chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reduced consciousness; Pain and swelling in the arm where she received the shot; Pain and swelling in the arm where she received the shot; Slight fever; Chills; Heart rhythms; Tiredness; Sudden severe headache; Imbalance; Trouble walking; Dizziness; Vertigo; Slight vision changes; Confusion; Numbness or weakness of one side of her leg; Numbness or weakness of one side of her leg; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO9269), via an unspecified route of administration in right arm, on 10Feb2021 at 14:15 (at the age of 80 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included stroke (few years ago), multiple hip transplants, and rheumatoid arthritis (for 35 years). The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol tartrate. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a clinic. On 11Feb2021 at 16:45 PM, normal side effects felt are pain and swelling in the arm where she received the shot. In addition, the patient may have a slight fever, chills, heart rhythms, tiredness, headache, and imbalance (trouble walking) on 11Feb2021 at 16:45 PM. On the patient's first two days (starting on 11Feb2021 at 16:45 PM), the patient experienced dizziness or vertigo, slight vision changes, sudden severe headache, confusion or reduced consciousness, and numbness or weakness of one side of her leg. It was unknown if treatment was given for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Sudden severe headache", "Dizziness", "Vertigo", "Slight vision changes", "Confusion", "Reduced consciousness", and "Numbness or weakness of one side of her leg" in Feb2021; and from the other events in 2021.   No follow up attempts are possible. No further information is expected.
PNEUMOVAX vacc was administered on Thurs 2/27/14 around 1:45 pm; Thurs evening pt. experienced muscle pain/joint pains along rt side of body, no headache, extreme fatigue and felt very sleepy.
Child given imms. Mother returned with child complaining of feet itching and rash on back. Child had no problem swallowing. Two nurses removed his shirt and saw dry skin and no evidence of a rash. No swelling or redness at injection sites. However, eyes were somewhat puffy. Mother had purchased benadryl and gave child 1 teaspoon. 10/26/05 Follow up call to mother. She related she left clinic and called MD. He instructed her to give one more teaspoon benadryl. As of 10/26/05 11am child is feeling fine, no itching.
Redness at injection site, region surrounding injection site very tender and sensitive. Excruciating pain that made me tear up whenever I attempted to lift my arm more than 1 1/2 inches. Unable to use right arm for any activities due to pain.
Information has been received from a nurse practitioner concerning a female with pcn allergy who was vaccinated with hep b vaccine recombinant. Subsequently, the pt experienced an allergic reaction. Unspecified medical attention was sought. No further info is available.
Had never received the Prevnar vaccination before. He also had never had any ear infections ever. Within the week after receiving the PV shot he developed an ear infection. He had an ear infection for about 3 months straight. Since he had that reaction he has not received this vaccination again, neither has any of my other children. I don't know the lot number of the vacinations. He recieved a DTap/DTP shot on the same day. He had already received the Dtap/DTP 3 previous times with no reactions. Both were shots and both were in his legs/thighs.
The day after vaccination, I began to feel slight tingles and numbness in the left side of my face. Two days after that, it had intensified and had also spread to my left arm and left leg. The day after that, I became aware of a large floater in my left eye. On occasion, I have also felt milder tingles in the right side of my face.  I first visited the ER, and all they could determine was that I hadn't had a stroke. I later talked to my PCP, who explained that he has seen these kinds of effects with some regularity following COVID vaccination. He believes I have a case of Bell's palsy, and that my nerves should gradually return to normal without further action. At his suggestion, I'm taking an 81 mg aspirin once a day as a precaution against micro blood clots.  I believe my left arm and left leg have returned to normal, though my face is still irregular. Exact symptoms seem to depend on the temperature. The floater in my left eye is still there, and I intend to talk to my eye doctor about it.
This spontaneous report as received from a health care worker refers to 10 patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the 10 patients were vaccinated with improperly stored VARIVAX (strength, route unspecified) lot # L001327, expiration date 13-JAN-2017. No adverse symptoms reported. The outcome of events reported was unknown. No product quality complaint was involved. This case is linked to the cases 1507USA008508, 1507USA004977 via same reporter link. Additional information has been requested.
