chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; post herpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 19-DEC-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On unspecified dates, the patient experienced shingles and post berpetic neuralgia. On unspecified dates, the patient was treated by a healthcare provider for shingles and post berpetic neuralgia. The outcome of both events was not reported. The reporter considered both events to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Immediately after inject of the first Pfizer vaccine, she could taste the vaccine in her mouth.  Then developed her mouth started  "watering profusely".   She had to swallow constantly.  Then swallowing became difficult, she had chest tightness, and numbness in hands/arms. S he was moved to the rescue area with "fire rescue".   Her BP  160/105.  EMS arrived, transfer recommended.  You consulted with your daughter who is a nurse, and opted to return home.    She was at the fairgrounds for 2 house.  She did not receive medications.  Was provided crackers and water.   After arriving home, her  initial symptoms  resolved, but she felt nauseated and "terrible".    Over the next 3 days she had  swollen lymph nodes on the side of the injection and felt "like she had been hit by a truck".    After 3 days, those symptoms resolved and she felt well.
Pt's arm swollen from shoulder to elbow, received antibiotic and steroid from ER.
Near fainting after immunizations, pt placed supine and vital signs taken (all WNL), and observed for approximately 30-45 minutes. Released to home with pt mother in good condition.
Pneumovax used for pneumonia; This spontaneous report has been received from a lawyer referring to a 69 year old female patient. Historical medications included lidocaine (LIDODERM), zoster vaccine live (ZOSTAVAX), olopatadine hydrochloride (PATANOL), nystatin, alendronate sodium, escitalopram oxalate (LEXAPRO), tramadol hydrochloride, desoximetasone, calcium carbonate (OYSCO) and etodolac. The patient's medical history included carpal tunnel, disability, left shoulder replacement, bone disorder, familial risk factor and arrhythmia. Family history included type 2 diabetes (sister, nephew, daughter), hyperglycemia (sister, nephew, daughter), high cholesterol (mother), hypertension (father, mother, daughter), heart attack (mother, aunt), stroke (mother, aunt), obesity (father, mother, aunt, daughter), loss of vision, blindness, alcoholism. The patient's concurrent conditions included tobacco user, alcohol use, hypertension, drug allergy (penicillin and naproxen sodium (ALEVE)), high cholesterol, depression and diabetes mellitus. Concomitant therapies included simvastatin (manufacturer unknown), omeprazole, gabapentin, metoprolol, lisinopril (manufacturer unknown), escitalopram, lorazepam, fluticasone, amlodipine besylate, hydrochlorothiazide, acetaminophen (+) hydrocodone bitartrate, terconazole and ondansetron.    On 16-OCT-2013 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, strength, batch/lot# and expiration date were unknown) for pneumonia (product use in unapproved indication).        The case is linked to case# US-009507513-2001USA010186 due to the same patient.; Sender's Comments:  US-009507513-2001USA010186:
focal erythema, edema, induration, tenderness @ inj site, lt deltoid region;
Pfizer was prepared with sterile, preservative free water rather than sterile, preservative free 0.9% NaCl. Pt is asymptomatic and needed no interventions.
