chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 07-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47°F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013991: US-009507513-1801USA003526: US-009507513-1801USA003527: US-009507513-1801USA003520: US-009507513-1801USA003521: US-009507513-1801USA003522: US-009507513-1801USA003523: US-009507513-1801USA003612: US-009507513-1801USA003524.
pt recv vax OCT96 & approx 2 wk p/vax pt devel a mild rash w/spots in the hair, stomach & chest areas;
(METFORMIN ER) and ATORVASTATIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Little bleeding at the injection site during vaccination and a bandage was out on it). At the time of the report, VACCINATION SITE HAEMORRHAGE (Little bleeding at the injection site during vaccination and a bandage was out on it) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a casual relationship cannot be excluded.
Narrative:  COVID infection following COVID vaccine series 03/05 Janssen, dose #1 08/07 pt cc: fatigue, sore throat, cough, exposure: unknown 08/08 - 08/16 pt symptoms continue 08/12 COVID swab, result: detected
4-5 days after injection, I started experiencing congestion about dinner time (7pm). Approx 9 pm - full head congestion.  Took benadryl thinking it was some pollen that was affecting me. Went to bed and was awoke around 12-1 with mucus coming from nose. Was able to return to sleep after a couple of hours of nose running. After waking up, nasal congestion passes and during the day I am fine. This process has happened repeatedly now for over a month. Approx 3 weeks in, I went to Dr. That ran covid test, and other rhinovirus tests. All came back negative.
No additional AEs were reported; a patient received an expired PNEUMOVAX 23 on 4/17/2022; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-APR-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, lot #T022294 was confirmed to be valid, expiration date 26-MAR-2022 (expired product administered) (dose, route of administration and injection site were not provided) for prophylaxis. No additional adverse events were reported.
pt recv vax 28MAR97 & pt was refusing to walk;pt was seen 3MAR97 & had 3inch diameter region of mild erythema;pt was able to pull to stand & bear weight for a few seconds;lt hip was tender when moved;4APR97 pt took few steps then fell;
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age who received GARDASIL series "off schedule". The patient was vaccinated on 23-DEC-2011, 29-MAY-2012 and 27-JUL-2012, with the first, second and third dose of GARDASIL respectively (doses, routes and lot numbers not reported). No symptoms were reported, Additional information has been requested.
I got very sick after booster. Fever, body aches, joint pain, haven't been the same since. Rapid heart rate & high blood pressure. Going back to Doctor tomorrow.
I woke up around 3am with my heart beating very quickly. It would not slow down. I put on my husband's smart watch. My heart rate was 95-100 beats a minute laying in bed. When I went to the restroom my heart went up to 112 beats per minute. I took a baby aspirin, ate some chicken soup, and went back to bed around 6:30am. I slept soundly for 5 hours. My husband looked at my heart rate on his phone (connected to his smart watch) while I was sleeping. He says the rate was usually around 60 beats a minute while I was asleep. My heart rate has seemed normal since then.
Minutes after shot my left deltoid started to twitch.  10 minutes after shot I became light headed and passed out for 15-30 seconds.  I was clammy, nauseous  and sweaty.  I was unable to sit up without intensifying symptoms for 45 minutes.  An ice pack and water were brought to me.  Pharmacist asked me how I felt a couple of times and said low blood pressure was a known side effect.  Was able to leave.  Felt nauseous on the way home, extremely fatigued and my left arm was numb and tingly down to my fingertips.  Started to have chills and muscle ache and slight headache.  Slept for an hour when I came home.  4 hours after the shot I am still nauseous and tired with slight headache.
Swelling and heat in (L) thigh, mild s/s 24 hours after injection. Worse by 48 hours. Swelling was 20cm x 8cm, warm, slightly tender to touch. Was walking well. No fever.
101.9 -highest fever got; body aches; a little bit of joint pain and dry heaving (didn't have anything in me); diarrhea. Headache. It lasted until about 6 in the morning and then started getting better. By 4:00 pm on 20th I felt better. Just tired.  I called in sick on the 20th. No treatment.
