chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner refers to a 10 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 12-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information or patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
I received the flu shot in my left deltoid. A very short few minutes after that, I got up and felt very weak. I was profusely sweating and felt like something heavy was sitting on my chest. The sensation then radiated to my head, I felt a very heavy pressure, like someone was squeezing me. I could feel my own heart beating, it was beating very fast, racing.  I felt very nauseous. I walked around the store to cool off and see if that would help, for I?ve never had an allergic reaction to medicine/vaccines before and did not know what to expect.  I was going to go back to pharmacy if my symptoms worsened but they did not.  I contemplated going to the ED based on the symptoms I experienced but by the time I got to my car, I felt better and decided to go home. I haven?t noticed any new or similar symptoms since  I received my flu shot a few hours ago.
Patient was give a full 0.5ml dose as the 4th dose instead of the 0.25ml dose.
Shingles pox many blisters the size of a quarter; Breakouts occur on abdomen or buttocks; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles pox many blisters the size of a quarter) and RASH (Breakouts occur on abdomen or buttocks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced RASH (Breakouts occur on abdomen or buttocks). On 30-Jan-2021, the patient experienced HERPES ZOSTER (Shingles pox many blisters the size of a quarter). The patient was treated with ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles pox many blisters the size of a quarter) and RASH (Breakouts occur on abdomen or buttocks) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. Patient said since the first dose and post second dose that they have had 3 outbreaks of shingles outbreaks.   This case was linked to MOD-2021-037485, MOD-2021-037485 (Patient Link).
28Jun95 pt recv 1dose vax. 01Dec97 Pt exp varicella w/"18 itchy lesions on his back & trunk lasting 6 days. No fever.
Patient noticed severe itching on both legs and feet and he developed hives on right inner thigh and outside right foot and left foot.
Tremors; This spontaneous case was reported by a non-health professional and describes the occurrence of TREMOR (Tremors) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced TREMOR (Tremors). At the time of the report, TREMOR (Tremors) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment and concomitant medication provided
Patient fully vaccinated with Pfizer: dose 1 on 3/17/21 and dose 2 on 4/7/21. patient is known to be immunocompromised at baseline.  Patient reported COVID symptoms of cough, shortness of breach, headache, body aches, runny nose, watery eyes, fever, sore throat, fatigue, loss of taste starting on 8/13/21. Patient reported to the Hospital Emergency Department on 8/29/21 for worsening symptoms and then received a COVID test which was positive. Patient remains symptomatic as of 8/31/21.
8:30pm: pale, fever Overnight: chills, fever, difficulty sleeping 7:30am: headache, sore arm, stomach ache
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies reported. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot# reported as L0010144, expiration date 24-MAR-2017, dose, anatomical location and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
deep burning pain @ inoculation site on 12APR97 intermittent;5MAY97 upon awaking had tingling lt little finger;
It was reported that a female pt received a Tripedia vaccination on 4/3/01. Reportedly, on 4/4/01, the pt developed swelling, redness, induration and blistering. Physician treated with Keflex to be safe. Reaction resolved by 4/7/01.
arm became very red & hot in area where flu shot was given;this was the very next day & it also itched all the time;this has lasted the full two wk after;
Headache, weakness.  Observed for approx 1 hour.  No worsening of symptoms, but did not feel well enough to remain at school.  Returned to school 12/8/09.
18 hours after the shot, I experienced a rash with itching and clear visible sign of redness and liquid (1 inch wide and 3 inch long). This was at the area between my right leg and stomach (groin).  I took a Benadryl and the rash went down after a few hours.