Information has been received from a physician concerning his 15 year old niece, with no known drug allergies and no history of seizures, who on 01-JUN-2007 was vaccinated with Gardasil (lot # 656051/0244U). There was no concomitant medication. On 01-JUN-2007, within 2 to 3 seconds of receiving the first dose of Gardasil, the patient had a vasovagal reaction and sought unspecified medical attention. No laboratory/diagnostic tests were performed. The fainting lasted for 1 to 2 minutes and then she had a tonic clonic seizure that lasted 4 to 5 seconds. The patient was lethargic for about 1/2 hour. The patient was given oxygen and pulse ox. On 01-JUN-2007, the patient recovered from vasovagal reaction and tonic clonic seizure. The physician considered one or more of the events to be disabling and/or an other important medical event. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of Hepatitis B in a male patient who received Hepatitis B vaccine. Co-suspect products included TRIUMEQ tablet for HIV-1 infection. Previously administered products included Hepatitis B vaccine (in 2011 office records show the patient had immunity to Hepatitis B because of previous vaccination) and TRUVADA (the patient was previously on a TRUVADA regimen for his HIV, which has anti HepB activity, so it could have controlled or hidden any active HepB infection). Concurrent medical conditions included HIV infection. In 2011 (or before), the patient received Hepatitis B vaccine. In 2014, the patient started TRIUMEQ (oral) at an unknown dose once daily. In 2014, unknown after receiving Hepatitis B vaccine and an unknown time after starting TRIUMEQ, the patient experienced Hepatitis B (serious criteria GSK medically significant). TRIUMEQ was continued with no change. On an unknown date, the outcome of the Hepatitis B was unknown. It was unknown if the reporter considered the Hepatitis B to be related to Hepatitis B vaccine and TRIUMEQ. Additional details provided: The patient was vaccinated with Hepatitis B vaccine sometime in 2011 or before according to physician. During routine blood work in the past year, the physician noted elevated LFTs. Further tests diagnosed the patient with active Hepatitis B infection. The physician does not know if TRIUMEQ contributed to the HepB infection. The patient was still on TRIUMEQ and will be starting HepB therapy. The patient's labs have normalized as of the most recent lab work. Patient's viral load was undetectable, and he has had a good increase in CD4 count. The patient was sexually active. Patient was on other medications, but the health care professional did not provide the names. The reporting physician stated that he did not want any follow-up.
Pt recv vax on 10/7/98; 1 hr later pt exp nausea, painful arm, headache, body ache; tx=Tylenol
1:05 had vaccine up to move to waiting room, felt dizzy, sat down passed out, slight jerky movement, contracted wrists, lasted 20 sec. treated with ammonia inhalant, BP and Pulse taken, woke up thought she had been sleeping. Sent to MD. MD called approx 2 hrs later, ok per MD
Patient described a few pimples on torsel on second day after vaccines. Since then, she has had additional pimples and itchy raised welts on the back of her back and lower legs. Treated with OTC allergy medication.
Vaccines received 3/30/05. Mother reported a tennis ball size knot, on 3/31/05. Pt seen 4/1/05 by ARNP, and reported 3cm induration. Pt with redness on fever. Taking antihistamine for unrelated dx. No other meds or Tx ordered.
Information has been received from a physician concerning a 17-50 year old female who on 12/21/2004 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649732/0513P).  Subsequently, the patient experienced pain at the injection site, myalgia, arthralgia, low grade temperature and fatigue.  The patient's outcome was unknown.  Unspecified medical attention was sought.  No product quality complaint was involved.  The physician requested an investigation into this lot number.  Additional information has been requested.  It was also reported that 2 other patients were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and experienced adverse effects.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards and was released.
Provider states to only give patient half (0.25ml) of the licensed dose (0.5ml).  0.25ml was given to patient on 9/14/21.  Immunization department was contacted 9/16/21 when I was made aware of. They advised patient should come back in and receive full 0.5ml dose, there is no interval time to receive this dose. Patient should return 4 weeks after or the second dose. I have advised staff on correction plan and to notify parent to bring child in.
next morning little swelling around collar bone and noticed a knot; 10 or 11 that next morning she noticed a little smaller knot noticeable a little painful; 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 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 18:00 (Lot number: FC3181, Expiration Date: 31Oct2021) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension (ongoing); TRIAMTERENE taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, Expiry Date: 30Sep2021), administration date: 17Jul2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 11Aug2021, outcome "not recovered", described as "next morning little swelling around collar bone and noticed a knot"; PAIN (non-serious) with onset 11Aug2021, outcome "not recovered", described as "10 or 11 that next morning she noticed a little smaller knot noticeable a little painful". Therapeutic measures were not taken as a result of swelling, pain.  Follow-up (19Aug2021): This is a Follow up spontaneous report from a contactable consumer. This 47-Year-old female consumer (patient) reported for herself that she is having a side effect from the last shot of the Pfizer COVID vaccine.She noticed she is having a little swelling around her collar bone area. It is a small little knot. It is a little painful . She wanted to know if that is normal.   Additional information:No History of all previous immunization with the Pfizer vaccine considered as suspect.No Additional Vaccines Administered on Same Date of the Pfizer Suspect.Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.Patient's Medical History (including any illness at time of vaccination):  Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and no obesity.No List of other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI)    Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
No adverse effects were reported; the patient was inadvertently administered an expired dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patint of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 23-APR-2019, the patient was vaccinated with an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) recombinant Human albumin (rHA), subcutaneous for prophylaxis (lot # N025718 with expiration date on 17-MAR-2019, dose, strength and frequency were not reported). No adverse effects were reported. No temperature excursion was involved. The outcome of expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to the patient was unknown at the moment of this report.
