chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 2y ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 2 years ago).   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: 28-Sept-2022 Reporter's comment: The patient was the reporter. The patient never receive 2nd shot. The patient provided limited information.  The patient did not want to answer any further questions.  Did not get an opportunity to ask for doctor of medicine (MD) contact information as the patient wanted to get off the phone. Additional supportive information: Till the time of reporting, the patient did not receive 2nd shot of Shingrix, which led to incomplete course of vaccination.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 80 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EN9810), on 27Feb2021 as dose 2, single (Lot number: EN6203), on 19Aug2021 as dose 3 (booster), single (Lot number: FA7485) and on 22Mar2022 as dose 4 (booster), single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history included: "Cancer" (unspecified if ongoing), notes: States she went off all her cancer pills because she was afraid and she didn't want to overdose. The patient took concomitant medications (Stated she went off all her cancer pills during PAXLOVID treatment because she was afraid and she didn't want to overdose) The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: Blood test: It all came back fine, notes: Tests: Caller states her Gastro Doctor sent her to get blood work done after to make sure her electrolytes were okay because she had diarrhea for 5 days; SARS-CoV-2 test: Positive, notes: Tested positive for Covid 19 after having the Covid 19 Vaccines and Boosters; Weight decreased: she lost a lot of weight, lost 4 pounds, notes: Height: States she is shrinking she lost a lot of weight, lost 4 pounds in 5 days. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 28-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-051570 (Patient Link).
Starting  Sunday April 11th I began having diarrhea   in the afternoon it would need to frequent the restroom roughly every hour or so. As the day progressed The frequency increased and I began having a fever in the afternoon around 4:00 p.m.   The fever continue to increase into the night and reached a point around 102?F and was paired with loss of energy/lethargy. Temperature reach just above 103?F over the night but bounced to a low as 98?but stayed around a 101-102.  The night was filled with chills and it was highly challenging to sleep.   That Monday 4/11 brought serious headache to the frontal lobe and behind my eyes in a way of not felt before along with severe stomach cramps and frequent needs to go to the restroom due to diarrhea. There was also total loss of appetite. I was bed ridden and slept all day. The combined pain brought me to tears regularly.  I went to urgent care that afternoon and also took a covid test. That night the fever broke.  Tuesday 4/12  The fever dropped to roughly 99?F In the headache mostly went away But the stomach cramps became more severe . The stomach cramps may have been equally as bad the previous day but I don't recall due to the fever and lethargy. I began tracking the times of each stomach pain and restroom visit and my results show a frequency of stomach pain/craming every 10-15 min.  These  Pains also brought me to tears and i had no appetite.   On Wednesday there were also stomach cramps in the morning through the evening but they were much less frequent going from roughly once an hour to once every few hours
Husband reports warm, red puffy reaction at injection site. Area measures about 1 x 3 inches.
Date of Admission: 11/15/2021   Date of Discharge: 11/17/2021  Reason for Hospital Admission (Admitting Diagnosis):  Acute hypoxemic respiratory failure from COVID Pneumonia 81 yo lady from home, s/p COVID vaccine x 2 in 02/2021, with known HTN, preDM, chronic bronchitis developed URI s/s on 11/08/21, found to be COVID positive on 11/11/21, presented to ED on 11/15/21 due to 3 days duration of worsening sob with hypoxemia.   1. Acute hypoxemic respiratory failure from COVID pneumonia. Elevated ddimer likely due to inflammatory process from COVID infection rather than VTE. Clinically not consistent with acute CHF or COPD exacerbation. - now on NC 2-3 L.min. Goal SpO2 >92%. Consider ICU evaluation if requiring >40LPM and 60% FiO2 for SpO2 >/= 90% - Self-proning as tolerated for O2 req >3L - Decadron 6mg IV or PO qday for up to 10 days (started on 11/15/2021) or until no longer hypoxic. - Remdesivir 200mg IV x1 on 11/15/21, followed by 100mg IV daily until clinical improvement or 5 days. - Daily LFTs. Noted slight elevated, likely due to remdesivir, will cont to trend, will hold Remdesivir if ALT >10xULN or CrCl<30 - GI prophylaxis with pepcid - trend inflammatory markers every other day  - Lovenox 40mg SQ BID (BMI>40) and hold for Plt <25k, Fibrinogen <100, active bleeding - enhanced isolation in hospital per Regional/Local ID guidance.   