chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She reports there was a knot there that formed on Saturday afternoon 7/24/21.  On 7/25/21, it had doubled in size. She describes it as baseball size red area. Describes upper back pain and small pain in LL chest. Advised her to take Benadryl and report to local ER.
Myalgia Narrative: Swelling in l axillary lymph and on left deltoid at injection site
immun 12noon 19JUN97 during the evening pt had uncontrollable crying & temp 104-105;
Burning in veins/arteries. Lower extremities weakness. Unable to be on feet over 2 hours a day
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. A Nurse Practitioner (NP) at a family practice recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of prevention and protection against shingles and zoster-related conditions. In or about October 2016, a healthcare provider at the family practice (unclear if was the NP) administered ZOSTAVAX to the patient (dose, route, and lot # not provided). In or about February 2017, the patient was treated by the NP for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
This spontaneous report received from a patient concerned a 37 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient or the patient's immediate family had no history of Vertigo.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 04-NOV-2022) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced severe vertigo (felt very dizzy and light headed also felt like the room was spinning around). On 23-NOV-2021, treatment medications included: meloxicam.The action taken with covid-19 vaccine ad26.cov2.s was not applicable.The patient was recovering from vertigo (felt very dizzy and light headed also felt like the room was spinning around).This report was non-serious.
No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A.  Treatment information was not provided.
Patient was given the Pfizer bivalent booster instead of the first of the Pfizer primary series for covid.
Information regarding Flu Shield was received from a consumer, a 48 year old female patient who experienced injection site reaction, the site was big, red, hot. At 48 years of age, the patient received a dose in 1998. The patient's concurrent illness included hypothyroidism. Indication for Flu Shield was prophylaxis. Product was administered in 1998. Dose regimen was 1 dose 1 times per 1 day (IM). Concomitant therapy included Synthroid. In 1998, the patient developed an injection site reaction. The patient described the site as being big, red, hot. The event resolved with rubbing and massage. No additional information was available at the time of this report.
Swollen lymph node in the armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 31 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Jan2022 (Lot number: FE3594) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 07Jan2022, outcome "unknown", described as "Swollen lymph node in the armpit".  Additional information: The patient received the booster dose of the vaccine this past Friday (07Jan2022) and has had a swollen lymph node in that arm since then.  No follow-up attempts are possible. No further information is expected.
Fever of 102 - from about hour 18 to hour 24 it was the worst. It broke at 39 hours. Sweat in bed. Fatigue, from about hour 4 to hour 39 after the shot, I felt completely drained. Swelling of the throat and sinus passages. A full 74 hours later so I don?t know if it?s related or if it is some allergy outside.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Flu vaccine with an associated reaction of injection site pain (for tolerance of Flu vaccine refer case US2019GSK009119). On 26th July 2018, the patient received the 1st dose of SHINGRIX. On 26th July 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.  It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The SHINGRIX vaccine had hurt the patient's injection site badly. The reporter did not consent to follow up and patient did not wanted to provide any details. The reporter did not gave consent to follow up. The patient did not want to provide any details. For tolerance of Flu vaccine refer case US2019GSK009119.
Rendering provider during appointment ordered Hep A (Vaqta) adult vaccine which was administered by writer/medical assistant near end of visit. Further treatment and outcomes unknown by writer.
pain in back; tingling; heartburn; nausea; Fatigue; body ache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN, PARAESTHESIA, DYSPEPSIA, FATIGUE, and MYALGIA in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FATIGUE and MYALGIA. On 21-Feb-2021, the patient experienced BACK PAIN, PARAESTHESIA, DYSPEPSIA, and NAUSEA. At the time of the report, BACK PAIN, PARAESTHESIA, DYSPEPSIA, FATIGUE, MYALGIA, and NAUSEA outcome was unknown.            No concomitant medication reported  No treatment information was provided  COVID-19 Vaccination
Vomiting; Diarrhea; Body aches; Migraine; felt run down; This is a spontaneous report from a contactable health care professional (patient; other HCP). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on an unspecified date (at the age of 24-years-old) as fist dose, single dose for COVID-19 immunisation. Medical history included chronic migraines from an unknown date and unknown if ongoing. Concomitant medications included topiramate and spironolactone; both taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. The patient has no known allergies. On 02Mar2021 03:00AM (reported as Early Tuesday morning), the patient experienced vomiting, diarrhea, body aches, migraine and felt run down. No treatment was taken for the events. The outcome of the events was recovering. The patient was vaccinated with the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6206) intramuscularly in the left arm on 06Mar2021 04:45 PM.  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.
Left arm swelled and red from elbow to shoulder. Warm to touch x 3 days. Ice to arm, Benadryl, and Ibuprofen given.