Approximately 12 hrs post vaccine, developed arthralgias, chills, fever, dizziness, lasting approximately 36 hrs.
On 9-16-14 pt received High Dose flu vaccine (L) upper arm. Pt reports 9-17-14 she had raised red areas on (L) arm which cause itching. Appt. today for 6 mo. f/u and reported. A few red areas still evident. No treatment ordered.
Developed fibromyalgia and CFS due to receiving tainted anthrax vaccinations (squalene).  Currently under a physician's care for fibromyalgia & CFS. Vaccine A Lot Number FAV 072.
Information has been received from a nurse concerning a 75 year old female with hypertension, hypercholesterolaemia, osteoporosis and no allergy who on 18-DEC-2008 was vaccinated with the first dose of PNEUMOVAX IM, 0.5ml (lot # 661577/1161X). Concomitant therapy included simvastatin and alendronate sodium. On 18-DEC-2008 the patient experienced redness, pain, swelling and hot sensation on her arm at the injection site after receiving the vaccination. The patient sought medical attention by phone call. A lot check has been requested. A standard lot check investigation was performed. All in-process quality were satisfactory. The lot met the requirements of the Center and was released. This is one of  two reported received from the same source. Additional information has been requested;
3-4 cm deep swelling over lateral deltoid with some mild tenderness with redness. Pt also complained of weakness and numbness to ulnar nerve area.
Information has been received from a physician concerning her newborn 3 month old baby who on an unspecified date was vaccinated orally with the second 2ml dose of ROTATEQ (lot # not provided). The physician reported that the patient experienced mild diarrhea and spots of blood in stool. The patient would not be finishing the series. On an unspecified date, the patient recovered from mild diarrhea and spots of blood in stool. Unspecified medical attention was sought. Upon internal review, spots of blood in stool was considered to be an other important medical event. Additional information has been requested.
Heat radiating from rash; Itching on neck; Soft swollen lump in armpit; Warmness and irritation that they scratched while sleeping; Warmness and irritation that they scratched while sleeping; This spontaneous case was reported by a consumer and describes the occurrence of MILIARIA (Heat radiating from rash), PRURITUS (Itching on neck), SWELLING (Soft swollen lump in armpit), FEELING HOT (Warmness and irritation that they scratched while sleeping) and SKIN IRRITATION (Warmness and irritation that they scratched while sleeping) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21B) for COVID-19 vaccination.     no medical history reported by reporter.  Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN B3 and LINUM USITATISSIMUM SEED OIL (FLAXSEED OIL NATURE MADE) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MILIARIA (Heat radiating from rash), PRURITUS (Itching on neck), SWELLING (Soft swollen lump in armpit), FEELING HOT (Warmness and irritation that they scratched while sleeping) and SKIN IRRITATION (Warmness and irritation that they scratched while sleeping). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MILIARIA (Heat radiating from rash), PRURITUS (Itching on neck), SWELLING (Soft swollen lump in armpit), FEELING HOT (Warmness and irritation that they scratched while sleeping) and SKIN IRRITATION (Warmness and irritation that they scratched while sleeping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Strong pain in the hips. Numbness in the legs. Tingling in the legs.Difficulty to walk. Trouble breathing. Numbness in my left fingers. Pressure on the chest.High blood pressure.
Vaccine administered 6/12/12, on 6/13 patient had swelling, hot area, itching, redness and tenderness around site.
Patient's arm swelled up a lot. She went to urgent care where they started her on BENADRYL. According to patient, they did not think it was an allergic response, but rather a possible punctured blood vessel. She states she has gotten pneumonia vaccine in the past without event. Her arm swelling is going again when I spoke with her 2 days later and she feels good.
