chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inflammation of membrane surrendering the brain, Dr. advised no treatment and it would clear up in time but still dealing with the reaction 9 months later also effected hearing to the extent of feeling like you could not equalize the pressure, this comes and goes;
Nerve pain L face/head 9/10 pain gradual improvement over 7 days
Major pain at and around injection site. Pain through entire hand, shoulder and neck is accompied by nauisa
She received vaccine in the morning of 9/26/19, yesterday evening began having some fatigue, and over night area below injection site became swollen, red, and very hot to the touch. She is taking Advil/Tylenol for swelling/pain and is going to keep an eye on swelling and redness.
no adverse event; incorrect product storage; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided.  On 18-MAY-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot number was verified as T029532, expiry date 01-SEP-2022, dose 0.5 ml, (route of administration was not provided). There was no adverse events; it was also reported that the vaccine was "ok to use".   The reported stated that the vaccine was improperly stored (temperature 5.2 Fahrenheit (F) degrees for 24 minutes). Digital data logger involved. There was no previous temperature excursion.
This initial spontaneous report was received from a pharmacist referring to a 60 year old female patient. There was no pertinent medical history or drug allergies/drug reactions described. On 27-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX subcutaneous injection (lot # L011537 with expiration date 03-JUL-2016, 0.65 ml). There was no concomitant medication reported. The pharmacist stated on 29-OCT-2015, the patient reported to the physician that she developed redness (2 inches) at injection site. The physician recommended BENADRYL as treatment and when purchasing it at pharmacy, the reaction was reported to her/him. Lab test were not performed. Product quality complaint (PQC) was not involved. At the time of the report the outcome of the event was unknown. The relatedness between the event to ZOSTAVAX was not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
I started having a pain in my upper jaw. It seemed to get worse when I pushed on my tooth. I went to the dentist. He couldn't find anything wrong, so I went to a doctor who thought it was a sinus problem related to a CPAP machine that I use. She prescribed a steroid nasal spray, which seems to help some. The pain has improved, but it does still bother me. I'm going to follow up with my doctor in a few months.
2-3 hours post vaccination and after eating lunch, c/o nausea, vomiting, and later diarrhea. Resolved 48 hours later.
When reconstituting for Pfizer covid vaccine only 0.8ml of 0.9% sodium chloride diluent was used instead of the required 1.8ml amount. Patient was given vaccine and were notified the same day about the issue. Currently no side effects have been reported or noted
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # L035510, expiry: 13-MAY-2017, lot # L029615, expiry: 15-MAY-2017 (dosing details and route of administration were not reported). The vaccines were exposed to a temperature of 34.6 F for 1 hour. There was no previous temperature excursion. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Had fever on 9/27/07 redness 10 x 10 itching. Warm to touch left upper arm.
1/27/10 Staff made a reminder call for the second H1N1 shot and was told by Dad that both children developed hives approx 1 1/2 hours after receiving first H1N1 nasal spray. Upon f/u call Dad stated daughter's hives were mild only on extremities and son's hives were worse on extremities, chest and neck. Neither children had respiratory sx, no fever, no other sx. Parent gave children BENADRYL. Per Dad, hives disappeared within 5 minutes. Advised Dad to contact children's physician to discuss reaction and discuss if f/u with H1N1 injection rather than nasal spray would be appropriate. T.C. to clinic and informed nurse of my conversation with Dad.
This spontaneous report was received from a healthcare worker regarding an unknown number of patients of unknown age and gender. On an unknown date, the patients received improperly stored VAQTA (lot#, dose and route not reported). No concomitant medications were reported. The vaccines were exposed at 11 degree centigrade(C) for 96 hours. No adverse effects were reported. It was unspecified if the patients had sought medical attention. Additional information has been requested.
Dry patch where the shot was injected. Lighter and rougher than the rest of my skin. Also peels and flakes.
Extreme dizziness, malaise, low grade fever, body aches, chills, rhinorrhea. All X 2 weeks.
In the evening of the day the immunization received, pt fever was 104; she trembled all over/mom; Thigh was red, swollen & tender. A rash was already present on her leg.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: Z-PAK; ZYRTEC ALLERGY. Past drug history included: Biaxin, reaction(s): "Known allergies: Biaxin". Vaccination history included: Covid-19 vaccine (Dose 2 single, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 1 single, unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Clinical course: Anti-viral details: Product- COVID 19 Treatment. If treatment ae: No. Adverse event: Metallic taste in mouth. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 5/18/2000, the pt experienced swelling, redness, itching in the arm of injection. The pt also exprienced a fever of 102.4F
Thrombocytopenia; A spontaneous report was received from a NURSE, concerning a 74-Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced thrombocytopenia.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 25-Jan-2021, prior to the onset of the events, the patient received their first planned dose of mRNA-1273 (lot/batch: 042L20A) for COVID-19 infection prophylaxis.  On an unspecified date in 2021, the patient experienced the event thrombocytopenia and presented to emergency room and was hospitalisation on an unspecified date in 2021. His platelets dropped down to 2. The event was also considered to be medically significant. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event was considered unknown.  The reporter assessed the event thrombocytopenia as related to study drug.; Reporter's Comments: Very limited information regarding this event of thrombocytopenia has been provided at this time. onset date of event, patient's medical history full blood count results with reference ranges are lacking.   Further information has been requested.