Information was received from a male patient, age unknown. The patient reported that he participated in the ZOSTAVAX Trial, where he received the placebo. After completion of the clinical trial, he received the ZOSTAVAX (date of vaccination, dosage, and route of administration not provided). The patient reported that he experienced shingles after receiving ZOSTAVAX (onset date not provided). The outcome of the shingles was not reported. The causality was unknown for the event. Additional information has been requested.
The patient came in for J&J vaccine. He said he had no history of severe allergic reaction to anything, including meds, food, vaccines or any injections.  He said that he did not receive any other vaccine in the past 14 days. According to the patient, he did not have test positive for Covid or was in contact with anyone with Covid for the past 2 weeks. He appeared perfectly fine prior to receiving the vaccine. Once the vaccine was given, within about 5 seconds, he said that he was seeing spots, he closed his eyes and made sounds that were similar to snoring. His neck was completely down on his right side and he almost fell off his chair. I held him so he would not fall off the chair and called for help.  A few of the co-workers came to hold him. He was non responsive and my co-workers helped to put his legs on the chair. At point, I gave him an epipen. Once the epipen was given, he opened his eyes in about few seconds and became responsive. The nurses came and took over at this point.  I stayed with him and the nurses for a few minutes. The patient was fully responsive and talking by the time I left the nurses and the patient. 911 was activated after the first epipen was given.  The patient was then evaluated by EMS and the onsite nurses. The patient was AOx4 with stable vital signs.  The patient had orthostatic vital signs taken and were within normal limits.  The patient demonstrated that he was able to ambulate with no assistance.  The patient signed a refusal for transport to the hospital and was driven home by a colleague.  The patient remains in care of that colleague for monitoring.  The patient was instructed that if he were to begin feeling the previous symptoms that he is to activate 911 and be seen in a hospital.  Patient understood the instructions and went back to his residence.
received injection to right deltoid oin 10/20/03; "barely felt it go in", stung a little bit later, next day, her shoulder between the shoulder and the lateral neck surface felt painful, not the site of the injection and on 10/28/03 when she reported it to me, it still was tender at that area, not at the injection site. There was no redness there at all, never was, according to patient. She said she used Motrin but it didn't go away. I sent her to be evaluated. A doctor examined her and said he didn't know what relation there was of symptoms to the injection, but he coded it myositis right shoulder. He said it could have been that the needle hit a nerve, but pt told him that area never did hurt and when the injection was given, there was no pain there at all. A few minutes after injection she reported feeling the usual sting from a vaccine but did not report any sharp or immediate pain, tingling, numbness etc. She is able to move her arm and every day reports improvement. I spoke with her on 10/31/03, and by then she had a head cold, nasal stuffiness, no fever. She reported that her upper shoulder/neck area was improving.
Pt. in for a second dose of Covid Vaccine, Moderna, arrived in observation unit with c/o pain in the spine and tightness in the chest w/o s/s of sob, nausea, vomiting. Pt. states did not have any occurences with the first vaccine. Patient was transported to higher level of care via W/C in no acute distress.
15MAR94 pt recvd vax & 10 hrs later rt arm had a red bulls-eye ring & red freckles around site of inject; during the noc held head & screamed just like react @ 2m; had diarrhea 24 hrs p/shot; also cold sx;
Severe Abdominal Pain; nausea; This is a spontaneous report from a contactable consumer. A 53-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.The fa-cility type vaccine other was Drive thru.The patient had none Medical history. The patients Con-comitant medication included Allergy Medication and colecalciferol (VITAMIN D [COLECALCIFER-OL]) taken for an unspecified indication, start and stop date were not reported.The patient expe-rienced severe abdominal pain and nausea on 12Feb2021. No treatment was given to the patient.The outcome of the events was recovering.    Information about lot/batch number has been requested.
pt recv vax 1SEP97 & 20NOV97 pt exp upper resp sx for approx 2-3 days & devel 40-60 varicella like lesions;pt was afeb & had no significant discomfort;
approx 11 p/vax pt  had episode macular dermatitis, appeared on entire body. then devel left knee pain & edema & refused to gear weight;
Fatigue with insomnia. Skin turned red all over, not itchy, warm to touch. Swelling all over. Benadryl seemed to help. Palm of left hand, pain in muscle near thumb. Joint pain in wrist and fingers, not unbearable but consistently noticeable so far.  Pain at injection sight, swelling.