Within 24 hours, pain in right arm at injection site. Next 24-48 hours injection site on right arm had swollen to approximately 3X4 inches, red, painful, hot to touch. This continued through 10/21 when the swelling started to go down.  Today, 10/24 there is a clear discoloration on my right arm.   At day 4, experienced pain in right leg and glute area. Pain spread from buttock area to back of thigh.  painful to touch. Pain continues today.
Case number PHEH2015US021623 is an initial spontaneous report received from a pharmacist on 22 Oct 2015. This report refers to a 10 years old female patient. Medical history and concomitant medications were not reported as none. The patient was inadvertently administered only MenCYW-135 liquid conjugate of MENVEO (batch number, batch number, not reported) on 28 Sep 2015 ay 09:30 AM. On the same day the patient was also administered other unspecified vaccines. Post vaccinations the patient had a sore arm. It was not known which vaccine caused the event. The outcome, seriousness and causality of the event were not reported. The patient was given the full vaccine on the date of this reporting.
inadvertent administration is reported in a pt who recvd 1st dose of Fluogen on 20JAN94; pt was given vax that expired JUN93; pt recvd a 2nd dose of vax from a non-expired lot # on 20JAN94; pt also takes Calan SR, Premarin & multivitamins;
client was in observation area. Became lightheaded and felt like heart rate was increasing. laid down on the floor. EMT assessed patient. bp low at 81/45 and hr 41. breathing stable. client states has baseline low hr as she is a runner. Elevated feet and monitored. Gave juice and crackers. Color came back and hr up to 60 and bp at 109/67 10 minutes later.
he had Shingle in the middle of May/ Suspected vaccination failure; he had Shingle in the middle of May, 2023; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-DEC-2022, the patient received Shingrix (injection, unknown arm). In MAY-2023, 5 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: he had Shingle in the middle of May/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: he had Shingle in the middle of May, 2023). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK receipt date: 26-MAY-2023 The patient self-reported this case. The patient had Shingle in the middle of May 2023. The customer did not want to give his physicians information. The reporter consent to follow up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report was received from a office manager healthcare worker and refers to 18 year old patient of unknown gender.  There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications provided. On an unknown date, the 18 year old patient was inadvertently vaccinated with PROQUAD (dose, route, lot # and expiration date were not provided) for prophylaxis. This was outside the recommendations per the prescribing  information. No adverse effects were reported.  No further information was provided. Additional information has been requested.
Wife came on 12/24/2014 and said he has a red rash from his spinal cord to the belly. She established that their MD was on vacation. I counseled her to go to emergency room if symptons persist.
This spontaneous report as received from a physician via company representative regarding a 14-year-old female patient. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dosing details, frequency, route of administration, anatomical site, lot number and expiration date were not provided) for prophylaxis. It was reported that on an unspecified date, also reported as after receipt the vaccine, the patient was diagnosed with non-HPV warts on her hands and feet. The physician stated that the patient was a swimmer and was exposed to chlorine.  At the time of the report, the patient was not recovered from non-HPV warts on her hands and feet.  No treatment was given for this event, it was unknown if laboratory or studies were performed. There was any intervention to prevent serious criteria. The causality between the event and the therapy with GARDASIL 9 was unknown.
Information has been received from a nurse concerning her 15 year old niece who was vaccinated with HPV rL1 6 11 18 VLP vaccine (yeast) (0.5 ml). Subsequently, "soon after having injections", the patient experienced dizziness and flushing "about ten minutes after her injections".  It was reported that the patient received HPV rL1 6 11 16 18 VLP vaccine (yeast) with "other shots" and blood work.  The patient recovered ;about 15 minutes after injections". Unspecified medical attention was sought. Additional information has been requested.
Adverse Event: Redness, swelling, itching, hives, & soreness at & around the injection site. Tx: OTC Benadryl, Ibuprofen, cold compress over next 2-3 days. Outcome: symptoms resolved.
Patient developed a 2.5 x 3 inch reaction on lower anterior left thigh. He had erythema and swelling.
