chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning unspecified patients who might on unspecified dates have been administered with an unspecified number of unspecified doses of improperly stored GARDASIL 9 (lot # L016428, expiration date 30-JUL-2017, route unknown). The GARDASIL 9 was stored at 30.4 F for 8 hours 30 minutes. There was no previous excursions. No data logger reported. This is one of several reports received from the same reporter. Additional information has been requested.
weakness; fatigue; swollen and painful lumps and rash in armpit; swollen and painful lumps and rash in armpit; swollen and painful lumps and rash in armpit; loss of appetite; gastritis; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FE3592 and expiry date was not reported) via an unspecified route of administration in arm left, on an unspecified date in Sep2021 at 03:30 PM (age at the time of vaccination: 45 years), as a dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient's medical history includes auto immune disorder. The patient concomitant medications received within 2 weeks of vaccination was reported as 1. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FC3180 and expiry date was not reported), via an unspecified route of administration in arm left, on 01Sep2021 at 07:00 PM, as a dose 1, single for COVID-19 immunization. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. On 23Sep2021 the patient experience swollen and painful lumps and rash in armpit, loss of appetite, gastritis, weakness, fatigue. It was reported that the patient received treatment for the adverse event. Outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Sick for 48 hrs-fever, chills, headache. Body aches-could barely move-could not eat. Pain at injection site.
Patient informed technician over the phone that he wanted to receive the tetanus vaccine. We offered the Boostrix vaccine and pt accepted per MD recommendations. When he arrived at the pharmacy, pharmacist verified with pt that this was the vaccine and what it was for and asked why he needed the vaccine. Pt stated that he needed his vaccinations up to date.  Pt was vaccinated and given the forms for verification and left the pharmacy. MD called and stated that the patient has been very confused about the various vaccines he needed and she informed us that he was given the Boostrix vaccine 1 week prior in her office and that he actually needed the MMR vaccine.  He received the MMR vaccine today as well at a different pharmacy. He verified that he is fine, is not feeling any symptoms or side effects and just wanted the incident reported.
Pt reported "bumps" on her hands 24 hours after receiving vaccinations, slowly progressed into hives within 72 hours.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 10-NOV-2012 18:30, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
injection site became red, swollen, and warm to touch one week after administration of vaccine.  Prescribed Keflex to be taken 3 times daily.
During the 15 minute observation period post vaccination, the patient was seated in an armed chair and describes feeling like he "was in a dream state". He fell out of his chair, and was disoriented. He was assisted back to a chair. Paramedics were called. Blood pressure was taken 135/87 then 91/67. He was sweating and hot. Cold compresses were applied to the back of his neck. He drank a bottle of water then a bottle of Gatorade. The paramedics arrived and performed an EKG which was normal and his blood pressure was normal as well. The patient was transported to the hospital to be assessed further.
Pt. called 3-5-21 @ 8:34am to report that starting around 10:00 last night the pt. developed a raised rash approximately 1" in diameter at the injection site along with extreme itching and a painful burning sensation.  Pt. advised that she may use hydrocortisone cream and ice at the injection site, as well as alternate acetaminophen and ibuprofen for pain.
This spontaneous report was received from a medical assistant referring to 12 unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of PROQUAD (lot# M037012, expiration date 21-FEB-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion greater than 5 and less than 14 degrees Fahrenheit (also reported as ">-15 but <-10 degrees Celsius") for 1 hour and 40 minutes and 2 hours in two different time frames; digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA001634.
Started having a headache with a lot of sneezing, cough, and with sore throat and chest congestion. After 2 days of it not subsiding, I tested at home 2 days later and it was negative. Two days after that I started feeling nauseas so I took another home test and tested positive. Had telehealth visit and was prescribed PAXLOVID. Still feeling feverish at this point.
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 62-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. On 4th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, 1 day after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site warmth, injection site pain and tiredness. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site warmth were not recovered/not resolved and the outcome of the injection site pain and tiredness were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site warmth, injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. About a day or two after vaccination, the patient experienced soreness and swelling about 2 inches below the injection site down to her elbow and her wrist (extensive swelling of vaccinated limb). The patient felt tired and the area below the injection site was hot. The patient had recovered from the tiredness and soreness but the swelling and hot injection site was still persistent. No further details were provided by the reporter.