Information has been received from a physician concerning a female child patient who  was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Approximately one year pose vaccination, the pt developed full blown chickenpox. Unspecified medical attention was sought but no treatment was required. Subsequently, the pt recovered. A product quality complaint was not involved. The reporter also mentioned a second pt that developed chickenpox post vaccination with varicella virus vaccine live. Additional information has been requested.
could not pee; chemical taste in my mouth; headache; lower backache; heart is jumping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 16:00 (Lot number: ER8737) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "CHF" (unspecified if ongoing), notes: CHF; "hypertension" (unspecified if ongoing), notes: hypertension; "hypothyroidism" (unspecified if ongoing), notes: hypothyroidism. Concomitant medication(s) included: LOSARTAN; SPIRONOLACTONE. Vaccination history included: Bnt162b2 (other vaccine 4weeks product=COVID-19/PFIZER-BIONTECH,, other vaccine 4weeks lot number=EN6208,, other vaccine 4weeks vaccine location=Right Arm), administration date: 11Mar2021, when the patient was 70 years old, for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache"; DYSURIA (non-serious) with onset 03Apr2021, outcome "not recovered", described as "could not pee"; BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "lower backache"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "heart is jumping"; DYSGEUSIA (non-serious) with onset 01Apr2021, outcome "not recovered", described as "chemical taste in my mouth". Therapeutic measures were not taken as a result of headache, dysuria, back pain, cardiac disorder, dysgeusia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not tested for COVID-19. Allergies to medications, food, or other products was yes. The patient had other vaccine in four weeks. I have heart failure, hypertension, and hypothyroidism. I take medication and some of this medication is losartan and spironolactone. Within fifteen minutes of the first vaccination I got a slight headache and heart racing. Through the month, my medical conditions got worse. Second vaccination, just a slight headache. Within two days, I could not pee. Luckily, I have diuretics. I stopped taken the spironolactone. Still not peeing the way I should. Just wondering if I got an overload of potassium. Have a lower backache and my heart is jumping. Ten to fifteen minutes after the second dose I did get a chemical taste in my mouth. Still getting the chemical taste in my mouth.   No follow-up attempts are possible. No further information is expected.
The patient spit up his formula shortly after arriving home from the clinic. He spit up another unusual amount before going to sleep around 8:30 that same night. This was an extremely early time for the patient to go to sleep. The patient awoke about 9:00 am and did not call out as he usually does. The patient did not reach out or have his usually bubbly personality. He lay in the bed after awaking and made whining sounds. That PM it was noted that the patient's left cheek bone area was swollen. On 10/18/2001 the patient remained unresponsive and the swollen cheek now had a red line it it, which seemed to be inside the skin. The patient does not interact with others and will often sit and stare. When in his high chair he will lean over and lay his head to the side. The patient also coughs a lot now. The patient is now no longer active in his bath or when he is having his diaper changed. As of 10/23/2001, the patient has not regained his previous disposition. The patient is mopey, whines alot, leans or falls over slowly while being held as if he is going to sleep, but he is wide awake. He has spurts of joviality then returns to a lethargic state. He no longer wakes up playing.
After receiving vaccine, client stated he feels dizzy.  Vital signs obtained.  BP 160/81, HR 80, O2 sat 93%. Client states he feels better.  Client discharged home by EMS.
Could not drink from a cup. Left side of my face was drooping.  Eye Problems. The day of shot I got a bad                  headace on my left side of neck                 and back of head  Diagnoses                   Predisone Bells Palsy                  Valacycolvir  Renal Insufficiency
Slight headache; This is a spontaneous report from a contactable consumer (patient's sister). A 7-decade-old male patient (reporter's brother) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose for COVID-19 immunization and experienced sore arm.  The patient had a slight headache and took a Tylenol which dealt with it. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433358 Same reporter/patient/drug, different dose/AE (reporter's brother, first dose);US-PFIZER INC-2021434164 same reporter, product and event, different patient (reporter brother's wife, second dose).
p/recv vax pt one cheek started to devel red blotches similar to hives but w/tiny red raised bumps; 2days later rash was everywhere above the waist; given benadryl lotion;
ADMINISTRATION OF A DOSE OF THE VACCINE THAT WAS STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 76 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced incorrect product storage. On 26-AUG-2021, the patient experienced administration of a dose of the vaccine that was stored outside of the recommended storage conditions. The action taken with covid-19 vaccine was not applicable. The outcome of the administration of a dose of the vaccine that was stored outside of the recommended storage conditions and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210854749 and 20210855614.
