chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 3/6/01 had wheezing at 10:30 AM and at 14:30 had hives and woke up screaming. Seen at ER on 3/6/01 and given 2 doses of Benadryl. She was also treated for ear infection. Mom states was told to continue Prevnar series. We told pt we would not give at our facility and referred to MD. Directed mom to discuss thoroughly with MD before any further Prevnar vaccines given. Mother requested Prevnar insert be mailed to her.
Patient had extreme flu like symptoms (fatigued, upset stomach) that night and for the next three days. Patient missed work.
might have tracked a germ; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFECTION (might have tracked a germ) in a female patient of an unknown age 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) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced INFECTION (might have tracked a germ). At the time of the report, INFECTION (might have tracked a germ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided   This case was linked to MOD21-091802, US-MODERNATX, INC.-MOD-2021-148856 (E2B Linked Report).; Sender's Comments:  MOD21-091802:Same reporter, different patient US-MODERNATX, INC.-MOD-2021-148856:Same Reporter
This spontaneous report as received from a nurse practitioner refers to multiple unspecified patients of unknown age. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date the patients' were vaccinated with improperly stored ROTATEQ (lot # L033693 expiry date 31-MAY-2017, lot# M012495 expiry date 09-OCT-2017, lot# M025568 expiry date 07-NOV-2017). These vaccines were exposed to 46.8 F for 78 minutes. No adverse effects were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a female who was vaccinated with GARDASIL vaccine (yeast). The patient developed warts on hands after vaccination. The outcome of the patient was unknown. This is one of several reports from the same source. No further information is available.
Heart palpitations, shortness of breath, and near syncope x 8 episodes, Year of 2021. With any physical exertion, I have had above symptoms mentioned.  Symptoms will last 5-10 minutes, I have to lay down on my back and raise my legs up in the air to alleviate my symptoms. No previous h/o of heart problems prior to vaccination.
This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 20-Jun-2021. On 05-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). On 05-Jan-2021, EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Company Comment  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
The person is an emt and arrived to get a vaccine. The nurse triaged and administered the vaccine. Vaccine administration to a person below the age for EUA approval was discovered during a routine chart audit and looking for persons who did not complete immunizations for COVID. this was discovered on 5/14/2021. I spoke with the mother ( since person is a minor) and informed her of the vaccine error. The person reported that the person who received the vaccine did only experience local side effects for 1 day of pain at the vaccine administration site. the mother reported that the patient returned to  his regular duties.
I was on a trip abroad with a group, and two of my colleagues tested positive for COVID-19. I tested positive for COVID-19 on 1/13/2023. I isolated and took it easy. I just had aches, mild cold symptoms, and if I had a fever, it was a very minor one. I was mostly tired and achy. I also had sniffles that lasted maybe three or four days. I also had mild diarrhea. I had a phone consult with my doctor, who did not want me to take PAXLOVID on account of the diarrhea. I just took a little bit of ibuprofen. On maybe 1/27/2023, I tested negative for COVID-19.
Patient presented to the ED and was subsequently hospitalized for pulmonary embolism within 6 weeks of receiving COVID vaccination.
A report was received from a health care professional on 10/23/2003 concerning a 56 year old male vaccinee who inadvertently received 2 doses of Fluvirin on 10/22/2003. On 10/22/2003 the vaccinee inadvertently received 2 doses of Fluvirin, one in each deltoid. It was unknown at the time of the report whether or not the vaccinee had experienced an adverse event. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update report, 1/19/2004: Follow up information received from a health care professional indicated the vaccinee did not experience any adverse event following inadvertent administration of Fluvirin.  No follow up pending, all information received.
08:40am: vaccine administered, Patient was monitored x15 minutes post administration in office, no adverse reaction noted. Patient contacted clinic at 12:40pm stating she took a nap and woke up unable to move left arm and having pain throughout body. Triage nurse had patient report to the ER for emergency medical attention.
According to pt's mom child developed a few rash on body & face, 1/2 hr after receiving immunization which progress to covering entire body. Pt seen the following day 9/21/01, 12:30pm given epinephrine injection and benadryl.
Sneezing, redness, & cough after immunizations given.  BENADRYL & EPI given.  Pt observed X 1 hr d/c home in stable condition.
soreness around injection site; vaccine administered at inappropriate site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st May 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 21st May 2019, 2 hrs after receiving Shingrix, the patient experienced injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced injection site pain. The reporter stated that, the patient was vaccinated in the fat of their upper arm rather than in the muscle which led to intramuscular formulation administered by other route. The patient started to feel soreness around the injection site about 2 hours after the injection. It has improved, but at the reporting time his arm was sore a little bit around the injection site. The reporter mentioned that the pharmacist gave them some paperwork and the lot and expiry for the product could be on it. The reporter consented to follow up. This case has been linked with case US2019093219, reported by the same reporter.
