chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of EYE PRURITUS (Eyes became extremely itchy), OCULAR HYPERAEMIA (Eyes became very red), ERYTHEMA OF EYELID (Patient's eyes became very red, as did eyelids) and FLUSHING (Cheeks were flushed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01721A) for COVID-19 vaccination.  Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Graves' disease, Bee sting hypersensitivity and Allergy to wool. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from May 2012 to an unknown date for an unknown indication. On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE PRURITUS (Eyes became extremely itchy). On 25-Apr-2022, the patient experienced OCULAR HYPERAEMIA (Eyes became very red), ERYTHEMA OF EYELID (Patient's eyes became very red, as did eyelids) and FLUSHING (Cheeks were flushed). On 30-Apr-2022, EYE PRURITUS (Eyes became extremely itchy), OCULAR HYPERAEMIA (Eyes became very red), ERYTHEMA OF EYELID (Patient's eyes became very red, as did eyelids) and FLUSHING (Cheeks were flushed) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On the second day of taking Paxlovid (after 4 doses), patient's eyes became extremely itchy. Patient took a shower in the morning of the third day and eyes became very red, as did the eyelids; patient's cheeks were flushed. Patient continued taking the full dose of Paxlovid for the third day. Patient's provider and patient decided not to continue for days 4 and 5. Device Date was reported as 27May2022. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously received a COVID-19 Vaccine. No treatment medications were provided.
Within 24 hrs: headache, dizziness, weakness, vertigo, paresthesia. Seen 10/24 & 10/25/11. HA & vertigo (intermittent) persist. Dramamine helped.
Had pain both arms, shoulders back of neck and thighs. Muscle pain. Diagnosed polymyalgia. Prescribed Prednisone by PCP. Sent to rheumatologist.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-APR-2007, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 25-JUL-2016, the patient was treated by a physician at the Medical Offices for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed famciclovir and prednisone for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Tdap vaccine was givin in the clinic. The patient called on 2/15/2011 and reported that within 2-3 hours of the injection he was feverish, chilled, nauseated, had body aches, and chest congestion and overall felt very ill. Patient died on 2/20/2011 of an unusual strain of pneumonia.
Had outbreak of hives. Managed at home with steroid cream. Self-resolved after 48 hours.
extremeties except for left upper arm patient had an approximately 8  cm diameter area on his left upper arm at the site of the injection that is red  and slightly warm mildly tender without any fluctuance or induration noted.  Initially had some soreness at the site and some  mild redness but then subsided and the current area of redness developed 2 days  ago.  Patient does not have any systemic symptoms.  Does have some local  itching.  Given diphenhydramine, hydrocortisone cream and antibiotic--Delayed reaction to covid vaccine and possible early cellulitis less likely-
Headache, Myalgia & NauseaVomiting Narrative: Employee got the second dose vaccine on 02/05/21, at 830am she reported worsening fatigue, headache, body ache, nausea and vomiting on the 02/06/21. She had vomited 4 times since onset She stated that the reaction is getting worse progressively that she may be unable to come to work at night
COVID-19 breakthrough. When I got COVID-19 in February, it was short lived 3-4 days. I had mild symptoms; no treatment was sought. I then got it again a month later, it was much worse lasted 3 weeks. I had chest congestion and fatigue. I missed three days of work. When I went to the doctor, I was prescribed an antibiotic to treat a sinus infection because that COVID-19 test came back negative. However, I lost my taste and smell and it still hasn't come back until this day.  My doctor and I think it was COVID-19 even though it didn't show up on the test.
Fatigue, Headache, Redness around vaccination location, swelling of the left upper arm, Diarrhea, nausea,  left arm was itching
Vaginal spotting.  Spotting continued for 10 days and then she miscarried on 12/26/2009.
