chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my first dose of Moderna vaccine at around 9:45 am on Dec 24 and I was fine for like 4 hrs after receiving it, until I started feeling similarly to the way I felt when I tested positive for Covid and had it at the beginning of November (feverish, headache, body ache, stuffy mucusless nose, fatigue, hangover sensation like nauseated and weird, etc...) Things got a little bit worse when all of a sudden I started feeling feverish and my heart started beating so fast I could hear it myself. I had to stop doing what I was doing and called (my insurance/MCD) because I was getting anxious and started hyperventilating, which did not allow me to breathe normal. They told me to take Tylenol which I did and little by little my fever started decreasing; it must have been almost 100 F at that moment. Then once again like 5 hrs after I had taken Tylenol I started getting fever again and this time I got extremely cold also and I was shaking so much and felt so weak I had to lay down and call  once again; they told me to have someone take me to their urgent care center and I went there and they retested me for Covid but it was negative this time. Since I had taken Tylenol (2nd time same day, 6 hrs apart) just before I left, my fever was not that high when I showed up there. They told me studies have showed some people experience similar symptoms but when they get the 2nd not the 1st dose; however, they thought it could happen too. I had fever nonstop for almost 48 hrs; it was so high (101.7- highest reached). The rest of the time?at night when I was trying to sleep, obviously I could not take my temperature, I was half awake, half sleep hallucinating, shaking, cold, then hot and sweating a lot and speaking non sense in my sleep (according to my spouse)- this happened both nights. On Dec 26 I woke up feeling not great but definitely better but had a little headache and still felt somewhat nauseated. My last dose of Tylenol I took at 8 pm on Dec 25. I have been feeling better for the past two days but I still feel a little bit tired and not back to my normal self.
chills; Muscle ache; supraclavicular lymphadenopaty/lymph node swell; This is a spontaneous report from a contactable other hcp. A 32-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3246; Expiration Date: Apr2021), dose 1 intramuscular, administered in Arm Left on 08Jan2021 as SINGLE DOSE and dose 2 intramuscular, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EN5318) as DOSE 2 SINGLE for covid-19 immunisation. Medical history included back pain from an unknown date and unknown if ongoing. The patient's concomitant medications were Drospirenone and ethinyl estradiol (Birth control pills). Patient did not receive other vaccine in four weeks of vaccination. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events.The patient experienced supraclavicular lymphadenopathy on 13Jan2021, chills 02Feb2021, muscle ache on 02Feb2021. The outcome of the event supraclavicular lymphadenopathy was recovering, chills and muscle ache was recovered. No follow-up attempts are needed. No further information is expected.
due to communication gap patient was given a 2nd dose of bivalent vaccine 3 weeks after
Headache Fever Chills Body aches Nausea Diarrhea Joint pain Reddness and swelling to injection site Cold sweats
3 - 5 days post vax pt experienced systemic reactions of headache, general malaise, fever, nausea, vomiting and myalgia.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 10-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454 expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I began getting lesions in my mouth and gums.; I began getting lesions in my mouth and gums.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration, administered in the left arm on 10Feb2021 (Batch/Lot Number: EL3249) single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination and had no known allergies. The patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine) on 21Jan2021 (Lot number: EK9231) in the left arm. The patient had no other vaccines within four weeks. The patient stated that one week after the second vaccine, on 17Feb2021, he began getting lesions in his mouth and gums. He has consulted an oral surgeon and ENT specialist but have received no answers and no relief from the lesions. Stated that he had never had as much as a cold sore or ulcer in his mouth prior to his injection. He believed that the vaccine had some part in causing the lesions. Treatment for the events included mouthwash and prednisone. The patient was not tested for COVID post vaccination. Outcome of the events was not recovered.
Swelling, nausea,  hard time breathing, caused kidney stones and diverticulitis ,  ER visit,      2nd shot vax  felt like it tracked down inside of her arm. said nurse  put shot into top part of arm near shoulder.  Caused hyperventilating .
Administered the pediatric dose to 12 YO per parents request. No adverse events have been reported as of 12-12-21
excessive sleepiness & limpness the evening p/vax; on 9th day pt was very sleepy & couldn't be awakened easily;
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) 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 medications were reported. This case was linked to MOD-2021-395985 (Patient Link).
