chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nodules in a 3.5mm range with opacity, patterns of something in chest and lungs; Post infectious inflammator; Post infectious inflammator; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY MASS (Nodules in a 3.5mm range with opacity, patterns of something in chest and lungs), INFECTION (Post infectious inflammator) and INFLAMMATION (Post infectious inflammator) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M204) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY MASS (Nodules in a 3.5mm range with opacity, patterns of something in chest and lungs), INFECTION (Post infectious inflammator) and INFLAMMATION (Post infectious inflammator). At the time of the report, PULMONARY MASS (Nodules in a 3.5mm range with opacity, patterns of something in chest and lungs), INFECTION (Post infectious inflammator) and INFLAMMATION (Post infectious inflammator) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Found nodules in a 3.5mm range with opacity, a pattern of something in chest and lungs. Post infectious inflammatory..         Concomitant product use was not provided by the reporter.  On an unknown date, the patient experienced had an MRI done and they found nodules in a 3.5mm range with opacity, a pattern of something in her chest and in her lungs. Post infectious inflammatory.  Treatment information was not provided.
Headache, Myalgia, NauseaVomiting, photophobia, phonophobia Narrative:
A legal complaint was received from an attorney alleging that a male child received series of Hib-Titer, Acel-Imun, Fluzone (Aventis), and Recombivax-HB (Merck) vaccines as well as Tripedia (Aventis) vaccine from April 24, 1997 through October 29, 1999 and subsequently "suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via intramuscular injection of mercury" in the "thimerosal-containing vaccinations." According to legal complaint the child "was born a perfectly normal healthy boy whose APGAR scores at birth were well within the normal range." It is alleged that at approximately 24 months of age, the child was "neurologically devastated by the accumulation of Mercury in his body, having been exposed via intramuscular vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to engaging in repetitive behavior and the loss of language skills." According to the legal complaint, the child "suffered severe and permanent injuries" and "sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients. Pertinent medical history, allergies and drug reactions were not reported. ON 27-JUL-2016, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL9 (lots # M006709, M0010440, M014926, expiry date 06-DEC-2018, 09-DEC-2018, 09-DEC-2018 and 17-FEB-2019 respectively) (lot numbers (lot number) are an invalid lot number GARDASIL9). The doses and routes of administration were not reported. At the same date no adverse effects were reported. Additional information has been requested.
Severe headache Severe joint pain/muscle aches Fever of 101.5 degrees Fahrenheit  Nausea  Fatigue
Fever of 100.7 on 9.11 in evening. Rash appeared on face, neck and chest on 9.12 in evening. Rash worsened on 9.13 and spread to back and arms and stomach over next two days.
Chills 2 hours  Headache 36hours Body aches 36 hours
Sore arm at injection sight that itched.  Blood pressure elevated causing a trip to the ER.
Soon after vaccine, pt became pale, dizzy, lightheaded, diaphoretic, saw spots, nauseated. BP 110/80 HR 70 RR 22.
Metallic taste in mouth that continues today. Started a couple days after vaccine and has not subsided.
Individual woke up to hard, hot lump, with baseball size redness around injection site and it lasted 24 hours
Why do I feel so tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Why do I feel so tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, the patient experienced FATIGUE (Why do I feel so tired). At the time of the report, FATIGUE (Why do I feel so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Drug ineffective; Covid test result=Positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Feb2021 (Lot number: EN6201) at the age of 34 years as dose 2, single and administered in arm left, administration date 31Jan2021 (Lot number: EL9264) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "Acid reflux" (unspecified if ongoing), notes: Acid reflux; "Acquired hallux rigidus" (unspecified if ongoing), notes: Acquired hallux rigidus; "Insomnia" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Known allergies: Dairy" (unspecified if ongoing), notes: Known allergies: Dairy. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]; LISINOPRIL. Past drug history included: Meloxicam, reaction(s): "Known allergies: Meloxicam"; Morphine, reaction(s): "Known allergies: Morphine"; Drysol, reaction(s): "Known allergies: Drysol"; Androderm, reaction(s): "Known allergies: Androderm". Patient reported that prior to vaccination he was not diagnosed with Covid 19 but since the vaccination he was tested for Covid 19. It was also reported that patient did not received any other vaccine within 4 weeks prior to the Covid vaccine. Reporter reported that Sudden instantaneous sensorineural hearing loss in right ear on 14Apr2021 with no concurrent accident, injury or illness. Sudden instantaneous sensorineural hearing loss in left ear on 03May also with no concurrent accidents, injuries or illnesses. Patient received medications within 2 weeks of vaccination is Nexium, Lisinopril.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 14Jan2022, outcome "unknown" and all described as "Covid test result=Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Jan2022) positive, notes: covid test type post vaccination=Nasal Swab.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available
Rec'd vaccine on 10-23; on 10-24, arm became very sore and was painful to move; on 10-25, lymph nodes in (L) axilla became swollen and painful, site began having body aches, chills, fever, headache, sore throat; sxs lasted until 11-1; did not see MD.
