022, from a HCP. The case is maintained as non-serious. The HCP confirmed that no Adverse Events have been reported.  Due to the nature of the event, the causality between the event "Patient received Vaxelis and Engerix-B on the same date" and Vaxelis remained not applicable.  Further information is expected.
Act-HIB injection with an expired diluent/no AE; Initial information received on 21-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 months old male patient who received 0.5 ml HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] injection with an expired diluent/no AE(expired product administered) on 21-FEB-2020 via unknown route at the right thigh for prophylactic vaccination[lot UI951AA and expiry date 13-JUN-2020]. It was also reported that the expired portion, in particular, was the diluent(lot U6111AA and expiry date 24-JAN-2020).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was of actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  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 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.
Patient reports metallic taste in mouth from 8/2 and continues today. Also reports swollen glands in throat that began 8/4 and continues today. Reports burning in legs and aching joints that started 8/9 and continue today. Scheduled to see PCP 8/18/22.
2/9/09 DTaP: Sanofi Pasture Limited: Lot Number: C2957AA Exp: 21May10 and Hepatitis A: Glaxo Smith Kline Lot Number: AHAVB320BA EXP: 25AUG11.  Patient found by mother about 2:30 am on 2/11/09 with tonic eye movements to right, taken to ER, noted to have fever of 100.6, Oxygen sat 66% on RA, 100% with 1 liter NC, seizure had been present for about 40 minutes, given 0.5mg Ativan and seizure stopped within about 3 minutes, admited to Medical Center for observation. 2/16/09-records received for DOS 2/11/09-presented with C/O seizure and 1-2 day history of congestion and 1 day history of fever. Tonic eye movement to right. In ED febrile with prolonged seizure activity.  Assessment: complex febrile seizure. Upper respiratory infection.
Information has been received from a pharmacist referring to her son of unknown age. There was no concurrent historical conditions or drug reactions/allergies. On an unknown date, the patient was vaccinated with unspecified doses of (Oka/Merck) VARIVAX injection (dose, route, lot# and expiration date unknown) as a child. There was no concomitant medication. In December 2014, the patient was diagnosed with shingles. The patient was seen by an unspecified nurse practitioner on an unspecified date. No lab diagnostics studies were performed to the patient. The patient was treated with VALTREX 1 gram "three times a day for a week" on an unspecified date. The outcome of the event was reported as recovered on unspecified date. Causality between the event and (Oka/Merck) VARIVAX was not reported. This is one of the reports from the same reporter. Additional information has been requested.
Complaint of cough, chills, elevated temperature (102), sore/scratchy throat, headache, runny nose/congestion, myalgia, malaise, diarrhea, and nausea.
pt recv vax ID instead of IM by mistake 5JUL96;nurse consulted w/MD p/area became red-pt returned for f/u 8JUL96 & had no further problems;
Hematuria noted at 2:30 am on 10/29/2008.  Patient had received 1st GARDASIL shot on 10-28-08 at 09:05am
started having menstrual spotting; the night as I slept my period started unexpectedly; chills; muscle aches; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (started having menstrual spotting), MENSTRUATION IRREGULAR (the night as I slept my period started unexpectedly), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (Tiredness) 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 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERMENSTRUAL BLEEDING (started having menstrual spotting), MENSTRUATION IRREGULAR (the night as I slept my period started unexpectedly), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (Tiredness). At the time of the report, INTERMENSTRUAL BLEEDING (started having menstrual spotting), MENSTRUATION IRREGULAR (the night as I slept my period started unexpectedly), CHILLS (chills), MYALGIA (muscle aches) and FATIGUE (Tiredness) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2022-443324, MOD-2022-445119 (Patient Link).
have some numbness in my left arm but I have some numbness in my right fingers; This is a spontaneous report from a contactable consumer or other non health professional reporting for herself.   A female non-pregnant patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: unspecified) via unspecified route in the left arm, as a dose 1, single on an unspecified date for COVID-19 immunization. Medical history included arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient stated that had some numbness, both shot in her left arm but she had some numbness in her right fingers, also stated that she was elderly and had arthritis pretty badly so that may not be anything to do with shot. The reporter seriousness was unspecified for the event. The clinical outcome for the event was unknown.  Information about batch/Lot number has been requested.
