chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red, blotchy, irritable rash on chest and neck and then spread to shoulders and stomach; It was uncomfortable; It was very irritable; stinging sensation; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red, blotchy, irritable rash on chest and neck and then spread to shoulders and stomach), DISCOMFORT (It was uncomfortable), IRRITABILITY (It was very irritable) and PAIN (stinging sensation) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     The patient's past medical history included Syncope vasovagal in 2008, Hay fever and Wisdom teeth removal in 2016. Concurrent medical conditions included Penicillin allergy (Sores in mouth following wisdom teeth extraction) since 2016. Concomitant products included FLUOXETINE for an unknown indication.    On 23-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red, blotchy, irritable rash on chest and neck and then spread to shoulders and stomach), DISCOMFORT (It was uncomfortable), IRRITABILITY (It was very irritable) and PAIN (stinging sensation). On 28-Apr-2021, RASH ERYTHEMATOUS (Red, blotchy, irritable rash on chest and neck and then spread to shoulders and stomach), DISCOMFORT (It was uncomfortable), IRRITABILITY (It was very irritable) and PAIN (stinging sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that there was never any rash around the vaccinated area of her arm .The rash appeared to be healing on its own and was not as irritable. There were no other treatments used. Due to experiencing this allergic reaction, it was recommended and advised by a Moderna representative that she do not proceed to be administered a second dose of this vaccine.  The patient was treated with (HoneySkin) face and body cream anti-inflammatory cream -OTC   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Significant Follow-up received and patient demographics, medical history, concomitant medication, and event details updated.
I had a headache and bad body aches that lasted about 24 hours. The last weekend in June I started having dizzy spells on and off that makes me nauseous.
Area around the injection formed a 2-2 1/2 inch red hot rash. The area ached and hurt until Monday morning 10/10/2011.  I was told to go to the emergency romm if I became worse.
Reports he fainted for few minutes. History of same symptom to injection or venipuncture Refused to go to ER, refusal form signed
Case number PHEH2016US026125 is an initial spontaneous report received from a nurse on 26 Sep 2016. This report refers to a 10 months old patient of an unknown gender. Medical history and concomitant medications were not reported. The patient under the age of 4 years was vaccinated with FLUVIRIN (batch number: 1620201) at a dose of 0.5 ml (intramuscular) on 26 Sep 2016. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Initial unsolicited report received from a consumer on 07 October 2015. This case involves a adult female patient who was vaccinated with a dose of Fluzone (batch number: UH898AC, expiration date: 30 June 2014, dose, dose number, route and site of administration were not reported) on an unspecified day in 2013. It was reported that patient received Fluzone as required by her employment. The patient had several flu vaccines in the past and had the flu after each vaccine. Concomitant medication was not reported. On an unspecified date, four to five months following the vaccination, the patient experienced flu. Laboratory investigation and corrective treatment were not reported. The patient recovered from the event on an unspecified date. Upon internal review, company assessed the event of flu as serious and important medical event. List of documents held by sender: none. Sender's Comments: As with any other vaccine, INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE may not protect 100% of susceptible individuals. However, there is very little information in this case to confirm vaccine failure. No testing was done for flu strain identification. Information on the tests performed to confirm flu infection, the strain identified, as well as the patient's immune status at the time of vaccination (medical history, concomitant medications) would be needed to further assess this case.
45 minutes after received 4 month vaccination (DTaP, HIB) patient was asleep then began seizing (all extremities started shaking). Patients eyes were open and rolled back. Tongue was out and there were lip smacking.  The patient was unresponsive.  There was no rigidity or stiffening.  Mother did not look at time, but states that the whole incident might have taken about 10 minutes from start to finish. Event resolved in own.  Prior to incident mother claims that child had no fever, chills, cough, runny nose, vomiting, diarrhea.  Patient was admitted to hospital where the child had another event in the morning. 8/8/07-records received for DOS 7/24-7/26/07-DC DX: Complex febrile seizures. New onset seizures on morning of 7/24. According to mother, 45 minutes after vaccinations patient started to have bilateral arm and leg shaking, eyes were  opened and rolled back. Unresponsive. Aftewards patient was limp and poorly responsive with unfocused eyes for another 10 minutes. Fever spiked at 38.5.
ER diagnosis was right side Bell's Palsy. Began the standard 10 day treatment course of Prednisone and Valtrex within 48 hrs of onset. Recovery began 13 days after onset.
