chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hard lump on the arm of the injection/hard lump on my injection arm; Hard lump on the arm of the injection/hard lump on my injection arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (Hard lump on the arm of the injection/hard lump on my injection arm) and VACCINATION SITE INDURATION (Hard lump on the arm of the injection/hard lump on my injection arm) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Hard lump on the arm of the injection/hard lump on my injection arm) and VACCINATION SITE INDURATION (Hard lump on the arm of the injection/hard lump on my injection arm). At the time of the report, VACCINATION SITE MASS (Hard lump on the arm of the injection/hard lump on my injection arm) and VACCINATION SITE INDURATION (Hard lump on the arm of the injection/hard lump on my injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Pt recvd 2nd dose of Hep B vax on 15FEB91 & devel vaginal yeast infect;
Spoke with secretary at elementary school. Child was complaining of difficulty breathing, skin pale, blue lips, cold hands and eyes bulging. Mother stated that child also had a rash on chest. On 11/28/00, per call to mother, child is doing fine; no rash. Will return to school on 11/29/00. ER MD dx'd reaction to Hep-B vaccine. Per call to mother on 11/29/00, she is taking child back to doctor today for swollen eyes; not sure if vaccine related.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild
doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported. This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after first dose of Moderna vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of Moderna vaccine is not affected by this report   This case was linked to MOD-2021-364617 (Patient Link).; Sender's Comments: This case concerns a female patient, unknown age, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after first dose of Moderna vaccine. The rechallenge is not applicable due to the nature of the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Headache, Arthralgia, Fever, NauseaVomiting, F/N/V,joint pain, H/A Narrative:
tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 1 , single (Batch/Lot number: unknown), as dose 2 , single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) positive, notes: through a home kit in February. Reporter stated that her daughter tested positive for COVID through a home kit in Feb. Reporter stated that her doctors were against her staying with her daughter. It was reported that reporter got the shot in the doctors office, when she came home she didn't feel bad, the next day she even took her bandage off on 30Jun2022, and asked her daughter if she saw anything because her daughters usually gets red, hard, and hot but her daughter told her she saw nothing on the reporter arm. Reporter stated that her daughter and grandson they do had their card, she does know they had Pfizer for 2 shots, and a booster was what they had, but they did not had the last one, reporter states that she doesn't know if it's by age. When reporter was probed what was meant by Pfizer vaccine, reporter states that she doesn't know what the Pfizer vaccines were for and she does not know the names or had Lot numbers of her daughter and grandsons vaccines.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was administered an expired vaccine (exp 01/31/2023) on 02/03/2023
lump to lt deltoid area 1-2min p/vax;redness, swelling, ice pack applied 5min pea sized lump;no redness pt pleasant & alert;
Sniffles, sore throat, loose stools, body aches, back pain, loss of appetite, fever, weakness, unable to work for 3 days, stayed in bed for 3 days, and upon my research the flu shot contains gelatin a product of pork, which I do not eat pork.
8OCT91 PM fever, irritability, emesis; 9OCT91 t103.2, irritability lab xray neg; 10OCT91 per phone fever normal;
Patient received vaccine on 04/23 then began having complications on the morning  of 04/24 which included: body aches, fever, fatigue, runny nose, cough, soreness in elbows and wrists(left arm being worse), much limited range of motion in left arm, and pain and swelling at the site of injection.
This literature market report has been received from the authors of a published literature article as stated above, concerning a 27 year old female patient, who was a medical student. The patient had no known exposure to the other infected medical student or to any of the undergraduate students involved in the earlier outbreak. She had received 2 childhood MMR (manufacturer unknown) ( lot#, dose and route unspecified) vaccinations. On May 8 (year unspecified), MMR immunoglobulin G (lg G) levels were tested as a prerequisite for an away rotation: her measles and mumps lgG titers were negative (titers were <=0.90) and her Rubella lgG titer -was positive. She consequently received the (wistar ra 27-3) M-M-R II (lot#, expiration date, dose and route unspecified) booster vaccination on May 21 (year unspecified) to fulfill the rotation hospital's requirements. Eighteen days post vaccination, on June 8 (year unspecified), she developed mild generalized headaches and painful swelling under her right mandible. She had no symptoms of fever, coryza, or neck stiffness. At her June 9 appointment, she presented to the clinic and was afebrile with marked right parotitis and laboratory results revealed the following: a conversion to a positive mumps lgG titer of greater than 5 index (positive titer >1.10), a negative mumps lgM titer of less than 1:20, and buccal swab positive for mumps virus ribonucleic acid (RNA) Reverse transcription polymerase chain reaction (RT-PCR). Because the mumps RNA RT-PCR did not differentiate between wild type mumps and vaccination strain mumps, the buccal PCR sample was shipped to the CDC for further analysis. Genotypic analysis, by sequencing the variable region of the shot hydrophobic protein gene, distinguishes the 12 recognized mump strains (A L). Typing of the buccal PCR sample confirmed genotype A, consistent with the Jeryl-Lynn vaccine strain. The patient was self-isolated for 5 days during which time her symptoms completely resolved. Because she was otherwise healthy, a formal work-up for immunodeficiency was not pursued. In this report, through genotypic testing, the parotitis was proved to be vaccine-induced. A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same source (linked with MARRS # WAES1608USA014935, WAES1608USA015163 and WAES1608USA015164). Additional information has been requested.
