chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 23-MAY-2007, a health care provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Lower lip broke out with five large cold sores which is the herpes simplex; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Primary Immunization series complete), for COVID-19 immunisation. The following information was reported: ORAL HERPES (non-serious), outcome "unknown", described as "Lower lip broke out with five large cold sores which is the herpes simplex". Additional information: The patient has gotten all of her vaccines from Moderna and she is 74 years old. She stated that when the bivalent vaccine came out she got the Pfizer bivalent and less than 24 hours her lower lip broke out with five large cold sores which is the herpes simplex. She wants to know if she can get another bivalent vaccine or not or if she should go back with Moderna. She mentioned that her primary care physician told her to not get another COVID-19 vaccine for fear of anaphylactic shock.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient received the vaccine on 5/17/2019 or after (not sure of the date) but called the office on 5/20/2019 with complaints that her right arm is red, warm, and the area of the injection raised. She was advised to take Benadryl and use an ice pack in 15 minute cycles by one of our triage medical assistants. She didn't report any hives or breathing issues and doctor was okay with what the medical assistant advised and stated to have the patient  come back in if it gets any worse.   On 5/24/2019, patient called back with the swelling now persisting and the redness not going away. Doctor stated he will work her in if needed to address today and advised OTC Benadryl still with hydrocortisone cream. Our after hours team reported to the patient what do advised going to an urgent care or ER if the symptoms worsened over Holiday Weekend.  On 6/7/2019, Patient called back in the morning with complaints of shortness of breath as well as the swelling still ongoing. She came in on that day to follow with Dr for the reaction. He noticed at that time the arm was swollen and that she was having pain in that arm when it came to moving it. If she swelling wasn't going down, Dr was going to order imaging on her arm.  On 6/11/2019, another Medical Assistant was asked to follow up with the patient to see how she was doing and to verify the symptoms in order to report. She still notes she cannot fully move her right arm still and that it is still swollen and warm to touch even after nearly 4 weeks since she got the vaccine..
Information has been received from a physician concerning a female with DEMEROL allergy, arthritis, osteoporosis, hyperlipidaemia and hypothyroidism who was vaccinated with 1 dose of MM II (lot number not reported) on an unspecified date.  Concomitant therapy included LEVOTHYROXINE NA and LIPITOR.  Subsequently the patient had a negative mumps titer.  The patient was seen for medical attention.  Follow up information was received from a physician who reported the 67 year old patient was vaccinated with a dose of MM II on 03-APR-20006 (lot number not provided).  No physical adverse event other then a titer report negative on 12-NOV-2008.  Laboratory test results included:  VARICELLA -Z AB was positive, mumps IgG SCR was negative.  rubella AB (IgG) was positive, and rubella IgG AB was immune.  Additional information is not expected.
RASH ON FACE, HIVES ON LEGS, TUMMY ACHE.
Note MMR was #2, because first was given for travel previously. HPI: In March she was prescribed Amoxicillin.  In April, she was given Cefdinir, but developed rash with red dots a few days after the medication was given; she was switched to Azithromycin.  Unclear if truly an allergy vs drug reaction, as she had no wheezing or dyspnea or other symptoms.  In May she was prescribed Augmentin, and did develop a rash near the end of the 10 day course (05/31/2020).  Mom (a few days before todays visit) showed pictures of the rash to me.  There were three red lesions, that looked somewhat vesicular, two on the right chest and one on the right thigh (just looked like a red papule).  Dad notes that there is a subdermal induration in the thigh, and that is the same location where the Varicella #1 vaccine was given, the day she started antibiotics.  Today there is some crusting and shrinking of the lesions. EXAM:  Subcutaneous nodule in thigh, non-tender, ~1 cm in size. Small erythematous 1-2 mm papule over region, non-crusted and non vesicular. Above R nipple is a 1-2 mm slightly erythematous and crusted lesion, w/ few surrounding erythematous pinpoint papules. R lower chest has another erythematous papule, non-vesicular, not crusted.  Few pinpoint lesions, just slightly more erythematous than flesh colored, are scattered on R chest and R thigh (~5-10 total), that have no scale and no crust and no papules. ASSESSMENT: Patient has not fully recovered, but is recovering.