Information has been received from a lawyer regarding a case in litigation concerning a male 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, a pharmacist, recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-MAR-2013, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 14-JAN-2017, the patient was treated by a physician 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 (dates unknown), 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.
Sore arm beginning the day after the injection and lasted for 2 days.  A second side effect occurred on January 6 - a swollen lymph node under my left arm, which was not the injection arm.  However, I had lymph nodes removed due to breast cancer in 2001..  Lymph node is normal on January 9.
Left arm induration, red/hot 1" at injection site worsened by day 9 to 3" diameter with itching and radiation of pain/itching to left inner aspect and chest.  Day 10 was the worse and then started to improve.  No SOB or breathing difficulties.  No hives reported.  No other symptoms.    Telehealth visit with her personal provider - who is reluctant to advise 2nd dose.
Booster; Off label use; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198), on 25Mar2021 as dose 2, single (Lot number: ER8730), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Inflammatory Polyarthropathy" (unspecified if ongoing), notes: Inflammatory Polyarthropathy; "Interchange of vaccine" (unspecified if ongoing), notes: vaccine brand other=Moderna, vaccine lot number=Moderna 002M21A, vaccine dose number=4. Concomitant medication(s) included: HYDROXYCHLOROQUINE. The following information was reported: IMMUNISATION (medically significant) with onset 19Apr2022, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 19Apr2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162B2 to all the reported events cannot be completely excluded based on temporal association and known drug safety profile
COVID-19 symptoms started 06/29/22; tested positive 06/30/22. I had fatigue and it wasn't a red flag until that evening and I was tired and didn't sense that I had a temperature but I did and it was 102.4 which flabbergasted me. I decided then to test and it was negative and then the next morning I still had a temperature and didn't have any further symptoms and I tested positive for COVID-19. Along with that, I was having body aches, and lower back and knees were more pronounced. The throat was involved a little but I wouldn't exactly call it a sore throat, but I did develop a dry cough. As per doctor phone call when I tested positive, I started PAXLOVID on the 30th so now anything that I would have as a symptom could have been related to the PAXLOVID. I had a metallic taste in mouth after and that continue throughout the dosing period and as soon as I stopped PAXLOVID that funny taste was gone maybe within the next 12 hours. As far as eating, I would want to eat something but after I would eat I would feel extremely full so that I didn't want to think about eating for the next 7-8 hours. Whether that was still COVID-19 or PAXLOVID is a big question. That fullness has since passed and when I stopped PAXLOVID that situation improved a great deal. I had some weight loss but it was minimal and my weight is back up. Since then I no longer have a dry cough and close to day 10 I started having runny nose, tickle in throat, and one of my thought was this was the rebound because of taking the PAXLOVID. I tested myself around day 9 and I was done with PAXLOVID at that point and I still tested positive that day. I didn't test myself until 07/13. I have this lingering sore throat effecting my voice so it's still with me and I don't think it's allergies. I've had no temperature this whole time. There is something about my taste and taste buds aren't where I'd like them to be and I think there's been slight improvement since it started (started on day 9 or 10). It's not complete loss of taste or smell but it has affected taste buds for sure.
Information has been received from a nurse concerning a 15 year old female patient who in March 2008, was vaccinated with the second dose of GARDASIL.  In May 2008, the patient called and told that she experienced knot on her upper right arm.  According to the nurse, it was documented in their file that second dose of GARDASIL was given on left arm of the patient.  At the time of the report, the patient was not recovered.  Additional information has been requested.
Headache, fever, chills, aching, abdominal pain ; 24 hours after dose 1 1/12 and  24 hours after dose 2 on 2/9.
If he can "relapse" back into the coronavirus (rebound); If he can "relapse" back into the coronavirus (rebound); 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 male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "If he can "relapse" back into the coronavirus (rebound)". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reported that they already have 3 doses of the Pfizer COVID-19 vaccine. During the call he mentioned that Pfizer should make a medication more effective and with less adverse effect. If he can "relapse" back into the coronavirus (rebound) after finishing the treatment, and if there are adverse effects reported from stopping the treatment abruptly. Ritonavir is an HIV-1 protease inhibitor but was not active against SARS-CoV-2 Mpro. Ritonavir inhibits the CYP3A-mediated metabolism of Nirmatrelvir, resulting in increased plasma concentrations of Nirmatrelvir.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mother of child stated early AM 11/2/11 child had fever 104 degrees, vomiting and seizures. Taken to physician. Physician told mom seizures due to quick rise in temp. Fever reduced with MOTRIN. Child better by PM of 11/2/11. Provider told mother to "space out" next vaccination series to see which vaccine might be the cause.