This spontaneous report was received from a healthcare worker via a company representative and refers to a female patient, who is currently 15 years old. The patient had a history of epilepsy and it was reported that she has not had seizures or any medications for that in over 5 years. On an unknown date, the patient was vaccinated with GARDASIL 9, Lot number reported as M007728, expiry date 21-MAR-2018, intramuscularly (dose and anatomical site of injection were not reported). Concomitant therapies were not provided. It was reported that the patient was nervous about receiving the vaccine. Also, after the vaccination, the patient walked out of the clinic room and described that she was feeling dizzy. Afterwards, she said she was seeing black spots and then her eyes rolled back and she fell backwards. The patient's step mother also described that the patient experienced some generalized shaking for less than 10 seconds, without incontinence, and all the event last for about one minute. The patient's step mother called for first responders and then the patient was put on a wheelchair and received a pediatric treatment that included "ZAFRA" 4 mg for her nausea and "METRIN", however, it was reported that the patient could not take any pill. In addition, the patient's father stated that his daughter was acting like she used to when her seizures ended. No product quality complain (PQC) was involved. At the time of reporting, the outcome of seizure was reported as recovered. The reporter did not provide a causality assessment between the event and the GARDASIL 9. Upon internal review, the event seizure was considered to be a medically significant event. Additional information has been requested.
Parent reported pt had overall malaise with fever that spiked up to 103.8F. Also had spots (measles) that covered her whole body. It was not a rash!. Tylenol was recommended by doctor and taken every few hrs. It took a full week for her to fully recover. Photos included.
pt recv vax 4MAY97 & JU97 pt became pregnant & AUG97 had a miscarriage;
11 yo patient received 12+ vaccine after patient's parent wrote they were 12 on the consent form. No adverse event.
2/19/21 - 2:00pm  received Allergy skin testing for environmental and molds & indoor allergens.  Test included a series of scratch tests on back and 11 intradermal injections in right forearm.   5:00pm - right forearm started to swell and felt warm to the touch 6:00pm - right forearm was extremely swollen, hot, and painful from the wrist to the elbow.  8:00 pm - right forearm was severely swollen, hot, very painful from the hand to the elbow and starting to travel to inside of upper arm.   Took Benadryl at 8:00 pm and again at 3:00am  2/20/21 - 8:00am arm still very swollen, hot, painful.   I don?t think this is a normal reaction to Allergy Testing and would like to know if the immune response could possibly be related to the vaccine.
Patient received Moderna 0.5mL dose instead of indicated booster dose of 0.25mL.
Sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Janssen COVID-19 Vaccine EUA Chills & fever for 3 hours, 6 hours post shot Entire body aches for 12 hours Headache Tiredness Muscle & joint pain/weakness
runny nose; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  The reporter considered "runny nose" and "sore throat" not related to bnt162b2.  Additional information: Reporter is calling on behalf of his wife. She received her 1st dose on 12Mar2021 and was scheduled to receive the 2nd dose on 02Apr2021. She has a runny nose and sore throat. Reported asked if patient can she take OTC product like Cepacol. The reporter does not think the sore throat and runny nose was from the vaccine. According to the reporter their daughter currently has a cough and sore throat and they all live in the same house.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events running nose and sore throat cannot be totally excluded.
Pt. states that after receiving the 2nd dose of Phizer 05/07/2021, started experiencing symptoms 05/08/2021 of extreme fatigue, low Iron Iron Vitamins (8.9 Ferrous-Sulfate 325mg), Vitamin D deficient (prescribed D supplements),  low Blood Pressure, low Heart Rate, abnormal EKG, irregular ?heavy? menstrual, and 06/04/2021 ?Covid Pneumonia?. (Misdiagnosed) Primary visit shortly after ? Covid, Amoxicillin prescribed. Cardiologist visit (cleared with Normal range EKG). OBGYN visit (fibroids), IUD inserted 10/11/2021.
12 year old presented accompanied by his father for second dose Pfizer COVID vaccine. He previously received First dose, Pfizer adult dose 0.3 mL on  11/6/2021 (Lot number FG3527) Today, he received Pediatric dose Pfizer COVID vaccine 0.2 mL as his second dose. He was supposed to receive the COVID vaccine adult dose of Pfizer 0.3 mL. He was observed for 15 minutes. He did not present any medical issues. Patient's father was informed about the event. He verbalized understanding. The event was reported to the State Personnel on site  Event was reported to the Clinical Lead, NP.