This spontaneous report was received from a nurse practitioner via company representative refers to a male patient(who is also the physician) of unknown age. On an unknown date in OCT-2013 (reported as within past 2 weeks) the patient was vaccinated with a dose of PNEUMOVAX23, (lot number, expiry date was not reported)subcutaneous. Concomitant therapies included influenza (manufacturer unknown) and DTAP(manufacturer unknown). On an unknown date in OCT-2013(reported as within past 2 weeks), the patient experienced injection site reaction which included swelling and feeling hot to touch which lasted for few days. Treatment for the events included unspecified antibiotics. The outcome of the events were reported as recovered. The patient sought medical attention. Additional information has been requested.
Three damaged Prevnar 13 syringes/Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle; The initial case was missing the following minimum criteria: reportable event. Upon receipt of follow-up information on 23Mar2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. A child patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), as dose number unknown, single (Lot number: EY0433, Expiration Date: Nov2023) for immunisation, Device Lot Number: EY0433, Device Expiration Date: Nov2023. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Three damaged Prevnar 13 syringes/Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle". Additional information: NDC number of Prevnar 13: 0005197101. Three damaged Prevnar 13 syringes: Two of the Prevnar 13 syringes actually broke at the neck and another Prevnar 13 syringe leaked when put the needle on and went to administer, or well when just had gotten air out. Fortunately, was not in kids leg, leaked straight out of middle neck part. The reporter would like to know if Pfizer would give credit. They still had the Prevnar 13 syringes. Occurred fortunately before and another Prevnar 13 syringe was gotten out to be used. The reporter also clarified there were three separate patients involved, all prior to administration when preparing drawing up and never really got in room with the patients. The reporter did not have the patient information on hand to complete individual reports. Did not make to patient; therefore, the reporter did not keep the patient information. Unable to clarify which Prevnar 13 were involved with which patient. Unable to also clarify which Prevnar 13 were involved with which occurrence. The sample of the product was available to be returned.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300129342 same reporter/ vaccine/ event, different patients;US-PFIZER INC-202300129343 same reporter/ vaccine/ event, different patients;
Patient received the Covid-19 Moderna vaccine, lot # 041L20A, exp date 07/03/2021, approximately 11:52 am.  She then proceeded to the observation area.  At approximately 12:05 pm, she reported "left arm tingling and numb, and lightheadedness."   BP was 132/84, pulse 72.  Rapid response was already on the scene and went to consult with patient. Approximately 18 minuts post vaccine, the observeres recorded "flushing."  Patient declined to be transfered to the ED.  She recovered in the observation area before leaving.
Vaccine booster failed to prevent Covid19 infection. I tested positive on 08Oct with flu-like symptoms.; Vaccine booster failed to prevent Covid19 infection. I tested positive on 08Oct with flu-like symptoms.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 11:30 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Oct2023, outcome "recovering" and all described as "Vaccine booster failed to prevent Covid19 infection. I tested positive on 08Oct with flu-like symptoms.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other vaccine in four weeks and no other medications in two weeks. The patient stated that the vaccine booster failed to prevent Covid-19 infection. He tested positive on 08Oct2023 with flu-like symptoms. Therapy for the event included Albuterol inhaler to suppress cough. The patient did not have covid prior vaccination. The patient was covid tested post vaccination. The patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based upon the available information, the reported events DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Oct2023 are deemed associated to the administration of COMIRNATY.   The impact of this report on the benefit risk profile of the Pfizer product and is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review as well as any appropriate action in response will be promptly notified to regulatory authorities, Ethics committees and Investigators as appropriate.
Minutes after receiving the flu shot I experienced a dull "tightening" in my left, upper jaw. As it got worse I felt an aching, throbbing sensation in it. That night I took an ADVIL which relieved the pain but as the ADVIL wore off I felt an ache in my left ear as well as the jaw. I already have tinnitus and the ringing became even louder. My cheek was slightly swollen. I became concerned that this feeling might become permanent. The aching in my ear and jaw has mostly subsided (It is now Tuesday, Sept 18) but the tinnitus remains louder than usual.
The next day, she developed an injections site reaction characterized by swelling, redness, and warmth.