Diarrhea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and PYREXIA (Fever) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and PYREXIA (Fever). At the time of the report, DIARRHOEA (Diarrhea) and PYREXIA (Fever) had resolved.            This case was linked MOD-2021-051527 (E2B Linked Report).; Sender's Comments:  MOD-2021-051527:First dose case
In the first couple of days - some fever.  tiredness.   Persisting arm pain (for about a week).  Then (till present time)  Abdominal discomfort; occasional sharp pains. Tiredness.  Slight shortness of breath, occasionally throughout the day. Mouth dryness and a feeling that reminded me of when I was infected with Covid (sometime 1st Q. 2020).  Sleep disruption; anxiety. My main worry is the abdominal pains and the shortness of breath.
Had moderate dizziness starting on 4/10 in the morning . Dizziness has not resolved as of 4/16.   Very debilitating.
The pt developed muscle and joint pain. Her left wrist was especially sore and swollen area on inner forearm. (Naproxen for 10 days with no results)
pt recvd vax 6NOV95 & 11NOV95 exp fever, cough & dx w/pneumonia 21NOV95;dx w/pericarditis 22NOV95 & hospitalized 2DEC95 w/carditis, pneumonitis & atrial fibrillation
Patient explained that general shoulder muscle soreness started the afternoon after receiving the vaccination. This soreness persisted for a few days and then turned into more of a nerve pain in her shoulder when performing tasks around the house. The pain has persisted for 3 weeks now, but has been getting better. This is the first time patient had received the high dose flu vaccine.
Doctor gave 1/2 Pentacel only the liquid portion with no reported adverse event; Initial information received on 13-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient states doctor gave 1/2 pentacel only the liquid portion with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Suspension for injection DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious doctor gave 1/2 pentacel only the liquid portion with no reported adverse event (incorrect dose administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Doctor gave 1/2 Pentacel only the liquid portion with no reported adverse event).  At time of reporting, the outcome was Unknown for the event doctor gave 1/2 pentacel only the liquid portion with no reported adverse 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 guidelines. 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.
Pt witness to fall to floor, caught by MA and mom, this nurse noted pt to have seizure like jerking and shaking. Pt also was very pale and cold. Lasted approx 1 min and it happened within 60 seconds of vaccine administered. Pt sent out via EMS.
Patient felt lightheaded and had shortness of breath within a minute of receiving flu vaccine. Within 2 minutes she was crying and complaining of pain in her arms, neck, spine, and hips. Her blood pressure was elevated, oxygen 100%. No changes on EKG in ambulance.
The patient received only the liquid portion of the PENTACEL with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00504437) and transmitted to Sanofi on 04-Mar-2021.  This case involves a four months old female patient who received only the liquid portion first 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Solution for injection, lot of powder portion UJ336AA, lot number of liquid portion U6842BA and expiration date: 05-Jul-2021) via intramuscular route in the right quad for prophylactic vaccination on 04-Mar-2021 (product preparation issue). This occurred because the powder was not mixed with the liquid as administrator did not see the powder portion in the box.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  It was actual medication error due to inappropriate reconstitution technique (on same day).  The reporter asked what should he/she do now?  At the time of report, the patients experienced no adverse 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 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.
Since that day I have experienced dizziness, pain in the arm, swollen lymph nodes both sides of the neck and under arms and lot of nausea.. I also had severe body ache for 4 days after the shot. Dizziness gets worse if I walk faster.
The patient accidentally received a third COVID vaccine. The pharmacist administering the vaccine saw two record cards, questioned the nurse on the floor about it. The nurse told her that the second record card was an error. After administering the vaccine, a representative came and said the patient received a third vaccine. No side effects were reported at the time. But the doctor on staff was to monitor the patient.