Missed second dose appointment which was scheduled for four weeks after first dose; sick; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment which was scheduled for four weeks after first dose) and ILLNESS (sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2L120A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment which was scheduled for four weeks after first dose) and ILLNESS (sick). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose appointment which was scheduled for four weeks after first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported by the reporter. No treatment information was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: TCR: event added
SEVERE BODY ACHES TOO PAINFUL TO LAY DOWN ON BED; CHILLS; FEVER; VERY PAINFUL HEADACHE FELT LIKE BLOOD VESSELS  IN HEAD WERE SQUEEZING HIS BRAIN; FATIGUE; PAIN AT INJECTION SITE; This spontaneous report received from a vaccine facility concerned a 20 year old male. 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced severe body aches too painful to lay down on bed. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced very painful headache felt like blood vessels in head were squeezing his brain. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe body aches too painful to lay down on bed, chills, fever, and very painful headache felt like blood vessels in head were squeezing his brain on 03-APR-2021, and was recovering from fatigue, and pain at injection site. This report was non-serious.
Pt complained of chest tightness few minutes after vaccine given with no shortness of breath or dizzines
Donor felt stomach upset, head was hurting, and threw up about 24 hours after 10/11/14 injection was administered. Referred to HCP.
Approximately about 1 month after my 4th dose vaccination I contracted COVID-19 and had the following symptoms: Scratchy throat,Stuffy nose, Cold. I took Dayquil, Aspirin and Theraflu and Vicks vaporub at night. I had a televisit with my Doctor and was prescribe to take Paxlovid for 5 days. I have finished all 5 days of Paxlovid and I have noticed that I am feeling so much better each day.
It was noticed by office staff on 01/24/2023 that the ProQuad had been stored in the vaccine fridge and not the vaccine freezer.  Patient had not reported any side effects from the initial vaccine, but will need to be revaccinated due to improper storage of the vaccine.
Hives, rashes, itchy, red--Began day 9 and continues through today, day 13. Splotches move around, under chin, on both upper arms, on upper chest, inside arms, base of thumb. Strangely, started on right upper arm, then went to left upper arm, and pops up and disappears in many places.
pt recvd vax approx 8AM @ approx 2PM called hosp & c/o generalized aches & pains-denies fever;
immed felt hot esp head-became pale-placed on stretcher nauseated w/vomiting p/1hr felt better; fainted on way to work station; ER-monitor;
This spontaneous report has been received from a pharmacy student referring to a 27 year old female patient. Information about concurrent condition, concomitant medication and medical history was not reported. On unknown dates, the patient was vaccinated with 6 VARIVAX (strength, dose, route, lot number and expiration date were unspecified) for prophylaxis (extra dose administered), since the patient's serologic testing keeps showing low immunity to VARICELLA (no therapeutic response). The outcome of the low immunity to VARICELLA was unknown. The causality between the low immunity to VARICELLA and VARIVAX was unknown.
Dizzy; This is a spontaneous report from a contactable consumer (patient's wife). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the COVID-19 shot on Tuesday (unspecified date) and he is complaining of being dizzy on an unspecified date. She stated that her husband had called in sick for two days in a row. She was wondering how long this side effect is expected to last. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
3 hours later caller had a rash and hives/caller has been taking allegra; 3 hours later caller had a rash and hives/caller has been taking allegra; Joint pain; hands hurt; problems bending her fingers; This is a spontaneous report from a Pfizer-sponsored program (contactable female consumer). An female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 31Jan2021 at single dose for COVID-19 immunization. Medical history included she has carpel tunnel syndrome and had a shot many months ago, The patient had first dose of the covid-19 vaccine on 31Jan2021, 3 hours later caller had a rash and hives, her MD suggested Benadryl, her allergist suggested Allegra, caller has been taking allegra, a day ago caller stopped taking Allegra and experienced all over joint pain, hands hurt and problems bending her fingers in 2021. caller states she has carpel tunnel syndrome and had a shot many months ago. 3 hours later caller had a rash and hives. The outcome for the events was unknown.  Information about lot/batch number has been requested.
Per parents, patient had a fever up to 102°F shortly after vaccination on 06/05/19. Patient had been having on and off fevers up until around 5am on 06/07/19 when patient had a febrile seizure that lasted 5 minutes per parents. Parents treated with Tylenol and Motrin and fevers subsided.
04/02/2021 extreme fatigue for a little over a week, I was not able to function as normal, no energy to do anything. Something was wrong with my heart; it was a very irregular heartbeat. I was having a cough and runny nose. When I went to urgent care, they put me on antibiotics or steroids I don't remember. After being on the antibiotics, the problem I was having with my heart, my symptoms started to get better. I have days where I am unusually tired. I don't know what that is about, but I continue to have those days.
Redness, swelling to right arm which started yesterday. Erythema, edema, warmth noted to right arm. Proximal lower (R) arm and distal upper (R) arm on posterior and anterior medial surfaces.