chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches, joint pain, headache, severe nausea, diarrhea, dizzy, sleepy.  All day.  At 3:00 pm, cough started.
Patient puked, has high fever, stomach ache, has been walking on tip toes often falling over with a hunched back.  Went to ER, they gave Motrin and monitored her and checked urine.  She still is walking with aches, has a stomach ache, intermittent fever and low energy.
Immediately post vax pt became apneic with central cyanosis. Recovered rapidly with stimulation. Observed for approximately 30 minutes. Feeling well discharged home. Follow up next day.
RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 31 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: 07-MAR-2022) 2.5 ml, administered on 20-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 20-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious.
The patient was administered the wrong Pfizer vaccine based on age group. The patient was supposed to be administered a pediatric dose but was given an adult dose. The patient was observed 15 min post vaccine and did not experience a reaction. Mother was contacted on an error and states the patient has had no symptoms just a sore arm.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. No medical history was reported. On 29-SEP-2014, the patient was vaccinated with ZOSTAVAX 19400 PFU (plaque-forming units) (lot # J003723, expiry: 28-JUN-2014) (route and dose was unknown). On 29-SEP-2014 (also reported as yesterday), the patient may have received an expired ZOSTAVAX. The reporter stated that, the lot number does not seem to match a product according to OMC. No adverse effects were reported. No product quality complaint (PQC) was reported. The outcome of the events was unknown. Additional information has been requested.
The day of the shot my arm became painful, red, and swollen by the3rd day I was having the beginning of shortness of breath. Within a week more tachycardia, then hoarseness, coughing, and some whezzing. This has been going on now for 2 mons. First they treated it like a flare up of my COPD from the shot but it hasn't gone away. I've been on antibiotics and prednisone, breathing treatments. I've been to the hospital 2x and kept once. I have 3 appts. With my PCP and with my Lung Dr. I can't do the simplest tasks. Everything makes me out of breath. Its been very hard.
pt recv vax & devel sl redness & soreness @ inj site, arm & shoulder pain, followed by joint pain; MD did not feel sx were related to vax; 02MAR94 pts joint pain persisted; pt declined to allow MD to release any addtl details;
Presented to ED d/t no improvement w/outpt tx for COVID-19 pna; tx w/O2, abx, steroid, zinc; during stay, pt developed head bleed; d/t age and decline in mental/physical status, pt made comfort care and expired 1/8.
Severe pain in both legs, increases when bearing weight.  Started at ankles, now all the way up his legs.  Fevers since the 19th.  Fatigued and irritable.
Received Influenza Vaccine 10/17/2002.  Seen by PCP 10/22/02 with c/o severe HA.  DX with migraine, treated with Compazine IV.  Later referred to Neurologist for F/U secondary to continued HA.  MRI and spinal tap done.  Per pt., dx with adverse reaction to Influenza vaccine.  Seen in ED 11/09/2002 for c/o HA and backache after spinal tap done 11/07/2002. Demerol/Phenergan given IM.
Since my daughter received the vaccine series she has had a series of unexplained nose bleeds, mouth ulcers, dizziness, blackouts, blurred vision, severe joint pain, abdominal pain, numbness & tingling in her hands and feet and fatigue.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 19-APR-2018, the patient was vaccinated with expired dose of VAQTA (lot # N002921, expiry date: 08-APR-2018) for prophylaxis (expired product administered). No adverse effects were reported. No product quality complaint involved.
ACUTE PULMONARY EMBOLISM HYPOXIA 8/8/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I occasionally feel like there is a lump or knot in the injection location of my left arm. More importantly, every night while I'm sleeping both of my arms and hands "go to sleep," becoming completely numb. In addition, my fingers are stiff and it takes about 30 seconds of opening and closing to get the numbness and stiffness/soreness to subside. Throughout the day I can feel a little arthritic pain in my fingers, though not extreme - just uncomfortable. The final thing I'm experiencing is having very little stamina when working out. I'm in very good shape and have done a spin class for cardio several times a week for years. Since getting the vaccine I am finding it much harder to push through my class from a cardiovascular perspective. I get a physical every year and my blood work and everything is perfect.