Per the previous page-heart palpitations, shortness of breath and premature atrial contractions. Intermittent tachy rate
Had moderna  booster at 10:00am on 12/17/2021.  Approximately 30 minutes later left arm went numb, and had severe headache.  Took 2 Tylenol for headache which helped some.  Next day felt tired and started having left side chest pain and left arm numbness.  Still having chest pain especially when lying down on left side.
She got pain and muscle cramps at site of injection w/in 5 minutes. After 2 hrs, she felt nauseated and severe migraine headache that lasts until the next day.
This spontaneous report as received from a Healthcare Worker refers to a 85 year old female patient. In 2007 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous in the left arm. The reporter stated that the patient now had shingles. Onset date was unspecified. On an unknown date the patient was hospitalized. However, the reporter stated she did not know the date of when the client was hospitalized, whether it was yesterday, today, or when. Unspecified treatment was given. The outcome of shingles was reported as recovering/resolving. Additional information has been requested.
Fever began 7/12/01 PM, highest temp around 101F, lasted approx 2 days, then developed rash spreading over entire body. Described rash as itching with wh? on 3rd day. Mom states child well until Prevnar given.
pt recv vax 22MAR96 & several days p/vax exp knee pain & joint pain arthralgias;
Lymph node swelling (right arm and right leg)--still ongoing Inflammation in lymphs near ears (improved)
Nothing wirh 1st one. Exactly 24 hours later after second got chills. Fever body aches vomiting
miscarriage; booster vaccine at 27Dec2021, 2 days after I was conceived; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Dec2021 19:00 (Lot number: 330258D) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Date of last menstrual period: 14Dec2021. The patient was 2 days pregnant at the time of exposure to bnt162b2. The patient was 2 weeks pregnant at the event onset. The patient was expected to deliver a baby(s) on 20Sep2022. Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 18Apr2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 27Mar2021, when the patient was 31 years old, for COVID-19 Immunization. The patient had not received any other vaccines in 4 weeks and was not diagnosed with COVID prior to vaccination and had no known allergies. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (medically significant) with onset 27Dec2021, outcome "recovering", described as "booster vaccine at 27Dec2021, 2 days after I was conceived"; ABORTION SPONTANEOUS (medically significant) with onset 29Jan2022 12:30, outcome "recovering", described as "miscarriage". The event "miscarriage" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of abortion spontaneous. The patient reported she received the booster vaccine at 27Dec2021, "2 days after I was conceived." After one week of booster shot, she was lab tested positive for COVID; almost the same time, she was confirmed pregnant. Until 29Jan2021, she experienced the extreme pain in lower "ab" and bleeding. Later on, she was confirmed miscarriage by her provider. The events did not require hospitalization.
Took Benadryl at home before arriving at shot clinic - began to feel tightness &  burning sensation in throat  shortly after injection - taken to ER for observation and was administered prednisone
This spontaneous report was received from a health care professional refers to an unspecified patient of unknown demographics. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL injection (lot # K016966; expiry: 10-MAY-2017) (dose and route unspecified). No medical history, concurrent conditions or concomitant therapies were reported. No adverse effect reported. No additional information provided. Additional information has been requested.
