chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had live SARS-CoV2 in March and recovered. The evening after receiving the vaccine, I felt similar to how I felt the night before I came down with Covid. 12 hours after vaccination, I felt chills and fatigue along with a sense of generalised confusion. Began shaking uncontrollably after I took a shower. Could not maintain normal body temp throughout the night. Feeling fine but tired today.
This spontaneous report was received from a nurse practitioner regarding a 12 month 1 day old patient of unknown gender. No information about concurrent condition and historical medication was reported. On 14-APR-2015, the patient was vaccinated with PROQUAD (Merck) dose 1 and VARIVAX (Merck) dose 1 on the same day. No adverse event was reported. No product quality complaint (PQC) was involved. The outcome of accidental overdose was unknown. Additional information has been requested.
A HARD RED AREA THE SIZE OF A SMALL APPLE WHICH WAS WARM, RED AND PAINFUL TO TOUCH. CALLED MD SAID TO APPLY ICE. REDNESS CONTINUED TO EXPAND UP LOWER ARM. SEEN ON 4/12/12.
R11.2 - Nausea with vomiting, unspecified VOMITING NAUSEA
Patient was incorrectly administered Covid-19 monovalent vaccine. Patient should have received Covid-19 bivalent booster. Patient received initial series on: 4/8/21, 4/29/21 and initial booster on 12/28/2021.
FEVER UP TO 102 OR ABOVE THROUGH 10/11/13. NO FEVER 10/12 THEN FEVER RETURNED AGAIN 10/13/13.  SEEN IN OFFICE 10/15/12 FOR FEVER WITH MILD REDNESS OF EAR DRUM.
Patient had a fever of 99.8 degrees; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP and Other HCP). The reporter is the parent.  A 16-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: PYREXIA (non-serious), outcome "unknown", described as "Patient had a fever of 99.8 degrees". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient's mother reported that patient received COVID-19 Vaccine and she had symptoms. She stated that patient had a fever of 99.8 degrees.  No follow-up attempts are possible. No further information is expected.
Very swollen lymph node in left neck under ear. Mild swelling of lymph node in neck under jaw..  No other symptoms. No treatment. No change as of time of report.
This spontaneous report was received from a pharmacist, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with an improperly stored dose of VARIVAX for prophylaxis, lot #N031001 and expiration date 03-NOV-2019 (strength, dose, frequency and route of administration were not reported); the vaccine was reconstituted with a properly stored sterile diluent (MERCK). No adverse effect was reported. The temperature of excursion was reported as from 47°F to 77°F during a time frame of 20 hours. There was no previous temperature of excursion reported. There was a digital data logger involved.
4 doses (patients) Got expiration doses past day 30; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease (all of them were under treatment for this illness). Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.   On 10-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30). On 07-Feb-2022, EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that clinic accidentally administered 26 doses of Moderna COVID-19 Vaccine past the expiration date. The vials had been moved to the fridge on 28-DEC-2021, and had the expiration date of 27-JAN-2022 (30 days at fridge temps). The expiration date was not caught in time, and these doses were administered in error. On 09-FEB-2022 case MOD-2022-475926 became invalid as it was confirmed there are no patient identifiers. Therefore, this case will be logically deleted from the safety database   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Significant follow up information contains Patient Demographic added, Patient Medical history added, Dosage regimen, Route of administration for 2 nd dose vaccine, concomitants were updated.