Employee stated that about 1330 she started itching all over body. T 99. The itching progressed from chest to back, down legs. Injection site hot, indurated. Benadryl 25mg PO given and Prednisone prescribed.
several pt from this site exp various sx including kidney pain, achiness, nausea, vomiting, & diarrhea p/vax;
tingling of arms & legs & diff walking;progressively worsening symmetric paresthesia, began distally & moved peripherally over 2wk;pt adm rx of GBS;
Initial report received from a vaccine provider on 07 January 2013. This case is not medically confirmed as the reporter was not identified as a healthcare professional or not. The report involves a cluster of 6 children from the same reporter and same lot number UH753AB. This case captures one of the children and the other children are captured in cases 2012-11111, 2013-00526, 2013-00527, 2013-00528 and 2013-00530. A nine year-old female patient whose illness at the time of vaccination was reported as "N/A" and past medical history was unknown had received a dose of FLUZONE (lot number UH753AB, IM) on 06 November 2012 and tested positive for Influenza A and influenza B via the Binaxnow quick test on 14 November 2012. The patient's outcome was not recovered. Documents held by sender: none.
Information has been received from a physician concerning an adult male without a spleen who in October 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P).  Subsequently, the patient developed swelling of upper arm with redness, fever, chills and headache.  The physician reported that the patient was to be seen on 10/29/2004.  The physician reported 3 other patients who had similar reactions post vaccination with pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) (WAES 0411USA00004 and 0411USA01788).  Additional information has been requested.
arm soreness occurred after dose 1; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported however patient could be 65 or 66 years at time of vaccination. The patient experienced arm sorenss after 1st dose which was recovered. The reporter consented to follow up. This case is linked to case US2020AMR137938, reported by same reporter for same patient (2nd dose).; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR137938:same reporter
Patient was given vaccine on 2/26/15. Pt. called us on 2/27/15 in evening stating she had "itchy" small rash around injection site. Patient asked if she could take BENADRYL, I stated it was okay to take, and we would let her MD know.
Patient reported an extremely sore arm unable to lift it above their head. Patient reported taking tylenol and naproxen for the pain as well as massaging the affected area.
VACCINE-RELATED LYMPHADENOPATHY, symptoms started within hours at mid-throat, right side only. This began to radiate pain outwards and upwards over the course of few days. By the fourth day, the pain and swelling had spread to entire jawline and neck, right side. Visit to ER confirmed periodontal abscesses, in total 3. After one week of antibiotic, symptoms returned with greater pain, spreading back to entire right neck and jawline into right ear. As of this writing, it has been 19 days since the second Moderna shot and the lymph nodes in the entirety of my right side hurt.
A number  of adult pt may have inadvertently recv DT which is not recommended for immunizing person on or p/their seventh birthday;As of 12NOV97 no adverse exp had occurred;addtl info states 3 devel inj site rxn;8 days later pain, swelling
NO ADVERSE EVENT. IMMUNIZATION INFORMATION SHOWS PATIENT RECEIVED 2 DOSES OF MODERNA FROM ANOTHER FACILITY AND RECEIVED A PFIZER DOSE FROM US.
Hospitalized for acute on chronic hypercapnic resp failure.   dexamethasone and remdesivir Pt hospitalized 9/12 to 9/23 when transferred here due to needing higher acuity level of care.
The first day I felt a little body aches and a little more fatigue. The 2nd days those symptoms were more severe, and I had a fever ranging between 101-103. As the day progressed, I started to feel worse and worse. I had a tele visit and was prescribed Molnupiravir for 5 days. I had tested for COVID-19 on February 2, 2023, and it was positive. On February 4th, my symptoms started to improve. By February 6th I felt mostly back to normal. I have completely recovered from all COVID-19 symptoms. I would say it took about 2 weeks to recover from everything.
1st dose years ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received couple of years ago, prior to the pandemic from the 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: 06-OCT-2022 Reporter's comment: The patient self-reported this case. The patient had not yet received his second dose of Shingrix. The details were reported for 1st dose. The reporter gave consented to follow-up with health care professional (pharmacy) Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination.
The patient reports experiencing blurred vision, vertigo, throbbing unilateral headache upon arrival to her seat.  The medical team assessed her and found her HR to be 76 bpm, BP 142/80, BG of 72, and her oxygen saturation was 99%.  She reported that she had not eaten all day and had not had a lot of water during work.  She reported that she typically gets migraine headaches lasting for several hours.  She was given some water and her symptoms started to resolve.  She asked if she was able to go home.