Immediately after vaccinated, felt weak, dizzy, and nausea's. Symptoms persisted throughout the day and worsened next day to generalized weakness requiring assistance to walk.
Within 24 hours client complained of itching, but didn't seek medical care.  By Friday, August 24th, hives appeared on his back.  He then went to a local medical clinic and was treated with a Medrol dose pack and Zrtec.  By Monday,August 27th, the hives had spread from his neck to his knees and complained of difficulty swallowing.  He then received an injection of Prednisone 20mg and then oral Prednisone 20mg for 9 days and then a decreasing dose there after.  As of August 30th he is seeing a disappearance in the hives.
Patient was administered ActHib that had expired on 9/11/23, 2 days prior to her appointment in the office.     Called Immunization Program and spoke with nurse who advised there were no health concerns for the child, however, she would have to repeat the dose of Act Hib.
severe diarrhea; terrible headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "severe diarrhea"; HEADACHE (non-serious), outcome "unknown", described as "terrible headache".   Additional information: The report was not related to a study or programme. The reporter had a very bad reaction to the first dose of the Pfizer Covid vaccine, and someone told her that she had similar symptoms, severe diarrhea and terrible headache. It was (name withheld) and she was over the study, that was who reported the same symptoms that the report also experienced.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received Anthrax #1 on 9/3/03 and #2 on 9/17/03; left tricep. Swelling that began at shot site and expanded past elbow. Required 3 physician visits and possible admission. Abx and pain reliever.
Pt reported chest and side pain to the pharmacist following immunizations. Pain started within the hour of receiving the immunizations and resolved within 10 minutes after it started. Pharmacist followed up with patient about an hour after the pain and he said he was still feeling all right. He believed the pain to be gas pain.
Fever, headache, joint pain, pain at the vaccination site, swelling, irritation, Faustian, fatigue among others
Expired vial was stored in the refrigerator the day before administration; expired doses administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered to patients) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses administered to patients) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported.  Patient received the first booster dose of Moderna vaccine on 04-Apr-2022 (Expiry date: 02-Apr-2022).   It was reported that, the vials was initially stored in refrigerator a day before the administration and vials did not undergo any temperature excursions. The patient had not reported any adverse reactions to the dose.   No information on treatment medications was reported.   This case was linked to MOD-2022-558954 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Live follow up received contain no new information
Patient was diagnosed with COVID on 7/31/2021 after being vaccinated with the Johnson & Johnson vaccine in April 2021.
After receiving Dose #1 of Pfizer vaccine in left shoulder, severe swelling of lymph nodes in left neck, left collarbone and left armpit occurred for about a week before subsiding. Lymph nodes were very tender to the touch with the collarbone area protruding enough to be noticed without touch. After around 1 week after discovery, lymph nodes reduced in swelling.
Information has been received from a health professional concerning a child who was vaccinated with a dose of varicella virus vaccine live. it was reported that the patient experienced breakthrough chickenpox sometime from 27-FEB-2006 to the present, 17-MAR-2006. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Information has been received from a consumer concerning his 81 year old wife with high blood pressure and a history of heart failure who on 5/27/05 was vaccinated with a 0.5ml IM dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included warfarin sodium, furosemide, irbesartan, digoxin, Penorim, and CATAB. On 5/28/05, the patient experienced swelling at the injection site, described as a bump. It was reported that the patient was groggy and sickly. The patient was told by the doctor to apply ice, which she did not do. At the time of the report, the patient was recovering. No product quality complaint was involved. No other information was provided. Additional information is not expected.
pt recv vax in early fall 1994 & pt fainted fully recovered w/o tx;
10:55 AM-after taking the flu/H1N1 vaccines she started having R lower leg numbness/weakness. No SOB, no rash. Pt examined by provider, alert oriented, happy, talkative. Pt referred to ER for further evaluation.
Feeling bloated and stressed out. I feel the heart skips a beat few times, and the heart rate drops by 6 to 8 beats each time I have the feeling.
Mother states 2 days after pt received vaccinations, she developed a puritic rash to her abdomen. Over time, it spread over her torso, back, bilateral upper and lower extremities. Diffuse raised papules, surrounding skin is dry.  Treatment: Prednisone, Benadryl, Pepcid, TAC cream Outcome: Unknown- came to urgent care center, but received vaccinations at health department
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 10-Sep-2014, the patient was inadvertently vaccinated with the fourth dose of GARDASIL (dose, route, lot # and expired date were not reported). Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
10 pm became extremely fatigued. Midnight nausea and dizziness. 2am vomiting increased nausea. 4 am vomiting. 8am body aches sever headache
On 3/28/06 Pt came into DR office complaining of fever, vomiting and diarrhea for 3 days. He had been treated with Motrin and Tylenol. ON exam he was lethargic has white nasal discharge, mildly erythematous tonsils and lymphadenopathy. He tested positive for influenza B on Quidel Quickvue.