Significant pain and swelling in left elbow joint, starting about one week post vaccine. Saw my doctor for this. Then on October 6th I went to Urgent Care for pain in my chest. I was diagnosed with Costochondritis. I was prescribed Meloxicam for inflammation. I've also been experiencing significant hyperthyroid symptoms. My TSH was recorded as 0.083 on 10/11/2021. I am now being monitored every two weeks by my endocrinologist to see what happens with my thyroid levels, and have an upcoming ultrasound appointment to see how much my goiter has grown and if it will need to be removed.
PATIENT STARTED GETTING HIVES, WAS ADVISED TO TAKE BENADRYL AND GO TO ER IF REACTION GOT WORSE.  REACTION DID GET WORSE OVER THE NEXT DAY TO HIVES SPREADING MORE AND SWELLING AROUND THE LIPS. PATIENT WENT TO ER THEN AND GOT EPINEPHRINE SHOT AND BENADRYL IV.
Information has been received from a physician concerning an approximately 64 year old female who in May 2008, was vaccinated with a dose of ZOSTAVAX (Merck0 (lot #659411/0293X) 0.65 mL. Concomitant therapy included ZYRTEC, NEXIUM, ACTIVELLA, TOPROL, CRESTOR and BENICAR. The physician reported that "this past week" the patient experienced blisters, itching and swelling and could be a case of shingles, however it was still unknown. The patient was on antibiotics. At time of reporting had not recovered. The patient sought unspecified medical attention. Follow-up information was received from the physician, who reported that patient is a retired 63 year old female with myasthenia gravis, ptosis and "problems wit the same side". The patient was vaccinated with ZOSTAVAX (Merck) on 27-MAY-2008 subcutaneously into her left arm. The physician reported that on 10-MAR-2009, the patient experienced " possible shingles episode - face". At the time of reporting, the patient recovered from the adverse experiences. No further information is available.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 16-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route of administration, anatomical location were not reported; lot number S008153 was confirmed to be valid, expiration date 20-NOV-2021) for prophylaxis. Administered dose of vaccine was stored in a temperature of 1.1 degrees Celsius for 27 hour and 45 minutes and at temperature of 9 degrees Celsius for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. There were no further adverse events reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.;  devicelotnumber: S008153; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Vaccine given 2/26/16 as part of physical exam. Per pt next morning 2/27 all over body red patchy blanching rash, neck tenderness, painful swallowing, body ache, joint ache, fatigue, fever, chills.
Has not receive the 2nd dose (beyond day 35 after 1st dose); Back pain; Felt like he was going to collapse; Felt like he was going to vomit; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not receive the 2nd dose (beyond day 35 after 1st dose)), BACK PAIN (Back pain), PRESYNCOPE (Felt like he was going to collapse) and NAUSEA (Felt like he was going to vomit) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not receive the 2nd dose (beyond day 35 after 1st dose)), BACK PAIN (Back pain), PRESYNCOPE (Felt like he was going to collapse) and NAUSEA (Felt like he was going to vomit). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not receive the 2nd dose (beyond day 35 after 1st dose)), BACK PAIN (Back pain), PRESYNCOPE (Felt like he was going to collapse) and NAUSEA (Felt like he was going to vomit) outcome was unknown.        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.   No Concomitant medications were provided No treatment information provided.