Pt admit to hosp w/encephalitis & optic neuritis on 25-MAR-90. Brain biopsy consistent w/post viral or post immunization.  Viral titers pending 5th DTP no prior problems. No known drug allergies. Pt has milk allergy.
Pt. said she encountered the following symptoms an hour and half after receiving her 1st adult Hep B, and TST test (in the other arm). She could not say definitively that she'd had the Hep B series as a child:  Nausea, dizziness, severe HA, body aches, malaise, bilateral swollen lymph nodes, jaw pain and stiff neck, left eye pain (burst blood vessel in same), blurred vision-left eye, elevated BP-138/88 (normal 90/75), chest pain/"pounding heart", transient pressure in ears with hearing loss.  The symptoms have lessened but have not completely gone away. She is still taking acetaminophen/butalbital/caffeine for severe HA.
Immediately after vaccine was administered I had vision changes with extreme sensitivity to light in left eye, which continued for 48 hours. After 48 hours, I began having flashing lights and floaters in left eye.
Received the vaccine in the early afternoon. When leaving home for work that day, felt lethargic. The next morning, she developed headache, fever 102, chills, body aches and was out of work for 2 days.
Flu like sxs, generalized muscle aches. C/O pain (L) arm/shoulder, that progressed to pressure and swelling (R) side of chest, generalized hives.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On19-OCT-2012 14:34, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
A non-serious report "given FLUMIST to 19-month-old" was received from a doctor's medical assistant involving a 19-month-old male. On 14-Dec-2008 the patient received FLUMIST. On the same day, the patient received hepatitis B, DTap, PCV, IPV/OPV vaccines. The patient had no relevant medical history. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with a post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 month of age for FLUMIST.
nose bleed for 45 minutes day of (25 minutes after shot) fatigue brain fog Bad headache that lasted days (still have it while filling out this report 3 days later) rashes in random places all over my body develped 2 days later
a dose of MMRII that was given intramuscularly instead of subcutaneous injection; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JUL-2020, the registered nurse in the office was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 0.5 milliliter, once, intramuscularly instead of subcutaneously (injection site, lot # and expiration date were not reported) for prophylaxis by another registered nurse. The outcome of the event was unknown.
flu shot given 11/14/06 245pm. Mom called MD 11/15/06 8:20am to report tennis ball sized warm red lump at shot site. Has received flu shot in past without incident. Benadryl and Motrin given seen in office 11/15/06 and 11/16/06 now taking Zyretec. The marked area increased slightly in size 2nd day otherwise no complaints.
BODY SORENESS; FEELING MISERABLE; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 07-APR-2021, the subject experienced body soreness. On 07-APR-2021, the subject experienced feeling miserable. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache, body soreness and feeling miserable was not reported. This report was non-serious.
Immediately following the final immunization (GARDASIL given last) the patient fainted. Patient was monitored for 20 minutes by RN's after the incident. A cool compress was applied around his neck, and he was given a glass of water. Mother declined for on site Pediatrician to assess her son. After 20 minutes patient stated he felt fine. Left clinic with his mother, normal gait and stable.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-MAY-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 3396, unknown and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Slight swelling, rash, redness in area per patient on 8/1/12.  Redness noted when patient presented on 8/2/12--no swelling or rash.
felt sick; very sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL3247) at the age of 38 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes", start date: Nov2012 (ongoing); "Major Depressive Disorder", start date: Jun2013 (ongoing); "Appendectomy", start date: 1987 (ongoing), notes: Summer; "Gallbladder Removal", start date: 1993 (unspecified if ongoing), notes: Fall; "Depression" (ongoing); "Graves Disease", start date: Mar2022 (ongoing). The patient's family history included: "Asthma" (unspecified if ongoing), notes: Mother has asthma, diabetes, bipolar disease (Age: 76 years old); "Diabetes" (unspecified if ongoing), notes: Mother has asthma, diabetes, bipolar disease (Age: 76 years old); "Bipolar Disorder" (unspecified if ongoing), notes: Mother has asthma, diabetes, bipolar disease (Age: 76 years old). Concomitant medication(s) included: METFORMIN oral taken for diabetes mellitus (ongoing); GLIMEPIRIDE oral taken for diabetes mellitus (ongoing); LANTUS taken for diabetes mellitus (ongoing); PROZAC oral taken for depression (ongoing); METHIMAZOLE oral taken for basedow's disease (ongoing); PROPRANOLOL oral taken for basedow's disease (ongoing). The following information was reported: ILLNESS (non-serious) with onset 29Jan2021, outcome "unknown", described as "felt sick"; PAIN IN EXTREMITY (non-serious) with onset 29Jan2021, outcome "unknown", described as "very sore arm".
COVID-19 INFECTION; This spontaneous report received from a patient concerned a 43 year old female of unknown ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 204B21A, expiry date: 10-MAY-2022) dose was not reported, 1 total, administered on 13-FEB-2021 in left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in Series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date in FEB-2022 patient had covid-19 and also stated that it had been more than 90 days since the patient had covid-19 (coronavirus disease-19) (Dose number in Series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.