chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GONE FROM NORMAL TO NOT NORMAL/NOT LIKE BEFORE VACCINE; LOST ALMOST 50 POUNDS SINCE GETTING THE VACCINE GONE FROM 155 POUNDS TO 110 POUNDS; GASTROINTESTINAL SIDE EFFECTS; NOT BEEN WELL SINCE RECEIVING VACCINE; This spontaneous report received from a parent concerned a 28 year old male. The patient's weight was 110 kilograms, and height was 68 inches. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no known allergies and had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 14-OCT-2021 for covid-19 prophylaxis. Age at time of vaccination 28 years old. No concomitant medications were reported. On OCT-2021, the patient experienced not been well since receiving vaccine. On NOV-2021, the patient experienced gastrointestinal side effects. On 2022, Laboratory data included: Computerised tomogram abdomen showed clean, Endoscopy showed clean, and Esophagram showed clean. On an unspecified date, the patient experienced gone from normal to not normal/not like before vaccine, and lost almost 50 pounds since getting the vaccine gone from 155 pounds to 110 pounds. Laboratory data (dates unspecified) included: Weight lost from 155 pounds to 110 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gastrointestinal side effects, and the outcome of not been well since receiving vaccine, gone from normal to not normal/not like before vaccine and lost almost 50 pounds since getting the vaccine gone from 155 pounds to 110 pounds was not reported. This report was non-serious. This case is a duplicate of 20230147196. This case, from the same reporter is linked to 20230145585, 20230146610, 20230146524 and 20230146842.
A non-serious spontaneous report of administration of expired product was received from a registered nurse concerning a 34-month-old female who received FLUMIST.  Neither the patient's medical history nor concomitant medications were reported.   The patient received FLUMIST on 19-Feb-2009, which expired on 12-Feb-2009.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Heart palpitations severe headache, eyeballs pounding, dizzy, temp 102, glands swollen, neck pain, ears hurt, cough, sore throat,  pain in L & R arms, all over body aches & pains, nauseau, bad "paint" taste/smell (still ltd senses taste & smell from CoVid19 since 12/15/2020), tiredness/fatigue, chest pain (costochondritis)
This spontaneous report as received from a health professional refers to a 4 years old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient experienced nausea, vomiting, numbness and tingling. Stroke like symptoms caused patient's mother to report to Hospital.
Itchy; He did broke up hives; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration on 25Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cerebrovascular accident from an unknown date and unknown if ongoing, back pain from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; oxybutynin hydrochloride (OXYBUTYNIN HCL) taken for an unspecified indication, start and stop date were not reported;  (MORHINE SULPHATE ER) taken for an unspecified indication, start and stop date were not reported; ondansetron hydrochloride (EMITIVA) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported;  (MYBETRIQ) taken for an unspecified indication, start and stop date were not reported; lactulose (ENULOSE) taken for an unspecified indication, start and stop date were not reported; etoposide (ETOPOSIDE) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (DULOXETINE HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported; varenicline tartrate (CHANTIX) taken for an unspecified indication, start and stop date were not reported; diclofenac sodium (DICLOFENAC SODIUM) taken for an unspecified indication, start and stop date were not reported; ibandronate sodium (IBANDRONATE SODIUM) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported. Patient received Benadryl as treatment after the second dose of vaccination. The patient experienced itchy on an unspecified date, he did broke up hives on an unspecified date. The outcome of the events pruritus, urticaria was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Five days before I started showing symptoms, my wife started having severe symptoms. I used an at-home test. I started feeling a sore throat, sinus pressure, a little fever of 100 constant sneezing, nasal dripping and coughing, and body aches. With Paxlovid my symptoms got better. 5 days after my wife finished her Paxlovid and as I was finishing mine, my wife started developing a sinus infection. I was getting much better until 5 days later, and then I got the sinus infection. I was still testing positive during this second round.
Patient came in and received first shot on 1/18/21, received Pfizer lot # ek9231. After first shot patient experienced muscle weakness, headache, fatigue for up to 3 days after receiving first dose.  Patient has a history of medical conditions (currently on reclast). Recommended talking to PCP before receiving second shot and delayed second shot at this time until she talked to her PCP. Patient was worried about not being able to receive second dose if she waits, however confirmed she will be able to receive it.
Child began having symptoms of extreme fatigue, dizziness and frequent fainting. Over the course of a few months became so severe, she was taken out of school and put in a wheelchair for her own safety.
Upon vaccination the patient exhibited marked swelling and bleeding at the injection site.  The patient was monitored for signs/symptoms of allergic reaction.  The patient did not exhibit redness at the injection site, itching, or difficulty breathing.  The injection site swelling was most likely pooling of blood post arterial laceration.