On Tues 05/17/16 in evening developed soreness, on Wed 05/18/16 developed swelling in left upper arm, warmth to touch and more pain in her arm, Fri "feels like she is coming down with FLU".
dry heaves; quite in distress; pain on right leg between the calf and shin; fever - 99.5F; Her whole body hurts and she's just lying on the couch; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), EMOTIONAL DISTRESS (quite in distress), PAIN IN EXTREMITY (pain on right leg between the calf and shin), PYREXIA (fever - 99.5F) and MYALGIA (Her whole body hurts and she's just lying on the couch) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gastroesophageal reflux. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for Gastroesophageal reflux.    On 05-May-2022 at 6:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced RETCHING (dry heaves), EMOTIONAL DISTRESS (quite in distress), PAIN IN EXTREMITY (pain on right leg between the calf and shin), PYREXIA (fever - 99.5F) and MYALGIA (Her whole body hurts and she's just lying on the couch). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RETCHING (dry heaves), EMOTIONAL DISTRESS (quite in distress), PAIN IN EXTREMITY (pain on right leg between the calf and shin), PYREXIA (fever - 99.5F) and MYALGIA (Her whole body hurts and she's just lying on the couch) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2022, Body temperature: 99.5 (High) 99.5 F.         Caller reports that patient is feeling better after taking meds and having electrolytes.
Vaccine shot it hurts and very sore 4 x 4 cm area with swelling/erythema.
G62.9 PERIPHERAL NEUROPATHY 4/7/2023 ADENOCARCINOMA, STOMACH, UNSPECIFIED SITE
doctor has me getting two more; doctor has me getting two more; This case was reported by a consumer via interactive digital media and described the occurrence of circumstance or information capable of leading to medication error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received two Shingrix shots in 2018).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error and extra dose administered. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and extra dose administered were unknown.  Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: This case was reported via interactive digital media. The patient reported that he/she had two Shingrix shots in 2018 and the doctor had him/her getting two more this year. The reporter enquired of the doctor's action was right. Additional Supportive Information: The patient had received two doses of shingrix and the doctor had him/her getting two more therefore, if received, could led to potential error, extra dose administered.
FEVER; FATIGUE; EXTREME JOINT PAIN IN ARMS AND HANDS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included neuroendocrine tumor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  Concomitant medications included octreotide acetate for neuroendocrine tumor. On APR-2021, the subject experienced extreme joint pain in arms and hands. On APR-2021, the subject experienced fatigue. On 02-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, fatigue and extreme joint pain in arms and hands was not reported. This report was non-serious.
Burning pain when injected and lasting for 2 days,  Fever, chills and muscle aches through 4/6/21.  Blood in urine beginning approximately 4/8/21 through 4/14/21.
PATIENT STATES SHE HAS SUFFERED FROM COLLAGENOUS COLITIS FOR YEARS AND HAS HAD EXACERBATIONS OVER THE YEARS BUT IS EXPERIENCING A BAD EXACERBATION SINCE THE SECOND PFIZER DOSE.
According to pt.'s chart, Pt's mom called office the next day stating that pt. had a headache and a low grade fever and requested a school excuse for the day. Client did not come to office to be seen.
c/o (L) cheek NUmbness 3/10 scale at 9:50 AM BP 118/52, 100, 20, 98% RA. Rechecked VS at 9:57 BP 127/77, 91, 18, 98% RA. (L) cheek numbness 2/10 scale. Rechecked VS at 10:11 AM BP 137/83, 91, 18, 99% RA (L) cheek numbness 2/10 scale.
VARIVAX underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 10-JUN-2021, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T029533 exp date 01-SEP-2022) (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
NVD, diaphoresis, severe rash to face. Complaints of throat "feeling funny". Immediately rushed to ER where Epi Jr. steroids, fluids, and Benadryl were administered. Pt is currently under observation and stable at this time.
Pt devel tenderness @ inject site, SOB, laryngospasms, high fever & enlarged lymph nodes approx 24-48 hrs p/receiving vax; Seen in ER 15JUN91; 2 days later taken to Hosp, due to breathing difficulty, was admitted;
17-year-old sister who received the Moderna COVID19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old sister who received the Moderna COVID19 Vaccine) in a 17-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old sister who received the Moderna COVID19 Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old sister who received the Moderna COVID19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-069858, US-MODERNATX, INC.-MOD-2021-067318 (E2B Linked Report).; Sender's Comments:  MOD21-069858: US-MODERNATX, INC.-MOD-2021-067318:Brother case
FEVER OF 103 DEGREES FAHRENHEIT, CHILLS, SHIVERING, LOSS OF APPETITE, HEADACHE, SKIN SENSITIVITY.  SYMPTOMS NOT SUBSIDING, LEADING TO TRIP TO EMERGENCY ROOM ON 10/31/21
I received the first dose on 12-29-2020. i was exposed to Covid on 12-31-2020. I experienced chills, left arm was incredibly sore at the site and radiated down my arm up to four inches. I tested positive for Covid on 01-05-2021.  I received my second dose on 01-29-2021.
1. Injection site soreness and swelling, 24-48 hours following administration. 2. Severe, uncontrolled diarrhea, 24 hours following administration 3. Severe body aches 24-48 hours following administration
Nausea  Vomiting  Extreme Muscle Fatigue  Chills  These symptoms began 24 hours after my second vaccination and lasted for 3.5 weeks. Today, they all recurred.  I have had no treatment.