Presented and given Pfizer vaccine approximately 9:30am. Approximately 9:37 am was asked how she was feeling and she complained throat feeling itchy and having trouble taking a deep breath. Complained of numbness in the fingers of the right hand. Blood pressure taken in the right arm at 9:48 am 193/108. EMS called at approximately 9:55 am. Client was taken out to the ambulance with EMT's at each side. Client complained of dizziness upon standing. Client transported by ambulance to Hospital.
patient came in on 1-16-21 and said he had rash all over trunk 12 hours after patient got vaccine, He complained of muscle pain, fatigue, rapid heart  rate  too. He said the rash didnt itch , had no trpuble breathing or throat closing in , just more worried about the rash. The rash did not spread anywhere else. Told patient he had to call doctor in the morning on Monday
Once vaccine was administered patient was still seated in vaccine room and we were reviewing the vaccine card, he reported that he was 'not feeling well'.  He then had stated he was feeling dizzy and had an episode of syncope.  He remained in the chair but was not able to respond to me.  His mother was present and I called for assistance and she came into the room at which point the patient was able to respond to me verbally but he reported being confused, feeling nausea and fatigued. He was visibly sweating.  His mother reported that he had previous episodes of syncope when having blood draws or other injections.  He remained seated and I offered multiple times to contact emergency medically services but he and his mother wanted to just wait as he usually feels better after a short time.  We did give him cold water bottles which his mother used at the nape of his neck.  We also provided him with wet paper towels.
I woke up around 5 am to go to the bathroom. On the way, I started feeling nauseous and a little lightheaded. I don't recall what happened next but I woke up with my head next to the toilet and my right hand in the toilet bowl. After coming to, I continued to feel nauseous and dry-heaved 3 or 4 times followed by intense trembling and cold sweat running down my face. After about 5 minutes, I felt better and have had no more adverse symptoms.
Started with tenderness and mild redness, and itching at the injection site on day 9 after the inject. Proceeding to get bigger each day. Using ice and Antihistamine cream for the itching.
Ringing in the ears within two days of receiving the second dose. It is constant and most distracting at night time, when watching TV or reading. It has not lessened in any way since it has started. My primary care physician says there is nothing he can do.  I noticed other on-line feedback about this side effect after the 2nd dose of the covid vaccine so I wish to report it.
Productive cough, sore throat, myalgia, fatigue, hives at injection site
pt recv vax 7AUG97 & AUG97 pt exp 2 lesions one lesion @ one inj site on rt arm & 1 lesion on chest;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 10-year-old female patient who received BOOSTRIX. On 7th March 2018, the patient received BOOSTRIX (subcutaneous). In March 2018, less than a week after receiving BOOSTRIX, the patient experienced injection site reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site reaction 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 reaction to be related to BOOSTRIX. Additional details were provided as follows: The patient was the healthcare professional's child. The healthcare professional did not have the product information available but the patient was given Tdap vaccine after cutting her leg on a fence. The patient received a dose of Tdap inadvertently which was given subcutaneously, which led to inappropriate route of vaccine administration. The healthcare professional additionally reported that the patient was experiencing tightness in her arm where the vaccine was administered.
Patient reported to pharmacy with symptoms of fever, chills, back pain, nausea, not eating, chest pain.  symptoms started friday after receiving FLUARIX QUAD immunization.
Severe diarrhea , nausea , severe pain and soreness in left arm , discomfort and headache.
experiencing a fever; This is a spontaneous report from a Pfizer sponsored program. A non-contactable female consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. It was mentioned that, patient received 2nd dose 1 month ago and recently started experiencing a fever and patient was wondering if this was normal. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
uncontrollable crying for 2hr leg was red @ inj site & small amount of swelling;
Headache, Diarrhea, muscles cramped up, chills, tired Narrative:
side effects including hives; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Physician reported patient side effects including hives. The outcome of the event was unknown.  Information about batch/lot number has been requested.