He is shrinking a little; patient has gained weight; completely deaf in his left ear/hearing loss; wife thinks the patient is not hearing well out of his right ear; he had walked straight into half of a wall because he was so off kilted; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer sponsored program. A 71-years-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EP6955), via an unspecified route of administration on 26Mar2021 09:00 as SINGLE DOSE for covid-19 immunization (Age at vaccination: 71 years). Medical history included transidential Global Amnesiatic Episode from Mar2021, blocked carotid artery on his left side and tinnitus (had a history of Tinnitus in his left ear for about 4 years but he could hear). Concomitant medication included acetylsalicylic acid (BAYER ASPIRIN) for carotid artery blockage. The reporter stated that the patient was completely deaf in his left ear and had hearing loss on 10Apr2021. The reporter also stated that he had walked straight into half of a wall because he was so off kilted on 27Mar2021 . The wife thinks the patient is not hearing well out of his right ear on 10Apr2021. The reporter also stated that he is shrinking a little and the patient has gained weight on an unspecified date. The reporter also says that she thought that her husband's side effects started a little late after the vaccine date, has that been reported? Her husband had made the mistake of getting on the internet even though she said not to do that. She jokingly says that her husband is like a medical manual and he thinks that he is going to die from everything. The patient underwent lab tests and procedures which included height: shrinking and weight: gained on an unspecified date and CAT scan and MRI: Transidential Global Amnesiatic Episode on Mar2021. Outcome of the event deafness and hearing decreased was not recovered while outcome of the remaining events was unknown.
This spontaneous report was received from a pharmacist via company representative, regarding to a patient of unknown age and gender. Patient demographics were not reported. Information on their concurrent conditions, pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (lot, expiry date, dose, units, route and anatomical location were not reported) at age 40 (inappropriate schedule of drug administration) an again in their 50's. Concomitant medications were not reported. There was no Product Quality Concerns (PQC) involved. No further information was available. Additional information is not expected as no reporter details were provided.
was also late to receive her vaccinations for polio, measles, mumps, rubella, meningitis, diphteria, tetanus and pertusis; received PROQUAD and M-M-R II; Inappropriate age at vaccine administration; This spontaneous report was received from a nurse referring to a 14-year-old female patient.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-AUG-2019, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, frequency, route, lot# and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age). The nurse reported that on an unknown date, the patient was late to receive her vaccination with meningococcal vaccine (unspecified), poliovirus vaccine inactivated (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (inappropriate schedule of vaccine administered, extra dose administered).
I had limited movement in my left arm 2 days after shot along with alot of pain. I couldn't wash myself while taking a shower and I went to my doctor and he gave me some cream. The pain has never gone away although it seemed a little better but now I have severe pain and very little range of motion along with weakness. I cannot close my car door or pull my blankets up at night or carry a water jug or a paint can. I can only move my arm certain ways. My doctor told me that he thinks the vaccine was administered too high in my arm
My son received the Pfizer Covid booster on 1/31 at 10:15 AM.  I had to wake up him the following morning and he was very lethargic and wanted to lay on the floor (very unlike him).  After getting him up, noticed wheel-shaped rash on the side of his stomach and back.  This lasted until the following day on 2/2.  The rash has not returned as of 2/10/23.
a lot of dental work done today and "they cut into my gums and stuff''; This spontaneous case was reported by a patient and describes the occurrence of TOOTH DISORDER (a lot of dental work done today and "they cut into my gums and stuff'') in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced TOOTH DISORDER (a lot of dental work done today and "they cut into my gums and stuff''). At the time of the report, TOOTH DISORDER (a lot of dental work done today and "they cut into my gums and stuff'') outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.   It was reported that the patient had to undergo dental work on 18-May-2022 including cutting into gums and stuff. Patient stated that she had an appointment set a day after reporting for her 2nd Moderna booster dose.  No treatment medication was reported.   Reporter did not allow further contact
Headache, chills, nausea, difficulty breathing, body pain, swelling and redness of injection site. The next day after receiving it.