This case was reported by a physician and described the occurrence of poor oral feeding in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ROTATEQ (non-gsk). There were no concurrent medications. On 30 March 2012 the subject received 2nd dose of PEDIARIX in the left thigh and unspecified dose of ROTATEQ. On 31 March 2012, 1 day after vaccination with PEDIARIX and ROTATEQ, the subject experienced poor oral feeding, severe hypotonia (weakness) and weak crying. The physician reported that these symptoms appeared to be severe and the child's decreased tone was to the point that intubation was being considered to protect the child's airway. Tests and work-up for possible metabolic and neurological causes were being performed (results pending). It was reported that the subject was hospitalized in the intensive care unit. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
Received vaccines on 9/10/07 before trip to abroad.  Noticed subcutaneous bumps surfacing around 9/20/07.  Had ~ 10 of these spread diffusely over torso.  Reports pain and slight itching comparable to an acne breakout.  Reports also a whitish drainage before the bumps healed.  Acute stage bumps lasted about 1 week and then turned into scabbed bumps and healed.  Denies fever associated with the bumps.
Pt received MCV4 vaccine on 9/11/17. No symptoms of reaction was seen 15 min after administration of vaccine. Pt returned to clinic on 9/13/17 w/ c/o  (L) upper arm swelling and erythema. ATARAX, PRELONE was advised and ice to site TID and return to clinic for follow up in 5 days.
Got shot around 1:20PM. no pain or problems reported. Went home and felt fine. Around 6 PM started experiencing shooting pain in the shoulder. Pain got worse progressively. Tried heating pad and ice pack but did nothing. Took two TYLENOL #3 with codeine and one tizanidine 2mg but neither gave him any relief. Cannot raise arm above hip and arm is extremely weak.
Since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ALOPECIA (Since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time). The patient was treated with FINASTERIDE on 11-Nov-2021 for Hair loss, at an unspecified dose and frequency. At the time of the report, ALOPECIA (Since the booster dose experiencing hair loss/strands of hair are coming in my hands/hair loss/hair falling few strands at a time) had not resolved.            No concomitant medications were provided.  Patient's dermatologist gave her a steroid Medication for her scalp.  Reporter stated that the blood work would be performed to see if there were any other reason for the hair loss. She did not get COVID.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Added date of birth and added treatment. On 23-Nov-2021: Updated reporter details and event verbatim On 13-Dec-2021: Follow up received contains significant information, medical history was updated.
I just threw up; This case was reported by a consumer via interactive digital media and described the occurrence of vomiting in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 21st October 2022, unknown after receiving Shingles vaccine, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 21-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, he/she just threw up.  The reporter wanted to know if he/she could this still be from the shingles vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Swollen eyelids; Migraine with aura; A spontaneous report was received from a Nurse of a 55-year-old female was participating in the mRNA-1273 Emergency Use Program and developed migraine aura and swollen eyelids.   The patient's medical history, as provided by the reporter, included anemia, migraine, sciatica, seasonal spring and fall allergies and ADHD. Concomitant medications reported were gabapentin, amfetamine aspartate/ amfetamine sulfate/ dexamfetamine saccharate/ dexamfetamine sulfate and certirizine hydrochloride.    On 24 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection (Lot# unknow).   On 24 Dec 2020, within 20-40 minutes post vaccine administration, the patient began to experience migraine aura. The patient then experienced bilateral eyelid swelling 3.5 hours post vaccine administration. Swelling and migraine worsened throughout the day so patient sought treatment in the emergency room by midnight. Patient reports all symptoms are improving.    Treatment for the event included methylprednisolone, diphenhydramine, and prednisone taper.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events migraine aura and swollen eyelids was reported as recovering.  The reporter did not provide an assessment for the events.; Reporter's Comments: This case concerns a 55-year-old female patient with a medical history of migraine and seasonal allergies who experienced non-serious unexpected events of Migraine with aura and Swelling of eyelid. The events occurred 1 day (same day) after receiving the first dose of mRNA-1273, lot # unknown. Treatment included methylprednisolone, diphenhydramine, and prednisone taper. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. Of note, patient's previous history of migraine and seasonal allergies are considered risk factors to the occurrence of the events.