my face swelled up; my neck to my chest area then my neck broke out; like a burn; My body has been heating up in the inside; swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 53 (unit not reported) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included latex allergy. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jan2021 for COVID-19 immunization and experienced soreness. The patient experienced face swelled up, her neck to her chest area then her neck broke out; like a burn, her body has been heating up in the inside, swollen lymph nodes on 22Feb2021. The course of the events was as follows: The 2nd vaccine, 3 days later her face swelled up, her neck to her chest area then her neck broke out; like a burn. The patient been using a steroid cream. Her body had been heating up in the inside (like she had a fever but she does not have a fever) throughout the day (like menopause though she have not had menopause). It calms down and comes up again. This had been going on since the 3rd day of the 2nd dose. She felt it (the injection) move from her arm into her breast area. Her doctor thought it was swollen lymph nodes. Her doctor said they will be watching it. It's a little swollen. She did not feel that anymore. The heating up sensation worried her. The outcome of event swollen lymph nodes was recovered on an unspecified date in 2021; outcome of events her neck to her chest area then her neck broke out; like a burn, her body has been heating up in the inside was not recovered; outcome of event face swelled up was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen, painful injection site; Painful injection site; "knot" at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In January 2020, less than a week after receiving Shingrix, the patient experienced injection site lump. On 17th January 2020, the patient experienced injection site swelling and injection site pain. On 20th January 2020, the outcome of the injection site swelling and injection site pain were recovered/resolved. On 21st January 2020, the outcome of the injection site lump was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site pain and injection site lump to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix on left arm. After receiving 1st dose, on same day developed a swollen, painful injection site which resolved 2-3 days later. The patient reported that, 1-2 days after her first dose she developed at knot at the injection site that lasted for 2 days and then resolved. The reporter did not consent to follow-up. This case has been linked with US2020159648, same patient, 2nd dose of Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159648:same reporter
Injection in left arm slight pain. Pain dissipated in two days. Six days after getting shot I woke with very severe pneumonia like symptoms. All my joints, back, neck ache with pain. Constantly running fever (104), eyes hurt. I periodically sweat a lot, then shiver for hours. This has been going on from July 26 to present. On July 29, 2019 I visited my PCP. He stated symptoms were very serious & I needed to go to Emergency room. My wife immediately drove me to emergency  room at Hospital. I was having a hard time standing & walking, I was extremely weak. I was asked by several healthcare persons if I had recently had a flu shot etc. I told them on July 20 I had taken the Shingrix shot none seemed to know anything about Shingrix  (I explained to them what it was for). I told healthcare persons I did not have much of an appetite since getting the Shingrix shot. I told them I felt that if I ate I would vomit. I have been trying to avoid that at all cost. I can only imagine what the pressure if vomiting would be like on my aching head & body. They diagnosed me with pneumonia. I told them that before the shot & after I had not been around large groups of people with the exception of being in grocery store to get the shot. I truly believe that the Shingrix vaccine was the cause of this. I have not been sick in years. Bad diarrhea started on 7/31/2019. Entered emergency room on 7/29/2019 - 6:00 PM Released on 7/30/2019 - 5:00 PM
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent conditions, pertinent medical history and concomitant therapies were not reported. The registered nurse stated that an unspecified number of improperly stored doses of RECOMBIVAX HB (lot # J007946, expiration date: 24-MAR-2016 (also reported as 26-MAR-2016) (dose, frequency and route of administration were unspecified) were inadvertently administered to the patients on unknown dates. No adverse events were reported. No product quality complaints were reported. This is one of several reports from the same source. Additional information has been requested.
05/29/02 PM-chills, body aches, redness and swelling of L upper arm. 05/31/02 seen by a physician, no treatment recommended.
Approximately 5 hours after vaccination, patient reports that she felt difficulty breathing, severe fatigue, nausea, diarrhea, hyperthermia, and general malaise.  She also reports urticaria from shoulder area distally to elbow.  Difficulty breathing, and flu-like symptoms resolved after 24 hours, while mild urticaria were reported at time of our discussion (approx. 1000hrs, 10/25/21).