2. PreDM - ssi in house while on steroid   3. HTN/HLD - cont PTA lisinopril/HCTZ - cont PTA lipitor    4. Moisture Associated Skin Damage to the buttocks/cleft, groin, labia with erythema + Scar tissue to the right distal lower leg from previous ulcers related to lipodermatosclerosis. No open ulcers at this time.  - To the buttocks, cleft, bilateral groin, peri area and labia, clean with warm water cleansing cloths and pat dry. Apply Critic Aid Anti Fungal ointment BID and PRN soiling. Protect Sacrum/buttocks with Mepilex sacrum border dressing, changing every 3 days and PRN soiling - To the right lower leg, clean with warm water cleansing cloths and apply Atrac Tain Superior Moisturizer BID - appreciate wound nurse iput Condition on Discharge:  Stable to be transfer to another acute hospital for continue care.   Code Status at Time of Discharge: Full Code   Discharge Disposition:  Another acute hospital
Pt fainted approx 5-10  mins after receiving vaccine. No Hit to head VSS left after 15 min.
patient experienced fever, chills, body aches, and odd metal taste in mouth for several days after receiving shot
Significant swelling and erythema of arm from acromion process to below biceps; radiating pain down back and chest.
pt devel redness & swelling (8inches) of lt deltoid p/vax; swelling, no fever or cellulitis;
devel fever 105 several hr p/vax; 48 hr later devel rash, red throat-throat culture done;
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 57-year-old male patient received BNT162b2 (BNT162B2), on 01Jul2022 as dose 4 (booster), single (Lot number: FP7135), in right arm for covid-19 immunisation, Covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: Unknown), as dose 2, single (Batch/Lot number: Unknown) and as dose 3 (booster), single (Batch/Lot number: Unknown) for covid-19 immunisation. The patient relevant medical history included: "Known allergies: CT contrast dye" (unspecified if ongoing). Concomitant medication(s) included: VIT C, start date: Jul2022; VIT D [VITAMIN D NOS], start date: Jul2022, ZINC, start date: Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering'', and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID-19 Treatment, (25Jul2022) Negative, (31Jul2022) Positive. Therapeutic measures were taken because of drug ineffective, covid-19. The patient received treatment of Paxlovid for COVID-19 from 18Jul2022 to 23Jul2022.  Clinical course: Patient Tested Covid negative 25Jul after treatment, and tested Covid positive 31Jul. Rebound Covid and patient experienced hardly any symptoms second time.
This spontaneous case reported by a pharmacist, describes the occurrence of product administered to patient of inappropriate age (16-year-old/unauthorized age group received Moderna COVID-19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 068H21A) for COVID-19 immunization. No medical history reported. On Jan 18, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 18, 2022, patient experienced product administered to patient of inappropriate age (16-year-old/unauthorized age group received Moderna COVID-19 vaccine). On Jan 18, 2022, product administered to patient of inappropriate age (16-year-old/unauthorized age group received Moderna COVID-19 vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Reported receiving the Tetanus injection on 09/28/13 and developed a rash, small itchy red bumps to both of his inner thighs and to both upper arms the bicep area with onset of sx on 09/29/13, approximately 24 hours after the injection and lasted approximately 24 hours until 09/30/13. Denied any itching or rash to the injection site or any other s/s. Stated, applied OTC Hydrocortisone cream once to the affected areas 16 hours after the onset of sx.
patient reports bilateral hand discoloration and swelling morning after covid vaccination- hands discolored no appreciable swelling, not clearly an allergic reaction, for reporting purposes
Upon receipt of second dose of Moderna COVID-19 vaccine, patient reported signs and symptoms of SIRVA (Shoulder Injury Related to Vaccine Administration). Patient indicated a little after 3 hours from receiving her first dose of vaccine she experienced severe shoulder pain and stiffness. She reported the pain and stiffness is still persistent and indicates she is unable to raise her arm above her shoulde.