After vaccine, pt went to observation area. He felt hot and asked staff for water. Staff returned with water and he stated he felt light headed. Staff concerned pt might pass out so they assisted him to floor with feet elevated. 911 and onsite MD and EOA called. Pt was unresponsive with agonal breathing and seizure like activity. Epi 0.3 mg administered IM into right thigh. Pt became responsive and breathing 15 RR a minute. Pt remained diaphoretic with rash noted on upper extremities. VSS. EMS arrived and transported pt to local ED for further evaluation.
exposed to son who lives with her who was COVID positive 2/5 through School testing and she became sick 2/9 with mild sx and she tested PCR positive on 2/11; exposed to son who lives with her who was COVID positive 2/5 through School testing and she became sick 2/9 with mild sx and she tested PCR positive on 2/11; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01Oct2021 (Lot number: FF2589) at the age of 40 years as dose 3(booster), single, administration date 18Feb2021 (Lot number: EL3247) as dose 2, single and administration date 28Jan2021 (Lot number: EL3247) 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Feb2022, outcome "unknown" and all described as "exposed to son who lives with her who was COVID positive 2/5 through School testing and she became sick 2/9 with mild sx and she tested PCR positive on 2/11". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (11Feb2022) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and COVID-19 cannot be excluded.
Slight pain at injection site, slight swelling of lymph nodes in left arm, slight body aches. Took Tylenol and all self resolved in 48 hours.
I'm on day 5 of things going on. I might have had some sniffles, but I did not think twice about it until I got the positive test on Friday the October 22th. On Sunday it lingered, I tried staying hydrate and around 2:00 pm I became flushed in my cheeks and postnasal drip started. This was on October 23rd. I took a COVID-19 test on the Sunday and Saturday my throat. I have not seen my doctor in person, but I called my doctor, and he prescribed the antivirals and told me to keep track of my oxygen levels. I had my first dose last night. I felt I was slightly improving prior to taking it and there has not been significant change in symptoms. I have had body aches and a fever but after the first 18 hours I no longer have a fever. Last night it was at 101.0, I still have postnasal throat and congestion in the back of my nose, a hoarse voice and throat discomfort. I occasionally feel like I can't think as well, and I have a disoriented type feeling. It made me feel silly, but it lasted about 10 minutes and went away. I have an occasional light cough due to the postnasal drip.
This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # K015946, expiration date 23-SEP-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 25-JUN-2014 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J013324, expiry date: 12-FEB-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Children vaccinated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Children vaccinated) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Children vaccinated). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Children vaccinated) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Consumer states that they had 900 vials left that they will not use as the children that wanted to get vaccinated did and the rest do not wanted to.  It was reported that nknown amount of children involved and specifics.  No concomitant medications were reported.  No treatment information was provided.
Initial unsolicited report received from a non- healthcare professional on 15 September 2015. This case involves 74 years old female patient who was vaccinated with a dose of FLUZONE HD (batch number UI454AA, expiry date-21 April 2016, dose and route of administration were not reported) in left deltoid and first dose of PREVNAR 13 (manufacturer- Merck, batch number, expiry date, dose and route of administration were not reported) in left deltoid on 11 September 2015. Illness at time of vaccination was reported as none. Birth defects and medical conditions were unknown and patient did not have known allergies. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced jaw swelling. It was unsure if it was on the same side as the injections or any other description to the swelling. It was planned to advise the patient to seek medical treatment (required ER visit). The patient required emergency room and physician visit. Laboratory investigation was reported as none. Corrective treatments were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Within 3 hours (4 pm same day - Wed.), sore arm near injection site, continued until mid-morning Fri. 04/23 (~45 hours after vaccine). Within 6 hours (evening same day), headache and fatigue continued until mid-morning Fri. Within 8 hours (evening same day), nausea/lightheaded and chills continued until late night Thurs. 04/22 (~30 hours after vaccine). My period started about a week (5-6 days) early (two days after I received the vaccine). Cramping has been worse than normal.
No adverse event; pediatric patient was administered a dose from the Multiple-Dose Vial with Dark Pink Cap and Label with Yellow Box, instead of Multiple-Dose Vial with Dark Blue Cap and Label with Gray Border.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (pediatric patient was administered a dose from the Multiple-Dose Vial with Dark Pink Cap and Label with Yellow Box, instead of Multiple-Dose Vial with Dark Blue Cap and Label with Gray Border.) and NO ADVERSE EVENT (No adverse event) in a 7-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (pediatric patient was administered a dose from the Multiple-Dose Vial with Dark Pink Cap and Label with Yellow Box, instead of Multiple-Dose Vial with Dark Blue Cap and Label with Gray Border.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (pediatric patient was administered a dose from the Multiple-Dose Vial with Dark Pink Cap and Label with Yellow Box, instead of Multiple-Dose Vial with Dark Blue Cap and Label with Gray Border.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (pediatric patient was administered a dose from the Multiple-Dose Vial with Dark Pink Cap and Label with Yellow Box, instead of Multiple-Dose Vial with Dark Blue Cap and Label with Gray Border.).    No concomitant medications were reported.  The patient had not reported any adverse reactions at this time.  No treatment medications were reported.    Reporter did not allow further contact
Chills, neck pain, could not hold up head, nausea, dizziness, balance problems, muscle pain.