3 DAYS CONTINUED HEADACHE, JOINT/MUSCLE PAIN ON BOTH LEGS
joint pain in knees & hips. Started the very next day after receiving shot. Had some of these same symptoms after getting 1st shot in Oct 2018, but symptoms much worse with 2nd shot. Still has some aching, but not as severe as it was initially after inj.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Lot number: gj3277) at the age of 51 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 16Apr2021 as dose 1, single (Lot number: ew0170), in left arm, on 07May2021 as dose 2, single (Lot number: ew0182), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: fh8030), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: fj9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mild anxiety" (unspecified if ongoing); "Allergy: sulfa drugs" (unspecified if ongoing); "Allergy: fish, shellfish, banana, avocado, kiwi, persimmon, mushrooms, broccoli" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19 from 29Sep2023 to 04Oct2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300322813 same patient, different drug/ event;
Began with rash on front and back torso. Spread over entire body (head to toe) within 2 days; Extreme itching, burning and swelling. Went to dr twice; Had 2 DECADRON Shots, 1 KENALOG shot, 1 ZANTAC shot, oral MEDROL, SINGULAIR, and multiple antihistamines;  Also topical sarna, BENADRYL, AND AVEENO bath.
Fatigue next day and severe outbreak of herpes simplex on lips inside and out; nares
Numbness in hand; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hand), NAUSEA (nausea) and HEADACHE (headache) 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 an unknown date, the patient experienced HYPOAESTHESIA (Numbness in hand), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, HYPOAESTHESIA (Numbness in hand), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Scattered multiple small  papules, left thigh, mother states similar event happenedwith previous vaccination in both thighs
Guardian of 16 yof called and scheduled client a Moderna COVID Vaccine. Nurse administered client a 1st dose Moderna vaccine and then quickly realized client was only 16 years of age. Nurse that made error notified myself, RN and Coordinating Nurse, of the issue. I, spoke with client and guardian regarding the vaccine error. Client and guardian were not upset and stated they had requested Moderna and wanted client to have Moderna. I informed them that regardless of their desire it was still a vaccine error on our part seeing that client does not qualify for Moderna vaccine due to age. Client and Guardian were not upset and were understanding. Client waited 30 minutes after shot and denied any issues. No treatment required, no signs or symptoms to report.
No other adverse events reported; patient received their second dose of GARDASIL 9 too early.; This spontaneous report was received from medical assistant and concerns the patient of unknown gender, who would be 14-year-old at the time of report. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 18-FEB-2022, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #: T030746, expiration date 16-MAR-2023 (concentration, dose, route of administration and anatomical location were not reported) for prophylaxis.  On 25-MAR-2022, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot #: T030746, expiration date 16-MAR-2023 (concentration, dose, route of administration and anatomical location were not reported) for prophylaxis (inappropriate schedule of product administration).   No other adverse events were reported.
moms states pt extremely fussy & crying noc of 20AUG;states slept only 1hr that noc;began crying cont @ 430PM 21AUG & cried for 2-2 1/2hr;
Patient returned to pharmacy approximately 24 hours after immunization complaining of fever, rash, malaise, N/V and sore arm.
Arm began to hurt and he had swelling and redness from around the injection site (2/20/15), he noticed the swelling, redness, and discomfort to have spread. He denied any wheezing or dyspnea. No itching or hives. Per doctor exam and note 2/20/15 (L) arm with irregular, warm, erythematous, patch over upper arm only. Mild tenderness. No e/o urticaria or excoriation. Skin rash and pain. Hydrocortisone BID, ibuprofen TID.
"Moderna COVID-19 Vaccine EUA"  Received second dose at ~3pm on 1/26/21. Symptoms began ~6am on 1/27/21 (~15 hours post vaccination). Symptoms experienced included: significant injection site pain, axillary tenderness, headache, fever, body/flu-like aches, nausea, and significant back pain resulting in missed day of work on 1/27/21. Fever, body/flu-like aches, nausea, and back pain persisted on 1/28/21 resulting in leaving work 3 hours early on 1/28/21. All symptoms were gone by ~5am on 1/29/21 (~47 hours hour post onset of symptoms; ~62 hours post vaccination).