The patient was immunized on 4/2. 3 weeks later seveloped a rash, swelling and severe pain in the scalp and forehead on one side of the head.  Once this resolved, a second vaccination was done in august, followed in 2 days by recurrence of neuropathic left sided head and face pain and slight vesicular rash near eyebrow
Patient started having headaches/tired eyes/ floaters/ and flashes of light in peripheral  vision 2 days after shot. She also had the same symptoms 1 day after Fluzone HD shot in 2021. Both times diagnosed with  PVD by optometrist. No reaction to shot in 2022.
Headache, Myalgia, Arthralgia, Fever, Exhaustion Narrative:
11/17/04 mother states: redness, swelling of rt upper arm following Dtap. Dr. saw pt in the office and documented a 6x4cm erythmatic area surrounding injection site. Tx was w/ cold compresses, Motrin and Benadryl.
Pt reports feeling heavy chested, difficult to take a deep breath. Some loss of appetite, "feels warm" and mild fatigue. Noticed one "itchy red spot" on Lt leg. Sx persisted 09/29/2011 and has a second spot on Lt leg. Discussed normal vaccination side effects which can include mild rash in small percentage of adults, some mild fever or malaise. But not changes in breathing. Pt referred to call her PMD right away. Spoke with pt on 09/30/2011 AM. She was seen by PA at facility. She reports that PA did confirm two pox on Lt leg, but stated that heaviness in chest was likely due to developing URI/cold symptoms and asthma, likely not vaccine related. Pt is feeling a bit improved now.
Information was received regarding a case in litigation concerning a 39 year old male. Information received from the patient and medical records. The patient claims that in 20-DEC-2012, he was vaccinated with PNEUMOVAX 23 and experienced an allergic reaction. The patient stated that the effects of the allergic reaction severely discolored his face. As a result of the patient's allergic reaction, the patient reported "ongoing fear of public exposure, depression and mental stress." Information received from medical records concerning a 39 year old male (210 pounds, 71 inches) with penicillin allergy and history of asthma as a child. On 20-DEC-2012, the patient was vaccinated with PNEUMOVAX 23 (lot Number H014283, expiration date 17-APR-2014) via right deltoid. On 20-DEC-2012 at 1130 (approximately one hour after the vaccination), the patient was brought to the clinic with complaints of "upper body feeling itchy, feel a buzz in face and face feels red and hot." On examination the patient was noted to have some facial flushing, no shortness of breath noted and no rashes noted on his body. The physician noted that according to nursing assessment, the patient complained of tightness and itching of the chest as well. The physician reported the patient remained alert and oriented and appropriate vital signs were obtained. The patient was monitored for signs and symptoms of allergic reaction and also educated to report symptoms and return if needed. On 27-DEC-2012 examination, the patient felt improved and denied any shortness of breath, or feeling of flushing in his face. The physician explained to the patient that he may have had an allergic reaction. On examination, the physician reported the patient's skin showed no rashes or urticarial type lesions. The physician stated the patient with history of allergic reaction possible to PNEUMOVAX 23 on 20-DEC-2012 when he was given ZANTAC and hydroxyzine twice a day for the next five days. The physician reported this issue has been resolved. All available medical records will be provided upon request. Additional information has been requested.
I Tested positive by PCR on 11Jul2022; I Tested positive by PCR on 11Jul2022; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 23Dec2020 at 12:00 as dose 1, single (Lot number: EH4899), in left arm, on 13Jan2021 at 12:00 as dose 2, single (Lot number: EL1283), in right arm, on 01Oct2021 at 18:00 as dose 3 (booster), single (Lot number: FD0810), in left arm and on 01Apr2022 at 17:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 69 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing), notes: Other medical history: Type 2 Diabetes; "Hypertension" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 01Jan2022; JARDIANCE, start date: 01Jan2022; METOPROLOL, start date: 01Jan2022; AMLODIPINE, start date: 01Jan2022; LEVOTHYROXINE, start date: 01Jan2022; HCTZ, start date: 01Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "recovering" and all described as "I Tested positive by PCR on 11Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) Positive, notes: I Tested positive by PCR on 11Jul2022,; (25Jul2022) Positive, notes: on vacation tested positive 25Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Tested positive by PCR on 11Jul2022, took Paxlovid for 5 days for cough runny nose mild body aches all very mild , got better went to work on day 6 worked two days went on vacation tested positive 25Jul2022 I did not test again after firt one, the symptoms sneezing and coughing did not take Paxlovid again today is day 3 of symptoms and no other symptoms so far.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.