After first dose on March 18th, I did not have a menstural cycle. I didn't have one before my second dose in April and still haven't had one in the 3 months after. I had been having regular cycles before receiving the vaccine.
headache; I get a discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Apr2021 10:00 (Lot number: ER2613) as dose 2, single and administered in arm left, administration date 17Mar2021 09:15 (Lot number: En6207) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. The patient's concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious), outcome "recovered with sequelae", described as "headache"; DISCOMFORT (non-serious), outcome "recovered with sequelae", described as "I get a discomfort". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, discomfort. No other vaccine in four weeks. No COVID tested post vaccination. No known allergies. Adverse event: So there are many reasons for a headache but I believe that every time I'm in contact with COVID-19 And my body senses it's presence it quickly fights it but a slight headache comes on. I have taken my blood pressure check see if I'm congested maybe your allergies but nothing. Only after being in large crowds like beach at work and not always strange theory of mine I'm no Dr. but the coincidences got me thinking I get a discomfort and I think it's when my body is fighting covid because I was exposed. No treatment for adverse events. Recovering with lasting effects.  Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.
sore arm; due to pain was unable to sleep; migraine for 24 hours; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunisation and was fine after the first injection. On an unspecified date, the patient experienced migraine for 24 hours, sore arm and due to pain was unable to sleep. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
felt malaise immediately p/vax 12NOV92; lt arm @ site of inject swelled-30x40mm-erythema-induration, bruising-16NOV92 area remains red, swollen & itching;
child's face and hands turned red/flushed with mild swelling  (lungs clear, no respiratory symptoms, airway was not compromised), chidl was alert and crying HR 156 and 99% oxygen saturation  child was given Benadryl 5 mL (12.5 mg) and was monitored for next 15-20 minutes. eventually the redness/swelling resolved  This was the 4th flu vaccine she has had in her lifetime.
emotionally distraught and crying. It got really bad the second day after the shot and slowly improved over a week
Red warm area which continued to enlarge in size decreased go down to at 1" above elbow.
Vaccine exposure during pregnancy; pregnancy; 5 weeks pregnant but in need of her second dose; 1st dose of the vaccine given on an unspecified date in May or June 2021; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given on an unspecified date in May or June 2021), PREGNANCY (pregnancy) and INTENTIONAL PRODUCT USE ISSUE (5 weeks pregnant but in need of her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. The patient's last menstrual period was on 30-Jun-2021 and the estimated date of delivery was 06-Apr-2022. On 09-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given on an unspecified date in May or June 2021). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PREGNANCY (pregnancy) and INTENTIONAL PRODUCT USE ISSUE (5 weeks pregnant but in need of her second dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given on an unspecified date in May or June 2021) and PREGNANCY (pregnancy) had resolved and INTENTIONAL PRODUCT USE ISSUE (5 weeks pregnant but in need of her second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up information included  new event
Mild rash with blistering on neck and right shoulder. Dr. prescribed and anti-viral then and suspected a Shingles reaction to the vaccine so then a month later I received the first dose of the Shingles vaccine.
MILD BODY ACHES; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk and expiry: unknown) dose was not reported, administered on 15-MAR-2021 14:15 for prophylactic vaccination on right arm. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced mild body aches. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild body aches, and headache. This report was non-serious.
fever over 102, chills and shakes.  chills went away around 4:00 am, fever was gone when I woke up....Slight headache during the day Saturday, headache was gone on Sunday when I woke up.
From initial information received on 11/07/2003 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 3 year old male patient received a dose of Fluzone SV '2003-'2004 USP, lot number U1131AA, route and site of administration not reported, on 11/05/2003.  Two days later, the patient developed erythema mulitforme.  No other reactions were reported by the physician.  The patient's recovery status is unknown.
w/in 45 mins p/vax pt states felt weird just not feeling right; by 630PM pt was exhausted-fatigued; by 11PM had shooting pains originating lt lower posterior neck & radiating to lt posterior head; lt arm hurt, was stiff & painful;
No symptomatic AE reported during time of call. No additional AE details or PQC.; Inbound call from HCP stating that a VAQTA was inadvertently administered to 6 month old. No symptomatic AE reported during time of call. No additional AE details or PQC.; This spontaneous report was received from a nurse and refers to a 6-month-old infant of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-JAN-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #W036135, expiration date: 13-MAY-2024, administered for prophylaxis (strength, dose number, and route of administration were not provided) (product administered to patient of inappropriate age).  No adverse event reported.
covid arm.  Red, itchy rash appearing 7 days after injection. Approximately 3 inches in diameter
Broke out in hive like blisters/rash. Itching and burning about week after. Problem with both outer/inner on the below elbows.