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves female patient of an unknown age who experienced pruritic medication rash, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number, dose, expiry date, route and site of administration were not reported). On an unknown date, patient developed a non-serious pruritic medication rash within two-hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. She has had the rash and recurrent pruritus for 4 days now. No lab data was reported. Final diagnosis was pruritic medication rash. It was not reported if the patient received a corrective treatment. The event was ongoing at the time of report. Documents held by sender: none.
After four days after receiving the second injection, my left arm turned red and swollen with a red rash all around the site and reaching to my elbow.  It was hot to the touch and lasted approximately five days.
1. Febrile to 100.5 on day following vaccine. Fever resolved with one dose of acetaminophen and a subsequent dose of ibuprofen. 2. Loss of appetite. Lasted 24 hours post-vaccine. 3. Increased sleepiness. Lasted for 36 hours post-vaccine.  4. Small amount of blood and mucus in stool. One episode, 3 days after vaccine (7/23). All treated with supportive care at home. No medical therapy sought.
developed fever and become short of breath, admitted to hospital on 2/17. placed on O2, started on decadron and remdesivir
Pt recvd Engerix-B on 11JUL90, 18SEP90, & 30JAN91; p/3rd dose pt exp a non-response & an allergic rxn to sulfa; poss interaction of Pred, Cimetidine, DPH & Hep B antibody tests to dec test accuracy;
Arterial ischemic stroke, multifocal, multiple vascular territories, acute (HCC). ED to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 26-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX with an unspecified lot and expiration date 30-APR-2014. The pharmacist stated that the dose of ZOSTAVAX was reconstituted with an unspecified diluent that was expired since on an unknown date in January (date and year not provided). No adverse effects reported. Additional information is not expected as the pharmacist did not wish to be contacted.
Child had MMR SC right thigh. 2 days later slight redness. Doctor checking injection site.
The side of her nose was swollen; polyps; Bump on the side of her nose; Nose hurting, tender; Little headache; Little nauseous; Felt a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Apr2021 14:00 (Lot number: ER8729) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinus" (unspecified if ongoing), notes: she has had sinus related stuff in the past.; "urinary tract" (unspecified if ongoing), notes: she was having problems with her Urinary tract. Concomitant medication(s) included: PROZAC taken for menopausal symptoms; PROGESTERONE taken for menopausal symptoms; D MANNOSE. The following information was reported: HEADACHE (non-serious) with onset 22Apr2021, outcome "recovered" (22Apr2021), described as "Little headache"; NAUSEA (non-serious) with onset 22Apr2021, outcome "recovered" (22Apr2021), described as "Little nauseous"; RHINALGIA (non-serious) with onset 24Apr2021, outcome "recovering", described as "Nose hurting, tender"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (23Apr2021), described as "Felt a little tired"; NASAL OEDEMA (non-serious), outcome "unknown", described as "The side of her nose was swollen"; POLYP (non-serious), outcome "unknown", described as "polyps"; MASS (non-serious) with onset 24Apr2021, outcome "recovering", described as "Bump on the side of her nose". She says she noticed they were normal side effects, she was fine to eat and drink. She said she noticed her nose bump and pain in the daytime, it seems to have almost gone away, she hasn't looked up inside, just the outside, she feels much better, something slightly there, no big lump there anymore, she had not looked, if she presses it it is tender, it did not hurt, before it was hurting without touching it, it was uncomfortable, kind of like she got smacked in her face, punched in her face. She says it doesn't feel like it is even really there, last night she could feel it slightly, she can't see it, just feel it mainly on the inside. She says her husband looked at her nose and kind of noticed a difference. She says when she felt it she could feel the outside as well as inside, it is swollen she guesses. She says she tried to stick a Q-Tip up there to see if it was tender, she couldn't do it. She laughs and says she was trying to do a self assessment here. She says she was not sure the exact date of headache and nausea, not sure if it was Thursday or Friday, later confirmed as Thursday 22Apr2021. She was feeling puny the next day, but when she woke up Saturday she noticed the bump on nose. She clarified that by feeling puny she means she felt a little tired but she still continued about her day.   No follow-up attempts are possible. No further information is expected.