expired Menactra was administered to a patient (with no reported adverse event); Initial information regarding an unsolicited valid non-serious case was received from Other Health Care Professional via Agency (Reference number- 00533762) and transmitted to Sanofi on 24-Mar-2021.  This case involves a 16 years old female patient who received 0.5 mL expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number lot U6486AC expiry date- 10-Jan-2021 via intramuscular route in unknown administration site for prophylactic vaccination on 24-Mar-2021.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was a case of actual medication error due to expired vaccine used (latency same day).  The caller would like to know if the patient must be revaccinated.  At the time of report there was 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 came to the Clinic requesting a Pfizer vaccine. Patient stated she had not been vaccinated for COVID-19 prior to 9/23/2021. When patient checked out, the staff noted there was a prior MODERNA vaccine for COVID-19 administered on 2/5/21. When questioned about this, patient stated: " I vaguely remember getting a vaccine, it could have happened and I just don't remember"
Vaccine was administered at approx 9:45am on 11/13/06. at 12:50pm pt came back to the office and reported bad itchiness on hands and soles of feet, spread to legs and face. Areas were all erythematic. 50mg of Diphenhydramine (1cc) Deep IM in right hip given. The itchiness had started at approx 12 noon. By 1:10 pm S/S were subsiding by 1:30 pm they resolved.
Headache fATIGUE Narrative:  missed several hours work following second dose due to fatigue.
Pt presented to PCP on 12/6/07 with 2d hx N/V and 1.5 wk hx gen. malaise. Chem 7 revealed ARF and pt admitted on 12/6/07. Pt hydrated and on 12/8/07 had rapid resp. decompensation requiring intubation. No renal biopsy obtained but final diagnosis rapidly progressing glomerular nephritis w/no response to steroids. 1/20/2010 Patient still requires dialysis-no appreciable improvement in GFR. Follow-up: Patient continues to have ERSD requiring hemodialysis 3x /wk. Pt still wishes not to provide identifying information. However, if any further cases are reported, please contact me and I will speak with the patient again.
Small hives occurred on the left forearm and the forearm started to itch, approximately 6 hours after the shot was administered at 3:10 PM.  The itching progressed on the left forearm and started on the right arm over the next 20 to 30 minutes.  If you put it on a 1-10 scale, 10 being the worst itch.  The left arm was an 8 and the right was a 2.  The right arm did not appear to have any noticeable hives. No swelling occurred in the face or throat.  When the forearm itching progressed to the point it became unbearable an 8.  A topical Cortisone-10 ointment was applied on both forearms and one Clemastine Fumarate 1.34mg tablet was administered.  This helped with the forearm itching, it went down to a 1.5.  Experienced random itches on the head, neck, back, and legs; 7 to 12 hours after the shot was administered.  No hives where present in any other body locations.
positive COVID-19 test with symptoms/ running 103.4 fever; This is a spontaneous report from a contactable consumer (reporting for her daughter). An 8-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Nov2021 (batch/lot number: FK5127) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported that her daughter got her first COVID vaccine on Saturday (06Nov2021) and on Monday (08Nov2021), she tested positive for COVID and she was running 103.4 fever. She was due for her next COVID shot on 27Nov2021 and she wanted to speak with someone about whether she should get it after these side effect or not. If that is safe or she's going to have another reaction. It was reported that the consumer (parent) took her daughter to the pediatrician. The outcome of the event "positive COVID-19 test with symptoms/ running 103.4 fever" was unknown.
Body aches, diarrhea, vomiting, dehydration. All progressively worse since having COVID booster plus flu shot administered at a local pharmacy. Resulted in ER visit and treatment with IV fluids.
Low grade fever 100. tired, body aches, fatigue, some redness around injection sites 10-10-23.  10-11-23 Redness expanded to 3" in length and 2.5" in diameter, sore to touch but no induration.   Recommended Benadryl and close monitoring, call back if expands.