Feeling spacey; severe diarrhea; Sweats; severe body aches; Chills; A spontaneous report was received from a consumer concerning a 78 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe body aches, severe diarrhea, sweats, chills and feeling spacey.  The patient's medical history was not reported. Current condition included lung cancer. Concomitant products included chemotherapy pill for lung cancer.  On 05 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 05 Mar 2021, 3 hours after receiving vaccine, the patient developed severe body aches, severe diarrhea, sweats, chills and feeling spacey.  Treatment information was unknown.  The event of feeling spacey was considered to be serious with criteria of important medical event and the rest events were considered as non-serious.  Action taken with mrna-1273 in response to the events was unknown.   The outcome of event, feeling spacey was considered resolved on 08 Mar 2021 and the remaining events were considered resolved on 07 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Nausea (almost vomited), headache, fever, chills, left arm pain at injection site, muscle aches and pain, general malaise through 15-Nov-2021. As of 16-Nov, he feels better but has a runny nose.
PRESSURE HEADACHES; This spontaneous report received from a patient concerned a 49 year old female. 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, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced pressure headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pressure headaches. This report was non-serious.
Information has been received from a pharmacist concerning a 69 year old male with no history of drug reaction or allergies, and a history of post herpetic neuralgia (PHN) and shingles, diagnosed in 2006 who on 02-NOV-2007 was vaccinated subcutaneously with 0.65 ml into the left arm with ZOSTAVAX (Lot # 658602/1080U).  On 01 OCT 2007, approximately four weeks prior to the administration of ZOSTAVAX, the patient was administered an influenza virus vaccine (unspecified) (manufacturer unknown).  Two to three days post ZOSTAVAX vaccination, on approximately 04-NOV-2007; the patient had a "possible slight increase in redness at the original site of his shingles lesion", along with an increase in PHN to a level of 8-9.  Prior to his vaccination with ZOSTAVAX; the patient rated his PHN as a 4, on a scale of 1-10.  At the time of reporting the patient was not recovered.  No lab diagnostic studies were performed.  There was no product quality complaint.  Additional information has been requested.
Redness, sore "2-3" on scale 1-10 warmth to touch, rash like rxn. left deltoid slightly raised.
12 hours after vaccine - intense pins and needles feeling in arms and legs. Excruciatingly uncomfortable, unlike other pins and needles feelings/numbness I?ve experienced before. Could not stop moving.
Patient admitted to Supervisor she had received a previous vaccine pfizer a  month  ago and did not tell the nurse. She was given the Johnson vaccine whom she stated was advised by her family physician. There was no reaction.
Approximately 28 hours after the injection, upon going to bed at a friend's house, the throat was swollen and a headache ensued. It was severe enough that it caused Sleep Apnea episodes that awoke me. I was required to drive over an hour in the middle of the night to get back home so I could sleep with my CPAP to prevent further episodes. I had previously always been able to sleep elsewhere besides home without the CPAP, and no further episodes occurred once I went back to sleep at home using the CPAP. When I awoke the following morning my throat was still swollen, the headache was worse, and I had ringing in my ears. Fifty-two hours later, now my throat is still swollen, there is still ringing, but I have worked.
Hoarseness and coughing. Later that evening, high fever, chills, swollen and red injection site, severe headache, nausea, bed-ridden for a couple days.
Syncope--  about 10 sec after administration, patient became tonic  that lasted approximately 5 seconds,  then passed out for approximately 20-30 seconds Immediately, EMS was alerted and responded in approximately 8 minutes. Patient's blood pressure was monitored and then  patient declined to be transported to the hospital
"Moderna COVID-19 vaccine EUA" Patient received 0.50 instead of 0.25ml of COVID booster vaccine.