Generalized hives, lip & eyelid edema within 15 minutes of receiving vaccines.
5 pts recvd 3 doses of Engerix-B vax in 1991 & all 5 of the pts did not respond to the vax series & 1 of the 5 pts also exp flu-like sx; booster dose is planned;
pt had a positive COVID test 6/28/22; pt passed away at home; no medical records on patient; PCP unknown
Information has been received from a registered nurse concerning a 39 month old white male with epilepsy who on the afternoon of 6/18/02 was vaccinated SC in the right thigh with a dose of varicella virus vaccine live (lot # 638810/0497L). Concomitant vaccine therapy included a fourth dose given IM in the right lower thigh of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (lot # 975A2) and a fourth dose given IM in the right lower thigh of HIB conjugate vaccine (lot # 477255). There was no illness at the time of vaccination. On 3/3/04 at 0900 the patient's mother reported that she noticed a macular rash on the patient's left side that had spread to the chest, back, down the legs, on the face, and in the hair. The nurse reported that the patient had chicken pox. On 3/15/04 the rash was beginning to dry with scabbing. The mother used calamine lotion for itching. On 3/17/04, after about 2 weeks, the patient recovered, which was reported as uneventful. It was noted that the patient had no adverse events following prior vaccinations. No further information is expected.
Headache, arm swollen/sore, body aches, back ache, runny nose, hands swollen, unable to sleep
Fever of 103.1, seizures needing 911 to be called by my child and a trip to the ED, and entire body aches.   The fever started within the hours after the injection and lasted through the night and and my child found me seizing the next morning.
Rigors, myalgia, nausea, syncope x 2, vomiting, loss of bowel control.  I receive the vaccine around 5:00 PM and I went to bed around 8:30 PM with no symptoms. While I was sleeping I experience rigors and myalgia. Around 10:30 PM I got up to go to the bathroom and I had to syncopal episodes before making it to the bathroom. I had a mild hematoma to my right forehead. When I didn?t make it to the toilet half of my feces ended up in my pants and half of it ended up in the toilet. Shortly after defecating, vomited all of the food that I had for dinner. Once I had assistance, I made it to the shower and in rigorous for another 10 to 15 minutes. I was guided back to bed where I was able to sleep for about four hours or so every hour or so with nausea but no vomiting in. I feel like I am alert and oriented, but my care team would like to keep an eye on me for the next day or so.
tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report received from a contactable physician. This physician reported similar events for 11 patients. This is the 2nd of the 11 reports.  A 39-year-old male patient received bnt162b2 (BNT162B2) intramuscular, first dose administered in Deltoid Right on 23Dec2020 (Batch/Lot number EH9899), second dose intramuscular, administered in Deltoid Right on 13Jan2021 (Batch/Lot number EK9231), bot at single dose for COVID-19 immunization. The patient medical history and patient's concomitant medications were none. The patient had a positive test for SARS-CoV2: Sars CoV-2 RNA PCR (Test for SARS-CoV-2 by PCR, or other commercial or public health assay) on 03Feb2021 (as reported): positive, new infection. The patient was not hospitalized, was not admitted to an intensive care unit. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. No new or worsened symptoms/signs during the COVID-19 illness experienced. The event did not require the initiation of new medication or other treatment or procedure. The patient was not taking any medications routinely prior to the event being reported. No pre-existing diseases was worsened during the SARS-CoV2 infection (please specify). No Prior Vaccination (within 4 weeks). Patient received COVID 19 vaccination on 23Dec2020 and 13Jan2021. Patient had an exposure to a symptomatic COVID 19. This patient was exposed to COVID by his child's caretaker prior to testing positive. infected individual who then tested positive for COVID 19 on 03Jan2021. This patient went for post exposure testing on 03Mar2021, tested positive for COVID 19, then developed symptoms of loss of taste and smell, headache, muscle aches, congestion. The outcome of the events was recovered on an unspecified date.; Sender's Comments: The 39-year-old male patient received bnt162b2 (BNT162B2), first dose on 23Dec2020, and second dose on 13Jan2021. On 03Mar2021, the patient tested positive for COVID 19, then developed symptoms of loss of taste and smell, headache, muscle aches and congestion.  Based on information available, Vaccination failure cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021389615 same reporter/vaccine, similar events, different patients
ENGERIX 20 mc gm IM on 3-28 - within 3 hrs chills, nausea, vomiting occurred. Re seen 3/29 at same facility. Lab work drawn. IV hydration - ZOFRAN 4 mgm IV. No fever.