Parent reported small hives on area of arm at injection site. Possibly had a slight fever last evening.
Patient passed out on our way out of the DR office.  She did come to pretty quickly without assistance.  She has not had this happen before after shots.  She also had the Varinox #2 (Merck/0368U) shot that day - I couldn't find it on the drop-down box below.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 040A21A) for COVID-19 vaccination.     The patient's past medical history included Herniated disc. Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included TELMISARTAN (MICARDIS) from 01-Jun-2009 to an unknown date and HYDROCHLOROTHIAZIDE from 01-Jan-2012 to an unknown date for Blood pressure high, ATORVASTATIN CALCIUM (LIPITOR) from 01-Jan-1989 to an unknown date and EZETIMIBE (ZETIA) from 01-Jun-2009 to an unknown date for Cholesterol high.   On 22-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021 at 3:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Sore arm). On 12-Apr-2021, MYALGIA (Sore arm) had resolved.            No treatment medication was provided.   This case was linked to MOD-2021-057192 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up information received on 09-Jul-2021 does not contain any new information.
Joint inflamation after shots.  Low back after first shot, left shoulder after second shot.  Neither was brought on by acute injury.  Overall inflamation was much higher following vaccination
10 mins after receiving vaccine. Feels swalloen + tingling of throat; tongue feels "weird" No where else. Always cold, feels colder than usual BP 136/ usually runs low BP Ate lunch @ 1PM - went for a run pizza/cookie refused to take Benadryl at ICF. Then agreed. 1) dose 5:45 PM 2) still tingling (12.5 mg) 6:11 PM swollen, Given (12.5 mg) Benadryl (12.5 mg) Pepcid 20 mg  3) 6:30 PM slight tingly less, less swelling
She had no reaction to the first 2 doses other than being extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (She had no reaction to the first 2 doses other than being extremely tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot 022M20A and Lot-019B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (She had no reaction to the first 2 doses other than being extremely tired). At the time of the report, FATIGUE (She had no reaction to the first 2 doses other than being extremely tired) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported. Patient had no reaction to the first 2 doses other than being extremely tired.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-368416 (Patient Link).
23SEp93 fever, chills pain in lt side neck & axilla; LBP rt side w/freq urination w/sm voids; lt temporal frontal h/a, anorexia, nausea, lightheadedness; 24SEp93 c/o inc pain lt arm, tenderness, reddness; erythematous area lt upper arm;
Severe joint stiffness and pain, mild relief with Aleve.   Severe Headache/ Migraine,  so far with Aleve, Tylenol and Hydrocodene, no relief.  Cold compress over the eyes seems to help with comfort but pain remains.      Considering ER visit.
3 pant sizes up in a week/Still up 3 due to the bloat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jul2021, for COVID-19 immunization, reaction(s): "severe bloating"; Bnt162b2 (Dose 1, Verbatim: Within a day severe bloating and stomach distention began), administration date: Jul2021, for COVID-19 immunization, reaction(s): "stomach distention". The following information was reported: ABDOMINAL DISTENSION (non-serious) with onset 2021, outcome "not recovered", described as "3 pant sizes up in a week/Still up 3 due to the bloat".  Additional information: The patient stated that today I received my Pfizer Covid booster. Within an hour my stomach ballooned by 5 inches. It was then it all came flooding back to me. Patient asked Why it was I have been fighting severe bloating and stomach distention for 6 months. In Jul2021 I received my first Pfizer Covid vaccine. Within a day the severe bloating and stomach distention began. In Aug2021 the second dose and oh so much worse. 3 pant sizes up in a week. Still up 3 due to the bloat. They enquired What, how and why What is in this thing to do that.  Follow-up attempts completed. No further information is expected.
Pt recv vax on 10/21/98; on same day pt exp vomiting & illness; pt seen in E.R.