lip was swelling / spread to his forehead, eyes, nose, cheeks and jaw.; lip was swelling / spread to his forehead, eyes, nose, cheeks and jaw.; This case was reported by a consumer via call center representative and described the occurrence of lip swelling in a 58-year-old male patient who received HAV (Havrix) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   Previously administered products included Havrix (patient received his first dose of Havrix (Lot N34BM) in January of 2020 and had no issues).   On 30th October 2020, the patient received the 2nd dose of Havrix (intramuscular). On 30th October 2020, 7 hrs after receiving Havrix, the patient experienced lip swelling and facial swelling. The patient was treated with benadryl (nos) (Benadryl) and cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the lip swelling and facial swelling were not recovered/not resolved.   The reporter considered the lip swelling and facial swelling to be related to Havrix.  Additional details were provided as follows: The patient received his first dose of Havrix (Lot N34BM) in January of 2020 and had no issues.   The patient received the 2nd dose was administered morning at 10:00 AM.   Around 4:00pm, he noticed his lip was swelling. It has now spread to his forehead, eyes, nose, cheeks and jaw.   He consulted with his primary doctor who advised him to take Benadryl and Zyrtec. The reporter did not consent to follow up.
Pt seen @ clinic on 28DEC92 & blood culture was obtained & grew Haemophilus influenzae type B; pt recvd 3 HIB vax 5MAR91, 1MAY91; 5JUL91;
pt recv vax 27SEP95 & 7AUG96 pt devel a varicella-like rash that itched & was uncomfortable & a fever of 102.7l;pt was seen by a resident & an ER MD who diagnosed varicella;
In chair immediately following injection, patient completely lost consciousness and slumped against table.  Nurses moved patient into wheelchair, then to gurney where patient was monitored.  Patient woke up and returned to being awake, alert and fully oriented in roughly 3 minutes.  Patient was seen by Dr and monitored for additional 30 minutes.  No medications were given and patient was discharged to home with family member.
After 1st Dose: Immediately experienced tight feeling in throat, difficulty breathing, assumed an asthma attack was going to happen, difficulty breathing on first day. The second day, extreme difficulty breathing (assumed it was bad asthma again), extreme tightness in chest and trouble breathing. Took usual medications, then took albuterol inhaler, then nebulizer, neither of them made any difference.  Felt more and more sick throughout second day. Third day was having trouble breathing, bedridden the entire day. By Day 4 started to subside and recover. Within a week was totally normal. Now taking prednisone because of asthma, but was not at the time of the vaccine doses. Unsure if that had an effect on recovery, etc. After 2nd Dose: Had tight throat, and difficulty breathing, but was much less severe, occurred in episodes and then would go away. Felt fine by 3rd day.
Odd behavior approx. 6 days post receiving MMR vaccine. Saw purple bugs. Felt bugs crawling on body. Stated his dad died. Blurted out cursing. Stated he was hearing things. Had nightmare these events happened over 24 hr period.
Likely new onset lichen planus eruption beginning a few months after initial dose, continuing symptoms. Misdiagnosed many times, starting new therapy next week.
The pt was difficult to arouse the morning following the vax. The pt was shaky, sleepy, unable to stand. It took the pt approximately 4 hours to return to normal.
Headache on the evening of the vaccine 7 out of 10.  Extreme fatigue, pain, swelling, redness and itching at injection site.  Mild headache the next day 4 out of 10.  Pain, swelling, redness and itching at injection site 5 days after the injection.  Alternated with Tylenol and Ibuprofen to treat pain and swelling.  Benadryl at bedtime for the itching.  Applied warm compress to injection site.
Fever of 99.6-100.6 from 9 hours after shot through about 54 hours after shot, with extreme muscle, joint, internal, and head pain throughout that time. Intermittent infrequent stabbing pains in left chest at 10 hours through about 24 hours after shot. Extremely painful swelling at shot site beginning at the same time as other effects, about 9 hours after shot: the swelling was extremely hard, obling, about the size and shape of a pickle underneath the skin with a round, navel orange shaped pinkness on the skin from about 10 hours through 15 hours after shot; then the swelling grew to the diameter of an acorn squash under the skin, still hard, darker pink and the pink part still being navel orange size and shape, and extremely painful causing a limp and all movement to be extremely painful until the end of the fever at about 54 hours after the shot. After that, beginning today, day 4 after the shot, the swelling is now soft and gelatinous, about the diameter of a grapefruit, with the pink part being lighter but still navel orange size/shape. Not as painful, but more itchy. Itching was intermittent throughout, coming in mild attacks. It was painful throughout but itchy only intermittently.