Information has been received from a medical assistant concerning a 5 year old male with no past medical history who on 5/13/02 at 14:00 was vaccinated with the first dose of hep A vaccine inactivated (641153/0072M) RA, IM. Concomitant therapy that date and time included a second of MMR II (640318/1085L) LA, SC, the fourth dose of poliovirus vaccine (U0344) LA, IM, and a fourth Mantoux test (c0942AB) LA, dermal. There was no illness at the time of vaccination. On 5/14/02 at 14:00 the pt developed redness and swelling at the injection site. The pt was given bydrocortisone cream for the rash and given warm compresses for the injection site. Follow-up reported that the pt had a red right swollen arm, that was reported to be "warm to touch," and a rash along the neck and lower lobe of ears. There were no relevant diagnostic tests or laboratory data performed. The pt had sought medical attention. It was also noted that the pt did not have any adverse events following previous vaccinations. It was reported that the pt recovered on 5/21/02. It was also reported that another pt was vaccinated from the same lot and had a similar reaction (WAES0205USA02296). No further info is expected.
Patient received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's comment:No other data was available. The reporter did not consent to follow up. Additional supportive information: The patient had received the 3rd dose of Shingrix, which led to extra dose administered.
Muscle pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Muscle pain at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Muscle pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Muscle pain at the injection site) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  No concomitant medications reported.  No treatment information was provided.
not to be able to get pregnant; This spontaneous case was reported by an other health care professional and describes the occurrence of INFERTILITY FEMALE (not to be able to get pregnant) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 INFERTILITY FEMALE (not to be able to get pregnant). At the time of the report, INFERTILITY FEMALE (not to be able to get pregnant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   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.
After second COVID vaccine, patient had nausea, lightheadness, and newar-syncopal event. Patient went to the ED for further monitoring and labs were drawn. Patient then discharged from the ED.
Vaccinee experienced sweating, chest tightness, sob, nausea, tingling of hands, (Hyperventilating upon arrival in ER) & headache on 15OCT90 1/2 hr p/ vax. Tx w/ Benadryl 50mg/IM) w/ no relief of sxs.  Pt felt better early pm p/ resting.
Initial report was received on 16 March 2010 from another manufacturer, with document number WAES 1003USA00893. The initial reporter to this manufacturer was a healthcare professional. Verbatim from the report: "Information has been received from a physician and licensed practical nurse. Information concerning a 14 year old female with attention deficit disorder and allergic to Penicillin who on 25-Feb-2009 was IM vaccinated with a first dose of GARDASIL vaccinated on 25-Feb-2010 with a dose of GARDASIL (Lot no. 662529/1317Y) given in left upper thigh; a dose of VAQTA (Lot no. 666201/1538Y) given in right upper thigh; a dose of MENACTRA (Lot # 430800AA) given in left lower thigh and a dose of ADACEL (Lot # C3352AA) given in right lower thigh. Concomitant medication included ADDERALL." "It was reported that the patient called the physician's office at the afternoon, the patient experienced hives, nausea and dizziness and also complaint of tingling in both legs. Patient had taken 12.5 mg. of BENADRYL twice before going to the emergency room. The patient was seen at approximately 23:00PM the same day and symptoms were gone. Patient received a dose of SOLU MEDROL IV and ZANTAC prior to being discharged from emergency room. At the time of the report the patient was recovered." "Upon internal review, hives, nausea, dizziness and tingling in both legs were considered to be other important medical events." "No further information is available." Of note, MENACTRA lot number 43080AA (also reported as 430800AA) is not a valid sanofi pasteur lot number. Documents held by sender: None.
First day after had sore arm and 101 fever. Woke up next day and fever was gone, then went to sleep and high fever came back ranging between 102 and 103.5 for the next 4 days. Had difficulty urinating due to inflamed prostate and UTI and fever that only lowered mildly from medicine
My arm swelled up about an hour after my shot.  About a week after, I got hives all over my body.  I did telehealth for them to look at the rash and to provide me something.  They prescribed me steroids'.   I had the hives for about a month.  After a month I got into an allergist.  They diagnosed me with dermatographia.  So, for the last couple of my life, I have been on 3 medicine for this.