Suspect COVID breakthrough case respiratory failure secondary to underlying malignancy and covid-19 infection- patient died
One-half hour after receiving my 2nd Zoster (SHINGRIX) injection, I experienced: intense pain throughout my entire body #9 on a 10 point scale - much more severe than I've ever had with severe flu - #4 on a 10 point scale, a severe headache - as bad as my worst migraine - #9.5 on a 10 point scale, I was unable to move, lay on, lift even a glass of water and/or reach out more than 25 degrees from the side of my body. I was either very hot or very cold but never ran a fever. The only thing I consumed for 3 days was flat Seven-Up. It took 24 hrs to consume 12 ounces, I was, and still am, experiencing intense pain when trying to pull on underwear or slacks, when raising my right arm to put on a pull-over sweater, and when rotating my right arm like when wiping after urinating. While the intense pain in my whole body and severe headache settled down in 24 hours but did not completely go away, my right arm continues to experience intense pain in the situations explained above. I'm very concerned since my injection was on November 7, 2018 and my right arm is still in the same amount of pain to date, December 25, 2018.
Nightmare that caused hallucinations when wakened up. Saw things that were not there and lasted 2 hours. Is now currently showing signs of fear that were not there before.
Patient has reported that she is experiencing numbness and tingling in fingers of left arm. She visited doctor on 8/4 or 8/5 and was told the injection was given on a nerve. She was told to call doctor back if the symptoms do not go away or increase.
Patient was given primary series Covid-19 vaccine, was suppose to be given updated Covid-19 booster.
My first dose of the vaccine was a Phizer dose which I received on February 15.  I went for my second dose on March 8 and was inadvertently given the Moderna vaccine.
Noticed bruising and petechiae over L upper arm around area of injection upon waking 4 days after vaccination.
Note: Unknown what the exact rotavirus vaccine was. Will have to verify with pediatrician. The evening of the day of the vaccination, put baby got a fever and cried uncontrollably, in a different way than she has every cries before. Stomach hard. Screaming nonstop for a couple hours.
Swelling of right hand. Patient instructed to follow up with PCP if symptoms return/persist or worsen. Stable, released from vaccination site.
patient fainted minutes after shot administered. emergency services called after it was determined patient hit her head during fall.
Prolonged high pitch cry - 6 plus hrs. Post vaccinal encephalits. Patient diagnosed with autism in 2003. Motor incoordination, gross motor delay, Mom noticed a knocked knee stance and also with ambulation along with his feet pointing out around this time, falls more often then other children, extra bulge on inside of his knees with standing. In standing patient had a tendency to rotate his feet with some pronation and stood with his knees in valgus and hyperextened position. However, this was not constant but intermittent throughout evaluation. Increase in muscle mass which looked like it was in the medial side of the knee. This may be indicative of an umbalance muscle activation with the Vmo being more activated the VL. Gait abnormal. Patient has been diagnosed with autism. Everytime he has received immunizations, he has regressed in development milestones. After the above immunization he lost speech milestones and became catatonic. He is making some progress ent very slowly.
pt calmed easily p/vax;estimated 15-30min later was noted to be pale, diaphoretic, limp, unresponsive-no fever, vomiting, jerking;this state lasted approx 20min;exam in ER T98.4, P120, RR20 nl exam but extent of responsiveness not recorded
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. No known allergies noted.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with antiviral treatment drug Paxlovid, dtarting from 07Jun2022 till 11Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upon administering all three vaccines, the child cried intensely, paused her breathing, turned a pale blue color.  Parents held and picked up child, fanning then blowing air into child's face, and calling her name.  Child alert,  breathin, and waiting with parents in Lobby.  RN present and reports this is a rare occurrence; a Valsalva incident.  Interpreted this info to parents in Spanish.  RN notifies NP.  NP assesses child.  Water given to family; juice and crackers given to child.  Parents advised to monitor child.
About January 1, I had a sore throat about 24 hours and then it moved into my chest and created a cough and stayed a cough for about a week and I stayed exhausted. I recovered completely after about 1 week.
rt leg @ inj site-red, then blue, hard knot-area is hot w/fever;
Patient came back after 4 days the shot (PNEUMOVAX) was given, he described that after 3 hours of receiving the shot, he had tingling, burning sensation, then became swollen from the site of injection down to the elbow. The affected part was still red, hot, swollen after 4 days but more on the elbow part.