From telephone contact with reporter, it was stated that a 4 year old patient (3 of 3) received a Tripedia vaccination (date not specified).  sometime after vaccination, the patient developed swelling at the injection site Further information is requested.
Per ED note:  Patient here for possible allergic reaction.  Brought in by EMS.  Patient reports a history of asthma, last major symptoms were around age 10 or 11.  States that about an hour prior to calling EMS he had preemployment vaccinations.  Computer records indicate that these included anthrax, Japanese encephalitis, typhoid and yellow fever.  He was feeling normal before the vaccination but about an hour later he started to feel short of breath and had some vague right-sided chest discomfort.  EMS was called and noted that his oxygen sat was around 90% and that he was wheezing apparently.  They administered Solu-Medrol 125 mg, Benadryl 25 mg and a DuoNeb.  The shortness of breath and wheezing completely resolved.  Patient still describes some vague right-sided discomfort of the chest.  He has no other symptoms.  Denies any swelling of the lips, tongue, throat, difficulty breathing or swallowing.  No vomiting.  No nausea.  No history of similar reaction.  11:16 -patient evaluated after EMS arrival.  Sent here is 98-99% on room air.  Lung exam and rest of physical exam completely normal at this time.  We will continue to monitor.  Do not feel any new or other medication required at this time.  1323: Patient has been largely asymptomatic throughout ED course.  Sleeping most of the time.  He woke up now states he feels back to normal except he noticed that his upper back is a little bit itchy.  On exam the upper portion of his back has a few small urticarial lesions.  Nothing extensive and no others patches on his body.  Will give extra Benadryl and continue to observe.  1453: Patient rechecked and doing well.  No symptoms.  No itching.  No significant rash.  Patient has been observed here for several hours without significant changes or signs of anaphylaxis.  Will give prescriptions for prednisone, Benadryl, EpiPen, albuterol inhaler.  Patient instructed on use of the medications.  Patient to follow-up with PCM.  Also, I spoke with Dr. from allergy clinic.  We will follow-up as a routine consult for specific testing for allergy to vaccine components.  Nurse to list vaccines under his allergy list in the meantime.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 11th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th February 2019, 1 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The patient developed a rash that was later diagnosed as shingles outbreak. The reporter gave consent to follow up.
Systemic: Severe back spasms-Severe, Additional Details: Approximately 5 minutes post vaccination, patient was overcome with severe back pain due to a spasm, patient's pain resolved about 10-15 minutes after the start of incident. Patient was evaluated by EMS in store and refused to be taken to the hospital for further evaluation. Patient had history of back spasms, clots, and kidney transplant but stated this incident was one of the most painful ever. Did not report any issues post 1st dose.
Has not received a second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine prior to COVID happening).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-APR-2022 Reporter's comments: The pharmacist reported that, patient received his first dose of Shingrix prior to COVID happening and patient did not receive second dose of Shingrix vaccine. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Redness & cellulitis at immunization site. Clindamycin 300mg tid x7days Fexofenedine 30mg bid.
The pt received immunizations on 8/9/00. The mother returned with child on 8/11/00. The child had large, red whelps on body. Mom stated they came up the night of the vax, within a few hours post. The pt was treated with epinephrine, decadron, depo-medrol, atarax. Pt went to ER on 8/18/00 and received epinephrine and decadron, and returned to office. On 8/14/00, the child was sent to the ER for evaluation.
Child woke with redness on right side of face from hairline down to upper lip not passing midline and well demarcated, right eye was swollen and watering and child fussy with event.  Event lasted several minutes then faded spontaneously.  Incident reoccured after afternoon nap and again faded and then reoccured several minutes later and child was transported to physicians office.  Redness had faded by arrival at office but eye was still red and swollen.
Tachycardia-heart rate up to 140's.  Resolved with deep breathing and rest.  Physician notified-observe. Client denies "anxiety reaction".  Left after 30 minutes of observation with heart rate in the 90's.
arm was sore at the place/soreness in the arm around his injection site; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 31Jan2021 14:15 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Patient got the shot on 31Jan2021 at 1415 and everything was fine and it didn't hurt at all. Then this morning (01Feb2021) at 0600 - 0700 AM, he noticed his arm was sore at the place, also reported as soreness in the arm around his injection site. He was asking if he can take anything. He mentioned he has a bottle of acetaminophen and was asking if he can take it. The outcome of the event was unknown.   Information on about lot/batch number has been requested.