PT DISCOVERED WITH HEAD DOWN. PT C/O OF DIZZINESS, SWEATING, AND FEELING SLUGISH.  PT DENIES ANY PREVIOUS ADVERSE REACTIONS TO VACCINES. DENIED  CHEST PAIN OR PRESSURE.  PT WAS DISCOVERED TO BE HYPOTENSIVE. VS @ 15:24 PM BP 65/40 HR 68 SpO2 91% PT DID NOT APPEAR IN ACCUTE DISTRESS AFTER ONSET OF INITIAL SYMPTOMS. HE WAS INSTRUCTED TO  BRING HIS KNEES  UP TOWARDS HIS CHEST AND GIVEN GATORADE TO INCREASE HIS BP. AFTER 15-18 MIN PT SYMPTOMS RECOVERED AND BP RETURNED TO NORMAL. PT WAS STABLE TO LEAVE THE OBSERVATION SITE WITH WIFE. PT INFORMED TO F/U WITH PCP. BP 124/80 HR 88 SpO2 96%
Within one minute after having vaccines redness to injection sites, except IPV site.  Dime size, baby was easily consoled by Mom, after initial crying.  No respiratory distress.
This spontaneous case was initially received on 03-Nov-2015. The case report was received from a(n) Health Professional and concerns a(n) 29 years old male patient. Weight: 240 pounds, Height: 74 inches. The patient received AFLURIA on 09-Oct-2015, Batch no: T51608, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 09-Oct-2015, the patient received an IM dose of expired AFLURIA.
Vaccine administered 3/27/15. That day, small, tender lump appeared at injection site. 3/28, more pain and swelling. 3/29 red, swollen, painful, went to urgent care. Put on doxycycline x 10 days. Area enlarged to 10 x 15 cm at f/u on 4/8/15. Improved area now soft and faded.
no additional AEs; LVN called to add unreported excursion time to supported TE evaluation on 1/10/23. Caller reports that 1 dose was administered on 2/20/23 after receiving supported TE result without knowledge of additional TE that occurred on 1/8/23. No further infor; This spontaneous report was received from a licensed vocational nurse, referring to a 6-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 20-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), at a dose of 0.5 milliliter (ml), once (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number W010523, expiration date was reported and validated as 25-SEP-2023) as prophylaxis, that experienced a temperature excursion (product storage error). No additional adverse events.  On 08-JAN-2023, the vaccine experienced a temperature excursion of 3.5 degrees Celsius (C) for 11 hours and 14 minutes and on 10-JAN-2023, a temperature excursion of 5.5 C for 15 hours and 45 minutes. There was no previous temperature excursion.
I had a sore arm and felt fatigued for a day after receiving the vaccine. I tested positive for COVID-19 via home test on 08/25/2022. I contacted my doctor which prescribed PAXLOVID.
Narrative:  Author inquired about patient's well-being and the presence of side effects.  Veteran had some malaise, but denies fever, chills, body aches, and other symptoms. Author advised sister to notify primary care RN triage line in the event patient feels worse.