Headache, Fever, Diarrhea, NauseaVomiting, Local symptoms: redness, swelling, tenderness. General Symptoms: Fatigue, sweating, chills, fever, headache, joint pains, muscle pains, nausea, vomiting x 2, diarrhea, swollen glands left arm pit. Narrative:
Patient started having small rash in area of shot the night of/day after vaccination and since then has started spreading across her body. She has started using benadryl but does not improve the reaction. Today is day 5 of symptom course. She is going to see urgent care for assistance.
Patient contracted COVID after being fully vaccinated - Shortness of breath, runny nose, congestion, dyspnea, cough, fatigue, myalgias
Patient's resting heart rate is normally 74, patient felt hot, lightheaded, and had a heart rate (as determined by EMS) of 144. Patient was transported to the hospital. Was confirmed to be a side effect due to the vaccine booster. Patient was also dehydrated, given 2 L of IV fluid. Patient had Moderna for all 3 doses. The booster was a half dose.
1hr p/vax t102 R, vomiting, high pitch scream all noc (6hr) sleeping only 15min in between not eat;inj site red & painful;APAP given;MD visit 18DEC96;
Firm/hard red bump that it is itchy around the injection site. It is growing. It was about the size of a pen tip and grew to nickel within a few hours and the size of a quarter within 30 min of  itching onset. It is still expanding in size, approximately 11 hrs after shot.
Area the following day way raised, bright red extended for 2 inches around site. Skin surface was raised about 1/4 inch. 2 days later rim of "color" extended 4 inches from site.
(5) hours after injection-severe swelling of entire rt. arm turned deep dark purple from shoulder to waist-severe flu symptoms-returned to pharmacy a few days later-very ill-unable to take prescribed medications. (12) days later-severe continued side effects-dizziness-numbness of rt. arm-throbbing at injection site-sharp headaches I decided to take photographs 12 days later.
Expired vaccine used/undergone a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/undergone a temperature excursion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/undergone a temperature excursion). On 04-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/undergone a temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up information received on 14 Jul 2021 event Description as reported and description to be coded were changed from Expired vaccine used to Expired vaccine used/undergone a temperature excursion
I woke and was feeling really bad, dry cough, fever, whole body aches, chills, runny nose. I went to the emergency room where I was tested for COVID-19, that came back positive. The emergency room doctor gave me monoclonal antibody therapy while I was there in the emergency room and told me to take Tylenol for any pain, discomfort and fever once I left yesterday. I do feel better than I did yesterday.
Large area of induration, redness and tenderness at site of injection that began 1 week after the dose, lasted about 2-3 days. No fevers, no systemic signs.
Moderate swelling and soreness at the injection site. I started feeling fatigued a few hours after the injection. And it continued through the next day. The swelling and soreness were one by the next day. No treatment was necessary.
Arm hurt, of course, and it was really weird; Head feels swooshy; Ears were clogged up; This is a spontaneous report from a contactable consumer received via medical information team. This consumer (patients friend) reported for a female patient (reporters girlfriend). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient's arm hurt and it was really weird, head felt swooshy and ears were clogged up. Reporter proceeded to share AE information regarding herself, her son, and her girlfriend. She said her "son's arm hurt, of course, and it was really weird. A day or two later her son said my head feels swooshy and his ears were clogged up. We thought it was water in his ears. Her girlfriend experienced the same thing". Caller asked about if the vaccine will protect her from the new variant. When asked which specific variant, she said "the big one, I think delta". She was responded that Pfizer-BioNTech COVID-19 Vaccine may not protect everyone. The Centers for Disease Control and Prevention (CDC) states that information about the characteristics of these variants is rapidly emerging. Scientists are working to learn more about how easily they spread, whether they could cause more severe illness, and whether currently authorized vaccines will protect people against them (Delta). So far, studies suggest that the current authorized vaccines work on the circulating variants. Scientists will continue to study these and other variants. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021863089 same reporter/drug/AE, different patient
severe vomiting, diarrhea, bad pain-severe, fever;h/a;sx began 4hr p/vax;all sx gone w/in 48hr;
right arm he has two fingers that have been numb for 3 weeks; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number and Expiry Date were not provided), via an unspecified route of administration, administered in Left arm on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Investigation Assessment was not provided. The Reporter was calling about the Pfizer covid vaccine. The patient had the vaccine on his left arm but his right arm, he has two fingers that have been numb for 3 weeks on an unspecified date. The second dose was supposed to be this Friday. The reporter asked, what should he do? Should he get the second dose? His doctor said to call Pfizer? The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
In August, 2000 and October, 2000, the pt received first and second doses of Lymerix. The pt recently discovered that she was pregnant. The date of the last menstrual period was 10/24/2000 and the estimated delivery date is 08/01/2001. As of 11/27/2000, the outcome of the pregnancy is ongoing.