INJECTION SITE REACTION. REDNESS, SWELLING, SKIN FIRMNESS AROUND INJECTION SITE.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 46-years-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EP6955),  at the age of 46, on Apr 13, 2021, in left arm, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (batch/lot# EP6955, location of injection: left arm, manufacturer: Pfizer), on Mar 22, 2021, for COVID-19 immunization. The patient developed injection site pain and symptom recurrence, onset Apr 2021, with outcome of unknown. Patient  described "recurring pain at injection site in left arm only/periodic and mild pain." No therapeutic measures/treatment taken as a result of injection site pain or symptom recurrence. Additional information: The patient had recurring pain at injection site in left arm only. Periodic and mild pain. She had no other vaccines in 4 weeks. She did not have COVID-19 prior to vaccination and it was unknown if she tested for COVID-19 post vaccination.
after the shot i felt sob, chest tightness, asthma got triggered, i developed fever and chills, body aches that lasted 3 days
Diarrhea likely due to COVID 19 viral infection:  Improving.  Patient tested positive on 02/04/2022.  No apparent respiratory symptoms, saturating well on room air does not in any COVID-19 specific treatment will continue supportive care for diarrhea, patient was having low potassium due to GI losses, improved significantly,
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported. On 05-JUN-2018, the patient was vaccinated with an improperly stored dose of PROQUAD lot # R002931, expiration date 29-JUL-2019, for prophylaxis (strength, dose, route and frequency were not reported) reconstituted with a properly stored sterile diluent lot # R002518, expiration date 12-DEC-2019 (concomitant therapy). The temperature excursion was -12.5 Centigrade degrees (°C), during 4 hours 19 minutes. However, a previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA006184.
Diarrhea starting around 10 am two days after vaccine lasting approximately 8 hours
dystonic reaction; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced dystonic reaction on an unspecified date with outcome of unknown.   Information on the lot/batch number has been requested.
first dose over 2 years ago / Missed second dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose was taken 2 years ago).   On an unknown date, the patient received 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report.. The patient got first dose of Shingrix over 2 years ago and missed second dose, which led to incomplete course of vaccination. The patient did not consent to follow up.
Expired Havrix Administered; A Health Care Professional called to ask for information regarding the administration of an expired dose of Havrix to a 14-month old patient. The reporter asked for information about the stability of the vaccine after the expiration date.  ~~~~~~~Consented to follow up.
Generalized pain across shoulders and back settling in low back with nerve pain shooting down leg for greater than 1 week
History taken from mom. Patient is a 4 y.o. O m.o female who presents in office today for evaluation of RT thigh swelling with onset mom noticed today but mom was not with pt yesterday. Pt has redness on right thigh at site of DTaP/IPV injection that was done in office this Wednesday. Raised and Warm to the touch of pain. No discharge. Appetite and activity levels are normal. Sleep is normal. No ill contact. No other contributing factors.
approximately 10 minutes after vaccine patient started feeling numming tingling in left hand and right leg. then also tweeching of right eye
Rash on neck, numb upper lip; treating rash presently with hydrocortisone cream
Itching at injection site, nauseous, drank water. BPs 101/59 (pulse 57), 106/58 (pulse 60).
Swollen glands; severe headache; muscle pain; extremely tired; body hurts; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number El3248/expiration date: unknown), via unknown route of administration, on 09Jan2021 12:30 PM (at the age of 60 years old) as a single dose on left arm for COVID-19 immunisation for COVID-19 immunisation at a Public Health Clinic/Veterans Administration facility. Relevant medical history included breast cancer last year. The patient had no allergies to medications, food or other products. Relevant concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient experienced swollen glands, severe headache, muscle pain, extremely tired, body hurts on 14Jan2021. The outcome of the events swollen glands, severe headache, muscle pain, extremely tired, body hurts was not recovered. No treatment was received for the events. Since the vaccination, the patient has not been tested for COVID-19.
I started getting symptoms of sore throat, cough, and lethargic. I took a COVID-19 test that was positive. I contacted my doctor and was prescribed PAXLOVID. After 3-4 days, my symptoms subsided.
Pt has pain swelling in left deltoid area. Warm and pink for 5 cm x 6 cm.
pt recv vax 5SEP95 & 30OCT95 pt by elisa method registered a neg seroconversion;lab eval on 27NOV95 revealed varicella antibody titer to be neg,again;
Female patient refers an episode of paresthesia in her left upper extremity immediately after receiving the third dose of the Pfizer Vaccine.
Case completed Covid Vaccine 2-dose series on 2/6/21, and tested positive for Covid on 7/21/21, when he was admitted to hospital for Covid pneumonia. He was discharged home 8/9/21.
Information has been received from a physician concerning a 34 year old male who on 09/16/2004 was vaccinated with a dose of varicella virus vaccine live.  On 09/17/2004 the patient developed chickenpox with 20 lesions with lasted 6 days.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
BIG INCREASE IN JOINT PAIN  ARTHRITIS AND HEADACHES LASTING  TO DATE  OVER ONE MONTH
Patient received Pfizer COVID vaccines on 02/19/2021 and 03/12/2021. Pt tested positive for COVID on 04/20/2021 and 05/17/2021.