RASH. PT CURRENTLY SEEING DERMATOLOGIST AND WAITING FOR RESULTS FROM BIOPSY.
Temperature excursion; Vaccine administered to patient after temperature excursion; Temperature excursion; Vaccine administered to patient after temperature excursion; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Lot number: EW0167, Expiration Date: 31Aug2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 2021, outcome "unknown" and all described as "Temperature excursion; Vaccine administered to patient after temperature excursion".  Additional information: It was reported temperature excursion on the Pfizer vaccine, the Covid vaccine. So, the first one is from, actually this is not the freezer, it is a refrigerator excursion and it happened 4 different times. The first time this was on 01Jul2021, it happened at 5:20 AM, the temperature went to 8.6 Celsius and it was there for about 10 minutes and then on 08Jul2021 at 1:05 AM, 8.28 degrees for 5 minutes and then on 20Jul2021 at 9:55 AM, 8.2 Celsius it lasted less than a minute and then 28Jul2021 at 9:25 AM, 8.4 Celsius, it lasted 10 minutes.The vaccine was administered to patient after excursion, reporter stated. Reporter stated did not had any patient's demographic details or medical history. The vaccination happened here in the district of on hospital campus.  No follow-up attempts are possible. No further information is expected.
Tiny rash-like red dots appeared on torso and back in the morning. By 3pm, the rash had become larger, more visible and had spread to extremities. By the next morning, 7/27/16, the rash had intensified and spread to face.  Bumps become extremely red, raised and some clustered together (none blistered or oozed - just red and raised). Had consistent temperature above 100-degrees F for 24 hours. Temperature reached up to 101.9. Called Doctor everyday, and spoke with nurses. Finally, we were able to go to Dr. and he indicated this was worst reaction to MMR Vaccine he had seen in over a decade. Rash symptoms still present after 6 days.
patient was given moderna bivalent booster that was expired after the 12 hour expiration date. This has been reported to moderna. Case spoke with agent. Per agent states we must wait for moderna to contact us when patient is able to get revaccinated.
A little over 24 hours after shot experience all listed symptoms occurred (headache, nausea, chills, tiredness, muscle pain). The level for each was at about a 2 or 3. Symptoms persisted the following day. On day 3 I began to start feeling like myself again.
Moderna COVID-19 Vaccine EUA. I have had insomnia and anxiety everyday since 1 month after 2nd dose.
S:- Pt noticed rash on the face, neck and trunk on 3/5/10. O:- vitals stable, Macule papular rash on the sides of face, forehead but mainly on trunk no pustules no vesicles. A:- possible MMR related rash P:- Reassurance no meds prescribed.
I have had ongoing dizziness since receiving the Pfizer vaccine.  Doctors have not been able to provide any decisive explanation for the dizziness
Received injection at 9:15 AM and that same day at 6:00 PM starting feeling a headache.  At 4:00 AM on 2/5/21, woke with body aches, severe headache, and significant fatigue.  Took Tylenol morning of 2/5/21 which helped some and the side effects lessened throughout the day.  Woke with only mild headache on 2/6/21.
4 weeks of limb weakness and fatigue, UE first, then LE. No pain, soreness, numbers or tingling. Intermittent muscle twitching.
An MA reported that a child received Acel-Imune, Prevnar, Hib and Varivax vaccines on 5/25/00 and within 24 to 48 hours, post vax, the child developed an injection site reaction characterized by a red, warm and hard welt at the site of the Acel-Imune administration. This is 1 of 6 pts from this facility who experienced this event following receipt of 3 different lots of Acel-Imune.
I had my appointment to get my COVID-19 booster and I was not sure if I was just tired or was feeling sick. I was feeling tired and run down, it's also allergy season where I am at, and I had postnasal drip and did not think too much of it as it could be just allergies kicking up. The appointment was in the morning and as the day went on, I got worse. I had a headache, body aches, some respiratory issues that got worse that I had attributed to allergies, I was having to go the rest room super frequently which happens to me when I am sick, I had body chills and a fever which the highest it reached was 101. I ended up taking a COVID-19 home test on the morning of the 30th and it was positive. I reached out to my health care provider, and they did give me a prescription for Paxlovid which I did get from the pharmacy because of the holiday and was worried I may be able to get it. Friday night I was feeling a little better and I was using Tylenol to help with the fever.  By the 31st I was doing much better and at this point have not taken the Paxlovid becacuse each day I am feeling better.