High fever 102, chills, aches, lethery, headache, burning eyes, trouble concentrating, nausea
Information has been received from a 20 year old female with no pertinent medical history and no drug reactions or allergies who on 10-AUG-2010 was vaccinated in her upper left arm with a 0.5 ml dose of GARDASIL (Lot# unknown). There was no concomitant medication. The patient reported that on 10-AUG-2010, within 1 hour after receiving the GARDASIL, she started getting hives at the injection site. The patient also stated that she called her doctor and was told to take BENADRYL. 24 hours later the itching continued and the hives were still present. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from a medical assistant concerning the 20 year old female student with no illness at the time of vaccination and not pre-existing allergies, birth defects or medical conditions, who on 11-AUG-2010 (previous reported as 10-AUG-2010) at 11:30 am was vaccinated in her left deltoid with the second dose second (also reported first dose) of GARDASIL (Lot # 666929/0331Z). On 11-AUG-2010 (previous reported as 10-AUG-2010) at 12:00 pm the patient developed nausea, hives around injection side and down her left arm. The medical assistant reported that the patient took BENADRYL. On 12-AUG-2010, the patient still had hives. At the time of the report, the patient had not recovered. The medical assistant reported that patient's next injection due on 11-OCT-2010. It was noted that they left it up to the patient if she want to received next two injections. Follow-up information has been received from a medical assistant. On 08-OCT-2010 (also reported as 20-OCT-2010), the patient received the second dose of GARDASIL (lot# unknown). The patient did not have any reactions this time. On unspecified date, the patient recovered. No further information is available.
rash on legs and hands still active on 6-20-19 . taking  prednisone .
received Johnson and Johnson vaccine after receiving Moderna; interval of both vaccines is only 11 days; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 IMMUNISATION (received Johnson and Johnson vaccine after receiving Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of both vaccines is only 11 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced COVID-19 IMMUNISATION (received Johnson and Johnson vaccine after receiving Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of both vaccines is only 11 days). On 10-May-2021, COVID-19 IMMUNISATION (received Johnson and Johnson vaccine after receiving Moderna) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval of both vaccines is only 11 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Fever; she was dazed/she didn't feel good; Her arm was hurting; Sleepiness; sick; This is a spontaneous report from a contactable Nurse (patient's mother). A 17-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 30Jun2021 15:30 (at the age of 17-years-old) (Batch/Lot Number: EW0172) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient had been a healthy child, she had not ever had any problems. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). There was no AE(s) following prior vaccinations. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 09Jun2021 (at the age of 17-years-old) (Batch/Lot Number: EW0150) for COVID-19 immunisation and with the first dose she was aright. The patient was 17 years old and got the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine last day (30Jun2021) and was currently experiencing sleepiness and fever. With the first dose she was aright this second one was hitting her hard. She had came down with a fever and she was pretty much been sleeping all day. On 01Jul2021, morning at 4:30 AM, the patient got her mother up telling that her arm was hurting and that she didn't feel good after that mother gave her some Tylenol. She felt her and she was pretty warm so she gave her the couple Tylenol and they would go from there and she had been asleep ever since. The patient woke up at 4:30 AM this morning (01Jul2021) and it was hitting her hard, she woke up and the caller gave her Tylenol to break the fever. She confirms the fever started 01Jul2021. The fever seemed to have broken with the Tylenol but when she checked on her she was dazed, she had been sleeping all day she has never had her sleeping like this. When asked when sleepiness began she said, they all went to bed around 10 or 10:30 last night and her daughter had been asleep ever since then, it was ongoing. She had been a healthy child, she has not ever had any problems with her being sick. Her fever had improved but the sleepiness it seems had gotten worse. They wanted to know if sleepiness and fever are included among the commonly reported side effects after the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine. She wanted to know if that was a normal situation. They were referred to HCP. The AE(s) did not require a visit to: Emergency Room/Physician Office. There were no relevant tests and investigation assessment done. Outcome of the event fever was recovered on 01Jul2021, sleepiness was not recovered and other events was unknown.  Follow-up actions are needed. Further information has been requested.
This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. The patient's concurrent conditions included fibromyalgia. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient's arm that was vaccinated became swollen. The patient sought medical attention by contacting the pharmacist and she was advised to apply ice to the affected arm. The outcome of peripheral swelling was reported as not recovered. The causality between PNEUMOVAX 23 and peripheral swelling was not reported.
first dose of Shingrix sometime last year and has not yet received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix sometime last year).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Shingrix sometime last year and has not yet received a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27 June 2023 The reporter stated patient was around 80 something years old, exact age and initials not available at time of reporting. The pharmacist stated that the patient received first dose of Shingrix sometime last year and had not yet received a second dose.  The pharmacist did not know exact date of initial dose, or lot number / expiration date information.  The reporter consented to follow up.  Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.