Red rash & itching over most of body; came to our office today for assessment; no shortness of breath, angioedema; treated with Medrol dose pack & hydroxyzine.
Pt recv vax on 9/26/98; on 10/2/98 pt exp fever &chills which imp.  On 10/7/98 pt exp runny nose, sneezing, red macular/papular rash of face spread to upper arm & chest.
On 09/08/2022 I received my Covid-19 vaccine. On 02/16/2023 I started having a sore throat and headache for about a week. I reached out to urgent care and was prescribed doxycycline HYC after being diagnosed for a sinus infection. Symptoms lasted approx. 1 month.
45 minutes after I received the vaccine, I began to itch on the left side of my neck and face. The outer part of my neck swelled. The left side of My face became puffy and  red. I had sharp prickly feelings in my top lip. And my blood pressure went extremely high 169/100. All this lasted about six hours.
Pt reported scratchy throat after receiving the vaccinations (Pfizer Bivalent booster dose)- previously had Pfizer vaccine series, and the Flublok vaccination- occurred on 10/30/22 at 3:30pm, Provider administered Benadryl 12.5mg IM and continued to monitor the patient for 20 minutes, pt was stable and no acute distress when leaving the clinic- O2 sat was 98% and patient was calm with normal respirations, no complaints of difficulty swallowing or breathing
Patient presented to the ED on 2/18/2021. She was admitted to the hospital on 3/15/2021. These visits were within 6 weeks of COVID vaccination.
This spontaneous report as received from a pharmacist refers to a 57 year old female patient with high blood pressure and with no drug reactions/allergies. On 01-AUG-2013, the patient was vaccinated with ZOSTAVAX (Lot number and expiry date was not reported), 0.65 milliliter (ml), subcutaneous. Concomitant therapies included lisinopril (manufacturer unknown) and nifedipine (manufacturer unknown). Approximately on an unknown date in August 2013, the patient experienced rash and lump around the injection site following vaccination. Patient sought medical attention (pharmacy visit). Patient was treated with ice pack. None of the lab diagnostic tests were performed. Approximately on an unknown date in August 2013, the event rash around the injection site was resolved, but the event lump around the injection site was not recovered/not resolved. Additional information has been requested.
Top lip discoloration; Top lip discoloration and swelling with a numbness; Top lip discoloration and swelling with a numbness; Discomfort on left side of neck; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 16Apr2021 at 12:15 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD). The patient received unspecified medications within two weeks of vaccination. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 26Mar2021 at 11:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 14:45, the patient experienced top lip discoloration and swelling with a numbness and discomfort on left side of neck. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events top lip discoloration and swelling with a numbness and discomfort on left side of neck was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
No adverse event; Accidentally administered with 3 different EXPIRED lot numbers; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers ) and NO ADVERSE EVENT (No adverse event) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057B22A) for COVID-19 prophylaxis.     It was unknown if the patient had relevant medical history/conditions, allergy, concomitant diseases and risk factor. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 16-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Accidentally administered with 3 different EXPIRED lot numbers ).    Concomitant medication was not provided.  Pharmacist stated 6 patients were administered with 3 different lot numbers of monovalent Moderna COVID-19 Vaccine. Patient number 5 was vaccinated on 16-Feb-2023    Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717776 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717776:Master case
Information has been received from a pharmacist concerning a 75 year old male with allergic reaction to bee sting who on 07-DEC-2007 was vaccinated with Zostavax (Oka/Merck) ( lot # 658604/1088U).  On 09-DEC-2007, two days after vaccination the patient developed injection site rash.  The rash was on the injection site arm and the whole lower arm was swollen, warm and red.  The pharmacist reported that on 10-DEC-2007 the patient was treated with a steroid dose pack.  The patient sought medical attention.  No product quality complaint was involved.  The physician reported that the patient recovered.  Additional information has been requested.
I received the first of two doses of the Recombinant Zoster (Shingles) Vaccine, RZV. About 12 hours after the shot, I woke up sweating and with a rapid heartbeat. I got up and drank some fluids, and after about 5-7 minutes my heartbeat started going back to somewhat normal but still slightly elevated. I was able to go back to sleep. The next morning I felt fine.
Rash and swelling at injection site greater than 1 week after the first shot. Swollen lymph node under left arm.