8/18/08 - Pt. called today to report adverse reaction to Tdap vaccine given on 8/13/08.  Client reports awakening at approx 530AM on 8/14/08 with violent vomiting 3 times, vivid dreams, and a temp. (hot to touch) did not take temp.  Then developed diarrhea a few hours later.  Drank lots of H2O.  Took PEPTO BISMOL & TYLENOL PRN.  Client reports calling Dr. office (primary provider) and the lady that answered the phone told him to call the health dept. that he probably had an adverse reaction to the vaccine received on 8-13-08.  Client also reported difficulty breathing at times.  But did not seek professional assistance.
reports local rxn @ inj site-raised hard red area 6.5cm, painful resolved w/warm packs;no systemic effects
pt recvd vax 12MAR93 & 22MAR93 pt exp nausea, vomiting, h/a, muscular neck pain, fatigue; subsequently presented to MD; 29MAR93 pt had completely recovered; No further details were provided;
Sudden cease of menstruation; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 16Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration on 22Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 01May2021, the patient experienced sudden cease of menstruation. The event sudden cease of menstruation resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sudden cease of menstruation was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Flashing semi circle of light in left eye followed by many floaters - went to doctor was inconclusive and basically have to live with it. One month later identical incident in right eye. About 5 eye doctor visits.
injection site pain/soreness, fatigue, headaches, and muscle aches beginning 4-6 hours after injection; fatigue, headaches, and muscle aches resolved by day 4; mild residual injection site tenderness
Pt c/o of light headedness while in observation. Pt had slurred speech, skin was cold and clammy, and pt had intermittent loss of consciousness.  Maintained pt in a comfortable position until EMS arrived. BP 193/130, HR 124, O2 99%, RR 14.
Administered 2nd Moderna Booster dose 0.25ml, no adverse reactions, Health Department requested to be reported due to Monovalent given instead of Bivalent.
Pt vaccinated, 5 minutes later pt was standing with his mom and brother at the register.  At this time, the pt lost consciousness briefly and fell to the floor.  Pt complained his nose hurt(probably from hitting it on something on the way down, lip slightly broken open and shaky).  911 was called, pt refused transport and said would drive themselves. Pt left on their own.
Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L023936, expiration date 15-MAR-2017, dose and route not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
extreme muscle cramps in both legs; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at the left arm on 21Jan2021 15:00 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medication included magnesium, cannabidiol, and docusate sodium (COLACE). The patient experienced extreme muscle cramps in both legs on an unspecified date after the first shot. The patient underwent lab tests and procedures which included nasal swab: negative both on 15Feb2021 and 16Feb2021. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome of the event was recovering.
Pain in elbows and upper back. The pain was so great and continuous I could barely lift anything. Strength greatly reduced.
patient received 1st dose in 2019 and is there today for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On 18th June 2021, the patient received the 2nd dose of Shingrix. On 18th June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. Pharmacist stated that, exact date of 1st dose in 2019 was unknown. Pharmacist reported that, on the day of reporting, the patient was there for 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case had been linked with case US2021134503, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134503:same reporter
Got Flu shot on 9/25/08: Pain at injection site "like sore muscle"- Difficulty moving arm and shoulder past a certain point (upwards)
Information has been received from a pharmacist referring to unspecified patients of unknown age and gender. On 23-MAR-2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 (lot number, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever; Myalgias; Arthralgias; Costovertebral angle tenderness; Fatigue; This is a spontaneous report received from a contactable physician. A 30-year-old female patient (non-pregnant) received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, in left arm, on 11Jan2021 at 18:45, for COVID-19 immunization. The patient received the first vaccine dose on 21Dec2020 at 16:00, intramuscular, in right arm, for COVID-19 immunization. No other vaccine was given in 4 weeks. The patient's medical history was none. The patient had no COVID before vaccination. Concomitant medication included drospirenone, ethinylestradiol betadex clathrate (YAZ). On 12Jan2021 at 13:00 the patient experienced fever, myalgias, arthralgias, costovertebral angle tenderness and fatigue. COVID was not tested after vaccination. No treatment was given. The events were resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial unsolicited report received from other healthcare professional on 22-Aug-2018. This case involves a [6 months] male patient who was vaccinated with a 0.7 ml once third dose of suspect vaccine PENTACEL along with sterile water. (Batch number: C507AB, expiration date- 15-Sep-2019, site of administration left thigh and route was intramuscular) and ACT-HIB site of administration right thigh on 21-Aug-2018 . The patients medical history were not reported. Concomitant medications included PREVNAR 13 administered on left thigh. It was an actual medication error due to inappropriate reconstitution technique, extra dose administered and overdose. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Right after the shot within 24 hours or so my arm was extremely sore. To the point I didn't want to move it. That lasted for about 2 days. Within the week I tested positive for Covid. That Monday at work I went in, and I was feeling fine. They made us check in every time we came in. I didn't have a fever. By mid-morning my eyes were really irritating and itchy and my throat felt clogged. I was coughing pretty much nonstop. It felt different than a bronchitis cough. When I went to work on Tuesday morning it was worse. I was running a low-grade fever. I contacted the doctor office and they had me come in that afternoon. The coughing was in the upper part of my chest. I got tested for Covid and they recommended any over the counter stuff for my head. I took some Mucinex and sinus stuff. The cough lasted for 7-8 weeks. The low-grade fever finally subsided after 11 days. I had not major fatigue but I could not focus. It was a good thing I was off work because there was no focus other than 15 or 20 at the time. That lasted for a couple of weeks. I never lost my sense of smell or taste. I was not sleeping all the time. I just did not have the energy to get up.