patient was given a extra dose of MENACTRA in error; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via Agency (Reference number- 00365781) and transmitted to Sanofi on 19-Nov-2020.  This case involves a 16 year old female patient was given a extra dose of MENACTRA in error (extra dose administered), while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included first booster dose of MENACTRA in unknown date in 2016. Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was a potential medication error due to extra dose administered.  On 02-Nov-2020, the patient received a second booster dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of 0.5 mL (lot number U6827BB, Expiration Date: 18-FEB-2022, Strength Standard) via an intramuscular route in the left arm and On 19-Nov-2020, she also received a third booster dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE in error (extra dose administered).  At the time of this report, 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.
Moderna COVID-19 Vaccine EUA. No adverse reaction or side effect from the first Moderna COVID-19 Vaccine administered on 25 Feb 21.   Approximately 15 hours after the second shot, administered 25 Mar 21, I developed a moderately severe tension headache on the lower left side of my head near the neck.  This continued for approximately 72 hours, slowly fading during that time period.  I also experienced general fatigue and overall mild pain for 24 hours, similar to a case of the flu but with no nausea.  Symptoms responded to Tylenol and one day bedrest.  No other adverse reactions.
Itching at the site of injection within hours of receiving the injection. Large red welt about a half inch beneath the needle stick. Over the next 1-2 days, the welt it grew in size and became hard and painful. My arm continued to itch for 3-4 additional days and the welt slowly resolved. Finally, after about a week, the welt was no longer raised and was a flat red circle that slowly faded over the next 8-10 days until it resolved fully.
W/in 24 hrs p/vax experienced fever & hives (Covered entire body), tx included Atarax 1/4 tsp every 6 hrs. 3 days p/immun, parents reported child was asymptomatic.
Initial burning and pain left arm that subsided- try local chills/fever etc. But about four days after: severe  throat ache,  Full sinus infection and full asthma attack episodes. Lack of air
Vaccine administered yesterday, patient had dysphagia, slurred, slow speech upon waking at 0530 AM.  ED results  showed no acute changes on MRI Brain with contrast, CTA Head and Neck with Contrast, or CT  of Head without contrast.  Tele-Neuro and Hospitalist recommended transfer to a stroke center and patient transferred.
Site: Pain at Injection Site-Medium, Systemic: Magnet was sticking to arm-Mild, Additional Details: Pt produced a magnet and demonstrated it sticking to her left deltoid, the site of her 1st COVID vaccine dose. Pt demonstrated this was indeed a real magnet as it stuck to a piece of metal in the store. The magnet did not stick to her other arm. Pt reported she had arm pain for the first 48 hours after the dose, and no other adverse reactions. Pt tested positive for COVID in January 2021.
This spontaneous report as received from a registered nurse refers to an approximately 2-year-old female patient with no known allergies and no pertinent medical history. On 07-OCT-2010 the patient was vaccinated with dose 1, 0.5 milliliter M-M-R II (lot # not reported) subcutaneously in the left arm. Concomitant medications included: diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) te) (reported as DtAP. On 31-OCT-2010 patient presented to the doctor office with a lump on the left side of the neck. Patient was then taken to the emergency room (ER) for follow-up and was diagnosed with Parotitis, which ER staff stated was caused by the M-M-R II. Patient was not hospitalized. On an unknown date the patient recovered from the event. Nurse stated that she was awaiting the reports of the ER for further data. The event Parotitis is related to M-M-R II. Treatment information was unspecified by the reporter. The patient sought medical attention, came into office and went to ER. Additional information has been requested.
Batch number on my vaccine report 1) FE9174 (26/07/21)  2) EY0581 ( 08/09/21) Major Menstrual Disruption  in my accurate 27 days menstural cycle.  No possibility of pregnancy. Had no menstrual cycle after my first injection 26 July which was due on 30th of July 2021 For 1 week, 48 hours after my second dose - extreme random heat surges predominently over legs and arms, sweating a lot at night.  difficulty regulating body temperature.  2nd missed menstural cycle due on 25th August 2021 although mild cramping had been experienced. 3rd missed menstrual cycle due on 20th September 2021.  I have no menstrual conditions and have a precise 27 days cycle. No life style change.