discoloration on her breast; immediately felt the vaccine in their arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm (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: BREAST DISCOLOURATION (non-serious), outcome "not recovered", described as "discoloration on her breast"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "immediately felt the vaccine in their arm". The event "discoloration on her breast" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information : The patient (Age: 74, Unit: Unknown) reported that, after the first dose that patient received on a Friday, that Monday when patient was getting dressed, noticed discoloration on her breast and it was on opposite side on where patient got the injection. Patient saw a gynecologist in which they did a mammogram and an ultrasound, but did not see any lumps. The patient reported that the gynecologist did not think it was anything, but the "discoloration is still there, had not changed, other than faded some. The patient reported that her and her husband (74-year-old, male) immediately felt the vaccine in their arm with the first dose, but felt nothing with the second injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately p/vax pt devel inj site rxn of swelling & warmth.Pt devel neck pain,shoulder & joints. Md rx Motrin.As of report date,pt still had pain,weakness in 1 knee.
On 12/22/2006, about 2 hours post injection, patient noticed Left upper arm began to ache. No redness or bruising noted. 24 hours post injection, patient noticed swelling in Left arm extending from Left upper arm through Left forearm. Slight residual edema noticed in Left arm yet today on 12/26/2006. No redness noticed. No longer has pain in arm.
3 hrs unconsolable crying, followed by 12 hrs /w fussy, whiney, behavior. Local rxn characterized by redness & swelling 2-3" in dia for 3 days
Dizziness for month following Burning eyes for month following Skin rash below injection site - 7 days later; lasted week
Like there is a knot/ like a lump at the injection site; site itself is a little burny and hot; The site itself is burny; pain at injection site/Really sore injection thing/It hurt really bad when they injected it/A bit of a bitch/ site itself is a little burny; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Like there is a knot/ like a lump at the injection site), VACCINATION SITE WARMTH (site itself is a little burny and hot), VACCINATION SITE PAIN (The site itself is burny) and VACCINATION SITE PAIN (pain at injection site/Really sore injection thing/It hurt really bad when they injected it site itself is a little burny) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included NAPROXEN SODIUM (ALEVE), APIS MELLIFICA, GELSEMIUM SEMPERVIRENS, PSEUDOGNAPHALIUM OBTUSIFOLIUM (MAGNILIFE PAIN RELIEVING FOOT CREAM), DULCAMARA and BERBERIS VULGARIS BARK (BARBERRY [BERBERIS VULGARIS BARK]) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE MASS (Like there is a knot/ like a lump at the injection site), VACCINATION SITE WARMTH (site itself is a little burny and hot), VACCINATION SITE PAIN (The site itself is burny) and VACCINATION SITE PAIN (pain at injection site/Really sore injection thing/It hurt really bad when they injected it site itself is a little burny). At the time of the report, VACCINATION SITE MASS (Like there is a knot/ like a lump at the injection site), VACCINATION SITE WARMTH (site itself is a little burny and hot), VACCINATION SITE PAIN (The site itself is burny) and VACCINATION SITE PAIN (pain at injection site/Really sore injection thing/It hurt really bad when they injected it site itself is a little burny) outcome was unknown.        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.   Treatment medication:- The patient is taking arnica and Excedrin and applied adsorbent to the site to alleviate the symptoms.  Concomitant medications: Typing error : Barberry extract( Tarberry extract ).  Follow-up received on 17 May 2021 included no new information.  Event outcome was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: This follow-up was received on 17-MAY-2021 which did not have any new information. On 17-May-2021: This follow-up was received on 18-MAY-2021 which did not have any new information.
Approximately 10 days from vaccination, began to experience hives across entire body; patchy; vary throughout the day skin becomes irritated when put under pressure; lots of itching
Patient received the vaccine and when she stood she got very white. Patient sat in a chair and had a water and orange juice. Within a few minutes the patient was fine. Patient left on their on.
High fever followed by seizures admittance to hospital ER for 8 hrs. Vomiting. Lethargy.
POOR QUALITY VACCINE ADMINISTERED; HEADACHE; FEVER; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the subject experienced poor quality vaccine administered. On 18-MAY-2021, the subject experienced headache. On 18-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The outcome of the poor quality vaccine administered, headache and fever was not reported. This report was non-serious. This case, involving the same patient is linked to 20210538801.