On 9/30/09 client reported that 1 week post administration of vaccines she felt like "pins and needles" in both legs, arms, shoulders and hip but not trunk area."felt like she was going to jump out of her skin" and it was "intermittent day to day". Areas affected had increased but the intensity of discomfort had decreased. Client stated she also received a flu shot on 9/23/09 from her work and it seemed to increase the problem somewhat. Client saw her primary MD on 10/1/09 and was Rx'd steroids and reported feeling better on 10/2/09 but still c/o parathesis in legs, arms were better and was able to sleep. On 10/7/09 client reports not doing much better, has been referred to Neurologist and further testing is pending. 10/13/09 Medical record received for date of service 9/23/09.   Pt. was administered Afluria vaccine (0.5 cc in left deltoid).  Risks and benefits of influenza vaccine discussed and information sheet given.   10/16/09 Medical records received for date of service 10/8/09. DX:  Normal study without electrophysiological evidence of neuropathy or GBS. Assessment:   Pt. presented with sx. of restlessness, anxiety, vague sense of muscle fatigue and muscle pain as well as an inability to sleep associated with parasthesias in varying distributions in her body.  Motor exam showed normal strength in limbs and normal neck flexor muscle strength.  Reflexes were physiologic but grading at 1+ in UE's, trace in LE's.  Normal gait, heel walking, getting up from one knee and tandem gait.  Sensory exam normal.  Likely that sx. reflect some kind of nonspecific vaccination reaction coupled with considerable anxiety.   NC studies normal.  Pt. reassured.   10/23/09 Received MR from date 10/08/09. Neurology consult. Pt. presented with same symptoms as previous entry. Assessment: Sensory exam WNL, Nerve conduct test WNL. DX: nonspecific vaccine reaction. Impression: symptoms will probably resolve.
Severe abdominal pain started on 6-27-21.  Went to ER on 6-28-21 they did ultrasound on gallbladder  & prescribed pain medication & was released.  Went to ER on 6-29-21 with severe abdominal pain, they done a CT scan was admitted with diagnosis of Mesenteric Venous Thrombosis(blood clots in veins to intestines & liver).  At Hospital was given Heparin, via intravenous until released on 7-4-21.   Hospital released me on 7-4-21 with prescript of Eliquis with multiple follow-up doctors appointments
Two blood clots in right lung two days after second vaccine. I was hospitalized and I am now on oxygen 24/7 and I?m taking blood thinner Eliquis.
vaccine given on Left upper arm. Reaction on Left hand, hives(local) itching and localized swelling. Given Prednisone 60 mg, Zantac 150 mg, Benadryl 25mg. Patient states that lips and throat were swollen at Mar 07 until 0130 same day, still stated they itch. Localized swelling/welts on right hand.
When I look in the mirror, my left ball appears to hang a couple of inches lower than my right ball. Given that I got the shot in my left arm, I?m convinced that it was either the shot or else my mirror is playing tricks on me and might need to be replaced.
J96.00 ACUTE RESPIRATORY FAILURE 3/30/2022 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION J96.00 ACUTE RESPIRATORY FAILURE 3/30/2022 ELEVATED LIVER FUNCTION TEST
One day after vaccine, patient developed arm pain, swelling, inability to open hand.  Swelling, warmth, pain from upper shoulder to fingers.
Patient developed red, circular rash around injection site measuring 3.5 x 5.0 cm. The rash area was warm, red, and painful to patient. These symptoms occurred within 24 hours of vaccines. Patient was seen and treated in Urgent Care 9/27/09 and has a follow up appointment 9/28/09. The area referenced to is the upper left arm.
Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported
Sore neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Sore neck) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced NECK PAIN (Sore neck) and HEADACHE (headache). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache and Neck pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Sore neck) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
This spontaneous report as received from a nurse refers to a female patient of unknown age. The patient was vaccinated with expired dose of VARIVAX (Merck) lot # J013905, 0.5 ml injection, subcutaneously, expiration date: 30-OCT-2015 (frequency and indication not reported) as her booster dose on 05-NOV-2015. No adverse effects were reported. Additional information has been requested.
p/vax w/in 1 1/2min pt was leaving exam room & began to fall w/eyes focused & fixed & open;then began to tremble for approx 2-3min;