Varicella-form rash on extremities & trunk. Rx'd - Acyclovir 400 mg qid x 7d.
Pt developed itching sensation approx 30hrs /p inject,intensified over next 3-4 days.Day 6 itching pronounced& noticed "bumps" on back,this intensified on day 7.Day 8 5Feb91 /p walking had pallor,sweating&c/o difficulty breathing.. see WORM
Patient had fever the day after the of receipt of the vaccine (on 7/18)  but then on 7/20 started to complain of mid sternal chest pain which lasted that day. He was evaluated in the ER and based on labs and history, admitted for evaluation. His chest pain had resolved by the following day.
The left arm that the ENGERIX B was given in became very sore and stiff and hard to lift. It also started to go numb. The provider diagnosed a type of bursitis and believes the shot was given too high. She prescribed physical therapy.
Serious vertigo, started as Positional Vertigo, evolved into general dizziness and nausea, currently less violent but still present
This spontaneous report as received from a Registered Nurse (RN) refers to 5 patients who were vaccinated with doses of PNEUMOVAX 23 (dose, frequency and route unknown). Nurse was reporting that the patients reported to had reactions after receiving PNEUMOVAX 23. All the patients experienced fever and chills along with swelling and tenderness at the injection site. One patient experienced blisters (which was captured in Marss # 1212USA005230). Three patients required antibiotic treatments. This case refers to one of the patients who on 31-OCT-2012 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H010515, expired date 14-FEB-2013). At the time of reporting the patient had recovered from the adverse events. This is one of several reports received from the same source. Additional information has been requested.
Patient developed seizure like activity that evening after she received the varicella vaccine. Then had respiratory arrest resulting in her being placed on ventilator for 48 hours.  Discharge summary received on 4/13/2003 indicates fever and pneumonia.
Chills started the next evening at approx. 1900 and lasted 8-10 hours. Could not get warm.
Rash 2 weeks after 1st injection, skin irritation, swollen bilateral supraclavicular lymph nodes.
Feeling weak; Tired; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ASTHENIA (Feeling weak) and FATIGUE (Tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 01-Feb-2021, the patient experienced FATIGUE (Tired). On 02-Feb-2021, the patient experienced ASTHENIA (Feeling weak). On 01-Feb-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ASTHENIA (Feeling weak) and FATIGUE (Tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient reported using Pepto tablets for Diahrrea
Headache; Tiredness; Sleepy; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via unspecified route on right arm single dose for COVID-19 immunization on 09Jan2021, 10:00 AM, at 44-year-old. Medical history included: allergies: dust. The patient did not have COVID prior vaccination. Concomitant medication was not reported. No other vaccine received in four weeks. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on left arm for COVID-19 immunization on 19Dec2020, 10:15 AM. On second day after the second dose of BNT162B2, on 10Jan2021, 08:00 AM, the patient had headache, tiredness, sleepy. No treatment received. The patient was tested for COVID, by saliva with negative result on 16Dec2020, by nasal swab with negative result on 07Jan2021. Action taken for BNT162B2 was not applicable. Outcome of the events was resolving.
Gave client Td, MMR, and Hepatitis B. Client had seizure within seconds of after administering the last vaccine, Hepatitis B. She had her eyes rolled and muscle contracted. Seizure lasted about a minute. Client gained her conscious back. Client didn't remember her having a seizure. Client went to E.R. by ambulance.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. The patient was prescribed the ZOSTAVAX vaccine by a pharmacist for the long-term prevention of shingles and zoster-related conditions. On or about 22-JAN-2013, the patient was administered the ZOSTAVAX vaccine. The patient was treated by a healthcare provider for the following injuries resulting from the patient's ZOSTAVAX use: shingles and post-herpetic neuralgia. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the event was unknown. Causality assessments were related.
Patient said she experienced a cooling sensation that  started a few minutes after her vaccination and it goes across the roof of her mouth and stays for about a week. She said it is not painful, just noticeable.
Patient experienced swollen upper left arm and fever reaching 103.6 degrees. Both occurred right after shots. Patient went to hospital. Patient was admitted to hospital for 2 days and put on KEFLEX for one week. Patient now ok.