Initial unsolicited report received from pharmacist on 03-Aug-2017. This case involves two-month-old female patient who was vaccinated with a dose of MENOMUNE (Batch number: UI041AA, expiration date, dose, route and site of administration was not reported) via subcutaneous route on 15-Jun-2017. The patient's medical history was reported as none. Illness at time of vaccination was no. pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was none. Patient's concomitant medications was not reported. On 22-Jun-2017, one week following the vaccination, the patient broke out is a rash on her arms and trunk. It was reported that rash appears to look like hives, but larger, and it now looks like a plaque, where the skin is flakey. The patient required ER/ doctor visit. The relevant diagnostic tests or laboratory data was none. The patient's corrective treatment was not reported. The patient had not recovered from the events (reported as symptoms persists). List of documents held by sender: none.
Flare and exacerbation of symptoms of Polymyalgia Rheumatica. now on going for 3 weeks
Tinnitus, Headaches, Pressure, Pins and Needles to skin on face, metallic taste and tooth sensitivity. All right side of face. Ear pressure
I received numbness all down my right side from my finger tips to my toes, my upper and lower back and my right thigh get super warm when I am more active though out the day. My left arm became weak and I could not lift my arm above my head. This all occurred after the first vaccine. After the second vaccine I just got chills and muscle aches the following day. I am still experience some numbness on my right side and I still can not lift my arm above my head. 2.1.2021
Vaccine administered on 3/17/2010 in left arm. The same evening, began experiencing muscular pain in left quadriceps muscles only- no pain on hamstrings or calf muscles- no other neurological signs, no pain elsewhere. Resolved over 48 hours.
Rash to the thighs and groin. Could be explained by contact with diaper, but mom says he gets it after all his vaccines (not previously mentioned). He is being referred to allergist for multiple food allergy history.
Possibly was contact dermatitis; A rash on arms and legs; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 5-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, SINGLE, UNKNOWN MANUFACTURER), for COVID-19 immunization.  The following information was reported: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "Possibly was contact dermatitis"; RASH (non-serious), outcome "unknown", described as "A rash on arms and legs".  Additional information: Patient received 2nd dose of orange cap for 5-11. Two days later, patient was fine in the am, but woke up from nap at daycare with a rash on arms and legs. It was individualized, and not grouped together, and without welts. The injection site was clean with no rash. The patient was seen by a provider who believes it was not related to the vaccine, and possibly was contact dermatitis. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a pharmacist via a field representative referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of ZOSTAVAX (dose, route, lot# and expiration date were not reported). On unknown dates the patients experienced redness and a knot at the injection site following the administration of ZOSTAVAX. The outcome of the events and causality were not reported. Additional information has been requested.
Initial report received from healthcare professional on 12 December 2013. A 59-year-old female patient, whose medical history and concomitant medications were not reported, received FLUZONE ID (lot number, expiration date and route were unknown) in right deltoid on 22 September 2013. On 22 September 2013, patient experienced severe pain when she received the vaccine. Sore for a couple of day, arm sore. Now almost 2 months, still feels throbbing in her arm intermittently. No pain now but achy throbbing feeling at the insertion site and travels down her arm. Laboratory investigation and corrective treatment were not reported. As of this report, the patient was not recovered from the events. Documents held by sender: none.
adm w/2 days hx of bruising on legs, face, penis & mucous membranes;1mo prior to admission pt recv vax;4 days prior to adm had temp 103 & runny nose;tx w/med;
approx 40 hrs p/vax pt taken to ER for blisters of upper lt arm to elbow; given PCN & cortisone inject; blisters sitll present 16AUG93;
Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions  .No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received, additional reporter was added.
SM woke up with chest pain, headache, fever and trouble deep breathing due to pain in chest. Was vaccinated on 4/7/10 with SPV and AVA.
Patient developed rib pain on Friday night March 12, chest and chest wall pain after the shot, Sat night it was more severe, could not lay down, thought it was muscle pain originally.  It continued to get worse.  Patient went to hospital on Monday March 15th, was diagnosed with a pulmonary embolism with partial infarction of right lower lobe. Was hospitalized until Wed March 17th.